***AFF*** 1AC Solvency DHHS is adequately ensuring private sector compliance with health privacy protection laws now Charles Ornstein (senior reporter for ProPublica covering health care and the pharmaceutical industry) March 20, 2015 “Despite A Wave Of Data Breaches, Fed Says Patient Privacy Isn't Dead” http://www.npr.org/sections/health-shots/2015/03/20/394116837/despite-a-wave-of-data-breachesfed-says-patient-privacy-isn-t-dead The task of investigating medical data breaches falls to the Office for Civil Rights, a small agency within the Department of Health and Human Services. Last month, ProPublica and NPR reported how, as the number of breaches has increased, the office infrequently uses its authority to fine organizations and health providers that fail to safeguard patient records. The office's director, Jocelyn Samuels, spoke Monday to health privacy and security experts gathered in Washington, D.C., for the National HIPAA Summit, named for the Health Insurance Portability and Accountability Act. After her talk, Samuels sat down with ProPublica to talk about the current state of health privacy. The conversation has been edited for length and clarity. Highlights are below; a fuller version is available on ProPublica's website. To start off with, the Anthem breach is still at the top of mind for so many people. Does this change the landscape in terms of health data breaches? We won't know until after we have investigated what the causes of the Anthem breach are or were, or whether there are concerns about HIPAA compliance. But I think that it illustrates both the increasing risks that exist in the cybersecurity space and the need for covered entities [health providers and others subject to HIPAA's requirements] to continue to update and evaluate their risk analyses to ensure that their risk management plans adequately anticipate all of the kinds of threats they may face. Since HIPAA was passed in 1996, how would you say the state of play has changed with respect to patient privacy and the security of records? The ability to access electronic health records is something that we obviously have clarified and expanded over time since HIPAA was enacted. And I anticipate that we will continue to evaluate the application of HIPAA standards to emerging issues, whether they are posed by new technology or new forms of risk that aren't being adequately addressed. From a macro perspective, we are seeing an explosion of new approaches to delivering health care, to treating patients, to sharing information. And that changes on an exceptionally rapid basis, and so ensuring that we are providing adequate guidance about how HIPAA applies and what the standards are in these new environments is something that's a high priority. Some people have suggested that the notion of patient privacy is sort of outmoded and that you really don't have privacy anymore. Do you accept that? No. I think that you are talking about some of the most intimate facts about any individual, whether it is their health condition or their diagnosis or their treatment choices, and that it is really critical to ensure that they feel confident that that information will be protected from public disclosure. That's the underlying premise of patient involvement in health care decisionmaking, that they can entrust their providers with this really intimate information knowing that it won't be misused or inappropriately disclosed. Although there are new threats and cybercriminals get smarter every day, we have to do our best to keep up and ensure that there are adequate protections in place so that we can gain the benefits that technology and delivery system reform are promising. Your office has the ability to issue fines in ways that a lot of federal agencies can't and in denominations that a lot of federal agencies can't. You've noted that you used them about two dozen times. Is that enough? You know, each case depends on its facts and I do think that we have been committed to using settlement agreements and monetary recoveries in situations where we think that the conduct has been egregious or where we want to create a deterrent or where we feel that the monetary settlement will help to reinforce the message that we're serious about HIPAA compliance. That said, we are very serious about HIPAA compliance even in situations where we don't seek monetary settlements or civil money penalties. And I think if you look at our corrective action plans [agreements in which providers promise to make changes following a complaint], you will see that those are uniformly robust efforts to ensure that covered entities and business associates undertake the infrastructure and structural reforms that are necessary to ensure compliance going forward. But, emergent public health surveillance models will create invasive privacy violations and dragnet health data collection by the federal government - Applying strict scrutiny solves. The plan forces the government to narrowly tailor surveillance to further a compelling government interest – creates a consent-based model that stems overreaching medical surveillance Margaret Hoppin (J.D., New York University School of Law, licensed attorney for the District Court For The Southern District Of New York) 2012 “OVERLY INTIMATE SURVEILLANCE: WHY EMERGENT PUBLIC HEALTH SURVEILLANCE PROGRAMS DESERVE STRICT SCRUTINY UNDER THE FOURTEENTH AMENDMENT” http://www.nyulawreview.org/sites/default/files/pdf/NYULawReview-87-6-Hoppin.pdf C. Strict Scrutiny Should Apply So far, this Note has suggested in part that emergent public health surveillance programs invade an extremely important personal privacy interest. Courts can and should recognize that privacy interest as “fundamental” for purposes of the Fourteenth Amendment. Accordingly, constitutional challenges to emergent public health surveillance should be analyzed under a strict scrutiny standard.164 Courts can apply a strict scrutiny standard because, contrary to commentators’ widespread assumption, a deferential standard of review need not apply in the context of emergent public health surveillance programs. No court has considered the privacy implications of programs like the A1C Registry,165 and the few relevant precedents leave room to adjust Fourteenth Amendment analysis as public health surveillance develops (much as courts have adjusted Fourth Amendment analysis in response to developments in security surveillance).166 Courts should do so for at least two reasons. First, the personal privacy interest at stake satisfies existing tests for a “fundamental” right. Second, emergent programs are likely to involve ongoing and increasingly comprehensive surveillance and analysis of a wide range of personal behaviors. If the interest at stake in emergent programs is not recognized as “fundamental,” it is difficult to imagine that Fourteenth Amendment protection would apply at all to personal privacy outside of the subject matter domains already specifically identified by courts. The precise method for determining that a right is “fundamental”—and therefore protected under the Due Process Clause of the Fourteenth Amendment—is somewhat obscure.167 Courts and commentators have suggested that the confusion arises in part because the Supreme Court employs at least two different tests.168 In Washington v. Glucksberg, 169 the Supreme Court emphasized the importance of historical practice and national tradition.170 Since Glucksberg, courts have usually asked whether the purportedly fundamental right is “deeply rooted in this Nation’s history and tradition”171 to determine whether it is fundamental for the purposes of the Fourteenth Amendment.172 The first task of a court applying any test is to characterize the purportedly fundamental interest at stake.173 Emergent public health surveillance programs present an interesting challenge to doing so, because they employ new and evolving technologies. As a result, there is not a readily available concept of the privacy interest actually or potentially invaded, or a consensus about why it is important. What is clear is that the surveillance at issue in emergent public health surveillance verges on comprehensive in both depth and breadth. Given the methods of surveillance and the nature of the health conditions likely to be targeted, emergent programs may involve the lifetime collection of information about the behaviors and habits of millions of people. Such surveillance invades an area of personal privacy that previously challenged programs did not, and it does so on an unprecedented scale. In addition, there are some jurisprudential indications that a new—and constitutionally significant—privacy interest is at stake. Courts are currently grappling with the implications for Fourth Amendment jurisprudence of both continuous surveillance and sophisticated data analysis capabilities.174 A number of courts have concluded that continuous government surveillance of public movements has constitutional significance, even though episodic or shortterm gathering of the same information does not.175 However, even while affirming that there is an important difference between the privacy interest invaded by information-gathering that is limited in duration or frequency, and the privacy interest invaded by the continuous gathering of similar information, courts have generally not explained what it is.176 Fortunately, a precise definition of the interest invaded by emergent programs is not required: A fundamental right to personal privacy is deeply rooted in this country’s history and tradition. A complete account of legal and cultural protections for personal privacy is far beyond the scope of this paper, but two examples are particularly worth noting. First, the history of Fourth Amendment jurisprudence demonstrates that the “most sacred of all areas . . . is the home,” not because “it is a physical structure in which someone chooses to live,” but because there is a societal consensus that people have “virtually unlimited expectations of privacy from intrusions” into their homes.177 A cursory review of Supreme Court cases suggests that we protect the “home” at least in part because it serves as a proxy for personal privacy.178 Scholars have made the same observation.179 Moreover, robust Fourth Amendment protection of the home is a product of a deep national commitment to preventing government incursions upon personal privacy that dates to the founding era.180 Second—and also relevant in the context of emergent public health surveillance programs—there is a clear history of judicial and legislative protections against nonconsensual disclosures of medical information.181 Fourth Amendment jurisprudence and commentary on security surveillance programs identify features of modern government surveillance that (i) raise serious concerns about the nature of the privacy invasion, and (ii) in some cases have prompted courts to expand the scope of corresponding constitutional privacy protections. The similar- ities between emergent public health surveillance and security surveillance provide an additional indication that emergent programs may necessitate heightened constitutional privacy protections. Recognizing that the privacy interest at stake is fundamental would trigger strict scrutiny, under which a reviewing court would inquire whether the challenged surveillance program was narrowly tailored to further a compelling government interest.182 In one sense, the proposed analysis would not depart from past practice. Arguably, the public health surveillance programs reviewed by courts to date have not involved a fundamental privacy interest, due to technological limits on the breadth and depth of surveillance, the type of information collected, or program design. In particular, most public health surveillance programs, such as those that involve anonymized or consensual data collection, do not intrude upon a fundamental privacy right at all. In addition, the strict scrutiny analysis may be satisfied when the surveillance model at the heart of emergent programs—ongoing, intimate, and individualized surveillance —targets people with a highly infectious disease in order to prevent the disease from spreading. The critical question is whether emergent surveillance programs satisfy the narrow tailoring requirement of a strict scrutiny analysis. Part III describes one approach to finding an answer. III ESSENTIAL FEATURES OF A STRICT SCRUTINY ANALYSIS In Part A, I argue that a court reviewing an emergent public health surveillance program under a strict scrutiny standard should focus its narrow tailoring analysis on the efficacy of the public health interventions enabled by the challenged surveillance program. Many public health activities would satisfy a stringent efficacy requirement. However, two kinds of interventions should not: those that are effectively indistinguishable from surveillance and, in the case of noncontagious, non-exposure related disease, those that are unlikely to improve the health of the individuals surveilled. In Part B, I analyze the A1C Registry and conclude that it probably does not survive a narrow tailoring analysis because it likely cannot enable more than de minimis health improvements for diabetics. I propose several ways the program can be changed to comport with the proposed Fourteenth Amendment requirements. A. Efficacy of Government Intervention Strict scrutiny requires that an emergent public health surveillance program that infringes upon a fundamental right to privacy be narrowly tailored to achieve a compelling government purpose. Emergent public health surveillance programs would likely survive a strict scrutiny analysis in many contexts, like serious infectious disease and exposure investigations.183 Assuming that governments have a compelling interest in combatting widespread and costly chronic conditions, the critical question is whether a particular emergent public health surveillance program is narrowly tailored to meet that interest. The principal requirement of a narrow tailoring analysis is that the government intrusion “must be necessary in order to be justified.”184 The Supreme Court articulates the standard as a requirement that “the government’s chosen means be ‘the least restrictive alternative’ that would achieve its goals.”185 In the context of public health programs, asking whether surveillance is “necessary” should mean—at a minimum—asking whether the surveillance enables the government to improve the public health. Accordingly, to evaluate the constitutional status of emergent public health surveillance programs, courts should consider whether those programs enable public health interventions that are more than minimally effective. Surveillance that targets individuals with non-communicable health conditions but does not enable interventions that improve the health of the surveilled individuals does not advance the government’s public health goals. By the same token, emergent public health surveillance programs are not the “least restrictive alternative” available if equally or more effective public health measures can be implemented without comprehensive, individually-identified data.186 Under the proposed narrow tailoring analysis, a government would have a compelling interest in fighting the “obesity epidemic” but an emergent public health surveillance model would be appropriate only if it enabled interventions that improved health or mitigated risk for the individuals surveilled.187 Historically, there was no need to make explicit an efficacy requirement for public health surveillance programs, because governments can and have effectively combatted the spread of serious communicable disease. Quarantine and other restrictions may be draconian, but at least they work.188 As government broadened public health surveillance to include non-infectious disease, it generally did not engage in extreme invasions of privacy, and it generally conducted anonymous statistical surveillance only.189 By contrast, emergent public health surveillance, which in many ways replicates the model deployed to combat infectious diseases like tuberculosis, and which targets diseases that are not communicable or exposure-related, raises novel constitutional concerns about public health surveillance. Diabetes is not infectious; neither is obesity, nor are obesityrelated chronic conditions. There are no individually-targeted interventions that can stop a chronic condition from “spreading.”190 In addition, there is no single action that fixes or dramatically improves the affected individual’s health status. Instead, secondary prevention (preventing a condition for which one is at risk) and tertiary prevention (avoiding complications from a condition) both require lifetime effort by the individuals whose health is at risk.191 For many chronic conditions, that effort is directed to mundane, but personal, decisions about behavior and lifestyle—what to eat, how much stress to accept in jobs or personal life, how much to exercise, and what proportion of limited time and energy to devote to health management. Accordingly, with respect to noncommunicable, non-exposure related health conditions, two types of government public health activities should not be considered sufficiently effective to justify the privacy invasion inherent in the emergent public health surveillance model. First, activities that are essentially surveillance—like tracking diseases over time and evaluating the success of public health initiatives—provide no direct benefit to the individuals surveilled. Moreover, traditional models of public health surveillance can support disease tracking and program evaluation.192 Second, government interventions that target “lifestyle” conditions should be viewed skeptically under an efficacy standard because—as supporters of the emergent public health model frequently argue—“a person’s own behavior is often the root cause of [obesity and obesity-related conditions like diabetes].”193 It is almost a platitude to say that human habits are hard to change, even when the human involved desperately wants to change them. With respect to diabetes, a comprehensive review of diabetes research and literature published between 1985 and 2001 revealed that “simply improving the person’s level of knowledge rarely, if ever, led to the type [of] behavior changes necessary to manage the disease effectively.”194 The public health and medical communities have not yet found a way to induce the kinds of behavioral changes needed both to reduce the impact of obesity, diabetes and other chronic conditions, and to rein in escalating health care costs.195 B. Application: Why the A1C Registry Likely Fails Strict Scrutiny Most commentators assume that a rational basis standard of review would apply to New York City’s A1C Registry,196 and accordingly predict that the program would survive a constitutional challenge.197 However, applying the strict scrutiny analysis outlined in Part A suggests that the A1C Registry may effect an unconstitutional invasion of privacy. New York City government has a compelling interest in preventing both diabetes and diabetes-related complications. The problem is that the A1C’s surveillance model does not enable sufficiently effective interventions.198 The Department has explained why it believes the A1C Registry is valuable,199 but its explanation is far from satisfactory. The Department’s public statements suggest that comprehensive, individualized data is the primary value of the A1C Registry, because it currently enables the government to deliver “feedback” and may enable the government to deliver useful services.200 In addition, the Department believes the existing A1C Registry interventions can improve patient health outcomes.201 According to the Department, “[p]ersonal identifiers are essential to enable both accurate surveillance” and communication with health care providers about individual patients.202 The Department also emphasizes the severity of the diabetes “epidemic,” which it argues “warrants an urgent public health response.”203 The A1C Registry interventions likely do have some value. The patient letters204 inform by telling people that their blood sugar is poorly managed, by explaining that high blood sugars have adverse health consequences, and by advising diabetics to get regular medical care.205 However, there are at least two reasons why informing patients in this manner should not be considered sufficiently effective to justify the surveillance component of the A1C Registry. First, the City government is not the best entity to inform diabetics of their health status and its associated risks. One alternative is community health providers, which have the significant advantages of (i) interacting with patients under normal conditions of confidentiality and (ideally) trust, and (ii) being far better situated to connect patients with resources that may help in each individual case.206 More fundamentally, the ravages of uncontrolled diabetes are common knowledge in the communities most heavily impacted by the disease, even if the quantified risk level associated with each A1C test result is not.207 Second, the benefit of an unsolicited letter stating that the recipient is unhealthy seems dubious at best. After all, far more resourceintensive programs intended to help willing diabetic participants make needed lifestyle changes have achieved very modest and short-lived success.208 The letters to health care providers identifying at-risk patients are arguably more valuable. But again, how valuable? Improving the health outcomes of a diabetic requires at least the following additional steps: (i) the doctor contacts the patient, (ii) the patient visits the doctor, and (iii) the patient implements the doctor’s recommendations. The diabetics who testified at the Department’s 2005 hearing strongly contested the utility of provider letters.209 Increasingly, health care providers also recognize that the principal obstacles to successful diabetes management are practical, not informational. Accordingly, some experts have called for a new approach to treating diabetes, which emphasizes identifying and resolving the practical barriers that prevent each individual diabetic from making needed behavioral changes.210 Easy modifications to the surveillance component of the A1C Registry surveillance would remove doubt about its constitutional status. For example, the program could be consent based, like Vermont’s diabetes registry.211 Consent would remove privacy concerns; in addition, people who opt in to the program are presumably indicating that they would benefit from reminders about their health status. Alternatively (or additionally), the A1C Registry could identify patients by community or health center, instead of by name and personal information. That method would enable city government to direct resources to the communities that need them most. Advocates of the A1C Registry describe diabetes in New York City as a public health crisis, a financial crisis, and “a raging epidemic.”212 The rhetoric used by public health officials legitimately concerned about the physical and financial tolls of chronic disease has been useful in bringing public attention to the destructive power of conditions that often seem mundane and undramatic.213 But the rhetoric is also profoundly misleading.214 Those who use the word “epidemic” argue that diabetes is so like an infectious disease that it should be treated as one.215 But diabetes is like an infectious disease only in the sense that it is widespread and increasingly prevalent. Unlike infectious disease, it cannot be “stopped” by government intervention in the lives of people who have it.216 Proponents also cite the cost of chronic disease and related complications as a justification for emergent public health surveillance.217 That argument implies, without explaining, that financial crisis—as opposed to a direct threat to the public health—justifies intimate medical privacy intrusions. Coupling the rhetoric of “crisis” with a call for government action suggests that government action can effectively address the crisis. My limited claim here is that the A1C Registry’s model of ongoing, comprehensive, and individualized surveillance may not enable government interventions that sufficiently mitigate risk to the City’s diabetics. CONCLUSION Emergent public health surveillance programs adopt a surveillance model that was developed in the context of infectious disease and apply it to non-communicable health conditions. But the original justification for the extreme privacy invasions at the heart of individualized surveillance no longer applies. In addition, the emergent public health surveillance model shares three features with security surveillance, all of which have been identified as sources of troubling privacy invasions, and at least one of which is changing Fourth Amendment analysis. Courts should recognize that diabetes, obesity, and other chronic conditions that threaten the public health implicate highly personal information, including sensitive medical data and a wide array of personal behaviors. As a result, ongoing, name-based surveillance of populations with those conditions effects an extremely intimate privacy invasion. Applying strict scrutiny to emergent public health surveillance programs would permit those invasions only to the extent necessary to successfully mitigate the risk from diabetes and other chronic diseases. The result of a balanced strict scrutiny standard is flexible - privacy regulation and oversight – federal implementation is key Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 In addition, where we do have information about local procedures, it is clear that there remains significant variation in the use of this tool.293 Furthermore, it is also difficult to design an effective regulatory scheme in this context because the technology itself is evolving and because our understanding of whether forensic DNA profiles may ultimately be used to predict behavioral traits remains limited.294 As such, any proposed regulations should be flexible. With these limitations in mind, this Section outlines five substantive regulations that should be adopted to oversee the use of local databases. Two scholars have previously proposed regulations that would severely curtail law enforcement’s use of these databases. For example, Professor Elizabeth Joh has proposed that law enforcement should be required to obtain a “warrant whenever police seek abandoned DNA from a targeted person.”295 Professor Wayne Logan has gone further, recommending that the “government should be barred from using identity evidence secured from a lawful arrestee for any purpose other than identity verification.”296 The recommendations offered below would not go as far. However, they would help limit many of the potential negative implications of local databases while at the same time leaving sufficient room for law enforcement to expand its use of DNA to high-volume crimes. 1. Requiring Adequate Record Keeping Maintaining adequate and accurate records is crucial to regulating law enforcement’s use of local databases.297 Agencies using local databases should be required to record aggregate data regarding the DNA profiles in their databases. This information should include the percentage of DNA profiles from known individuals versus profiles derived from crime-scene evidence. Furthermore, the DNA profiles from known individuals should be further disaggregated. For example, regulations should mandate the collection of information regarding whether the known profiles were collected by consent, from abandoned biological material, or surreptitiously. Law enforcement should also be required to collect information regarding the sources of the known DNA profiles. That is, was the profile generated from a suspect, a victim, a victim’s family member, or a witness? Finally, regulations should require the collection of data on the age, race, and gender of the individuals whose profiles are in local databases. In addition to collecting this aggregate data, law enforcement should be required to track these same categories for each individual officer who collects reference samples. Finally, this data should be recorded in a manner that makes it readily accessible. If law enforcement is not required to collect this information, it will be difficult to monitor whether local databases are utilized in a fair manner and if their burdens are sufficiently distributed.298 This is particularly true because law enforcement officials have considerable discretion in who they target.299 For example, it would be important to know if a law enforcement agency only collects abandoned DNA samples from young men of color. It would also be helpful to know if an individual officer’s practices follow the same pattern.300 Without this information we will not be able to reliably measure the extent of several of the potential negative consequences identified in Part II. 2. Regulating Consent As is demonstrated in Part I.B., law enforcement’s use of local databases is dependent on collecting consensual samples from known individuals. In particular, local databases are different from CODIS because they often include profiles from people police have identified as suspects or potential future suspects. The reliance on consensual samples as opposed to legally coerced samples—e.g., from arrestees or convicted individuals— renders it important for regulations to address under what circumstances law enforcement should be able to request a consensual sample. Regulations should also help to ensure that consent is voluntary. In the absence of regulation, law enforcement can approach anyone and request a consensual DNA sample for inclusion in its local database. Furthermore, no external regulation requires that law enforcement disclose to the targeted individual its plan to add the profile to the local database. Without regulation, there are only two things limiting law enforcement’s ability to request a sample from every person police encounter. First, despite the fact that DNA processing is significantly less expensive than it was even five years ago, it is still economically prohibitive to develop DNA profiles from everyone willing to submit samples. Second, and in part motivated by those costs, some agencies have adopted minimal internal regulations to limit from whom they seek reference samples.301 However, these limitations will ease as the cost of DNA processing declines. As a result, it is reasonable to consider whether law enforcement should face limits on seeking consensual DNA samples. Privacy scholars often frame this question as whether one has a right to be left alone.302 Courts have addressed this issue in regulating police-citizen encounters. For example, New York courts have identified a common law right that provides more protection than the Fourth Amendment to limit law enforcement’s ability to initiate consensual searches. In short, “[b]efore the police may stop a person pursuant to [law enforcement’s] common law right to inquire there must exist at that moment a founded suspicion that criminal activity is present.”303 In People v. Hollman, New York’s highest court applied this right in reversing a narcotics conviction that resulted from narcotics found after a citizen consented to the search of his bag.304 The court held that the undercover officer did not possess sufficient suspicion even to seek consent to search the bag.305 Admittedly, the protection offered by Hollman is limited. It would not prevent officers from seeking consensual DNA samples from individuals for whom police possessed a reason to stop.306 Furthermore, the Supreme Court’s holding in Whren would seem to permit pretextual stops designed to give police an opportunity to seek consensual DNA samples.307 However, recognizing a minimal right to be free from law enforcement’s request for a consensual sample—which is often an inherently coercive interaction given the imbalance of power between law enforcement and the target—would limit law enforcement’s discretion to some degree. Independent of whether law enforcement should be prohibited from seeking consensual DNA samples without limitation, whenever seeking samples by consent, law enforcement should at least be required to disclose its plans for the sample. If those plans include adding the profile to law enforcement’s database, then that should be made clear. Such a requirement would help ensure that the consent was truly voluntary. 3. Prohibiting the Inclusion of Victim DNA Profiles Regulations should prohibit local law enforcement from including DNA profiles from victims in local databases. The practice of including victims’ profiles is driven by law enforcement’s presumption that there is often overlap between crime victims and perpetrators.308 Indeed, many law enforcement officials interviewed during this project repeated variations on the phrase, “Today’s victim is tomorrow’s perpetrator.” Without questioning the accuracy of this presumption, there remain many reasons to prohibit law enforcement from including victim profiles in local databases. Crime victims seek the assistance of law enforcement to remedy the wrong they faced. In the context of the property crimes that are often the focus of local databases, victims seek to recover their belongings, to obtain a police report needed to file an insurance claim, or simply to alert law enforcement that an offender has targeted them so as to help law enforcement identify patterns or develop leads. In reporting crimes to police, victims voluntarily give up some privacy. Reporting the crime may mean that law enforcement enters their home, takes a statement from them, talks to other potential witnesses, and, in some cases, collects a DNA sample for elimination purposes. To the extent that law enforcement turns the tables on a victim, making the victim the target of law enforcement’s broader investigative and surveillance activities, they undermine the justification for their initial intrusion. Collecting DNA samples from victims for inclusion in databases adds a significant cost to what victims must already bear when reporting a crime. Such a practice requires victims not only to submit to the immediate invasion of privacy that results from seeking law enforcement’s help, but it also requires victims to submit to a lifetime of genetic surveillance. This cost will undoubtedly cause some victims to avoid calling police. Others may reluctantly seek assistance from police, but they will remain dismayed that they were required to pay a genetic-surveillance tax in exchange for police assistance. 4. Time Limits for Suspect DNA Profile Retention Regulations should address how long law enforcement is able to retain DNA profiles in local databases. For example, if police collect a consensual sample from a 22year-old suspect that an officer stopped while walking down the street in a manner that caught the officer’s attention, that profile should be removed automatically from the database after five or 10 years if, during that period, the profile had not been matched to a crime-scene DNA profile. Such a regulation would at least cap what would otherwise have been a lifetime of genetic surveillance for the 22-year-old for simply appearing suspicious. Given the Supreme Court’s holding in Maryland v. King, in which it upheld the constitutionality of collecting DNA samples from arrestees,309 the time limit restrictions could be limited to samples collected from mere suspects, as opposed those arrested or convicted of crimes.310 5. Monitoring Use Regulations should also require adequate procedures to ensure that individual officers do not abuse the use of local databases.311 For example, the architect of Palm Bay’s database emphasized his stern warning that officers not use the database for personal snooping.312 But stern warnings are not enough. The infrastructure for local databases already includes the ability to monitor individual users. For example, SmallPond includes a feature called Audit Trail, which produces a record of every user interaction with the system, including which searches where performed and which DNA profiles were uploaded.313 Given that this tool is readily available, law enforcement agencies should be required to utilize it to help ensure against misuse.314 D. Implementing Reforms Despite the dearth of statutory or constitutional restrictions of local databases,315 there is reason to believe that the reforms outlined above could be adopted. Legislatures have demonstrated the ability to protect privacy interests in other settings, most notably demonstrating a remarkable nimbleness in quickly passing legislation regarding law enforcement’s use of drones.316 Additionally, the Court’s interpretation of the reach of the Fourth Amendment may evolve.317 Furthermore, the promise of at least some minimal external regulation is more likely given that some of the early adopters of local databases have indicated an openness to regulation.318 The most effective way to implement the reforms recommended in Part III.C. is through federal legislation. Given that federal laws already regulate law enforcement’s use of genetic surveillance in CODIS, there is precedent for federal regulation in this space. One obvious challenge to such regulation is ensuring that regulations are sufficiently flexible to allow law enforcement to continue using local databases while limiting the external costs discussed in Part II. The reforms offered here are designed to provide that flexibility. A new federal law could follow the statutory model used for CODIS. For example, current federal law requires states to certify their compliance with quality standards for DNA processing and with privacy protections for genetic information in order to qualify for participation in CODIS.319 A new, expanded law could require that in exchange for participation in CODIS, states certify that local databases in their jurisdictions follow the five reforms outlined above. There is good reason to expect that such a law would quickly cause states to comply.320 While local databases are expanding, states still value their participation in CODIS.321 Such a regulatory structure would also respect the ability of states to adopt stricter limits on the use of local databases.322 While a federal law would be most effective, there are other options to achieve some of the benefits of the reforms outlined in Part III.C. For example, each state could be encouraged to adopt a model statute that includes these reforms. The prospect of quick action by each state seems considerably less likely to occur without the stick of being excluded from CODIS that could be a part of federal regulation. However, Alaska, Vermont, and Washington have demonstrated that some states are capable of regulating local databases. In addition, there are options aside from legislation. Existing regulatory bodies could promote these reforms as best practices for local DNA databases. For example, the recently created National Commission on Forensic Science (“NCFS”), a joint project of the Department of Justice and the National Institute of Standards and Technology (“NIST”), describes part of its mission as “reduc[ing] fragmentation and improve[ing] federal coordination of forensic science.”323 Similarly, NIST’s newly-formed Organization of Scientific Area Committees (“OSACs”) represents another potential source for external regulation.324 Whereas the NCSF will outline broad policies, the OSACs are designed to adopt specific “standards and guidelines” for each forensic discipline.325 These organizations, which include national leaders from law enforcement, practice, and academia, are limited to adopting non-binding recommendations. However, even recommended procedures could be powerful forces to alter current practices. Federal government is key – they fund the development and management of local DNA databases – the plan restricts “its” domestic surveillance Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 3. Federal Funding Because local, non-CODIS databases are in some ways duplicative of CODIS, it is reasonable to presume that even if these databases had strong support from law enforcement officials, their expansion would be limited by cost-conscious local government officials not eager to fund them. This has not been the case, in part, because some local databases have been supported by federal, not local funds.65 It is ironic that after allocating such a significant amount of money to develop CODIS,66 the federal government is funding non-CODIS databases that are at least potential rivals to the CODIS network.67 More importantly, federal funding has allowed local agencies to bypass the local budget process and the limitations it imposes on other law enforcement surveillance techniques.68 The primary source of federal funding for local DNA databases are the federal forfeiture laws that return money to local law enforcement officials in exchange for their participation in federal task forces.69 These laws allow the Department of Justice to share the proceeds of the seized property with local agencies that “participated directly in the seizure or forfeiture of the property.”70 Local law enforcement agencies have come to depend on this revenue stream,71 and it has been crucial to the evolution of local DNA databases. For example, resources from federal forfeiture laws fully fund the local database in Bensalem Township,72 and local officials view this as a reliable source of funds for the foreseeable future.73 Without this revenue stream, it is unlikely that local databases would have developed as quickly as they have. 1AC Advantage – Health Surveillance The public is highly conscious of health privacy issues - but the pressure for access will be enormous – it is the historical cornerstone of doctor-patient confidentiality Alan Rubel (University of Wisconsin Law School Assistant Professor , Ph.D., Department of Philosophy, University of Wisconsin-Madison; J.D., magna cum laude) 2014 “Privacy, Surveillance, and Autonomy” p. 312 Introduction We all like at least some privacy, and there isn't much dispute that privacy in health and medical information matters. This is for a variety reasons. One is that support for privacy protections is strong; public opinion research consistently indicates that persons care deeply about health privacy. Another is that health privacy has significant historical roots, dating back to the provisions for physician—patient confidentiality in the Hippocratic Oath. The popular appeal and historical protections for health privacy make sense because privacy implicates important interests. Information about a person's health can be used to deny that person employment, financial, or other opportunities; and learning about a person's medical condition may lead others to define or view that person disproportionately in light of that condition. Accordingly, there are a variety of legal protections for health information privacy. In the U.S., these include the Health Insurance Portability and Accountability Act, the Genetic Information Nondiscrimination Act, and the Common Rule covering certain human subjects research. But the sheer usefulness of health information creates enormous pressure for access. Information about disease incidence aids in protecting public health; information about the behavior of patients is useful in providing care; information about drug prescribing and use can help in enforcing drugs laws; and many kinds of health information can serve as data for research. Health information can also be important for democratic governance: Health information may be relevant in determining candidates' fitness for public office, and government transparency may require that people have access to information about government-provided health services, even where that information contains individually identifiable information. Health surveillance expansion will be perceived - that will shatter trust and result in disengagement from the health care system Brase 13 (Twila Brase. President Citizen’s Council for Health Freedom. “Patient Privacy and Public Trust: How Health Surveillance Systems Are Undermining Both.” August 2013. P. 7. http://www.cchfreedom.org/pr/50%20States%20Databases%20Full%20Report.pdf)//EMerz Furthermore, in the future, health officials may use a patient’s private data to restrict certain access to care if medical records indicate a persistent unwillingness to submit to government-endorsed vaccinations, a history of unhealthy behaviors or ongoing engagement in unhealthy lifestyles, such as smoking, drug use, overeating, or a failure to exercise. For example, the Patient Protection and Affordable Care Act of 2010 (“Obamacare”) requires federal officials to gather outcomes data “from employers who provide employees with access to wellness programs.”254 As the public learns about government patient tracking and health surveillance, hospitals and clinics may be seen as intrusive arms of the government’s data collection process rather than caring and trusted institutions. Thus, government health surveillance through state and federal reporting mandates threatens to diminish patient trust and violates the freedom and privacy rights of all Americans. As government lays hold of the most private of individual data, patients may also lose access to the full realm of private medical choices. Their willingness to engage with the health care system may be limited by their unwillingness to give up their privacy rights. A 1999 study found 15 percent of Americans already engaged in privacyprotecting behaviors that compromise their access to timely and accurate medical care.2 Privacy protective behavior will wreck the entire medical system – the result if epistemologically and methodologically bankrupt medical decision-making – faulty data destroys the integrity of all medical research Goldman, from the College of Physicians and Surgeons, Columbia University, November 1998 – (Janlori, “Protecting Privacy To Improve Health Care”, published in HealthAffairs volume 17 number 6)//roetlin In many ways, the relationship between people and their doctors bears the greatest burden in the health privacy debate; this relationship is the “hot spot,” the originating point on the health information continuum. In this setting people are routinely asked to disclose detailed, sensitive information about themselves and their family members.4 They are beginning to understand, however, that the open-ende waivers for disclosure signed by patients as a condition of treatment and payment leave them vulnerable to a wide array of uses and reuses of their health information. In reaction, people are developing “privacy-protective” behavior to shield themselves from what they consider to be harmful and intrusive uses of their health information. To protect their privacy, patients may pay out-of-pocket for medical care, “doctor-hop” to avoid having all of their health information entrusted to one provider, withhold information, lie, or even avoid care altogether.5 The consequences of such “privacy-protective” behavior are significant:(1) The patient may receive poor-quality care, risking undetected and untreated conditions. (2) The doctor’s abilities to diagnose and treat accurately are jeopardized by a lack of complete and reliable information from the patient. (3) A doctor may skew diagnosis or treatment codes on claim forms, may keep separate records for internal uses only, or may send on incomplete information for claims processing, to encourage a patient to communicate more fully. (4) The integrity of the data flowing out of the doctor’s office may be undermined. The information the patient provides, as well as the resulting diagnosis and treatment, may be incomplete, inaccurate, and not fully representative of the patient’s care or health status. Ultimately, if doctors and other health care providers are receiving incomplete, inaccurate information from patients, the data they disclose for payment, research, public health reporting, outcomes analysis, and other purposes will carry the same vulnerabilities. In essence, information that lacks integrity at the front end will lack integrity and reliability as it moves through the health care system. Our solvency claim is reverse causal Pritts 13 (Joy L. Pritt. “The Importance and Value of Protecting the Privacy of Health Information: The Roles of the HIPAA Privacy Rule and the Common Rule in Health Research.” 2013. P. 6-8. http://iom.nationalacademies.org/~/media/Files/Activity%20Files/Research/HIPAAandResearch/PrittsPr ivacyFinalDraftweb.ashx)//EMerz If privacy is essentially having or being in a relatively personal space, it is difficult to think of an area more private than an individual’s health or medical information. Medical records can include some of the most intimate details about a person’s life. They document a patient’s physical and mental health, and can include information on social behaviors, personal relationships and financial status. It is hardly surprising that when surveyed, people consistently report that they are concerned about protecting the privacy and confidentiality of such personal information. In one recent survey, 67% of respondents said they were concerned about the privacy of their medical records, with ethnic and racial minorities showing the greatest concern. When presented the possibility that there would be a nationwide system of electronic medical records, 70% of respondents were concerned that sensitive personal medicalrecord information might be leaked because of weak data security, 69% expressed concern that there could be more sharing of medical information without the patient's knowledge and 69% were concerned that strong enough data security will not be installed in the new computer system. People have identified being in control of who could get information about them; being able to share confidential matters with someone they trust; and controlling what information is collected about them as three of the facets of privacy that were most important to them.39 Half of the respondents in a recent survey believed that “[P]atients have lost all control today over how their medical records are obtained and used by organizations outside the direct patient health care such as life insurers, employers, and government health agencies.” These public opinions about the “privacy” of health information reflect in a very real way the practical importance of privacy to members of the public. They desire control over and security and confidentiality of their health information. They want to know who is using their information and why. A significant portion of Americans are concerned enough about the privacy of their health information that they take matters into their own hands. In response to a recent California HealthCare Foundation survey, one out of eight respondents reported that they had engaged in a behavior intended to protect his or her privacy, including taking such actions as avoiding their regular doctor, asking their doctor not to record their health information or to “fudge” a diagnosis, paying out of pocket so as not to file an insurance claim and even avoiding care altogether.41 In very functional terms, adequately protecting the privacy of health information can help remedy these concerns and, hopefully, reduce this behavior. Ensuring privacy can promote more effective communication between physician and patient, which is essential for quality of care, enhanced autonomy, and preventing economic harm, embarrassment and discrimination.42 A number of studies suggest that the relative strength of confidentiality protections can play an important role in people’s decisions whether to seek or forgo treatment, particularly with respect to mental health and substance abuse. The willingness of a person to make self-disclosures necessary to such mental health and substance abuse treatment may decrease as the perceived negative consequences of a breach of confidentiality increase.44 Privacy or confidentiality is particularly important to adolescents who seek health care. When adolescents perceive that health services are not confidential, they report that they are less likely to seek care, particularly for reproductive health matters or substance abuse. These studies show that protecting the privacy of health information is essential to ensuring that individuals will obtain quality care. Protecting privacy is also seen by some as enhancing data quality for research and quality improvement initiatives. When individuals avoid health care or engage in other privacy protective behaviors, such as withholding information or doctor shopping, inaccurate and incomplete data is entered into the health care system. This data, which is subsequently used for research, public health reporting, and outcomes analysis carries with it the same vulnerabilities. Ensuring individuals that the privacy and confidentiality of health information will be protected should reduce these behaviors and result in more complete and accurate data for these research, public health and quality purposes. Protecting the confidentiality of health information also protects against the perceived and real potential for economic harm resulting from discrimination in health insurance and employment. Polls consistently show that people are most concerned about insurers and employers accessing their health information without their permission. This concern arises from fears about employer and insurer discrimination. Concerns about employer discrimination based on health information, in particular, increased 16% between 1999 and 2005 with 52% of respondents in the later survey expressing concern that their information might be seen by an employer and used to limit job opportunities. Reports of major employers such as Wal-Mart basing their hiring decisions on the health of applicants appear to justify these concerns. Studies focusing on genetic information show that individuals go to great lengths to keep their genetic information private and out of the hands of their insurers and employers. Even health care providers are affected by these concerns. In a survey of cancer-genetics specialists, more than half indicated that they would pay out of pocket rather than bill their insurance companies for genetic testing, for fear of genetic discrimination. While surveys do not reveal a significant percentage of individuals who have experienced such discrimination, geneticists have reported that approximately 550 individuals were refused employment, fired or denied life insurance based on their genetic constitution. In addition, studies in the United Kingdom suggested that while insurers in that country do not have a full grasp on the meaning of genetic information and do not assess or act in accord with the actuarial risks presented by the information. There is, therefore, some legitimate basis to individuals’ concerns about potential economic harm and the need to protect the privacy of their genetic information. In addition to these utilitarian reasons for protecting privacy, some privacy scholars emphasize the value of protecting the privacy of health information in its own right, seeing it as a fundamental human right.53 They believe that respecting privacy (and autonomy) is a form of recognition of the attributes that give humans their moral uniqueness. Thus, there are a variety of reasons, both concrete and perceived, functional and philosophical, for placing a high value on protecting the privacy, confidentiality and security of health information. We control the determining factor – high quality clinical trials are a pre-requisite to ANY quality research Sean Tunis (Centers for Medicare & Medicaid Services, Baltimore, Md) Daniel Stryer (Agency for Healthcare Research and Quality, Rockville, Md) and Carolyn Clancy (Agency for Healthcare Research and Quality, Rockville, Md) 2003 “Practical Clinical Trials” http://umassmed.edu/uploadedFiles/QHS/Content/Tunis%20article1.pdf The production of high-quality clinical trials will increase significantly when health care decision makers decide to consistently base their decisions on high-quality evidence. Research sponsors (public and private) will be motivated to provide the type of clinical research required by decision makers. Payers and purchasers can clearly indicate to the drug and device industry that favorable coverage and payment decisions will be expedited by reliable evidence from PCTs. In particular, manufacturers will be motivated to perform head-to-head comparative trials if these are required to justify payments higher than the existing less expensive alternatives. Physicians and medical professional organizations can also increase the degree to which care of individual patients and professional society clinical policy are guided by attention to reliable evidence. Patients and their advocacy organizations have a critical stake in the quality of clinical research. The fundamental premise of improving health care through informed patient choice cannot be realized if unreliable evidence is used to inform patients. Patient advocacy organizations should become more insistent on the production of highquality evidence and work with research funders to increase support for PCTs. These groups could also facilitate the research by encouraging patients, physicians, and health care organizations to participate in clinical trials in those situations for which current evidence is uncertain. Many years and lives could have been saved had advocates worked to ensure the rapid completion of clinical trials on bone marrow transplantation for breast cancer, instead of putting pressure on state and federal policymakers to force payers to cover this procedure when supportive high-quality data were lacking.58 Its vital for developing any effective new drugs Norrgard 8 – PhD, Department of Human Genetics at Virginia Commonwealth University (Karen, “Human Subjects and Diagnostic Genetic Testing,” Nature Education 1(1):82) There is a vital need for human subjects in research related to drug development, but can we properly balance the welfare of human research subjects with the need for experimental data? Medical and psychological studies involving human subjects remain a critical factor in advancing our scientific knowledge. Despite historical episodes of tragically unethical treatment of humans in the name of medical science, such as the Tuskegee study, the need for human subjects in biomedical research is vital for the development of any new drug. But how can we balance the welfare of human research subjects with the need for valuable data from human experimentation? Several solutions to this conundrum have been proposed, but none is without its flaws. Learning from the Tuskegee Study Sadly, there is a long history of the unethical treatment of human subjects in various types of medical and biological research. For example, one of the most notorious clinical studies of all time was initiated in 1932, with the goal of tracking the progression of untreated syphilis infection. At the time, treatments for syphilis included highly toxic mercury, bismuth, and arsenic-containing compounds of questionable effectiveness. The study was a collaboration between the Tuskegee Institute and the U.S. Public Health Service in Alabama, and was intended to determine the progression of the disease, the effectiveness of treatments at different stages, and modes of disease transmission. Doctors recruited 399 black men thought to have syphilis, as well as 201 healthy black men as controls. Study participants were kept unaware of their diagnosis of syphilis but, in return for participating in the study, the men were promised free medical treatment if they tested positive, rides to the clinic, meals, and burial insurance in case of death. The initial aim of the Tuskegee Study of Untreated Syphilis in the Negro Male, as it was known, was perfectly legitimate: to gather medical knowledge. However, during the mid-1940s, when penicillin had been shown to be a highly safe and effective cure for syphilis infection, the researchers did not abandon the study, but continued to subject their unwitting participants to painful complications and death due to syphilis infection until 1972, when a story about the study appeared in the national press. Public outcry caused an abrupt end to this research, followed by the filing of a class action lawsuit against the U.S. government on behalf of the survivors. In spite of the ethical dilemmas associated with the use of human subjects, no new drugs could ever be developed without thorough human testing to demonstrate their effectiveness; this process of testing is known as a clinical trial. Clinical trials occur at the end of the incredibly lengthy and expensive process of drug discovery. Only one of about every 5,000 screened substances that are originally synthesized or identified from natural products makes it through the clinical trial process and is approved as a new medicine (Pritchard, 2003). Only new research can keep up with disease evolution Cangelosi 5 – Prof of Environmental and Occupational Health Sciences and Adjunct Prof of Epidemiology and of Global Health at the University of Washington, PhD in Microbiology from UC Davis (Gerard A., Nancy E. Freitag, PhD, Prof in the Dept of Microbiology and Immunology at the University of Illinois Chicago School of Medicine, and Merry R. Buckley, Ph.D. in environmental microbiology at Michigan State University, “From Outside to Inside: Environmental Microorganisms as Human Pathogens,” http://academy.asm.org/index.php/environmental-microbiology-ecology-evolution/553from-outside-to-inside-environmental-microorganisms-as-human-pathogens) The key difference between environmental pathogens and other human pathogens is their ability to survive and thrive outside the host. Their widespread occurrence in the environment makes them difficult to monitor and control. Inroads have been made to understand the persistence of these organisms in the environment, the reservoirs they inhabit, the ways they exchange virulence factors, and their diversity, but a great deal more research is needed. By grouping together phylogenetically diverse organisms under the umbrella of "environmental pathogens," it is hoped that the topic can gain the critical mass needed for sustained progress. ¶ Colloquium participants examined other research needs for the field, including the diagnostic and environmental technologies that will be necessary for taking the next steps. It was agreed that because of the complex nature of studying organisms that can exist in the environment and in human hosts, work in this area is best carried out in an interdisciplinary fashion with coordinated input from medical, molecular, and environmental microbiologists, specialists in host responses, epidemiologists, ecologists, environmental engineers, and public health experts. The development of improved diagnostic techniques is critical for accurate assessment of health risks and potential human or animal population impact associated with environmental pathogens. ¶ If the impacts of these diseases are to be effectively controlled, the techniques used to monitor and control infections by environmental pathogens—including interventions, exposure controls, drugs, and vaccines— require improvement. The processes surrounding drug and vaccine development must be tailored to the special problem of environmental pathogens, which often strike small numbers of individuals or individuals in less developed areas of the world and, therefore, offer less potential for drug development profit than more common diseases. A challenge exists, therefore, in meeting the need for targeted, specific interventions, including development of drugs and vaccines for infections by environmental agents, in the face of a lack of financial incentive for development of these tools. Trust key to medical research advances Jacobs, 5 – MD; Boston University professor of medicine [Alice, director of Cardiac Catheterization Laboratory and Interventional Cardiology, "Rebuilding an Enduring Trust in Medicine," Circulation, 2005, circ.ahajournals.org/content/111/25/3494.full#xref-ref-3-1,] To be sure, we will learn about the emerging science and clinical practice of cardiovascular disease over the next four days. But there is an internal disease of the heart that confronts us as scientists, as physicians, and as healthcare professionals. It is a threat to us all—insidious and pervasive—and one that we unknowingly may spread. This threat is one of the most critical issues facing our profession today. How we address this problem will shape the future of medical care.¶ This issue is the erosion of trust.¶ Lack of trust is a barrier between our intellectual renewal and our ability to deliver this new knowledge to our research labs, to our offices, to the bedside of our patients, and to the public. Trust is a vital, unseen, and essential element in diagnosis, treatment, and healing. So it is fundamental that we understand what it is, why it’s important in medicine, its recent decline, and what we can all do to rebuild trust in our profession. Trust is intrinsic to the relationship between citizens around the world and the institutions that serve their needs: government, education, business, religion, and, most certainly, medicine.¶ Albert Einstein recognized the importance of trust when he said, “Every kind of peaceful cooperation among men is primarily based on mutual trust.”1 In our time, trust has been broken, abused, misplaced, and violated. The media have been replete with commentaries, citing stories of negligence, corruption, and betrayal by individuals and groups in the public and private sectors, from governments to corporations, from educational institutions to the Olympic Organizing Committee. These all are front-page news. Perhaps the most extreme example is terrorism, in which strangers use acts of violence to shatter trust and splinter society in an ongoing assault on our shared reverence for human life.¶ Unfortunately, we are not immune in our own sphere of cardiovascular medicine. The physician-investigator conflicts of interest concerning enrollment of patients in clinical trials, the focus on medical and nursing errors, the high-profile medical malpractice cases, the mandate to control the cost of health care in ways that may not be aligned with the best interest of the patient—all of these undermine trust in our profession. At this time, when more and more public and private institutions have fallen in public esteem, restoring trust in the healthcare professions will require that we understand the importance of trust and the implications of its absence.¶ Trust is intuitive confidence and a sense of comfort that comes from the belief that we can rely on an individual or organization to perform competently, responsibly, and in a manner considerate of our interests.2 It is dynamic, it is fragile, and it is vulnerable. Trust can be damaged, but it can be repaired and restored. It is praised where it is evident and acknowledged in every profession. Yet it is very difficult to define and quantify.¶ Trust is easier to understand than to measure. For us, trust may be particularly difficult to embrace because it is not a science. Few instruments have been designed to allow us to evaluate it with any scientific rigor. Yet, trust is inherent to our profession, precisely because patients turn to us in their most vulnerable moments, for knowledge about their health and disease. We know trust when we experience it: when we advise patients in need of highly technical procedures that are associated with increased risk or when we return from being away to learn that our patient who became ill waited for us to make a decision and to discuss their concerns, despite being surrounded by competent colleagues acting on our behalf.¶ Many thought leaders in the medical field understand the importance of trust.3 When asked whether the public health system could be overrun by public panic over SARS and bioterrorism, C enters for D isease C ontrol and Prevention Director Julie Gerberding replied, “You can manage people if they trust you. We’ve put a great deal of effort into improving state and local communications and scaled up our own public affairs capacity…we’re building credibility, competence and trust.”4¶ Former H ealth and H uman S ervices Secretary Donna Shalala also recognized the importance of trust when she said, “If we are to keep testing new med icine s and new approaches to curing disease, we cannot compromise the trust and willingness of patients to participate in clinical trials.”5¶ These seemingly intuitive concepts of the importance of trust in 21st century medicine actually have little foundation in our medical heritage. In fact, a review of the early history of medicine is astonishingly devoid of medical ethics. Even the Codes and Principles of Ethics of the American Medical Association, founded in 1847, required patients to place total trust in their physician’s judgment, to obey promptly, and to “entertain a just and enduring sense of value of the services rendered.”6 Such a bold assertion of the authority of the physician and the gratitude of the patient seems unimaginable today.¶ It was not until the early 1920s that role models such as Boston’s Richard Cabot linked patient-centered medical ethics with the best that scientific medicine had to offer,6 and Frances Weld Peabody, the first Director of the Thorndike Memorial Laboratory at the Boston City Hospital, crystallized the ethical obligation of the physician to his patient in his essay “The Care of the Patient.”7 In one particularly insightful passage, Peabody captures the essence of the two elements of the physician’s ethical obligation: He must know his professional business and he must trouble to know the patient well enough to draw conclusions, jointly with the patient, as to what actions are indeed in the patient’s best interest. He states: “The treatment of a disease may be entirely impersonal: The care of the patient must be completely personal. The significance between physician and patient cannot be too strongly emphasized, for in an extraordinarily large number of cases both diagnosis and treatment are directly dependent on it.” Truly, as Peabody said, “The secret to the care of the patient…is in caring for the patient.”7¶ This concept that links the quality of the physician-patient relationship to health outcomes has indeed stood the test of time. Trust has been shown to be important in its own right. It is essential to patients, in their willingness to seek care, their willingness to reveal sensitive information, their willingness to submit to treatment, and their willingness to follow recommendations. They must be willing for us to be able.\ of the intimate personal relationship A new outbreak can emerge at any time and have unimpeded virulence – it’s only a question of when [Roger Highfield director of external affairs at the Science Museum Group “Ebola Shows the World Is Primed for the Perfect Microbial Storm” 8/13 14] The deadly outbreak of Ebola, the largest in recorded history, comes as little surprise to scientists. In the light of recent research, expect to see more global public health emergencies, faster spreading scourges and more novel diseases. True enough, modern technology has brought us a range of extraordinary tools, from diagnostics to drugs to global, instantaneous communications. But the relentless rise of modern civilisation has also made the possibility of a pandemic greater than at any time in history. Emerging diseases that have devastating effects internationally, with millions infected and billions spent, are all foreseeable consequences of changes in the way we live our lives. This is not simply the price of our success in dominating the planet and its ecosystems but, importantly, of allowing so many of the planet's human inhabitants to live in poverty. The Ebola emergency reminds us that we now have the conditions for a perfect microbial storm. Most human infectious diseases originated in animals and, as human populations and their road networks expand, as we clear more land for agriculture, hunt for wildlife and trade more animals, they are coming into contact with more animal diseases, explains Angela McLean of Oxford University's Institute for Emerging Infections. Meanwhile, we are increasingly farming vast numbers of domestic animals that can provide reservoirs for existing bugs and fertile breeding grounds for new ones. There are also unprecedented opportunities for rapid spread, thanks to air travel, as in the current Ebola outbreak. The role of wild animals in the origin of novel diseases was laid bare in 2008 when Peter Daszak, now president of the EcoHealth Alliance, Kate Jones of the Institute of Zoology and University College London, and colleagues from Columbia University, New York, analysed 335 emerging diseases from 1940 to 2004. Maps which correlated disease with human population density, rainfall and wildlife biodiversity revealed that disease emergence events have roughly quadrupled over the past 50 years. Some 60% of the diseases spread from animals to humans – such diseases are called zoo-noses – and the majority of those came from wild creatures. The HIV/AIDS pandemic started from human contact with chimps and sooty mangabey monkeys; recent outbreaks of SARS (Severe acute respiratory syndrome) originated in Chinese bats; CJD (Creutzfeldt-Jakob disease) in cattle; and MERS (Middle East Respiratory Syndrome) to camels. The Zaïre subtype of the Ebola virus responsible for human outbreaks in Gabon and the Republic of the Congo was linked to the handling of the carcasses of great apes that in turn had been infected by fruit bats. The global map of emerging disease revealed the hotspots span sub-Saharan Africa, India and China, with smaller spots in Europe, and North and South America. They tend not to be in the richer countries in the North that can afford surveillance but in relatively impoverished areas such as the tropics, a region rich in wildlife species and under increasing human pressure, and in dense human populations, where one would expect them to take hold more easily. The risks are now worse than suggested in their 2008 study, says co-author Marc Levy, deputy director of the Center for International Earth Science Information Network at Columbia University in New York. They had assumed populations would fall faster than they have. Moreover, political violence and instability has "led to refugee flows and deliberate incursions into wild areas where rebels find timber, wildlife and minerals to finance their activities. In the case of Ebola, we have also seen that it is difficult to deal with effectively when public trust in a government is low". In 2010, another study also involving Jones and Daszak, showed that species losses in ecosystems spur rises in pathogens as we intrude into areas of high biodiversity. This is significant because current extinction rates are estimated at 100 to 1,000 times higher than in past epochs, and are projected to increase at least a thousand times more in the next 50 years. Medical innovation solves antibiotic resistance O’Neill 15 – Syndicate @ Guardian (Jim, “A call to antimicrobial arms,” February, The Guardian, http://www.theguardian.com/business/2015/feb/10/a-call-to-antimicrobial-arms) Resistant infections already claim more than 700,000 lives a year. Unless action is taken, antimicrobial resistance will kill 10 million people a year by 2050 – more than the number of people who currently die from cancer. It will also have a cumulative cost of at least $100tn, more than 1.5 times today’s annual global GDP. We are not doing nearly enough to combat this danger. The world urgently needs new drugs to replace the antibiotics, anti-malarial regimes, antiretroviral Aids and HIV medications, and tuberculosis treatments that are losing effectiveness. But we do not invest enough in research and development. It is critical that we find new sources of funding to support the academic researchers and small companies whose discoveries are laying the foundations for tomorrow’s medicines. That is why I In December, I reported the first findings of the Review on Antimicrobial Resistance, which I chair. The news wasn’t good: am calling on international donors – philanthropic and governmental alike – to work with the Review on Antimicrobial Resistance to create a new fund to support R&D in this important area. The fund will provide grants for blue-sky science and act as a non-profit incubator for promising discoveries. Over the coming months, the Review will be working out the details of how such a fund could operate effectively. The problem is straightforward: as valuable as scientific breakthroughs may be, it takes a lot of work to turn them into marketable drugs. And, because antibiotics generally produce low – and sometimes even negative – returns on investment for the pharmaceutical makers that develop them, many companies and venture capital funds steer clear. The Review is studying ways to align financial incentives for developing new antimicrobial drugs more closely with these medicines’ true social value. But time is of the essence. New drugs take decades to discover and develop. Even if we were to fix every problem in the development pipeline today, it would be at least another 10 years before the first new antibiotics became commercially available. In the coming months, the Review will make recommendations regarding market incentives for developing new antibiotics and searching for potential alternatives – such as vaccines – to the use of these drugs in agriculture. The Review will also highlight innovative approaches to addressing resistance. In its most recent paper, the Review has identified specific measures that could provide creation of the a starting point for the fight against antimicrobial resistance. The first is the innovation fund to support early research. In addition to providing money for efforts to develop new drugs, the fund should encourage research into diagnostic tools, basic research is where surveillance methods, techniques to slow the development of resistance, and social and economic studies of consumer behavior. This kind of medical innovation starts, and the sums involved need not be huge to make a significant difference. We should also invest more in the people who will solve the problem. Evidence seems to show that young scientists and doctors are reluctant to enter fields related to antimicrobial resistance. We need to nurture the next generation of academics, scientists, hospital workers, and pharmaceutical technicians. The impact is extinction Engelhardt 8 – PhD, MD, Professor of Philosophy @ Rice (Hugo, “Innovation and the Pharmaceutical Industry: Critical Reflections on the Virtues of Profit,” EBrary) The volume opens with Engelhardt's examination of the central place of the market, especially in liberal, secular, pluralist, limited democracies. As is argued, the market and the pursuit of profit have their central place by default and because of their cardinal benefits. First, the market is a cardinal place for peaceable cooperation in the face of moral disagreement. As Engelhardt argues, when moral strangers meet, the market, along with limited democracies and contracts, offers one of their major means for morally authoritative collaboration. Even when persons cannot agree about anything else, they can at least agree to buy and sell goods and services. This essay explores why the market and the pursuit of profit are not only a default mechanism for collaboration in a world marked by intractable moral controversy and diversity; it is also indispensable if one is interested in securing human survival and in decreasing morbidity and mortality risks. If the allure of profit drives innovation in the pharmaceutical and medical-device industry, then one should be concerned with any policies that limit profit in these industries as compared to others. Any attempt to curtail profit will likely lead not only to slower advances in the ability to lower morbidity and mortality risks, but it may as well threaten the capacity of humans to adapt to new microbial (such as multi-drug-resistant tuberculosis) and other threats. Critical concerns for policies that limit the profitability of the pharmaceutical and medical-device industries should also include a re-assessment of easily acquired, poorly grounded, and large liability judg-ments against the manufacturers of pharmaceuticals and medical devices. These concerns should also include a critical regard of policies that would limit profits through the breach of patents by developing countries. Such limitations will encourage virtuous stewards of invest-ment capital to avoid investing in the cure of diseases found primarily in such countries. The very character of human finitude places money, market and profit as central elements in the project of improving the human condition. 1AC Advantage – Genetic Surveillance States are circumventing status quo federal precedent and statutory law – huge expansion of genetic surveillance is coming now – oversight, regulations, and limiting federal budgetary authority are key Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 The past five years have seen a dramatic, and until now wholly unexamined, splintering of genetic surveillance by law enforcement. Investigators have shifted from using the FBI’s centralized, national DNA database network to a growing number of unregulated local databases.1 These databases operate outside the federal laws and rules that govern law enforcement’s use of the FBI’s national DNA database network. As a result of this regulatory void, police departments have pushed the boundaries of genetic surveillance, using this tool in ways not previously permitted.2 The aggressive use of local databases has helped police to increase clearance rates and decrease crime rates.3 But the story is not all positive. The expansion of this surveillance tool at the local level has unleashed significant negative forces that threaten privacy and dignity interests, exacerbate racial inequities in the criminal justice system, and undermine the legitimacy of law enforcement. This Article analyzes these costs and proposes reforms to minimize them while preserving law enforcement’s ability to use this tool on the local level. The Article is the first full-scale examination of these unregulated, local DNA databases. It is supported by original qualitative empirical research based on interviews with law enforcement officials, prosecutors, and representatives from the major firms developing these local databases. This Article makes three claims. First, cutting-edge genetic surveillance issues are playing out on the local level, free from federal regulation and, often, in the absence of state or local laws.4 Second, this Article responds to Professor Rachel Harmon’s challenge to scholars to help law enforcement establish “harm-efficient policing” practices by identifying and measuring external harms generated by policing that are not captured by law enforcement’s narrow focus on solving crime.5 In this sense, this Article is a case study in regulating law enforcement’s use of rapidly evolving surveillance technology. Third, contrary to the proposals of many scholars who have advocated for the devolution of power to the local level in the criminal justice system,6 this Article urges that national standards are needed to address the costs of genetic surveillance. The expansion of locally-controlled DNA databases follows two decades of federal oversight of law enforcement’s use of genetic surveillance. Since 1994, when Congress authorized the creation of a national network of DNA databases commonly referred to as CODIS,7 the FBI has overseen what has become one of the largest genetic surveillance tools in the world.8 CODIS includes DNA profiles from over 12.9 million known individuals and from over 565,000 crime scene samples.9 It has been built with millions of dollars in federal funding,10 and law enforcement officials and politicians routinely support its expansion.11 CODIS has survived every legal challenge it has faced.12 And it has delivered many law enforcement victories.13 Nonetheless, many local agencies have turned away from CODIS to set up their own local databases.14 Despite the emergence of local databases as a core investigative tool, scholars and courts have not focused on their creation or use.15 This is in stark contrast to the comprehensive attention paid to CODIS.16 This Article seeks to shift scholarly attention from CODIS to these local databases. The analysis of local databases usually amounts to a paragraph or a few sentences in a larger critique of CODIS, in which the commentator either pans their use, labeling them "rogue" databases, or notes their promise as a new tool that can reduce crime, lock up offenders who would have otherwise escaped detection, and generally revolutionize policing. This paltry coverage contrasts with the buzz local databases have received in other circles. The topic has received significant attention in police trade publications,17 and early adopters have offered unvarnished praise.18 Proponents of local databases argue that freedom from CODIS’s regulations allows police to maximize the potential of genetic surveillance to solve crime. This belief has led several early adopters to become evangelists for local databases, recruiting other police departments to create their own databases.19 These proponents herald local databases as a solution to an assortment of policing challenges, arguing that they increase clearance rates while using fewer resources than other investigative methods; deter criminal activity; decrease the opportunity for latent biases and negative stereotypes to affect policing decisions; and strengthen the public’s perception of the police.20 No doubt, this list of positive attributes is what the Supreme Court envisioned when it concluded that DNA “has the potential to significantly improve both the criminal justice system and police investigative practices.”21 It is true that law enforcement’s use of local databases has the potential to yield positive outcomes,22 but these benefits must be weighed against the negative effects of expanded use. The external harms of local databases arise from the gulf between how law enforcement is permitted to use CODIS and the wild west of genetic surveillance practices currently permitted with local databases.23 For example, like CODIS, local databases include genetic profiles from convicted individuals and arrestees. However, they also often include genetic profiles of suspects (including juvenile suspects), witnesses, crime victims, family members of victims, and citizens who responded to police DNA dragnets, which sometimes follow violent, unsolved crimes. Furthermore, local agencies are free to search these databases however they see fit, unconstrained by the regulations Congress adopted when it authorized CODIS24 and the additional regulations the FBI promulgated for CODIS.25 As a result, local databases amplify some of the same external harms generated by CODIS while simultaneously generating new ones. These harms include exacerbating racial inequities, threatening privacy and dignity interests, and undermining the legitimacy of law enforcement. While local databases have the potential to mitigate some of the racial inequities in the criminal justice system by replacing police reliance on intuition and hunches with more reliable investigative leads based on DNA evidence,26 local databases increase distributional inequities because local police have total discretion about who to target for inclusion in these databases. This has resulted in police seeking out the “usual suspects”—poor people of color—to secure DNA samples for these databases.27 These databases threaten privacy and dignity interests in several ways. With respect to privacy, they increase surveillance on innocent, lawabiding citizens, expand the use of familial DNA searching, and have the potential to limit self-expression and self-determination for targeted individuals.28 Furthermore, they impose dignity costs in the short- and longterm. There is the immediate indignity and stigma associated with being stopped by police in public to provide a DNA sample.29 And there is the long-term dignity cost when these stops communicate that someone needs to be watched—not because he was arrested or convicted, but based on law enforcement’s belief that he will be a future criminal. Collectively, these costs carry the potential to undermine the legitimacy of law enforcement.30 As local agencies circumvented the federal regulations that govern CODIS by creating their own databases, legislatures and courts have remained aloof, allowing these databases to evolve with little oversight. However, the external costs generated by local databases demonstrate the need for regulation; the current reliance on self-regulation is not sufficient. Law enforcement’s success is commonly measured by a narrow focus on crime rates and clearance rates. As a result, police chiefs lack incentives to identify and measure external costs of surveillance practices.31 Current external regulations of genetic surveillance are also insufficient. The vast majority of local databases operate outside of federal and state statutory regulations.32 Furthermore, these databases operate largely beyond the reach of the Fourth Amendment because of their extensive reliance on obtaining DNA samples by consent or from abandoned DNA.33 This freedom from regulation was welcomed by early adopters of local databases. It was a driving force behind their creation.34 However, even proponents of local databases recognize the value in embracing some external regulations.35 This Article offers five modest yet effective proposals for reform.36 First, the Article calls for a robust mandatory recordkeeping scheme designed to minimize the potential for local databases to diminish privacy and dignity interests and to exacerbate existing racial inequities in the criminal justice system. This requirement will largely monitor the inputs of local databases—e.g., what profiles are included, from whom were they collected, and in what manner were they secured. Second, the Article proposes that law enforcement must have some minimal level of suspicion before seeking consensual DNA samples from people who cannot be compelled to provide DNA samples—i.e., people other than arrestees and convicted individuals—and that, when seeking consensual DNA samples, law enforcement must clearly disclose its intent to add the resulting profile to its local database. This will curb law enforcement’s ability to populate local databases with the “usual suspects,” a practice that will result in a disproportionate number of profiles from people of color and other demographic minorities. Third, the Article calls for prohibiting the inclusion of DNA profiles from victims. This will limit the crime-solving power of local databases because the line between victims and perpetrators often shifts over time. Nevertheless, it will help to ensure that victims do not have to pay a genetic surveillance tax in exchange for police assistance. Fourth, the Article proposes a time limit for retaining DNA profiles from suspects to counter the negative implications of the necessarily over-inclusive nature of local databases and to minimize the privacy costs they inflict.37 Finally, the Article proposes comprehensive monitoring of local databases, including tracking what searches are performed in order to monitor outputs and to deter deliberate misuse. If reforms are not adopted, the negative effects of local databases will remain unchecked. Future empirical work will be needed to accurately measure these external costs, but it is certainly possible that they will outweigh the immediate crime-solving power of local databases. If that turns out to be the case, two options remain for regulating local databases. First, states could follow Vermont’s lead and abolish all non-CODIS databases.38 Second, states could take the opposite approach and pursue population-wide databases. The latter option at least would address some of the negative externalities of local databases by more fairly distributing the burdens of genetic surveillance across the population. Having outlined its path in detail, the Article proceeds as follows. Part I sets the landscape, documenting the fragmentation of genetic surveillance and explaining its causes. These causes include law enforcement’s perception that CODIS is over-regulated, advancements in forensic DNA processing combined with decreasing costs, federal funding that has allowed agencies to bypass local political and budgetary processes, and a nascent genetic surveillance-industrial complex. After describing the expansion of local databases, Part I provides a detailed description of the operations of the local databases in Palm Bay, Florida; Bensalem Township, Pennsylvania; and the state of Arizona. This Section fills a large hole in our collective knowledge of law enforcement’s use of genetic surveillance. Part II identifies and examines the implications of the expansion of local databases, including analyzing their external costs. This analysis is particularly important because the issues raised by local databases do not map directly onto those raised by CODIS. This critique sets the stage for Part III, which identifies five reforms for local databases and explains how these reforms can be implemented. Emergent health surveillance models are creeping into genetics and DNA databases – the federal government will wildly repurpose databases and push to make them comprehensive – genetic surveillance society coming soon Candice Roman-Santos (Corporate Counsel and Manager, Healthcare Compliance at Nevro, Associate, Enterprise Regulatory Law Group, Juris Doctor, Certificate in Health Law & Policy, Health Law at University of California, Hastings College of Law) 2011 “Concerns Associated with Expanding DNA Databases” 2 Hastings Sci. & Tech. L. J. 267 http://hstlj.org/articles/concerns-associated-withexpanding-dna-databases/ VIII. Privacy Implications of DNA Privacy is not threatened by the means of obtaining DNA samples, but rather the information inherent in DNA and the individual’s lack of control over such information.[cliii] There are few subject areas more personal and more likely to implicate privacy interests than that of an individual’s health or genetic make-up.[cliv] The concern is that as the uses for and access to the DNA database increases, the threat to privacy also increases.[clv] DNA samples have been analogized to medical information stored on a computer disk because both can be “read” by the application of technology.[clvi] Though medical information may be strongly correlated with particular diseases, DNA is inherently linked to one person (except in the case of identical twins).[clvii] An individual’s medical information may change over the course of his or her lifetime (e.g., people being diagnosed with diabetes, asthma, high cholesterol, or heart disease well into adulthood), but with the exception of mutations, DNA does not change over time.[clviii] An individual’s medical information may have implications for others (e.g., a virus infection has implications for others as the infected person may get others sick), just as DNA has implications for individuals other than the person from whom the information was derived.[clix] However, the implications of medical information are not as serious as those of DNA, which involve invading the privacy of a person’s family when no family member is guilty of any wrongdoing. Close relatives such as parents, siblings and children share about fifty percent of each other’s genetic variants and STR lengths, and more distant relatives such as uncles, aunts, nephews, nieces, grandparents, grandchildren, and half-siblings share about twenty-five percent of each other’s DNA variants.[clx] Thus, using partial matches to identify potential suspects radically expands the power and purpose of DNA databases, implicating a number of people who may have nothing to do with the original crime. There are substantial differences between DNA profiles and ordinary fingerprints and it trivializes DNA to call a DNA profile a genetic fingerprint.[clxi] Fingerprints are two-dimensional representations of the physical attributes of fingertips and provide no information about a person other than identity.[clxii] In addition to providing an individual’s identity, DNA can also provide medical characteristics, physical attributes, who the individual may be related to, and other personal information that, in the wrong hands, can perpetuate discriminatory practices.[clxiii] Whereas a latent fingerprint provides a fixed amount of information, all of which is used by the forensic scientist, a DNA sample provides a wealth of information and the forensic scientist has substantial control over the amount of information to be obtained from the sample.[clxiv] DNA is more probative than fingerprints because unlike fingerprints which establish that a suspect was present at a location and does not automatically imply guilt, it is more difficult to advance innocent reasons for the presence of DNA in the form of bodily fluids.[clxv] These differences are relevant to how DNA databases should be used and maintained, especially considering the privacy concerns unique to DNA. Proponents of DNA databases claim that DNA profiles consist merely of “junk DNA” that is incapable of revealing information about an individual’s genetic make-up or health.[clxvi] However, a British team has discovered that the standard DNA profile contains a subtle signature which can be linked to a person’s susceptibility to type 1 diabetes.[clxvii] This research was buried in an academic paper, did not comment on the implications for forensic science, and has been overlooked by the forensic and legal communities.[clxviii] DNA forensic testing relies on the principle that DNA profiles are only useful for identification, which is how people justify storing DNA profiles on law enforcement computers because they do not infringe anyone’s medical privacy.[clxix] Sir Alec Jeffreys was a member of the research team that made this discovery, and he predicted that “further troubling links between DNA fingerprints and disease will emerge as scientists probe the completed draft of the human genome.”[clxx] The U.S. has failed to employ comprehensive privacy regulations that would prevent the government from sharing DNA profiles in a DNA database with other groups, such as insurance companies, employers, or academia.[clxxi] DNA database statutes can be grouped into broad categories based on authorized uses of both DNA profiles and raw DNA samples: 1) statutes that allow access to DNA for non-law enforcement purposes, 2) statutes that allow access to DNA information to public officials other than law enforcement, 3) statutes that allow law enforcement to use DNA evidence for purposes other than identification, and 4) statutes that do not require expungement of DNA records upon reversal.[clxxii] Some state laws, such as Massachusetts, Louisiana and North Carolina, include a vague, open-ended authorization that allows the database to be used for “other humanitarian purposes.” [clxxiii] Alabama’s statute explicitly authorizes the creation and use of a DNA population statistical database “to provide data relative to the causation, detection and prevention of disease or disability,” as well as to assist in educational or medical research.[clxxiv] Mississippi’s law authorizes the Mississippi Crime Laboratory to determine any restrictions, and Utah’s law provides insurance companies, psychologists, and other third parties with access to information in the state DNA database.[clxxv] Some argue that creating a whole-population database is logical because a larger database is more useful than a smaller one, and it has the added effect of purging racial bias from the system, thereby avoiding criticisms of discrimination that result from selective sampling of the population.[clxxvi] However, this alone is insufficient to justify a wholepopulation database, and for many the critical factor is not merely the creation of a whole-population database of genetic profiles, but the retention of all of the DNA samples used to generate the genetic profiles. The potential for the government to use the DNA samples for a purpose not originally conceived of at the time that the DNA sample was obtained is frightening. The problem of function creep will be explored in the next section. The United States, Germany, and other countries have been guilty of implementing national programs in the name of eugenics that clearly violated human rights.[clxxvii] The eugenics movement lost credibility after the rise of Nazism in the 1930s, but reemerged as a scientific endeavor and social issue following the advent of biotechnology in the 1970s.[clxxviii] Science fiction literature and movies have dealt with the issue of “new eugenics” – the use of technology to make directed changes to human evolution.[clxxix] These works convey the danger that the ability to manipulate an individual’s genetic makeup will result in removing physical and behavioral traits not desired by society as a whole.[clxxx] The movie GATTACA is an example projecting, from current knowledge and technology, a world where the new eugenics is a reality.[clxxxi] If researchers are able to access the DNA profiles or DNA samples accumulated pursuant to a DNA database statute, they will inevitably try to identify the genes responsible for particular traits. Thousands of citizens would essentially be contributing to this future reality without their knowledge or consent. This reality is not as far off as some may think. President George W. Bush enacted the Newborn Screening Lives Act in April 2008, which mandates the screening of the DNA of all newborn babies in the U.S., and sections of the bill make it clear that the DNA may be retained and later used in genetic experiments and tests.[clxxxii] In addition, all 50 states now routinely provide the results of such tests to the Department of Homeland Security.[clxxxiii] The National Conference of State Legislatures has created a list of the various statutes or regulatory provisions by state under which newborns’ DNA is being collected.[clxxxiv] IX. Function Creep State and federal DNA database statutes include no provisions for destroying DNA samples once a DNA profile for inclusion in CODIS has been generated.[clxxxv] Proponents of forensic DNA testing claim that retaining DNA samples is necessary because science and technology is constantly improving and these samples may yield more information in the future.[clxxxvi] Paul Ferrara, Director of Virginia’s DNA program, additionally claims that retaining DNA samples is necessary so that agencies can rerun DNA profiles to verify cold hits before notifying law enforcement agencies to further investigate, and that agencies encounter many different situations requiring consultation with original database samples.[clxxxvii] The term function creep refers to the “operationally driven use of the existing resource for new purposes not envisaged when the resource was established,” which is “made possible by technological innovation and lack of inhibiting measures” like public opposition or legislation.[clxxxviii] Historically, databases that were created in the U.S. for a discrete purpose were eventually assigned new functions and purposes.[clxxxix] The government began issuing drivers licenses in the name of public safety, and yet the average adult American citizen now has more direct dealings with government through licensing and regulation of the automobile than through any other single public activity.[cxc] Eventually, states began earning millions of dollars per year from selling drivers’ personal information to direct marketers, charities, political campaigns and various commercial interests.[cxci] An unintended consequence of this practice was the real threat to public safety. In some instances, abuse of drivers’ personal information lead to murders.[cxcii] Congress reacted by passing the Drivers Privacy Protection Act, which effectively prohibits the disclosure of personal information obtained in connection with a motor vehicle record for unauthorized uses unless the individual waives his or her right to privacy.[cxciii] The U.S. Supreme Court upheld the constitutionality of the Drivers Privacy Protection Act, reasoning that it is a proper exercise of Congress’ authority to regulate interstate commerce under the Commerce Clause and does not violate principles of federalism contained in the Tenth Amendment.[cxciv] The government introduced social security numbers (SSNs) to track individuals’ accounts within the Social Security Program in 1935.[cxcv] Executive Order 9397, issued in 1943, expanded its use by requiring federal agencies to use SSNs exclusively whenever a new identification system for individuals needed to be created.[cxcvi] Eventually, the Internal Revenue Service adopted the SSN as its official taxpayer identification number and the Department of Defense began using SSNs to identify Armed Forces personnel. [cxcvii] Then during the 1970s, the Bank Records and Foreign Transactions Act required all financial institutions to obtain the SSNs of all of their customers, the Privacy Act authorized local governments to use SSNs, and the Tax Reform Act authorized registration authorities of a state or local tax, welfare, driver’s license, or motor vehicle registration to use SSNs to establish identities.[cxcviii] Finally, in 1987, the Social Security Administration began automatically issuing SSNs to newborns when the birth was registered by the State, and currently all 50 states, plus Washington D.C. and Puerto Rico, participate in this program.[cxcix] Once intended to track individuals’ accounts within the Social Security Program, SSNs have become a universal identifier for individuals within the U.S. The U.S. Constitution expressly states that “an enumeration shall be made within three Years after the first Meeting of the Congress of the United States, and within every subsequent Term of ten Years in such Manner as they shall by Law direct.”[cc] Census records are a constitutional requirement used to allocate congressional seats, electoral votes and government program funding. Though the Constitution only requires a head count, a substantial amount of data is collected during a census.[cci] More and more detailed information has been gathered over the years, including data on race/ancestry, health, housing, and transportation.[ccii] After the Japanese Attack on Pearl Harbor, census records were used to facilitate the internment of Japanese-Americans.[cciii] Presently, however, census data cannot be used for any purpose other than its intended statistical purposes, and no federal agency is allowed to access census reports.[cciv] The Texas Tribune recently published a story about how the Department of State Health Services in Texas turned over newborn DNA samples to an Armed Forces lab “to build a national and, someday, international mitochondrial DNA registry.”[ccv] However, the newborn blood samples were stored without parental consent and records uncovered government efforts to limit the public’s knowledge of the state newborn blood program.[ccvi] Parents sued officials over these actions, but the state settled the case quickly before anything could be revealed in the discovery phase.[ccvii] As of 2004, the Department of Defense (“DOD”) had collected three million biological samples from service personnel “for the stated purpose of identifying remains or body parts of a soldier killed on duty.”[ccviii] However, samples are retained for fifty years, which greatly exceeds the subjects’ time with the military. Further compounding the issue, the DOD has refused to establish regulations to guard against third parties accessing the accumulated biological samples.[ccix] It is not hard to foresee pressures mounting to use these biological samples for purposes other than identifying soldiers killed on duty, such as identifying criminal suspects and medical research.[ccx] Although there is a Fourth Amendment concern associated with obtaining DNA samples, the Fourth Amendment applies only to government action and is inapplicable to private parties who do not act as agents of the government.[ccxi] This doctrine, however, does not preclude the possibility that law enforcement may be able to access existing repositories of DNA from cooperative private hospitals or laboratories, provided that the government had no involvement in how the DNA was originally obtained and that the state is not engaging in any search or seizure in acquiring DNA in this way.[ccxii] The National Bioethics Advisory Commission estimated that as of 1998, more than 282 million human biological specimens were collected and stored in the U.S. for research studies, newborn screening tests, organ banks, blood banks, forensic DNA databases, and for other purposes, which increases at a rate of 20 million samples per year.[ccxiii] The issue lies in the fact that an individual undergoing diagnostic tests or donating samples for clinical or research purposes has a reasonable expectation of privacy that their test results and DNA will not be shared with a non-medical third party without his or her consent.[ccxiv] Function creep has already begun with DNA databases as law enforcement has expanded DNA collection to include new categories of people.[ccxv] Examples of future uses of DNA databases include research to increase understanding of patterns of criminal behavior, research to correlate genetic variation with disposition to certain behaviors, and creation of a universal database by combining all existing databases to facilitate data sharing.[ccxvi] X. Conclusion DNA database statutes provide inadequate privacy protections. There is a lack of national oversight, no uniform quality control process of obtaining DNA samples and maintaining DNA databases, and there is no consistency regarding who may access DNA databases and for what reasons. DNA is a useful crimefighting tool, but its potential makes it likely to be abused. Because DNA databases already exist, it is hard to imagine that their viability will diminish in the future. Therefore, leaders must work to ensure that all DNA profiles and DNA samples are used for the limited purpose for which they were collected, and advocates should push for the eventual destruction of all DNA samples once DNA profiles have been generated so that no one will be tempted to use them for purposes that go beyond forensic identification. The way cold hit statistics are used to determine guilt or innocence in litigation is another area of potential abuse. Increasingly, convictions are relying on DNA evidence alone. Moreover, when the DNA evidence is a partial match on less than 13 loci, the risk of injustice is greater, as evidenced by the report of Arizona’s DNA database in 2005. It is frightening that most people are blinded by a belief that DNA is the panacea of crime detection and do not recognize the potential threat to privacy and other civil liberties. Researchers should be provided with access to the genetic profiles within CODIS after all of the personal identifiers have been removed so that they can conduct independent scientific scrutiny to ensure the scientific integrity of DNA forensic science. The NDNAD in the UK is even more controversial than the DNA databases in the U.S. Despite negative media coverage and successful legal challenges to DNA collection and retention practices, British leaders are forging ahead with the hope of one day expanding the database to cover the entire UK population. Given the history of eugenics and discrimination in the U.S. and abroad and the atrocities that have befallen millions of innocent human beings, everyone should be aware of and fear the dangers associated with becoming a genetic surveillance society. If people are not vocal in opposing current DNA database practices, the only people who will be shaping the future of how DNA is used are those with a political agenda who are not as concerned with individual privacy and the ethics of their actions. As science and technology continue to advance, visions of a brave new world that are the substance of science fiction movies like GATTACA may no longer be a distant reality. Racial biases have been routinely documented in study after study – genetic surveillance codifies a new Jim Crow database that results in a new wave of biopolitical eugenics Dorothy Roberts (Kirkland & Ellis Professor, Northwestern University School of Law; faculty fellow, Institute for Policy Research) 2011 “Collateral Consequences, Genetic Surveillance, and the New Biopolitics of Race” 54 Howard L.J. 567 2010-2011, HeinOnline II. THE COST OF SURVEILLANCE Government DNA data banking began as a targeted procedure to assist law enforcement in identifying perpetrators of a narrow set of crimes.51 It has expanded into a form of state surveillance that ensnares innocent people or petty offenders who have done little or nothing to warrant the collateral intrusion into their private lives. Databanks no longer detect suspects-they create suspects from an ever-growing list of categories. Even so, the public shows little alarm about the massive retention of genetic information because the balance between protecting individual privacy and keeping the streets safe seems to fall in favor of more law enforcement. DNA profiling is a far more precise and objective method of identifying suspects compared to less sophisticated law enforcement techniques, such as eyewitness identification or smudge fingerprints found at a crime scene.o Far from feeling threatened by this gigantic storehouse of genetic data, many Americans see it as a surefire way of catching criminals and ensuring that only guilty people are convicted of crimes.61 Storing an innocent person's DNA seems a small price for such a great public good. The countless cases where DNA data banking either yielded no benefit or produced erroneous identifications received little attention from the media. Moreover, the public does not hear from the thousands of innocent people whose DNA was seized and stored against their will. Although DNA testing has shed light on the injustice of false convictions, it cannot solve the underlying problems that lead innocent people to be convicted in the first place. Most wrongful convictions result from deep biases in the criminal justice system that make poor, minority defendants vulnerable to police abuse, misidentification, and inadequate representation. 62 False confessions coerced by the police are one of the main causes of wrongful convictions. According to the Innocence Project, "In about [twenty-five] percent of DNA exoneration cases, innocent defendants made incriminating statements, delivered outright confessions or pled guilty."64 Coerced false confessions were a factor in fifteen of thirty-three exonerations won by the Center on Wrongful Convictions.65 It makes no sense to correct a problem created by law enforcement's abuse of power by handing over even more authority to law enforcement in the form of DNA collection. The way to reduce wrongful convictions is to remove the biases based on race and class that corrupt our criminal justice system. Extending the reach of state surveillance does just the opposite. Besides, contrary to the public's belief that DNA evidence is infallible, there have been numerous cases of errors in the handling and analysis of DNA that have led to false accusations and convictions of innocent people.6 6 These weaknesses in the state's use of DNA data banking as a tool for reducing crime make it harder to justify the resulting breach of individual privacy. Society recognizes that the government violates its civil liberties if it taps our telephones or secretly searches our homes without court permission. 7 Collecting and storing our DNA is also a serious intrusion into our private lives because DNA is a part of the body; taking it without consent violates our bodily integrity. In addition to this material aspect, DNA contains sensitive personal information that can be used to identify our family members and us, can be matched with other private records, including medical files. 8 Society tolerates the state forcibly extracting highly personal data from people convicted of serious crimes because these offenders have a diminished right to privacy as a result of their antisocial conduct. 9 But as the categories of people who are compelled to submit DNA broaden, it becomes less clear why the state should have so much power over them. Once compelled DNA collection goes beyond murderers, rapists, and armed robbers, law enforcement's need for a sus- pect's DNA lessens and the right to retain control over their private information strengthens.70 Although people convicted of heinous crimes may forfeit their claim to privacy, there is no such justification for seizing genetic samples from someone who has, say, forged a check. State agents should be required to obtain informed consent to take or test DNA from anyone who has not been convicted of a serious crime. Although U.S. courts have been slow to recognize this threat to civil liberties," in 2008, the European Court of Human Rights unanimously held that the United Kingdom's storage of DNA for purposes of criminal investigation infringed privacy rights protected by Article 8 of the European Convention.72 The European Court was especially troubled by the indefinite retention of genetic information taken from children and adults who were never convicted of a crime,73 stigmatizing them as if they were convicted criminals. This equation of the innocent and the guilty disregards the presumption of innocence accorded to citizens in a democracy. Massive government collection of DNA transforms the relationship between citizens and their government in ways that contradict basic democratic principles.74 Government becomes the watchdog of citizens instead of the other way around. Although they are guilty of no wrongdoing, huge segments of the population are perpetually under suspicion. Citizens can no longer rely on the state to safeguard their privacy by forgetting their past behavior because evidence about them is stored forever. The state has the authority to take citizens' private property-in this case, their genetic information-without due process. 76 Those are features of a totalitarian state, not a liberal democracy. III. JIM CROW DATABASES These privacy violations are exacerbated by the racial inequities that plague every part of the U.S. criminal justice system. The most stunning aspect of this injustice is the mass incarceration of African American men." Radical changes in crime control, drug, and sentencing policies over the last thirty years produced an explosion in the U.S. prison population from three hundred thousand to two million inmates." Additionally, the United States has the highest rate of incarceration in the world at a magnitude unprecedented in the history of Western democracies.79 The gap between black and white incarceration rates has increased along with rising inmate numbers.o Black men are eight times as likely as white men to be behind bars.8 ' One in nine black men aged twenty to thirty-four is in prison or in jail.82 In fact, most people sentenced to prison today are black. In her 2010 book, The New Jim Crow, legal scholar Michelle Alexander demonstrates that black incarceration functions like a modern-day Jim Crow caste system because it "permanently locks a huge percentage of the African American community out of the mainstream society and economy," replicating the subjugated status of blacks that prevailed before the civil rights revolution.8 4 The targeted imprisonment of black men is translated into the disproportionate storage of their genetic profiles in state and federal databases. We can look to the United Kingdom to gauge the likely racial impact of our own federal database now that it has surpassed theirs in size. Their database reveals that 40% of all black men and 77% of black men aged fifteen to thirty-five, compared with only 6% of white men, were estimated to have genetic profiles in the UK national DNA database in 2006.8 Also in 2006, Stanford bioethicist Hank Greely estimated that at least 40% of the genetic profiles in the U.S. federal database were from African Americans, although they make up only 13% of the national population. 86 Sheldon Krimsky and Tania Simoncelli arrive at a similar estimate in which 41 % to 49% of CODIS profiles are from African Americans." The extension of DNA collection by the federal government and a number of states to people who are only arrested-as opposed to charged or convicted-brings many more whites into the system, but it is also on its way to creating a nearly universal database for urban black men.88 These men are arrested so routinely that upwards of 90% would be included in databases if the collection policy is strictly enforced.8 9 In April 2010, Arizona Governor Jan Brewer signed a controversial law giving police broad authority to detain anyone suspected of being in the country illegally.90 This law is held up as a model for immigration enforcement policy in other states.91 When combined with congressional authorization of DNA sampling from all federal detainees,92 these immigration laws will cause the number of Latino profiles in CODIS and state databases to skyrocket. Police routinely consider race in their decision to stop and detain an individual.93 A New York Times/CBS News Poll conducted in July 2008 asked: "Have you ever felt you were stopped by the police just because of your race or ethnic background?" 94 Sixty-six percent of black men said yes, compared to only 9% of white men.95 The United States Supreme Court has authorized police to use race in determining whether there is reasonable cause to suspect someone is involved in crime. 96 Michelle Alexander calls the Court's license to discriminate the "dirty little secret of policing." 97 In recent decades, a conservative Supreme Court has eroded the Warren Court's protections against police abuse in ways that promote the arrest of blacks and Latinos-relaxing, for example, the standard for reasonable suspicion- and has blocked legal channels for challenging racial bias on the part of law enforcement." There is overwhelming evidence that police officers stop motorists on the basis of race for minor traffic violations, such as failure to signal a lane change, often as a pretext to search the vehicle for drugs.99 One of the first confirmations of this was a 1992 Orlando Sentinel study of police videotapes that discovered that, while blacks and Latinos represented only 5% of drivers on the Florida interstate highway, they comprised nearly 70% of drivers pulled over by police and more than 80% of those drivers whose cars were searched." A study of police stops on the New Jersey Turnpike similarly found that, although only 15% of all motorists were minorities, 42% of all stops and 73% of all arrests were of black drivers.1ox In Maryland, only 21% of drivers along a stretch of 1-95 outside of Baltimore were African Americans, Asians, or Latinos, but these groups made up nearly 80% of those who were stopped and searched.o 2 Likewise, an Illinois state police drug interdiction program, known as Operation Valkyrie, targeted a disproportionate number of Latinos, who comprised less than 8% of the Illinois population but 30% of the drivers stopped by drug interdiction officers for petty traffic offenses.os Police officers also make drug arrests in a racially biased manner. Although whites use drugs in greater numbers than blacks, blacks are far more likely to be arrested for drug offenses-and, therefore, far more likely to end up in genetic databases. 104 The latest National Survey on Drug Use and Health, released in February 2010, confirms that young blacks aged eighteen to twenty-five years old are less likely to use illegal drugs than the national average.os Yet, black men are twelve times more likely than white men to be sent to prison on drug charges." This staggering racial disparity results in part from the deliberate decision of police departments to target their drug enforcement efforts on urban and inner-city neighborhoods where people of color live. Indeed, the increase in both the prison population and its racial disparity in recent decades are largely attributable to aggressive street-level enforcement of the drug laws and harsh sentencing of drug offenders. 0 7 A crusade of marijuana arrests in New York City in the last decade provides a shocking illustration. 0 Since 1997, the New York Police Department ("NYPD") has arrested 430,000 people for possessing tiny amounts of marijuana, usually carried in their pockets." o' In 2008 alone, the NYPD arrested and jailed 40,300 people for the infraction."f0 Even more alarming is the extreme racial bias shown in whom the police target for arrest. Although U.S. government studies consistently show that young whites smoke marijuana at the highest rates, white New Yorkers are the least likely of any group to be arrested."1 ' In 2008, whites made up over 35% of the city's population but less than 10% of the people arrested for marijuana possession. 112 Instead, the NYPD has concentrated arrests on young blacks and Latinos. Police arrested blacks and Latinos for marijuana possession at seven and four times the rate of whites, respectively."13 The racist marijuana policing strategy is based on the routine police practice of stopping, frisking, and intimidating young blacks and Latinos. According to Harry Levine, the City University of New York sociologist who exposed the arrest campaign, "In 2008, the NYPD made more than half a million recorded stop and frisks and an unknown number of unrecorded stops, disproportionately in black, Latino and low-income neighborhoods."1 14 Although New York City is the "marijuana arrest capital of the world," other cities like Atlanta, Baltimore, Denver, Houston, Los Angeles, Philadelphia, and Phoenix are also arresting and jailing huge numbers of blacks and Latinos for marijuana possession.1 1 5 The widespread arrests of young blacks and Latinos for marijuana possession and other petty offenses, such as truancy, skateboarding, and playing loud music, have devastating consequences. A first-time offender who pleads guilty to felony marijuana possession has a permanent criminal record that can block him or her from getting a student loan, a job, a professional license, food stamps, welfare benefits, or public housing.' Even if they avoid prison on a first offense, those who are arrested a second time risk a harsh sentence for being a repeat offender."17 In addition to harsh sentencing, a lifetime of genetic surveillance can now be added to the long list of collateral consequences created by discriminatory arrests. IV. RACIAL HARMS Racial disparities in DNA databanks make communities of color the most vulnerable to state surveillance and suspicion."' The disproportionate odds faced by blacks and Latinos of having their DNA extracted and stored will, in turn, intensify the racial disparities that already exist in the criminal justice system. People whose DNA is in criminal databases have a greater chance of being matched to crime scene evidence. While a guilty person may have no right to complain, that is no excuse for unfairly placing certain racial groups at greater risk of detection. Blacks and Latinos have greater odds of being ge- netically profiled largely because of discriminatory police practices.119 Moreover, people whose profiles are entered in DNA databases become subject to a host of errors that can lead to being falsely accused of a crime. As the federal government and a growing number of states extend the scope of DNA collection to innocent people, they are imposing this unmerited risk primarily on minorities. The problem is not only that all of these harms are placed disproportionately on people of color, but also that the dangers of state databanks are multiplied when applied to blacks and Latinos because these groups are already at a disadvantage when they encounter the criminal justice system. Blacks and Latinos have fewer resources than whites to challenge abuses and mistakes by law enforcement officers and forensic analysts.120 They are stereotyped as criminals before any DNA evidence is produced, making them more vulnerable to the myth of DNA infallibility.121 "The experience of being mistaken for a criminal is almost a rite of passage for African-American men," writes journalist Brent Staples.122 One of the main tests applied by a disturbing number of Americans to distinguish law-abiding from lawless people is their race. Many, if not most, Americans believe that black people are prone to violence and make race-based assessments of the danger posed by strangers they encounter. 23 One of the most telling reflections of the presumption of black criminality is biased reporting of crime by white victims and eyewitnesses.124 Psychological studies show a substantially greater rate of error in cross-racial identifications when the witness is white and the suspect is black. 25 White witnesses disproportionately misidentify blacks because they expect to see black criminals.126 According to Cornell legal scholar Sheri Lynn Johnson, "This expectation is so strong that whites may observe an interracial scene in which a white person is the aggressor, yet remember the black person as the aggressor."127 In numerous carefully staged experiments, social psychologists have documented how people's quick judgments about the criminal acts of others are influenced by implicit bias-positive or negative preferences for a social category, such as race or gender, based on unconscious stereotypes and attitudes that people do not even realize they hold.' 28 Whites who are trying to figure out a blurred object on a computer screen can identify it as a weapon faster after they are exposed to a black face.129 Exposure to a white face has the opposite effect.130 Research participants playing a video game that simulates encounters with armed and unarmed targets react faster and are more likely to shoot when the target is black.' The implicit association between blacks and crime is so powerful that it supersedes reality; it predisposes whites to see black people as criminals. Most wrongful convictions occurred after witnesses misidentified the defendant.132 Databanks filled with DNA extracted from guilty and innocent black men alike will enforce and magnify the very stereotypes of black criminality that lead to so many wrongful convictions in the first place. Collecting DNA from huge numbers of African Americans who are merely arrested, with no proof of wrongdoing, embeds the sordid myth of black criminality into state policy. As databanks swell with DNA from black people who are arrested or convicted on petty offenses and as their relatives also come under suspicion in states with familial searching, the government effectively treats every black person in many communities as a criminal suspect. It seemingly also legitimizes the myth that blacks have a genetic propensity to commit crime. In 2010, Florida State University criminologist Kevin Beaver published a widely reported study claiming to show that young men with the low-activity form of the monoamine oxidase A ("MAOA") gene-dubbed by the press as the "warrior gene"-were more likely to join gangs than those who had the high-activity version of the MAOA gene.'33 He concluded that "male carriers of low MAOA activity alleles are at risk for becoming a gang member and, once a gang member, are at risk for using weapons in a fight."' 34 The public, who already implicitly associates blacks with violence, may link research claiming that genes cause gangbanging and aggression to the disproportionate incarceration of African Americans along with the disproportionate banking of African Americans' genetic profiles, to reach the false conclusion that blacks are more likely to possess these crimeproducing traits-or even that most blacks actually possess them. Americans will become even more indifferent to racial injustice in law enforcement if they are convinced that black people belong behind bars because of their genetic predilection to crime. CONCLUSION Despite the racial harms of DNA data banking, civil rights advocacy groups have done little to challenge the threat posed by government genetic surveillance. Their silence stems from a tension surrounding DNA testing. Although it is serving an unjust criminal justice system, DNA technology is also responsible for one of the biggest successes in criminal justice reform. As of 2010, more than half (151 out of 254) post-conviction DNA exonerations involved African Americans.1' There could not be a better public-relations campaign for DNA than the compelling stories of falsely imprisoned people released after DNA testing. As criminologist Simon Cole notes, "At first glance, post-conviction DNA exonerations appear to be a powerful example of the use of technoscience to offset social inequality."' 36 Civil rights organizations that may have ordinarily opposed the expansion of DNA databanks because of their intrusion into communities of color instead embrace DNA technology as a result of its ability to exonerate victims of the system. However, while it appears DNA databanks would decrease mass incarceration, this Article has argued that DNA databanks are actually more likely to intensify it and its collateral consequences. Champions for racial justice who support expanded DNA databanks or are silent about them should not make the mistake of embracing DNA technology without analyzing its full role in the criminal justice system.' 7 Although DNA testing can correct injustices when used narrowly to confirm a suspect's guilt or innocence, the massive genetic surveillance we are witnessing threatens to reinforce the racial roots of the very injustices that need to be corrected. Wrongful convictions are a symptom of our Jim Crow system of criminal justice, which is systematically biased against blacks and Latinos. 38 Creating a Jim Crow database filled with their genetic profiles only intensifies this travesty of justice, adding yet another collateral consequence of criminal injustice and fortifying a dangerous biopolitics of race. Racism makes all forms of violence inevitable, it must be rejected in every instance. Memmi 2k - MEMMI Professor Emeritus of Sociology @ Unv. Of Paris Albert-; RACISM, translated by Steve Martinot, pp.163-165 The struggle against racism will be long, difficult, without intermission, without remission, probably never achieved, yet for this very reason, it is a struggle to be undertaken without surcease and without concessions. One cannot be indulgent toward racism. One cannot even let the monster in the house, especially not in a mask. To give it merely a foothold means to augment the bestial part in us and in other people which is to diminish what is human. To accept the racist universe to the slightest degree is to endorse fear, injustice, and violence. It is to accept the persistence of the dark history in which we still largely live. It is to agree that the outsider will always be a possible victim (and which [person] man is not [themself] himself an outsider relative to someone else?). Racism illustrates in sum, the inevitable negativity of the condition of the dominated; that is it illuminates in a certain sense the entire The anti-racist struggle, difficult though it is, and always in question, is nevertheless one of the prologues to the ultimate passage from animality to humanity. In that sense, we cannot fail to rise to the racist challenge. However, it remains true that one’s moral conduct only emerges from a choice: one has to want it. It is a choice among other human condition. choices, and always debatable in its foundations and its consequences. Let us say, broadly speaking, that the choice to conduct oneself morally is the condition for the establishment of a human order for which racism is the very negation. This is almost a redundancy. One cannot found a moral order, let alone a legislative order, on racism because racism signifies the exclusion of the other and his or her subjection to violence and domination. From an ethical point of view, if one can deploy a little religious language, racism is “the truly capital sin.”fn22 It is not an accident that almost all of humanity’s spiritual traditions counsel respect for the weak, for orphans, widows, or strangers. It is not just a question of theoretical counsel respect for the weak, for orphans, widows or strangers. It is not just a question of theoretical morality and disinterested commandments. Such unanimity in the safeguarding of the other suggests the real utility of such sentiments. All things considered, we have an interest in banishing injustice, because injustice engenders violence and death. Of course, this is debatable. There are those who think that if one is strong enough, the assault on and oppression of others is permissible. But no one is ever sure of remaining the strongest. One day, perhaps, the roles will be reversed. All unjust society contains within itself the seeds of its own death. It is probably smarter to treat others with respect so that they treat you with respect. “Recall,” says the bible, “that you were once a stranger in Egypt,” which means both that you ought to respect the stranger because you were a stranger yourself and that you risk becoming once again someday. It is an ethical and a practical appeal – indeed, it is a contract, however implicit it might be. In short, the refusal of racism is the condition for all theoretical and practical morality. Because, in the end, the ethical choice commands the political choice. A just society must be a society accepted by all. If this contractual principle is not accepted, then only conflict, violence, and destruction will be our lot. If it is accepted, we can hope someday to live in peace. True, it is a wager, but the stakes are irresistible. 1AC Impact Framing Their impacts are a function of neuroscientific biases and heuristics – reject their risk framing – war, terrorism, and mass political conflict wont happen and wont escalate Rauch 03/2015 (Jonathan Rauch, senior fellow at the Brookings Institution, contributing editor of National Journal and The Atlantic. “Be Not Afraid,” published in the March 2015 issue of The Atlantic http://www.theatlantic.com/magazine/archive/2015/03/be-not-afraid/384965/) It often befalls presidents to be most criticized in office for what later turn out to have been their particular strengths. Disparaged at the time as simplemindedness, timidity, and slickness, Ronald Reagan’s firmness, George H. W. Bush’s caution, and Bill Clinton’s adaptability look in hindsight like features, not bugs. (Unfortunately, George W. Bush’s bugs still look like bugs.) President Obama catches flak for his supposed underreaction to crises in the Middle East, Ukraine, and elsewhere. Instead of leading, the professorial president lectures the American public not to be so darned worried. “If you watch the nightly news, it feels like the world is falling apart,” he said last August. “I promise you things are much less dangerous now than they were 20 years ago, 25 years ago, or 30 years ago. This is not something that is comparable to the challenges we faced during the Cold War.” Blame social media, he tells us, for shoving so much upsetting stuff in our faces. Naturally, Obama’s pontifications draw protests. “I strongly disagree with the president’s assertion last night that America is safer,” said Senator John McCain. “By no objective measurement is America safer.” Danger abounds! In 2012, General Martin Dempsey, the chairman of the Joint Chiefs of Staff, pronounced the world “more dangerous than it has ever been.” That was before the Islamic State, or ISIS, took over swaths of Iraq. Senator Lindsey Graham has warned that failure to defeat ISIS “will open the gates of hell to spill out on the world.” Obama appears to have his doubts: a few months after Chuck Hagel, then the defense secretary, pronounced ISIS an “imminent” threat, not just to the United States but “to every stabilized country on Earth,” Obama sacked him. The American people deserve to hear complex, multifaceted debates about any number of complex, multifaceted matters. This is not one of them. Obama is simply right. The alarmists are simply wrong. America is safer than it has ever been and very likely safer than any country has ever been, a fact that politicians and the public are curiously reluctant to believe. Danger is a broad category. In principle, it includes everything from workplace accidents and natural disasters to infectious diseases and pollution. In pretty much all of those categories, we’re doing well, although we have much work to do. For present purposes, however, let’s limit ourselves to threats in the usual political sense: malevolent violence against Americans. The Historically, warfare has been the biggest violent killer of humans. According to Steven Pinker, the author of The Better Angels of Our Nature: Why Violence Has Declined, today is probably the most peaceful time in human history. By the numbers, he writes, “the world was a far more dangerous place” in the 1960s, ’70s, and ’80s. According to the Uppsala Conflict Data Program, armed conflicts have declined by almost 40 percent since right after the end of the Cold War. “Today,” write Micah Zenko and Michael A. Cohen in Foreign Affairs, “wars tend to be low-intensity conflicts that, on average, kill about 90 percent fewer people than did violent struggles in the 1950s.” War between major nation-states has dwindled to the verge of extinction. In the context of human evolution, this is an astounding development. Of course, the world remains turbulent, but most of today’s military conflict, as in Syria right now, takes the form of civil war rather than war between nations, and implicates American interests but not American lives (unless America enters the fighting). The United States faces no plausible military invader or attacker. All we are really talking about, when we discuss threats from Iran or North Korea or ISIS, is whether our margin of safety should be very large or even larger. “No great power in world history comes close to enjoying the traditional state security that the United States does today,” writes Stephanie Rugolo in A Dangerous World? Threat Perception and U.S. National Security, a new collection of essays from the major menaces here would be warfare, crime, and terrorism. Cato Institute. Here at home, criminal violence is, as ever, a serious problem. But its reduction over the past couple of decades is one of the great success stories of our time. The violent-crime rate (which excludes homicides) has declined by more than 70 percent since the early 1990s. The homicide rate has declined by half, and in 2011 it reached the lowest level since 1963. According to the National Crime Victimization Survey, between 1995 and 2010 the rate of rape and sexual assault fell from five per 1,000 females to two. And how do Americans celebrate this extraordinary success? By denying it. Every year Gallup asks whether crime has gone up or down since the previous year. Every year, rain or shine, the public insists, usually by overwhelming margins (63 percent to 21 percent in 2014), that crime has risen. “Most Americans Unaware of Big Crime Drop Since 1990s,” announced the Pew Research Center in 2013; only 10 percent of those surveyed knew that gun crimes had gone down since the 1990s. Criminologists say that many people get angry when told that crime is decreasing. Perception is even more skewed where terrorism is concerned. “Terror-ism Worries Largely Unchanged,” ran another Pew headline, also in 2013. That year, 58 percent of the public was worried about another terrorist attack in the United States, a rate not all that much lower in October 2001, immediately after the 9/11 attacks, when 71 percent of the public was worried. A few months ago, perhaps influenced by ISIS’s atrocities, a large plurality of respondents told NBC News/Wall Street Journal pollsters that the country is less safe than it was before 9/11. Reality, once again, tells us otherwise. State-sponsored international terrorism, writes the intelligence analyst Paul R. Pillar in Cato’s A Dangerous World?, “is today only a shadow of what it was in the 1970s and 1980s.” As for the risk posed by terrorism inside the United States, to characterize it as trivial would be very generous. Americans are about four times as likely to drown in their bathtub as they are to die in a terrorist attack. John Mueller of Ohio State University and Mark G. Stewart of Australia’s University of Newcastle estimate the odds of such deaths at one in 950,000 and one in 3.5 million, respectively. Surely we can at least agree to worry about a nuclear Iran, or nuclear terrorism, or ISIS? All are indeed worrisome, but Mueller persuasively argues that none merits the alarm it begets. Since Nagasaki in 1945, the few countries that have obtained nuclear weapons—including dangerous rogue states like Mao’s China, the Iran of its day—have consistently found them militarily and diplomatically useless, except as ego boosters and perhaps as defensive weapons to forestall attack. The odds of terrorists’ obtaining and deploying nuclear weapons are much lower than most people appreciate, for a host of technical and political reasons. ISIS, meanwhile, is an unusually vicious and destabilizing actor in a region that is full of them, but its menace has been almost entirely local. (In this issue’s cover story, Graeme Wood examines this threat, and the appropriate response, in detail.) Pinker, a psychologist at Harvard, mused in a recent speech about Americans’ odd refusal to appreciate their security. The bad news for Obama, if Pinker is correct, is that presidential palaver will have no effect, because people are hardwired to overreact to threats, real or perceived. In today’s world, social systems keep us safer than our forebears could ever have imagined, overreaction is maladaptive: it is often more disruptive and damaging than whatever provoked it. In the world we evolved for, where intricate however, humans needed to be hyperalert. Something rustling in the bush was more likely to be a predator or an enemy than a friend with glad tidings. Moreover, Pinker says, people are biased to overestimate the likelihood of the sorts of events that stand out in our memory, as violence and mayhem do, and as peace and quiet do not. Add alarmism’s usefulness to politicians and pressure groups, and you have a standing order for overreaction—always, not just now. Still, now is special. Given how safe we are, and how frightened people nonetheless feel, it seems unlikely that Americans’ threat perception has ever before been quite as distorted as it is today. Never have so many feared so little, so much. In an era of overreaction, a president who lectures the public about its insecurities, instead of pandering to its fears, necessarily seems impolitic, out of touch, tone-deaf, pedantic, negligent, complacent—choose your adjective. For precisely that reason, we can be grateful his instinct is to underreact. Historians will thank him, even if we don’t, for his steadfastness in the face of unprecedented safety. “Miscalculation” and “escalation” are not things – warfare and conflicts will not go nuclear Quinlan ‘9 (Sir Michael Quinlan, Former Permanent Under-Secretary of State UK Ministry of Defense, Thinking About Nuclear Weapons: Principles, Problems, Prospects, p. 63-69, The book reflects the author's experience across more than forty years in assessing and forming policy about nuclear weapons, mostly at senior levels close to the centre both of British governmental decision-making and of NATO's development of plans and deployments, with much interaction also with comparable levels of United States activity in the Pentagon and the State department, 2009) There have certainly been, across the decades since 1945, many known accidents involving nuclear weapons, from transporters skidding off roads to bomber aircraft crashing with or accidentally dropping the weapons they carried (in past days when such carriage was a frequent feature of readiness arrangements it no longer is). A few of these accidents may have released into the nearby environment highly toxic material. None however has entailed a nuclear detonation. Some commentators suggest that this reflects bizarrely good fortune amid such massive activity and deployment over so many years. A more rational deduction from the facts of this long experience would however be that the probability of any accident triggering a nuclear explosion is extremely low. It might be further nested that the mechanisms needed to set of such an explosion are technically demanding, and that in a large number of ways the past sixty years have seen extensive improvements in safety arrangements for both the design and the handling of weapons. It is undoubtedly possible to see respects in which, after the cold war, some of the factors bearing upon risk may be new or more adverse; but some are now plainly less so. The years which the world has come through entirely without accidental or unauthorized detonation have included early decades in which knowledge was sketchier, precautions were less developed, and weapon designs were less ultra-safe than they later became, as well as substantial periods in which weapon numbers were larger, deployments immure widespread arid diverse, movements more frequent, and several aspects of doctrine and readiness arrangements more tense. Similar considerations apply to the hypothesis of nuclear war being mistakenly triggered by false alarm. Critics again point to the fact, as it is understood, of numerous occasions when initial steps in alert sequences for US nuclear forces were embarked upon, or at least called for, by indicators mistaken or misconstrued. In none of these instances, it is accepted, did matters get at all near to nuclear launch— extraordinary good fortune again, critics have suggested. But the rival and more logical inference from hundreds of events stretching over sixty years of experience presents itself once more: that the probability of initial misinterpretation leading far towards mistaken launch is remote. Precisely because any nuclear weapon processor recognizes the vast gravity of any launch, release sequences have many steps, and human decision is repeatedly interposed as well as capping the sequences. To convey that because a first step was prompted the world somehow came close to accidental nuclear war is wild hyperbole, rather like asserting, when a tennis champion has lost his opening service game, that he was nearly beaten in straight sets. History anyway scarcely offers any ready example of major war started by accident even before the nuclear revolution imposed an order-of-magnitude increase of caution. It was occasionally conjectured that nuclear war might be triggered by the real but accidental or unauthorized launch of a strategic nuclear-weapon delivery system in the direction of a potential adversary. No such launch is known to have occurred in over sixty years. The probability of it is therefore very low. But even if it did happen, the further hypothesis of its initiating a general nuclear exchange is far-fetched. It fails to consider the real situation of decision-makers, as pages 63-4 have brought out. The notion that cosmic holocaust might be mistakenly precipitated in this way belongs to science fiction. One special form of miscalculation appeared sporadically in the speculations of academic commentators, though it was scarcely ever to be encountered—at least so far as my own observation went—in the utterances of practical planners within government. This is the idea that nuclear war might be erroneously triggered, or erroneously widened, through a state under attack misreading either what sort of attack it was being subjected to, or where the attack came from. The postulated misreading of the nature of the attack referred in particular to the hypothesis that if a delivery system—normally a missile—that was known to be capable of carrying either a nuclear or a conventional warhead was launched in a conventional role, the target country might, on detecting the launch through its earlywarning systems, misconstrue the mission as an imminent nuclear strike and immediately unleash a nuclear counter-strike of its own. This conjecture was voiced, for example, as a criticism of the proposals for giving the US Trident SLBM, long associated with nuclear missions, a capability to deliver conventional warheads. Whatever the merit of those proposals (it is not explored here), it is hard to regard this particular apprehension as having any real-life credibility. The flight time of a ballistic missile would not exceed about thirty minutes, and that of a cruise missile a few hours, before arrival on target made its character—conventional or nuclear—unmistakable. No government will need, and no non-lunatic government could wish, to lake within so short a span of time a step as enormous and irrevocable as the execution of a nuclear strike On the basis of early-warning information alone without knowing the true nature of the incoming attack. The speculation tends moreover to be expressed without reference either to any realistic political or conflict-related context thought to render the episode plausible, or to the manifest interest of the launching country, should there be any risk of doubt, in ensuring—by explicit communication if necessary—that there was no misinterpretation of its conventionally armed launch. It may be objected to this analysis that in the cold war the two opposing superpowers had concepts of launch-on-warning. That seems to be true, at least in the sense that successive US administrations declined to rule out such an option and indeed included in their contingency plans both this and the possibility of launch-under-attack (that is launch after some strikes had been suffered and while the sequence of them was evidently continuing). The Soviet Union was not likely to have had more relaxed practices. But the colossal gravity of activating any such arrangements must always have been recognized. It could have been contemplated only in circumstances where the entire political context made a pre-emptive attack by the adversary plainly a serious and imminent possibility, and where moreover the available information unmistakably indicated that a massive assault with hundreds or thousands of missiles was on the way. That was a scenario wholly unlike that implicit in the supposition that a conventional missile attack might be briefly mistaken for a nuclear one. The other sort of misunderstanding conjectured—that of misreading the source of attack—envisaged, typically, that SLBMs launched by France or the United Kingdom might erroneously be supposed to be coming from US submarines, and so might initiate a superpower exchange which the United States did not in fact intend. (An occasional variant on this was the notion that 'triggering' in this way might actually be an element in deliberate French or UK deterrent concepts. There was never any truth in this guess in relation to the United Kingdom, and French thinking is unlikely to have been different.) The unreality in this category of conjecture lay in the implication that such a scenario could develop without the US government making the most determined efforts to ensure that Soviet (or now Russian) leaders knew that the United States was not responsible for the attack, and with those leaders for their part resorting, on unproven suspicion, to action that was virtually certain to provoke nuclear counter-action from the United States. There used occasionally to be another speculation, that if the Soviet Union suffered heavy nuclear strikes known to come from France or the United Kingdom, it might judge its interests to be best served by ensuring that the United States did not remain an unscathed bystander. But even if that were somehow thought marginally less implausible, it would have been a different matter from misinterpretation of the initial strike. As was noted earlier in this chapter, the arrangements under which nuclear-weapon inventories are now managed are in several important respects already much less open to concern than they were during much of the cold war. Worries voiced more recently sometimes relate to 'cyber-attack'—hostile interference, whether by states or by other actors such as terrorists, with information systems used in the control of armouries. It is highly unlikely, though details are (again understandably) not made public, that regular reviews of control arrangements are oblivious to any such risks. Perceptions of them do however reinforce the already-strong case that whatever arrangements still remain in place for continuous high readiness to launch nuclear action at short notice should be abandoned. Chapter 13 returns to this. Structural violence outweighs Scheper-Hughes and Bourgois, 4 – professor of anthropology and Cal-Berkeley; professor of anthropology at University of Pennsylvennia (Nancy and Philippe, “Introduction: Making Sense of Violence, in Violence in War and Peace,” 2004, pg. 19-22) //RGP This large and at first sight “messy” Part VII is central to this anthology’s thesis. It encompasses everything from the routinized, bureaucratized, and utterly banal violence of children dying of hunger and maternal despair in Northeast Brazil (Scheper-Hughes, Chapter 33) to elderly African Americans dying of heat stroke in Mayor Daly’s version of US apartheid in Chicago’s South Side (Klinenberg, Chapter 38) to the racialized class hatred expressed by British Victorians in their olfactory disgust of the “smelly” working classes (Orwell, Chapter 36). In these readings violence is located in the symbolic and social structures that overdetermine and allow the criminalized drug addictions, interpersonal bloodshed, and racially patterned incarcerations that characterize the US “inner city” to be normalized (Bourgois, Chapter 37 and Wacquant, Chapter 39). Violence also takes the form of class, racial, political self-hatred and adolescent self-destruction (Quesada, Chapter 35), as well as of useless (i.e. preventable), rawly embodied physical suffering, and death (Farmer, Chapter 34). Absolutely central to our approach is a blurring of categories and distinctions between wartime and peacetime violence. Close attention to the “little” violences produced in the structures, habituses, and mentalites of everyday life shifts our attention to pathologies of class, race, and gender inequalities. More important, it interrupts the voyeuristic tendencies of “violence studies” that risk publicly humiliating the powerless who are often forced into complicity with social and individual pathologies of power because suffering is often a solvent of human integrity and dignity. Thus, in this anthology we are positing a violence continuum comprised of a multitude of “small wars and invisible genocides” (see also Scheper- Hughes 1996; 1997; 2000b) conducted in the normative social spaces of public schools, clinics, emergency rooms, hospital wards, nursing homes, courtrooms, public registry offices, prisons, detention centers, and public morgues. The violence continuum also refers to the ease with which humans are capable of reducing the socially vulnerable into expendable nonpersons and assuming the license - even the duty - to kill, maim, or soul-murder. We realize that in referring to a violence and a genocide continuum we are flying in the face of a tradition of genocide studies that argues for the absolute uniqueness of the Jewish Holocaust and for vigilance with respect to restricted purist use of the term genocide itself (see Kuper 1985; Chaulk 1999; Fein 1990; Chorbajian 1999). But we hold an opposing and alternative view that, to the contrary, it is absolutely necessary to make just such existential leaps in purposefully linking violent acts in normal times to those of abnormal times. Hence the title of our volume: Violence in War and in Peace. If (as we concede) there is a moral risk in overextending the concept of “genocide” into spaces and corners of everyday life where we might not ordinarily think to find it (and there is), an even greater risk lies in failing to sensitize ourselves, in misrecognizing protogenocidal practices and sentiments daily enacted as normative behavior by “ordinary” good-enough citizens. Peacetime crimes, such as prison construction sold as economic development to impoverished communities in the mountains and deserts of California, or the evolution of the criminal industrial complex into the latest peculiar institution for managing race relations in the United States (Waquant, Chapter 39), constitute the “small wars and invisible genocides” to which we refer. This applies to African American and Latino youth mortality statistics in Oakland, California, Baltimore, Washington DC, and New York City. These are “invisible” genocides not because they are secreted away or hidden from view, but quite the opposite. As Wittgenstein observed, the things that are hardest to perceive are those which are right before our eyes and therefore taken for granted. In this regard, Bourdieu’s partial and unfinished theory of violence (see Chapters 32 and 42) as well as his concept of misrecognition is crucial to our task. By including the normative everyday forms of violence hidden in the minutiae of “normal” social practices in the architecture of homes, in gender relations, in communal work, in the exchange of gifts, and so forth - Bourdieu forces us to reconsider the broader meanings and status of violence, especially the links between the violence of everyday life and explicit political terror and state repression, Similarly, Basaglia’s notion of “peacetime crimes” - crimini di pace - imagines a direct relationship between wartime and peacetime violence. Peacetime crimes suggests the possibility that war crimes are merely ordinary, everyday crimes of public consent applied systematically and dramatically in the extreme context of war. Consider the parallel uses of rape during peacetime and wartime, or the family resemblances between the legalized violence of US immigration and naturalization border raids on “illegal aliens” versus the US governmentengineered genocide in 1938, known as the Cherokee “Trail of Tears.” Peacetime crimes suggests that everyday forms of state violence make a certain kind of domestic peace possible. Internal “stability” is purchased with the currency of peacetime crimes, many of which take the form of professionally applied “strangle-holds.” Everyday forms of state violence during peacetime make a certain kind of domestic “peace” possible. It is an easy-to-identify peacetime crime that is usually maintained as a public secret by the government and by a scared or apathetic populace. Most subtly, but no less politically or structurally, the phenomenal growth in the United States of a new military, postindustrial prison industrial complex has taken place in the absence of broad-based opposition, let alone collective acts of civil disobedience. The public consensus is based primarily on a new mobilization of an old fear of the mob, the mugger, the rapist, the Black man, the undeserving poor. How many public executions of mentally deficient prisoners in the United States are needed to make life feel more secure for the affluent? What can it possibly mean when incarceration becomes the “normative” socializing experience for ethnic minority youth in a society, i.e., over 33 percent of young African American men (Prison Watch 2002). In the end it is essential that we recognize the existence of a genocidal capacity among otherwise good-enough humans and that we need to exercise a defensive hypervigilance to the less dramatic, permitted, and even rewarded everyday acts of violence that render participation in genocidal acts and policies possible (under adverse political or economic conditions), perhaps more easily than we would like to recognize. Under the violence continuum we include, therefore, all expressions of radical social exclusion, dehumanization, depersonal- ization, pseudospeciation, and reification which normalize atrocious behavior and violence toward others. A constant self-mobilization for alarm, a state of constant hyperarousal is, perhaps, a reasonable response to Benjamin’s view of late modern history as a chronic “state of emergency” (Taussig, Chapter 31). We are trying to recover here the classic anagogic thinking that enabled Erving Goffman, Jules Henry, C. Wright Mills, and Franco Basaglia among other mid-twentieth-century radically critical thinkers, to perceive the symbolic and structural relations, i.e., between inmates and patients, between concentration camps, prisons, mental hospitals, nursing homes, and other “total institutions.” Making that decisive move to recognize the continuum of violence allows us to see the capacity and the willingness - if not enthusiasm - of ordinary people, the practical technicians of the social consensus, to enforce genocidal-like crimes against categories of rubbish people. There is no primary impulse out of which mass violence and genocide are born, it is ingrained in the common sense of everyday social life. The mad, the differently abled, the mentally vulnerable have often fallen into this category of the unworthy living, as have the very old and infirm, the sick-poor, and, of course, the despised racial, religious, sexual, and ethnic groups of the moment. Erik Erikson referred to “pseudo- speciation” as the human tendency to classify some individuals or social groups as less than fully human - a prerequisite to genocide and one that is carefully honed during the unremark- able peacetimes that precede the sudden, “seemingly unintelligible” outbreaks of mass violence. Collective denial and misrecognition are prerequisites for mass violence and genocide. But so are formal bureaucratic structures and professional roles. The practical technicians of everyday violence in the backlands of Northeast Brazil (Scheper-Hughes, Chapter 33), for example, include the clinic doctors who prescribe powerful tranquilizers to fretful and frightfully hungry babies, the Catholic priests who celebrate the death of “angel-babies,” and the municipal bureaucrats who dispense free baby coffins but no food to hungry families. Everyday violence encompasses the implicit, legitimate, and routinized forms of violence inherent in particular social, economic, and political formations. It is close to what Bourdieu (1977, 1996) means by “symbolic violence,” the violence that is often “nusrecognized” for something else, usually something good. Everyday violence is similar to what Taussig (1989) calls “terror as usual.” All these terms are meant to reveal a public secret - the hidden links between violence in war and violence in peace, and between war crimes and “peace-time crimes.” Bourdieu (1977) finds domination and violence in the least likely places - in courtship and marriage, in the exchange of gifts, in systems of classification, in style, art, and culinary taste- the various uses of culture. Violence, Bourdieu insists, is everywhere in social practice. It is misrecognized because its very everydayness and its familiarity render it invisible. Lacan identifies “rneconnaissance” as the prerequisite of the social. The exploitation of bachelor sons, robbing them of autonomy, independence, and progeny, within the structures of family farming in the European countryside that Bourdieu escaped is a case in point (Bourdieu, Chapter 42; see also Scheper-Hughes, 2000b; Favret-Saada, 1989). Following Gramsci, Foucault, Sartre, Arendt, and other modern theorists of power-vio- lence, Bourdieu treats direct aggression and physical violence as a crude, uneconomical mode of domination; it is less efficient and, according to Arendt (1969), it is certainly less legitimate. While power and symbolic domination are not to be equated with violence - and Arendt argues persuasively that violence is to be understood as a failure of power - violence, as we are presenting it here, is more than simply the expression of illegitimate physical force against a person or group of persons. Rather, we need to understand violence as encompassing all forms of “controlling processes” (Nader 1997b) that assault basic human freedoms and individual or collective survival. Our task is to recognize these gray zones of violence which are, by definition, not obvious. Once again, the point of bringing into the discourses on genocide everyday, normative experiences of reification, depersonalization, institutional confinement, and acceptable death is to help answer the question: What makes mass violence and genocide possible? In this volume we are suggesting that mass violence is part of a continuum, and that it is socially incremental and often experienced by perpetrators, collaborators, bystanders - and even by victims themselves - as expected, routine, even justified. The preparations for mass killing can be found in social sentiments and institutions from the family, to schools, churches, hospitals, and the military. They harbor the early “warning signs” (Charney 1991), the “priming” (as Hinton, ed., 2002 calls it), or the “genocidal continuum” (as we call it) that push social consensus toward devaluing certain forms of human life and lifeways from the refusal of social support and humane care to vulnerable “social parasites” (the nursing home elderly, “welfare queens,” undocumented immigrants, drug addicts) to the militarization of everyday life (super-maximum-security prisons, capital punishment; the technologies of heightened personal security, including the house gun and gated communities; and reversed feelings of victimization). 1AC Plan The United States Federal Government should apply strict scrutiny to federally funded public health surveillance programs. ***Solvency*** Solvency – Informed Consent Breach notifications fulfill informed consent – increases trust Pritts 13 (Joy L. Pritt. “The Importance and Value of Protecting the Privacy of Health Information: The Roles of the HIPAA Privacy Rule and the Common Rule in Health Research.” 2013. P. 9-10. http://iom.nationalacademies.org/~/media/Files/Activity%20Files/Research/HIPAAandResearch/PrittsPr ivacyFinalDraftweb.ashx)//EMerz Under the principles of fair information practices, patients should be given notice, in plain language, of the information practices of those who generate and maintain their health information. The notice should inform patients how information will be used and to whom it will be disclosed. Notices can also serve to bolster trust between health care providers and patients to the extent they remove the element of surprise about the use and disclosure of health information. Although there seems to be little dispute that the principle of providing a notice of information practice is a sound one, only a few states require health care providers to Under accepted principles of fair information practices, those who maintain identifiable health information should have in place appropriate safeguards to protect unauthorized use or disclosure of the information. These safeguards identify the means by which a provider protects the confidentiality of health information. A few states such as California, Florida and Washington have statutorily required providers to undertake security measures to ensure that health information is used and disclosed properly. Florida, for example, requires those who maintain medical records to develop and implement policies, standards, and procedures to protect the confidentiality and security of the medical record, and to train their employees in these policies, standards, and procedures. Solvency – Data Deletion Congress should delete DNA databases- not doing so enforces the panopticon McNeal 13 (Gregory S. McNeal. Associate Professor of Law and Public Policy at Pepperdine University. “Congress Should Act To Protect DNA From Genetic Surveillance.” June 3, 2013. http://www.forbes.com/sites/gregorymcneal/2013/06/03/congress-should-act-to-protect-dna-fromgenetic-surveillance/)//EMerz It’s time for innocent people to open their mouths for royal inspection and DNA collection by agents of the government. That is the likely consequence of the Supreme Court’s opinion in Maryland v. King, at least in the view of Justice Scalia who believes that innocent people wrongfully arrested may now have their DNA collected and permanently stored in a national database. To protect the genetic information of innocent arrestees, Congress should take a cue from our royal forebears and adopt legislation similar to that which the U.K. adopted in May of 2012. In today’s opinion in Maryland v. King, the Court authorized the collection of DNA from anyone arrested for a “serious crime.” While the majority claimed to limit its holding to “serious crimes,” there was no articulated Constitutional principle to limit its judgment, suggesting to the dissenters (Scalia, Ginsburg, Sotomayor and Kagan) that “[w]hen there comes before us the taking of DNA from an arrestee for a traffic violation, the Court will predictably (and quite rightly) say, ‘We can find no significant difference between this case and King.’” As a consequences of this judgment, they continued, “your DNA can be taken and entered into a national DNA database if you are ever arrested, rightly or wrongly, and for whatever reason.” The opinion thus narrowed the difference between an innocent arrestee and convicted criminal, with innocent arrestees bearing the brunt of the narrowing. Convicted criminals can already have their DNA collected as a consequence of their conviction, thus the Supreme Court’s opinion extending the collection of DNA to arrestees will have its biggest impact on those who have been acquitted of the crime for which they were arrested. In the dissent’s words, “this Act manages to burden uniquely the sole group for whom the Fourth Amendment’s protections ought to be most jealously guarded: people who are innocent of the State’s accusations.” If you’re arrested by the police for a crime they may swab your mouth for DNA, and if it turns out they made a mistake and arrested the wrong person, you’ll be released but your DNA may (subject to local policies) sit indefinitely in a government database somewhere. In the eyes of the dissent there is nothing to stop the police from creating a policy that DNA will be collected for every arrest, or perhaps even collected for every government interaction. As Noah Feldman has observed, the possible future use of DNA might be one of bureaucratic identification. Is it implausible to think that in a decade the government may ask for a drivers license, registration and a DNA sample at a traffic stop? After all, the police need to ensure that the person handing over their identification is the person depicted on the drivers license, and DNA is far more accurate than an outdated drivers license photograph. So what can Congress do to protect innocent people while still ensuring DNA can be used to solve crimes? Why not take a cue from Europe and automatically delete the DNA of innocent persons from government databases. In 2008, the European Court of Human Rights handed down its opinion in the Case of S. and Marper v. UK. In the opinion the ECHR found that blanket and indiscriminate retention of “fingerprints, cellular samples and DNA profiles of persons suspected but not convicted of offenses…fails to strike a fair balance between the competing public and private interests.” Such indefinite retention of innocent persons data is in the ECHR’s words an “interference with the applicants’ right to respect for private life and cannot be regarded as necessary in a democratic society.” Following the decision the UK passed the Protection of Freedoms Act which required the removal of innocent persons DNA from government databases, prohibited the storage of DNA from people arrested and charged but not convicted of a minor offense, and imposed a three-year limit on the storage of DNA for people charged, but not convicted, of a serious offense. Thus, the opinion and the Protection of Freedoms Act, shifted the U.K.’s approach from one of automatic indefinite retention (with a right to request deletion similar to the U.S. expungement policy) to one of automatic deletion after a period of time. Congress should follow the U.K.’s lead and pass legislation to protect innocent people. Such legislation should should require that the government delete DNA records of arrestees who are not charged with crimes or who are acquitted of minor offenses. Second, for serious offenses (which Congress will need to define), the legislation should require that the government delete the DNA records of persons who are charged with but not convicted of serious offenses (perhaps after 3-5 years). For those concerned about the impact of such a decision on national security, Congress could implement procedures to allow for the continued retention of DNA information about suspects in ongoing national security investigations, subject to regular certification by the Secretary of Homeland Security or Attorney General. Some people concerned about crime prevention may not be troubled by the Supreme Court’s opinion, likening it to fingerprints. But DNA is far more revealing than a fingerprint, it gives the government ethnic and familial information and as technology advances may enable far more intrusive tracking and analytical capabilities. Collecting DNA in government databases will no doubt have the beneficial effect of solving more crimes, but as the dissent notes “so would the taking of DNA samples from anyone who flies on an airplane, applies for a driver’s license, or attends a public school. Perhaps the construction of such a genetic panopticon is wise. But I doubt that the proud men who wrote the charter of our liberties would have been so eager to open their mouths for royal inspection.” Congress should act to protect innocent people from the collection and storage of their genetic information. Solvency – Breach Notification Breach notification as a legal oversight to surveillance is an effective regulatory strategy- it deters future surveillance Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 11-13 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz In contrast, the FTC rule applicable to non-HIPAA PHR vendors relies on the somewhat “older” approach to “breach,” whereby “[u]nauthorized acquisition will be presumed to include unauthorized access to unsecured PHR identifiable health information” absent “reliable evidence showing that there has not been, or could not reasonably have been, unauthorized acquisition of such information.”63 Not only do somewhat different rules apply to breach notification regarding essentially similar EMR or PHR data, but security breaches regarding health data in the hands of custodians who are neither HIPAA entities nor PHR vendors generally do not require breach notification. Specifically, this regulatory gap works in favor of big data custodians of non-HIPAA (medically inflected) health data or “laundered” HIPAA data. A sufficiently serious breach in the face of poor security practices or technology might trigger an FTC inquiry.64 Such eventuality aside the only possible regulatory model would be state law breach notification. As already noted few state laws include health information within their definitions of protected data, though there are exceptions such as the Californian law. Breach notification as a data protection model is deserving of some criticism. It is only triggered when, necessarily, data protection has failed, and it is a somewhat immature data protection model that likely will need additional calibration as we analyze its underregulation or over-regulation tendencies. For example, to the extent that more experience tells us that we may be over-regulating some types of minor breaches it might be sensible to allow for an apologyplus-purchase of insurance defense or safe harbor. Notwithstanding, HITECH’s version seems to have some value. First, as clearly intended by the statute, 68 the “Wall of Shame” website acts as a strong deterrence system.69 As more data is collected about the porousness of our health care providers’ systems, a simple web listing could evolve into a more robust and useful ranking model across privacy and security dimensions, as (for example) with the quality/safety-based Hospital Compare. 70 Second, the notification system has become an important part of OCR enforcement as the agency relies on breach notifications to initiate privacy and security rule enforcement. On balance, breach notification has strengthened its fellow downstream protection models – HIPAA confidentiality and security. First, the HITECH Act’s breach notification model includes a public “shaming” deterrent designed to improve compliance with the HIPAA rules.72 Second, and obviously, notifying HHS of a substantial breach invites investigation by OCR. Overall (and likely this was an unintended consequence) breach notification is an endorsement of health privacy exceptionalism with its regulatory model applying to very narrow slices of health data custodians (HIPAA, PHR and “others”). However, the narrowness of its definition and its quintessential downstream data protection model confirm its irrelevance in any search for a federal privacy response to big data’s growing hold on medically inflected data. Solvency - Courts/Scrutiny Key Centralized federal action is key – providing uniform guidance is key to prevent policy fragmentation – key to prevent over- and under-reactions by the government Azarchs 14 (Timothy Azarchs, Articles Editor, University of Pennsylvania Journal of Constitutional Law, Volume 16. J.D. Candidate, 2014, University of Pennsylvania Law School; B.A., 2011, Bard College.)(“INFORMATIONAL PRIVACY: LESSONS FROM ACROSS THE ATLANTIC”, JOURNAL OF CONSTITUTIONAL LAW, Vol. 16:3, Feb. 2014)//ASMITH Even if we accept that these holes should be filled, it would not necessarily be clear that the federal judiciary should be the one to fill them. The most obvious problem is one of democratic legitimacy: if there is no constitutional basis for the right, then the federal courts have no authority to impose a remedy. This may be why the Court has been so reluctant to make a definitive decision on the existence of a right. To step forward and acknowledge a right would be to risk judicial overreach, yet, at the same time, to step back would be to re-verse three decades of jurisprudence in the lower courts and deny a right that may be desirable to protect.97 Another problem with common law privacy protections is that, developing on a case-by-case basis, they would be less transparent and coherent than a comprehensive legislative effort.98 This is particularly true when there is no clear principle guiding the decisions as to what should be protected and what should be sufficient justification.99 Without guiding principles, judges are left to their own value judg-ments rather than uniform philosophical principles or democratically agreed-upon consensus. Furthermore, there is little basis on which to predict what activity will be deemed a violation until after a court has decided, leaving little guidance ex ante as to when an action should not be taken, when a right needs vindicating, and when a suit is frivo-lous.100 These critiques apply with equal force to the current state of affairs, however, where the Supreme Court hypothesizes about a right to informational privacy while the lower courts continue to feel their way in the dark towards disparate ends.101 It is therefore not a reason for the Court to maintain its current course. While the legislature may have more democratic legitimacy and greater ex ante perspective from which to develop a cohesive frame- work, leaving the decisions on privacy rights to the political process as opposed to the judiciary is problematic from another perspective. One of the primary purposes of a constitution is to prevent the will of the majority from oppressing the minority—why else constrain the power of a democratically elected legislature?102 There is admittedly no clear minority group disfavored by a lack of privacy protections. There are undoubtedly some kinds of information each of us may consider worth protecting, and the legislatures may eventually re-spond to that desire. However, legislative action is not always effective at protecting dis-favored minority groups.103 The majority may wish to oust these out-siders, or it may simply lack the motivation to overcome the inertia of the legislative process. For instance, it might be easier to pass a law that allowed the government to collect information about immi-grants—ostensibly because they are more likely to be terrorists or drug runners—than to pass a law that protects homosexuals from dis-closure of their sexual orientations. The right to privacy is funda-mentally a minority protection, allowing a sphere of autonomous de-cisionmaking and freedom from the fear of the majority’s ridicule of one’s personal choices. To lay the burden of protecting this right at the feet of the majority suffers from the same problems as asking the majority to decide whether one might engage in consensual homo-sexual relations or join the communist party.104 Recognition by the courts that informational privacy is an important right with constitu-tional dimensions could help ensure that the courts will scrutinize such infringements, whether affirmatively enacted by the legislature or committed by the executive in the absence of legislative protec-tions. The idea that so important a right can exist on so shaky a ground–or indeed not exist at all—is fundamentally problematic. In addition, these gaps in legislative protections for the right to privacy have persisted for a very long time, and it is not altogether clear that the gears are turning to close them now.105 Even if legisla-tive clarity is preferable to judicial clarity, one clear answer from the Supreme Court is preferable to twelve vague ones from the circuits. The current uncertainty has several detrimental effects. First, insofar as there is a “correct” answer to the question, a circuit split im-plies that one side or the other is “incorrect.” Either constitutional rights are being underenforced in jurisdictions that improperly nar-row the right, or nonexistent rights are being enforced in jurisdic-tions that improperly broaden it. Second, this assumed, but unconfirmed, right leaves the lower courts, government actors, and potential claimants with little guid-ance. As Justice Scalia suggested in his concurrence in NASA v. Nel-son, this encourages an endless stream of hopeful plaintiffs to flood the courts with claims that are different on one or another dimension from decided cases because they have no grounds on which to de-termine whether those differences are relevant.106 A vague right may therefore result in even more litigation than a broad but clear one. Another possibility is that, for fear of prosecution, government agencies will be unwilling to cross a boundary whose location is un-certain and will be deterred from beneficial policies that approach but do not step over that boundary.107 The question should be set-tled, one way or the other, and the Supreme Court may be the only institution that can settle it. Government specification on justifications for patient surveillance need to be reformed in order to protect privacy Mariner 07 (WENDY K.MARINER, Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health; Professor of Law, Boston University School of Law; Professor of SocioMedical Sciences, Boston University School of Medicine. J.D., Columbia University School of Law; LL.M, New York University School of Law; M.P.H., Harvard School of Public Health.)(“MISSION CREEP: PUBLIC HEALTH SURVEILLANCE AND MEDICAL PRIVACY”, BOSTON UNIVERSITY LAW REVIEW, Vol. 87:347, 2007)//ASMITH In contrast to the broad, future-oriented ideas of public health they embrace, first generation cases like Whalen sometimes treat patient privacy as narrow and concrete. Under this approach, highly speculative benefits could be accepted as legitimate reasons to override patient consent. At the same time, costs to the patient must often be both probable and substantial, often in the form of financial loss, in order to weigh in the balance. Even if public health goals are more specifically identified, the definition of privacy in one’s medical information may also require more precision in order to achieve meaningful balance. Like public health, the concept of privacy can be fraught with ambiguity and possibilities for expansion. Privacy is often understood to mean an individual’s right to control access to information about herself.175 Yet the literature contains ample acknowledgement that this is hardly sufficient to explain the many, sometimes contradictory, facets of privacy, much less its exceptions.176 Certainly the Supreme Court has yet to define the whole of its scope and limits. Even in the absence of consensus on the overall concept, however, it is still both possible and defensible to treat personal medical information privacy as a specific aspect of privacy for the purpose of examining when that information is justifiably subject to involuntary disclosure – and re-disclosure – to government. The analysis of the concept of privacy for purposes of public health surveillance should be limited to information, from whatever source, about an identifiable individual’s health status, medical care, genetic characteristics, personal behavior, or exposure to health risks. The Supreme Court has referred to information privacy in part as “‘the individual interest in avoiding disclosure of personal matters.’”177 This “disclosure” can take several forms. The first and most commonly thought of is disclosure to the public, in the form of deliberate or negligent publication of personal facts to society at large. This is the type of injury that impelled Warren and Brandeis to argue for a right to privacy.178 However, it is probably the least likely harm to individuals whose information is reported to a public health surveillance program. The second form of disclosure, and the primary focus of this discussion, is the compulsory revelation or transmission to a government agency. As emphasized by several judges in the abortion cases discussed above, this form of disclosure is more accurately characterized as a possible invasion of privacy, because, metaphorically at least, the government forces its way into one’s personal space to extract information that a person wishes to keep secret. This form of disclosure/invasion takes place at each level of surveillance. While concern for deliberate or negligent revelations to the public at large may exist with respect to any collection of information, including information voluntarily disclosed, it is likely that the core concern of information privacy is with invasions of privacy in which the government obtains personal information without consent.179 The concept of privacy attached to one’s personal information seems to include, at its essence, a sense of autonomy and self-determination – not just physical control over papers or computer files. Unlike other forms of property, the information has value because of what it reveals about a person.180 Personal information is thus an aspect of the human being; it involves one’s identity and dignity.181 Loss of personal information can seem as much a violation of a person’s dignity as a physical invasion of the body. In this respect, privacy protects one’s sense of self. When government has the power to take that personal knowledge, it invades that sense of self. This may be why the violation of privacy often provokes feelings of outrage, even when the facts acquired are not embarrassing. An invasion of privacy violates one’s dignity, even if it fails to produce economic injury. Yet courts have failed to frame this aspect of privacy as a cognizable cause of action. Even though not everyone would agree on what types of information would be embarrassing if revealed, the central issue is whether that choice is theirs to make. If we conclude that the information should be revealed because a majority of people don’t care, we dispense with the principle that everyone has prima facie control over the choice of revelation. That is not an especially persuasive argument against requiring consent, and it fails to consider whether revelation should be a matter of personal or social choice. Even where there is a persuasive argument for social choice, the question remains whether that choice should be made through legislation or by some other more stringent mechanism, such as obtaining a warrant based on probable cause. Court clarification on health and privacy laws are necessary in order to protect privacy Mariner 07 (WENDY K.MARINER, Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health; Professor of Law, Boston University School of Law; Professor of SocioMedical Sciences, Boston University School of Medicine. J.D., Columbia University School of Law; LL.M, New York University School of Law; M.P.H., Harvard School of Public Health.)(“MISSION CREEP: PUBLIC HEALTH SURVEILLANCE AND MEDICAL PRIVACY”, BOSTON UNIVERSITY LAW REVIEW, Vol. 87:347, 2007)//ASMITH The central question is whether there is a right of privacy that prevents the government from obtaining medical information about an individual to be used for various public health surveillance purposes without first obtaining the individual’s consent. States adopt reporting laws, of course, because most recognize common law, if not statutory, rights of privacy and confidentiality in medical information, which forbid physicians from disclosing patient information and records without consent.127 Additionally, federal courts of appeal have recognized Fourteenth Amendment protection for a person’s privacy interest in personal medical information and from involuntary disclosure to state and federal agencies.128 Unfortunately, this extensive body of case law provides little guidance for determining the justifications for mandatory reporting laws. Such laws have rarely received judicial review. The few U.S. Supreme Court decisions that have addressed the subject have granted state legislatures substantial, but not unlimited, deference. But the Court has yet to consider the constitutionality of modern public health surveillance systems – specifically those that compel disclosure of personally identifiable medical information to allow deduplication and ensure that such data are accurate enough to be used for research and budget analyses. Indeed, the Court’s decisions have rarely analyzed the actual use of the data to be collected, referring to it generally as intended to prevent disease or promote public health. In light of recent challenges to the use of personal medical information for other purposes,129 however, it is unlikely that such surveillance programs will remain under the radar forever. In Whalen v. Roe,130 the Supreme Court upheld a state law requiring any physician who prescribed a Schedule II controlled substance to submit a copy of the prescription to the New York State Department of Health.131 The petitioners had challenged the law’s requirement that patients’ names and addresses be collected and retained by the state, arguing that it violated their right to privacy as protected by the Fourteenth Amendment.132 The law was intended to prevent the diversion of drugs into “unlawful channels,” specifically by preventing individuals from obtaining controlled substances from more than one physician or using stolen or altered prescriptions, preventing pharmacists from refilling dangerous prescriptions, and preventing physicians from over-prescribing.133 If prevention failed, the records would enable investigators to identify – and possibly prosecute – those who were breaking the law. Not surprisingly, the Court found that the goal was reasonable,134 and that the prescription system “could reasonably be expected to have a deterrent effect on potential violators as well as to aid in the detection or investigation of specific instances of apparent abuse.”135 The Court noted that the reporting requirement was not “meaningfully distinguishable from a host of other unpleasant invasions of privacy that are associated with many facets of health care,”136 comparing it to “reporting requirements relating to venereal disease, child abuse, injuries caused by deadly weapons, and certifications of fetal death.”137 A stricter level scrutiny protects privacy rights and prevents government inefficiencies due to excessive numbers of privacy cases Azarchs 14 (Timothy Azarchs, Articles Editor, University of Pennsylvania Journal of Constitutional Law, Volume 16. J.D. Candidate, 2014, University of Pennsylvania Law School; B.A., 2011, Bard College.)(“INFORMATIONAL PRIVACY: LESSONS FROM ACROSS THE ATLANTIC”, JOURNAL OF CONSTITUTIONAL LAW, Vol. 16:3, Feb. 2014)//ASMITH The urgency of this intuitive need for protection is reinforced by the fact that state law remedies do not cover the full range of privacy issues, not even in the cases of government executive action.86 Defamation claims may only be leveled when disclosed information is false: not when the information is true, not when the government collects private information without disclosing it, and not when the First Amendment is implicated and no malice is shown.87 In most states, an action exists for publication of a private fact, but only if there has been disclosure of “highly offensive” matters to a wide audience: not when the disclosure is merely private but not highly offensive, or when the audience is a small but important group such as a person’s spouse, parents, or employer.88 Nor does it exist in the fourteen states that do not have this cause of action.89 Finally, there is a remedy for intentional infliction of emotional distress, but this reaches only the most “extreme and outrageous” disclosures, and even then, only when the disclosure is at least reckless.90 Thus, a case in which a police officer needlessly discloses a person’s HIV status, causing that person’s entire family to be ostracized, would likely not be cognizable under any state law remedy because the information was true, disclosed only to a small audience—who later told the press—and likely not outrageous enough to be intentional infliction of emotional distress.91 Similarly, a case in which a boy commits suicide after the police threaten to tell his grandfather that he is a homosexual would be unlikely to fall under any of these state law torts.92 There is some question whether the gaps left by this patchwork of state law privacy protections should be closed. Ingrid Schüpbach Mar-tin argues that they should not be closed because the law should favor free dissemination of information over privacy.93 In other words, she believes that society would be a better place if everyone came out of the closet and had a frank discussion about their lifestyle. She worries that allowing someone to sue for disclosure of their sexual orientation officially acknowledges that that status is shameful and embar-rassing.94 Martin may be right that society would be a better place if everyone came out of the closet. But to force individuals to disclose their sexual identity for our own betterment—to force them to sacrifice their privacy and suffer the real if unfortunate costs that might attend that sacrifice—may ask too much. Martin further argues that closing the gaps left by state tort law and allowing challenges to potentially unconstitutional lawmaking could produce excessive litigation against government agents that impede their efficiency.95 The thought that closing the gaps would produce substantially more cases than have already been dealt with over the last three decades hardly seems plausible, however. In the majority of circuits, the courts have accepted some level of protection for informational privacy rights already and must hear cases on these issues even where those protections are limited to “fundamental” rights protected by the decisional line of privacy.96 There may even be less litigation when clear standards deter frivolous suits and a recognized, defined right reduces the incidence of violation. While such a right may cause a police officer to pause and consider whether dis-closure of a particular piece of information collected in his or her investigation implicates a privacy right, the potential harm to the fact-finding process can be minimized by an appropriately deferential level of scrutiny, and the mitigating benefits to privacy rights may be worthwhile. Solvency – Fed Key Federal laws control state action Gostin 2k (Lawrence O. Gostin, JD, LLD, Georgetown/Johns Hopkins University Program in Law and Public Health, Washington, DC, and Baltimore)(“ Public Health Law in a New Century”, 2000 American Medical Association, JAMA, June 14, 2000—Vol 283, No. 22)//ASMITH No inquiry is more important to public health law than understanding the role of government in the constitutional design. If public health law principally addresses government’s assurance of the conditions for the population’s health, then what activities must government undertake? The question is complex, requiring an assessment of duty, authority, and limits. In addition, this query raises a corollary question: Which government is to act? Some of the most divisive disputes in public health are among the federal government, the states, and localities about which government has the power to intervene. The Constitution allocates power among the federal government and the states (federalism) and limits that power (to protect individual liberties). In the realm of public health, the Constitution acts as both a fountain and a levee; it originates the flow of power to preserve the public health, and it curbs that power to protect individual freedoms. Federalism functions as a sorting device for determining which government (federal, state, or local) may legitimately respond to a public health threat. Often, federal, state, and local governments exercise public health powers concurrently. Where conflicts among the levels of government arise, however, federal laws preempt or supercede state actions, and state actions may preempt local laws. States must conform to federal regulatory standards Gostin 2k (Lawrence O. Gostin, JD, LLD, Georgetown/Johns Hopkins University Program in Law and Public Health, Washington, DC, and Baltimore)(“ Public Health Law in a New Century”, 2000 American Medical Association, JAMA, June 14, 2000—Vol 283, No. 22)//ASMITH In theory, the United States is a government of limited, defined powers. In reality, political and judicial expansion of national powers allows the federal government considerable authority to act in the interests of public health and safety. The federal government has a number of powers at its disposal to prevent injury and disease and promote the population’s health. The most important public health powers are the powers to tax, spend, and regulate interstate commerce. The powers to tax and spend are important because they enable the government to raise revenue and to allocate re- sources for the public’s health. Resource allocation, of course, can be highly contentious as evidenced by contemporary debates about spending money from the tobacco settlement. The taxing power also provides a powerful means to regulate, both directly and indirectly, private activities that endanger health. Tax relief provides incentives for private activities that government views as advantageous to public health (eg, employer-sponsored health care). Taxation also regulates private behavior by economically penalizing risk-taking activities (eg, taxes on tobacco and alcoholic beverages). Similarly, the spending power does not merely provide Congress with independent authority to allocate resources for the public good; it also allows Congress to set conditions on the receipt of funds.2 The need for federal public health funds effectively induces state conformance with federal regulatory standards. Congress uses conditional spending to induce states to conform to federal standards in numerous public health contexts, including Medicaid and Medicare, occupational health, and highway safety. Of all the provisions bestowing federal public health power, none is more important than Article 1, §8 of the Constitution, which grants Congress the power to “regulate Commerce . . . among the several States.” Practically speaking, the power to regulate commerce has enabled the national government to invade traditional realms of state authority including environmental protection, occupational health, food and drug purity, and safe drinking water. The Court’s modern construction of the power to regulate commerce has been described as plenary or all-embracing, and has been exerted to affect virtually every aspect of social life.3 Constitutional protections and heightened scrutiny maintains rights and dictate lower courts actions Azarchs 14 (Timothy Azarchs, Articles Editor, University of Pennsylvania Journal of Constitutional Law, Volume 16. J.D. Candidate, 2014, University of Pennsylvania Law School; B.A., 2011, Bard College.)(“INFORMATIONAL PRIVACY: LESSONS FROM ACROSS THE ATLANTIC”, JOURNAL OF CONSTITUTIONAL LAW, Vol. 16:3, Feb. 2014)//ASMITH The Supreme Court has left many unanswered questions. It has not decided whether a right to informational privacy exists; it has not decided what might constitute an infringement upon such a right; and it has not decided what level of scrutiny might be applied to such an infringement. Therefore, the lower courts have each gone their separate ways. Some courts have followed Justice Potter Stewart’s concurrence in Whalen, Justice Antonin Scalia’s in NASA, and the ma-jority opinion in Paul v. Davis, finding a restricted or nonexistent right.73 Others have created a broader sphere of protection, from medical information to anything with a legitimate expectation of pri-vacy, but nevertheless disagree on the level of scrutiny to be applied when a right is infringed.74 The majority, however, have ruled in favor of a relatively broad right and some form of heightened scrutiny.75 The courts that refuse to find a constitutional right protecting in-formational privacy typically express two lines of reasoning. The first is that no such right has any support in the text of the Constitution, and it is inappropriate to create that right judicially.76 The second is that an informational privacy right would be implicated in nearly eve- ry action of the government. Forcing the government to justify intru-sions and asking the courts to hear those justifications would be a burden too great to bear: the courts can hear only so many cases, and every minute a government agent spends defending his actions in court is a minute spent not performing his other duties.77 The perceived danger is that creating so broad a right would force courts to provide limited protection against individual infringements.78 Greater scrutiny means that statutes must be more narrowly tailored and government actions must have greater countervailing interests before they are justified, potentially forcing the government to use less efficient means to accomplish its goals. Demanding narrower tai-loring and greater justifications may be particularly difficult when the judicial branch has so little textual support for making such burden-some demands. Those courts that have accepted a broad right have typically simp-ly cited Whalen and the Supreme Court’s other privacy decisions and announced tests.79 The tests may reflect what Mary D. Fan refers to as the “creepiness emotional meter.”80 The gist of this concept is that there is an intuitive sense that the government should not be able to demand or divulge private information without good reason.81 Cer-tain actions taken by government officials or legislatures can and do step beyond the pale, so there must be some constitutional protec-tions when they do.82 The idea that a sex tape taken as evidence of extortion could be passed around the precinct for the viewing pleas-ure of the officers,83 or that humiliating details of a rape—details that the victim had not even told her husband—could be released at a press conference without public purpose,84 is so viscerally horrifying to the courts that it seems intuitively impossible that no constitutional right exists to prevent such behavior.85 Although state and federal governments have authority over health legislation, federal action is uniquely key- state action is inconsistent and stalls legal process Evans 13 (Barbara J. Evans. Professor of Law; Co-director, Health Law & Policy Institute; Director, Center on Biotechnology & Law, University of Houston Law Center, Yale Law School; M.S., Ph.D. Stanford University; Post-doctoral Fellow, The University of Texas M.D. Anderson Cancer Center. “Institutional Competence to Balance Privacy and Competing Values: The Forgotten Third Prong of HIPAA Preemption Analysis.” P. 1185-1188. http://lawreview.law.ucdavis.edu/issues/46/4/Articles/46-4_Evans.pdf)//EMerz Congress and state legislatures throughout our nation’s history have possessed the power to order actions to promote the public’s health. In the modern context, this includes the power to authorize programs that require the use of people’s health data and biospecimens. Shortly after Platt’s data were reported to the FDA and Institute of Medicine,40 Congress took such action in the Food and Drug Administration Amendments Act of 2007,41 which authorizes pharmacoepidemiological42 studies of postmarket drug safety using data for one hundred million Americans.43 Congress also called for largescale informational studies in the comparative effectiveness provisions of the Patient Protection and Affordable Care Act of 2010.44 Public health legislation (both state and federal) authorizing studies of people’s health data and biospecimens is likely to be a recurring feature of the twenty-first century legal landscape. There is great concern that privacy laws may thwart the objectives of these types of public health statutes. The HIPAA statute focused primarily on insurance and healthcare fraud issues, but it also expanded federal regulation of medical privacy and data security. The Administrative Simplification provisions in Subtitle F of Title II of HIPAA45 required the Secretary of the U.S. Department of Health & Human Services (HHS) to develop a group of interrelated regulations.46 Authority to develop Standards for the Privacy of Individually Identifiable Health Information (the “Privacy Rule”47) appears in section 264 of HIPAA, which is codified as a note to 42 U.S.C. § 1320d-2. The main text of § 1320d-2 authorizes HHS to develop various other regulations such as the Transactions Rule48 published in August 2000, the Security Rule49 promulgated in 2003, and standards for unique patient identifying numbers which proved controversial and encountered delays.50 HIPAA deposited a new layer of federal regulations onto a field already densely covered with state law.51 When healthcare providers and insurers initially began to comply with the HIPAA Privacy Rule in 2003-2004, there already was a “patch quilt” of state privacy statutes as well as a large body of common law, such as evidentiary privileges that protect medical communications and tort causes of action for privacy violations. In an excellent recent study, John W. Hill et al. explain how daunting this state-by-state patchwork has become.56 They argue that it threatens to obstruct the development of large, interoperable health data systems.57 Interoperable data networks that muster data for tens or hundreds of millions of persons are, of course, a critical infrastructure for the types of large-scale public health surveillance and investigations58 described in recent legislation.59 Not all public health studies require nationally-scaled data infrastructures, but a number of very promising approaches do. Thus, maintaining state-by-state privacy requirements has the potential to stall important public health initiatives by impeding access to data and biospecimens. State reforms can only ever be patchwork --- they don’t apply once the information leaves the physician’s possession Goldman, from the College of Physicians and Surgeons, Columbia University, November 1998 – (Janlori, “Protecting Privacy To Improve Health Care”, published in HealthAffairs volume 17 number 6)//roetlin In the absence of federal health privacy legislation, a number of states have moved to enact such legislation. In the past year alone more than 250 bills with medical privacy provisions were introduced in the states. More than thirty-two of these bills became law.22 However, there is little consistency to the state laws in this area. Many states “impose on physicians the duty to maintain the confidentiality of medical records,” but such protection may no longer apply after the records leave the physician’s possession (for example, to process a claim).23 State laws also may only address specific medical conditions, instead of the medical record as a whole. Virtually every state, for instance, has some form of special protection for communicable diseases.24 States have more recently enacted laws to protect the confidentiality of genetic test results.25 Other state laws address a specific activity. A recent Minnesota law, for example, requires that a patient’s consent be obtained before his or her medical records are used in research.26 The end result is what many have called a “patch- work” of protections at the state level. State law patchwork doesn’t provide enough protection Pritts 13 (Joy L. Pritts JD is a lawyer who practices in Washington DC and earned her degree at Georgetown Univeristy. “Altered States: State Health Privacy Laws and the Impact of the Federal Health Privacy Rule” http://digitalcommons.law.yale.edu/cgi/viewcontent.cgi?article=1047&context=yjhple)///CW Medical records contain some of the most intimate details about an¶ individual that can be found in a single place. Health information privacy¶ is based on the principle that individuals should be able to exercise control¶ over this intimate information, both by having full knowledge about what¶ information is contained in the records and by being able to control who¶ has access to the information. Because professional ethical requirements¶ do not adequately protect health information in today's complex health¶ care system, we have increasingly turned to the law as a source of¶ protection.¶ Until the recent promulgation of the Federal Health Privacy Rule,'¶ states have been the primary regulators of health information through¶ their constitutions, common law, and statutory provisions. Although all¶ three of these legal sources remain important, recent focus has been on¶ the enactment of detailed health privacy statutes that apply the fair¶ information practice principles to health information. However, for the¶ most part states have adopted these principles in a fairly haphazard fashion¶ resulting in a patchwork of legal protections both within and between¶ states.¶ The recently issued Federal Health Privacy Rule has effectively evened¶ out some of this discrepancy by establishing a federal floor of privacy¶ protections based on fair information practices. The Federal Rule,¶ however, does not afford adequate protection of health information¶ because it has limited applicability and areas of lax protection. Because the¶ Federal Rule only preempts conflicting, less protective state laws, there is¶ still room for states to protect their own citizens by retaining or enacting¶ health privacy protections that mirror and improve upon those in the¶ Federal Health Privacy Rule Only federal standards can solve – states fail Andrea Wilson (Senior Business Practices Analyst at The Methodist Hospital System, Houston, TX) 2009 “MISSING THE MARK: THE PUBLIC HEALTH EXCEPTION TO THE HIPAA PRIVACY RULE AND ITS IMPACT ON SURVEILLANCE ACTIVITY” 9 HOUS. J. HEALTH L & POL’Y 131-156, https://www.law.uh.edu/hjhlp/Issues/Vol_91/Wilson.pdf State law, however, is so widely varied in terms of privacy protections currently in place124 that “some public health officials support federal preemption, claiming that uniformity is necessary and that federal law should provide strong patient protection.”125 How much privacy an individual has depends largely on his state of residence, and “the legal protection of health privacy is uneven, not simply across state lines, but within them.”126 Though state control is an advantageous approach, weak federal guidelines do a disservice to the nation’s population: Independent evolution of state law has produced considerable variation and inconsistency. Variability, of course, can be a strength in a federal system of government, allowing state experimentation with complex issues. Variability in surveillance and privacy protection, however, creates problems in an increasingly mobile society in which disease outbreaks may erupt rapidly in several states, requiring systematic and consistent collection of comparable data sets.127 Due to this incongruent accumulation of legislation, the privacy an individual enjoys in one state may be entirely altered if he moves to another state or simply crosses state lines to seek medical treatment.128 Thus, there is an identifiable need for a raising of the “floor” in the public health exception The exception in its current form provides only ambiguous terms and no guidance as to the use of PHI once in the possession of public health authorities. Model rules for privacy protection and the suggestions for amendment discussed in this paper will have little to no impact if not uniformly adopted and implemented in every jurisdiction. As one scholar noted, “When the law is comprehensive and wellconsidered, it can provide substantial protections.”129 However, when it “fail[s] to provide clear criteria and useful sanctions,” it has the potential to “hamper public health work in a variety of ways.”130 In order to ensure that basic privacy protections are uniform in every state, regulations for justification, access, and disclosure must be added to the HIPAA public health exception as standardized national criteria in the form of a “single, strong federal law.”131 There has been some suggestion that HHS lacked the authority needed to implement such regulations at the time of drafting the original Rule.132 Accordingly, Congressional authorization may be necessary before clearer guidelines for public health agencies could be promulgated. “Despite the virtues of state privacy laws, the public is calling for Congress to take action. The ‘patchwork system’ of state privacy laws does not afford comprehensive privacy protection, and so Congress must provide additional protection through comprehensive federal legislation.”133 State law preemption for privacy regulations should remain the standard for PHI disclosures. However, the only way to ensure the privacy of personal medical records in the hands of public health authorities is to strengthen the existing regulations. Without further standards at the national level, the individual is left with incomplete and inadequate protections, and public health officials will continue to encounter reluctance when soliciting PHI. The plan is key to prevent privacy protective behavior while still allowing for the flexibility to respond quickly to immediate threats Gostin and Hodge 2002 (Lawrence O. Gostin (Professor at Georgetown University Law Center) and James G. Hodge Jr. (Professor at Arizona State University). “Personal Privacy and Common Goods: A Framework for Balancing Under the National Health Information Privacy Rule.” 2002. http://scholarship.law.georgetown.edu/cgi/viewcontent.cgi?article=1086&context=facpub)//EMerz National privacy safeguards are needed because of the proliferation of and access to health records resulting from the ongoing shift from paper to electronic records within the national health information infrastructure. The increasing potential to use or reveal sensitive health data raises concerns about privacy violations. Health information can include intimate details about the patient's mental and physical health as well as social behaviors, personal relationships, and financial status.4 Polling data have consistently shown that Americans are concerned about the privacy of their medical data.5 Over 80% of respondents in one survey suggested they had "lost all control over their personal information."6 In another national survey, 78% of respondents felt it is very important that medical records be kept confidential. 7 Yet, there are multiple justifications for sharing health data to accomplish various communal interests. Sharing data may be necessary to achieve important health purposes (e.g., health research and public health) or for non-health-related purposes (e.g., the administration of justice and law enforcement). We (and others) have previously suggested that health information privacy laws should carefully balance the need for individual privacy with the benefits of using health data for the common good.8 For many, protecting the rights of individuals to control how their identifiable health data are accessed, used, or disclosed is the ultimate goal of national health information privacy standards. Individual interests in privacy, however, should not be regarded as absolute. Some disclosures of health data without specific informed consent are ethically appropriate and legally authorized, such as requirements to report infectious diseases to state health departments and the duty to warn persons at significant risk of harm. The national privacy standards set a "floor" for protections that, DHHS suggests, "balance[s] the needs of the individual with the needs of the society."" Reaching this balance, however, is precarious. In some cases, the common good to be achieved is not worth the infringement of privacy. In other circumstances, the need for data may be sufficiently strong to outweigh the individual's claim to autonomy and privacy. Privacy laws at the federal, state, and local levels are fragmented and inconsistent, and do not reflect any coherent formula for balancing. In particular, the national privacy rule does not always achieve a fair and reasonable allocation of benefits and burdens for patients and the community. We suggest rules for balancing private and public interests that go beyond the traditional conception of individual autonomy as a dominating factor. Rather than seeing autonomy as a "trump card" that always prevails, our framework values both privacy and common goods, without a priori favoring either. We instead seek to maximize privacy interests where they matter most to the individual and maximize communal interests where they are likely to achieve the greatest public good. Thus, where the potential for public benefit is high and the risk of harm to individuals is low, we suggest that public entities should have discretion to use data for important public purposes. Individuals should not be permitted to veto the sharing of personal information irrespective of the potential benefit to the public. Privacy rules should not be so arduous and inflexible that they significantly impede, for example, health services research or surveillance necessary to promote the public's health. Provided that the data are used only for the public good (e.g., research or public health), and the potential for harmful disclosures are negligible, there are good reasons for permitting data sharing. If the data, however, are disclosed in ways that are unlikely to achieve a strong public benefit, and the personal risks are high, individual interests in autonomy should prevail. For example, if health care professionals disclose personal health data to family, friends, neighbors, employers, or insurers, the public benefits to be achieved may not be worth the cost in personal privacy. Such disclosures can cause stigma and embarrassment. Disclosure to employers or insurers (e.g., health, life, or disability) can result in discrimination. These kinds of unauthorized disclosures can lead to a loss of patient trust in health care professionals. Individuals may be reluctant to seek medical treatment for some conditions (e.g., HIV/AIDS, other sexually transmitted conditions, or genetic diseases) or to disclose important information to health professionals. 12 Consequently, for these kinds of disclosures where the public benefits are negligible and individual privacy risks are high, the law should strictly prohibit the release of information without the patient's consent. The framework for balancing we offer attempts to maximize individual and communal interests in the handling of identifiable health data. Acquisition, use, or disclosure of health information that can lead to harm would be subject to strict privacy protections. Correspondingly, acquisition, use, or disclosure of health information for important public purposes would be permitted provided that (1) uses are restricted to the purposes for which the data are collected, and (2) subsequent disclosures for other purposes are prohibited without individual authorization. This framework defends autonomy when individual interests are high and public interests are low. We recognize that adherence to this balancing test will entail a certain diminution of autonomy. However, it will be worth the cost in terms of the benefits that everyone will achieve in living in a society that values the communal goods offered by research, public health, and other public enterprises. ***Advantages*** Privacy Protection Low - General No expansive genetic privacy jurisprudence now Scherr 13 (Albert E. Scherr. Professor of Law, University of New Hampshire. “Genetic Privacy & the Fourth Amendment: Unregulated Surreptitious DNA Harvesting.” 2013. P. 448. http://georgialawreview.org/wp-content/uploads/2015/02/Download-PDF-V47-I2-Scherr.pdf)//EMerz The nature and scope of the Fourth Amendment’s protection against an intrusion on genetic privacy is not readily apparent from the text. It guarantees that “[t]he right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated . . . .” The prohibition reads like one against intrusions on an individual’s physical privacy by the government—be it real property, bodily integrity, other physical items—and makes no explicit mention of more intangible conceptions of privacy. The Fourth Amendment also says nothing about security from intrusions into out-of-body DNA left in a public place, just as it says nothing about intrusions involving a host of other modern technologies like a GPS, public surveillance cameras, or various kinds of technological eavesdropping. Each involves a type of technology that the Framers had not contemplated. Each intrudes on more than purely property- or place-based privacy. Historically, the Supreme Court’s Fourth Amendment jurisprudence reflected a relatively narrow and somewhat rigid, legalistic focus on property and place in defining the extent of Fourth Amendment privacy.84 Without a physical invasion, or a search of a person, papers, or tangible material effects, no Fourth Amendment violation occurs.85 In this conception, privacy “was tied very closely to notions of property rights. Current government surveillance is expanding rapidly without patient knowledge Brase 13 (Twila Brase. President Citizen’s Council for Health Freedom. “Patient Privacy and Public Trust: How Health Surveillance Systems Are Undermining Both.” August 2013. P. 1-2. http://www.cchfreedom.org/pr/50%20States%20Databases%20Full%20Report.pdf)//EMerz With funding primarily from Congress, state health departments have created a multitude of government patient-tracking systems. Increasingly, these systems are being linked together, creating individual health profiles and lifelong records. The emergence of computerized medical records—and the federal requirement that physicians, hospitals and other health care professionals have interoperable electronic medical records or be penalized in 2015—has accelerated and facilitated government access to private patient data.1 2 Often without consent, patient data is collected from doctors, hospitals, and clinics – in some cases annually for lifelong monitoring. But while most assume that patient privacy rights are protected by patient consent requirements, government health surveillance is characterized by a surprising lack of patient consent and little to no public awareness or discussion of the growing databases and registries. Even worse, the government seizure of data often happens at a time and in a place when individuals are in a vulnerable state—at the clinic or in the hospital. Today, state government agencies collect illness, injury, hospitalization, diagnostic, medication, genetic, birth and death data on individual citizens. This collection and connection of private medical records data occurs often without patient consent or knowledge—and sometimes without specific authority in state law. These state collections of personal information include, but are not limited to, the following conditions or test results, which may exist in databases, registries or biobanks. States vary greatly in their collection of data. Although all states have one or more of the following collections of data, not every state maintains all of these collections. This private data is not only routinely collected without patient consent, it is increasingly being linked together for analysis, research and tracking. For example, as part of its application for a federal Title V Maternal and Child Block Grant, Kansas reports: “Kansas Maternal and Child Health (MCH) is building data infrastructure, epidemiological capacity, and products of analysis in order to carry out core public health assessment functions. We continue to improve Kansas MCH data capacity by: 1) improving data linkages between birth records and other data sets such as infant death certificates, Medicaid eligibility and/ or paid claims files, WIC eligibility files, and new born [sic] metabolic screening files; 2) improving access to hospital discharge data, Youth Risk Behavior Survey (YRBS) data, Birth Defects Surveillance System (BDSS) data, Pregnancy Risk Assessment Monitoring System (PRAM) data, and Children and Youth with Special Health Care Needs (CYSHCN) program data…”6 Furthermore, the amount of government health surveillance just keeps growing. The U.S. Centers for Disease Control and Prevention (CDC) recently created the National Public Health Surveillance/Biosurveillance Registry for Human Health (NPHSB Registry), which they describe as, “a comprehensive electronic catalog of over 280 CDC public health surveillance and biosurveillance assets related to human health. Launched in December 2012, the Registry provides information to foster collaboration among surveillance subject matter experts, and provides critical information about CDC’s surveillance capabilities to decision-makers as they address a wide range of public health preparedness and response issues that depend on effective coordination. ... The registry is currently located on CDC’s intranet and available only to members of the CDC community. Physician-public trust has declined substantially; the US need a solution now Blendon, Benson, and Hero 14 (Robert J. Blendon, Sc.D., John M. Benson, M.A., and Joachim O. Hero, M.P.H., “Public Trust in Physicians — U.S. Medicine in International Perspective”, from the Department of Health Policy and Management, Harvard School of Public Health, Boston (R.J.B., J.M.B.); and the Program in Health Policy, Harvard University, Cambridge, MA ( J.O.H.).The New England Journal of Medicine, 371;17, nejm.org, October 23, 2014)//ASMITH The U.S. health care reform process is entering a new phase, its emphasis shifting from expanding health coverage to improving our systems for delivering patient care. One emerging question is what role the medical profession and its leaders will play in shaping future national health care policies that affect decision making about patient care. Research suggests that for physicians to play a substantial role in such decision making, there has to be a relatively high level of public trust in the profession’s views and leadership. But an examination of U.S. public opinion data over time and of recent comparative data on public trust in physicians as a group in 29 industrialized countries raises a note of caution about physicians’ potential role and influence with the U.S. public. In a project supported by the Robert Wood Johnson Foundation and the National Institute of Mental Health, we reviewed historical polling data on public trust in U.S. physicians and medical leaders from 1966 through 2014, as well as a 29-country survey conducted from March 2011 through April 2013 as part of the International Social Survey Programme (ISSP), a cross-national collaboration among universities and independent research institutions (ISSP 2011– 2013) (see box for poll information). We found that, as has been previously reported, public trust in the leaders of the U.S. medical profession has declined sharply over the past half century. In 1966, nearly three fourths (73%) of Americans said they had great confidence in the leaders of the medical profession. In 2012, only 34% expressed this view (Harris 1966–2012). But simultaneously, trust in physicians’ integrity has remained high. More than two thirds of the public (69%) rate the honesty and ethical standards of physicians as a group as “very high” or “high” (Gallup 2013). Our review of numerous analyses of public-opinion data about public trust in institutions and professions suggests that the decline in trust is probably attributable to broad cultural changes in the United States, as well as rising concerns about medical leaders’ responses to major national problems affecting the U.S. health care system.1,2 Today, public confidence in the U.S. health care system is low, with only 23% expressing a great deal or quite a lot of confidence in the system (Gallup 2014). We believe that the medical profession and its leaders are seen as a contributing factor. This phenomenon does not affect physicians in many other countries. Indeed, the level of public trust in physicians as a group in the United States ranks near the bottom of trust levels in the 29 industrialized countries surveyed by the ISSP. Yet closer examination of these comparisons reveals findings similar to those of previous U.S. surveys: individual patients’ satisfaction with the medical care they received during their most recent physician visit does not reflect the decline in overall trust. Rather, the United States ranks high on this measure of satisfaction. Indeed, the United States is unique among the surveyed countries in that it ranks near the bottom in the public’s trust in the country’s physicians but near the top in patients’ satisfaction with their own medical treatment. The United States is tied for 24th place in terms of the proportion of adults who agree with the statement, “All things considered, doctors in [your country] can be trusted.” About 6 in10 U.S. adults (58%) agree with this statement, as compared with more than three fourths in Switzerland (83%), Denmark (79%), the Netherlands (78%), and Britain (76%) (ISSP 2011–2013) (see table). Part of the difference may be related to the lack of a universal health care system in the United States. However, the countries near the top of the international trust rankings and those near the bottom have varied coverage systems, so the absence of a universal system seems unlikely to be the dominant factor. By contrast, the United States ranks third in terms of the proportion of adults who say they were completely or very satisfied with the medical treatment they received at their last physician visit (56%). Of the 10 countries that rank lowest in public trust in their countries’ physicians, all but the United States also rank 19th or lower in patients’ satisfaction with their own medical care. The United States also differs from most other countries in that U.S. adults from lowincome families (defined as families with incomes in the lowest third in each country, which meant having an annual income of less than $30,000 in the United States) are significantly less trusting of physicians and less satisfied with their own medical care than adults not from low-income families. Less than half (47%) of low-income Americans surveyed agreed that U.S. doctors can be trusted — significantly less than the 63% of non–low-income Americans who expressed that view. Low-income Americans were also less likely than non–low income Americans (48% vs. 59%) to be completely or very satisfied with their treatment at their last physician visit (ISSP 2011–2013) (see the Supplementary Appendix, available with the full text of this article at NEJM.org). Although non–low-income Americans expressed greater trust in physicians than their low-income counterparts did, when responses were analyzed by income group, the United States still ranked 22nd in trust among the 29 countries. On the flip side, although low-income Americans were less likely than non–low income Americans to report being completely or very satisfied with their own care, the United States still ranked seventh in satisfaction among low-income adults (ISSP 2011–2013). The same pattern is seen in subpopulations defined by age or sex. Americans 65 years of age or older were significantly more likely than younger Americans to agree that U.S. physicians can be trusted (69% vs. 55%), and U.S. men were significantly more likely than U.S. women to think so (63% vs. 54%). However, the United States ranked lower in terms of trust in the profession than most other countries among both men (21st) and people 65 years of age or older (22nd) (ISSP 2011–2013). In drawing lessons from these international comparisons, it’s important to recognize that the structures in which physicians can influence health policy vary among countries. We believe that the U.S. political process, with its extensive media coverage, tends to make physician advocacy seem more contentious than it seems in many other countries. Moreover, the U.S. medical profession, unlike many of its counterparts, does not share in the management of the health system with government officials but instead must exert its influence from outside government through various private medical organizations. Some other countries’ systems have more formal structures through which physician leaders may bargain and negotiate with the government over such issues as payment, professional autonomy, and quality of care.3 Moreover, in terms of health policy recommendations, the U.S. medical profession is split among multiple specialty organizations, which may endorse competing policies. Nevertheless, because the United States is such an outlier, with high patient satisfaction and low overall trust, we believe that the American public’s trust in physicians as a group can be increased if the medical profession and its leaders deliberately take visible stands favoring policies that would improve the nation’s health and health care, even if doing so might be disadvantageous to some physicians. 4,5 In particular, polls show that Americans see high costs as the most important problem with the U.S. health care system (RWJF/HSPH 2011), and nearly two thirds of the public (65%) believes these costs are a very serious problem for the country (NPR/RWJF/HSPH 2012). To regain public trust, we believe that physician groups will have to take firm positions on the best way to solve this problem. In addition, to improve trust among low-income Americans, physician leaders could become more visibly associated with efforts to improve the health and financial and care arrangements for low-income people. If the medical profession and its leaders cannot raise the level of public trust, they’re likely to find that many policy decisions affecting patient care will be made by others, without consideration of their perspective. Privacy Protection Low – Judicial Guidance Lack of clear court ruling on HIPAA surveillance limitations results in confusion- that can justify more surveillance Evans 13 (Barbara J. Evans. Professor of Law; Co-director, Health Law & Policy Institute; Director, Center on Biotechnology & Law, University of Houston Law Center, Yale Law School; M.S., Ph.D. Stanford University; Post-doctoral Fellow, The University of Texas M.D. Anderson Cancer Center. “Institutional Competence to Balance Privacy and Competing Values: The Forgotten Third Prong of HIPAA Preemption Analysis.” P. 1180-1183. http://lawreview.law.ucdavis.edu/issues/46/4/Articles/46-4_Evans.pdf)//EMerz The HIPAA statute was enacted on August 21, 1996 and recently marked its sixteenth anniversary. In those sixteen years, no court has ever decided a case that posed a HIPAA preemption question in the context of public health surveillance and investigations. In their fascinating survey of 113 HIPAA preemption cases litigated through the fall of 2006, Sara Rosenbaum et al. did not find any case in which the underlying controversy involved access to data or tissue resources to use in such activities. A more recent search of all state and federal cases decided between 1996 and July 2012 found only two HIPAA related cases that ever cited 42 U.S.C. § 1320d-7(b),17 the provision that defines the enumerated public health activities and affords them special protection. The two cases that cited § 1320d-7(b) had nothing to do with public health surveillance or investigations. Those whom this provision aims to help — members of the medical and public health communities seeking access to data and tissue resources to improve the public’s health — perhaps have a negative perception of lawyers and are reluctant to turn to courts to clarify confusion about the law. As a consequence, rumor rather than valid statutory interpretation has informed much of the debate about HIPAA preemption and public health access to data. Discussions of HIPAA preemption often rely heavily on secondary sources of literature and, less frequently, on regulations, but almost never consult the relevant statutes. For example, the Institute of Medicine, a highly respected advisory body that typically produces rigorous, peer-reviewed analyses of policy issues affecting biomedical research, discussed HIPAA preemption in a recent report without once citing the preemption provisions of the HIPAA statute. Beliefs about HIPAA preemption are circulated and recirculated in the secondary literature and eventually attain the status of well-settled rumor. Even among law scholars, the HIPAA preemption provisions have attracted little interest. Whalen fails – lack of guidance Wilson 7 (Jessica, Juris Doctor at Duke University, “Protecting Privacy Absent a Constitutional Right: A Plausible Solution to Safeguarding Medical Records,” January 2007, Washingtion University in St. Louis)//JL Whalen v. Roe provided little guidance for lower courts dealing with medical privacy issues. Regarding the first of the Court’s dual privacy interests, “the individual interest in avoiding disclosure of personal matters,” Whalen left unclear what constituted a violation of the right, and failed to establish what type of constitutional treatment the courts were to use when assessing it.58 Unlike the Court’s second privacy interest in “independence in making certain kinds of important decisions,” which had been fleshed out by several previous Supreme Court decisions59 including Roe v. Wade60 and Paul v. Davis,61 there was no clear legal precedent for a privacy interest in nondisclosure of personal matters.62 Lower courts fail – outdated and inconsistent Hoppin 12 (Margaret, J.D. at New York University School of Law, “Overly Intimate Surveillance: Why Emergent Public Health Surveillance Programs Deserve Strict Scrutiny Under The Fourteenth Amendment,” December 2012, NYU Law Review, Hein Online)//JL Emergent surveillance programs intrude upon a pri-vacy interest that courts should recognize as fundamental for the Fourteenth Amendment emergent programs should be reviewed under a strict scrutiny The Supreme Court recognized the Fourteenth protects an interest in not disclosing private health information However, the Supreme Court has never explained the contours of that right. lower court opinions that address the constitutionality of government public health surveillance programs are sparse, outdated, and inconsistent they have upheld public health surveillance programs against privacy public health purposes of standard.64 . Accordingly, has that Amendment to the govern-ment.65 66 Moreover, . In general, challenges, after applying rational basis review or a deferential balancing test.67 Precedents are outdated and too easily distinguishable Hoppin 12 (Margaret, J.D. at New York University School of Law, “Overly Intimate Surveillance: Why Emergent Public Health Surveillance Programs Deserve Strict Scrutiny Under The Fourteenth Amendment,” December 2012, NYU Law Review, Hein Online)//JL existing Fourteenth Amendment privacy protections that apply to government public health surveillance pro-grams. Those protections are widely understood to be limited, and—to the extent the question has been addressed—scholars assume similarly limited protection would apply to emergent programs.68 That assumption is unwarranted: The relevant precedents are inconsistent, outdated, and address readily distinguishable surveillance models. Moreover, several courts and judges have suggested This Subpart describes that develop-ments in public health surveillance could or should trigger more rig-orous scrutiny. Genetic Surveillance – Expanding Now Local DNA databases are rapidly expanding now Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 I. THE EXPANSION OF LOCAL DNA DATABASES The expansion of local DNA databases comes on the heels of a deep and sustained commitment from Congress to build a national network of DNA databases overseen by the FBI. In a flurry of legislation beginning in 1994, Congress authorized the creation and expansion of that network, which is called the Combined DNA Index System (“CODIS”).39 Under the CODIS umbrella, the FBI created a three-tiered hierarchy of databases made up of the National DNA Index System (“NDIS”), the State DNA Index System (“SDIS”), and the Local DNA Index System (“LDIS”).40 Congress designated the FBI to regulate CODIS, and the FBI designed protocols to integrate the three levels into a unified whole.41 In the decade after authorizing CODIS, Congress passed several laws to expand the CODIS network.42 Yet, despite this expansion, local law enforcement agencies have increasingly sought to create their own, non-CODIS DNA databases. This Part analyzes what caused this shift. It then provides a description of the local databases in Palm Bay, Florida; Bensalem Township, Pennsylvania; and the state of Arizona. A. Fragmentation of Genetic Surveillance While the FBI continues to exert significant control over law enforcement’s use of DNA databases, its grip is weakening as a result of the expansion of local databases. This fragmentation, which leaves local agencies increasingly in control of the use of genetic surveillance, is the result of several factors. They include: 1) restrictions in the CODIS regulations, which, according to many local law enforcement officials, limit law enforcement’s ability to take full advantage of DNA databases to solve crime;43 2) advances in DNA technology—allowing for quicker processing and the analysis of extremely small biological samples— that have coincided with reduced costs; 3) federal funding that allows local law enforcement officials to bypass the local budget process; and 4) private firms interested in expanding the use of forensic DNA analysis. 1. CODIS Limitations Early adopters of local DNA databases have pointed to two reasons why CODIS does not adequately meet their needs. First, they argue that the CODIS authorizing statute and the FBI’s regulations for its use are too restrictive, preventing law enforcement from performing certain searches and from including DNA profiles from certain individuals in CODIS.44 Second, they argue that because much of CODIS’s growth is the result of adding DNA profiles from known violent offenders who are often serving lengthy prison sentences, CODIS remains an ineffective crime-solving tool. The FBI has adopted an extensive regulatory scheme for CODIS,45 and it regularly audits participating public crime laboratories to ensure compliance.46 These regulations are designed to ensure the database is reliable and secured.47 For example, the FBI will only allow the inclusion and search of DNA profiles if the profiles were processed by public DNA laboratories that are a part of the CODIS network.48 Second, federal regulations prohibit inclusion in CODIS of many types of partial DNA profiles,49 and limit law enforcement’s ability to compare a partial profile to the other profiles in CODIS.50 Third, the process of confirming a match in CODIS can take up to one month,51 and this is in addition to the six to 12 months often needed for the actual DNA processing at CODIS-participating laboratories.52 Fourth, federal regulations require the removal of profiles from CODIS if a convicted offender’s conviction is overturned, or, in the case of an arrestee, if the charges are dismissed.53 Finally, as a result of its emphasis on building a database of convicted offenders and arrestees, the FBI’s regulations prohibit the inclusion of DNA profiles from individuals, including suspects, who provide law enforcement consensual DNA samples.54 Local DNA databases are not required to comply with any of these federal regulations. For example, they are free to include consensual DNA samples from people deemed merely suspicious, victims, victims’ family members, and witnesses. These consensual samples have driven the growth of local databases.55 Local DNA databases are also built with DNA processing from private laboratories.56 Furthermore, local law enforcement is free to set its own protocols for including and searching partial DNA profiles in their databases and for expunging DNA records.57 Genetic surveillance spills over into other areas of privacy – lack of privacy protections snowballs into acceptance of even more intrusive pratices Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 The expansion of local DNA databases also brings into sharper focus the fears many privacy advocates raised about CODIS. In short, they feared that once the FBI’s DNA database was created, it would be too tempting for law enforcement to limit its use, causing the tool to evolve to reach deeper into our lives.216 CODIS’s growth demonstrates the merit of these fears. CODIS expanded from an initial focus on collecting profiles from offenders convicted of certain violent crimes, to all felony offenders, and now to arrestees.217 Similarly, after first prohibiting familial searches, CODIS now permits them in certain circumstances.218 These advocates also fear what might come next when technology allows us to glean even more information from an individual’s DNA sample. They are particularly fearful of the possibility that law enforcement might use genetic samples to attempt to identify a genetic predisposition to crime.219 Finally, the expansion of local databases will contribute further to the erosion of privacy protections to the extent that people come to expect increased surveillance. Fourth Amendment privacy protection is linked to society’s reasonable expectations of privacy.220 As many have noted, this standard is fluid, but it has historically moved in the direction of society accepting lesser privacy protections. Law enforcement’s expansion of genetic surveillance has contributed to this trend, and the trend will continue as it becomes routine for even small agencies to build local databases. FBI is increasing surveillance—disproportionately affects minorities Moore 9 (Soloman, reporter for the New York Times, “F.B.I. and States Vastly Expand DNA Databases” http://www.nytimes.com/2009/04/19/us/19DNA.html?_r=0 4/18/09 JM) Law enforcement officials are vastly expanding their collection of DNA to include millions more people who have been arrested or detained but not yet convicted. The move, intended to help solve more crimes, is raising concerns about the privacy of petty offenders and people who are presumed innocent. Until now, the federal government genetically tracked only convicts. But starting this month, the Federal Bureau of Investigation will join 15 states that collect DNA samples from those awaiting trial and will collect DNA from detained immigrants — the vanguard of a growing class of genetic registrants. The F.B.I., with a DNA database of 6.7 million profiles, expects to accelerate its growth rate from 80,000 new entries a year to 1.2 million by 2012 — a 15-fold increase. F.B.I. officials say they expect DNA processing backlogs — which now stand at more than 500,000 cases — to increase. Law enforcement officials say that expanding the DNA databanks to include legally innocent people will help solve more violent crimes. They point out that DNA has helped convict thousands of criminals and has exonerated more than 200 wrongfully convicted people. But criminal justice experts cite Fourth Amendment privacy concerns and worry that the nation is becoming a genetic surveillance society. “DNA databases were built initially to deal with violent sexual crimes and homicides — a very limited number of crimes,” said Harry Levine, a professor of sociology at City University of New York who studies policing trends. “Over time more and more crimes of decreasing severity have been added to the database. Cops and prosecutors like it because it gives everybody more information and creates a new suspect pool.” Courts have generally upheld laws authorizing compulsory collection of DNA from convicts and ex-convicts under supervised release, on the grounds that criminal acts diminish privacy rights. DNA extraction upon arrest potentially erodes that argument, a recent Congressional study found. “Courts have not fully considered legal implications of recent extensions of DNA-collection to people whom the government has arrested but not tried or convicted,” the report said. Minors are required to provide DNA samples in 35 states upon conviction, and in some states upon arrest. Three juvenile suspects in November filed the only current constitutional challenge against taking DNA at the time of arrest. The judge temporarily stopped DNA collection from the three youths, and the case is continuing. Sixteen states now take DNA from some who have been found guilty of misdemeanors. As more police agencies take DNA for a greater variety of lesser and suspected crimes, civil rights advocates say the government’s power is becoming too broadly applied. “What we object to — and what the Constitution prohibits — is the indiscriminate taking of DNA for things like writing an insufficient funds check, shoplifting, drug convictions,” said Michael Risher, a lawyer for the American Civil Liberties Union. This year, California began taking DNA upon arrest and expects to nearly double the growth rate of its database, to 390,000 profiles a year from 200,000. One of those was Brian Roberts, 29, who was awaiting trial for methamphetamine possession. Inside the Twin Towers Correctional Facility in Los Angeles last month, Mr. Roberts let a sheriff’s deputy swab the inside of his cheek. Mr. Roberts’s DNA will be translated into a numerical sequence at the F.B.I.’s DNA database, the largest in the world. The system will search for matches between Mr. Roberts’s DNA and other profiles every Monday, from now into the indeterminate future — until one day, perhaps decades hence, Mr. Roberts might leave a drop of blood or semen at some crime scene. Law enforcement officials say that DNA extraction upon arrest is no different than fingerprinting at routine bookings and that states purge profiles after people are cleared of suspicion. In practice, defense lawyers say this is a laborious process that often involves a court order. (The F.B.I. says it has never received a request to purge a profile from its database.) When DNA is taken in error, expunging a profile can be just as difficult. In Pennsylvania, Ellyn Sapper, a Philadelphia public defender, has spent weeks trying to expunge the profile taken erroneously of a 14-year-old boy guilty of assault and bicycle theft. “I’m going to have to get a judge’s order to make sure that all references to his DNA are gone,” she said. The police say that the potential hazards of genetic surveillance are worth it because it solves crimes and because DNA is more accurate than other physical evidence. “I’ve watched women go from mug-book to mug-book looking for the man who raped her,” said Mitch Morrissey, the Denver district attorney and an advocate for more expansive DNA sampling. “It saves women’s lives.” Mr. Morrissey pointed to Britain, which has fewer privacy protections than the United States and has been taking DNA upon arrest for years. It has a population of 61 million — and 4.5 million DNA profiles. “About 8 percent of the people commit about 70 percent of your crimes, so if you can get the majority of that community, you don’t have to do more than that,” he said. In the United States, 8 percent of the population would be roughly 24 million people. Britain may provide a window into America’s genetic surveillance future: As of March 2008, 857,000 people in the British database, or about one-fifth, have no current criminal record. In December, the European Court of Human Rights ruled that Britain violated international law by collecting DNA profiles from innocent people, including children as young as 10. Critics are also disturbed by the demographics of DNA databases. Again Britain is instructive. According to a House of Commons report, 27 percent of black people and 42 percent of black males are genetically registered, compared with 6 percent of white people. As in Britain, expanding genetic sampling in the United States could exacerbate racial disparities in the criminal justice system, according to Hank Greely, a Stanford University Law School professor who studies the intersection of genetics, policing and race. Mr. Greely estimated that African-Americans, who are about 12 percent of the national population, make up 40 percent of the DNA profiles in the federal database, reflective of their prison population. He also expects Latinos, who are about 13 percent of the population and committed 40 percent of last year’s federal offenses — nearly half of them immigration crimes — to dominate DNA databases. Enforcement officials contend that DNA is blind to race. Federal profiles include little more information than the DNA sequence and the referring police agency. Subjects’ names are usually kept by investigators. Rock Harmon, a former prosecutor for Alameda County, Calif., and an adviser to crime laboratories, said DNA demographics reflected the criminal population. Even if an innocent man’s DNA was included in a genetic database, he said, it would come to nothing without a crime scene sample to match it. “If you haven’t done anything wrong, you have nothing to fear,” he said. Status quo federal courts and legislation allow for exceptionalism Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 19-21 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz While the ethical basis (autonomy) for exceptional protection for health privacy is robust, a strong legal basis for health privacy exceptionalism is harder to articulate. The US Constitution is silent on the issue although the decisional privacy cases do recognize limited penumbral privacy claims.169 Whalen v. Roe did articulate the duality of informational and decisional privacy in a case that, broadly at least, concerned health privacy. Yet Justice Stevens’ broadest pro-privacy statement in Whalen failed to articulate any exceptional treatment of health information. Of course, in Jaffee v. Redmond, the same Justice did recognize a broad federal common law psychotherapist privilege rooted in confidence and trust, yet it was hardly exceptional as it was analogized to the spousal and attorney-client privileges. More recently, the Supreme Court, while restraining some aspects of the surveillance state, generally has favored data liquidity over data protection. Outside of the health-related HIPAA, the Genetic Information Nondiscrimination Act of 2008 (GINA)176 and a few other narrow sector-specific statutes like GLBA, most federal privacy law is quite general in its reach. For example, the Privacy Act of 1974, while applicable to health care data collected by the federal government, does not seem to apply exceptionally.177 The same can be said of federal scrutiny of the privacy standards of private, non-health care entities. In this general space the FTC asserts two types of claims under Section 5(a) of the Federal Trade Commission Act: “unfair or deceptive acts or practices in or affecting commerce.” Thus, with regard to privacy, an unfair business practice case might be brought against a business for, say, failing to have adequate security, while a deceptive or misleading claim might apply to a business that, say, failed to comply with its own stated privacy policy. The FTC will leave most health care privacy cases to the HHS Office of Civil Rights although it has asserted its jurisdiction in cases involving nonHIPAA entities. For example, In the Matter of CBR Systems, Inc., the FTC entered into a settlement with a provider of umbilical cord blood and umbilical cord tissue-banking services. The proceeding related to the theft of unencrypted computer drives exposing the health information of almost 300,000 of the bank’s customers. There has been little Congressional consideration of the implications of health privacy exceptionalism or, for that matter, its absence. A rare exception was at the 1999 hearings on GLBA. When it became apparent that health insurers would be covered by the proposed legislation a provision was added with the intent to protect health data. However, that provision would have had the unintended consequence of opening up health data to broad opt-out sharing among financial institutions with attendant secondary use risks. Organizations such as the American Medical Association and the American Psychiatric Association (APA) strongly voiced their concerns, and the provision was dropped from the final bill. The APA’s Dr. Richard Harding argued before the House of Representatives, “[i]t is critically important to recognize the difference between medical records privacy and financial privacy,” so making the case for health privacy exceptionalism: [T]he damages from breaches of medical records privacy are of a different nature. Medical records information can include information on heart disease, terminal illness, domestic violence, and other women's health issues, psychiatric treatment, alcoholism and drug abuse, sexually transmitted diseases and even adultery . . . . These disclosures can jeopardize our careers, our friendships, and even our marriages. And if such disclosures occur, there are truly few meaningful remedies. Seeking redress will simply lead to further dissemination of the highly private information that the patient wished to keep secret . . . . Just a few months later this model of health privacy exceptionalism was confirmed when President Clinton introduced the first version of the HIPAA privacy rule. 185 The rhetoric of exceptionalism was clear. As the President noted, the purpose of the regulation was “to protect the sanctity of medical records,” and it represented “an Today the federal commitment to health privacy exceptionalism seems strong. Of course there were a couple of bumps in the road as the Bush Administration unprecedented step toward putting Americans back in control of their own medical records.” replaced the original Clinton Administration requirement of patient consent to disclosure for treatment, payment or health care operations (TPO) purposes with the more permissive statement that “[a] covered entity may obtain consent of the individual to use or disclose protected health information to carry out treatment, payment or health care operations.”188 On the other hand the Bush Administration seemed to endorse health privacy exceptionalism when it championed the Genetic Information Nondiscrimination Act. GINA, signed into law by President Bush in May 2008, broadly prohibits discrimination by employers and health insurers based upon genetic information. It does so primarily by using an upstream data protection model whereby would-be data custodians are prohibited from collecting genetic information. Two recent federal government reports that have recommended the strengthening of data protection both recognize health privacy exceptionalism. Unfortunately, in doing so they may drive the unintended consequence of keeping strong, upstream protections out of the health care space. First, the White House report Consumer Data Privacy in a Networked World, while calling for Congress to enact legislation that includes an impressive Consumer Privacy Bill of Rights rotating around “Fair Information Practice Principles” (FIPPs), limits that request “to commercial sectors that are not subject to existing Federal data privacy laws.”191 Second, the FTC’s Protecting Consumer Privacy in an Era of Rapid Change, which calls for privacy by design and best privacy practices, expresses its sensitivity to burdens introduced by “overlapping or duplicative requirements on conduct that is already regulated” but more positively suggests the potential for the FIPPs framework to provide “an important baseline for entities that are not subject to sector-specific laws like HIPAA or GLBA.” 193 Their considerable promise aside, neither report has led to legislation. And with the political classes closing ranks over the Big Data-tainted NSA spying controversy, a privacy law reform proposal does not seem likely to emerge from either the White House or Congress. Genome surveillance is easier than ever now- low costs and accessibility in recent years- this makes surveillance more frequent McEwen et al 13 (Jean E. McEwen, Ethical, Legal, and Social Implications Program, Division of Genomics and Society, National Human Genome Research Institute, National Institutes of Health,Ethical, Legal, and Social Implications Program, Division of Genomics and Society, National Human Genome Research Institute, National Institutes of Health. Joy T. Boyer, Senior Program Analyst, and Kathie Y. Sun, Program Analyst. “Evolving Approaches to the Ethical Management of Genomic Data.” February 28, 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665610/)//EMerz Plummeting sequencing costs, along with ongoing advances in bioinformatics, now make it possible to generate an enormous volume of genomic data about vast numbers of people. Depending on the cost calculation method used, the cost of sequencing the first human genome was somewhere around $300 million (see: http://www.genome.gov/10002192); today, it is less than $8,000 (see: http://www.genome.gov/sequencingcosts), and prospects for the “$1,000 genome” and even cheaper genomes are within sight [4]. Data from genome-wide association studies (GWAS), from whole genome and whole exome scans, and from other high-throughput technologies are proliferating [5, 6]. Although the ethical challenges associated with the management of information have always been present in the field, the greater comprehensiveness and informativeness of today’s genomic data now makes these challenges even greater, as was recently recognized in a report by the Presidential Commission for the Study of Bioethical Issues [7]. First, unlike targeted genetic data of 20–30 years ago, or even the more comprehensive (but often not very informative) SNP data of 10 years ago, the whole exome and whole genome sequence data now being generated will eventually be able to reveal many of a person’s specific health risks - even if the data emerge from research or diagnosis related to a specific condition [8]. The growing informational richness of genomic data not only facilitates the range of questions it can be mined to help answer, but magnifies its potential for misuse. Second, because of its comprehensiveness, genomic information – even when stripped of traditional identifiers – has, at least in some sense, the potential to re-identify the individual from whom it was obtained [8]. This characteristic, coupled with the data’s overall richness, amplifies concerns about who should be able to have – and control -access to it. Until recently, it was thought that re-identifying a sample or data from which traditional identifiers had been removed required a reference sample or data from the same person available for comparison [9], However, we now know that it is possible, in some cases, to identify the source of a sample or data by consulting genetic genealogy databases (readily available on the Internet) that link Y chromosome short tandem repeat (STR) data to particular surnames, and then combining that information with other publicly available data (e.g., information about age, state of residence, or facts contained in obituaries) [10]. Although the actual extent of this previously underappreciated risk is still unknown, the risk will almost certainly grow in the future, as more people are sequenced and as the genetic genealogy industry grows. Indeed, the Advance Notice of Proposed Rulemaking (ANPRN), a pending set of revisions to the Common Rule (the regulations that apply to all U.S. federally funded research conducted with human subjects) explicitly recognizes the potential for reidentification inherent in all genomic data (see: http://www.gpo.gov/fdsys/pkg/FR-2011-0726/html/2011-18792.htm). Finally, the complexity and frequently uncertain meaning of the information being generated today through whole genome analyses, compared to the more limited (and thus often more easily interpreted) information typically derived through earlier, more targeted genetic tests, enhances the possibility that the information, if shared, will be misunderstood [8]. This is creating new challenges for researchers and clinicians, who must increasingly decide which, if any, individual findings they should offer to return to those whose samples they have analyzed [11, 12]. Incidental findings (findings unrelated to the disorder that initially motivated the research or testing) are inevitable – not merely possible - in GWAS and in whole genome and whole exome scans, and as will be discussed later, these present particular challenges [8, 13–16]. Although concerns about the ethical management of research and clinical data are by no means new to the field, the transition over the past 20 years from a narrowly “genetic” orientation to today’s much more comprehensive “genomic” one has been accompanied by shifts in the way the information is being conceptualized and managed. It is thus useful to step back and review systematically the events that have steered the course of these developments and the new challenges emerging as a result. Technology is lowering the cost of mass health data sharing – huge momentum for genomics coming McEwen et al 13 (Jean E. McEwen, Ethical, Legal, and Social Implications Program, Division of Genomics and Society, National Human Genome Research Institute, National Institutes of Health,Ethical, Legal, and Social Implications Program, Division of Genomics and Society, National Human Genome Research Institute, National Institutes of Health. Joy T. Boyer, Senior Program Analyst, and Kathie Y. Sun, Program Analyst. “Evolving Approaches to the Ethical Management of Genomic Data.” February 28, 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665610/)//EMerz The field of genomics has long been distinguished by steadfast adherence to the principle of broad data release. This commitment, first enshrined in the 1996 “Bermuda Principles” and subsequently reaffirmed, is aimed at maximizing the pace of research and ultimately, its benefit to society [27]. As targeted genetic research began to give way to research with a more genomic focus, the expectations regarding broad data sharing - and rules to enforce them - were gradually extended to apply not only to the data produced in large, community resource projects, but to genomic data more generally. The introduction of SNP chips and the development of improved statistical methods in the early 2000s, which suddenly made studies of common, complex conditions more tractable, contributed to this trend [28]. GWAS of common disease accelerated in the 2000s and quickly overshadowed the previous focus on single gene disorders. To be adequately powered, however, such studies typically required larger sample sizes (or datasets) than any single researcher could amass. This circumstance, along with improvements in informatics technology that made it cheaper and easier to share large amounts of data, provided further momentum for sharing, and set the stage for the 2008 adoption of the NIH GWAS Data Access Policy. That policy requires the deposition of summary-level information and aggregate genotype data in the open access portion of the NIH Database of Genotypes and Phenotypes (dbGaP), and the deposition of individual-level data (genotypes and phenotypes) in the controlled access portion of the database (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html). Under the policy, controlled access data are made available to any qualified researcher following review and approval by an NIH Data Access Committee (DAC) [29]. Two other developments occurring in the late 2000s helped further “pave the way” for expanded data sharing by (at least temporarily) helping to quell lingering concerns of some institutional review board (IRB) members about the associated risks. One development was the enactment of the Genetic Information Nondiscrimination Act (GINA) (see: http://www.eeoc.gov/laws/statutes/gina.cfm), which was initially greeted, at least by some, with optimism that it would “put to rest” public worries about possible misuses of genomic information, thus making protocols that relied on the use of shared data or incorporated plans for broad data sharing more ethically acceptable [30]. The second was the issuance by the Office of Human Research Protections (OHRP) of guidance reaffirming a previously-stated position that research using only deidentified materials falls outside the definition of “human subjects research” and thus outside the protections outlined in the Common Rule (see http://www.hhs.gov/ohrp/policy/cdebiol.html). This guidance provided some (again, at least temporary) reassurance to IRBs that protocols involving the use of de-identified, archived samples or data, without re-consent, rested on firm ethical (or, at least regulatory) footing. It also bolstered the confidence of institutional officials charged with certifying the appropriateness of the data generated by investigators at their institutions for deposition into dbGaP. The trend toward broader sharing of data has been accompanied by a trend toward broader sharing of samples, often through large biorepositories [31]. The new sequencing technologies make it possible to conduct genomic studies with much smaller quantities of material, increasing researchers’ willingness to share more of the valuable sample resources they have acquired. Genetic surveillance industrial complex entrenching itself now – constitutional and legislative protections are weak Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 II. IMPLICATIONS OF THE EXPANDED USE OF LOCAL DNA DATABASES The results from Palm Bay and Bensalem demonstrate that local databases have the potential to be a powerful law enforcement tool. Indeed, Director Harran concluded that local databases are “the best thing to come to law enforcement since fingerprints,”150 and Palm Bay claims that its database prevented $6 million worth of property crime.151 Given the reduction in property crime and the increased clearance rates credited to local databases, it may appear difficult to question law enforcement’s enthusiasm, particularly when the Supreme Court recently blessed the expansion of DNA databases in Maryland v. King. 152 However, in addition to the promise of more efficient crime-solving, local databases carry the potential for serious negative implications that have not been fully considered by law enforcement. This Part discusses the forces that will help to solidify local databases as an accepted surveillance tool, categorizes and analyzes the potential negative effects of these databases, and sets the stage for reforms proposed in Part III A. Entrenching Local DNA Databases There are powerful external forces helping to ensure that once local databases are adopted, they quickly become routine surveillance tools. This Section focuses on three of these external forces: 1) current Fourth Amendment doctrine, which allows law enforcement to tap into the everexpanding pool of personal information collected and stored by private companies; 2) a nascent genetic surveillance-industrial complex; and 3) growing public acceptance of law enforcement’s use of genetic surveillance techniques Current Fourth Amendment doctrine—in particular the principles of the third-party doctrine153—allows law enforcement to benefit from the vast amount of information the public voluntarily shares with private companies.154 This has led some scholars to conclude that law enforcement will respond by altering their surveillance practices. Professor Paul Ohm predicts that “[a]s the surveillance society expands, the police will learn to rely more on the products of private surveillance, and will shift their time, energy, and money away from traditional self-help policing, becoming passive consumers rather than active producers of surveillance.”155 Professor Ohm’s instincts are correct about certain types of surveillance activities. It seems likely that police will be inclined to use information amassed by private sources, decreasing the need for law enforcement to conduct duplicative surveillance. However, not all information sought by law enforcement is captured in the private sector. Specifically, genetic surveillance is one area where law enforcement will continue to be producers, as opposed to consumers, of surveillance. Whereas Google, Facebook, and other companies will feed law enforcement’s desire for digital surveillance, the expansion of local databases demonstrates that law enforcement will be the driver of collecting and analyzing genetic evidence. In addition, local law enforcement’s use of genetic surveillance will be shaped by corporate interests.156 Corporate interests have played a role in the development of local DNA databases since their inception.157 The first local DNA database was designed jointly by a private DNA lab and the Palm Bay Police Department.158 And private firms are integral to the continued expansion of these databases. Large firms, such as Bode Technology and Orchid Cellmark, view local law enforcement databases as potential revenue streams, particularly because they promise to promote the use of DNA beyond violent crimes (sexual assaults and homicides) to property crimes.159 These firms see a business opportunity in processing the evidence swabs collected from property crimes. Indeed, in marketing their products, they trumpet the studies that have highlighted DNA’s promise for solving these crimes.160 Similarly, smaller firms have also sought to benefit from and to drive the expansion of local databases. These include SmallPond and IntegenX.161 These companies have been consistent participants in law enforcement conferences in the last several years,162 and they have sought meetings with local agencies to pitch their products. Furthermore, IntegenX offers to help potential buyers secure grants to purchase its products.163 The influence of private firms on policing techniques is not new and is certainly not unique to genetic surveillance.164 However, it is important to recognize that these private interests will influence the expansion, use, and long-term viability of this surveillance tool. And because these private interests have evolved simultaneously with local law enforcement’s push to enter the genetic surveillance space, the prospect of a genetic surveillance industrial complex further entrenching the practice of local databases seems likely. Finally, the very use of these databases will also contribute to the public’s acceptance of them. Even those with only a casual understanding of surveillance techniques accept without question law enforcement’s ability to collect personal information—including photographs, fingerprints, addresses, etc.—for investigative databases. Furthermore, because CODIS has been around for 20 years, there is widespread understanding that law enforcement collects DNA profiles from at least some segments of the population. Thus, local databases are not a completely new surveillance tool. This incremental evolution of law enforcement investigative databases in general, and DNA databases in particular, will help to solidify local databases as a tolerated, if not accepted, law enforcement tool.165 Doctor-Patient Trust - Uniqueness Doctor trust is collapsing now Harding 14 - Contributing Writer @LiveScience (Anne, “Americans' Trust in Doctors Is Falling,” October, http://www.livescience.com/48407-americanstrust-doctors-falling.html] Americans' trust in the medical profession has plummeted in recent years, and lags well behind public attitudes toward doctors in many other countries, according to a new report. That lack of trust comes from how Americans' perceive doctors' motivations, said 34 percent of U.S. adults polled in 2012 said they had "great confidence in the leaders of the medical profession," down from 76 percent in 1966 ¶ Robert Blendon, a professor of health policy and political analysis at the Harvard School of Public Health in Boston and co-author of the new report. While physician leaders elsewhere in the world often take public stands on key health and medical issues, Americans perceive the medical profession as looking out for itself, not advocating for public health, he said.¶ Just , according to the report.¶ And a survey of people in 29 countries found the United States ranked 24th in public trust of doctors. Just 58 percent of Americans surveyed said they "strongly agreed" or "agreed" with the statement that "doctors in your country can be trusted," versus 83 percent of people who said the same in t op-ranked Switzerland, and 79 percent in runner-up Denmark.¶ Only Chileans, Bulgarians, Russians and Poles were less trusting of the medical profession, the researchers analyzed dozens of opinion polls looking at the public's trust in doctors. The findings indicate that, these days, Americans see physicians as just another interest group among many, Blendon said. "What's driving [trust levels] down is that physicians in the U.S., as groups and leaders, are not seen as advocates for health and health care according to the report, which is published in the Oct. 23 issue of the New England Journal of Medicine. [7 Absolutely Evil Medical Experiments]¶ For the study, ¶ broad public issues," Blendon told Live Science. "In the U.S., they're seen more as a group concerned with their own professional problems and economic issues." Robust survey of a broad range of indicators proves Bynum & Porter, 13 W. F. Bynum, Roy Porter, British historian noted for his prolific work on the history of medicine, former director of the Wellcome Institute for the History of Medicine at University College, LondonRoutledge, Jun 20, 2013, “Companion Encyclopedia of the History of Medicine” 794-795, accessed online via Google Books One of the great ironies of the social history of medicine is that, at the ¶ supreme moment of achieving this therapeutic power, the crown of glory was ¶ snatched from the doctor's head. In the last quarter of the twentieth century, ¶ as an ever-broader stream of antibacterial, anti-inflammatory and antineoplas- ¶ tic medications became available, patients became increasingly alienated from ¶ the former 'demigods in white'. Recent statistics illustrate these changes. For ¶ example, rising numbers Of malpractice suits point to growing alienation: one ¶ half of all surgeons in Florida had been sued for malpractice within the ¶ period 1975—80, and the better trained the surgeons were, the greater the ¶ number of suits.23 Between and 1985, claims per 100 physicians in the ¶ United States as a whole more than doubled. Some specialities were exceed- ¶ ingly vulnerable: over the five-year period 1976—81, claims against obste- ¶ u-icians tripled. The average claim itself climbed from 98,000 in 1975 to almost $100,000 in 1988.2' Ch. 69 Medicine and the law; Ch. History of ¶ ethics) ¶ Second, patients responded to their perception Of physicians' coolness ¶ and lack of interest with a lack Of loyalty. Several different American polls ¶ commissioned in the mid-1980s found that two-thirds of all patients would ¶ be willing to 'change their provider in an attempt to find more satisfactory ¶ medical care'.2S One contrasts this high volatility with patients in the days ¶ before the Second World War who, with their families, would often develop ¶ lifelong attachments to the same family doctor. ¶ The whole persona of the 'family doctor', the elderly pipe-puffing figure ¶ present both at birth and death, is now disappearing, both in fact and in the ¶ minds of patients. In the United States in 1988, only slightly more than one ¶ doctor in ten was in 'general family practice'.26 Nor were American patients ¶ particularly interested in the advice of their physicians: the percentage of ¶ patients willing to use the family doctor as a source of 'local health care ¶ information' declined from 46 per cent in 1984 to 21 per cent in 1989.27 ¶ How did families select which hospital to attend? More than 50 per cent of ¶ patients polled in 1989 said that 'they or their family have the most influence ¶ in selection of a hospital' — as opposed to listening to the doctor — up from ¶ 40 per cent in previous years." (Non-American readers will recall that private ¶ American hospitals compete for patients.) ¶ This alienation from the doctor—patient relationship has diminished the ¶ public's former hero-worship of the doctor. According to a Gallup poll in ¶ 1989, 26 per cent of patients said they respected doctors less now than ten ¶ years ago (14 per cent said more). And of those who respected doctors less, ¶ 26 per cent said, 'they (the doctors) are in it for the money'. Seventeen per ¶ cent claimed that doctors 'lack rapport and concern'.29 Best data proves trust is sinking Blendon et. al, 10-23-‘14 Robert J. Blendon, Sc.D., John M. Benson, M.A., and Joachim O. Hero, M.P.H., The New England Journal of Medicine, October 23, 2014, “Public Trust in Physicians — U.S. Medicine in International Perspective” http://pnhp.org/blog/2014/10/24/improving-trust-in-the-profession/ Research suggests that for physicians to play a substantial role in such decision making, there has to be a relatively high level of public trust in the profession’s views and leadership. But an examination of U.S. public-opinion data over time and of recent comparative data on public trust in physicians as a group in 29 industrialized countries raises a note of caution about physicians’ potential role and influence with the U.S. public.¶ In a project supported by the Robert Wood Johnson Foundation and the National Institute of Mental Health, we reviewed historical polling data on public trust in U.S. physicians and medical leaders from 1966 through 2014, as well as a 29-country survey conducted from March 2011 through April 2013 as part of the International Social Survey Programme (ISSP), a cross-national collaboration among universities and independent research institutions.¶ In 1966, nearly three fourths (73%) of Americans said they had great confidence in the leaders of the medical profession. In 2012, only 34% expressed this view. But simultaneously, trust in physicians’ integrity has remained high. More than two thirds of the public (69%) rate the honesty and ethical standards of physicians as a group as “very high” or “high” (Gallup 2013).¶ Today, public confidence in the U.S. health care system is low, with only 23% expressing a great deal or quite a lot of confidence in the system. We believe that the medical profession and its leaders are seen as a contributing factor. Longitudinal studies establish US doctor-patient relationships are amongst the worst in the world Collins, 10-23-‘14 Sam P.K. Collins is a health reporter for ThinkProgress, OCTOBER 23, 2014, Think Progress, “Americans Don’t Trust The Medical Profession” http://thinkprogress.org/health/2014/10/23/3583625/americansskeptical-doctors/ Americans count among the least trusting of the medical profession, according to an international health care survey. The findings, which appeared in a recent issue of the New England Journal of Medicine, show significant levels of suspicion of doctors, especially among those who make less than $30,000 annually.¶ Researchers studied public health polls dating back four decades, including one conducted by a consortium of universities between 2011 and 2013 during which people in 29 countries answered survey questions. In that poll, 58 percent of Americans said they trust the medical profession, placing the United States in 24th place with Croatia.¶ “It fits with decades of data on the American public’s trust in institutions, in general,” Michael Gusmano, a scholar at the Hastings Center, a Garrison, N.Y.-based research institute that focuses on health care, told WebMD. Doctor-Patient Trust – Privacy Key Increased health care privacy is key to doctor-patient trust Greenspun 15 (Harry Greenspun M.D. is the director of the Deloitte Center for Health Solutions, “Earning Patient Trust Crucial to Health Care Reform” 4/27/15 http://deloitte.wsj.com/cio/2015/04/27/earning-patient-trust-crucial-to-healthcare-reform/)///CW Maintaining privacy in health care used to be relatively straightforward. As a physician, I was bound by doctorpatient confidentiality. This gave my patients the confidence that they could share with me intensely personal information. Security focused on limiting access to paper charts. Breaches typically involved only a handful of individuals. ¶ Now, in an era of electronic health records (EHR) and clinical data shaken. From lapses in protocols to sophisticated cyber attacks, the public is confronted with exposure on a massive scale warehouses, consumers’ confidence in the security of their data continues to be. The value of health care data on the black market is even beginning to exceed that of financial data, as scammers and hackers can use information about individuals’ physical characteristics to steal identities. The information that comes with a person’s medical identity is also more difficult to move back into the private realm once it leaks to the public. ¶ Some of this news could not come at a worse time. The future of health care depends on secure flow of information. Nearly every major delivery reform, from value-based care and population health to personalized medicine and use of real-world evidence, relies on data and the willingness of those who have it to share it. The ability to better serve individuals depends on the health care industry’s ability to view its data in aggregate.¶ Compounding the problem is the awareness that our overall privacy–not just health privacy–is slowly eroding. A casual glance at online ads reveals how quickly your consumer data gets shared, but technology has taken us well beyond that. Last year, while participating in a conference on privacy in Abu Dhabi, one of the speakers asked, “Who knows you’re here?” The list grew rapidly: my office, the airline, customs and immigration, the hotel, the taxi company, the coffee shop, my cellphone carrier, the conference center, and the owners of the literally thousands of security cameras I’d passed during my trip. Add notes to family and friends along with followers on social media, and it was clear that the record of my trip had been broadly dispersed.¶ As we sit on the cusp of the era of big data in health care, there are several important things to consider:¶ Health data concerns are different. While the loss of financial disclosure of certain medical information can be devastating with far-reaching consequences. In addition, breaches and misuse can introduce inaccuracies into a medical record, potentially impacting patient safety.¶ Privacy preferences fall along a continuum and vary even within individuals information can be distressing, the impact can usually be mitigated and consumer liability is often limited. By contrast, depending on the topic. While many consumers may freely share certain health information for clinical research, on social media, and with disease-specific websites, they fiercely protect other personal health data. As we strive to gather more data to advance health care, the tension between the need for individual privacy and knowledge for the greater good is only going to increase.¶ The industry has a communication challenge. Do your own survey and ask some friends, “What are the risks of having your medical information stored electronically?” Once they have talked your ear off about identity theft, discrimination, and even extortion, ask them, “What are the benefits?” Having done this many times myself, I’ve found that few have a compelling answer. While we have invested heavily in EHRs and health information exchange, we have done little to educate the public whose data may be at risk. Perception of information collection crushes patient trust Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB A significant body of research has examined the perception of privacy concerns from the viewpoint of a special class of patients, including mental health patients, seekers of HIV testing and adolescents. In a recent survey of past research on healthcare confidentiality, Sankar et al. (2003) make four overarching conclusions. First, patients strongly believe that their information should be shared only with people involved in their care. Second, patients do identify with the need of information sharing among physicians, though HIV patients are less likely to approve sharing of their health information. Third, many patients who agree to information sharing among physicians reject the notion of releasing information to third parties, including employers and family members. Lastly, the majority of patients who have undergone genetic testing believe that patients should bear the responsibility of revealing test results to other at-risk family members. This extensive body of research has primarily focused on the use of identifiable or potentially identifiable information by others outside of immediate health providers, such as employers, families and third parties (Sankar et al., 2003). However, very limited research has examined patients’ perceptions of sharing anonymised health records (perhaps with the exception of more recent studies that examine patients’ perceptions about consent for data use (Bansal et al., 2007; Campbell et al., 2007)). Bansal et al. (2007) developed a set of constructs based on utility theory and prospect theory as antecedents of trust formation and privacy concern that impact users’ personal disposition to disclose their health information to online health websites. In particular, they reported that users’ current health status, personality traits, culture, and prior experience with websites and online privacy invasions play a major role in users’ trust in the health website and their degree of privacy concerns. On the other hand, in a mail-based survey with adult patients in England, Campbell et al. (2007) found that about 28–35% of patients are neutral to their health information – such as age, gender, ethnicity, reason for treatment, medical history, personal habits impacting health, type of treatment obtained, side effects of treatment – being used by physicians for other purpose. Only about 5–21% of patients, however, expected to be asked for permission to use their information by their physicians. Similarly, only about 10% of the patients expected to be asked for permission if their doctors used their health information for a wide variety of purposes, including combining data with other patients’ data to provide better information to future patients, sharing treatment outcomes with other physicians, teaching medical professionals and writing research articles about diseases and treatments. Patient-physician trust is critical to provide companies with access to healthcare and information Muller et al 14 (Evamaria Muller, Jordis M. Zill, Jorg Dirmaier, Martin Harter, Isabelle Scholl, University Medical Center Hamburg-Eppendorf, Department of Medical Psychology, Hamburg, Germany)(“Assessment of Trust in Physician: A Systematic Review of Measures”, September 10, 2014, PLoS ONE 9(9): e106844. doi:10. 1371/journal.pone.0106844)//ASMITH Patient-centeredness has gained importance in research, health policy and clinical practice. Trust is considered a central factor in determining a positive patient-physician relationship [1–3], which is an important dimension of patient-centeredness [4]. Trust in the context of healthcare has received increasing attention in the last two decades [5]. This is partly due to the voice of concerns about the effects of organizational changes in the healthcare system on patients’ trust in their healthcare professionals, healthcare institutions and the healthcare system itself [6,7]. Patients’ trust has a particularly delicate notion, as patients who are ill and may have to face high risks regarding their health find themselves in an extremely vulnerable situation. Reliance on patients’ individual physicians and the healthcare system is often inevitable [6,8]. The patient-physician relationship is characterized by a knowledge and power imbalance in which patients depend on the physicians’ expertise and execution of treatments to solve their health problems [6,8,9]. Hence, trust in physician plays an important role and has been studied extensively. Trust in physician can be defined as the patient’s optimistic acceptance of a vulnerable situation and the belief that the physician will care for the patient’s interests [2]. Empirical studies have revealed that patients’ trust in physician is associated with patient satisfaction [10], continuity of care [11] and adherence to treatment [12]. Trust in physician facilitates access to healthcare, disclosure of relevant information and thereby supports accurate and timely diagnosis to be made [8]. Trust in physician is also associated with self-reported health improvement [13] and patients’ self-reported ability to manage their chronic disease [14]. As the body of work increases, the question of how to measure trust in physician gains importance. The validity of empirical findings is fundamentally dependent on the quality of the measures in use. Therefore, the selection of a measure should be carefully considered and based on the measure’s psychometric properties. Some studies addressed the quality of trust in physician measures [5,7,15], but no systematic review on trust in physician measures and their psychometric properties has been published to date. A thorough overview and comparison of different validated measures is needed a) to facilitate the choice of an appropriate instrument in accordance with the individual research purpose, b) to identify research gaps and needs for further psychometric testing of instruments and c) to inspire new measurement developments, if necessary. Thus, the aims of this systematic review of measures on trust in the physician are 1) to identify existing psychometrically tested measures of trust in physician, 2) to determine the methodological quality of the studies that report on psychometric properties of measures, and 3) to evaluate the quality of identified measures based on their psychometric properties. Privacy and trust between doctors and pacients are critical to successful medicine practices Glen and Montieth 14 (Tasha Glenn, ChronoRecord Association, Inc., Fullerton, CA & Scott Monteith, Michigan State University College of Human Medicine, Traverse City Campus)(“Privacy in the Digital World: Medical and Health Data Outside of HIPAA Protections, 14 September 2014, Curr Psychiatry Rep,16:494 DOI 10.1007/s11920-014-0494-4)//ASMITH Trust between doctor and patient is fundamental to the practice of medicine. A patientmust trust the physician sufficiently to share personal details that may be stressful, embarrassing, or potentially damaging. A physician must trust that a patient is sharing enough information to make an accurate diagnosis, and that a patient is able to give informed consent about treatments that may pose significant risks. Trust in psychiatrists may be more important to patients with mental disorders than to patients with other serious illnesses [1]. An essential component of the trust between doctor and patient is privacy. Over two thousand years ago, Hippocrates emphasized the importance of privacy, and the practice of medicine has recognized and valued the importance of privacy ever since. Privacy of medical data is regulated by federal and state laws but primarily HIPAA. HIPAA regulates patient data that is collected by providers and their business associates in relation to treatment, payment or healthcare operations. Most privacy discussions relate to concerns about HIPAA, such as the relative ease of reidentification of deidentified data [2, 3]. This review will focus on the medical and health data that are increasingly being collected outside of HIPAA protections. Medical and health data outside of HIPAA can be volunteered by consumers directly, observed by corporations recording consumer actions, and inferred by calculated models [4]. The rapidly expanding stores of data collected outside of HIPAA are encroaching on the traditional doctor patient relationship and eroding medical privacy Patient-Doctor relations key to medical efficiency Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB Privacy is viewed as a key governing principle of the patient–physician relationship. Patients are required to share information with their physicians to facilitate correct diagnosis and treatment, and to avoid adverse drug interactions. However, patients may refuse to divulge important information in cases of health problems such as psychiatric behaviour and HIV, as their disclosure may lead to social stigma and discrimination (Applebaum, 2002). Over time, a patient’s medical record accumulates significant personal information including identification, history of medical diagnosis, digital renderings of medical images, treatments, medication history, dietary habits, sexual preference, genetic information, psychological profiles, employment history, income and physicians’ subjective assessments of personality and mental state (Mercuri, 2004). Figure 1 shows a typical information flow in the healthcare sector. Patient health records serve a range of purposes apart from diagnosis and treatment provision. For example, information could be used to improve efficiency within the healthcare system, drive public policy development and administration, and in the conduct of medical research (Hodge, 2003). A patient’s medical records are also shared with payer organisations (e.g., private insurance or Medicare/Medicaid) to justify payment of services rendered. Healthcare providers also use records to manage their operations and improve service quality. Furthermore, providers may share health information through Regional Health Information Organisations (RHIOs) to facilitate care services. Public doesn’t perceive gains from health surveillance Andrea Wilson (Senior Business Practices Analyst at The Methodist Hospital System, Houston, TX) 2009 “MISSING THE MARK: THE PUBLIC HEALTH EXCEPTION TO THE HIPAA PRIVACY RULE AND ITS IMPACT ON SURVEILLANCE ACTIVITY” 9 HOUS. J. HEALTH L & POL’Y 131-156, https://www.law.uh.edu/hjhlp/Issues/Vol_91/Wilson.pdf Public health officials have always faced obstacles in the collection of data needed for evaluating public health concerns and developing effective policy. 42 Agencies frequently suffer from a lack of funding at the state level, resulting in a loss of personnel for surveillance efforts. 43 Public health law aims to improve the health of the population as a whole by implementing policies, which require the cooperation of individual members of society. 44 However, citizens rarely see direct personal benefits from public health efforts because these activities are designed for aggregate well-being, as opposed to medical treatment which focuses on the individual patient. 45 The public does not perceive substantia l gain from surveillance, though it can clearly see that such activities require an inquiry into personal medical histories. 46 As a result, patients and their health care providers are reluctant to release private information. 47 Thus, there was cognizable difficulty in gathering needed surveillance data before the promulgation of HIPAA, and despite HHS’s attempts to broaden the means by which public health authorities could access this information, the terms of the regulations have exacerbated the problem. Doctor-Patient Trust – Key to Medical Treatment Doctor-patient trust is key to effective medical treatment Leng 13 (Shirie Leng MD is an anesthesiologist, “How can doctors and patients regain trust in each other?” 8/3/13 http://www.kevinmd.com/blog/2013/08/doctors-patients-regain-trust.html)///CW The Mayo Clinic Proceedings came out with a study that shows that many of the treatments that doctors once swore by are useless or worse.¶ The New York Times did a piece on it and the commentary contained a great deal of doctor-bashing. So of course I opened my big mouth and pointed this doctor hatred out. The comment I got back was this: “It’s not hatred, it’s fear.”¶ Wow. If people are starting to fear physicians then we’ve got a real problem. Trust has always been the basis of the doctor-patient relationship. If you can’t trust us then we might as well go back to the days of charlatans and quacks. I know, some people are going to say we’re all quacks anyway but those folks had shoddy upbringing. If you can’t trust us then we’re done. If you can’t trust us then our relationship becomes adversarial: you against me. If you can’t trust us, you won’t tell us things, you won’t do what we say, you will constantly be doubting our motives. And vice versa. Actually, now that I think of it, the doctorpatient relationship becomes basically teenager-parent.¶ The literature on doctor-patient trust suggests that a patient’s health or recovery depend in part on the doctor-patient relationship. Judith Hall, a researcher at Northeastern University, wrote with colleague Debra Roter,¶ Once the patient and physician are brought together, they enter a relationship predicated on the expectations each olds for the conduct of the other. The relationship thus formed has substantial implications for how the curing and caring process will be accomplished and the extent to which needs and expectations will be met, satisfaction achieved, and health restored. (Doctors Talking with Patients/Patients Talking with Doctors)¶ Trust has many components. It is based partly on compatible communication styles. The Journal of General Internal Medicine points to the patient’s assessment of the physician’s communication, level of interpersonal treatment, and knowledge of the patient. In these times of short visits, short-tempered doctors and patients, and fragmented treatment, all those factors are in jeopardy. Patient dissatisfaction implies poor trust. Race and gender of both patient and doctor has an impact. Patients who genuinely like their doctors tend to trust them more.¶ In the 1950s it was thought that the basis of physician trust is the understanding that doctors treat everyone equally. The media has made sure we all know this is not true, and this has to do with economics and geography as well as regional differences in standard of care. That old-fashioned trust of the physician resulted in a paternalistic approach to medicine with the resulting backlash by the autonomy movement. The basic function of the doctor, to diagnose and treat, has been called into question by the Mayo Clinic article as well as a number of other stories such as over-prescribing, doctors taking money from drug companies, the guy who performed illegal and unsanitary abortions, doctors turning down medicaid patients, etc. Doctors trust patients less too. Part of the reason doctors don’t follow the latest recommendations is fear of litigation, especially if they don’t do something. Lack of mandated privacy results in less overall information and decreased trust in the medical system Goldman, from the College of Physicians and Surgeons, Columbia University, November 1998 – (Janlori, “Protecting Privacy To Improve Health Care”, published in HealthAffairs volume 17 number 6)//roetlin Insufficient attention has been paid to date to the role that privacy and confidentiality play in the health care setting. There is no comprehensive federal law to protect the privacy of people’s health records, and state laws are scattered and inconsistent. Although the American Medical Association (AMA) and other provider groups have long considered confidentiality a key component of preserving the doctor/patient relationship, others view patient privacy as a barrier or a stumbling block to achieving health care–related goals. There is a fear that protecting privacy will clog the free flow of health information and make less information available for out- comes analysis, research, and other public health activities.2 Ultimately, however, the converse is true: Without trust that the personal, sensitive information that they share with their doctors will be handled with some degree of confidentiality, patients will not fully participate in their own health care. In the absence of such trust, patients will be reluctant to accurately and honestly disclose personal information, or they may avoid seeking care altogether for fear of suffering negative consequences, such as embarrassment, stigma, and discrimination. The plan is key to sustained participation in medical research studies Weir and Olick 4 (Robert, PhD and Professor Emeritus of Pediatrics at the University of Iowa; Robert, Associate Professor of Bioethics and Humanities at SUNY Upstate Medical University, “The Stored Tissue Issue: Biomedical Research, Ethics, and Law in the Era of Genomic Medicine,” 2004, Oxford university Press, p. 179)//JL The state of the law governing genetic privacy and the risks of genetic discrimination are relevant to biomedical research in at least three significant ways. First, though investigators are not obligated to quote chapter and verse about existing law, fulfilling the duty of confidentiality and making accurate representations about the bounds of this promise require a basic familiarity with the legal terrain. Second, the legal landscape necessarily informs IRB judgments whether the research protocol poses minimal risk and the shaping of informed consent requirements. Last, as observed elsewhere, concerns about privacy and discrimination may play a pivotal role in a potential participant’s willingness to enroll in a research study. Trust is essential to doctor-patient relationships and quality health care Russo 13 (Nicholas J. Russo is a 2012 honors graduate of the MBS program at TCMC. Before attending TCMC, he received a Bachelor of Science degree in technological systems management engineering and biology from Stony Brook University in New York. He plans to continue his education in medicine.)(“In medicine, doctor-patient trust vital”, February 18, 2013, The Scranton-Times Tribune, http://thetimestribune.com/news/health-science/in-medicine-doctor-patient-trust-vital-1.1445937)//ASMITH Amos was an Amish patient treated for pneumonia with penicillin injections by Dr. Henry. On the final day of his regimen, Dr. Henry told Amos that he did not have a bill prepared and asked him to return another day. Amos replied by writing a blank check. Dr. Henry refused the blank check, explaining that he would be able to write in any amount he wished. Amos replied without hesitation: "I trusted you with my life. I do not see why I cannot trust you with my money." This story from the book "Patients Are a Virtue," by Henry S. Wentz, demonstrates that trust is an essential component of the doctor-patient relationship. The sanctity of this relationship is the very essence of quality health care and is the basis for patient satisfaction and positive outcomes. Studies show that patients feel strongly that trust should be the No. 1 factor when it comes to choosing the "right" physician for you. A recent study published in the Internal Journal of Medical Education demonstrated that better patient outcomes and compliance with treatment increase when doctors are trusted and more proactive in involving patients in their own health care. Patients agreed they trusted their doctors more when extra time was spent explaining a procedure and treatment. These patients were more likely to get regular checkups and medical tests and take their medications properly. They were also more likely to follow a healthy lifestyle, including diet and exercise, and control diseases such as blood pressure and diabetes. Trusting your physician plays a much larger role than you might imagine when making medically informed decisions. Dr. Janet Townsend, founding chairwoman of the department of family, community and rural health at the Commonwealth Medical College, believes that establishing a foundation of trust with patients and their loved ones is the basis for delivering quality health care. "People need to trust you as a doctor and know that you are truly here for them," she said. Dr. Townsend's experiences have taught her that there is no simple equation for establishing trust, but it is a powerful tool for improving patient outcomes. Dr. Mark White, an educator and community health researcher at TCMC, takes great pride in his Physician and Society course for first-year medical students. He believes that trust is an integral part of the doctor- patient relationship; it is the root of passionate, patient-centered medicine, something he emphasizes in his curriculum. In fact, doctor-patient relationships may be improving. A recent MSNBC report presented a compelling argument that the traditional "authoritative attitude" of some doctors with their patients is rapidly becoming a thing of the past. More and more patients are taking responsibility for their health education, and trust may be the key underlying factor that allows this open communication and better patient treatment. Today's doctor-patient relationship is one in which both parties are more equal than ever, which allows both to be rewarded for establishing lasting relationships built on trust. New partnership In Northeast Pennsylvania, our communities are grounded in trust. On a regular basis, senior citizens come to my office for a consultation, and the first question they ask me is, "Who is your father, Paul?" This is followed by, "Was Al your uncle?" "Are you related to Mike?" While I was not sure of the importance of these questions early in my career, I have come to realize that patients were just trying to make a connection with me. They wanted to know if they could "trust" me. Nick Russo, a recent graduate of the Commonwealth Medical College's Master of Biomedical Sciences program, presents new research that supports their instincts: Patients who trust their health care provider have better outcomes; the doctor-patient relationship matters. Lack of doctor-patient trust causes lack of information communication and prevents effective treatment Goold and Lipkin 99 (Susan Dorr Goold, MD, MHSA, MA, Received from the Division of General Medicine, University of Michigan Medical Center, Ann Arbor, Mich. AND Mack Lipkin, Jr., MD, New York University Medical Center, New York)(“The Doctor–Patient Relationship: Challenges, Opportunities, and Strategies”, J Gen Intern Med. 1999 Jan; 14(Suppl 1): S26–S33. doi: 10.1046/j.15251497.1999.00267.x)//ASMITH The relationship between doctors and their patients has received philosophical, sociological, and literary attention since Hippocrates, and is the subject of some 8,000 articles, monographs, chapters, and books in the modern medical literature. A robust science of the doctor–patient encounter and relationship can guide decision making in health care plans. We know much about the average doctor's skills and knowledge in this area, and how to teach doctors to relate more effectively and efficiently.11, 12 We will first review data about the importance of the doctor–patient relationship and the medical encounter, then discuss moral features. We describe problems that exist and are said to exist, we promulgate principles for safeguarding what is good and improving that which requires remediation, and we finish with a brief discussion of practical ways that the doctor–patient relationship can be enhanced in managed care. The medical interview is the major medium of health care. Most of the medical encounter is spent in discussion between practitioner and patient. The interview has three functions and 14 structural elements (Table 1).13 The three functions are gathering information, developing and maintaining a therapeutic relationship, and communicating information.14 These three functions inextricably interact. For example, a patient who does not trust or like the practitioner will not disclose complete information efficiently. A patient who is anxious will not comprehend information clearly. The relationship therefore directly determines the quality and completeness of information elicited and understood. It is the major influence on practitioner and patient satisfaction and thereby contributes to practice maintenance and prevention of practitioner burnout and turnover, and is the major determinant of compliance.15 Increasing data suggest that patients activated in the medical encounter to ask questions and to participate in their care do better biologically, in quality of life, and have higher satisfaction.16 Effective use of the structural elements of the interview also affect the therapeutic relationship and important outcomes such as biological and psychosocial quality of life, compliance, and satisfaction. Effective use gives patients a sense that they have been heard and allowed to express their major concerns,17 as well as respect,18 caring,19 empathy, self-disclosure, positive regard, congruence, and understanding,20 and allows patients to express and reflect their feelings21 and relate their stories in their own words.22 Interestingly, actual time spent together is less critical than the perception by patients that they are the focus of the time and that they are accurately heard. Other aspects important to the relationship include eliciting patients' own explanations of their illness,23, 24 giving patients information,25, 26 and involving patients in developing a treatment plan.27 (For an overview of this area of research, see Putnam and Lipkin, 1995.28) Doctor-Patient Trust – Privacy Protection Behavior Strong widespread support for public health information privacy – the aff is key to avoid action to avoid discrimination Rubel 12 (Alan Rubel. Ph.D., Department of Philosophy, University of Wisconsin-Madison; J.D., magna cum laude, University of Wisconsin Law School Assistant Professor. “Justifying Public Health Surveillance: Basic Interests, Unreasonable Exercise, and Privacy.” 2012. P. 14-15. https://kiej.georgetown.edu/home_files/22.1.rubel.pdf)//EMerz There is, however, a question as to whether privacy is an important enough good that it is a basic interest. In some contexts it may be. Privacy is best understood as a three-part relation between a person, some domain of information, and some other person, persons, or entity. Any discussion of interests in, claims regarding, or rights to privacy should therefore specify who the privacy holder is, what information is at issue, and who the other parties are that can learn that information (Rubel 2011). Privacy in some information with respect to some entities would very likely rise to the level of a basic interest. Consider privacy regarding how one votes with respect to the state, privacy regarding one’s intellectual habits with respect to the state, and privacy regarding sexual orientation, genetic predispositions, aspirations and fears, and one’s naked body with respect to the general public. In the public health context, the privacy at issue is generally privacy regarding one’s medical information with respect to certain government actors. If we assume that no information conveyed will be disclosed to other agencies and to entities not already involved in a person’s health care, it is difficult to see a basic interest at work. At least this is true in most cases; below I address some particular contexts in which medical privacy may rise to the level of a basic interest. But the first premise states that claims to privacy in health information are based on deep personal interests. By this I mean that they are based on interests that are more weighty than (mere) personal interests but not sufficiently weighty to be considered basic. One reason is that health information privacy is important to many persons’ conceptions of the good. As I have already noted, the desire for health information privacy is strong, widespread, and resilient. Moreover, there is no reason to think such a desire is based on a misplaced fear or a mistake about facts. Many people are concerned about receiving ill treatment or being discriminated against on the basis of health information. The possibility of having their health information disclosed may lead people to avoid care, which is generally detrimental to their health and hence interests regardless of their particular conceptions of the good. Health privacy also implicates autonomy and dignitary interests, regardless of whether there is a chance of ill treatment, discrimination, or care avoidance (Bloustein 1964; Reiman 1976; Benn 1971; DeCew 1997). Some people may wish not to have their identities shaped by information about their health and so may want to control who views them in terms of their health conditions and who views them without such information.12 A further reason that claims to health privacy are based on deep interests has to do with a sense of fair terms of social cooperation. Given the widespread desire for privacy generally and health information privacy in particular, any mandatory diminution of that privacy by state actors should be justifiable in terms that the subject of the information gathering could agree to as fair in light of others’ reasonable conceptions of the good. Certainly some information collection is justifiable in this way: keeping track of motor vehicles and drivers’ licenses in order to assure only qualified drivers are on the roads and that they are using nonstolen vehicles is surely justified in such a way. But not all health information collection can be so justified. Where collection of health information does not redound to the benefit of the subject of the information, and where any health benefits to others are tenuous, small, or attainable in other ways, it would be difficult to justify the collection as fair to the persons whose conception of the good includes (or relies on) health information privacy.13 Finally, there is an important liberty interest at stake in health information privacy. Boudewijn de Bruin has recently made the case that privacy losses both limit persons’ freedom to act in certain ways and decrease those same persons’ knowledge about their freedom. If others have information about a person, they may use that information in a way that affects that person’s ability to act. So, a data breach might give a bank officer information that would lead her to reject a person’s loan application on the ground that she’s receiving, say, cancer treatment (2010). Moreover, de Bruin points out that the value of freedom stems from knowing that we possess it: uncertainty about the effects of information breaches undermines a person’s ability to act. Relatedly, there is an autonomy interest in understanding such effects, since information collected for public health can often be used to delimit a person’s opportunities. Information about tuberculosis may be used to quarantine or isolate people; information about HIV status is used to punish people who have sex without disclosing their status; information about HIV affects persons’ ability to travel and immigrate; information about vaccination affects whether people can enroll in schools; information about body weight has been proposed as a basis for an insurance surcharge for diabetics (Lacey 2011); and so forth. More importantly, the effects of the information may not be known at the time it is collected. We do not know how information will be used in the future. For these reasons health privacy with respect to state actors is best understood as a deep, personal (and nonbasic) interest. It is worth emphasizing that at this point I am outlining a condition for justifying surveillance and arguing that it is justified to restrict a claim based on a deep personal interest where exercising that claim unreasonably threatens basic interests. A fortiori, it would be justified to restrict a claim based on a nondeep personal interest. Now, in some cases privacy regarding one’s health with respect to state actors may implicate basic interests. As noted, TB (especially TB that is multidrug resistant or extensively drug resistant) may be grounds for quarantine or isolation (42 USC 264; 42 CFR 70, 71). Freedom of movement would seem to be a basic interest. So, at least in some cases, privacy with respect to state actors, in conjunction with laws enabling further actions based on that surveillance, implicates basic interests. In such cases, we are not confronted with conflicts between the basic interests of some individuals and the less weighty personal interests of others but with conflicts between basic interests. Subordinating some basic interests for the sake of other basic interests can be justified by appeal to the number or magnitude of basic interests at stake, such that if enough others’ interest in not contracting a disease that is likely to cause serious illness or death is strongly enough implicated, it can be justified to surveil others and to quarantine or isolate some. That does not entail that only aggregated interests matter, just that some degree of aggregation of basic interests can provide sufficient justification for subordinating of basic interests of others.1 Fears of privacy breaches causes withholding of patient data, inconsistent care, and lack of care coordination Glen and Montieth 14 (Tasha Glenn, ChronoRecord Association, Inc., Fullerton, CA & Scott Monteith, Michigan State University College of Human Medicine, Traverse City Campus)(“Privacy in the Digital World: Medical and Health Data Outside of HIPAA Protections, 14 September 2014, Curr Psychiatry Rep,16:494 DOI 10.1007/s11920-014-0494-4)//ASMITH Although the public routinely gives away most personal information, medical privacy remains uniquely important to most, as underscored by the very existence of HIPAA and HITECH. The use of technology in medicine is widely supported but concern remains about the security of the medical information that is protected by HIPAA, such as in EMR, as summarized in Table 2. In a study of psychiatric outpatients almost 90 % had concerns about confidentiality with the use of EMR, such as unauthorized access within a university healthcare system, inappropriate use of information, and stigmatization [126]. There are serious consequences when patients fear their privacy is at risk. Patients may become selective about the information they provide, offering an incomplete or misleading description of their condition. In recent surveys, a substantial number of people said they would withhold data from their physician due to privacy concerns related to technology, as shown in Table 3. Patients who are worried about privacy are also less likely to seek care or return for follow-up treatment, or may seek care outside of their provider network undermining the benefits of care coordination [126, 128]. Much of the general public is unaware of the large amount of medical and health data being amassed outside of HIPAA confidentiality protections. As the public becomes more informed about the secondary market for health data, concern about privacy and security of all medical data is likely to increase. This, in turn, may dissuade more people from seeking help or revealing the information to physicians. This is of particular concern to psychiatry, since patients with mental disorders are more likely to withhold information from their doctors than patients with other serious illnesses [1]. Electronic health records prevent effective data integration and are subject to data errors Hoffman and Podgurski 13 (Sharona Hoffman, the Edgar A. Hahn Professor of Law and Professor of Bioethics and the Co-Director of the Law-Medicine Center at Case Western Reserve University School of Law and Andy Podgurski, a Professor of Electrical Engineering and Computer Science at Case Western Reserve University)(“Big Bad Data: Law, Public Health, and Biomedical Databases”, Journal of law, medicine & ethics, public health law conference: practical approaches to critical challenges • spring 2013, Case Western Reserve University)//ASMITH *EHR = Electronic Health Record The proliferation of available data is generating much excitement in the public health community. However, this enthusiasm must be tempered by recognition of the potential limitations of EHR data. EHRs often contain data entry errors, in part because they can increase physicians’ documentation burden. Busy clinicians sometimes type quickly and invert numbers, place information in the wrong patient’s record, click on incorrect menu items, or copy and paste narrative from prior visits without carefully editing and updating it.8 Much of the information in EHRs is coded using not only the International Classification of Diseases (ICD- 9) but also customized lists incorporated into EHR products, and coding can introduce further errors. Codes may be confusing, misleading or too general to indicate the specifics of patients’ conditions.9 Furthermore, EHRs may not accommodate detailed and nuanced natural language notes about patients’ medical histories and diagnostic findings.10 Commentators have noted that providers collect data for clinical and billing purposes rather than for public health reasons. Thus, EHR content is not always wellsuited for public health uses. Furthermore, clinicians may have incentives to “upcode” in order to maximize charges, and this practice can systematically compromise the accuracy of many records.11 The menus and lists built into EHR systems may facilitate upcoding by suggesting items for which physicians should bill and making it easy to click boxes for charge purposes. In some instances, EHRs are incomplete, lacking essential information such as treatment outcomes. Patients who receive medication from their doctors often do not report whether the therapy was effective. The absence of return visits may mean that the patients were cured, but it could also indicate that they failed to improve or deteriorated and decided to visit different doctors or specialists.12 In addition, patient records are often fragmented. A patient may see multiple doctors in different facilities, and if these practices do not have interoperable EHR systems, pieces of the individual’s record will be scattered in different locations. Such fragmentation can hinder surveillance and research efforts because the patient’s medical history cannot easily be put together into a comprehensive whole.13 EHR vendors are making slow progress towards achieving interoperability, the ability of two or more systems to exchange information and to operate in a coordinated fashion. In 2010 only 19% of hospitals exchanged patient data with providers outside their own system.14 Vendors may have little incentive to produce interoperable systems because interoperability might make it harder to market products as distinctive and easier for clinicians to switch to different EHR products if they are dissatisfied with the ones they purchased. The lack of interoperability in EHR systems can also impede data harmonization. Different systems may use different terminology to mean the same thing or the same terminology to mean different things. For example, the abbreviation “MS” can mean “mitral stenosis,” “multiple sclerosis,” morphine sulfate,” or “magnesium sulfate.”15 If the term’s meaning is not clear from the context, then analysts may not be able to interpret it correctly. Health information privacy prevents privacy protective behavior Alan Rubel (University of Wisconsin Law School Assistant Professor , Ph.D., Department of Philosophy, University of Wisconsin-Madison; J.D., magna cum laude) 2014 “Privacy, Surveillance, and Autonomy” p. 312 One possibility is that privacy protections are justified by the potential negative effects of information disclosure on persons' welfare. For example, a lack of privacy may under- mine persons' healthcare: Where individuals worry about privacy regarding their medical information, they are likely to engage in "privacy protective" behaviors, such as lying to their care providers, seeing multiple providers, using different pharmacies, not participat- ing in research, and paying in cash rather than using insurance (Goldman 1998: 49; California Healthcare Foundation 2010: 20). Likewise, privacy may increase or protect one's opportunities. Information about a person's health status, medical history, or genetic attributes may undermine her employment prospects, insurance eligibility, financial back- ing, promotion potential, or opportunities for positions of responsibility. Privacy may also protect people from stigma. Some may believe that aspects of a person's health and med- ical status reflect negatively on that person (for example, sexually transmitted infections, mental illnesses, some chronic diseases). Hence, where others learn that one has such a condition, she may lose some degree of social esteem. Doctor-Patient Trust – Drug Resistance Mis-diagnosis from lack of patient trust makes solving drug resistance impossible Stein et al. 6/25, (Uri Obolski, Gideon Y. Stein, Lilach Hadany, PLOS Computational Biology, University of New South Wales, “Antibiotic Restriction Might Facilitate the Emergence of Multi-drug Resistance,” June 25, 2015, http://journals.plos.org/ploscompbiol/article?id=10.1371/journal.pcbi.1004340)//IB Antibiotic resistance management is one of the most pressing public health issues challenging modern medicine [1]. Resistance frequency is continually rising in abundant pathogenic bacteria [2,3], entailing higher risk for patients and increased economic costs [4,5]. Especially perilous are infections of multi-drug resistant (MDR) bacteria, which can lead to higher rates of inadequate treatment and mortality [6–8], and at times are resistant to almost all available antibiotics [9,10]. Even drugs of last resort, with relatively low prescription rate, are revealed to have increasing resistance frequencies [11,12]. The increase in antibiotic resistance frequencies is a consequence of microbial evolution and adaptation, induced by vast anthropogenic antibiotic consumption and dissemination [13]. This arms-race hinges on two main forces, acting at opposite directions: resistance acquisition and spread in bacterial populations, and new antibiotic production [14]. Seeing that rates of new antibiotics' production are steadily decreasing [15] (although efforts are made to motivate the development of new antibiotics [16,17]), we are left to consider measures to impede the emergence of new resistant, and particularly MDR, bacteria. Reducing superfluous antibiotic usage, both in human consumption and veterinary usage, is currently considered the prominent course of action [18,19]. Albeit the benefit of reducing overall superfluous antibiotic usage is easy to justify and seems to have almost no drawbacks; restricting specific antimicrobial agents involves a compromise between increasing resistance to a drug saved for the most acute scenarios, versus increasing the probability of correct treatment. The rationale of restricting specific drugs is an evolutionary one. The use of a certain antibiotic exerts selective pressure on microbes to acquire resistance to that antibiotic. However, restricting an antibiotic does not amount to complete avoidance of its usage, as it will still be used against infections resistant to all other antibiotics [20]. Thus an increase in the frequency of bacteria resistant to the common antibiotics might result in increased usage of the restricted antibiotic as well. Medical efficiency is key to solving drug-resistance Cobey el al. 15, (Gabriel G. Perron, R. Fredrik Inglis, Pleuni S. Pennings and Sarah Cobey, Evolutionary Applications, “Fighting microbial drug resistance: a primer on the role of evolutionary biology in public health,” 23 MAR 2015, http://onlinelibrary.wiley.com/doi/10.1111/eva.12254/full)//IB Given the seemingly unavoidable nature of antibiotic resistance, evolutionary biologists have a large role to play in microbial resistance management. A better understanding of resistance evolution could not only help extend the use of antibiotics but could also help identify future antibiotics and strategies that may be more successful (Bush et al. 2011). For example, models based on community ecology could uncover how resistance is influenced by competition, migration, and environmental conditions. This direction is especially important given the accumulating evidences for the contribution of resistance genes already present in nature to the evolution of novel traits (Martinez 2012; Wellington et al. 2013). Evolutionary biologists can further understanding of fitness costs of resistance in many ways. This issue contains several articles on this topic, from the distributions of fitness costs in experimental populations (Melnyk et al. 2015) and the costs’ associations with their genetic basis (Vogwill and MacLean 2015), to the relationship between costs of resistance and strain backgrounds in different environments (Hall et al. 2015) and the pleiotropic effect of resistance mutation in the presence of multiple antibiotics (Schenk et is crucial to predict the distribution and persistence of antibiotic-resistant bacteria. More generally, understanding the evolutionary and community ecology of drug resistance is essential for successful long-term management of antibiotic-resistant infections. The introduction of penicillin helped cure al. 2015). This information infections caused by Streptococcus but potentially enabled other bacteria, such as S. aureus, to fill the vacant niche (Levy and Marshall 2004). More recently, multiple-antibiotic-resistant bacteria such as Clostridium difficile have spread in hospitals around the world, most often infecting patients treated with antibiotics. Other opportunistic pathogens that can evolve multidrug resistance, such as Pseudomonas aeruginosa and Acinetobacter baumannii, have increased in frequency in hospitals (Chen et al. 2008; Giske et al. 2008). Future treatment strategies should consider how host microbial communities affect patients’ resistance to infections (Lemon et al. 2012). The study of social interactions in microbes also shows great promises. Excreted proteins can act as public goods (Griffin et al. 2004), meaning that extracellular resistance mechanisms can contribute to the protection of whole communities (Dugatkin et al. 2005). Such effects can maintain resistance plasmids in experimental populations of bacteria (Yurtsev et al. 2013) and confer protection to unrelated bacteria species (Perlin et al. 2009). Applying principles of social evolution could lead to new treatments (Boyle et al. 2013). For example, antivirulence drugs are an especially promising method to control bacterial infections. Rather than trying to kill bacteria, these drugs modulate social interactions between microbes, selecting for less virulent variants (Brown et al. 2009; Ross-Gillespie et al. 2014). For more discussion of the role of evolutionary biology in managing antibiotic resistance in human medicine and agriculture, refer to Baquero et al. (2015) and Chang et al. (2015), respectively. Bacteria resistance increasing, its only a matter of time before Omni-resistant bacteria are here Cobey el al. 15, (Gabriel G. Perron, R. Fredrik Inglis, Pleuni S. Pennings and Sarah Cobey, Evolutionary Applications, “Fighting microbial drug resistance: a primer on the role of evolutionary biology in public health,” 23 MAR 2015, http://onlinelibrary.wiley.com/doi/10.1111/eva.12254/full)//IB Shortly after the discovery of penicillin, Abraham et al. (1941) demonstrated that cultures of Staphylococcus aureus could be made resistant by continuous subculture in the presence of the antibiotic in vitro. Because of the large mutation supply rate in some bacterial populations, the evolution of microbial resistance via random mutations is often seen experimentally or during clinical treatment (MacLean et al. 2010a). The first signs of de novo antibiotic resistance of clinical relevance were observed in Mycobacterium tuberculosis soon after the introduction of streptomycin in infected patients (Crofton and Mitchison 1948; Youmans and Williston 1948). It was later found that resistance most often arose from mutations in the ribosomal proteins, the cellular target of the antibiotics (Gillespie 2002). De novo evolution of resistance is often caused by either a modification of the antibiotic's cellular target (Spratt 1994) or by increased expression of certain genes, such as those coding for efflux pumps. Expression may change due to mutations in expression pathways (Ahmetagic and Pemberton 2011; Suzuki et al. 2014) or gene amplification (Sandegren and Andersson 2009; Sun et al. 2009a). Modification of cellular targets is especially common when the genes encoding the targets are large, increasing the likelihood of spontaneous beneficial mutations affecting the target (MacLean et al. 2010a). Resistance mutations due to increased expression of cellular machinery tend to confer resistance to multiple antibiotics, especially for efflux pumps, and can be difficult to identify (Suzuki et al. 2014). High-throughput sequencing now makes it possible to track the evolution of resistance during single infections and to identify possible interactions between resistance mutations and other traits (Lieberman et al. 2011). Because the evolution of resistance depends greatly on the mutation supply rate (i.e., the combined effect of population size and mutation rate), mechanisms that increase the mutation rate are likely to increase the rate of resistance evolution as well. Many mutations, especially those affecting the fidelity of DNA replication and repair, can cause hypermutability (Denamur and Matic 2006). Even though deleterious mutations usually outnumber beneficial mutations, an increased rate of mutation may promote adaptation in stressful environments, where fluctuating selective pressures favor phenotypic change (Taddei et al. 1997; Tanaka et al. 2003). For this reason, mutator populations of bacteria are often associated with antibiotic resistance (Björkman et al. 2000; Chopra et al. 2003; Oliver et al. 2004; Macía et al. 2005; Daurel et al. 2007; Henrichfreise et al. 2007). Interestingly, some antibiotics have mutagenic properties and therefore increase the mutation rate of bacteria (Iyer and Szybalski 1958, 1959; Kohanski et al. 2010; Gutierrez et al. 2013). The mutagenic effect of different antibiotics is mainly associated with the induction of the SOS response, which is caused by oxidative stress and DNA damage (Radman 1975; Friedberg et al. 2002). Rapid adaptation to new environments In many infections, the emergence of antibiotic resistance involves the action of specialized traits that were already present in the environmental populations of bacteria. Soon after the discovery of penicillin, Abraham and Chain (1940) described an instance of such rapid adaptation when they observed an enzyme capable of inhibiting the activity of penicillin. Following the introduction of penicillin in London's hospitals, resistant strains of S. aureus repeatedly appeared and caused treatment failure (Barber 1947). The penicillin-resistant strains, most often harboring penicillinase activity, quickly outnumbered penicillin-sensitive strains in most hospitals, and penicillin ceased being the drug of choice to treat the bacterium (Barber and Rozwadowska-Dowzenko 1948; Nichols and Needham 1949; Rountree and Thomson 1949). The story repeated itself countless times with resistance emerging in hospitals following the introduction of each new antibiotic. For example, aminoglycoside kinases, a large group of enzymes modifying the structure of aminoglycoside antibiotics, were discovered after the introduction of streptomycin, the first antibiotic discovered through a directed search for an antimicrobial (Davies 1994). Efflux pumps, one of the last major groups of resistance genes to be discovered, were first associated with tetracycline resistance in the 1970s (Ball et al. 1980; McMurry et al. 1980). Soon after, other efflux mechanisms in a variety of organisms were found that conferred resistance to different antibiotics. Efflux pumps remain one of the most common forms of antimicrobial resistance (Poole 2005). Over the past sixty years of research, multiple variants of each resistance mechanism group have been described. Multidrug-resistant bacteria first emerged in European hospitals. As early as 1952, it was reported that most infectious staphylococcal strains were resistant to penicillin and tetracycline (Rountree and Thomson 1949; Clarke et al. 1952; Lowbury et al. 1952; Kirby and Ahern 1953). Today, it is estimated that between 20% and 80% of healthcareassociated infections worldwide result from multiple drug-resistant bacterial infections (Levy and Marshall 2004). Horizontal gene transfer The rapid evolution of drug resistance, and multidrug resistance in particular, highlights the important role of horizontal gene transfer in microbial evolution (Ochman et al. 2000). Unlike meiotic sex in eukaryotes, genetic exchange of DNA fragments in bacteria is unidirectional and independent of reproduction (Redfield 2001; Vos 2009). Genetic material, including drug-resistant genes, can spread from one bacterium to another through plasmids, bacteriophages, and transposons [for a comprehensive review, see Thomas and Nielsen (2005)]. Although many of these mobile genetic elements can in theory evolve somewhat independently from other genes (e.g., as selfish genetic elements), many carry traits that benefit their hosts (Rankin et al. 2011). In fact, many of the most common resistance genes found in hospitals today are encoded on small plasmids that can be exchanged among different bacterial strains and species (Bennett 2008). In bacteria, chromosomal genes can also be transferred via homologous recombination or transformation, the uptake of naked DNA in the environment (Vos 2009). Transformation is believed to have enabled the evolution of penicillin-resistant Streptococcus pneumoniae, an important pathogenic bacterium, through the acquisition of genes from Streptococcus viridans, a naturally occurring penicillin-resistant bacterium (Spratt 1994). Transformation can also promote multidrug resistance, especially in the presence of standing genetic diversity (Perron et al. 2012). The capacity of microbes to acquire resistance genes from their surroundings highlights the potentially important role of environmental reservoirs in the spread of resistance across ecological niches (Perron et al. 2008a; Forsberg et al. 2012; Finley et al. 2013). Global disease resistance is increasing rapidly – the ability to treat diseases is close to collapsing – ending modern medicine Fukuda 14 - Assistant Director-General Health Security, World Health Organization (Keiji, “Antimicrobial resistance: global report on surveillance 2014” April, http://www.who.int/iris/bitstream/10665/112642/1/9789241564748_eng.pdf?ua=1) Antimicrobial resistance (AMR) within a wide range of infectious agents is a growing public health threat of broad concern to countries and multiple sectors. Increasingly, governments around the world¶ are beginning to pay attention to a problem so serious that it threatens the achievements of modern¶ medicine. A post-antibiotic era—in which common infections and minor injuries can kill—far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century.¶ Determining the scope of the problem is essential for formulating and monitoring an effective response to AMR. This WHO report, produced in collaboration with Member States and other partners, provides as accurate a picture as is presently possible of the magnitude of AMR and the current state of surveillance globally. The report focuses on antibacterial resistance (ABR) in common bacterial pathogens. Why? There is a major gap in knowledge about the magnitude of this problem and such information is needed to guide urgent public health actions. ABR is complex and multidimensional. It involves a range of resistance mechanisms affecting an ever-widening range of bacteria, most of which can cause a wide spectrum of diseases in humans and animals.¶ One important finding of the report, which will serve as a baseline to measure future progress, is that there are many gaps in information on pathogens of major public health importance. In addition, surveillance of ABR generally is neither coordinated nor harmonized, compromising the ability to assess and monitor the situation.¶ Nonetheless, the report makes a clear case that resistance to common bacteria has reached alarming levels in many parts of the world indicating that many of the available treatment options for common infections in some settings are becoming ineffective. Furthermore, systematic reviews of the scientific evidence show that ABR has a negative impact on outcomes for patients and health-care expenditures. Doctor-Patient Trust – Bioterror Trust solves bioterror response compliance and disease Glass 2 - Dept. of Epidemiology, Johns Hopkins University Bloomberg School of Public Health (Thomas, Bioterrorism and the People: How to Vaccinate a City against Panic Clin Infect Dis. (2002) 34 (2): 217-223) The public will not take the pill if it does not trust the doctor. Stopping a disease outbreak will require that public health professionals and government leaders carefully nurture the general population's trust and confidence in the institutions of public health and government and their actions, especially if largescale disease containment measures are necessary. After a bioterrorist attack, public trust could be a fragile asset, yet it is essential. The issue of trust bears significantly on 2 critical aspects of the medical and public health response to bioterrorism: (1) the choice of strategies for effective communication with the public, and (2) the processes for debating, as a society, some of the more ethically complex dimensions of disease containment. Although there is a tendency to view the media as an impediment to emergency response, a bioterrorist attack would necessitate a close working relationship between the media, decision-makers, and those involved in response operations. Given the speed with which news reports circulate today, and given the importance of the media in shaping public responses, health departments and hospitals would need to be responsive to media requests for information [28, 44]. An important step toward maintaining an effective, nonadversarial relationship with the press is to have more routine interactions with reporters, producers, and editorial boards before periods of crisis. During an emergency, health professionals could then build on their relationship with the media to effectively disseminate an accurate account of events, provide vital disease control information, and communicate the rationale and justification for the necessary medical and public health responses. Mass media outlets can get vital information to the largest numbers of people the most quickly. However, the mass media and the Internet are not sufficient. Additional communication strategies would be critical to enlisting the public as partners in implementing epidemic controls. Multilingual materials and culturally relevant messages that are endorsed and delivered by persons who have local respect and authority can help ensure that control measures are successfully disseminated to all sectors of a diverse community [6, 45]. Direct personal contact has the most significant effect on a person's willingness to trust and act on health-related information [17, 45]. Public outreach strategies of health departments and emergency services should include interpersonal exchanges of information—for example, town meetings and public workshops. On the other hand, the realities of an outbreak of a disease that is propagated by person-toperson transmission would require alternatives to such public meetings. Under those circumstances, means of remote communication (e.g., “telephone trees,” Internet-based communications, and newsletters) would be important alternatives. Continual research solves and deters bioterror Chyba 4 - Co-Director of the Center for International Security and Cooperation (CISAC), Stanford Institute for International Studies, and an Associate Professor at Stanford University [Christopher & Alex Greninger, “Biotechnology and Bioterrorism: An Unprecedented World” Survival, 46:2, Summer 2004, http://iis-db.stanford.edu/pubs/20722/Chyba_2004.pdf] In the absence of a comprehensive and effective system of global review of potential highconsequence research, we are instead trapped in a kind of offence–defence arms race. Even as legitimate biomedical researchers develop defences against biological pathogens, bad actors could in turn engineer countermeasures in a kind of directed version of the way natural pathogens evolve resistance to anti-microbial drugs. The mousepox case provides a harbinger of what is to come: just as the United States was stockpiling 300m doses of smallpox vaccine as a defence against a terrorist smallpox attack, experimental modification of the mousepox virus showed how the vaccine could possibly be circumvented. The United States is now funding research on antiviral drugs and other ways of combating smallpox that might be effective against the engineered organism. Yet there are indications that smallpox can be made resistant to one of the few known antiviral drugs. The future has the appearance of an eternal arms race of measures and countermeasures. The ‘arms race’ metaphor should be used with caution; it too is in danger of calling up misleading analogies to the nuclear arms race of the Cold War. First, the biological arms race is an offence–defence race , rather than a competition between offensive means. Under the BWC, only defensive research is legitimate. But more fundamentally, the driver of de facto offensive capabilities in this arms race is not primarily a particular adversary, but rather the ongoing global advance of microbiological and biomedical research. Defensive measures are in a race with nefarious applicationsof basic research, much of which is itself undertaken for protection against natural disease. In a sense, we are in an arms race with ourselves. It is hard to see how this arms race is stable – an offence granted comparable resources would seem to be necessarily favoured. As with ballistic missile defence, particular defensive measures may be defeated by offensive countermeasures. In the biological case, implementing defensive measures will require not only research but drug development and distribution plans. Offensive measures need not exercise this care, although fortunately they will likely face comparative resource constraints (especially if not associated with a state programme), and may find that some approaches (for example, to confer antibiotic resistance) have the simultaneous effect of inadvertently reducing a pathogen’s virulence. The defence must always guard against committing the fallacy of the last move, whereas the offence may embrace the view of the Irish Republican Army after it failed to assassinate the British cabinet in the 1984 Brighton bombing: ‘Today we were unlucky, but remember we have only to be lucky once – you will have to be lucky always’.40 At the very least, the defence will have to be vigilant and collectively smarter than the offence. The only way for the defence to win convincingly in the biological arms race would seem to be to succeed in discovering and implementing certain de facto last-move defences, at least on an organism-by-organism basis. Perhaps there are defences, or a web of defences, that will prove too difficult for any plausible non-state actor to engineer around. Whether such defences exist is unclear at this time, but their exploration should be a long-term research goal of US biodefence efforts. Progress might also have an important impact on international public health. One of the ‘Grand Challenges’ identified by the Bill and Melinda Gates Foundation in its $200m initiative to improve global health calls for the discovery of drugs that minimise the emergence of drug resistance – a kind of ‘last move’ defence against the evolutionary countermeasures of natural microbes.41 Should a collection of such defensive moves prove possible, bioterrorism might ultimately succumb to a kind of globalised dissuasion by denial :42 non-state groups would calculate that they could not hope to achieve dramatic results through biological programmes and would choose to direct their efforts elsewhere. Doctor-Patient Trust – Medical Research Doctor-patient trust is key to human participation in medical research Miller, 1 Frances H. Miller*, * Professor of Law, Boston University School of Law; Professor of Public Health, Boston University School of Public Health; Professor of Health Care Management, Boston University School of Management, Boston University Law Review, April, 2001, 81 B.U.L. Rev. 423, “SYMPOSIUM TRUST RELATIONSHIPS PART 1 OF 2: TRUSTING DOCTORS: TRICKY BUSINESS WHEN IT COMES TO CLINICAL RESEARCH” Lexis Trust is the sine qua non for public support of medical research. Clinical investigations inevitably subject human participants to the risk of harm in order to produce scientific results designed to advance the social good. n92 Research subjects must trust that those risks have been limited to an irreducible minimum, and that the potential consequences of their participation have been completely explained to them, before they assume the status of experimental animals. n93 Without that trust, societal support for human participation in clinical trials will simply vanish - or ought to. Civilized society's deeply-rooted ethical and legal traditions of respect for the autonomy of human beings demands [*440] no less. n94 Human participation is the bedrock of life-science innovation---trust is key NCEHR 13 - National Council on Ethics in Human Research, national organization mandated to advance the protection and well-being of human participants in research and to foster high ethical standards for the conduct of research involving humans. (http://www.ncehr-cnerh.org/) Innovation in many areas of science depends on the use of human volunteers as research subjects.The involvement of human participants is not confined to bio medical science, but extends to many areas of social sciences and humanities. In Canada and elsewhere, research on humans fulfils many functions – the creation of new knowledge, the formation of new social and economic policy, and the development of innovative new products and processes for human health, education and social development. The research enterprise is viewed by many in the public and private sectors as a driver of economic and social development, innovation, and national prosperity. A sub-sector of this research enterprise, research with humans, depends on the willingness of individuals, organizations, collectivities and communities to become engaged in research in the social, behavioural, natural, and medical and health sciences. It is essential that the public trust on which the participation of volunteer subjects depends be maintained and increased. Doctor Patient Trust – Medical Innovation Trust solves frivolous lawsuits Roter 6 – Professor @ JHU (Debra, “The Patient-Physician Relationship and its Implications for Malpractice Litigation,” J. Health Care L. & Pol'y 304) The current review does not bring forward any new ideas; the link between malpractice litigation and the power of communication to support or undermine the doctor-patient relationship is widely recognized by patients and physicians alike. As noted in a New York Times essay on medical malpractice: [P]atients who like their doctors don't sue, no matter what their lawyer says. Our efforts in medical schools to turn out skilled yet empathetic physicians who communicate clearly and who can put themselves in their patients' shoes is critical to stemming the malpractice crisis. Patients sue when their feelings are ignored or when they are angered by lack of genuine concern for their welfare. . . . Though it provides no guarantee, a sound physician-patient relationship is a powerful antidote to frivolous lawsuits." Relationships matter to both patients and physicians and the relationship itself may be the most powerful antidote to the malpractice crisis that medicine can provide. Frivolous litigation collapses medical innovation Curley 14 – member of the Healthcare Fraud and Abuse practice group of Bass, Berry & Sims PLC and a former assistant U.S. attorney and civil chief at the U.S. Attorney’s Office for the Middle District of Tennessee in Nashville. (Matthew, “Balance needed in fighting health-care fraud,” The Tennessean, http://www.tennessean.com/story/opinion/contributors/2014/11/15/balance-needed-fighting-healthcare-fraud/18988193/) It is important for government regulators to understand that even the most frivolous whistleblower lawsuits can result in lengthy and expensive investigations and business disruptions. Dollars and time devoted to responding to such lawsuits and investigations are diverted from patient care and innovation at a time when health-care providers are facing historic changes from health-care reform and tremendous downward pressure on the payments they receive. High litigation costs collapse medical innovation Robert 14 – Headaches & Migraines Expert, citing Connell, MD, OB/GYN and former FDA advisory panel chairperson (Teri, “Are Frivolous Lawsuits Driving Up Healthcare Costs?,” http://headaches.about.com/cs/advocacy/a/lamus_cala.htm) Dr. Elizabeth Connell is an OB/GYN and former FDA advisory panel chairperson. She has joined the Sick of Lawsuits Campaign as Senior Counselor. Dr. Connell has been involved in lawsuit abuse issues for years and wants Americans to know how frivolous lawsuits threaten our healthcare system by driving up costs, jeopardizing medical innovation, limiting access to healthcare and making doctors afraid to practice medicine. "I am fed-up with the shameless tactics of some personal injury lawyers and the outof-control litigation that endangers our access to healthcare," Dr. Connell said. "I am very pleased to be part of the Sick of Lawsuits campaign and to help to inform Americans about how lawsuit abuse threatens our entire healthcare system." In a recent press release, stated the following "Lawsuit Abuse Facts: " According to a recent Towers Perrin study, the U.S. tort liability system cost each U.S. citizen $721 in 2001 ($205 billion total). More than 40 percent of doctors reported avoiding prescribing appropriate medication because they knew the drug might be involved in litigation. Personal injury lawyers walk away with 30-50 percent of any jury award to the plaintiff, plus an additional percentage of the award to cover expenses. Since its widely used cholesterol-lowering drug Baycol was withdrawn from the market, Bayer is facing more than 8,000 lawsuits. The New York Times notes that at least 6,000 of those lawsuits, however, are being filed by people who did not suffer any side effects whatsoever. Their web site state these "Fast Facts - Symptoms of Lawsuit Abuse:" Lawsuit abuse affects all Americans on different levels. 80% of Americans say personal injury attorneys take too much of their clients' winnings. 76% of Americans believe medical liability lawsuits threaten access to quality healthcare for families. 74% of Americans describe medical liability issue as crisis or major problem. By 61% to 22% margin, Americans say lawsuits against doctors result in wealthy lawyers rather than improved quality of care for patients. Lawsuit costs passed on to consumers add up to nearly $721 per year for every person in America today. Because of litigation fears, 79% of doctors said they had ordered more tests than they would based only on professional judgment of what is medically needed. It takes at least a year to resolve most lawsuits, and delays of three to five years are not uncommon. Unfortunately, injured people with legitimate claims can wait years before their cases go to trial. An estimated $50 billion per year is spent on unnecessary test procedures designed only to guard doctors and hospitals against malpractice claims. Almost half of the money spent by physician insurers goes towards defending cases that ultimately are closed without compensation paid to the claimant. Doctor-patient trust is key to medical research---applies even to research projects not done by the doctor NIH 7 (Ethical Obligation Towards Research Subjects, Mens Sana Monogr. 2007 Jan-Dec; 5(1): 107–112, doi: 10.4103/0973-1229.32153) An issue of major concern is protection of the interests of research subjects. The reason why patients agree to become research subjects is not only for personal medical benefit but, as an extension, to benefit the rest of the patient population and also advance medical research. These areas are hardly served if research data is doctored or concealed, as can happen to protect industry interests or if industry solely decides the terms and conditions of research contracts. The ethical obligations of investigators to protect the rights and interests of research participants have been articulated repeatedly (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979; Declaration of Helsinki, 1964, updated 2004). Moreover, although informing subjects about risks and benefits empowers them to protect their interests and their rights as decision makers, it is equally the case that patients expect and trust guidance given by their doctors on whether or not to participate in research, which therefore puts added responsibility on researchers to ensure protection of the rights and interests of their research subjects: It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decision makers, but also empowers them to protect their own interests. Yet interviews with patientsubjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient-subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators and IRBs must assure that such trust is not misplaced (Kass et al., 1996). The case of trust is often much more so in countries like India where patient trust may land them in various exploitative situations. Trust is the fragile foundation of contemporary research (Kass et al, 1996). Since it is fragile, it needs careful handling. Scientific research is especially prone to manipulation as the temptation to utilise one's power over trusting subjects has a great opportunity to get misused. Science, we know, offers great powers, without the necessary obligation to utilise it responsibly. This is its greatest drawback. Scientific research involving human subjects can be the most tragic example of this truism. Processes inbuilt into research protocols that protect against exploitation need faithful implementation. Doctor-Patient Trust - A2 Data Breaches Inevitable HHS final rule regulation implementing HITECH/HIPAA reform ushers in a new era of compliance – cleans up data breaches and solves private sector data breaches Daniel Solove (the John Marshall Harlan Research Professor of Law at George Washington University Law School, the founder of TeachPrivacy, a privacy/data security training company, and a senior policy advisor at Hogan Lovells) 2013 “HIPAA Turns 10: Analyzing the Past, Present, and Future Impact” file:///C:/Users/Jordan%20Foley/Downloads/HIPAA%20Turns%2010%20Analyzing%20the%20Past%20Present%20and%20Future%20Impact.pdf In January 2013, after years of industry anticipation, HHS issued the final regulation implementing the HITECH Act’s HIPAA modifications. According to OCR Director Leon Rodriguez, the rule “marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented.” One of the most notable changes was expanding HIPAA to be directly applicable to business associates. Subcontractors of business associates receiving or processing PHI were also deemed to be “business associates.” Previously, business associates were governed by their contract with a covered entity, but after HITECH’s HIPAA modification, they are now subject to HIPAA sanctions and enforcement. “Moving to hold business associates to the same high standard as covered entities is a huge step in the direction to protect patient privacy,” Lucci says. This is because more than 20 percent of all the breaches reported on the HHS website “known as the ‘wall of shame’” are caused by business associates, she says. “This equates to over 12 million patients who have had their information at risk due to an organization outside of the healthcare organization itself,” Lucci says. The changes made by the HITECH Act to HIPAA will usher in a new level of compliance, according to Rebecca Herold, a longtime information security and privacy expert and CEO of The Privacy Professor. Herold notes that when many covered entities saw no sanctions were being applied for non-compliance by OCR, many “became much less concerned with implementing the Security Rule requirements” and “have not updated any of their privacy polices since they were first established back in 2002 or 2003.” Business associates were generally not concerned with HIPAA beyond simply having the business associate agreement in place, she says. However, today many in the healthcare industry are beginning to realize the importance and seriousness of HIPAA compliance. Doctor-Patient Trust - A2 Research Turn Privacy key to trust – the aff wont hinder research Deborah Peel (M.D. psychiatrist and president of the Patient Privacy Rights Foundation) April 2006 “Privacy and health research can co-exist” http://www.govhealthit.com/news/peel-privacy-and-healthresearch-can-co-exist Some health care professionals are concerned that medical privacy is hindering health care research. Nothing could be further from the truth. As a practicing psychiatrist, I would like nothing more than research that looks longitudinally at thousands of people with depression to learn what medications are best for treating someone after 10 to 15 years. Studies that track thousands of people over many years will be one of the greatest benefits of having a national electronic medical record system. But that kind of research does not require knowledge of patients' names. The vast majority of legitimate research can be conducted using aggregated data that doesn't include patients' names, addresses or Social Security numbers. To protect our medical privacy, technology now provides the tools to segment our most sensitive medical information. It also allows the sharing of aggregated health information for research to improve health care. Privacy and research can benefit from technology. It's not an either/or proposition. If we are smart and we care about sound scientific medical practices, we will build patient-controlled access to medical records into the network. That will ensure that information in the electronic medical record is accurate and reliable. Why? If people believe they do not have medical privacy, they will lie about their medical illnesses or omit mentioning critical tests and details rather than have the information flow to any number of health-related businesses. Such firms are allowed under the Health Insurance Portability and Accountability Act (HIPAA) to receive medical information about patients without their knowledge and consent. How can that be? Our existing federal privacy law is toothless. The federal government amended HIPAA in 2003, allowing more than 600,000 types of businesses and millions of their business associates to access medical records without patient consent for the "treatment, payment and operations of health-care related activities." To argue that medical privacy will result in higher costs and obstruct research is simply wrong. How can anything possibly be private with this type of loophole? Americans need and want the benefits that can come from lifelong, electronic medical records that allow the gathering and sharing of anonymous medical data to improve health care for all. But Americans must have medical privacy protections to trust a high-tech national health system. There's no reason we can't have both. Anton Vedder, Colette Cuijpers, Petroula Security of databases and communications is a quintessential precondition for trust in electronic services, including e-health services. While user trust is already considered essential for online commercial transactions,31 building user trust in e-health services is deemed extra important as users may fear unwarranted access to sensitive personal information or vulnerability to identity theft or online fraud—risks that do not arise as easily in comparable traditional offline practices, at least not to the same degree.32 The factors mentioned so far have been shown to be important for users’ trust in online services in general, and can therefore be expected to be important for patients’ trust in e-health as well. In addition, for caregivers, trust in the reliability of data, data exchange and communication is reported to be of high importance.33 Means for establishing reliability are of course to be found in the creation of possibilities for checking correctness and correction of information, for example through transparency and simplicity, and security safeguards in databases and communications. For health professionals, reliable authentication methods are also extremely important in order to guarantee that a patient is who she suggests she is and that the data introduced are really hers. This brings us to data protection regulation as a precondition for user trust. According to the WHO report cited in the introduction, privacy and trust in a healthcare context are intrinsically linked. The relationship between the patient and the healthcare provider Medical Research – Antibiotic Resistance Antibiotic resistance threatens extinction—UK National Threat list Sample 1/23/13, PhD in biomedical materials from Queen Mary's, University of London, worked at the Institute of Physics as a journal editor (Ian, “Antibiotic-resistant diseases pose 'apocalyptic' threat, top expert says”, The Guardian, http://www.theguardian.com/society/2013/jan/23/antibiotic-resistantdiseases-apocalyptic-threat)AM Britain's most senior medical adviser has warned MPs that the rise in drug-resistant diseases could trigger a national emergency comparable to a catastrophic terrorist attack, pandemic flu or major coastal flooding. Dame Sally Davies, the chief medical officer, said the threat from infections that are resistant to frontline antibiotics was so serious that the issue should be added to the government's national risk register of civil emergencies. She described what she called an "apocalyptic scenario" where people going for simple operations in 20 years' time die of routine infections "because we have run out of antibiotics". The register was established in 2008 to advise the public and businesses on national emergencies that Britain could face in the next five years. The highest priority risks on the latest register include a deadly flu outbreak, catastrophic terrorist attacks, and major flooding on the scale of 1953, the last occasion on which a national emergency was declared in the UK. Speaking to MPs on the Commons science and technology committee, Davies said she would ask the Cabinet Office to add antibiotic resistance to the national risk register in the light of an annual report on infectious disease she will publish in March. Davies declined to elaborate on the report, but said its publication would coincide with a government strategy to promote more responsible use of antibiotics among doctors and the clinical professions. "We need to get our act together in this country," she told the committee. She told the Guardian: ""There are few public health issues of potentially greater importance for society than antibiotic resistance. It means we are at increasing risk of developing infections that cannot be treated – but resistance can be managed. "That is why we will be publishing a new cross-government strategy and action plan to tackle this issue in early spring." Antibiotic development cannot keep pace with superbugs Sample 1/23/13, PhD in biomedical materials from Queen Mary's, University of London, worked at the Institute of Physics as a journal editor (Ian, “Antibiotic-resistant diseases pose 'apocalyptic' threat, top expert says”, The Guardian, http://www.theguardian.com/society/2013/jan/23/antibiotic-resistantdiseases-apocalyptic-threat)AM The issue of drug resistance is as old as antibiotics themselves, and arises when drugs knock out susceptible infections, leaving hardier, resilient strains behind. The survivors then multiply, and over time can become unstoppable with frontline medicines. Some of the best known are so-called hospital superbugs such as MRSA that are at the root of outbreaks among patients. "In the past, most people haven't worried because we've always had new antibiotics to turn to," said Alan Johnson, consultant clinical scientist at the Health Protection Agency. "What has changed is that the development pipeline is running dry. We don't have new antibiotics that we can rely on in the immediate future or in the longer term." Changes in modern medicine have exacerbated the problem by making patients more susceptible to infections. For example, cancer treatments weaken the immune system, and the use of catheters increases the chances of bugs entering the bloodstream. "We are becoming increasingly reliant on antibiotics in a whole range of areas of medicine. If we don't have new antibiotics to deal with the problems of resistance we see, we are going to be in serious trouble," Johnson added. The supply of new antibiotics has dried up for several reasons, but a major one is that drugs companies see greater profits in medicines that treat chronic conditions, such as heart disease, which patients must take for years or even decades. "There is a broken market model for making new antibiotics," Davies told the MPs. Davies has met senior officials at the World Health Organisation and her counterparts in other countries to develop a strategy to tackle antibiotic resistance globally. Antibiotic resistance bacteria is rapidly proliferating Sample 1/23/13, PhD in biomedical materials from Queen Mary's, University of London, worked at the Institute of Physics as a journal editor (Ian, “Antibiotic-resistant diseases pose 'apocalyptic' threat, top expert says”, The Guardian, http://www.theguardian.com/society/2013/jan/23/antibiotic-resistantdiseases-apocalyptic-threat)AM Drug resistance is emerging in diseases across the board. Davies said 80% of gonorrhea was now resistant to the frontline antibiotic tetracycline, and infections were rising in young and middle-aged people. Multi-drug resistant TB was also a major threat, she said. Another worrying trend is the rise in infections that are resistant to powerful antibiotics called carbapenems, which doctors rely on to tackle the most serious infections. Resistant bugs carry a gene variant that allows them to destroy the drug. What concerns some scientists is that the gene variant can spread freely between different kinds of bacteria, said Johnson. Bacteria resistant to carbapenems were first detected in the UK in 2003, when three cases were reported. The numbers remained low until 2007, but have since leapt to 333 in 2010, with 217 cases in the first six months of 2011, according to the latest figures from the HPA. Antimicrobial resistance mounting in the squo Alford 5/1/14, PhD in life sciences from the University of Warwick and science communicator with a focus on infectious diseases and HIV (Justine, “Antibiotic Resistance Now A Global Threat According To Latest WHO Report”, IFL Science, http://www.iflscience.com/health-and-medicine/antibiotic-resistancenow-global-threat-according-latest-who-report)AM The World Health Organization (WHO) has issued a report that serves as a stark wake-up call to the growing worldwide problem of antimicrobial resistance. The report highlights the need for a concerted effort from both governments and society as a whole to tackle this ongoing issue which poses a “global health security threat.” Antimicrobial resistance (AMR) occurs when organisms such as bacteria and viruses evolve mechanisms to evade therapeutic agents, for example antibiotics, rendering them ineffective. We’re all familiar with the “hospital superbug” MRSA (methicillin-resistant Staphylococcus aureus), but that just scratches the surface on this now incredibly widespread problem. Not only does AMR make infections more difficult to treat, it also means that relatively minor injuries and common infections have the potential to become life threatening. If we don’t step up our game, the achievements of modern medicine are seriously at stake. In order to compile this report, the WHO gathered and analyzed surveillance data from 114 countries which detailed resistance rates amongst common disease causing pathogens. Amongst the findings was the worrying fact that the bacterial species K. pneumoniae, which commonly causes infections in hospitals and the community, is becoming increasingly resistant to last resort antibiotics, and drug resistance was found in every region surveyed. Other bacterial species demonstrating both widespread and high levels of drug resistance were E. coli and S. aureus, which can cause urinary tract infections and blood stream infections. Around 20% of tuberculosis cases were also found to have multidrug-resistant TB. The report also highlighted increasing resistance to antiviral drugs by both influenza viruses and HIV. In particular, they found that drug resistant HIV strains were being increasingly transmitted since between 10-17% of HIV infected patients in certain countries that had never received treatment were already resistant to at least one antiretroviral drug. Antibiotic resistance is on the rise because of overuse and misuse of antibiotics both in medicine and agriculture. Not finishing the course of antibiotics and prescribing antibiotics when they are not needed both encourage the emergence of resistance. There is therefore a dire need for the development of novel antibiotics before the current ones become useless, meaning that common infections risk becoming fatal. Hopefully this report will spur countries to come together to formulate a global plan to prevent this ominous situation from worsening, and may also serve to monitor future progress. Medical Research – Life Sciences Leadership Medical innovation is key to life-sciences leadership Atkinson 12 – PhD in City and Regional Planning, The Information Technology and Innovation Foundation and United for Medical Research (Robert, “Leadership in Decline,” http://www2.itif.org/2012-leadership-in-decline.pdf) Advances in life sciences—including pharmaceuticals, biotechnology, and medical devices—were a major driver of global economic growth in the second half of the twentieth century. Since World War II, the United States has stood firmly at the forefront of the life sciences revolution, with this leadership built upon a solid commitment to robust and sustained federal investment in biomedical research and development (R&D), channeled primarily through the National Institutes of Health (NIH). This public investment laid the foundation for the development of scores of breakthrough pharmaceutical drugs and therapies—from personalized gene therapies to synthetic skin to cures for certain types of cancer—and has catalyzed the development of a globally competitive, high-wage life sciences industry in the United States. Today, the U.S. life sciences industry supports more than 7 million jobs and contributes $69 billion annually to U.S. gross domestic product (GDP).1 But U.S. leadership in the global life sciences industry is today under threat on two fronts. First, federal investment in biomedical research through NIH has decreased, both in inflation-adjusted dollars and as a share of GDP, nearly every year since 2003. Put simply, the United States is not sustaining the historically strong investment in biomedical research that once propelled it to global life sciences leadership. At the same time, global competition has intensified, as a growing number of countries, including China, Germany, India, Singapore, Sweden, the United Kingdom, and others have recognized that life sciences represents a high-wage, highgrowth industry and have taken measures seeking to wrest life sciences leadership from the United States. These nations have not only significantly expanded their financial support for biomedical research, they have also implemented a range of policies designed to enhance their biomedical innovation ecosystems, such as tax incentives through “patent boxes,” regulatory reforms to speed drug approvals, and immigration and education policies designed to attract and to educate the best life sciences talent. As this report demonstrates, in an increasing number of indicators—from trade balances in pharmaceuticals to shares of global pharmaceutical-industry output—such policies and investments have enabled several countries’ life sciences industries to become competitive with that of the United States. China, for example, has identified biotechnology as one of seven key strategic and emerging (SEI) pillar industries and has pledged to invest $308.5 billion in biotechnology over the next five years. This means that, if current trends in biomedical research investment continue, the U.S. government’s investment in life sciences research over the ensuing half-decade is likely to be barely half that of China’s in current dollars, and roughly one-quarter of China’s level as a share of GDP. And China already has more gene sequencing capacity than the entire United States and about one-third of total global capacity. Other countries are also investing more in biomedical research relative to the sizes of their economies. When it comes to government funding for pharmaceutical industry-performed research, Korea’s government provides seven times more funding as a share of GDP than does the United States, while Singapore and Taiwan provide five and three times as much, respectively. France and the United Kingdom also provide more, as shares of their economies.2 Life-sciences leadership is key to tacit diplomacy---solves multiple existential risks Benson 14 - professor of microbiology in the Department of Molecular and Cell Biology at the University of Connecticut and a Jefferson Science Fellow. (David, “Tacit Diplomacy in Life Sciences,” Science and Diplomacy, http://www.sciencediplomacy.org/perspective/2014/tacit-diplomacy-in-life-sciences) Although some life science advances have generated worry in diplomatic circles, scientists using the technologies and conducting the research are far more likely to embrace new advances as they emerge, usually, but not always, without controversy. So what accounts for the different attitudes, and what might be done to reconcile the positive progression of science with diplomatic and security concerns? This article highlights the roles played by the unprecedented rise of international collaborations in scientific communities, the internationalization of science education, and the attendant slow but steady adoption of norms of behavior. These roles together knit a kind of “tacit diplomacy” that helps to mitigate concerns about advances in the life sciences. Diplomacy can involve scientific issues in diverse ways. For example, scientific cooperation can help to change a diplomatic relationship, or enhance the economic trade and/or security of the United States (or another country).1 Science also informs the diplomatic processes related to, for example, securing arms control, mitigating climate change, improving food security, or reducing illegal trade in endangered species.2, 3 Tacit diplomacy in science governs how the global community of scientists interacts via understood, but generally unstated, behavioral norms. Absent this foundation, science diplomacy cannot work optimally or sustainably. Tacit diplomacy in science governs how the global community of scientists interacts via understood, but generally unstated, behavioral norms. Most scientists recognize the set of norms that are tacitly assumed to operate in collaborative science and in the communication of scientific knowledge. The InterAcademy Council, an organization of national academies from countries around the world, lists seven values or norms that characterize successful scientific interactions: honesty, fairness, objectivity, reliability, skepticism, accountability, and openness.4 Tacit diplomacy among scientists assumes that these norms are at least nominally in place, unless proven otherwise, with the result being the evolution of that elusive, bilateral human behavior of mutual trust. The outcome of tacit diplomacy is that scientists interacting with colleagues from very different countries and cultures can achieve common goals. The power of tacit diplomacy derives from its implementation in international scientific interactions that globally number in the millions each year. Such interactions range from formal collaborations to less formal points of contact via email, video conference, or telephone, at international and national conferences and meetings and invited seminars. In the aggregate these contacts strengthen norms at an interpersonal level, for example in faculty-advisor–student or colleague– colleague relationships rather than government-to-government relationships. Importantly, such behavioral norms spread along with the migration of technology and scientific understandings. Tacit diplomacy cannot be imposed by international and national organizations or by governments that often desire to manage or “do something” about the risks of misuse or the spread of scientific advances that are of concern. Such management is often expressed in top-down notions of oversight (regulations), education (e.g., research integrity or biosecurity training), awareness-raising exercises, and written codes of conduct. While each of these notions has local utility, they are of questionable effect in dealing with broader underlying issues that are primarily ethical in nature.5 A number of global trends have promoted the spread of tacit diplomacy and are of considerably broader significance than management tools when it comes to garnering adherence to norms. Some trends can also erode tacit diplomacy in science. Both need to be understood to increase awareness and consideration in diplomatic arenas. Global Trends that Promote Tacit Diplomacy Trends that promote tacit diplomacy in the life sciences generally coincide with those in all of science and technology (S&T). Some are well-known contributors to globalization in general: the Internet lubricating collaborations, expanding information access, and facilitating research investment globally; greater ease of air travel allowing scientists to develop collaborations at meetings, use large shared facilities, and study overseas; and the expanding use of English, in particular the near universal acceptance of English as the common language of science.6 A more specific trend that reflects and promotes the internationalization of science is the steady increase in global research and development funding. From 1996 to 2011, global funding, life sciences included, increased nearly two and one-half times worldwide in real dollars, with the recognition that S&T is key to innovation and economic growth.7 Increased funding has allowed developing countries with emerging economies to aggressively seek international partners for developing science while building their own infrastructure and programs. For these countries to succeed, adherence to norms and development of trust are essential. There has been a dramatic increase in collaboration reflected by internationally coauthored articles. For example, the proportion of S&T publications from the United States having international coauthors rose from 7 percent in 1986 to 29 percent in 2010.8 Open-access scientific journals and still-evolving policies in the large publishing houses lower barriers to collaborative publication between scientists in developing and developed countries, creating a more integrated global science community.9 An increasing number of undergraduate and graduate students are seeking higher quality training outside their home country.10 For example, Brazil’s Science without Borders program has the goal of sending one hundred thousand students to study abroad by 2015. In 2012, foreign students received about 34 percent of all science and engineering doctorates awarded in the United States,11 an increase from about 15 percent in 1977.12 PhD programs have also proliferated in Asian countries, such as China, Singapore, and Australia, catering to students from less-developed countries. Returning students bring new technologies, fresh scientific perspectives and patterns of normative scientific behaviors that facilitate science diplomacy. Returning students bring new technologies, fresh scientific perspectives and patterns of normative scientific behaviors that facilitate science diplomacy. Finally, solutions to global challenges increasingly require pollination across disciplinary borders of basic and applied life sciences, social science, and engineering.13, 14, 15 Issues involving emerging infectious diseases, climate change, food security, fisheries management, for example, touch multiple countries and scientific disciplines. Diplomatic efforts aimed at their resolution proceed more effectively from a foundation of trust built by tacit diplomacy developed among scientists across appropriate disciplines. Medical Research – Hegemony Impact Medical research is key to hegemony Martinez-Lopez 4 – MPH, MD, commander of the U.S. Army Medical Research and Materiel Command (Lester, “Biotechnology Enablers for the Soldier System of Systems,” Biotechnology Revolution) The Army has historically recognized that the individual soldier, the critical element of operational success, is an integral component of weapons, transportation, and other hardware systems and that military hardware (and software) must be designed with human factors in mind. Today, we think of the soldier as a system; taken together with his or her equipment, the soldier is a system of systems. This more holistic approach encompasses not only the human-system interface, but also the full range of biological, environmental, and occupational factors that can affect a soldier’s health and performance. Soldiers today face more environments and threats than the soldiers of yesteryear, and we anticipate that the challenges will continue to increase. To maximize a soldier’s performance and prevent disease and injury in this changing operational setting, the U.S. Army is pursuing research, development, and engineering to transform the individual soldier into a fully protected and integrated Soldier System of Systems. Biotechnology-based strategies are key to achieving this goal.¶ Challenges¶ Soldiering remains a dangerous business, involving a wide variety of threats to health and performance. To protect the soldier, we must counter traditional threats from ballistics weapons, as well as from chemical and biological weapons. However, we often overlook the fact that the majority of casualties have historically resulted not from enemy weapons, but from diseases (especially infectious diseases), non-battlerelated injuries, and stress. For example, in the Vietnam War, 83 percent of all hospital admissions were for disease and non-battle injuries. A traditional rule of thumb is that there is one combat-stress casualty for every three physical casualties.¶ It is also important to recognize the unique features of the military environment that adversely affect human performance without directly causing casualties. If performance degradation is severe enough, however, missions can be compromised, which can lead to serious consequences, including casualties. The soldier’s occupational environment is extremely stressful, both physically and mentally. Work is conducted outdoors in all types of weather and at all altitudes. The workload continues around the clock and is subject to sudden, rapid changes in intensity. Soldiers are required to remain attentive and vigilant and process increasing amounts of information very quickly.¶ In the future, even greater demands will be made upon soldiers. Future operational concepts call for highly mobile forces enabled by increasingly sophisticated weapon and information systems. Currently, the military must be able to deploy one division (10,000 to 18,000 troops) into an operational theater on 120 hours notice and five divisions within 30 days. The soldier of the future must be physically ready to deploy on a moment’s notice; upon arrival, he or she must be ready to fight, anywhere in the world. Soldiers may also be required to change rapidly from humanitarian to peacekeeping to warfighting roles (as in Iraq). These requirements will make substantial cognitive, perceptual, and emotional demands on soldiers. Highly mobile operations will also increase the dispersion and isolation of small units and individual soldiers, changing the way support services, such as medical support, are delivered and making it imperative that soldiers remain fit and healthy. Future soldiers will have to be capable of going without sleep or resupply for extended periods of time and more reliant on self- or buddy-aid in the event of illness or injury.¶ The Soldier System of Systems¶ The Soldier System of Systems is a multi-tiered strategy in which the soldier and his or her weapon and support systems are considered as a unified system that encompasses the full range of medical and nonmedical systems for protecting and enhancing the soldier’s health and performance. This strategy consists of three levels of defense: Protection; Surveillance; and Intervention. Protection is subdivided into the three categories: Individual Force Health Protection; Individual Force Protection; and Force Protection.¶ Role of Biotechnology¶ The key to realizing the Soldier System of Systems is biotechnology. In 2001, the U.S. Army commissioned a National Research Council (NRC) committee, the Committee on Opportunities in Biotechnology for Future Army Applications, chaired by NAE member Michael R. Ladisch of Purdue University, to accomplish the following goals:¶ Examine trends in the bioscience and engineering industries, including small business involvement and university and other institutional research activities in biology, biomimetics, and related areas.¶ Determine whether trends in research, technology transfer, and commercialization could be used to predict advances likely to be useful for the Army through 2025. ¶ Identify the bioscience and engineering technologies with the most potential for Army applications, based on affordability and the likelihood of leveraging commercial research and development.¶ Identify critical barriers to the development of biotechnologies with strong potential for Army applications, especially barriers that could be surmounted by appropriate investments in science and technology.¶ Recommend research initiatives that could help the Army exploit promising developments in biotechnologies and engineering. ¶ The results of the NRC study published in 2003 identified 20 prospective applications for Army investment over the short term, midterm, and long term. ¶ Biotechnology in the Army¶ Based on the recommendations of the NRC Committee and internal assessments of technology readiness and soldiers’ needs, the Army is currently investing in several broad areas that cut across multiple technology applications. The Army’s intramural biotechnology effort is being conducted at facilities that fall under the U.S. Army Medical Research and Materiel Command (USAMRMC) and the U.S. Army Research, Development and Engineering Command (RDECOM). USAMRMC focuses on medical and human performance applications; RDECOM focuses on nonmedical systems applications. Extramural basic research is being coordinated by the Army Research Office (ARO), based in Research Triangle Park, North Carolina. ARO oversees two major collaborative ventures with academia that are focused on biotechnology enablers: the Institute of Collaborative Biotechnologies, which includes the University of California at Santa Barbara, California Institute of Technology, and Massachusetts Institute of Technology (MIT), to provide the Army with core competencies and expertise; and the Institute of Nanotechnologies, a $50-million research collaboration between the Army and MIT. The remainder of this article highlights examples of biotechnology-based systems being developed for the Soldier System of Systems. ¶ Vaccine-Based Protection against Endemic Diseases and Biological Agents¶ Current efforts to develop improved vaccines for Individual Force Health Protection are focused on molecular recognition and vaccine design and construction. In addition to potentially protecting against diseases for which little or no protection is currently available, molecular biology-based vaccines are expected to avoid causing some of the side effects commonly associated with traditional vaccines, which are based on whole killed or attenuated live organisms. DNA-based vaccines are being developed by the U.S. Army for several diseases, including dengue fever, malaria, and Hantaan virus, and for biowarfare agents, including anthrax, botulinum neurotoxins C through G, and staphylococcal enterotoxins A and B. Genetic and genomic technologies have shifted research and development efforts away from whole pathogens to specific viral or bacterial components that confer long-term immunity in those who survive infection. Army-sponsored vaccine research is currently being conducted at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Walter Reed Army Institute of Research (WRAIR), and the U.S. Naval Medical Research Center (USNMRC).¶ As an example of the current state of the art, DNA vaccines are being developed at USAMRIID to protect against hantaviruses, which cause hemorrhagic fever with renal syndrome (HFRS) or hantavirus pulmonary syndrome (HPS). Both HFRS and HPS are acute febrile illnesses that are lethal in 5 to 15 percent and 40 to 50 percent of victims, respectively. DNA sequences that code for specific hantavirus genes have been inserted into nonpathogenic viral vectors, precipitated onto gold microbeads, and injected into the skin of test animals with a needleless gene gun (Hooper et al., 2001). Hamsters injected with the vaccine were protected against challenge infection, and rhesus monkeys produced antibodies that neutralized virus particles. Hamsters injected with monkey serum as much as five days after viral challenge were protected from developing HPS (Custer et al., 2003).¶ Existing methodologies are continually being refined for more rapid identification of the immune-response-producing components of pathogens, the isolation of genes that code for these components, and large-quantity production of component-coding genes. Rapidly formulated DNA vaccines that are effective against multiple strains of the same organism or combinations of multiple organisms can render the soldier of the future resilient against threats posed by emerging diseases and genetically engineered biowarfare agents.¶ Drug-Based Protection against Endemic Diseases and Biological Threat Agents¶ Non-vaccine-based efforts in Individual Force Health Protection are based on molecular recognition and drug design and testing. The Army is currently focusing on preventive and therapeutic drugs for malaria, a disease for which vaccine-based approaches have not been effective. To ensure that the Soldier System of Systems includes protection against this common tropical disease, the Army is pursuing both vaccine-based and non-vaccine-based strategies. The recent completion of the malaria parasite genome sequence (Gardner et al., 2002) has opened the search to the full spectrum of gene-based drug discovery, coupled with more conventional biotechnological, pharmacological, and medicinal methods of drug optimization.¶ Drugs could also be potentially tailored to specific subpopulations to improve safety and increase effectiveness. When a large number of individuals receive identical doses of the same drug, their responses and side effects vary greatly. These differences are attributed to presumed variabilities in drug-metabolizing enzymes, receptor subtypes, and other genetic factors. Pharmacogenomic and toxicogenomic profiling can facilitate the identification of subpopulations of individuals for whom a given drug is less effective or more toxic. In some cases, differences may be correctable by introducing minor changes into the chemical structure of the drug.¶ Monitoring of Physiological Status¶ To further Surveillance and Intervention through the identification of impending degradations in physical or cognitive performance and improved casualty assessment, the Army is investing in molecular recognition technologies. Current prototypes of monitoring systems of physiological status are based on electrical or mechanical sensing of measures of physical activity, heart rate, temperature, and other parameters. A goal for the future is the detection of biomolecules in perspiration or other accessible body fluids that correlate with a soldier’s potential to execute a mission. This could be accomplished through biosensors for physiological surveillance or casualty diagnosis integrated into soldier ensembles. ¶ At present, little is known about which, if any, secreted biomolecules are appropriate for sensing. The molecules being investigated include proteins, such as growth factors, metabolites, such as glucose or lactate, and stress hormones, such as cortisol. With proteomics, researchers can profile the expression of all proteins in a tissue and identify patterns and relationships among them under specific performance environments. ¶ Investigators at the Natick Soldier Center are attempting to identify performance-relevant markers and develop additional types of biosensors. An example of the latter is a project at Georgetown University, cosponsored by the Army and the Defense Advanced Research Projects Agency, that has resulted in the development of a biofluidic chip that extracts molecules, such as glucose, that do not usually diffuse across skin, from subepidermal interstitial fluid. ¶ Protection against Environmental Injury¶ As part of Individual Force Health Protection and Intervention, genomic detection and drug design and testing technologies are being pursued for protection against environmental injuries. Genomic methodologies are being used to identify molecular regulators that enhance a soldier’s adaptation to environmental stressors, such as extreme heat, cold, and altitude, and biomarkers that predict increased or decreased susceptibility to environmental injuries. Investigators at the U.S. Army Research Institute of Environmental Medicine have characterized gene-expression patterns in peripheral blood mononuclear cells (PBMCs) isolated from soldiers who exhibit signs and symptoms of exertional heat injury (Sonna et al., 2004), as well as PBMCs isolated from health volunteers and then exposed to heat or cold under controlled conditions in the laboratory (Sonna et al., 2002a,b). They have also characterized changes in cultured human liver cells exposed to low oxygen tensions to mimick high altitude (Sonna et al., 2003). More than 50 proteins are affected by heat stress; fewer than 20 are affected by cold; and more than 380 are affected by hypoxia. Novel approaches being considered for preventing environmental injuries include nutritional supplements and smart suits with sensing capabilities. ¶ Host-Based Detection and Diagnosis of Exposure to Chemical and Biological Hazards¶ Army investment in genomic detection, molecular recognition, and molecular toxicology is funding the development of host-based detection systems in support of Individual Force Health Protection and Surveillance. A fundamental concept in toxicology is the dose-toxicity relationship, in which the adverse effects elicited by a toxic substance are dependent on the level of exposure to the toxic substance. Exposure levels too low to cause outwardly observable changes in health often cause changes at the molecular level. By detecting molecular changes in the soldier before observable signs and symptoms of toxicity appear, it becomes possible to prevent further exposure and initiate a protective or intervention-based strategy to avert or ameliorate adverse events. ¶ DNA microarray technology is being used at the U.S. Army Center for Environmental Health Research, the Edgewood Chemical and Biological Center (ECBC), and WRAIR to identify genetic markers of response to different classes of toxic hazards and long-term changes in gene expression following asymptomatic, low-level exposures to chemical warfare agents. An interesting finding is that male and female rats show different alterations in gene expression following whole-body inhalational exposures to low doses of sarin vapor (Sekowski et al., 2002).¶ DNA microarray technology is also being used at USAMRIID and WRAIR to assess immune system responses to a variety of biological agents. The expression patterns of isolated PBMCs exposed to biological agents in the laboratory setting support discrimination of agents that include bacteria (e.g., anthrax, plague, and brucella), toxins (e.g., staphylococcal enterotoxin B, cholera toxin, and botulinum neurotoxin A), and viruses (e.g., Venezuelan equine encephalitis and dengue fever) (Das et al., 2002). Furthermore, PBMCs isolated from nonhuman primates exposed to anthrax in vivo reveal patterns of gene expression that correlate with the impending onset of symptoms. The latter approach could be beneficial for detecting exposures to genetically modified organisms that cannot be detected by pathogen-based methods.¶ Hazard-Based Detection and Diagnosis of Exposure to Biological Hazards¶ Another element of Individual Force Health Protection and Surveillance is the combination of molecular recognition and bioderived electronic and photonic materials to detect pathogenic organisms in the environment. Investigators at the Natick Soldier Center are leveraging the electrical conduction and optical properties of polymers that have been complexed with single-stranded DNA or RNA to form sensitive gene chip biosensors. When the nucleic acid of a pathogenic organism hybridizes to a complexed nucleic acid probe, the properties of the polymers change. Investigators are also developing peptide-based receptors that bind selectively to pathogenic bacteria. Investigators at ECBC are working on peptide-based receptors that bind toxins, such as ricin and staphylococcal enterotoxin B, and on designing and fabricating a DNA/RNA microarray capable of detecting and identifying pathogens down to the level of different strains. These technologies can also be used for monitoring food and water for contamination. ¶ Catalytic Inactivation of Toxic Agents¶ Individual Force Health Protection, Individual Force Protection, and Force Protection are being addressed through investment in catalytic enzymes and drug design and testing to protect against toxic chemical and biological agents. At the U.S. Army Medical Research Institute of Chemical Defense, bioengineered recombinant butyrylcholinesterase is being investigated for use as prophylaxis against the adverse effects of exposure to nerve agents, such as sarin, soman, tabun, and VX. This enzyme mimics acetylcholinesterase and competes with it for binding nerve agents, thus reducing the level of acetylcholinesterase inactivation. It is anticipated that a single dose of this enzyme will be capable of scavenging nerve agent through stoichiometric binding for up to eight hours. Current efforts are directed at engineering the enzyme so that it has catalytic activity in vivo and exploring the use of a transgenic goat model for generating sufficient quantities of engineered enzyme to conduct clinical trials.¶ At ECBC, recombinant enzymes are being incorporated into fabrics and polyurethane foams for nonmedical protection and into sprays, detergents, degreasers, and other matrices for decontamination following exposure. Enzymes for hydrolyzing G-type and V-type nerve agents have been identified, cloned, and optimized. Organophosphorus acid anhydrolase, which works against the G agents sarin, soman, and tabun, is in large-scale process development. Random and site-directed mutagenesis has resulted in variants of organophosphorus hydrolase enzyme with increased activity against the V-type agent VX. Organophosphorus hydrolase is also currently in process development. In addition, a bacterial enzyme has been identified that hydrolyzes sulfur mustard, and a collaborative project is under way with Rockefeller University to assess the effectiveness of using bacteriophage lysins to destroy anthrax spores (Schuch et al., 2002).¶ Biomembrane and Fiber Generation¶ The Army is investing in bioderived materials and molecular recognition as part of Individual Force Protection, Force Protection, and Intervention. A process called electrospinning is being used at the Natick Soldier Center to produce high-surface-area nanofiber membranes with unique reactive sites for selective immobilization of biological recognition elements. The current focus is on including immobilized antibodies and antimicrobial peptides on electrospun nanofibrous poly(epsilon-caprolactone) (PCL) for selective binding to pathogens. These materials can be used in the development of clothing-based biosensors and in filtration of pathogens from food, water, and clothing. Other electrospun polymeric materials include polyurethanes and polyvinyl chloride. ¶ Biomembranes and fibers are also being investigated at the Institute for Soldier Nanotechnologies. There, electrospun polymers are being used as extracellular matrix-mimicking scaffolds to support tissue regeneration and as vehicles for delivering drugs and biologics that promote tissue healing after injury.¶ Protection against Ballistics¶ Hard and lightweight ceramic materials, such as boron carbide, are incorporated into body armor and other forms of protective shielding. Research is now focusing on bioderived nanoceramics in support of Individual Force Protection and Force Protection. ¶ In nature, organisms can form ceramics under mild conditions using protein-directed templated crystallization mechanisms. Identifying novel peptides that control inorganic ceramic architecture is a technical challenge being addressed at the Natick Soldier Center. Based on our current understanding of how nature nucleates inorganic nanocrystallization, researchers are attempting to use biomimetic approaches to create novel materials not found in nature. For example, the proteins that direct crystallization for generation of sea urchin spicules are being genetically modified to favor ions, such as boron and aluminum, rather than the naturally incorporated ions of calcium and silica. ¶ Systems Engineering Issues¶ A key challenge to realizing the Soldier System of Systems is to provide a comprehensive range of capabilities while simultaneously meeting stringent military requirements to minimize weight and power consumption. Today’s soldiers may carry as much as 100 pounds of equipment. In keeping with requirements for increased mobility, the objective is to reduce the effective load to less than 40 pounds by developing efficient multifunctional systems for the Soldier System of Systems. Examples include a single system for detecting exposures to chemical warfare agents, toxic environmental chemicals, biowarfare agents, and/or infectious pathogens and a single vaccine system for protecting against multiple pathogenic organisms. ¶ The problem is complicated because of potential interactions among drugs and vaccines that can decrease their effectiveness or increase their toxicity. Another concern about biologically based systems is their stability and durability. Many biological molecules are susceptible to degradation, and it remains to be seen whether bio-based materials and sensors will be able to perform well under rugged field conditions in which they are exposed to extremes of temperature and humidity, the possibility of oxidation, and other stresses. Biomaterials must also have a reasonably long shelf-life, because perishable materials could be logistically insupportable or unaffordable if stockpiles must be frequently refreshed..¶ Other major challenges to realizing the Soldier System of Systems are gaps in our knowledge. Despite substantial progress in the enabling technologies for engineering sensors and DNA vaccines, questions remain about which biomolecules are appropriate for sensing and why some vaccines fail to elicit a protective response. We will certainly need more basic research on enabling technologies and their applications.¶ By continually monitoring progress in basic and applied research in the academic, governmental, and industrial communities, the Army can hope to fill these knowledge gaps, identify the most promising enabling technologies, and promote their development by carefully directing its investments. Medical Research – Economy Impact Medical innovation is key to the economy Paranicas 14 – President and Chief Executive Officer @ HINJ (Dean, “THE VALUE OF MEDICAL INNOVATION: SAVING LIVES, SAVING MONEY,” HealthCare Institute of New Jersey (HINJ), http://hinj.org/the-value-of-medical-innovation-saving-lives-saving-money/) Medical innovations produced by American life sciences companies have vastly improved the human condition. Our pharmaceutical, biotech, medical technology, device and diagnostics companies have helped people live longer, with less pain and greater quality of life. Over the past century, the life sciences has eradicated some of the world’s most dreaded diseases such as polio and smallpox. More recently, the industry has made other diseases such as breast cancer, HIV/AIDS, heart disease and lung cancer no longer the death sentences that they once were. Collectively, new therapies are the greatest contributors to increased life expectancy. According to the National Bureau of Economic Research (NBER), between 1960 and 1997, new therapies accounted for 45 percent of the increase in life expectancy in 30 developing and high-income countries. Between 2000 and 2009, new therapies accounted for 73 percent of the increased life expectancy for these countries. Despite the dramatic lifesaving advancements that the life sciences sector has made, our work is far from done. Diabetes, Alzheimer’s, Ebola, different types of cancers, and other formidable medical conditions demonstrate the compelling need for America’s medical innovation community to build upon its tremendous achievements to continue saving lives around the world. Toward that goal, every day, teams of scientists from New Jersey companies go to work to research and discover the next generation of medicines, therapies, devices, technologies and diagnostic tools that will alleviate even more of these lifethreatening and life-altering diseases. Medical Innovation’s Overlooked Benefit With these medical innovations, past and future, comes an often-overlooked benefit: the incalculable billions of dollars in savings to patients, their families, insurers, employers, governments and hospitals in avoided medical expenses associated with keeping people healthy or curing them of a life-long, chronic condition. Certainly, these medicines, therapies, medical technologies, devices and diagnostic tools keep people healthier. They limit the need for frequent visits to the doctor. They help to avoid costly hospital stays. They help patients avoid expensive surgeries. Unfortunately, these tremendous cost savings often go unrecognized. Instead, we hear frequent reports about the high cost of medicine or about new technologies or diagnostic tools being deemed “too expensive” or “unnecessary.” We hear that medical innovation is a cost-driver, not a cost-saver. The reality is quite to the contrary. Medications, therapies and medical technologies and devices not only save lives — they save money. By eradicating a disease, people no longer need to seek or spend money on treatment. By better managing and preventing more serious complications from an existing disease, people avoid more costly medical care. By discovering a new treatment or cure, the costs that would have been incurred in addressing a patient’s ongoing medical issues can be avoided entirely. Therefore, developing new treatments, cures and health technologies is one of the most important steps we can take — not only to save lives and improve the quality of life, but also to avoid the expenditure of enormous amounts of health care dollars. How much savings does medical innovation produce? There is not one, simple answer to that question. However, there are numerous academic and government statistics that point to the economic benefits of innovation in the health-care marketplace. In a paper published by the Journal of Political Economy in 2006, it was estimated that over the preceding 50 years, medical innovation had been the source of nearly half of all economic growth in the United States. Impressively, for every dollar spent on innovative medicines, total healthcare spending is reduced by $7.20, according to an NBER paper. As for the price of medicine in America, only 9 cents of every health care dollar spent in America goes to medicines, according to the Centers for Medicare & Medicaid Services (CMS) in 2013. The other 91 cents goes to hospitals, physicians, clinics, long-term care facilities, and government administration and net cost of health insurance. Imagine if we could use that 9 cents to reduce the remaining 91 cents or even avoid significant portions of it in the first place. The result would be saved lives and even greater healthcare savings. Medication Adherence’s Important Role Medication adherence also plays an important role in health-care savings, as medical innovations can provide no benefit if they are not accessed by patients. Of the approximately 187 million Americans who take one or more prescription drugs, it is estimated that up to one-half do not take their medications as prescribed. Poor medication adherence results in 33 to 69 percent of medication-related hospital admissions in the U.S., at a cost of roughly $100 billion per year. In total, non-adherence to prescribed medicines results in approximately $290 billion in unnecessary spending annually. Americans with chronic conditions account for 84 percent of health care spending. In 2011, this totaled more than $2 trillion. By using medical innovations to prevent or better manage the most common chronic diseases, the U.S. could decrease treatment costs by $218 billion per year and reduce the economic impact of disease by $1.1 trillion annually. For diabetes, the total costs of this chronic disease rose to $245 billion in 2012 from $174 billion in 2007. Without a cure, in the next 25 years, annual spending on diabetes is forecast to increase steeply to approximately $336 billion annually. For Alzheimer’s disease, in the absence of disease-modifying treatments, the cumulative costs of care for people suffering with Alzheimer’s from 2010 to 2050 are expected to exceed $20 trillion. A treatment breakthrough that only postpones the onset of Alzheimer’s by as few as five years could result in annual Medicare savings of $33 billion in 2020 and climb to $283 billion by mid-century, while annual Medicaid savings could increase from $9 billion in 2020 to $79 billion in 2050. A 2007 Milken Institute paper reported that cancer treatment results in a tenfold increase in productivity — specifically, $37 billion in cancer treatments resulted in an estimated $373 billion in increased productivity. While the monetary cost savings of medical innovation are extraordinary, the value to patients is nothing short of priceless. For example, according to the American Cancer Society, U.S. cancer survivorship alone has more than tripled since 1970, with nearly 14.5 million cancer survivors alive in the country this year. Also, as of 2014, the U.S. five-year survival rate for all cancers diagnosed between 2003 and 2008 is 68 percent. With HIV/AIDS, medical innovation has delivered an astounding 3 million life years, which has produced an economic value of $1.3 trillion, according to a 2006 published paper. Medical Innovation: A Key Part of the Solution Medical innovation is complex, high-risk, time-consuming and extremely expensive. But it is clear that medical innovation is a key part of the solution — not only to alleviating human suffering, but also to reducing significantly the incalculable costs associated with treating that suffering. As a society, we need to recognize the enormous multifaceted return on the investment in medical innovation, and nurture — rather than stifle — the virtuous cycle of better health, longer life and economic benefit resulting from life sciences innovation. Medical innovation is key to growth Hugin 13 – Chairman, Pharmaceutical Research and Manufacturers of America (Robert, “Medical Innovation Benefits Patient Health, Economic Growth,” http://www.phrma.org/robert-hugin-remarks-japan-media-roundtable) But Celgene is by no means unique among PhRMA member companies. Our companies are vibrant and changing rapidly. All have impressive, committed, and dynamic leaders. We all have a common mission, to make a meaningful difference in the lives of patients around the world. PhRMA members have a common business proposition, that value can't be created if patients don’t benefit first. And the best way for us to deliver a transformational future of medicine that is in the best long-term interest of for patients is to invent it ourselves. We have a major responsibility to discover and develop new innovative therapies, and we are doing so, investing more, as a percentage of our revenues into R&D, than any other industry in the world. This came to almost $50 billion last year globally. But government policies also have a significant impact on investment and innovation and our ability to deliver transformational outcomes to patients. In the US, over the past 60 years, medical innovation has been the source of more than half of our economic prosperity and growth. In the US, since 1988, as a result of medical innovation, 42 million life years for cancer patients have been saved contributing nearly $3.5 trillion to our economy. Decades of health economic evidence reinforce that pro-innovation and pro-patient policies do make a difference for patients, healthcare and the economy. Medical innovation is key to the economy---increased life-expectancy positively correlates with growth ---answers the life-expectancy turn Wright 13 - editor-in-chief for Life Science Leader Magazine (Rob, “How Important Is Medical Innovation To The U.S. Economy?,” http://www.lifescienceleader.com/doc/how-important-is-medical-innovation-economy-0001) Living Longer, Better, Wealthier? From 1900 – 2010, the United States has witnessed a 96% decrease in deaths, and a 62% increase in life expectancy. By the year 2040, average U.S. life expectancy is anticipated at being 85 years of age, while the rest of the world is estimated to be at 72 years of age. According to Frank Lichtenberg, Ph.D., new therapies are the greatest contributor to increased life expectancy. A business professor at Columbia University, Lichtenberg assessed the contribution of pharmaceutical R&D to longevity and the economic growth which results. You may find some of his insights startling. First, the pharmaceutical industry is the most R&D-intensive sector of the economy, not technology. Second, the rate of return on investment in pharmaceutical R&D is 18%. Third, using newer drugs actually decreases overall healthcare costs, with much of the savings being due to reduced hospital stays and physician office visits. For $1 spent on innovative medicines, healthcare spending is reduced by approximately $7.20. So let me ask you — what type of financial impact does living longer have economically? According to University of Chicago economists Kevin Murphy, Ph.D., and Robert Topel, Ph.D., who calculated cumulative gains in life expectancy after 1900 to be worth over $1.2 million to the representative American in the year 2000. Further, in the 30 years between 1970 to the year 2000, life expectancy gains added approximately $3.2 trillion per year to the national wealth of the United States. But medical innovation contributes more than just living longer and accumulation of wealth. Medical Innovation Economics 101 Over the past 50 years, medical innovation has been the source of more than 50% of all economic growth in the United States. It is estimated that there are more than 650,000 jobs in the U.S. biopharmaceutical sector, with each of these jobs supporting an additional five jobs in other sectors. In a report by Battelle, a nonprofit R&D organization, the overall economic impact of the biopharmaceutical sector on the U.S. economy in 2009 (as measured by output) was estimated to be more than $917 billion on an annual basis. Further, the biopharmaceutical sector generated nearly $85 billion in state, local, and federal tax revenues for 2009. The annual average personal income of a biopharmaceutical worker in 2009 was nearly twice the average across all private sector industries ($118,690 vs. $64,278). When you compare export numbers among industries, you may be surprised to learn that in 2010 the U.S. biopharmaceutical industry exported $46.7 billion, which is more than automobiles ($38.4 billion), plastics and rubber products ($25.9 billion), communications equipment ($27 billion), and computers ($12.5 billion). With all of these positive U.S. economic attributes, why then does it seem everyone is intent on killing the golden goose that medical innovation represents? The Obama administration is pushing for policy changes to Medicare Part D, which if enacted will most likely result in decreased pharmaceutical R&D spending, as well as the loss of possibly 250,000 high wage jobs. So Paul, to answer your question, the pharmaceutical industry is BIG. How important is medical innovation to the U.S. economy – VERY! Medical Research – Quality Robust clinical trials are key – without them the medical knowledge gained causes long-term damage Sean Tunis (Centers for Medicare & Medicaid Services, Baltimore, Md) Daniel Stryer (Agency for Healthcare Research and Quality, Rockville, Md) and Carolyn Clancy (Agency for Healthcare Research and Quality, Rockville, Md) 2003 “Practical Clinical Trials” http://umassmed.edu/uploadedFiles/QHS/Content/Tunis%20article1.pdf The prevalence and significance of gaps in knowledge about clinical effectiveness are most readily appreciated by reviewing the results of most systematic literature reviews, technology assessments, and clinical practice guidelines. These reports are generally produced to provide comprehensive reliable information for decision makers and usually address common conditions with large aggregate cost, morbidity, and public health importance. A consistent finding of these reviews is that the quality of evidence available to answer the critical questions identified by experts is suboptimal. For example, a systematic review of newer pharmacologic agents for depression concludes that few studies provided data on the long-term effectiveness of treatment, the functional status of patients, or the outcomes of patients treated in typical practice settings.11 Furthermore, few studies compared the older inexpensive agents with newer agents in terms of adverse effects and clinical efficacy. Most well-done systematic reviews and clinical guidelines reach similar conclusions about the quality of evidence associated with common clinical problems. These gaps in evidence undermine efforts to improve the scientific basis of health care decisions in several ways. Organizations that develop evidencebased clinical practice guidelines may not be able to develop clear, specific recommendations.12 For example, the background report for clinical guidelines on outpatient management of exacerbations of chronic obstructive pulmonary disease found that although numerousindustry-sponsored clinical trials reported minor differences in the antimicrobial activity of alternative broadspectrum antibiotics, no trials had been performed to determine whether any of the newer broad-spectrum antibiotics were better than older generic antibiotics or even placebo (for mild exacerbation).13,14As a result, the guideline could not provide definitive recommendations on the appropriate choice of antibiotics for chronic obstructive pulmonary disease exacerbations. The limited quantity and quality of available scientific information also impede the efforts of public and private health insurers in developing evidencebased coverage policies for many new and existing technologies.7,15 Poor-quality studies of new technologies can lead to millions of dollars being allocated for new technologies for which the long-term benefits and risks have not been determined.4 Minimally invasive technologies for treatment of benign prostatic hyperplasia (BPH) are in widespread use, yet no clinical trials have been performed to compare the risks and benefits of these treatments with standard surgical interventions.16 The Medicare program has spent millions of dollars per year for home use of special beds for patients with pressure ulcers, despite the fact that no well-designed study demonstrates that they improve healing of these ulcers.17 The limited production of this body of research becomes increasingly problematic as major increases in public funding for basic research generate an expanding range of potentially valuable technologies in need of careful objective evaluation. Disease - Turns Economy Disease spread goes global- easy transmission of today’s viruses make it possible- that causes economic and healthcare collapse worldwide Nguyen-Van-Tama and Hampson 3 [Jonathan S. Nguyen-Van-Tama (Aventis Pasteur MSD,) and Alan W. Hampson (WHO Collaborating Centre for Reference and Research on Influenza). “The epidemiology and clinical impact of pandemic influenza.” 2003. P. 5. http://www.birdflubook.org/resources/tam1772.pdf]//EMerz The three influenza pandemics of the 20th century indicate what can be expected when the first pandemic of the 21st century makes its appearance. The pandemic virus may emerge in China or a nearby country and could include surface antigens or virulence factors derived from animal influenza viruses, much like the avian A/H5N1 virus that emerged in Hong Kong in 1997. Once the new virus acquires the ability to be transmitted efficiently from person to person, it will spread rapidly throughout the world. Several waves of infection will occur. Morbidity will be extensive in all age groups, and there will be widespread disruption of social and economic activity in all countries. Excess mortality will be evident in most if not all age groups. It is unlikely that health care systems in even the most economically developed countries will be able to adequately cope with the demand for health care services. Although modern medical care will offer life-saving treatment to some individuals who in earlier pandemics would not have survived, the principle determinants of the severity of the next pandemic will be the virulence and transmissibility of the virus and the susceptibility of human populations to infection. There is little that people can do to change or control these variables. What they can do, however, is prepare their societies for managing the consequences of the pandemic and ensure that there are adequate supplies of vaccines and antiviral agents to lessen if not control its impact. Disease turns free trade- any global spread of disease could collapse international trade- ensuring health is a prerequisite to the global economy Kerr et al 6 [William Kerr. Van Vliet Professor Senior Associate, Estey Centre for Law and Economics in International Trade. “A Trade Regime for Sub-National Exports Under the Agreement on the Application of Sanitary and Phytosanitary Measures.” 2006. P. 2. http://www.uoguelph.ca/catprn/PDFCP/Commissioned_Paper_2006-3_Kerr.pdf]//EMerz International trade can be a significant factor in the spread of diseases from one region of the world to another. As such, efficacious international movement controls on potential disease spreading entities such as people, animals, plants or products from plants and animals is a critical component of good disease management. Collectively, in international trade law these policies are known as sanitary and phytosanitary (SPS) measures. Many of these controls are implemented based on national borders as they are convenient separators of government responsibility. While governments have a legitimate obligation to prevent disease entry, spread and establishment in their country, they are also frequently pressured to utilize health regulations as disguised trade barriers to provide protection to their national producers from international competition (Kerr, 2004). To prevent this, international efforts were undertaken to promote measures being applied only when there is a scientific justification. One of the first steps taken was to create international expert bodies that could bring together technical expertise from around the world to form recommendations regarding what would constitute good scientific disease management practices. These included, but were not limited to, disease-related trade restrictions. Effective enforcement, however, was difficult as the international institutions involved lacked a binding dispute settlement mechanism (Kerr, 2004). As governments increasingly agreed to constrain their ability to utilize traditional protectionist measures, such as tariffs and quotas, through consecutive negotiating rounds at the General Agreement for Tariffs and Trade (GATT), illegitimate barriers to trade, such as SPS measures being applied when not scientifically warranted, were seen as a rising problem in international trade relations. Members decided to negotiate an agreement within the GATT, the precursor to the World Trade Organization (WTO), which would govern the use of SPS measures, allowing Members to enact them but only to the extent necessary to protect human, animal or plant health. The significance of having an agreement on the application of SPS measures in the newly created WTO was that it would now be subject to the WTO’s binding dispute settlement procedures, forcing governments to abide by the rules agreed upon or face retaliation instead. Disease – A2 Burnout Disease causes extinction -- Burnout is wrong Karl-Heinz Kerscher 14, Professor, “Space Education”, Wissenschaftliche Studie, 2014, 92 Seiten The death toll for a pandemic is equal to the virulence, the deadliness of the pathogen or pathogens, multiplied by the number of people eventually infected. It has been hypothesized that there is an upper limit to the virulence of naturally evolved pathogens. This is because a pathogen that quickly kills its hosts might not have enough time to spread to new ones, while one that kills its hosts more slowly or not at all will allow carriers more time to spread the infection, and thus likely out-compete a more lethal species or strain. This simple model predicts that if virulence and transmission are not linked in any way, pathogens will evolve towards low virulence and rapid transmission. However, this assumption is not always valid and in more complex models, where the level of virulence and the rate of transmission are related, high levels of virulence can evolve. The level of virulence that is possible is instead limited by the existence of complex populations of hosts, with different susceptibilities to infection, or by some hosts being geographically isolated. The size of the host population and competition between different strains of pathogens can also alter virulence. There are numerous historical examples of pandemics that have had a devastating effect on a large number of people, which makes the possibility of global pandemic a realistic threat to human civilization. Modeling/Leadership Global disease surveillance is modeled after the United States- even if they win there is no precedent, it’s empirically proven. Additionally, member nations won’t comply if federal surveillance overwhelms local authority. Calain 07 (Philippe Calain, Senior Researcher at the Research Unit on Humanitarian Stakes and Practices, based in the Swiss section of Me´decins sans Frontie`res. Trained as a medical doctor and a specialist in infectious diseases and tropical medicine, he has over ten years of experience in international public health “Exploring the International Arena of Global Health Surveillance,” Published in Health Policy and Planning http://heapol.oxfordjournals.org/content/22/1/2.full) In May 2005, the 58th World Health Assembly adopted a much overdue revision of the IHR, referred to as the IHR(2005) (WHO 2005a). Compared with the 1969, 1973 and 1981 versions of the IHR, the revised regulations expand considerably the scope of internationally notifiable epidemic diseases, they accommodate criteria for novel epidemic events and they set out conditions for involvement of the international community in outbreak response. In May 1995, the 48th World Health Assembly had already adopted two resolutions calling, respectively, for a revision of the IHR and for the establishment of a comprehensive programme to tackle new, emerging and re-emerging infectious diseases (WHO 1995a). Accordingly, in October 1995, a new unit was established at WHO as the Division of Emerging Viral and Bacterial Diseases Surveillance and Control (EMC) (WHO 1995b), to be later renamed successively as the Department of Communicable Diseases Surveillance and Response (CSR) and the Department of Epidemic and Pandemic Alert and Response (EPR). In 2000, under the operational support of CSR team members, a Global Outbreak Alert and Response Network (GOARN) was created to coordinate technical resources involved worldwide in combating outbreak-prone diseases (Enserink 2004). The apparent success of GOARN and collaborating technical partners in limiting the international spread of SARS in 2003 (Heymann and Rodier 2004) has vindicated efforts led by WHO to put the control of emerging or reemerging diseases high on the global health agenda. Next to giving itself the necessary legal instruments (through the revised IHR) and putting itself in a position to coordinate international response to outbreaks (through the GOARN), the WHO Secretariat has crystallized around the CSR/EPR Department a considerable amount of expertise in capacity building, in preparation for deliberate epidemics and in promoting public health surveillance at all levels. Inspired by a model developed from the early ages of the United States Centers for Disease Control and Prevention (US-CDC), WHO has become the flagship of the concept of global surveillance of communicable diseases (Heymann and Rodier 1998). Since 2003, a limited pandemic of SARS first, soon followed by the fearsome expansion of epizootic avian H5N1 influenza from South-East Asia to the entire Old World, have been putting this concept to the test. The SARS and avian influenza epidemics have certainly helped in facilitating the acceptance of the new IHR, through their combined health and economic impacts. Avian influenza H5N1 is now in the limelight of international health conc erns by being seen as a possible precursor of an upcoming human pandemic (WHO 2005b). Since the end of 2005, several high profile meetings in Geneva, Ottawa, Tokyo and Beijing have tried to mobilize the international community to shift health priorities and financial resources toward preparedness against the anticipated influenza pandemic (Health Canada 2005; World Bank 2005; WHO 2005c; WHO Regional Office for the Western Pacific 2005). In May 2006, the 59th World Health Assembly called upon Member States to speed up the implementation of the IHR(2005), or at least of the provisions that are deemed relevant to the hazards posed by avian influenza and pandemic influenza (WHO 2006). Historical landmarks of public health surveillance Public health surveillance applied to outbreak detection and monitoring is not a new idea. During the plague of London in 1665, parish clerks compiled weekly bills of mortality detailing about 40 different causes of death (Naphy and Spicer 2001). In a recent era, the most influential character was Alexander Langmuir who established and popularized the modern concepts of disease surveillance, following the footsteps of the 19th century statistician William Farr (Thacker and Gregg 1996).2 A public health epidemiologist by training, Langmuir pursued an academic career in parallel with holding high-level positions in committees of the US Department of Defense overseeing THE INTERNATIONAL ARENA OF GLOBAL PUBLIC HEALTH SURVEILLANCE 3 by guest on July 23, 2015 http://heapol.oxfordjournals.org/ Downloaded from biological warfare programmes during the World War II and the Cold War periods (Fee and Brown 2001). In 1949, he was recruited to the US-CDC, to become its chief epidemiologist. Building upon the US experience of malaria and poliomyelitis eradication programmes, he designed a remarkably successful national system of disease reporting and created the Epidemic Intelligence Service. The 1990s saw the rise of the ‘emerging diseases worldview’, a post-colonial concept rooted in new biomedical concerns as much as in perceived threats from a ‘de-territorialized’ world.3 A landmark 1992 report of the US National Academy of Science (Institute of Medicine 1992) formalized the definitions of ‘emerging’ and ‘re-emerging’ diseases and explicitly discussed their global implications. The social, humanitarian, economic and political fallout of (re)emerging diseases became obvious, first in 1991 when cholera reappeared in South America (Sa´nchez and Taylor 1997) and next in April 1994 when plague broke out in Surat, India (Garrett 2001). The latter circumstance showed how panic and lack of leadership can lead to unnecessary impacts on national economies and on local communities (Cash and Narasimhan 2000). In April 1995, an outbreak of highly fatal cases of haemorrhagic fever in Kikwit in the Bandundu Province of DRC (former Zaire) came to the attention of the international health community through a network of informal and rather delayed channels, before it could be confirmed as the re-emergence of an Ebola virus. It attracted an unusual amount of press coverage and scientific attention worldwide, partly justified by concerns over international spread. Lessons from the outbreak in Kikwit (Heymann et al. 1999) led to surveillance being put at the core of CSR activities, and to the revival of interest in the International Health Regulations.4 Precursor regimes of international governance on communicable diseases actually date back to the first International Sanitary Conference of 1851. Under their successive formats, they already incorporated mixed concerns over public health as well as related trade and political issues (Fidler 2003). Their impact seems, however, to have been rather limited. In contrast, the widespread interest in international health regulations seen at the present time reveals new dimensions to the global public health debate, as well as far-reaching implications of global surveillance. Semantic ambiguities When Alexander Langmuir (1963, 1971) redefined surveillance to fit his own public health purposes, he departed from a former meaning which restricted the term to individuals, i.e. typically contacts who had to be followed up for signs of disease without restricting their movements by isolation or quarantine.5 Instead of individuals, Langmuir’s (1963) modern view of surveillance applies to diseases, as defined by: ‘the continued watchfulness over the distribution and trends of incidence through the systematic collection, consolidation and evaluation of morbidity and mortality reports and other relevant data. Intrinsic in the concept is the regular dissemination of the basic data and interpretations to all who have contributed and to all others who need to know.’ With some prophecy, Langmuir anticipated future problems and cautioned that: ‘the actual performance of the research study should be recognized as a function separate from surveillance’. The blurred boundary between research and surveillance is a critical issue that was later emphasized by Stephen Thacker, a succeeding senior epidemiologist at the US-CDC.6 Thacker noted the ambiguities carried under ‘disease surveillance’ and ‘epidemiologic surveillance’, and he advocated the term ‘public health surveillance’ to avoid confusion with epidemiologic research (Thacker and Gregg 1996). Directly inspired by Thacker’s definition, the WHO definition of public health surveillance proposed under resolution WHA58.3 (WHO 2005a) is clear enough to avoid confusion with research activities: ‘Surveillance means the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary.’ Despite its clear merits, however, the latter definition carries two sources of ambiguity, which were further reflected during the international consultation process and in the drafting of advanced versions of the revised IHR(2005). These ambiguities relate to (1) the scope of health events targeted by surveillance, and (2) the sort of ‘public health action’ in which the international community – through WHO experts – will find itself involved by virtue of the IHR(2005) mandate. Shared concerns by some experts and policy makers over the scope of the new IHR appear in successive versions of a decision instrument annexed to the IHR(2005) (WHO 2004a). Initially designed exclusively as a criteria-based algorithm, the final version of the annex ultimately includes as well a number of specific diseases, leaving it open to frequent updates as new pathogenic agents become identified. In the same line, it is not explicit whether the IHR(2005) have regulatory authority over programme evaluation as well as detection of epidemics, both being classical components of communicable diseases surveillance.7 In a conceptual framework endorsed by members of the CSR team (McNabb et al. 2002), the two related components of ‘public health action’ (acute ‘epidemic-type’ response and planned ‘management-type’ response) are explicitly considered as complementary outputs of ‘public health surveillance’. What will be missing in some cases of new epidemic threats, especially when the risk assessment is inconclusive, is a gauge of the degree of urgency from which international action is legitimate. These issues have some relevance obviously in terms of national sovereignty. More recently, WHO has been promoting, developing and implementing in several countries the relatively new concept of Early Warning Systems (EWARS) for outbreak surveillance (WHO 2005d). Direct reference to EWARS would perhaps have lifted some ambiguities carried by too loose a definition of surveillance and would have better clarified the scope of the IHR(2005) and their derived requirements for Member States. Of equal relevance to the scope of the IHR(2005) is the lack of conceptual clarity over the term ‘global health security’ (Aginam 2005; McInnes and Lee 2006). ‘Global health security’ features prominently in WHO policy documents (for an example see WHO 2001) to summarize the overall strategy 4 HEALTH POLICY AND PLANNING by guest on July 23, 2015 http://heapol.oxfordjournals.org/ Downloaded from covered by epidemic alert and response activities. Other international alliances (Global Health Security Initiative 2006) use the term with a clear orientation toward the public health response to the specific threats of international biological, chemical and radio-nuclear terrorism. Sovereignty and ethical standards How and if Member States of WHO will abide by the IHR (2005) (which are to become legally binding in June 2007) will obviously depend on a delicate balance between perception of threats from specific health events (public health effects per se, or political or economical consequences), incentives set up by interested parties and any consideration of national sovereignty. Sovereignty has been one of the main matters of discussion during successive consultations leading to resolution WHA58.3 (WHO 2004a). The issue has an additional level of complexity for countries with federal governments, where authority over public health is generally devolved to regional jurisdictions (Wilson et al. 2006). The IHR(2005) do not include a sanctions regime for States that fail to comply with their provisions (WHO 2005e). Several jurists (Plotkin and Kimball 1997; Fidler 2003) have stressed the marginal role of former versions of the IHR compared with other international regimes, notably the World Trade Organization8 and its related multilateral agreements dealing in a more direct way with factors causing the emergence of communicable diseases. It is, however, likely that the new IHR will become more influential than their precursor versions of 1969, 1973 and 1981, for several reasons: (1) the broader scope of health events under consideration, (2) a more active and better defined role for WHO in the response phase, and (3) more flexible mechanisms for WHO to circulate information critical to control public health threats (including information from non-official sources or about non-compliant state parties). Despite the latter opportunity embedded in the new IHR, it will remain as difficult as ever for WHO to exercise its handling of sensitive information, especially in a world where the press and the public are the driving forces behind increased transparency. Courts model each other- constitution globalization Kersch 05, (Ken I, 4 Wash. U. Global Stud. L. Rev. 345, “New Legal Transnationalism, the Globalized Judiciary, and the Rule of Law,” 2005, http://heinonline.org/HOL/Page?handle=hein.journals/wasglo4&div=19&g_sent=1&collection=journals) //IB In recent years in the United States, constitutional reasoning and practice has been going global. For many, this trend became apparent for the first time when, in the course of its analysis in the recent affirmative action and gay rights cases, the U.S. Supreme Court made frank references to foreign practices, public opinion, and court decisions, as well as international agreements-those ratified by the United States and those not.' While, strictly speaking, not unprecedented, the Court's transnational references in these cases were notable for a number of reasons. First, because they took place cases involving domestic policy issues that are at the heart of partisan political contention, they were unusually prominent. Second, rather than amounting to casual allusions, they represent a calculated step by key justices on the Court--led by Justice Breyer, but also joined by Justices Ginsburg, in decisions not involving international affairs, as traditionally defined, but rather in Kennedy, and O'Connor-to bring the Court's approach toward constitutional interpretation into line with new approaches being taken by justices in the courts of other countries.2 And third, these efforts in the American judiciary are taking place in a distinctive in the United States and around the world, are coming to understand legal transnationalism as an imperative.' As is evident from even the most casual perusal of the reformist intellectual context in which many scholars and activists, both increasingly high profile journals of international law, scholars are now hard at work trying out alternative doctrines, seeking those that will be least politically vulnerable. Debates involving the applicability of the law of nations, customary international law, treaties, international agreements and pronouncements, and foreign practices, precedents, judicial reasoning (under the guise of "constitutional borrowing"), and public opinion to the decisionmaking processes of American judges deciding domestic constitutional cases, more and more are filling pages of these law journals. These calculated efforts to transform the way in which the Court considers domestic constitutional issues may very well mark the beginning of a major departure in the direction of American constitutional law. US is losing healthcare leadership Szarfenberg 10, (Ryszard, Culture and Education, “QUALITY OF SOCIAL WELFARE SERVICES,” 2010, http://janinewedel.info/KiE-nr-5-2010.pdf#page=61)//IB In recapitulation, despite ambiguity and multidimensionality of the notion of quality and discrepancies in the concepts of new public management, pro-quality reforms of general interest services have been and still are undertaken. Services of general interest include social welfare services and hence they are also concerned. Th e leading role in the adoption of this philosophy is played by health services sector, and in this connection also by social services similar to those provided by care homes or nursing and medical institutions that are closest to the health services sector. One of the presently dominant sources of ideas aimed to improve quality are the strategies and instruments recommended and applied in the private sector. However, quality assurance models in the sector of manufacturing and commercial services not necessarily work well in social services. Th erefore, approaches intended to take due account of their specifi cs are being developed. However, it is not certain whether even those service models and standards that are well adjusted to specifi cs of the social sector will have a signifi cant impact on improvement of the clients quality of life, in particular in social care institutions. Presently, Poland implements a systemic project Operational Programme Human Capital Creating and Developing Standards for Social Welfare and Integration Institutions, whose name originally contained the words “quality standards”, but “quality” was dropped from a successive version46. It is not known why this change was made (perhaps due to the conviction that ISO quality management standards are not adequate for social welfare organisation and services), but creation and development of standards with exclusion of such an extremely important premise for this process as the intention to improve services quality, seems at least puzzling. Disparate Impact Health surveillance disproportionately targets minorities and is ignored by activist – the plan is key Hoppin 12 (Margaret, J.D. at New York University School of Law, “Overly Intimate Surveillance: Why Emergent Public Health Surveillance Programs Deserve Strict Scrutiny Under The Fourteenth Amendment,” December 2012, NYU Law Review, Hein Online)//JL Security surveillance programs that target politically vulnerable domestic communities for dragnet surveillance have prompted wide-spread concern in the last decade, although legal challenges to national security programs generally have not reached a decision on the merits.141 For example, politicians and advocacy groups responded promptly to the revelation that New York City Police Department sur-veillance programs targeted Arab and Muslim communities in the Northeast.142 Some politicians publicly declared that the programs were “disturbing” and said they would not have allowed such a program if they had known about it.143 Academics and academic insti-tutions expressed similar concern and criticism.144 Community leaders petitioned the New Jersey Attorney General to investigate a New Jersey–based surveillance program and give “a full accounting” of ongoing surveillance.145 In the context of security surveillance, one commentator advo-cates robust constitutional privacy protections because “legislative efforts to regulate surveillance may . . . insufficiently protect the pri-vacy of certain politically unpopular minorities, like Muslim-Americans.”146 Like Arab and Muslim Americans in the security sur-veillance context,147 people with diabetes, obesity, and certain other chronic conditions are politically vulnerable in the health surveillance context. Diabetes “disproportionately affects black and Latino New Yorkers, [and] . . . those living in low-income households and neigh-borhoods,” both with respect to its prevalence and the rates and severity of related complications.148 The same is true of obesity and obesity-related health problems.149 In addition, many chronic condi-tions, including diabetes, are “often perceived as a self-inflicted problem among the elderly who are sedentary and obese.”150 The argument that governments have “a legitimate interest in controlling medical and social costs of individuals’ unhealthy behaviors that are borne by society at large”151 may be used to justify inappropriate pri-vacy invasions, especially given that public discourse about obesity is infused with moral condemnation.152 Judicial recognition that emer-gent programs infringe upon constitutionally protected privacy rights would require governments to develop substantive (instead of rhetor-ical) justifications for deploying the most invasive types of public health surveillance against vulnerable populations or, alternatively, to modify those surveillance programs. One indication that diabetics may be a politically vulnerable group is that, in stark contrast to security surveillance programs, the launch of the A1C registry provoked virtually no response. On July 13, 2005, the Department published in the City Record a notice of its intention to create the A1C registry and to hold a public comment period.153 On August 16, 2005, the Department held a public hearing on its proposal.154 In response, the Department received only thirty-one written comments;155 at the hearing, six health care practitioners and one member of the health care technology industry testified in support, and three private individuals testified in opposition.156 No civil liberties organization commented on the proposal.157 Despite its involvement in privacy debates relating to AIDS and bioterrorism surveillance, the ACLU was not even aware of the proposal.158 With a few notable exceptions,159 the public health community has responded to the A1C registry with approval, and the legal com-munity has not responded much at all. Of the handful of commenta-tors on the program, most emphasize its potential as a public health tool.160 Perhaps even more surprising, no one has challenged the pro-gram in court. In addition, despite similarities between the A1C Registry and an HIV surveillance program proposed by the Department at the same time,161 the objections of the better-organized HIV community “held more traction . . . [and] effectively thwarted more aggressive surveillance.”162 The HIV proposal prompted “both the medical community and a wider public [to take] notice and . . . grapple with the meaning of expanded surveillance.”163 Diseases can be used as a front to impose on minority privacy Bayer and Fairchild 10, (Ronald and Amy, Social Research, “When Worlds Collide: Health Surveillance, Privacy, and Public Policy,” September 1, 2010, http://web.b.ebscohost.com.proxy.lib.umich.edu/ehost/pdfviewer/pdfviewer?sid=e3a9c3e1-758e455d-8d55-bdb218570cd9%40sessionmgr111&vid=9&hid=125)//IB In June 1981 the Centers for Disease Control (CDC) reported the appearance in previously healthy gay men of conditions that usually occurred 908 social research only in individuals with compromised immune systems. One month later the CDC reported that in the prior two and a half years Kaposi's sarcoma, a malignancy rare in the United States, especially in young people, had been diagnosed in 26 gay men in New York and California. These were sentinel cases of an epidemic that would have a profound impact on gay men, intravenous drug users and their sexual partners, and African American and Latino communities in the last two decades of the twentieth century (Bayer 1989). Early on there would be some calls for rigid separation of the sick, though it soon became clear that the new disease could only be spread through sexual contact, from the sharing of drug injection equipment, by contaminated blood, and from infected pregnant women to their fetuses. That the disease arrived at the very moment when American politics had taken a sharp conservative turn with the election of President Ronald Reagan heightened the concern of those who feared that AIDS would provide the occasion for the widescale abrogation of the privacy rights that had gained recognition in the prior decade. Such fears would have a deep and lingering impact on the surveillance activities undertaken in response to the new epidemic threat. Health surveillance violates privacy and disproportionately affects minorities Hoppin 12 (Margaret, J.D. at New York University School of Law, “Overly Intimate Surveillance: Why Emergent Public Health Surveillance Programs Deserve Strict Scrutiny Under The Fourteenth Amendment,” December 2012, NYU Law Review, Hein Online)//JL Courts have not considered the implications for Fourteenth Amendment privacy protections important questions remain unan-swered: Does modern technology alter the scope or nature of constitutional privacy protections politically underrepresented populations disproportionately experience chronic diseases and obesity, and are therefore more likely to be targets of surveillance commentators have identified three features that make the privacy invasions especially troubling: the surveillance is increasingly comprehensive and intimate, it involves unprecedented size it targets politically underrepresented domestic communities all three features have provoked significant privacy concerns The nature of government surveil-lance is changing the analysis under the Fourth Amendment the targeting of politically underrepresented com-munities has not explicitly done so of the last thirty-five years of devel-opments in public health surveillance programs, technology, or data mining capabilities. As a result, the fact that permits ongoing and intimate surveillance of personal behaviors in the context of public health surveillance?103 What about the fact that ?104 and are therefore more likely to be targets of surveillance?104 B.Similarities in Security Surveillance and Public Health Surveillance Courts and have addressed similar questions in the context of security surveillance programs. In particular, they of government security surveillance registries of and data mining potential, and . In the context of security surveillance programs, . However, there is variation in the extent to which courts have incorporated each concern into Fourth Amendment anal-ysis: intimate and comprehensive and its state counterparts, , and the use of registries and data mining falls in the middle. Genetic information collection is being manipulated to reinforce racial order Roberts 11 (Dorothy E. Roberts, Kirkland & Ellis Professor, Northwestern University School of Law; faculty fellow, Institute for Policy Research)(“Collateral Consequences, Genetic Surveillance, and the New Biopolitics of Race”, Howard Law Journal, Vol. 54 No. 3, 2011)//ASMITH This Article considers state and federal government expansion of genetic surveillance as a collateral consequence of a criminal record in the context of a new biopolitics of race in America. As I discuss more fully in my book Fatal Invention: How Science, Politics, and Big Business Re-create Race in the TwentyFirst Century, the emerging biopolitics of race has three main components.1 First, some scientists are resuscitating biological theories of race by modernizing old racial typologies that were based on observations of physical differences with cutting-edge genomic research.2 These scientists are redefining race as a biological category written in our genes.3 Second, the biotechnology and pharmaceutical industries are converting the new racial science into products that are developed and marketed according to race and that incorporate assumptions of racial difference at the genetic level.4 Finally, government policies that appear to be colorblind are stripping poor minority communities of basic services, social programs, and economic resources in favor of corporate interests, while simultaneously imposing on these communities harsh forms of punitive regulation.5 Mass incarceration and its collateral consequences are the chief examples of the punitive regulation of African American communities. This Article contends that these dehumanizing policies of surveillance and control are obscured by the emerging genetic understanding of race, which focuses attention on molecular differences while ignoring the impact of racism in our society.6 Only a decade ago, the biological concept of race seemed to have finally met its end.7 The Human Genome Project, which mapped the entire human genetic code, proved that race could not be identified in our genes.8 Yet, there has been an explosion of race-based science and biotechnologies. For example in 2005, the United States Food and Drug Administration (“FDA”) approved the first race-specific drug, BiDil, to treat heart failure in black patients.9 In addition, fertility clinics solicit egg donations based on race and use race in genetic tests to determine which embryos to implant and which to discard.10 Consumers can send cheek swabs to dozens of online companies to find out not only their genetic ancestry, but also their racial identity.11 Furthermore, one of these companies used the same forensic tools to help law enforcement agencies identify the race of suspects.12 Most relevant to the subject of this Symposium, in the last decade, federal and state governments have been rapidly expanding the collection of genetic information for law-enforcement purposes.13 With eight million offender samples, the U.S. federal government has stockpiled the largest database of DNA seized from its citizens of any country in the world.14 Because of rampant racial bias in arrests and convictions, the government’s DNA databases, which are being amassed nationwide, effectively constitute a race-based biotechnology emerging from genetic science.15 Unlike voluntary genetic testing technologies that claim to help people cure their diseases, improve the genetic composition of their children, and find their identities, forensic DNA repositories are gathered by the state without consent and maintained for the purpose of implicating people in crimes.16 Theses repositories signal the potential use of genetic technologies to reinforce the racial order not only by incorporating a biological definition of race, but also by imposing genetic regulation on the basis of race. Discriminatory arrests causes lifetime genetic surveillance of blacks; government DNA collection is a means to create a universal database for black men Roberts 11 (Dorothy E. Roberts, Kirkland & Ellis Professor, Northwestern University School of Law; faculty fellow, Institute for Policy Research)(“Collateral Consequences, Genetic Surveillance, and the New Biopolitics of Race”, Howard Law Journal, Vol. 54 No. 3, 2011)//ASMITH These privacy violations are exacerbated by the racial inequities that plague every part of the U.S. criminal justice system. The most stunning aspect of this injustice is the mass incarceration of African American men.77 Radical changes in crime control, drug, and sentencing policies over the last thirty years produced an explosion in the U.S. prison population from three hundred thousand to two million inmates.78 Additionally, the United States has the highest rate of incarceration in the world at a magnitude unprecedented in the history of Western democracies.79 The gap between black and white incarceration rates has increased along with rising inmate numbers.80 Black men are eight times as likely as white men to be behind bars.81 One in nine black men aged twenty to thirty-four is in prison or in jail.82 In fact, most people sentenced to prison today are black.83 In her 2010 book, The New Jim Crow, legal scholar Michelle Alexander demonstrates that black incarceration functions like a modernday Jim Crow caste system because it “permanently locks a huge percentage of the African American community out of the mainstream society and economy,” replicating the subjugated status of blacks that prevailed before the civil rights revolution.84 The targeted imprisonment of black men is translated into the disproportionate storage of their genetic profiles in state and federal databases. We can look to the United Kingdom to gauge the likely racial impact of our own federal database now that it has surpassed theirs in size. Their database reveals that 40% of all black men and 77% of black men aged fifteen to thirty-five, compared with only 6% of white men, were estimated to have genetic profiles in the UK national DNA database in 2006.85 Also in 2006, Stanford bioethicist Hank Greely estimated that at least 40% of the genetic profiles in the U.S. federal database were from African Americans, although they make up only 13% of the national population.86 Sheldon Krimsky and Tania Simoncelli arrive at a similar estimate in which 41% to 49% of CODIS profiles are from African Americans.87 The extension of DNA collection by the federal government and a number of states to people who are only arrested—as opposed to charged or convicted—brings many more whites into the system, but it is also on its way to creating a nearly universal database for urban black men.88 These men are arrested so routinely that upwards of 90% would be included in databases if the collection policy is strictly enforced.89 In April 2010, Arizona Governor Jan Brewer signed a controversial law giving police broad authority to detain anyone suspected of being in the country illegally.90 This law is held up as a model for immigration enforcement policy in other states.91 When combined with congressional authorization of DNA sampling from all federal detainees,92 these immigration laws will cause the number of Latino profiles in CODIS and state databases to skyrocket. Police routinely consider race in their decision to stop and detain an individual.93 A New York Times/CBS News Poll conducted in July 2008 asked: “Have you ever felt you were stopped by the police just because of your race or ethnic background?”94 Sixty-six percent of black men said yes, compared to only 9% of white men.95 The United States Supreme Court has authorized police to use race in determining whether there is reasonable cause to suspect someone is involved in crime.96 Michelle Alexander calls the Court’s license to discriminate the “dirty little secret of policing.”97 In recent decades, a conservative Supreme Court has eroded the Warren Court’s protections against police abuse in ways that promote the arrest of blacks and Latinos—relaxing, for example, the standard for reasonable suspicion— and has blocked legal channels for challenging racial bias on the part of law enforcement.98 There is overwhelming evidence that police officers stop motorists on the basis of race for minor traffic violations, such as failure to signal a lane change, often as a pretext to search the vehicle for drugs.99 One of the first confirmations of this was a 1992 Orlando Sentinel study of police videotapes that discovered that, while blacks and Latinos represented only 5% of drivers on the Florida interstate highway, they comprised nearly 70% of drivers pulled over by police and more than 80% of those drivers whose cars were searched.100 A study of police stops on the New Jersey Turnpike similarly found that, although only 15% of all motorists were minorities, 42% of all stops and 73% of all arrests were of black drivers.101 In Maryland, only 21% of drivers along a stretch of I-95 outside of Baltimore were African Americans, Asians, or Latinos, but these groups made up nearly 80% of those who were stopped and searched.102 Likewise, an Illinois state police drug interdiction program, known as Operation Valkyrie, targeted a disproportionate number of Latinos, who comprised less than 8% of the Illinois population but 30% of the drivers stopped by drug interdiction officers for petty traffic offenses.103 Police officers also make drug arrests in a racially biased manner. Although whites use drugs in greater numbers than blacks, blacks are far more likely to be arrested for drug offenses—and, therefore, far more likely to end up in genetic databases.104 The latest National Survey on Drug Use and Health, released in February 2010, confirms that young blacks aged eighteen to twenty-five years old are less likely to use illegal drugs than the national average.105 Yet, black men are twelve times more likely than white men to be sent to prison on drug charges.106 This staggering racial disparity results in part from the deliberate decision of police departments to target their drug enforcement efforts on urban and inner-city neighborhoods where people of color live. Indeed, the increase in both the prison population and its racial disparity in recent decades are largely attributable to aggressive street-level enforcement of the drug laws and harsh sentencing of drug offenders.107 A crusade of marijuana arrests in New York City in the last decade provides a shocking illustration.108 Since 1997, the New York Police Department (“NYPD”) has arrested 430,000 people for possessing tiny amounts of marijuana, usually carried in their pockets. 109 In 2008 alone, the NYPD arrested and jailed 40,300 people for the infraction.110 Even more alarming is the extreme racial bias shown in whom the police target for arrest. Although U.S. government studies consistently show that young whites smoke marijuana at the highest rates, white New Yorkers are the least likely of any group to be arrested.111 In 2008, whites made up over 35% of the city’s population but less than 10% of the people arrested for marijuana possession. 112 Instead, the NYPD has concentrated arrests on young blacks and Latinos. Police arrested blacks and Latinos for marijuana possession at seven and four times the rate of whites, respectively.113 The racist marijuana policing strategy is based on the routine police practice of stopping, frisking, and intimidating young blacks and Latinos. According to Harry Levine, the City University of New York sociologist who exposed the arrest campaign, “In 2008, the NYPD made more than half a million recorded stop and frisks and an unknown number of unrecorded stops, disproportionately in black, Latino and low-income neighborhoods.”114 Although New York City is the “marijuana arrest capital of the world,” other cities like Atlanta, Baltimore, Denver, Houston, Los Angeles, Philadelphia, and Phoenix are also arresting and jailing huge numbers of blacks and Latinos for marijuana possession.115 The widespread arrests of young blacks and Latinos for marijuana possession and other petty offenses, such as truancy, skateboarding, and playing loud music, have devastating consequences. A first-time offender who pleads guilty to felony marijuana possession has a permanent criminal record that can block him or her from getting a student loan, a job, a professional license, food stamps, welfare benefits, or public housing.116 Even if they avoid prison on a first offense, those who are arrested a second time risk a harsh sentence for being a repeat offender.117 In addition to harsh sentencing, a lifetime of genetic surveillance can now be added to the long list of collateral consequences created by discriminatory arrests. DNA databanks magnify stereotypes and intensifies racial injustices and disparities Roberts 11 (Dorothy E. Roberts, Kirkland & Ellis Professor, Northwestern University School of Law; faculty fellow, Institute for Policy Research)(“Collateral Consequences, Genetic Surveillance, and the New Biopolitics of Race”, Howard Law Journal, Vol. 54 No. 3, 2011)//ASMITH Racial disparities in DNA databanks make communities of color the most vulnerable to state surveillance and suspicion.118 The disproportionate odds faced by blacks and Latinos of having their DNA extracted and stored will, in turn, intensify the racial disparities that already exist in the criminal justice system. People whose DNA is in criminal databases have a greater chance of being matched to crime scene evidence. While a guilty person may have no right to complain, that is no excuse for unfairly placing certain racial groups at greater risk of detection. Blacks and Latinos have greater odds of being genetically profiled largely because of discriminatory police practices.119 Moreover, people whose profiles are entered in DNA databases become subject to a host of errors that can lead to being falsely accused of a crime. As the federal government and a growing number of states extend the scope of DNA collection to innocent people, they are imposing this unmerited risk primarily on minorities. The problem is not only that all of these harms are placed disproportionately on people of color, but also that the dangers of state databanks are multiplied when applied to blacks and Latinos because these groups are already at a disadvantage when they encounter the criminal justice system. Blacks and Latinos have fewer resources than whites to challenge abuses and mistakes by law enforcement officers and forensic analysts.120 They are stereotyped as criminals before any DNA evidence is produced, making them more vulnerable to the myth of DNA infallibility.121 “The experience of being mistaken for a criminal is almost a rite of passage for African-American men,” writes journalist Brent Staples.122 One of the main tests applied by a disturbing number of Americans to distinguish law-abiding from lawless people is their race. Many, if not most, Americans believe that black people are prone to violence and make race-based assessments of the danger posed by strangers they encounter.123 One of the most telling reflections of the presumption of black criminality is biased reporting of crime by white victims and eyewitnesses.124 Psychological studies show a substantially greater rate of error in cross-racial identifications when the witness is white and the suspect is black.125 White witnesses disproportionately misidentify blacks because they expect to see black criminals.126 According to Cornell legal scholar Sheri Lynn Johnson, “This expectation is so strong that whites may observe an interracial scene in which a white person is the aggressor, yet remember the black person as the aggressor.”127 In numerous carefully staged experiments, social psychologists have documented how people’s quick judgments about the criminal acts of others are influenced by implicit bias—positive or negative preferences for a social category, such as race or gender, based on unconscious stereotypes and attitudes that people do not even realize they hold.128 Whites who are trying to figure out a blurred object on a computer screen can identify it as a weapon faster after they are exposed to a black face.129 Exposure to a white face has the opposite effect.130 Research participants playing a video game that simulates encounters with armed and unarmed targets react faster and are more likely to shoot when the target is black.131 The implicit association between blacks and crime is so powerful that it supersedes reality; it predisposes whites to see black people as criminals. Most wrongful convictions occurred after witnesses misidentified the defendant.132 Databanks filled with DNA extracted from guilty and innocent black men alike will enforce and magnify the very stereotypes of black criminality that lead to so many wrongful convictions in the first place. Collecting DNA from huge numbers of African Americans who are merely arrested, with no proof of wrongdoing, embeds the sordid myth of black criminality into state policy. As databanks swell with DNA from black people who are arrested or convicted on petty offenses and as their relatives also come under suspicion in states with familial searching, the government effectively treats every black person in many communities as a criminal suspect. It seemingly also legitimizes the myth that blacks have a genetic propensity to commit crime. In 2010, Florida State University criminologist Kevin Beaver published a widely reported study claiming to show that young men with the low-activity form of the monoamine oxidase A (“MAOA”) gene—dubbed by the press as the “warrior gene”—were more likely to join gangs than those who had the high-activity version of the MAOA gene.133 He concluded that “male carriers of low MAOA activity alleles are at risk for becoming a gang member and, once a gang member, are at risk for using weapons in a fight.”134 The public, who already implicitly associates blacks with violence, may link research claiming that genes cause gangbanging and aggression to the disproportionate incarceration of African Americans along with the disproportionate banking of African Americans’ genetic profiles, to reach the false conclusion that blacks are more likely to possess these crime producing traits—or even that most blacks actually possess them. Americans will become even more indifferent to racial injustice in law enforcement if they are convinced that black people belong behind bars because of their genetic predilection to crime. DNA databases target minorities- eliminating the government’s ability to conduct this form of surveillance minimizes racial targeting Grimm 7 (Daniel J. Grimm. Lawyer in Cape Girardeau, Missouri. “The Demographics of Genetic Surveillance: Familial DNA Testing and the Hispanic Community.” May 2007. P. 1165-1166. http://projects.nfstc.org/fse/pdfs/Grimm.pdf)//EMerz While familial testing potentially affects the privacy rights of every person whose relative is a suspect, perhaps an even greater concern is that these threats to privacy will not be distributed equally throughout the population.7 The databank system, representing the convergence of DNA profiles collected over the course of many years, is not racially neutral.8 Instead, years of disproportionately high arrest and conviction rates have created a data field in which African Americans are overrepresented.9 While troubling, a related concern that has yet to receive sufficient attention is the degree to which demographics, which also drive databank system configurations, may produce similarly disproportionate outcomes for the Hispanic community.10 As the demographic group with the highest rate of natural population growth, each profile input from a Hispanic defendant is likely, on average, to lead investigators relying on familial testing to a higher number of genetic relatives than if the profile had been obtained from a non-Hispanic person.11 Disproportionate distribution of privacy violations is nearly inevitable in such a system. The Hispanic community, like the African American community, is subject to disproportionate arrest and conviction rates, such that familial DNA testing will have an especially significant impact on Hispanic people. Under familial testing, Hispanics will be more likely than other demographic groups to be added to the databank system, more likely to partially match a sample once it is added to the database, and, therefore, will be more likely to be targeted by law enforcement for DNA sample collection. Nonetheless, familial DNA testing will likely survive a constitutional challenge under the Equal Protection Clause, but is likely to be rejected under the probable cause requirement of the Fourth Amendment. Allowing DNA databanks like CODIS magnifies racial disparities across all aspects of the justice system --- because people of color are disproportionately arrested, the databanks will have disproportionate amounts of their DNA in them --- this leads to unjust conviction and masks racialized violence --- ruling on the 14th amendment alone is impossible and has been tried --- the plans use of multiple grounds is key Risher, attorney with the American Civil Liberties Union (ACLU), July-August 2009 – (Michael, “Racial Disparities in Databanking of DNA Profiles”, published in Genewatch Volume 22 Issue 3-4, p. 2224)//roetlin Of the hundreds of thousands of arrests every year in California on suspicion of a felony, nearly 320,000 in 2006, approximately 30% never lead to any conviction.[1] A disproportionate number of these innocent arrestees are people of color. In the U.S. justice are arrested but never convicted are presumed innocent; yet, as of January 1, 2009, all arrestees have been forced to let the State of California take a DNA sample, analyze it and include the resulting profile in a criminal database, to be compared evermore with crime-scene evidence. There are system, people who procedures for some of these people to try to get the samples and profiles expunged; however, these procedures often require arrestees to wait three or more years before even requesting expungement and necessitate the help of a lawyer. As a result, the overwhelming majority of people arrested but not convicted of any crime are unlikely even to try to get their samples destroyed. Tens of thousands of profiles taken from innocent people will thus remain in these criminal databases. The consequence will be a magnification of the current racial disparities in our criminal justice system as more and more people of color's DNA profiles are included in databases that make them potential suspects whenever DNA is recovered from a crime scene. The effects of this disproportionate inclusion of people of color in the databanks are made clear by the other papers in this series on genetics and race. What is perhaps less clear is how our criminal justice system, which promises equal justice under the law, can tolerate this injustice. This paper, after outlining the legal growth and transformation of DNA databanks, examines how various steps in our criminal justice system create and magnify racial disparities, and how the law makes it nearly impossible to effectively address the problem. It also looks at how taking DNA samples at various stages in this process may affect these disparities and the factors that cause them. I use as my primary example California's system because it is one of the world's largest criminal justice systems in one of the nation's most diverse states. It is also the system in which I have practiced law for the last decade, and is representative of where DNA databanks throughout the country will likely be in the next few years as more and more states and the federal government collect DNA from arrestees.[2] DNA databanks comprise two distinct components: the actual biological samples and the computerized database of the profiles generated by analyzing these samples. In criminal-justice databanks, the biological samples are collected from crime scenes (forensic samples) and from known individuals (known samples). Until recently, known samples were usually obtained by drawing blood, although now most states and the federal government primarily obtain samples by swabbing the inside of the person's cheek to collect skin cells.[3] The government analyzes both forensic samples and known samples to create DNA profiles, which are essentially a digitized description of 26 parts of the DNA molecule. The profiles are then uploaded to the Combined DNA Index System ("CODIS"), a centralized, searchable law enforcement database accessible to state, federal, and international law enforcement agencies. CODIS was created by the FBI in 1994 after Congress authorized it to establish a national DNA database to link existing state and local databanks. The biological samples themselves are retained by the local police or crime lab for later testing. Once an arrestee's profile is uploaded into CODIS, it is immediately compared to the thousands of crime-scene samples in the CODIS forensic database. As long as the arrestee's profile remains in CODIS, any new crime-scene samples will be searched against it. When an arrestee profile exactly matches a crime-scene profile, CODIS automatically notifies agencies that provided the sample. Then that agency will usually provide the identity of the arrestee to the agency with jurisdiction over the crime so that it can follow up. DNA databanks have grown exponentially in the last decade as new laws have expanded the range of people subject to having their DNA forcibly seized, analyzed, and the resulting profile databanked. California's databank is a good example of this. It was originally conceived as a way to connect people convicted of serious violent crimes with other such crimes in which DNA evidence is most useful. The original 1989 DNA-collection law established a databank and required people convicted of murder or a felony sex offense to provide DNA samples before they were released from custody.[4] The state department of justice had the authority to analyze these samples and include the resulting analysis in the new statewide databank.[5] From today's perspective, this program seems quite limited: the only people subject to having their DNA databanked had been convicted of very serious crimes, either by pleading guilty or after the charges had been proved beyond all reasonable doubt to a jury. But the law soon began to expand to include more people. The first steps were modest: in the late 1990s, new crimes were added to the list of qualifying offenses, and the law was amended to require that samples be taken immediately after conviction, rather than just before release. The latter change was enacted as the focus shifted from preventing new crimes to solving old crimes. In 2004, California voters enacted Proposition 69, drastically expanding the database. The two biggest changes were that, as of November 2004, every person convicted of any felony - which can include simple drug possession, shoplifting, or even intentionally writing a check without sufficient funds to cover it - has had to provide DNA samples. And, as of January 1, 2009, every person arrested for a felony in California must give a DNA sample. Prop. 69 thus radically changed the database from one comprising profiles of individuals convicted of violent felonies to one that includes profiles from suspected shoplifters. This huge increase is not distributed equitably among all people. African-Americans comprise 6.7% of California's population, but 21.5% of those arrested for felonies in the state.[6] Although, as discussed below, the possibility of race-based decision-making at all levels of the criminal justice system makes it impossible to know whether changing from a database of people convicted of felonies to one including everybody arrested for felonies will result in an increase in the proportion of people of color in the database it will clearly result in a significant increase in the absolute number of minorities included. Racial disparities fluctuate depending on the stage of the criminal proceeding from the high-level initial decision to make certain acts criminal, to a police officer's decision to contact or arrest an individual, to the decisions made by prosecutors, judges, jurors, and defense lawyers. Thus, the stage at which DNA samples are taken will affect the racial disparities in the databank, albeit in unpredictable ways. The first and broadest stage at which racial disparities are introduced into the criminal justice system is at the legislative level, where crimes are defined and classified. The basic question is, of course what conduct is considered criminal: why is a person who possesses drugs subject to criminal sanctions while a business that puts its workers or consumers at risk with dangerous or unsanitary facilities subject only to civil sanctions? Even beyond that basic issue, our criminal justice system treats very similar conduct differently in ways that create racial disparities. The most notorious example of this is the crack versus powder forms of cocaine disparity in the federal system, which for years punished people convicted of crack cocaine offenses (well over 80% of whom are African- American) much more severely than powder cocaine offenders (72% of whom are white or Hispanic).[7] The legislative establishment of "drug-free zones," often around schools, parks, or public-housing projects, can also have racially disparate effects.[8] These laws mean that people who live and commit drug crimes in dense urban areas, where few locations are not close to a school or park, will be punished more harshly for the same conduct than are their suburban or rural counterparts. Because urban areas usually have higher proportions of people of color, these harsher punishments will reinforce racial disparities. Laws like these interact with seemingly race-neutral DNA collection laws to produce great disparities in the databank. A databank that includes all persons convicted of felonies will include every person - primarily people of color - convicted of possessing cocaine or heroin, no matter how small the amount; but it will not contain samples from people - primarily white - convicted of minor methamphetamine offenses that were prosecuted as misdemeanors. Conversely, a databank that includes only violent crimes or sex crimes - as many originally did - should result in fewer disparities than an all-felony database for the reasons just described. Excluding non-violent crimes is reasonable since DNA evidence is almost never involved in non-violent offenses. DNA databanks themselves create a feedback loop that further magnifies these disparities. Well over half of all serious crimes go completely unsolved, with the police never even identifying a suspect. If DNA databanks work as they are intended, they will identify suspects for at least some - perhaps many - of these crimes. But a racially skewed databank will produce racially skewed results; because racial disparities in the criminal-justice system have led to the inclusion of a disproportionate number of profiles of African-Americans in CODIS, the databank will return a disproportionate number of matches to African-American suspects. In contrast, crimes committed by members of groups that are underrepresented in CODIS will escape detection, particularly as the police spend an increasing amount of their limited time and resources focusing on cases where they have found a DNA match. The U.S. Constitution, as interpreted by the courts, does not prohibit this shift, regardless of the racial disparities it introduces. The courts have held that the Fourteenth Amendment's promise of equal protection of the law prohibits only intentional discrimination, which means that challenges to criminal laws that result in racially disparate impacts are extremely difficult. In the words of the U.S. Supreme Court, discriminatory intent means "more than intent as volition or intent as awareness of consequences. It implies that the decision-maker, in this case a state legislature, selected or reaffirmed a particular course of action at least in part because of, not merely in spite of, its adverse effects upon an identifiable group." If the governmental body would have acted the same way even without the discriminatory intent, the law stands. The United States Court of Appeals has applied these same principles to reject an argument that the racial disparities in the federal DNA database made it unconstitutional.[9] No matter how disparate the impact of the database, without indications that Congress enacted it in order to adversely affect African-Americans, the challenge failed. A second policy-level set of decisions also creates racial disparities: the allocation of law-enforcement resources. The clearest big-picture example of this is the so-called "war on drugs," which is largely responsible for filling our prisons with men and women of color over the last 30 years.[10] A war on securities fraud or tax evasion would result in the arrest and prosecution of a very different demographic. Yet resources for combating white-collar crimes have been cut, despite evidence that violations are common and devastating to our society, as evidenced by the current global impacts of finance fraud. On a smaller scale, police decisions to conduct buy-bust operations in specific neighborhoods - where undercover officers attempt to buy drugs from people on the street and then arrest anybody who sells them the drugs - mean that the police choose who will be targeted based on what neighborhood is chosen for the operation. These operations usually occur in poor, urban neighborhoods with large minority populations. Racial disparities also enter through racial profiling by individual officers. Studies have shown that some mixture of unconscious racism, conscious racism, and the middleground use of criminal profiles often leads law enforcement to focus its attention and authority on people of color. This can include everything from discriminatory enforcement of traffic laws to detainment and arrests of people of color without sufficient individualized suspicion. As with challenges to legislative actions, challenges to racial profiling under the Constitution are extremely difficult because of the need to show discriminatory intent. The difficulty is magnified because the law gives police officers substantial discretion as to who they approach, stop, question, or search. The Supreme Court has held that the police may lawfully make pretextual stops - for example, singling out one speeding driver among many because the officer has a hunch that they may be carrying drugs. This means that, although the police may not stop a person based solely on race, there are many explanations an officer can give if called upon to explain a stop: the driver or passenger's nervous glance, reduced speed upon seeing the officer, a pedestrian wearing a heavy coat on a warm day, and so on. None of this behavior alone would justify the stop of a car, but such seemingly innocent actions are enough to justify the officer's decision to stop this particular car for driving a few miles per hour over the speed limit while ignoring all the others that did the same, or to stop a particular individual for jaywalking while ignoring similar violations. Even if a court determines that an officer did make a stop based on nothing more than the driver's race, the only remedy is the possibility of a civil suit against the officer. Unless serious harm was done, this is highly unlikely to occur, so it is not a significant deterrent to such police abuse of power. Arrestee sampling adds another incentive for police officers to make questionable or outright illegal arrests. Whether or not the arrest leads directly to charges being filed, the arrestee's DNA profile will automatically be included in the database and run against all crime-scene evidence, now and in the future. Because of the barriers to having DNA samples removed, few arrestees will be able to have their samples and profiles expunged, thus allowing a single law enforcement officer the power to place people under lifetime genetic surveillance. The low level of proof required to make an arrest, combined with the difficulties of preventing arrests that are illegal for lack of proof or for discriminatory enforcement of laws, means that allowing DNA collection immediately after arrest will lead to large databases full of innocent people. Furthermore, given the ubiquity of racial profiling, people of color will largely populate the databases. The bottom line is that police end up with enormous discretion to determine who is in a database, with absolutely no review of many of their arrests. The consequence of the arrest of a plainly and indisputably innocent person will be not only a short stint in jail, but a lifetime of genetic surveillance. Genetic discrimination results in workplace discrimination- incentivizes companies to test potential employees Broome 2 (Zachary Broome. University of Alabama. MBA. “The Legal Issues of Genetic Discrimination.” P. 40-41. http://www.bama.ua.edu/~joshua/archive/aug06/Zach%20Broome.pdf)//EMerz In contrast to the positive benefit genetics presents in homosexual discrimination, a second area of legal debate stemming from genetic research is that of workplace discrimination. A watchword of many companies when considering employees is liability, or the potential responsibility a company might have for any employee who causes damage while at work. Presently, liability for things like violent behavior can only be determined based on prior offenses, such as a criminal record. With the advancement of genetic research, there have been 41 claims that some people contain predispositions towards violence and anger. Mark Rothstein, in an article for the American Judicature Society, questioned if “employers in the future have a duty to review medical records or conduct their own medical testing to determine whether applicants had genetic indicators of an increased risk for violent behavior… If behavioral genetic tests were on the market and their use by employers was not unlawful, it is possible that a jury might impose liability for failure to use them.” (Rothstein) For many companies, being liable for a single lawsuit could cost them millions of dollars. Testing would not be limited to violent characteristics, but could also be applied to any sort of negative predisposition, such as drug and alcohol abuse. Therefore, it is not only conceivable but also likely that many businesses would require testing of all potential employees and only hire those that possessed no threat of litigation or deviant behavior. Some critics of legislating against genetic discrimination argue that discrimination in the workplace is purely hypothetical and does not warrant creating new laws. They contend that critics like Rothstein are too focused on possibilities. The problem with that belief is it is simply not true. In a statement released by the ACLU, it was noted, Genetic testing in the workplace is on the rise. In 1982, a federal government survey found that 1.6% of companies who responded were using genetic testing for employment purposes. 1 In a similar survey conducted by the American Management Association in 1997, 6-10% of employers were found to be conducting genetic testing. 2 Moreover, there have been many documented cases of genetic discrimination. 3 In a survey of nearly 1,000 individuals who were at risk for genetic conditions, over 22% reported that they had experienced some form of discrimination based on their risk status. 4 The U.S. Department of Labor has found genetic information to be a very serious workplace issue. 5 ” (ACLU; all numerical citations reflect citations of ACLU columnist as noted in subsection of sources) As this release contends, genetic discrimination is rising, and rising unabated because it is legal. There is little opposition in contemporary legislation to employers enjoying a hiring bias based on genetic predispositions, primarily because the research of the Humane Genome Project is the first time such a possibility has existed. Realizing the high potential for, and beginnings of, discrimination by employers, the Humane Genome Project created a research department called Ethical, Legal, and Social Issues (ELSI) in 2003 to determine ways to prevent such problematic consequences of sequencing the genome. ELSI noted that the Americans with Disabilities Act of 1990 is the best source of protection against genetic discrimination, but is still weakened by the simple flaw that it never explicitly provides for discrimination based on genetic testing. The problem with the ADA is it only specifically prevents discrimination against expressed genetic conditions, not those merely represented in a person’s DNA. This makes the law almost useless in combating employer discrimination, which focuses on sifting out workers with the potential for problems. Genetic discrimination promotes eugenics- that treats disabled people as a lower class Broome 2 (Zachary Broome. University of Alabama. MBA. “The Legal Issues of Genetic Discrimination.” P. 40-41. http://www.bama.ua.edu/~joshua/archive/aug06/Zach%20Broome.pdf)//EMerz While the issue of discrimination is generally considered only in terms of limiting the rights of current members of society, one emerging branch of genetic discrimination being contested is eugenics. Eugenics carries a certain social connotation of radical ideals of racial purity, but actually refers to any sort of manipulation of the gene pool to produce desired offspring. The issue proposed by critics of new research is that advanced genetic testing allows potential parents to select which children they want to consider rearing based solely on genetic discrimination of potential flaws. While this seems an honest enough process, some groups, such as fundamentalist Catholics and radical disability activists, view this as a medical version of negative eugenics. Negative eugenics is defined by one group as “preventing the births of children, with characteristics (genotypes/phenotypes) viewed as unhealthy or undesirable or preventing child bearing by "undesirable" individuals.” (Wolbring) Many people who argue against discrimination of genetically flawed embryos and fetuses say that doing so not only reinforces the social stigma attached to those born with disabilities, but also implies that some forms of life are better. The law, by contrast, is in favor of those who do wish to be selectively pregnant and avoid genetic disorders. The most basic, and famous, ruling in the matter is Roe v. Wade, which contends that women have the right to abortion regardless of reason. In addition, there is no legal stipulation on in vitro fertilization clinics as to what embryos can or cannot be implanted into the mother. Unlike previous discussions of genetic discrimination, in the situation of pregnancy there is nothing legal the dissenting group can do. Selective pregnancy, through whatever means, is a constitutionally guaranteed right and precludes any arguments against discriminatory practices. The issue of genetic discrimination, especially in the workforce, is something that must be decided by changes in legal issues. As noted, when there is no legal recourse for those with unfavorable genetic conditions, both employers and insurance companies will take advantage of the unfortunate. In addition, both the government and scientific community have a responsibility to protect those who might be harmed by the decision to pursue knowledge of genetics. The advances in science allow for a better understanding of the genome, but also provide another potential outlet for social division on physical premises. In essence, measures must be enforced to ensure that the civil rights of those with genetic predispositions will be secure, or the country will create a potential for tragedy. Genetic discrimination otherizes people with diseases and disabilities Lemke 13 (Thomas Lemke. Heisenberg Professor of Sociology with focus on Biotechnologies, Nature and Society at the Faculty of Social Sciences of the Goethe-University Frankfurt. “Perspectives on Genetic Discrimination.” 2013. P. 2-3. http://samples.sainsburysebooks.co.uk/9781134056910_sample_508168.pdf)//EMerz One may wonder whether today we have reached the age of the “gene police” predicted by Canguilhem in an almost visionary fashion.2 A series of empirical studies conducted in different countries in the last twenty years has pointed to new forms of exclusion, disadvantage, and stigmatization caused by the increase of genetic knowledge (Billings et al. 1992; Geller et al. 1996; Low, Kind, and Wilkie 1998; Otlowski et al. 2007; Taylor et al. 2008). The spectrum of this “genetic discrimination” ranges from labor market exclusion and problems with insurance policies to difficulties involving adoption agencies. Thus, applicants’ job qualifications have been rejected, and they have been denied employment on the grounds of a possible future disease. Similarly, health and life insurance companies have cancelled or refused to issue policies when genetic risks were suspected among their (potential) customers. In other cases, couples were denied child adoption when one spouse had a disposition for a genetic disease. Experiences of genetic discrimination have also been documented with regard to the health sector, the education system, and the military. The hopes of a “molecular medicine,” able to identify and prevent disease before concrete symptoms manifest themselves, are overshadowed by the nightmare of a society in which career prospects, insurance options, educational pathways, and family planning are determined by genetic characteristics. The academic discourse surrounding the negative consequences of growing genetic knowledge is dominated by the fear of a “genetic underclass” (Nelkin and Tancredi 1994: 176; Nelkin 1992: 190; Keays 2000: 84–85; Kutter and Ruess 2001) or “new pariahs” (Kitcher 1996: 127)—individuals stigmatized, pathologized, and discriminated against on the basis Introduction 3 of their genetic properties. The main concern is that innovations relating to genetic knowledge will produce new types of class formation not based on socio-economic status, but on genetic criteria. A danger is seen in a “genetocracy with individuals, ethnic groups, and races increasingly categorized and stereotyped by their genotype, making way for the emergence of an informal biological caste system in countries around the world” (Rifkin 1998: 3; cf. also Dickens 2001: 105–106). Apart from academic discourse, the problem of genetic discrimination has now prompted regulatory initiatives at the juridical and political level to determine the conditions and limitations concerning the use of genetic information. Many countries have introduced laws designed to prevent the discriminatory treatment of individuals due to their genetic properties. These legislation projects guarantee the right to self-determination and “genetic privacy,” and protect personal data against misuse. Surveillance Bad - Privacy Medical privacy is a bulwark against violent totalitarianism and fascism Faria 98 (Miguel A. Faria Jr. MD is a consultant neurosurgeon and author of Vandals at the Gates of Medicine (1995) and the newly released Medical Warrior: Fighting Corporate Socialized Medicine (Macon, Georgia, Hacienda Publishing, Inc., 1997). He is also the Editor-inChief of the Medical Sentinel. , “Patient Privacy and Confidentiality --- Time to Draw the Line” http://www.haciendapub.com/medicalsentinel/patient-privacy-andconfidentiality-time-draw-line)///CW The dismemberment of the medical profession continues unabated in the age of managed care, HMOs, and corporate socialized medicine. The patient-doctor relationship, erstwhile based on trust and beneficence, has been eroded by the corporatist ethics imposed on the practice of medicine. The situation worsens daily as the excesses of HMOs are brought to light and patients realize many of their physicians are no longer their advocates but adversarial gatekeepers, enticed by the managed care organizations (MCOs) to ration medical care - for the network's (and the doctor's) economic benefit.¶ One area where this dismemberment is most pronounced, aimed like a dagger at the heart of Hippocratic medicine, is the relentless violation of patient privacy and medical record confidentiality. Privacy and trust in the patient-doctor relationship have been essential elements in medical ethics and the practice of medicine. Thus, it's worth examining what the Oath of Hippocrates states regarding this issue:¶ Whatever, in connection with my professional practice, or not in connection with it, I may see or hear in the lives of men which ought not to be spoken abroad I will not divulge, as reckoning that all such should be kept secret.¶ While I continue to keep this oath unviolated, may it be granted to me to enjoy life and the practice of the art, respected by all men at all times, but should I trespass and violate this oath, may the reverse be my lot.¶ Patient confidentiality, then, is not only a time-honored principle of medical practice, but indeed, a strong covenant of the ethics of Hippocrates, inherent to the honorable medical profession.¶ When President Clinton was asked to release his medical records to the public during the 1996 re-election campaign, he invoked the privacy of the patient-doctor relationship and his lawyers refused to do so (recently it has taken subpoenas and a grave criminal investigation by the Office of the Independent Counsel before the president surrendered certain biologic samples and medical information to government investigators). Americans should be entitled to, and afforded, this same right of privacy, and should be concerned about confidentiality for ultimately, as patients, we will all have sensitive medical information compiled. Yes, we will all have medical charts compiled documenting details of our medical history, which should only be inspected by medical personnel to whom explicit written consent has been given for continuity of medical care, or made accessible to third parties (including the government) upon written authorization from the patient - each time information is requested, and delineating the specific need for the disclosure, as well as outlining the manner in which the information will be used.(1)¶ This may not seem as important in our open and permissive society of the 1990s, as it was at the time of the Nazi Third Reich in Germany, where records of those whose life were deemed "not worth living" were compiled, inspected, and selected by government officials before the intended victims were sent to the extermination camps. Nevertheless, no one knows what the future will bring. The holocaust of Nazi Germany, after all, was preceded by the openness, permissiveness, and seemingly beneficent social and welfare policies of the Weimar Republic.¶ Confidentiality of medical records is, perhaps, particularly important in the case of psychiatric patient-doctor consultations. In the Soviet Union, "psychiatric" records of dissidents were kept and used to document the "illnesses" prior to sending the "patients" for "rehabilitation" in the gulags of Siberia. In America, only a few years after the stumble of the Soviet bear - and at the height of the 1993-1994 health care debate - Hillary Clinton wanted to establish a Health Security Card with an encoded computer chip capable of containing 60 pages of potentially prejudicial information (i.e., sexually transmitted diseases, drug and alcohol abuse, depression, etc.) and sensitive personal data (i.e., living arrangements, impotence, sexual practices, etc.) on every American - a federal dossier - from personal medical records to tabulations of individual health care costs (i.e., charges incurred by the government as a result of the individual acting as a "consumer of finite and scarce health care resources"). As U.S. Supreme Court Justice William O. Douglas stated in 1996: "Once electronic surveillance...is added to the techniques of snooping that this sophisticated age has developed, we face the stark reality that the walls of privacy have broken down and all the tools of the police state are handed over to our bureaucracy."(2)¶ Towards a National ID Card¶ Today, all three branches of government are making a mockery of patient record confidentiality and the privacy (and trust) of the patient-doctor relationship. In fact, patient medical records are being viewed increasingly as public property and considered "within the public domain" by many government bureaucrats! The administrative simplification provisions of the Kassebaum-Kennedy law (1996) and the various administrative edicts from the offices of the Department of Health and Human Services (HHS) and the Health Care Financing Administration (HCFA) militate, ever more insidiously, for the collection and the electronic transfer of records (including mental health records), and medical data generated by every patient-doctor encounter. Ironically, the Kassebaum-Kennedy law* requires HHS Secretary Donna Shalala to make recommendations for preserving patient confidentiality in medical records. Instead, Sec. Shalala contends that "individuals' claims to privacy must be balanced by their public responsibility to contribute to the common good, through use of their information for important, socially useful purposes..."(3) Although Sec. Shalala and the government in other communications have paid lip service, in Orwellian Newspeak fashion, to preserving personal privacy, the assignment of unique health identification requirements makes a mockery of patient confidentiality and personal privacy. DNA testing violates privacy—First and Fourth Amendment Nelkin and Andrews 1(Dorothy and Lori, Department of Sociology and School of Law, New York University 2 Chicago-Kent College of Law, Illinois Institute of Technology, “DNA identification and surveillance creep” Sociology of Health & Illness Vol. 21 No.5 1999 ISSN 0141–9889, pp. 689–706 http://onlinelibrary.wiley.com/doi/10.1111/1467-9566.00179/pdf 2001 JM) To the marines, prisoners, and immigrants who challenged mandatory testing, body tissue holds religious, social and political meanings, and privacy concerns were critical. For Native American Donald Power, the military’s taking of DNA violated his religious beliefs. Mayfield and Vlacovsky defined their DNA in terms of personal identity. And even prisoners, whose privacy rights are compromised, defined the taking of DNA as different from the searching of prison cells or body cavities. While convicted felons would have lesser rights than other individuals, the potential uses of forensic DNA banks affect more than just criminals. Those tested in a DNA dragnet because they happen to be in an area will then have their DNA samples on file. Victims also have their DNA tested at forensic labs and their samples may be banked. Family members related to the offenders are also affected because health information about the offender (say, a genetic predisposition to cancer) indicates genetic risks to relatives as well. Collecting tissue samples from an individual who has not been charged or convicted of a crime—as in a DNA dragnet—could violate the person’s Fourth Amendment right to be free from unreasonable searches and seizures. However, persuaded by the ‘scientific’ nature of ‘profiling’, courts have allowed the random stopping of individuals thought to fit criminal profiles of hijackers or drug smugglers. One judge, referring to a hijacker profiles as ‘elegant and objective’ was convinced that hijackers had characteristics ‘markedly distinguishing them from the general traveling public’ (US v. Lopez 1971 As a controlling tool for modern institutions and complex organisations, the use of DNA is appealing. But in light of problems of privacy and potentials for abuse, testing should be closely regulated. The Fourth Amendment could be used to prohibit non-consensual tissue collection so as to limit the taking of DNA samples (Krent 1992). Informed consent doctrines could be more widely enforced to limit possibilities of abuse. Or the property interests in the body could be recognised, giving people greater control over what is done with their tissue (Andrews 1986). There could be greater limits on access to DNA information: Vermont legislation, for example, includes language in a databanking bill to prohibit the use of genetic information as a basis for employment and insurance decisions. Though the practice of testing and banking DNA is extending to a widening range of people—from soldiers who go to battle to chaplain’s assistants, from violent to nonviolent felons, from immigrant families to foreign adoptees— there has been little public concern about the practice. The possibilities of error are deflected by faith in science and, especially, the promise of genetics. Potential abuses of DNA data are deflected by perceptions that surveillance pertains to ‘others’—the soldier, the criminal or the illegal immigrant—and a belief that DNA identification is an efficient means to maintain social order. Moreover, Americans these days have few expectations of privacy, accepting surveillance in many spheres. Shoppers accept television surveillance in department stores, strollers accept camera surveillance in public parks (Nelkin 1995). The dossier society that Laudon and Rule predicted years ago has crept up on us; facilitated by the ability to gather, store, and access information—not just about finances, credit rating, or consumer preferences, but about the body, identity, and health. In 1972, a legal scholar wrote that the social security numbers assigned to us at birth have become a ‘leash around our necks, subjecting us to constant monitoring and making credible the fear of the fabled womb-to-tomb dossier’ (Miller 1972). Could DNA identifiers eventually replace social security numbers, requiring every person to have DNA on file? Today, according to Janet Hoeffel (1990), ‘It is not merely paranoia to imagine the incremental steps the current government would take that would lead from a data bank with DNA profiles on criminals to a data bank with profiles on each of us’. Indeed, molecular biologist Leroy Hood has predicted that within 20 years all Americans will carry a credit card type plastic stripe that contains computer readouts of their personal genomes: ‘Your entire genome and medical history will be on a credit card’ (Hood 1996) Genetic surveillance is a serious intrusion of privacy and contradicts democratic principles—the result is totalitarianism Roberts 11 (Dorothy E. Roberts, Kirkland & Ellis Professor, Northwestern University School of Law; faculty fellow, Institute for Policy Research)(“Collateral Consequences, Genetic Surveillance, and the New Biopolitics of Race”, Howard Law Journal, Vol. 54 No. 3, 2011)//ASMITH Government DNA data banking began as a targeted procedure to assist law enforcement in identifying perpetrators of a narrow set of crimes.59 It has expanded into a form of state surveillance that ensnares innocent people or petty offenders who have done little or nothing to warrant the collateral intrusion into their private lives. Databanks no longer detect suspects—they create suspects from an evergrowing list of categories. Even so, the public shows little alarm about the massive retention of genetic information because the balance between protecting individual privacy and keeping the streets safe seems to fall in favor of more law enforcement. DNA profiling is a far more precise and objective method of identifying suspects compared to less sophisticated law enforcement techniques, such as eyewitness identification or smudge fingerprints found at a crime scene.60 Far from feeling threatened by this gigantic storehouse of genetic data, many Americans see it as a surefire way of catching criminals and ensuring that only guilty people are convicted of crimes.61 Storing an innocent person’s DNA seems a small price for such a great public good. The countless cases where DNA data banking either yielded no benefit or produced erroneous identifications received little attention from the media. Moreover, the public does not hear from the thousands of innocent people whose DNA was seized and stored against their will. Although DNA testing has shed light on the injustice of false convictions, it cannot solve the underlying problems that lead innocent people to be convicted in the first place. Most wrongful convictions result from deep biases in the criminal justice system that make poor, minority defendants vulnerable to police abuse, misidentification, and inadequate representation.62 False confessions coerced by the police are one of the main causes of wrongful convictions.63 According to the Innocence Project, “In about [twenty-five] percent of DNA exoneration cases, innocent defendants made incriminating statements, delivered outright confessions or pled guilty.”64 Coerced false confessions were a factor in fifteen of thirty-three exonerations won by the Center on Wrongful Convictions.65 It makes no sense to correct a problem created by law enforcement’s abuse of power by handing over even more authority to law enforcement in the form of DNA collection. The way to reduce wrongful convictions is to remove the biases based on race and class that corrupt our criminal justice system. Extending the reach of state surveillance does just the opposite. Besides, contrary to the public’s belief that DNA evidence is infallible, there have been numerous cases of errors in the handling and analysis of DNA that have led to false accusations and convictions of innocent people.66 These weaknesses in the state’s use of DNA data banking as a tool for reducing crime make it harder to justify the resulting breach of individual privacy. Society recognizes that the government violates its civil liberties if it taps our telephones or secretly searches our homes without court permission.67 Collecting and storing our DNA is also a serious intrusion into our private lives because DNA is a part of the body; taking it without consent violates our bodily integrity. In addition to this material aspect, DNA contains sensitive personal information that can be used to identify our family members and us, can be matched with other private records, including medical files.68 Society tolerates the state forcibly extracting highly personal data from people convicted of serious crimes because these offenders have a diminished right to privacy as a result of their antisocial conduct.69 But as the categories of people who are compelled to submit DNA broaden, it becomes less clear why the state should have so much power over them. Once compelled DNA collection goes beyond murderers, rapists, and armed robbers, law enforcement’s need for a sus-pect’s DNA lessens and the right to retain control over their private information strengthens.70 Although people convicted of heinous crimes may forfeit their claim to privacy, there is no such justification for seizing genetic samples from someone who has, say, forged a check. State agents should be required to obtain informed consent to take or test DNA from anyone who has not been convicted of a serious crime. Although U.S. courts have been slow to recognize this threat to civil liberties,71 in 2008, the European Court of Human Rights unanimously held that the United Kingdom’s storage of DNA for purposes of criminal investigation infringed privacy rights protected by Article 8 of the European Convention.72 The European Court was especially troubled by the indefinite retention of genetic information taken from children and adults who were never convicted of a crime,73 stigmatizing them as if they were convicted criminals. This equation of the innocent and the guilty disregards the presumption of innocence accorded to citizens in a democracy. Massive government collection of DNA transforms the relationship between citizens and their government in ways that contradict basic democratic principles.74 Government becomes the watchdog of citizens instead of the other way around. Although they are guilty of no wrongdoing, huge segments of the population are perpetually under suspicion. Citizens can no longer rely on the state to safeguard their privacy by forgetting their past behavior because evidence about them is stored forever.75 The state has the authority to take citizens’ private property—in this case, their genetic information—without due process.76 Those are features of a totalitarian state, not a liberal democracy. Public health surveillance risks invasions of privacy and previous cases fail to addresses status quo conditions Mariner 07 (WENDY K.MARINER, Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health; Professor of Law, Boston University School of Law; Professor of SocioMedical Sciences, Boston University School of Medicine. J.D., Columbia University School of Law; LL.M, New York University School of Law; M.P.H., Harvard School of Public Health.)(“MISSION CREEP: PUBLIC HEALTH SURVEILLANCE AND MEDICAL PRIVACY”, BOSTON UNIVERSITY LAW REVIEW, Vol. 87:347, 2007)//ASMITH Today, almost everyone, regardless of station, could be subject to public health surveillance. The scope of public health surveillance has grown significantly beyond its contagious disease origins. Public health organizations now recommend compulsory reporting of more than sixty infectious diseases, twenty-nine genetic conditions (for newborns), almost all types of cancer, and other chronic diseases like asthma and lupus.14 The Bush administration’s National Strategy for Pandemic Influenza has given the Department of Homeland Security the task of developing a National Biosurveillance Integration System (NBIS) to integrate surveillance data about agriculture, food, environment, and human diseases.15 In January 2006, the New York City Department of Health and Mental Hygiene began requiring laboratories to submit electronic reports of the blood sugar test results of all patients with diabetes, by name and without patient consent.16 The Health Department intends to contact patients who are not controlling their blood sugar to encourage taking medications, better diet, and more exercise.17 Although there will always be a need to investigate disease outbreaks in order to prevent epidemics, the more prevalent use of disease surveillance data today is for statistical analysis, planning, budgeting, and general research.18 This new generation of reporting laws reflects a goal of many people in public health: to collect data about chronic diseases outside the context of a research study and without the need to obtain any individual patient’s informed consent. The question is whether these new surveillance programs should be able to compel the collection of personally identifiable data. Is it possible to reconcile individual interests in personal privacy with modern forms of public health surveillance? Are mandatory public health surveillance programs that focus on statistical analysis, research, or monitoring personal health status a reasonable exercise of the state’s police power, or are they vulnerable to challenge as an invasion of privacy? Do they offer the promise of medical advances, or the threat of “general searches, which the authors of the Bill of Rights were so concerned to protect against”?19 This Article begins to answer these questions. Part I summarizes the evolution of public health surveillance programs. Part II describes three major functions of surveillance programs: outbreak investigation, identifying newborns who need essential medical care, and research. It also highlights how the aim of those who collect medical information has shifted from preventing the spread of contagious diseases to the more general purposes of research, budget analysis, and policy planning.20 This shift poses a challenge to the principles of liberty and privacy that underpin one’s individual autonomy to decide whether to participate in research or to accept medical care. Part III argues that the sparse case law on constitutional challenges to compulsory reporting laws offers only a fragile conceptual framework for modern public health statutes that compel the disclosure of personally identifiable information. The cases themselves offer little guidance, often ignoring how surveillance information is used and how valuable the right of privacy is to individuals. Modern health surveillance programs, with their focus on obtaining data accurate enough to use for statistical analysis and research, do not easily fit the legal constructs guiding earlier laws designed to prevent epidemics. At the same time, the general goal of improving public health fails to provide any principle for limiting government intrusions into medical privacy. The Article concludes that modern public health surveillance needs defensible principles that define the scope and limits of state power to collect personally identifiable medical information. Part IV outlines a more robust approach to balancing the state’s interest in public health and the individual’s interest in the privacy of medical information. This approach weighs the present value of the actual use of the information (instead of speculative longrange goals) against the dignitary value of privacy. Although space precludes a fully developed argument, I hope this Article will inspire thoughtful efforts to retain the value of modern public health surveillance without sacrificing the value of patient privacy. State data collection without consent invades subject rights Mariner 07 (WENDY K.MARINER, Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health; Professor of Law, Boston University School of Law; Professor of SocioMedical Sciences, Boston University School of Medicine. J.D., Columbia University School of Law; LL.M, New York University School of Law; M.P.H., Harvard School of Public Health.)(“MISSION CREEP: PUBLIC HEALTH SURVEILLANCE AND MEDICAL PRIVACY”, BOSTON UNIVERSITY LAW REVIEW, Vol. 87:347, 2007)//ASMITH Several states have gone beyond authorizing the creation of cancer registries, and have enacted laws or adopted regulations that either permit or require medical providers to report cancer cases to a registry without their patients’ consent.106 In some states, advocacy groups lobbied state legislatures and health departments for a centralized source of information, either in an attempt to explain unusually high rates of cancer in their communities or in response to fears of exposure to hazards from local manufacturing plants.107 The more important factor appears to be the availability of federal grant funds to create or expand a registry.108 CDC prefers that registries be located in states that require the reporting of cancer cases by law. Although the National Cancer Act does not require states to enact any particular laws, undoubtedly because such a federal requirement would violate state sovereignty,109 grants are unlikely without a mandatory reporting law. The Act requires that statewide cancer registries be legally authorized to obtain all medical records of cancer patients from any individual or organization providing cancer services in order to be eligible for funding.110 It would be difficult to assure access to “all records” without dispensing with consent.111 Arguably, any use of personally identifiable surveillance data – apart from outbreak investigation and epidemic containment – could qualify as research with human subjects. Cancer registries squarely present the question of whether the state can demand access to an individual’s personally identifiable information for use in research without consent. Since the Nuremberg Code was issued in 1947, research with human subjects has been deemed unethical and unlawful unless the subject gives voluntary, informed consent.112 The consent requirement is intended to protect the individual’s right of selfdetermination and the dignity of human beings recognized in all international declarations and covenants on human rights.113 Without informed consent, humans are being treated only as a means to an end.114 These foundational principles have been embodied in the common law,115 and in regulations governing federally funded research known as the “Common Rule,”116 and may have constitutional protection.117 All of these sources support the conclusion that the use of personally identifiable information for research purposes without the subject’s consent violates the subject’s rights.118 A2 Politics Link Turn The plan is popular – tech companies will push for the plan and it has widespread support Young 14 (Kerry Young, Roll Call Staff, graduate of Tulane University)(“Tech Firms Ask Congress to Redefine Medical Privacy Rules”, Sept. 8, 2014, Roll Call, http://www.rollcall.com/news/tech_firms_ask_congress_to_redefine_medical_privacy_rules-2360691.html?pg=3&dczone=policy)//ASMITH Tech firms, including Amazon.com Inc., are asking Congress to redefine the rules on medical privacy, saying the risks of potential disclosure should be weighed again against the anticipated benefits of wider sharing and easier access to crucial health data. Executives of tech companies and health organizations have told the House Energy and Commerce Committee in recent months that what they consider an excessively conservative stance on health data privacy is hindering development of new medical technologies and approaches to treatment, and also adding costs to already burdened state and federal budgets. “We, in our effort to protect the patients, are constructing a health care system that they and we cannot afford, and we’re putting the balance in the wrong spot,” Joseph M. Smith, a former Johnson & Johnson medical technology executive who has been involved with venture capital projects, told the committee in June. “In Congress’ view of trying to protect everyone from that information, we may be protecting them to death.” Much of what health researchers and executives seek involves more clear guidance on what are known as HIPAA privacy regulations. The name reflects their genesis as an add-on provision to the Health Insurance Portability and Accountability Act of 1996 (PL 104-191). Yet, these calls for a new look at HIPAA are coming at a time of marked concern about the sanctity of consumers’ online accounts — health and otherwise. House Republicans responded with great concern when the Department of Health and Human Services this month announced that common malware had been detected on the website for the federal medical insurance exchange. No personal information was comprised as a result of this intrusion on a healthcare.gov test server, HHS has said. June brought a furor over the revelation of an experiment seeking to alter the emotional state of about 690,000 of Facebook users. That’s likely to heighten people’s concern about how data in general is shared online, especially medical records, said Justin Brookman, director for consumer privacy at the Center for Democracy & Technology. “By and large, they don’t expect that they are going to be guinea pigs,” he said. “When we are talking about health information, people feel even more strongly about it.” In May, HHS reported a record HIPAA settlement of $4.8 million in a case involving New York Presbyterian Hospital and Columbia University and medical records for about 6,800 people, including laboratory results. The hospital and Columbia learned of the security lapse when the partner of a deceased patient found that person’s health information on the Internet. New York Presbyterian and the university notified HHS of the security lapse, and there’s been no indication any of that information was ever accessed or used inappropriately. Still, HHS found their “approach to guarding data” lacking and levied the record fine. The complexity of HIPAA regulations and the threat of inadvertently triggering fines keep many small companies from venturing into projects that would involve using medical data, Smith said at the Energy and Commerce meeting in June. “Once they understand the HIPAA penalties and the machinery involved and the limitations that imposes on the value that they could create, they demure,” said Smith, now the chief medical and science officer at the nonprofit West Health Institute, noting this has an effect on the United States health system at large. The “innovative spirit” falters when “it encounters that immovable object that we currently call HIPAA,” he said. Large companies also are looking for changes in HIPAA. Paul Misener, Amazon’s vice president for global public policy, in July told Energy and Commerce that current rules make it difficult to negotiate contracts for cloud computing services. Congress should direct HHS to provide more clear guidance on the HIPAA requirements for cloud computing when the host firm has no way of accessing the encrypted data that would be stored, he said. The current interpretation “impedes health-care delivery entities from leveraging cloud services by causing the parties to negotiate a ‘business associate agreement’ in which virtually all of the terms are inapplicable because the cloud services provider does not have access to health information,” Misener said These complaints about HIPAA have caught the attention of a powerful lawmaker who is intent on putting forth broad bipartisan health legislation in the next session of Congress. “We have heard on numerous occasions that there is a wealth of health data available, but there are barriers to using it,” House Energy and Commerce Chairman Fred Upton, R-Mich., told CQ Roll Call in an email last week. “We are exploring opportunities to break down those barriers, allowing for greater innovation and advancement, all the while protecting the privacy of our patients. A look at HIPAA has been part of what Upton calls his 21st Century Cures Initiative, which has drawn federal officials, including top Food and Drug Administration regulators, to sit and publicly hash out ideas with company executives and patient advocates. Upton’s lead partner in the project is Diana DeGette, D-Colo., and the backers so far include two Democrats competing for their party’s top spot on Energy and Commerce, Frank Pallone Jr. of New Jersey and Anna G. Eshoo of California. In May, HHS reported a record HIPAA settlement of $4.8 million in a case involving New York Presbyterian Hospital and Columbia University and medical records for about 6,800 people, including laboratory results. The hospital and Columbia learned of the security lapse when the partner of a deceased patient found that person’s health information on the Internet. New York Presbyterian and the university notified HHS of the security lapse, and there’s been no indication any of that information was ever accessed or used inappropriately. Still, HHS found their “approach to guarding data” lacking and levied the record fine. The complexity of HIPAA regulations and the threat of inadvertently triggering fines keep many small companies from venturing into projects that would involve using medical data, Smith said at the Energy and Commerce meeting in June. “Once they understand the HIPAA penalties and the machinery involved and the limitations that imposes on the value that they could create, they demure,” said Smith, now the chief medical and science officer at the nonprofit West Health Institute, noting this has an effect on the United States health system at large. The “innovative spirit” falters when “it encounters that immovable object that we currently call HIPAA,” he said. Large companies also are looking for changes in HIPAA. Paul Misener, Amazon’s vice president for global public policy, in July told Energy and Commerce that current rules make it difficult to negotiate contracts for cloud computing services. Congress should direct HHS to provide more clear guidance on the HIPAA requirements for cloud computing when the host firm has no way of accessing the encrypted data that would be stored, he said. The current interpretation “impedes health-care delivery entities from leveraging cloud services by causing the parties to negotiate a ‘business associate agreement’ in which virtually all of the terms are inapplicable because the cloud services provider does not have access to health information,” Misener said These complaints about HIPAA have caught the attention of a powerful lawmaker who is intent on putting forth broad bipartisan health legislation in the next session of Congress. “We have heard on numerous occasions that there is a wealth of health data available, but there are barriers to using it,” House Energy and Commerce Chairman Fred Upton, R-Mich., told CQ Roll Call in an email last week. “We are exploring opportunities to break down those barriers, allowing for greater innovation and advancement, all the while protecting the privacy of our patients. A look at HIPAA has been part of what Upton calls his 21st Century Cures Initiative, which has drawn federal officials, including top Food and Drug Administration regulators, to sit and publicly hash out ideas with company executives and patient advocates. Upton’s lead partner in the project is Diana DeGette, D-Colo., and the backers so far include two Democrats competing for their party’s top spot on Energy and Commerce, Frank Pallone Jr. of New Jersey and Anna G. Eshoo of California. A2 Bioterrorism DA No Link Changing health policies key—current policies are more ineffective Mauroni 11 (Al, Director of the U.S. Air Force Counterproliferation Center, “GAUGING THE RISK FROM BIOTERRORISM” http://warontherocks.com/2014/01/gauging-the-risk-from-bioterrorism/3/ 1/6/15 JM) The focus of the federal government has been on coordinating a medical response to biological incidents, given that in the event of certain contagious diseases, the impact may be global and fast moving. As a result of policy that addresses both natural disease outbreaks and bioterrorism, there are numerous government agencies involved. Others have talked about the need to work public health with national security to address shared health security concerns. However, any focus on bioterrorism is lost in the greater concern about natural disease outbreaks. The challenge is one of resources and priorities between public health threats and deliberate biological threats. The public health community has a prioritized list of global infectious diseases. Diarrhea, malaria, dengue fever, and seasonal influenza top the list, followed by strains of hepatitis, HIV/AIDS, typhoid, and meningitis. Anthrax and smallpox are not listed in the top 30 infectious diseases because there are not regular outbreaks of those diseases and vaccines exist for both. Among the 60-70 infectious diseases that are tracked by the public health community, about ten constitute military biological warfare (BW) or bioterrorism threats. If the public health community is leading the medical response to bioterrorism, we need to understand that it isn’t focused on deliberately released BW threats. A 2011 CRS report on federal efforts to address the threat of bioterrorism makes this point. Although there is clear presidential and congressional attention on bioterrorism, the report notes criticism on the lack of metrics and unclear goals across the interagency, leading to ineffective efforts. The risk assessment process does not adequately address the intent and capabilities of deliberate actors. National bio-surveillance is challenged by expensive environmental sensors. The investment of billions of dollars into medical countermeasures for BW threats has been slow to produce results, and has been criticized by those who would rather see funds invested against public health threats. The CRS report fails to address the public health community issues overshadowing bioterrorism concerns, but one should be able to read this between the lines. It may be correct that a response to a biological incident should not be determined by the threat source (Mother Nature versus a deliberate actor), but certainly it makes a difference to those federal agencies responsible to prevent those threat sources from acting and to protect specific populations (military service members versus the general population). Defending fit military troops against BW agents on the battlefield (bio-defense) is very different from protecting young and old civilians from biological hazards dispersed by extremists (bio-security), which is distinct from protecting the general public from natural disease outbreaks (biosafety). Currently, there is no clarity in national policy to reflect these distinct roles. It is clear that the federal government has been tasked to defend the public against the threat of bioterrorism. Numerous government agencies are involved, and given the breadth and depth of this subject, it is difficult (but not impossible) to address all aspects and programs associated with the subject. Public health threats are more probable and affect more people than bioterrorism threats do. But, attempts to get a “two for one” by tasking the public health system to address bioterrorism in a holistic “all-hazards” approach will fail, resulting in a loss of focus on bioterrorism. The future challenges of infectious diseases and new biotechnology will continue to require a hard focus on how we conduct bio-defense, bio-safety, and biosecurity. As DoD and the interagency comes together to develop policies and strategies for countering biological threats, we need to ensure we are asking the right questions and not shortcutting the system in favor of quick fixes that may fail to produce viable results. Above all, we need to abandon rhetorical statements about how “the threat is real” and how a terrorist WMD incident will happen “within the next five years.” These statements aren’t resulting in increased resources or attention. It’s not 2001 anymore. It’s time for relevant analysis against tomorrow’s challenges. No Impact No risk of a bioterror attack—its too technically difficult PressTV 15 (PressTV, reporting source from the UK, “Ebola can be weaponized for bioterrorism in UK: Study” page 3 http://www.presstv.com/Detail/2015/02/01/395598/Weaponized-Ebola-could-be-used-in-UK 2/1/15 JM) The Ebola virus could be weaponized to kill thousands of people in Britain, UK germ warfare experts have warned. According to an investigation carried out at the Defense Science and Technology Laboratory at Porton Down in Wiltshire, there are three scenarios in which the virus could be weaponized for use in the UK, British media reports. The study was conducted following a request by the government for guidance on “the feasibility and potential impact of a non-state actor exploiting the Ebola outbreak in West Africa for bioterrorism,” The Mirror reported on Saturday. Following the assessment which was carried out last October, the British government called for the screening of passengers at Heathrow airport. The results of the study have emerged in a redacted version edited by the Ministry of Defense (MoD) and show it would difficult for Ebola to be weaponized by terrorists without the backing of a government, implying the possibility of the bioterrorist act. “This scenario would be logistically and … technically challenging for a non-state group,” read part of the redacted document about the first scenario. “There are practical issues with such a scenario that of themselves are often not insurmountable but taken together add enormously to the complexity of successfully undertaking this attack,” The Mirror excerpted in relation to the second scenario. Regarding the third scenario the report said it would be very technically challenging. The report was redacted by the MoD because it “contains details whose disclosure would prejudice the capability and effectiveness of our forces and safety of UK citizens.” Ebola is a form of hemorrhagic fever, whose symptoms are diarrhea, vomiting, and bleeding. The virus spreads through direct contact with infected blood, feces, or sweat. It can be also spread through sexual contact or the unprotected handling of contaminated corpses. Checks in place to ensure no impact MNT 15 (Medical News Today, Leading reporting news source for medical and health news, “Genetic safety switches could help curb potential bioterror risks” http://www.medicalnewstoday.com/releases/288584.php 1/28/15 JM) The potential threat of bioterrorism using man-made biological organisms could be reduced, thanks to a new method developed by scientists. Synthetic biologists - who can design and modify the DNA of living organisms to give them novel, useful functions - have devised a way of containing their products to help ensure that they work only as intended. Researchers have developed a set of genetic switches that can be built into engineered organisms, to control the function of genes they need to survive. The genetic switches are controlled by the addition of a mixture of naturally occurring chemicals, which can be customised for a variety of products. These could prevent potential harm from either the theft or misuse of these substances, which are used in biofuels, food, and medicines. Researchers at the Universities of Edinburgh and NYU Langone Medical Center have developed two types of molecular switch that work in yeast, a commonly used model organism. The team inserted a second set of on and off switches to target another vital gene, to mitigate the risk that changes in the live yeast might enable it to circumvent chemical control. The study, published in Proceedings of the National Academy of Sciences, was funded by the US Defense Advanced Research Projects Agency and the Biotechnology and Biological Sciences Research Council. Dr Yihzi Patrick Cai of the University of Edinburgh's School of Biological Sciences, who jointly led the research, said: "Synthetic biology is a fast-developing field with huge potential to benefit society, but we need to be mindful about its potential risks and take active steps to limit them in our biological designs. With these genetic safety switches, we can contain engineered organisms with a special combination of small molecules." Bioterrorism unlikely—time, resources, danger, dissemination techniques all check Ivanov 14 (Sandra, postgraduate education in Peace and Conflict Studies. She is currently an editor of the blog “Conflict and Security“, and primarily works in the non-government sector, “HOW TO MAKE THE ‘EBOLA BOMB': WHY YOU SHOULD STOP WORRYING ABOUT BIOTERRORISM” http://cimsec.org/make-ebola-bomb-stop-worrying-bioterrorism/13069 9/23/14 JM) Many studies from a health, as well as a humanities perspective, assume that terrorists could successfully generate biological or chemical agents and weaponise them. Taking this initial premise, a lot of literature has been based around this looming threat, subsequently offering policy advice, public health recommendations, and technological investment to avoid such catastrophes. However it would be useful to deconstruct this claim entirely. So I’ll begin by offering a baking recipe, to explore at the very core, what a group would need to do to successfully create a biological weapon, in this case, utilising the Ebola virus. Ingredients Firstly, any terrorist group wanting to create and weaponise a biological or chemical agent will need to have an appropriate kitchen. In the case of the Ebola virus, a standard biosafety level 4 (BSL-4) scene will be required (Adeline M. Nyamathi et al., “Ebola Virus: Immune Mechanisms of Protection and Vaccine Development“, Biological Research For Nursing 4, No. 4, April 2003: 276-281). Some features of these laboratories include decontamination mechanisms, pest management systems, air filters, and special suits. Sometimes the kitchen will have to be in a separate building, or in an isolated area within a building to meet the safety requirements. Not only will the kitchen be under strict conditions, the baking process will need to be kept in total secrecy. The constant threat of law enforcements raiding facilities, and intelligence and secret services detecting activities will have to be avoided. Also, there are only some fifty of these laboratories successfully maintained worldwide. Before starting, make sure there is a baking dish of ‘uncertainty’ readily available to just throw all of the following ingredients into: 1 Tablespoon of Proper Agent Initially, a terrorist group must decide what kind of agent they would like to use in a bioterror attack. This is one part of the recipe which can be modified, but the other ingredients will be standard for all types of attacks. The recent spread of the deadly Ebola virus will be the agent of choice for this bomb. Ebola is a virus which is passed to humans through contact with infected animals. The spread of the virus from person-to-person is brought about through blood and bodily fluids, as well as exposure to a contaminated environment. An infected live host with Ebola would need to be maintained in a human or animal – only a few animals are able to be used as hosts, such as primates, bats, and forest antelope. Although Ebola infection of animals through aerosol particles can be effective, it has not successfully been transferred with this method to humans (Manoj Karwa, Brian Currie and Vladimir Kvetan, “Bioterrorism: Preparing for the impossible or the improbable“, Critical Care Medicine 33, No. 1, January 2005: 75-95). 1 Bucket of Resources and Money In order to develop a biological weapon, a substantial amount of material and money is required. Investment is needed from the very outset – taking into account membership size and capabilities of a terrorist group, financial assets of a group, and making sure territory and proper infrastructure is available for the biological agent. For a successful bomb to be created, a group must think about the resources they will need for each stage of the baking process, such as weapons production, potential testing phases, and logistics, such as transportation and communications technologies (Victor H. Asal, Gary A. Ackerman and R. Karl Rethemeyer, “Connections Can Be Toxic: Terrorist Organizational Factors and the Pursuit of CBRN Terrorism“, National Consortium for the Study of Terrorism and Responses to Terrorism, 2006). Resources needed for an “Ebola Bomb” will most likely need to be imported from the outside, and a group must determine the feasibility of acquiring the materials and technologies needed for the bomb (Jean Pascal Zanders, “Assessing the risk of chemical and biological weapons proliferation to terrorists“, The Nonproliferation Review, Fall 1999: 17-34). A surplus of money would also be a smart idea in case technical difficulties arise. 5 Cups of Expertise With all the correct resources and necessary amount of monetary support, the recipe will require the right kind of know-how. For an operation like this, a terrorist group should have members with high levels of education and training in science, engineering, and technological development, to deal with highly virulent agents, and for successful weaponisation (Zanders). A group may need to be integrated into knowledge flows and institutions, or be able to recruit members to their cause with this specific expertise (Asal, Ackerman and Rethemeyer). Knowledge and expertise is required to create the correct strain, handling the agent, growing the agent with the desired characteristics, and maintaining the agent. Taking Ebola specifically requires synthesising proteins which make it infectious, and becomes a task that is difficult and unlikely to succeed (Amanda M. Teckma, “The Bioterrorist Threat of Ebola in East Africa and Implications for Global Health and Security“, Global Policy Essay, May 2013). If Ebola is successfully created in the kitchen, it is not itself a biological weapon – an expert will be required to transform the virus into a workable mechanism for dissemination. A Teaspoon of Risk The decision to use biological weapons for an attack is in itself extremely risky. There is a risk that bioterrorism could cause dissenting views among followers, and that public approval and opinion may channel the way a group operates. After all, terrorists are political communicators, wanting to bring attention to their grievances. If a group becomes polarised or resented by their actions, they will not see the benefits of pursuing certain methods. Terrorists want to send powerful messages, gain more members, in which these members assist to bring about certain plans and demands. Therefore, public opinion and political opportunism will be risked in a quest to create a bioweapon such as an “Ebola Bomb” (Zanders). Secondly, a terrorist group may be subject to more scrutiny or attention. This is why keeping activities covert will be a key to success. States will be more vigilant towards groups that are known to be seeking and acquiring biological and chemical capabilities (Asal, Ackerman and Rethemeyer). And finally, risk will always cling on to funding requirements, and potential technical difficulties in all stages of the bioweapon making process. A Fist of Time Now this recipe is going to take a while to prepare and bake in the oven, and there is no particular moment to determine when it should be removed from the baking dish. So, whatever group wants to make this bomb, will need to realise this is a long-term and complex effort. It will not work like most conventional weapons, which produce a high number of casualties with a single explosion, and that could be a reason why bioterrorism is not the most popular means for a violent attack – demanding time, effort, and resources without guarantees of a concrete result. A fist full of time may be needed so that knowledge, both tacit and explicit, can be acquired, as well as accounting for the various mistakes and learning curves to overcome (Asal, Ackerman and Rethemeyer). It can also refer to how long it will take to cook up, maintain and prepare a virus for an attack. It will take time to create a successful weapon with prior testing, and wait for the correct environmental conditions when it comes to dissemination. Time will have to be a group investment – it is not the kind of bomb that will detonate immediately. A Pinch of Curiosity of the Unknown The teaspoon of risk coincides with uncertainty, and there will need to be a commitment to potential unknown factors. It is unknown what will happen once a virus is disseminated. Will the weapon even work in the first place? Weather conditions are unpredictable and Ebola will not have a prominent effect in certain environments. What happens to the terrorist group if the attack fails? What happens to the reputation of the group and its membership, or will the group cease to exist? If the recipe is a success, it is impossible to control the biological agent which is released – not only can it affect the targeted population, but it may annihilate the terrorist group itself. There will be an unknown into potentially losing local and international support, and donors if this causes widespread catastrophe. Method: Weaponisation and Dissemination Mix that up good in your baking dish of what is now “deep uncertainty” and pop it in the oven to bake. But as time passes, it seems as though the ingredients are not rising. The process of turning a biological agent into a weapon for attack is the phase with the most hurdles for terrorist groups. In order for a virus to inflict a lot of harm, it has to be disseminated through an effective delivery mechanism. As mentioned previously, the Ebola virus needs a live host. Weaponising a live host is more difficult than other agents which can be cultured on dishes of nutrients. The process has many stages which involve testing, refining, upgrading, and toughening. The methods to disseminate an agent are only known to few people, and rarely published – it is not a basement project (Teckman). Let’s take Aum Shinrikyo as an example of conducting a bioterrorist attack (even it was “only” a chemical attack). This apocalyptic religious organisation in Japan managed to release sarin gas inside a Tokyo subway, killing a dozen people, and injuring 50. However, even with money and resources, they failed to effectively weaponise the chemical. Factors which led to their failure included internal secrecy and breakdown in communication; selecting members only solely dedicated to their cause to work on the weapons, ultimately employing unskilled people to operate and maintain the project, causing accidents and leaks (Zanders). Aum Shinrikyo’s attempt to disseminate botulinum toxin into Tokyo using a truck with a compressor and vents, did not work because they had not acquired an infectious strain (Sharon Begley, “Unmasking Bioterror“, Newsweek, 13.03.2010; “Chronology of Aum Shinrikyo’s CBW Activities“, Monterey Institute of International Studies, 2001). Finally, a major obstacle to successfully disseminating Ebola, is because this virus requires a specific environment in order to thrive. Weather conditions can be unpredictable, and Ebola particularly needs high temperatures and humidity to remain effective. Obviously, this “Ebola Bomb” has not come close to containing the right requirements needed to explode. Looking back historically, pathogens, and all kinds of toxins have been used as tools in sabotage and assassinations since the beginning of time. Now, it would be silly to say this recipe will never work – there will always be a possibility that Ebola or other viruses may be used as biological weapons in the future. However, the likelihood of its development and use by a terrorist group is quite improbable. Mentioning Aum Shinrikyo again, they are an organisation which at the time, had a war chest of more than $300 million, with six laboratories and a handful of biologists, in the end having insurmountable difficulties with the weaponisation and dissemination processes, and killing a dozen people (Begley). There is a greater amount of knowledge and technology available in our day and age than in 1995 with the Aum Shinrikyo attacks, but it is still unlikely that this will be the weapon of choice. Examining state biological weapons programmes, Soviet Russia had almost 60,000 personnel employed in their weapons development, with only about 100 people that actually knew how to take an agent through the full production process. In the United States, at Fort Detrick, there were 250 buildings with 3,000 personnel, and it took them a while to weaponise a single agent, such as botulinum (Manoj Karwa, Brian Currie and Vladimir Kvetan). Nowadays, the narrative has assumed a worst case scenario analysis, and subsequently narrowed down bioterrorism to a single threat prognosis. There is little distinction made between what is conceivable and possible, and what is likely in terms of bioterrorism. Anything can be conceived as a terrorist threat, but what is the reality? The “Ebola Bomb” is not a danger. The likelihood of a bioterrorist attack remains highly unlikely (Teckman). The focus should be on preventing natural pandemics of human disease, such as tuberculosis, SARS, AIDS and influenza – emphasis placed on how we can cure diseases, and how medical training could be improved to contain, and avoid viruses such as Ebola altogether. Resources are being pumped into biodefence in the security as well as the medical sector, but preparedness and investment in bioterrorism needs to be in proportion to actual threats, otherwise, funds are diverted away from much needed public health programmes: Diversion of resources from public health in the United States include diversion of funds needed for protection against other chemical risks – spills, leaks and explosives – and infectious diseases. Each year in the United States there are 60,000 chemical spills, leaks and explosions, of which 8,000 are classified as ‘serious’, with over 300 deaths. There are 76 million episodes of food-borne illness, leading to 325,000 hospitalisations and 5,000 deaths, most of which could be prevented. There are 110,000 hospitalisations and 20,000 deaths from influenza, a largely preventable illness, and there are 40,000 new cases and 10,000 deaths from HIV/AIDS. Diversion of resources for public health outside the US reduce the resources that can help provide protection against diseases rooted in poverty, ignorance and absence of services. — Victor W Sidel, “Bioterrorism in the United States: A balanced assessment of risk and response“, Medicine, Conflict and Survival 19, No. 4, 2003: 318-325. The effectiveness of biological weapons has never been clearly shown, the numbers of casualties have been small and it is likely that hoaxes and false alarms in the future will continue to outnumber real events and create disruptive hysteria (Manoj Karwa, Brian Currie and Vladimir Kvetan). Emphasis needs to be back on medical research, as well as social science investigations into the roots of why terrorist groups would even want to pursue biological weapons, and the lengths they would go to use them. Let this be an avenue for further pondering and exploring, the realities of bioterrorism. Bioterrorism won’t happen—too many resources are put into defense Goonzer 12 (Merrill, reporter for The Fiscal Times, “Billions to Stem an Unlikely Bioterror Attack” http://www.thefiscaltimes.com/Articles/2012/03/30/Billions-to-Stem-an-Unlikely-Bioterror-Attack 3/30/12 JM) Republicans and Democrats agreeing on industrial policy to save the auto industry? Unthinkable. Republicans and Democrats agreeing on industrial policy to promote clean energy companies? Absurd. But Republicans and Democrats agreeing on industrial policy for the pharmaceutical industry to develop drugs and vaccines to combat bioterror agents? It not only passed by unanimous consent in the Senate earlier this month, it will likely be approved by the conference committee that will soon consider the $4.5 billion Pandemic and All-Hazards Preparedness Act (PAHPA), the reauthorization of the 2006 law coordinating the nation’s decade-long effort to prepare for a terrorist biological warfare attack. Despite the reality that the only bioterrorist attack that has ever taken place on U.S. soil (one week after 9/11) was launched by a rogue U.S. scientist who had worked in the Cold War biological weapons program and was one of the world’s few experts in weaponizing anthrax, the nation has spent an estimated $66 billion in the past decade preparing for the next assault. Tens of billions of dollars have been poured into basic science and applied research to develop vaccines and drugs to combat diseases like anthrax, smallpox (a disease that no longer occurs naturally on earth), botulism and plague. Billions more has gone into beefing up the public health system’s ability to respond to emergency health crises. Hospitals have been paid to expand their capacity to respond to surges of patients stricken by a pandemic or a terrorist attack. These nationwide grant programs have helped build a broad base of political support for the programs. And now, in the reauthorization bill sponsored by Sen. Richard Burr, R-N.C., Congress has earmarked $50 million for a “strategic investor” venture capital fund to invest in start-up biotechnology companies that are developing drugs and vaccines that combat bioterror pathogens. Structured as a public-private partnership outside the government, the goal is to bring more private funding into the hunt for new “countermeasure” products. It will be added to the $450 million a year the government already doles out in grants to companies through the Biomedical Advanced Research and Development Authority (BARDA) and the $2.9 billion earmarked over the next five years for procurement of new drugs and vaccines for government stockpiles. As the votes in Congress attest (the House version of the bill also passed on a voice vote), the massive commitment to biodefense spending in the 2000s has won broad support from the nation’s research and scientific establishment. The National Institute for Allergies and Infectious Diseases (NIAID), headed since the 1980s by Anthony Fauci, receives over $1 billion a year for bioterror-oriented scientific research. The National Cancer Institute, by comparison, receives about $5 billion to look for cures for the tumors that kill over a half million Americans annually. Officials at NIAID and legislators on Capitol Hill say the massive investment in preventing and curing diseases that rarely if ever occur naturally is providing a huge boost to the moribund U.S. effort to develop new antibiotics to fight the drug resistant bacterial strains that are causing tens of thousands of deaths annually in U.S. hospitals. “The goal of this basic research is to lay the groundwork for developing broad-spectrum antibiotics and antivirals—drugs that can prevent or treat diseases caused by multiple types of bacteria or viruses—and multi-platform technologies that potentially could be used to more efficiently develop vaccines against a variety of infectious agents,” the agency says on its website. But some scientists complain that the anti-bioterror research agenda has detracted from research that specifically targets infectious diseases that are already killing people, both in the U.S. and in the developing world. “I’m sure other programs are reduced because of the money we’ve put into this,” said Peter Agre, director of the Johns Hopkins Malaria Research Institute and winner of the 2003 Nobel Prize in chemistry for his work on cell membrane channels. “We’re seeing scientists who have to prematurely end their careers because they can’t get grants. Is this bioterror the most important and cost-effective research being done on infectious diseases? I don’t think it is.” However, the leaders of the Infectious Diseases Society of America, which represents the medical specialists and researchers in the field, back the program because it creates a stream of funding that otherwise wouldn’t exist. “While we understand the nation’s current fiscal pressures, we believe that greater investment in key areas is crucial to protect the American people and others from biothreats, pandemics and emerging infections,” Thomas Slama, the group’s president, wrote in a letter to House and Senate leaders last month. Beefed up biodefense spending also gets championed by the movement to broaden the pipeline of new antibiotics being developed by the pharmaceutical industry. Their argument is the same as NIAID’s: a new drug that fights an anthrax infection could also be used to treat the drug-resistant hospital-acquired infections that kill tens of thousands of Americans a year. “BARDA has pumped $200 million into critical developmental molecules that would either be dead or much less further along if BARDA wasn’t around,” said Brad Spellberg, a professor of medicine at the Los Angeles Biomedical Research Institute. He also consults for numerous drug companies working on new antibiotics. “The government has become a resource for companies that are not well capitalized.” Topicality A2 Surveillance We meet- health surveillance has intent and uses technology Rubel 12 (Alan Rubel. Ph.D., Department of Philosophy, University of Wisconsin-Madison; J.D., magna cum laude, University of Wisconsin Law School Assistant Professor. “Justifying Public Health Surveillance: Basic Interests, Unreasonable Exercise, and Privacy.” 2012. P. 2-3. https://kiej.georgetown.edu/home_files/22.1.rubel.pdf)//EMerz Public health surveillance is “the ongoing systematic collection, analysis, and dissemination of health data to those who need to know” (Thacker, Stroup, and Dicker 2003, p. 224). Its scope is wide, both in its purposes and its methods. Information gathered in public health surveillance is used “to assess public health status, to define public health priorities, to evaluate programs, and to conduct research” (Thacker 1994, p. 8). Surveillance is used in detecting epidemics, understanding the natural history of diseases, determining the magnitude and geographic distribution of problems, evaluating control and prevention efforts, planning and priority setting, detecting changes to health practices, and stimulating research (Thacker, Stroup, and Dicker 2003, pp. 8–14; Thacker 1994, pp. 8–24; CDC 2011a). Surveillance systems collect information in numerous ways. They may use mundane sources such as vital statistics (e.g., birth and death records), surveys, and environmental data regarding risk factors (e.g., air-monitoring data gathered under the Clean Air Act and hazardous materials spills reported to the federal Department of Transportation) (Thacker, Stroup, and Dicker 2003, p. 231). There are also sentinel surveillance programs, which monitor key health events. For example, occupational health conditions are monitored in the United States by key health care providers participating in the Sentinel Event Notification System for Occupational Risks (SENSOR) (Stroup, Zack, and Wharton 1994, pp. 45–46). The recognition that behavior is a crucial aspect of health has led public health agencies to gather information regarding the use of alcohol, cigarettes, and drugs, the use of safety devices such as seatbelts and bicycle helmets, and persons’ eating, exercise, and sexual habits (Gostin 2008, p. 292). A relatively novel approach, which may prove useful for early detection of outbreaks or bioterrorism, is syndromic surveillance. This involves “collecting and analyzing statistical data on health trends—such as symptoms reported by people seeking care in emergency rooms or other health care settings—or even sales of flu medicines” (Stoto, Schonlau, and Mariano 2004). Medical privacy is at the heart of the topic of surveillance and privacy – expert consensus is unanimous Goldman, from the College of Physicians and Surgeons, Columbia University, November 1998 – (Janlori, “Protecting Privacy To Improve Health Care”, published in HealthAffairs volume 17 number 6)//roetlin a comprehensive national health privacy law is critical to ensuring both the integrity of the doctor / patient relationship and the continued development of this nation’s health care system. 17 As an editorial in the Washington Post concluded: “Of all the threats posed to personal privacy by new information technologies, the threat to the privacy of medical records is by far the most urgent.” 18 In the past few years nearly every witness who has testified before Congress on this issue has stated that a comprehensive federal privacy law is critical to preserving people’s trust in their doctors and in the health care system. Every report on health privacy issued recently concludes that a federal Reports over the past twenty years unanimously conclude that health privacy law is necessary to plug existing gaps in law, policy, and practice. There also is strong public support for a comprehensive federal health privacy law. The aff deals with public health surveillance Lee et al, American Journal of Public Health, 12 (Lisa M. Lee, PhD, MS, Charles M. Heilig, PhD, and Angela White, MA, Lisa M. Lee is with the Office of Surveillance, Epidemiology, and Laboratory Services at the Centers for Disease Control and Prevention (CDC), Atlanta, GA. Charles M. Heilig is with the Tuberculosis Trials Consortium, Division of Tuberculosis Elimination, CDC. Angela White is with the J. L. Rotman Institute of Philosophy, University of Western Ontario, London, ON, Canada.) Health Policy and Ethics | Peer Reviewed | AMERICAN JOURNAL OF PUBLIC HEALTH, January 2012, Vol 102, No. 1)//ASMITH PUBLIC HEALTH Surveillance is defined as the ongoing, systematic collection, analysis, and interpretation of health-related data with the a priori purpose of preventing or controlling disease or injury, or of identifying unusual events of public health importance, followed by the dissemination and use of information for public health action.1 It is distinct from other types of surveillance (e.g., security or intelligence) in that the purpose of public health surveillance is to prevent or control disease or injury and to improve the public’s health.2 Surveillance is a foundational tool of public health, serving as the finger on the pulse of the health of a community. Public health surveillance is used, in some cases uniquely, to quantify the magnitude of health problems, describe the natural history of disease, detect outbreaks and epidemics of known or new pathogens, document the distribution and spread of health events, facilitate epidemiological and laboratory research, generate and test hypotheses, evaluate control and prevention measures, monitor isolation activities and changes in infectious agents, detect changes in health practices, plan public health actions and use of resources, and appropriate and allocate prevention and care funds.3 Public health surveillance consists of 7 ongoing, systematic activities in 3 basic steps––system development, data collection and analysis, and data use––that provide continuous feedback for system improvement. The first step, system development, involves (1) planning and design. The second step, data collection and analysis, involves (2) data collection, (3) collation, (4) analysis, and (5) interpretation. The third step, data use, involves (6) dissemination and (7) application to public health program. These 7 activities create the infrastructure of a coherent and stateof-the-art system.4 Findings from such systems are fed directly to public health programs that benefit the populations and communities from which the data are collected2; this feedback into programmatic action distinguishes public health surveillance from other ways of knowing about health.5 Public health surveillance systems vary according to their purpose, the condition monitored, and the planned uses of the data. Some systems use non---name-based reporting mechanisms; others require names and other personal identifiers for case reporting. We examine the conditions under which it is ethically justifiable to create and maintain a public health surveillance system that, in addition to the disease or health outcome, risk factors, and demographic characteristics, requires that a name or other identifying information be reported to the local or state health official for storage and future use. A2 Its Multi-jurisdictional law enforcement task forces transfer jurisdictional power to state authorities Brenda Grantland (private attorney in Mill Valley California, with 30 years' experience primarily in asset forfeiture defense, as well as federal criminal appeals and victims rights and restitution. Brenda handles federal cases throughout the country, and frequently works with other attorneys or legal teams as a consultant or co-counsel) February 2015 “The truth about federal multi-jurisdictional task forces: resources for reporters writing about Holder’s policy change” http://brendagrantland.com/truthjustice/the-truth-about-federal-multi-jurisdictional-task-forces/ My final rant (for tonight) about multi-jurisdictional drug task forces: The Holder policy order is partially a clever ploy to appease those clamoring for forfeiture reform – but also a Trojan horse. It is a Trojan horse because it will force state and local police agencies to form multi-jurisdictional task forces with the federal government if they want to preserve their previously abundant Equitable Sharing revenue streams. Task forces are governed by contract between participating police agencies. State and local police agencies are created and regulated by statutes and/or ordinances, and answer directly to the local or state government which created them, and the agency’s chain of command answers to the top official of the agency, with internal checks and balances to ensure that they enforce the law they were hired to enforce. The state or local legislature controls their purse strings and that is a big motivator to get them to obey the applicable state or local law. The fact that the federal government could override that statutorily established chain of command, substituting federal law for the law of the state, county or city that hired them is questionable in itself. That state and local officers’ chain of command could be supplanted by a board of directors created by private contract between law enforcement agencies is a topic of grave concern that warrants discussion. Once agents are detailed to task forces, the chain of command is no longer the usual government hierarchy of the county sheriff’s department, city police, or state police – even though those local agencies continue to pay their salaries. Who do the task force agents ultimately answer to? They owe their allegiance not to the chain of command of the agencies that pay their salaries, but to a board of directors chosen by their individual participating government agencies, governed by the task force coordination agreement. The Holder policy change will only cut off Equitable Sharing revenue to state and local police agencies that remain under the chain of command of their local agencies. This policy change will force the local agencies to form federal task forces to preserve their revenue streams. From what I conclude from reading the DEA’s website, forming a federal task force is an easy thing to do. They just negotiate a contract with surrounding local law enforcement agencies to create a multi-juridictional task force and apply to have the DEA sponsor it. The local agents get cross-deputized as federal agents (probably a brief ceremony with no entrance test or prerequisites except maybe a criminal background check). This empowers all of them to enforce federal law while they are on the payroll of state and local law enforcement agencies. The state and local agencies are rewarded by a kickback from the Equitable Sharing program of a percentage of the forfeiture revenue generated each time their agents on the task force help generate federal forfeiture revenue. The Equitable Sharing program promises law enforcement agencies up to 80% of the proceeds of the forfeiture case they work on, with the profits being split up according to how much each agency contributed, with the U.S. Department of Justice being the sole arbiter on who gets what percentage of the loot, with unreviewable discretion to decide as it pleases. Nation wide, police agencies are showing serious lacks of control already – violations of civil rights, use of excessive force, falsification of evidence and other misconduct. Stricter oversight is needed to regain control over the forces that are supposed to be maintaining law and order. They don’t need more autonomy. ***NEG*** ***Doctor-Patient Trust CP*** 1NC Text: The United States Federal Government should track healthcare companies’ quality of care by mandating that Department of Health and Human Services evaluate health care companies for privacy protections. The United States Federal Government should mandate that health institutions use high security cloud computing to store sensitive data about patients by enforcing encryption and redaction measures. Cloud computing has potential to secure patient data if health care providers implement encryption and redaction measures Filkins 14 (Barbara Filkins. Senior SANS Analyst and Healthcare Specialist. “New Threats Drive Improved Practices: State of Cybersecurity in Health Care Organizations.” December 2014. P. 19. https://www.sans.org/reading-room/whitepapers/analyst/threats-drive-improved-practices-statecybersecurity-health-care-organizations-35652)//EMerz This emphasis indicates that the cloud-computing industry has matured. Respondents are now looking toward secure access and data-centric controls and are less concerned with operational considerations such as monitoring of cloud applications for vulnerabilities and threats. Cloud computing may be an area where secure, multifactor authentication, which combines two or more independent credentials—such as what the user knows (password), what the user has (security token) and what the user is (biometric verification)—also takes off. This year, 60% of respondents said they are using multifactor authentication as their top control to address the risk to data and applications in the cloud. This represents a shift from 2013, where APIs for data reporting, auditing and providing alerts were cited by respondents as the top security control for addressing cloud security concerns. Cloud computing is also driving a more data-centric method of security, which focuses on protecting data rather than just protecting the network or application in which the data lives. Starting a data-centric security plan involves learning and understanding where sensitive data resides, as well as how that information will be used, accessed, managed, retained or retired across its life cycle. The next step is to assess the risks and determine the policies and resources needed and available to monitor and control risk in cloudbased computing models. For example, storing data in the cloud demands encryption for the data at rest. Is that provided through the internal application or the cloud services provider? Sharing that same data among individuals with different roles and levels of access might demand further modification of data to protect it, such as redaction, masking or a combination of both. Data breaches are likely with current cloud computing technology—new security measures and technology can prevent them Filkins 14 (Barbara Filkins. Senior SANS Analyst and Healthcare Specialist. “New Threats Drive Improved Practices: State of Cybersecurity in Health Care Organizations.” December 2014. P. 19. https://www.sans.org/reading-room/whitepapers/analyst/threats-drive-improved-practices-statecybersecurity-health-care-organizations-35652)//EMerz Trends such as mobile and cloud computing are game changers for the way individuals and organizations must approach the security of their systems, the privacy of protected sensitive data, and compliance. Health care organizations must complement traditional, infrastructure-driven controls such as network perimeter security with protections for the newer and evolving threat vectors where their data and applications are outside of the protected network. Providers, payment plans, insurers and other related industries now allow patients unprecedented access to helpful, sophisticated health information and digital tools. Patients have online access to their doctors, and immense social support is also provided online. The fact is that the attack surfaces are many, and the movement to detect, protect and defend in the health care industry, as shown by the small improvements in this survey, is still not enough to keep up the pace. Investment in understanding the new threat landscape and designing solutions to protect against these attacks, including leveraging newer tools for protecting data and responding to new forms of attacks, become critical to staying ahead of attackers. This institutional trust is key to solve Rowe and Calnan 6 (Rosemary Rowe and Michael Calnan. Professor of Medical Sociology, School of Social Policy, Sociology and Social Research at the University of Kent. “Trust Relations in Health Care- the New Agenda.” 2006. http://eurpub.oxfordjournals.org/content/eurpub/16/1/4.full.pdf)//EMerz Given that trust remains important, how can new forms of trust relations be developed and sustained? There is considerable evidence as to what factors encourage patient trust in clinicians: the clinician’s technical competence, respect for patient views, information sharing, and their confidence in patient’s ability to manage their illness.8 Patient participation per se does not necessarily result in higher trust, rather it is associated with value congruence regarding participation, patient involvement produced higher trust where patients wanted to participate.9 In contrast, evidence as to what builds institutional trust is sparse, with trust relations between providers and between providers and managers a particularly neglected area. Hall et al US survey of HMO members found that system trust could help the development of interpersonal trust, where there was no prior knowledge of the clinician, but it is not known how interpersonal trust affects institutional trust. Medical errors and cost containment are associated with distrust of health care systems, whereas relationship building with the local community is regarded as an important trust building mechanism. However, little research has been conducted to identify how different modes of governance affect institutional trust. The focus of trust relationships may of course differ according to the model of health care delivery; in market based systems such as the US patient trust may be more important to secure loyalty to particular providers whereas in tax-financed systems which are organized by national or regional agencies public trust may be more necessary. However, as health systems converge and increasingly share common challenges including: providing adequate patient choice; managing a mixed economy of provision; and more explicit rationing, then both interpersonal and institutional trust will continue to be important for all health systems. In conclusion, we would argue that clinicians and managers need to address and respond to the changing nature of trust relations in health care. The benefits of trust demonstrate the value to be Trust and the sociology of the professions 5 gained from ensuring that both interpersonal and institutional trust are developed, sustained, and where necessary rebuilt. Trust is still fundamental to the clinician–patient relationship but as that relationship has changed so has the nature of trust. Trust is now conditional and has to be negotiated but, whilst clinicians may have to earn patients’ trust, there is good evidence as to what is required to build and sustain such interpersonal trust. The lack of knowledge about how institutional trust can be developed indicates the need for research, ideally through inter-country comparisons to identify whether such trust varies by health system and how it can be generated. The cost of failing to recognize the importance of trust and to address the changing nature of trust relations could be substantial: economically, politically, and most important of all, in terms of health outcomes. 2NC Extensions Government monitoring of healthcare quality ensures trust in patients CQHCA ‘1 (Committee on the Quality of Health Care in America. “Crossing the Quality Chasm: A New Health System for the 21st Century.” March 1, 2001. http://www.ncbi.nlm.nih.gov/books/NBK222265/)//EMerz Recommendation 2: All health care organizations, professional groups, and private and public purchasers should pursue six major aims; specifically, health care should be safe, effective, patient-centered, timely, efficient, and equitable. The committee believes substantial improvements in safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity are achievable throughout the health care sector. This opportunity for improvement is not confined to any sector, form of payment, type of organization, or clinical discipline. Problems in health care quality affect all Americans today, and all can benefit from a rededication to improving quality, regardless of where they receive their care. The committee applauds the Administration and Congress for their current efforts to establish a mechanism for tracking the quality of care. Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.; Agency for Healthcare Research and Quality Part A) provides support for the development of a National Quality Report, which is currently ongoing. Section 913(a)(2) of the act states: “Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people.” Recommendation 3: Congress should continue to authorize and appropriate funds for, and the Department of Health and Human Services should move forward expeditiously with the establishment of, monitoring and tracking processes for use in evaluating the progress of the health system in pursuit of the above-cited aims of safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The Secretary of the Department of Health and Human Services should report annually to Congress and the President on the quality of care provided to the American people. Without ongoing tracking of quality to assess the country's progress in meeting the aims set forth in this chapter, interested parties—including patients, health care practitioners, policy makers, educators, and purchasers—cannot identify progress or understand where improvement efforts are most needed. Continued funding for this activity should be ensured. Health institutions use weak cloud services to transmit sensitive patient data Filkins 14 (Barbara Filkins. Senior SANS Analyst and Healthcare Specialist. “New Threats Drive Improved Practices: State of Cybersecurity in Health Care Organizations.” December 2014. P. 1011. https://www.sans.org/reading-room/whitepapers/analyst/threats-drive-improved-practices-statecybersecurity-health-care-organizations-35652)//EMerz Health care organizations rely on cloud services for applications processing sensitive information, including protected health care patient records as well as PCI-protected financial information. Respondents plan to expand these services in the next 12 months. Open-ended responses by several respondents reflect the bias against cloud services, most often prompted by concerns over loss of control or oversight over sensitive data, but more than 60% are either using or planning to use the cloud for multiple applications containing sensitive data, as shown in Figure 4. Mobile devices are also a source of additional risk, according to respondents. Not surprisingly, 92% of respondent organizations allow access to calendar and email via mobile devices. However, 52% also allow respondents to access health record information from their mobile devices, and nearly as many access data from cloud-based applications, through which they may be processing highly sensitive data, as discussed previously (see Figure 5). Secure cloud computing increases patient trust in health care institutions CSCC 12 (Cloud Standards Customer Council. Advocacy group dedicated surrounding the transition to the cloud. “Impact of Cloud Computing on Healthcare.” November 2012. P. 12. http://www.cloudcouncil.org/cscchealthcare110512.pdf)//EMerz “Patient centricity” has become the key trend in healthcare provisioning and is leading to the steady growth in adoption of electronic medical records (EMR), electronic health records (EHR), personal health records (PHR), and technologies related to integrated care, patient safety, pointof-care access to demographic and clinical information, and clinical decision support. Availability of data, irrespective of the location of the patient and the clinician, has become the key to both patient satisfaction and improved clinical outcomes. Cloud technologies can significantly facilitate this trend. Cloud computing offers significant benefits to the healthcare sector: doctor’s clinics, hospitals, and health clinics require quick access to computing and large storage facilities which are not provided in the traditional settings. Moreover, healthcare data needs to be shared across various settings and geographies which further burden the healthcare provider and the patient causing significant delay in treatment and loss of time. Cloud caters to all these requirements thus providing the healthcare organizations an incredible opportunity to improve services to their customers, the patients, to share information more easily than ever before, and improve operational efficiency at the same time. Doesn’t link to the net benefit- health businesses that use cloud computing still adhere to status quo HIPAA procedures CSCC 12 (Cloud Standards Customer Council. Advocacy group dedicated surrounding the transition to the cloud. “Impact of Cloud Computing on Healthcare.” November 2012. P.7. http://www.cloudcouncil.org/cscchealthcare110512.pdf)//EMerz In the United States, every healthcare entity (e.g., hospital, university research facility, physician’s office) that deals with Protected Health Information (PHI) must adhere to the guidelines stipulated under the Health Information Portability and Accountability Act (HIPAA). HIPAA is a U.S. Federal law that was designed to protect patient privacy, and does so by mandating and enforcing strict privacy and security rules over how medical information is collected, handled, used, disclosed and protected. While the HIPAA Privacy rule pertains to patients’ privacy and rights for their personal health information, the HIPAA Security rule, focuses on assuring the availability, confidentiality, and integrity, of electronic protected health information through a series of administrative, physical and technical safeguards. Under Title II of HIPAA, most of a patient’s medical record and payment history are considered PHI, and is protected under the law. PHI may only be disclosed to other medical entities on a “need to know” basis, only upon the permission of the individual patient and only the “minimum data fields required for the purpose involved”. As a result, one of the challenges is “Patient Consent Management” and managing PHI in a way that is sufficiently simple to enable use by the general public. The owner of the data must require the cloud service provider (aka the “business associate”) to contractually agree to maintain all PHI in adherence with HIPAA standards. The HIPAA Privacy rule defines a business associate as “a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity”. Covered entities are institutions, organizations or persons who electronically transmit any health information in connection with transactions for the United States Health and Human Services (HHS) adopted standards. While ultimate responsibility for compliance always resides at the covered entity, the actual implementation of certain operational and control aspects of securing the data occurs at the business associate cloud provider. ***States CP*** 1NC Text: The 50 states and relevant US territories should apply strict scrutiny to public health surveillance programs. State privacy protections are extremely effective Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 19-21 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz Health privacy and HIPAA frequently are viewed as indistinguishable. However, health privacy exceptionalism is not restricted to federal law. In the decade and a half since the appearance of the HIPAA regulations and notwithstanding the Privacy Rule’s limitation on preemption, state law regarding health privacy appears to have receded into the background. The Bush Administration’s health information technology narrative included the characterization of divergent state laws as impeding EHR implementation. 144 Furthermore, in the intervening years several states have normalized their laws with HIPAA. There are explicit protections of privacy in a handful of State constitutions.146 And some state supreme courts have implied such a right147 that subsequently has been applied in cases involving medical information.148 Yet there is nothing that could be as described as exceptional. In contrast, many state legislatures embraced strong, exceptional health privacy models (particularly in the pre-HIPAA state privacy statutes continue to escape preemption due to HIPAA’s “more stringent” provision. Any generalized account fails to credit the resilience of health privacy exceptionalism in some states. Of course, there should be little surprise that California has built on its enviable consumer protective reputation with additional substantive and enforcement provisions. The state’s original Confidentiality of Medical Information Act dates from 1981. It is notable for possessing a broader reach than HIPAA, applying, for example, to health data custodians who are not health care providers.151 California passed one of the first health information breach notification laws.152 More recently the state established the Office of Health Information Integrity to “ensure the enforcement of state years). 149 Indeed many law mandating the confidentiality of medical information and to impose administrative fines for the unauthorized use of medical information”153 which requires: Every provider of health care shall establish and implement appropriate administrative, technical, and physical safeguards to protect the privacy of a patient's medical information. Every provider of health care shall reasonably safeguard confidential medical information from any unauthorized access or unlawful access, use, or disclosure. Perhaps more surprisingly Texas enacted similarly broad protection for health information. In sharp contrast to the narrow HIPAA conception of a “covered entity,” the Texas law applies to “any person who . . . engages . . . in the practice of assembling, collecting, analyzing, using, evaluating, storing, or transmitting protected health information.” 155 Texas also requires “clear and unambiguous permission” before using health information for marketing 156 and broadly prohibits the sale of an individual's protected health information.157 As discussed above, HITECH (together with a change in administration) provided the enforcement focus that HIPAA had lacked.158 However, the 2009 legislation did not alter the longstanding HIPAA position of not permitting private rights of action.159 Of course a small number of states permit such actions under their health privacy statutes.160 However, almost all jurisdictions allow some species of the breach of confidence action in such cases,161 and some even allow HIPAA in through the “back door” establishing a standard of care in negligence per se cases.162 For example, Resnick v. AvMed, Inc., concerned two unencrypted laptops that were stolen from the defendant managed care company. The compromised data concerned 1.2 million persons, some of whom subsequently became victims of identity theft. Dealing with Florida law allegations of breach of contract, breach of implied contract, breach of the implied covenant of good faith and fair dealing, and breach of fiduciary duty, the Eleventh Circuit addressed the question whether plaintiffs had alleged a sufficient nexus between the data theft and the identity theft. The court concluded that the plaintiffs had “pled a cognizable injury and . . . sufficient facts to allow for a plausible inference that AvMed’s failures in securing their data resulted in their identities being stolen. They have shown a sufficient nexus between the data breach and the identity theft beyond allegations of time and sequence.”164 Overall there seems to be a proliferation of data breach cases being filed in state courts. State privacy case law and legislation are continually evolving both in and out of the health care space. However, there is reason to believe that health privacy exceptionalism remains an accepted tenet among state courts and legislatures. The states are sufficient Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 While a federal law would be most effective, there are other options to achieve some of the benefits of the reforms outlined in Part III.C. For example, each state could be encouraged to adopt a model statute that includes these reforms. The prospect of quick action by each state seems considerably less likely to occur without the stick of being excluded from CODIS that could be a part of federal regulation. However, Alaska, Vermont, and Washington have demonstrated that some states are capable of regulating local databases. In addition, there are options aside from legislation. Existing regulatory bodies could promote these reforms as best practices for local DNA databases. For example, the recently created National Commission on Forensic Science (“NCFS”), a joint project of the Department of Justice and the National Institute of Standards and Technology (“NIST”), describes part of its mission as “reduc[ing] fragmentation and improve[ing] federal coordination of forensic science.”323 Similarly, NIST’s newly-formed Organization of Scientific Area Committees (“OSACs”) represents another potential source for external regulation.324 Whereas the NCSF will outline broad policies, the OSACs are designed to adopt specific “standards and guidelines” for each forensic discipline.325 These organizations, which include national leaders from law enforcement, practice, and academia, are limited to adopting nonbinding recommendations. However, even recommended procedures could be powerful forces to alter current practices. Finally, while this Article argues that external regulation is optimal and necessary,326 it is at least possible that the early adopters of local databases could organize a working group to develop uniform standards. Director Harran of Bensalem has considered holding a meeting with the agencies that use local databases to explore the adoption of standard procedures.327 A working group offers at least three potential incremental benefits. First, simply starting the dialogue would force some agencies to articulate their practices and procedures. Second, a discussion about what regulations are needed could encourage law enforcement to consider some of the external costs of local databases. Finally, even if the working group did not possess the power to adopt binding regulations, it is possible that some agencies—motivated by the self-interested desire to continue using their own local databases—could pressure others to act more cautiously so as not to generate interest from external regulators. CONCLUSION Given the pressure on police to solve crimes and reduce criminal activity, it is not surprising that law enforcement aggressively adapts surveillance technology to its benefit. Such actions are often commendable and encouraged. Indeed, the very manner in which law enforcement agencies measure their absolute and comparative success—through crime rates and clearance rates— incentivizes local agencies to push the boundaries of crimesolving tools. Early adopters of local databases are doing just that, trying to maximize the ability of forensic DNA analysis to fight and deter crime. Palm Bay, Bensalem, and others have shown that local databases offer great promise when measured on that scale. But a narrow focus on crime rates and clearance rates is not the only relevant metric when allocating policing resources in general, and public surveillance in particular. Rather, policing has the potential to generate positive and negative externalities unrelated to crime rates and clearance rates, and these externalities are often difficult to measure reliably. Furthermore, there is little incentive for law enforcement to identify or measure these externalities, particularly negative ones. This Article is the first attempt to identify the full implications of local databases. While it is beyond its scope to measure these externalities, identifying their existence and recognizing law enforcement’s failure to consider them calls for some level of external regulation of local databases. Because the empirical work needed to measure the external costs of local databases has not been developed, the reforms proposed in this Article are modest. It is possible, although, in the opinion of the author, unlikely that the external costs of local databases will outweigh their benefits. If that proves true, states should follow Vermont’s lead and ban local databases. More than likely, the result of a fullscale empirical study of local databases will call for something in the middle, rejecting the total prohibition in Vermont and rejecting the current landscape, where local agencies are free to develop and use local databases without external regulation. Solvency – Flexibility States solve better Duffy et al 11(Effective State-Based Surveillance for Multidrug-Resistant Organisms Related to Health Care-Associated Infections,Jonathan Duffy, MD, MPH,a,b Dawn Sievert, PhD, MS,a Catherine Rebmann, MPH,a Marion Kainer, MD, MPH,c,d Ruth Lynfield, MD,c,e Perry Smith, MD,c,f and Scott Fridkin, MDa Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA 2011 Mar-Apr; http://www-ncbi-nlm-nih-gov.proxy.lib.umich.edu/pmc/articles/PMC3056030/?tool=pmcentrez) A primary aim of public health surveillance is to direct prevention and control activities and monitor their effectiveness. Collection of surveillance data by itself does not control disease or constitute public health action. As public health agencies operate with finite resources, implementation of surveillance tools should occur in conjunction with a plan to interpret and act on the data collected. Resources should be devoted to MDRO surveillance activities only when resources are also available for specific MDRO infection- or transmission-prevention activities or to build capacity to respond with public health action to the MDRO surveillance data. Moreover, integrating input from local partners and key opinion leaders in infection control and prevention to ensure that any surveillance and response strategy is consistent with regional priorities or concerns is critical. A state is more likely to develop a surveillance system that meets its particular needs and functions well within the constraints of its available resources if the state health department takes an active role in deciding what MDRO surveillance activities are appropriate for its circumstances. Surveillance activities developed in response to mandates created without health department input could lack these characteristics. Solvency - Speed Stats solve – quicker public health responses Galva et al 5 (Jorge, JD MHA, Christopher Atchison, MPA, Samuel Levy, PhD SM, analysts for Public Health Reports, “Public Health Strategy and the Police Powers of the State” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2569983/ 2005 JM) The preparedness of the U.S. public health system to respond to acts of terrorism has received a great deal of attention since September 11, 2001, and especially subsequent to the anthrax attacks later that year. The use of biologic agents as a weapon has served as a catalyst to better aligning public safety and health strategies through public health law reforms. Associated with this work is the renewal of the debate over the most appropriate means to both protect the public and asssure the rights of individuals when implementing readiness strategies. A key element of the debate focuses on what is a reasonable application of state-based police powers to ensure community public health standards. The doctrine of state “police power” was adopted in early colonial America from firmly established English common law principles mandating the limitation of private rights when needed for the preservation of the common good. It was one of the powers reserved by the states with the adoption of the federal Constitution and was limited only by the Constitution's Supremacy Clause—which mandates preeminence of federal law in matters delegated to the federal government—and the individual rights protected in the subsequent Amendments.1,2 The application of police power has traditionally implied a capacity to (1) promote the public health, morals, or safety, and the general well-being of the community; (2) enact and enforce laws for the promotion of the general welfare; (3) regulate private rights in the public interest; and (4) extend measures to all great public needs.3 The application of “police powers” is not synonymous with criminal enforcement procedures; rather, this authority establishes the means by which communities may enforce civil self-protection rules. More specifically, public health police power allows the states to pass and enforce isolation and quarantine, health, and inspection laws to interrupt or prevent the spread of disease. Historically, the exercise of public health police power was enforced with strong support of the courts and restraint of police power occurred only when there was open disregard for individual rights. The abilities of states to exercise their police powers has been constrained since the 1960s by the legal and social reexamination of the balance of power between the individual, the states, and the federal government, which affects contemporary efforts to reform public health law in the face of terrorism. Given the development of the criminally based threats to health marked by bioterrorism, the relatively recent emphasis on the personal rights side of the equation should be reassessed.4 A reexamination of the legal, ideological, and social limits of police power is appropriate since increased state capacity can be crucial for first responses to terrorist threats or actions. Effective first responses may be hampered in the absence of pragmatically designed realignments of the state-individual relationship and the redesign of state public health infrastructures.5 This article begins with an historical overview of the doctrine of state police power, addresses recent limitations imposed on the implementation of public health police powers, then uses the example of the imposition of quarantine orders to illustrate the state's capability to impose such orders in exercise of its police power. Finally, it suggests changes in state public health agency governance, focus, and regulation to rebalance public and private interests. Solvency – General States solve best—have a balance of privacy and effectiveness Galva et al 5 (Jorge, JD MHA, Christopher Atchison, MPA, Samuel Levy, PhD SM, analysts for Public Health Reports, “Public Health Strategy and the Police Powers of the State” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2569983/ 2005 JM) Population-based measures in response to increased public health threats assume diverse forms. These are essentially clustered in two distinct groups: prevention (detection, data-basing, and tracking), and remediation (containment of actual damage). Preventive measures entail mechanisms to control and track the movement of persons and things. This type of activity may involve the enactment and enforcement of unsympathetic laws and regulations affecting real or perceived spheres of rights. Effective enforcement will depend on the public health authorities' ability to safely overcome resistance to these measures. The control of the flow of information may also result in restrictions to the access and publication of public health information. Remediation demands even greater degrees of control over persons and property. Remediation measures could include: (1) quarantine and involuntary holds when and where necessary for an indefinite period limited only by the cessation of the state of emergency; (2) suspension of habeas corpus in case of quarantine with very limited post-detention remedies for the individuals affected; and (3) property rights (establishment of “public interest easements” on private property in anticipation of an emergency and deputization/commandeering private-sector resources for public use during an emergency). Remediation measures must be rapidly implemented in the event of biological attack or new infectious disease.65 Significant normative measures in this respect have been proposed at both the federal and state levels.66 The Model State Emergency Health Powers Act (MSEHPA) illustrates this effort. The MSEHPA contains projected measures based on potential terrorist threats and proposed preventive and remedial measures as well as a detailed description of the protection of individual and business rights during an emergency.67 The State Emergency Powers Act's purpose is to create a unified response system whereby the states put into effect standardized measures.68 The driving principle behind this uniform legislation is twofold: on the one hand, standardization and modernization of obsolete or inapplicable state laws regulating public health responses, and on the other, creation of balance between states' ability to control individual activity and constitutional rights.4 The goals of the MSEHPA are, inarguably, meritorious.69 Nevertheless, there are valid concerns regarding the effects of the attempted balance of public and private interests on the states' ability to carry out an effective public health response. There is foundation for these concerns. The MSEHPA's balancing act may sidestep the needed mechanics of infectious disease control by unduly incorporating post-Warren Court legal restraints—pre-intervention notices, hearings, heightened burden of proof, and access to witnesses—into the law.70 The MSEHPA fails to restore the historic deference to public health activities or enhance the crucial scientific and administrative underpinnings of public health enforcement actions. Stringent preventive and remedial public health measures are necessary to face contagion. The recent experience with quarantine measures as the principal method used against SARS validates this conclusion.44 Taiwan successfully implemented a broad quarantine program: 131,132 persons were placed under strict quarantine orders that required them to stay where they were quarantined, submit to periodic temperature checks, and sharply restrict transportation or visits to public places. These measures were needed because of the unknown transmissibility of SARS; they are associated with the rapid control of the epidemic in that country.71 Although the Canadian government attempted to use voluntary isolation, ultimately orders were issued for mandatory quarantine when the use of voluntary isolation became difficult.72 The Canadian government's response was later characterized as deficient, while the limited spread of SARS in Canada has been attributed to chance.73 It is hard to envision the application of the MSEHPA in a manner congruent with stringent quarantine measures. The procedural guarantees in the MSEHPA may well be impossible to implement due to the risk of exposing judges, witnesses, and the public to possible contagion. In addition, the judiciary and public authorities are not prepared to implement quarantine orders due to lack of familiarity with public health doctrines or logistical shortcomings.74,75 The effects of one successful injunction resulting from these shortcomings—very likely under the MSEHPA— allowing, for example, a single SARS super-spreader to avoid quarantine, could be devastating.76 A perfect balance between private and public rights in the face of a highly infectious disease may not be attainable, or even desirable. Emergency activities will be effective if the states' exercise of public health police power is strengthened by good scientific practices and rigorous application of justified means of control. Expiration of any extraordinary powers once the emergency is controlled remains an obligatory feature unless there is reauthorization on the basis of solid scientific evidence. The ultimate goal of public health law should be the reinforcement of public health on the basis of historic principles of police power allowing broad but temporary administrative activities that are needed to face an impending emergency when the situation warrants.77 This necessitates a return to the traditional historic bases of public health police power. Recommended steps in this direction should include: (1) reinforcing the administrative capability for the issuance of robustly evidence-based public health orders properly issued under authority of law; (2) removing all judicial pre-intervention review measures of such orders while limiting review of public health orders to the post-execution phase; (3) subjecting all public health orders to automatic expiration terms and making renewal of the orders contingent on the same robust degree of evidence allowing the original order. The issue of health information is the jurisdiction for the state O’connor et al 11(Informational Privacy, Public Health, and State Laws, 2011 October Jean O'Connor, JD, DrPHcorresponding author and Gene Matthews, JD with the Centers for Disease Control and Prevention, Atlanta, GA. Gene Matthews is with the North Carolina Institute of Public Health, Chapel Hill. http://www-ncbi-nlm-nih-gov.proxy.lib.umich.edu/pmc/articles/PMC3222345/?tool=pmcentrez) The US Constitution does not impart a broad right to the privacy of individual health information.7 At the federal level, statutes place boundaries around the collection, use, and disclosure of certain types of health-related information. These statutes include the Freedom of Information Act,8 the Privacy Act of 1974,9 the Department of Health and Human Services (HHS) Human Subject Protection Regulations,10 the E-Government Act of 2002, 11 the Family Educational Rights and Privacy Act,12 the Federal Drug and Alcohol Confidentiality provisions,13 and the Genetic Information Nondiscrimination Act.14 These statutes restrict the use of information for different purposes. For example, the HHS Human Subjects Protection Regulations focus on protecting information in the research context. However, the most frequently cited law in discussions of the privacy of public health information is the Health Insurance Portability and Accountability Act (HIPAA) and its associated regulations. The HIPAA Privacy Rule protects most health records from disclosure but permits health care providers to make disclosures to public health officials and for certain other purposes.15 The rule does not protect information possessed by public health officials from disclosure, except in limited circumstances. HIPAA also does not preempt state laws on the use or disclosure of data by public health authorities.16∂ Because there is no national standard for safeguarding all data held by public health agencies, state laws remain central to discussions of the privacy, confidentiality, security, use, and disclosure of information within the public health system.17 These state laws have been reported to be fragmented and antiquated, and to “fail to effectively balance competing individual interests in privacy with the need to share public health data and information for the common good.”18(p1389)∂ For more than a decade, both public health advocates and privacy advocates have responded to this need by calling for clearer protections for state public health information and developing model state policies.17,19,20 To disseminate ideas to update state public health privacy laws, Gostin et al. developed the Model State Health Privacy Act (MSHPA), a model statute for states to use as a guide in developing new laws, in 1999.18 The MSHPA contains detailed language about the appropriate acquisition and use of public health information, terms for when it is appropriate for state health departments to disclose that information, and penalties for noncompliance. After the events in the fall of 2001, the Model State Emergency Health Powers Act (MSEHPA) was drafted to promote the adoption of state public health emergency statutes that contained, among other things, language related to the disclosure of public health information.21 Despite these efforts, anecdotal information suggests that few states have adopted public health privacy and disclosure provisions recommended in the MSHPA and MSEHPA.∂ To address the lack of adoption of provisions by states and the continuing development of new approaches to data exchange, Lee and Gostin recently recommended a set of national principles for protecting public health data.17 The principles included discussion of use of data for legitimate public health purposes, collection or use of the minimum information necessary, data use agreements and security measures, and stewardship and trust. The need to develop a common approach to the use and disclosure of public health information has also been recognized as more than solely a domestic problem; various professional organizations (e.g., the International Epidemiological Association22) have developed guidelines for the use of data by their members, and an international collaborative is seeking to develop a collective code of conduct for the use of public health data.23 An analysis of current public health privacy laws can inform these efforts. The success of a national or international set of principles for the use and disclosure of personally identifiable health information under the control of the public health system depends, in part, on acknowledging the specific political and historical factors that have resulted in existing laws. In the United States, understanding current state laws may assist in identifying approaches to bridging the gap between the reality that state and local public health agencies face and ideal policies, frameworks, or practices for the use and disclosure of public health information. Identifying approaches and patterns in existing state laws is also an essential first step in further analyses of what laws are effective. States solve best – only way to avoid circumvention Pritts 13 (Joy L. Pritts JD is a lawyer who practices in Washington DC and earned her degree at Georgetown Univeristy. “Altered States: State Health Privacy Laws and the Impact of the Federal Health Privacy Rule” http://digitalcommons.law.yale.edu/cgi/viewcontent.cgi?article=1047&context=yjhple)///CW States have traditionally been the primary regulators of health care¶ information. While the promulgation of the Federal Health Privacy Rule¶ changes the regulatory landscape, it need not supplant the importance of¶ state health privacy laws. In fact, states have often become more active after¶ the enactment of federal privacy laws, enacting statutes that either mirror ¶ or build upon the federal protections. This approach, endorsed by the¶ Privacy Protection Study Commission in the 1970s, ensures that the states¶ will be able to enforce the law and protect their citizens.8 4 Because the¶ Federal Health Privacy Rule does not preempt current or future stronger¶ state health privacy laws, the states have ample opportunity to fill the gaps¶ and strengthen the weaknesses of the federal regulation.¶ States therefore should not rely solely on the Federal Health Privacy¶ Rule to protect the privacy rights of their citizens. Rather, states should¶ take advantage of the need to evaluate their health privacy laws in light of¶ the Federal Health Privacy Rule and take appropriate action.¶ States with little statutory protection of health information in place¶ may want to use Federal Health Privacy Rule as a roadmap for enacting ¶ comprehensive state health privacy laws. At a bare minimum, states can¶ mirror the federal protections, thereby allowing to afford truly comprehensive protection, states¶ should directly regulate not only the entities governed by the Federal¶ Health Privacy Rule, but also the other major generators and holders of¶ health information (such as employers and life insurers). Additionally,¶ states should directly regulate the recipients of health information from¶ these core record keepers. Furthermore, states should strengthen some of¶ the weak provisions of the Federal Health Privacy Rule, such as the use of¶ health information for marketing purposes.¶ States with fairly well enforcement to occur at¶ the state level. However, developed health privacy rules should also reevaluate¶ their laws in light of the Federal Health Privacy Rule. Some state¶ and federal rules may accomplish the same goals through slightly different ¶ requirements (e.g., different content requirements for a notice advising¶ the patient of information practices). In this situation, a state may want to¶ harmonize its provisions with the Federal Rule in order to avoid confusion¶ and to afford some degree of uniformity between states. States should also¶ use this as an opportunity to fill in gaps in state law that may exist (such as¶ having statutory access rights to hospital records but not doctor's records). CP solves – more stringent state laws take precedence over federal regs Holloway 3 (Jennifer Daw Holloway is a communications manager at Ipas, an organization dedicated to safe abortions. “What takes precedence: HIPAA or state law?” January 03, http://www.apa.org/monitor/jan03/hipaa.aspx)///CW With the Health Insurance Portability and Accountability Act (HIPAA) privacy rule compliance date--April 14--fast approaching, psychologists must explore how the new federal rules interact with their current state laws.¶ HIPAA's privacy rule governs how health-care providers handle the use or disclosure of protected health information (PHI). In effect, PHI is defined as individually identifiable health information relating to the condition of a patient, the provision of health care or payment for care. All states already have privacy laws that apply to such information. Areas such as patient consent, access to records and subpoena rights, to name a few, are included under HIPAA as well as state laws.¶ So, will HIPAA's rules preempt state laws?¶ "The general standard is that if a state law is more protective of the patient, then it takes precedence over HIPAA," says Doug Walter, legislative and regulatory counsel in APA's Practice Directorate.¶ Conversely, if a state law is less stringent than HIPAA, then HIPAA takes over, he says.¶ The following examples illustrate the interplay between state laws and HIPAA and how that will affect psychologists:¶ Consent for payment, treatment and health-care operations. Dr. Smith, a psychologist in Utah, has scheduled a new patient. When the patient comes for her general appointment, Dr. Smith's office must be sure she signs a consent form for the disclosure of her records. Utah law requires that psychologists obtain signed consent, while the HIPAA privacy rule does not require consent. So, Utah law applies instead of HIPAA in this case because the state law gives patients greater privacy protection. Other states may have similar laws that would take precedence over HIPAA. Patient access to psychotherapy notes. Under HIPAA, patients are granted access to their records, with the exception of "psychotherapy notes," better known as what psychologists traditionally call "process notes." But in some states, such as Vermont, patients can access their psychotherapy notes under state law. So, when a patient of Vermont practitioner Dr. Jones asks to see his notes, Dr. Jones must permit the patient to see the notes. Because Vermont law provides greater rights from the patient's standpoint for the patient to access his or her psychotherapy notes, it takes precedence over the HIPAA requirements. Again, several other states may have such protective laws. Subpoena of patient records. Dr. Milton, a psychologist in New Hampshire, receives a subpoena requesting one of his patient's records. Attached to the subpoena is a notice from the requesting party's attorney stating that her office has made diligent but unsuccessful efforts to reach the patient to serve notice that his records are being requested. This is an adequate attempt to notify the patient under HIPAA and, therefore, the psychologist would not be barred from producing the patient's records if HIPAA took precedence. However, under New Hampshire law, psychologists are precluded from producing their patients' records for a third party absent a court order or patient consent. New Hampshire law is more protective than HIPAA with respect to records subpoena. Therefore, state law preempts HIPAA in this case.¶ There are myriad examples--aside from the three above--of how state laws may take precedence over HIPAA. The simple rule of thumb is that any provision--in state laws or HIPAA--that gives greater protection to patients' privacy or right to access their own health information takes precedence. The HIPAA privacy rule "won't impair the effectiveness of state laws that are more protective of privacy," says Russ Newman, PhD, JD, APA's executive director for practice. And, he notes, in states where protective laws haven't been enacted, HIPAA will not prevent states from enacting laws that provide greater patient privacy protection.¶ HIPAA assumes that practitioners know the ins and outs of their state laws, but figuring out which law will take precedence involves a complicated analysis of state statutes, regulations and common law decisions.¶ The APA Practice Organization and the APA Insurance Trust are developing comprehensive resources for psychologists that will facilitate compliance with the HIPAA privacy rule. Along with several offerings, a new product, "HIPAA for Psychologists"--which will include the necessary state-specific forms that comply with both the HIPAA privacy rule and relevant state law--will be available for purchase online at the Practice Organization's new practitioner portal.¶ Health Data is important for state use O’connor et al 11(Informational Privacy, Public Health, and State Laws, 2011 October Jean O'Connor, JD, DrPHcorresponding author and Gene Matthews, JD with the Centers for Disease Control and Prevention, Atlanta, GA. Gene Matthews is with the North Carolina Institute of Public Health, Chapel Hill. http://www-ncbi-nlm-nih-gov.proxy.lib.umich.edu/pmc/articles/PMC3222345/?tool=pmcentrez) Developments in information technology that make it possible to rapidly transmit health information also raise questions about the possible inappropriate use and protection of identifiable (or potentially identifiable) personal health information.∂ Despite efforts to improve state laws, adoption of provisions has lagged. We found that half of states have no statutes addressing nondisclosure of personally identifiable health information generally held by public health agencies. Exceptional treatment of HIV, sexually transmitted infections, or tuberculosis-related information was common. Where other provisions were found, there was little consistency in the laws across states.∂ The variation in state laws supports the need to build consensus on the appropriate use and disclosure of public health information among public health practitioners.∂ Surveillance, epidemiological, and laboratory data are essential to the practice of public health, particularly at the state and local level.1 Public health practitioners within government agencies use data to identify new cases of disease and to make decisions about when to apply public health interventions. The exchange of information between health officials in different jurisdictions has been demonstrated to be essential to managing outbreaks of well-understood diseases, such as measles, and identifying and responding to new and emerging threats, such as severe acute respiratory syndrome and pandemic influenza A (H1N1). However, the very developments in information technology and health care policy that make it increasingly possible to rapidly transmit health information, such as electronic medical records and health information exchanges, continue to raise questions about the possible inappropriate use and lack of protection of personally identifiable health information.2–4∂ In highly charged situations, such as the recent influenza A (H1N1) pandemic, variations in state laws and incomplete understanding among jurisdictions can easily lead to inconsistent public health disclosure practices, resulting in media questions about the integrity of information access policies.5,6 Clearly, consideration should now be given to a more cohesive approach to public health information sharing. State prohibition of re-identification of patient information is crucial in preventing widespread sharing of personal patient files Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 16-19 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz There has always been something lopsided about the HIPAA regulatory model. Rather than concentrating on securing health data, most of the Privacy Rule provisions detail wide-ranging exceptions (public health, judicial and regulatory) to data protection or outline the process by which patients can consent to disclosure. Just recently, for example, a pharmacy chain made the headlines by conditioning its loyalty rewards program on a broad HIPAA authorization.86 It is no surprise, therefore, to learn that there has been leakage of health data through the very system set up to protect it. Such leakage has been exacerbated by the mission creep exhibited by the recipients of data under HIPAA, particularly public health agencies. As Wendy Mariner notes: Today, almost everyone, regardless of station, could be subject to public health surveillance. The scope of public health surveillance has grown significantly beyond its contagious disease origins. . . . [A] new generation of reporting laws reflects a goal of many people in public health: to collect data about chronic diseases outside the context of a research study and without the need to obtain any individual patient's informed consent. . . . Do they offer the promise of medical advances, or the threat of “general searches, which the authors of the Bill of Rights were so concerned to protect against?”87 For example, a 2013 report from the Citizens’ Council for Health Freedom alleges broad state health surveillance based on individual and often identifiable records.88 However, public health authorities are not only voraciously consuming patient data but also abetting the acquisition of the same by big data companies. Researchers at Harvard’s Data Privacy Lab have found that thirty-three states re-release patient hospital discharge data that they have acquired as HIPAA-permitted recipients of patient data. 89 Generally states release this data (that is no longer in the HIPAA protected zone) in somewhat de-identified or anonymized form but with little restriction on future use of the data. The naïve thought that such data was only being released to academic researchers was upended by the Data Privacy Lab’s discovery that many of the major buyers of such state health databases were big data companies.90 Most states only charge small fees that are not a major source of revenue for them, and many are oblivious to this practice.91 The obvious solution is for the state public health agencies to contractually prohibit re-identification. For example, the National Practitioner Data Bank (NPDB) collects information about physician malpractice awards, adverse licensure reports and Medicare/Medicaid exclusions. Although it is not a public resource the NPDB does release de-identified data. Following a re-identification episode NPDB now contains a prohibition on re-identification, specifically against using its “dataset alone or in combination with other data to identify any individual or entity or otherwise link information from this file with information in another dataset in a manner that includes the identity of an individual or entity.” Clearly, state health departments and any similarly placed recipients of HIPAA data should require similar restrictions. Indeed, the proposed FTC privacy framework would mandate such: . . . [I]f a company makes such deidentified data available to other companies – whether service providers or other third parties – it should contractually prohibit such entities from attempting to re-identify the data. The company that transfers or otherwise makes the data available should exercise reasonable oversight to monitor compliance with these contractual provisions and take appropriate steps to address contractual violations.”95 Until such prohibitions are instituted HIPAA’s public health exception unpardonably will continue to facilitate the “laundering” of protected patient data as it is transferred from a data protected domain to unprotected space. ***Disad Links*** Politics – Link Congress has no interest in changing health surveillance standards Evans 13 (Barbara J. Evans. Professor of Law; Co-director, Health Law & Policy Institute; Director, Center on Biotechnology & Law, University of Houston Law Center, Yale Law School; M.S., Ph.D. Stanford University; Post-doctoral Fellow, The University of Texas M.D. Anderson Cancer Center. “Institutional Competence to Balance Privacy and Competing Values: The Forgotten Third Prong of HIPAA Preemption Analysis.” P.1189-1190. http://lawreview.law.ucdavis.edu/issues/46/4/Articles/46-4_Evans.pdf)//EMerz The problem, however, is that Congress appears to lack this desire. An excellent opportunity to address this problem came and went when Congress introduced major amendments to the HIPAA statute in the 2009 Health Information Technology for Economic and Clinical Health (“HITECH”) Act.74 Congress declined to expand HIPAA’s preemption of state privacy law. Pragmatism counsels that HIPAA’s preemption provisions are not likely to change. Those who favor a more uniform legal framework to support large, interoperable public health data networks and public health uses of data must find a way to achieve these goals within the existing preemption framework. To paraphrase Donald Rumsfeld, “You go to war with the [HIPAA preemption provisions] you have, not the [provisions] you might want or wish to have at a later time.”75 Accordingly, this Article takes a fresh look at HIPAA’s existing preemption provisions to check for tactical opportunities that earlier scouts may have overlooked. Privacy rulings are extremely unpopular and take up the entire floor- HIPAA empirics proves Evans 13 (Barbara J. Evans. Professor of Law; Co-director, Health Law & Policy Institute; Director, Center on Biotechnology & Law, University of Houston Law Center, Yale Law School; M.S., Ph.D. Stanford University; Post-doctoral Fellow, The University of Texas M.D. Anderson Cancer Center. “Institutional Competence to Balance Privacy and Competing Values: The Forgotten Third Prong of HIPAA Preemption Analysis.” P. 1212-1213. http://lawreview.law.ucdavis.edu/issues/46/4/Articles/46-4_Evans.pdf)//EMerz The HIPAA Privacy Rule had a famously contentious rulemaking history. The proposed regulation drew more than 52,000 public comments and the final rule of December 2000 subsequently was reopened for a second round of comments and amendments. Consensus was hard to achieve and, in fact, was not fully achieved. The Privacy Rule continues to be disliked by all sides. For example, it is simultaneously criticized for allowing too much and not enough access to data and biospecimens. Modestly positioning the Privacy Rule as a floor of privacy protections may have had a calming effect during the fractious rulemaking process. By its own terms, the Privacy Rule is merely a floor, and that was all that needed to be discussed during the rulemaking. The Privacy Rule only becomes a ceiling in one narrow context — public health uses of data and biospecimens — and then only when read in conjunction with the HIPAA statute. The rulemaking carefully set the stronger statutory preemption provision at 42 U.S.C. § 1320d7(b) to one side and avoided making it a topic of rulemaking discussions. No political constituency for the plan – politicians will defer to law enforcement Jason Kreag (Visiting Assistant Professor, University of Arizona James E. Rogers College of Law) 2015 “GOING LOCAL: THE FRAGMENTATION OF GENETIC SURVEILLANCE” http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2583957 The lack of legislative interest in regulating local DNA databases is not surprising.287 Absent a public outcry, there is normally little political upside for politicians to initiate legislation to curb police use of a tool that law enforcement has identified as effective.288 And the possibility of a public outcry resulting from surveillance techniques like local databases, which disproportionately impact people with comparatively little socioeconomic standing and political power, seems unlikely because “citizens tend not to see themselves as the subjects of future police investigations.”289 Furthermore, even if policy makers would be interested in regulating a particular surveillance method, they are often not notified of new techniques in advance, leaving the new methods to gain a foothold absent external oversight.290 The debate over the plan get dragged into the ObamaCare debate Katherine Gasztonyi (associate in the firm’s Washington, DC office and a member of the Privacy & Data Security and Intellectual Property Rights practice groups) 2014 “House Republicans Signal Push for Data Breach Legislation” http://www.insideprivacy.com/united-states/congress/house-republicanssignal-push-for-data-breach-legislation/ In the wake of the recent Target Corp. credit card data breach, Congress is once again turning its attention to data breach legislation. In a memorandum to Republican lawmakers on January 2, House Majority Leader Eric Cantor (R-Va.) stated that he intends to schedule legislation on security and breach notification requirements for federally facilitated healthcare exchanges when Congress resumes session next week. Democratic leaders characterized the news as yet another effort by Republican lawmakers to undermine the Affordable Care Act rather than a serious effort to deal with data security issues. ***Case*** 1NC Link Turn Despite privacy concerns - substantial numbers of patients are still engaging the medical system now Erin McCann (Managing Editor of Healthcare IT News) November 2014 “Trust issues over health privacy persist” http://www.healthcareitnews.com/news/trust-issues-over-health-privacy-persist Healthcare industry, listen up: You've got a consumer distrust issue on your hands. The majority of American consumers continue to have serious doubts over the privacy and security of their medical records – so much so that a sizable number of them actually withheld information from care providers over those concerns. This according to a new Office of the National Coordinator for Health IT survey, which took a pulse of consumer perceptions toward healthcare privacy and security. The numbers are telling. After surveying more than 2,000 consumers, ONC officials found that about three-quarters of them were either very or somewhat concerned over the privacy and security of their medical records. What's more, 10 percent of respondents withheld information from their healthcare provider who used an electronic health record. (This compared to the 6 percent who withheld data from providers who used paper medical records.) The differences between the two were not statistically different, ONC pointed out. The lion's share of Americans are also not keen on their medical records being sent electronically or through fax, with about 60 percent of consumers indicating concern over unauthorized access of their medical records when they're sent in these two forms. These numbers appear to align with a similar study conducted by Harvard researchers just last year. The study, which assessed the privacy perceptions of U.S. adults, found similarly that more than 12 percent of the 1,500 respondents withheld information from care providers over medical security concerns. Findings supported "the need for enhanced and sustained measures to ensure the confidentiality, integrity and availability of PHI," Harvard School of Public Health researchers wrote in the study. Despite all these concerns, as ONC officials highlighted in Tuesday's HIT Policy Committee meeting, most respondents still "wanted healthcare providers to use an EHR despite any potential privacy and security concerns," with some 76 percent indicating this. "In spite of the fact that a majority of Americans expressed concerns regarding the privacy and security of both their medical records and with sharing of their medical records, support for EHRs and electronic health information exchange remained consistently strong," said Vaishali Patel, senior advisor at the Office of the National Coordinator for Health IT. Restrictions on health surveillance destroys medical research and disease prevention – anonymization and consent are too burdensome – turns the entire aff Chris Verity et al. (Child Development Centre, Addenbrooke's Hospital, past chairman, British Paediatric Surveilance Unit Executive Committee, Agnus Nicoll, PHLS Communicable Disease Surveillance Centre, and Donal Manning, Child Development Centre, Addenbrooke's Hospital) 2002 “Consent, confidentiality, and the threat to public health surveillance / Commentary” British Medical Journal, International edition324.7347 (May 18, 2002): 1210-3 Why is surveillance important? Since the 1980s the public has become increasingly concerned about health protection against real and perceived hazards, including HIV, bovine spongiform encephalopathy/variant Creutzfeldt-Jakob disease, food poisoning, possible adverse effects of medicines and vaccines, etc.16 People expect that health surveillance will be undertaken efficiently and effectively. When outbreaks of infectious disease occur, local public health doctors, regional epidemiologists, or, centrally, the Communicable Disease Surveillance Centre, mount rapid investigations to enable them to provide protective measures, identify hazards, and reduce the risk of further infections and disease. Is surveillance acceptable? When the rationale for surveillance is explained to colleagues in primary care and in hospitals, they are almost always cooperative, as are affected patients and healthy "controls," sometimes providing personal information over the phone. Similarly, feedback from parents of children with rare but important disorders indicates that they support surveillance and would not welcome changes that threaten its completeness or accuracy. No major effort, however, has been made to explain surveillance mechanisms or their importance to the public. Threats to health surveillance The present arrangements for health surveillance are threatened by the proposal that either explicit consent should be sought from patients for use of their personal data, or data must be completely anonymised. Obtaining explicit consent before sharing identifiable patient data Simple but unrealistic suggestions have been made to solve the complex problems surrounding surveillance, consent, and confidentiality One is that consent for reporting can readily be obtained from patients or parents. Almost all reporting and referral of clinical specimens relies on the cooperation of busy people such as clinicians and microbiologists who are providing patient care with growing workloads in an increasingly bureaucratic environment For example, over 90% of paediatricians return the British Paediatric Surveillance Unit's monthly surveillance card, but the data the card requests are purposely kept to a minimum in order to sustain good response rates.17 It is our considered opinion, and that of our colleagues, that if explicit consent for sharing data had to be obtained the completeness and timeliness of reporting would be dangerously disrupted. Obtaining explicit consent would be most difficult for single consultations-for example for an acute infectionwhen the need for a report is often only appreciated some time after collection of the specimen or after initial diagnosis. It is usually impossible to determine at the time of a consultation which specimen will reveal a significant pathogen. For laboratory reporting, clinicians would have to ask for consent for sharing of data or specimens for every proposed investigation, or else pathologists would later be ringing up clinicians to ask them to trace and contact patients for consent. Neither system could be expected to work well. When approached, families almost always wish to cooperate,4 but reporting doctors do not readily want to add the task of obtaining consent to their other work commitments,4 18 as a sequential surveillance and research investigation undertaken by the Royal Colleges of Ophthalmologists and Paediatrics and Child Health on retinopathy of prematurity illustrates. In this study, 235 cases were initially reported through conventional surveillance (without seeking explicit consent from parents). Later, reporting doctors were asked to obtain consent because an additional research study involved seeking parental views. In some cases repeated reminders to clinicians were needed although there were only three parental refusals. Eventually consent was obtained for 188 of 221 eligible cases (85%), and each consent took on average 3 months to obtain (L Haines, personal communication, 2001). The percentage would have been far lower had not the investigators been able, from prior knowledge of existing cases, to remind clinicians that consent was outstanding. Other specialties have had similar experiences. Introduction of the requirement for consent for cancer registration resulted in a 70% drop in notifications to the long established Hamburg cancer register, destroying its comparative value-it is no longer referred to in European publications (M Parkin, International Agency for Research on Cancer, personal communication, 2001). An American study on consent found that the requirement for consent led to selective exclusion of some patients and hence introduced bias.19 In the United Kingdom, a belief that patient consent was needed before inclusion in a general practitioner diabetes register contributed to ascertainment of only 60% of eligible diabetic patients,20 mainly because some doctors never got round to obtaining consent (S Burnett, UCL London, personal communication, 1999). A disturbing recent development is that, notwithstanding official reassurances 9 10 12 some NHS trusts have instructed doctors not to transfer data about patients unless they do have consent, and this has inhibited some doctors who were keen to contribute to, for example, cancer registries. This has already impaired the work of the cancer registries, and the reporting of infectious diseases might be similarly affected. Anonymising data before transfer It has been suggested that removal of the identifiers from patient data will obviate the need for consent, but in a number of health surveillance studies the identifiers are essential links to other sources of health information about individuals that provide validation and eliminate duplication (table). An alternative suggestion is to use NHS numbers instead of such identifiers as names and dates of birth, but at present NHS numbers are rarely included in routine data sets, so this solution would also interfere with surveillance. Conclusions Health surveillance is essential to protect public health, and existing surveillance mechanisms work reasonably well. Surveillance could be seriously threatened if it was thought that there was an overriding need to maintain patient confidentiality or always to have to seek explicit consent to sharing of data. We are very concerned that restrictive interpretations of some of the recent guidance on patient consent would so damage surveillance mechanisms that they would cease to protect the health of the public, thus resulting in preventable ill health and deaths. 2NC Link Extensions Rigid health privacy protections collapses public health – expansive surveillance key Amy Fairchild (associate professor in the Department of Sociomedical Sciences and assistant director for scholarly and academic affairs at the Center for the History and Ethics of Public Health at the Joseph L. Mailman School of Public Health, Columbia University in New York City) Ronald Bayer (professor of public health and codirector of the Center for the History and Ethics of Public Health at the Joseph L. Mailman School of Public Health, Columbia University in New York City) and James Colgrove (assistant professor in the Department of Sociomedical Sciences at the Joseph L. Mailman School of Public Health, Columbia University in New York City) December 2007 “Privacy and Public Health Surveillance: The Enduring Tension” http://journalofethics.ama-assn.org/2007/12/mhst1-0712.html The discovery that cases of paralytic polio in 1955 were caused by a single manufacturer of Salk vaccine, the linkage of toxic shock syndrome to tampons in 1979, the identification of the sentinel cases of AIDS on the East and West coasts in the early 1980s, the recognition of West Nile, SARS, and avian flu at the turn of the twenty-first century—were all the result of surveillance systems, through which alert and troubled physicians could communicate with public health officials, thus enabling emerging patterns to be identified. In each instance, such vigilance made it possible to initiate measures that could limit the human toll. Surveillance serves as the eyes of public health. Name-based reporting of cases has provided the foundation for planning, intervention, and prevention and has been critical for epidemiological research into patterns of morbidity and mortality for a wide variety of diseases and conditions. Registries have been essential for tracking individuals and their conditions over time. Surveillance has also served to trigger the imposition of public health control measures, such as contact tracing, mandatory treatment, and quarantine. The threat of such intervention and long-term monitoring has provoked alarm and rendered surveillance suspect for those concerned about the unwarranted exercise of state authority in the name of public health. Thus the history of surveillance has been bounded by a promise and a specter. Over the course of the 20th century, public health officials reiterated the importance of surveillance, arguing that without the name and location of diseased individuals they worked "in the darkness of ignorance" and might "as well hunt birds by shooting into every green bush" [1]. It was the prospect of what surveillance might offer that raised hopes—for the delivery of services, for lifesaving knowledge, and for protection of individuals and communities. Hermann Biggs, a titanic figure in the history of public health, who was perhaps the most important late 19th- and early 20thcentury architect and philosopher of U.S. public health surveillance, made it clear that names of the diseased were never collected "in order to keep clerks or adding machines busy" [2]. Toward the end of the 20th century, Surgeon General David Satcher would state the value of surveillance as plainly as had Biggs: "In public health, we can't do anything without surveillance. that's where public health begins" [3]. When surveillance opened the doors to vital services and knowledge, its subjects could well become among its most ardent advocates, thus underscoring a politics that goes beyond the politics of privacy. In the late 19th and early 20th centuries, as public health was extending the ambit of surveillance, the medical community reacted with hostility, particularly when it came to tuberculosis surveillance and seemingly threatened to intrude on the sanctity of the clinical relationship, over which the physician was guardian. Medical Record editor George Shrady thus complained of TB surveillance, The compulsory step taken is a mistaken, untimely, irrational, and unwise one.... The real obnoxiousness of this amendment to the sanitary code is its offensively dictatorial and defiantly compulsory character. It places the Board [of Health] in the rather equivocal position of dictating to the profession and of creating a suspicion of an extra bid for public applause [4]. "Already," he continued, "the profession as a whole has watched with jealous eye the encroachments of the Board upon many of the previously wellrecognized privileges of the medical attendant" [4]. Over time, disease reporting was extended to chronic, noncontagious conditions such as cancer, birth defects, and occupational illnesses. Not only physicians but laboratories were often required to report cases to local health authorities. The surveillance of chronic diseases, of course, differs because these conditions do not represent a direct threat to the health of others. And, indeed, when state and local health departments first began tracking conditions like congenital malformations and cancers in the first half of the 20th century, these initiatives typically served epidemiological or research purposes only. These reporting efforts, critically, also became linked to the assessment and improvement of clinical care. Tumor registries, for example, emphasized patient care improvement since the 1950s and, currently, data from the National Cancer Institute's SEER program (Surveillance, Epidemiology, and End Results Program) are routinely used for quality improvement initiatives. It was not until the AIDS epidemic that activists challenged the longstanding tradition of name-based reporting. Even so, as AIDS has become a more treatable disease, resistance to reporting has all but vanished. In the 1990s, the promulgation of national standards to safeguard the privacy of medical records, as dictated by HIPAA (the Health Insurance Portability and Accountability Act), provoked intense public debate. But there was virtually no opposition to carving out an exception in the guidelines for the reporting of diseases to public health agencies. While there was initial uncertainty among physicians and researchers about whether hospitals could continue to provide cancer data to state registries, the Department of Health and Human Services made clear that HIPAA did not serve as an obstacle to reporting. In the early 20th century it was physicians who spearheaded opposition to surveillance; since the 1970s, patients have often been at the forefront of challenges to reporting diseases. Parents of children with disabilities, for example, successfully changed the terms of birth defects surveillance in Minnesota, requiring the state to allow unwilling parents to opt out of reporting. Patient advocates within the American Diabetes Association forced New York City health officials to place limits on an initiative to track cases of diabetes. But just as often, patients with serious illnesses have pushed for better tracking of their conditions. Breast cancer survivors have emerged as the most ardent defenders of universal name-based cancer reporting, recognizing how important surveillance and the research it makes possible is to their own well-being. Similarly, communities concerned about "cancer clusters" and environmental threats have demanded access to the data that only cancer registries can accumulate. Patients expect their privacy to be protected, of course, but also maintain that a rigid commitment to privacy could hobble the usefulness of registries. In these instances, public health officials, committed to the paramount importance of surveillance, have been extremely wary about disclosing any data that could potentially compromise individual privacy. Disrupts biomedical research Hannson et al 12 (Mats, Centre for Research Ethics & Bioethics at Uppsala University; Bengt Simonsson, Department of Medical Sciences at Uppsala University; Nils Feltelius, The Swedish Medical Products Agency; Joanna Forsberg, Centre for Research Ethics & Bioethics at Uppsala University; Joerg Hasford, Institut for med Informationsverarbeitung, “Medical registries represent vital patient interests and should not be dismantled by stricter regulation,” July 2012, The International Journal of Cancer Epidemiology, Detection, and Prevention, p. 3-4)//JL Rothstein foresees criticism of his proposal for leading to selection bias in research, delaying the introduction of new treatment and safety procedures in medicine, but he claims that at present there is an ‘‘insufficient empirical basis to assert that adding some level of privacy and autonomy protection to deidentified health information and biological samples will invariably and unreasonably disrupt biomedical research’’ (p. 8). However, as has been argued by several, inclusivity and universality are the keys to successful registry research [10,11]. There is a price to be paid since all requirements for informed consent, opt-out, re-consent, etc. imply that the registry will be affected both by those included and those not included. The likely result is incomplete information and data bank bias that will prevent researchers from tracking success and failure of treatment and drug efficacy and safety. The immediate victims of this will be the patients, with those suffering from rare diseases like CML paying the highest price. There are several examples of bureaucratic ethical review procedures and requests for consent that seriously jeopardized the possibility of doing biomedical research, at the end exposing patients to increased risks [12,13]. There are recent assessments available of the cost in lives caused by hurdles related to information and consent procedures [14]. Privacy is a prerequisite to any form of successful health surveillance Khaled El Emam (founder and CEO of Privacy Analytics Inc, senior scientist at the Children’s Hospital of Eastern Ontario (CHEO) Research Institute and Director of the multi-disciplinary Electronic Health Information Laboratory (EHIL) team) 2014 “Public Health Surveillance and Privacy in the Age of Ebola” https://privacyassociation.org/news/a/public-health-surveillance-and-privacy-in-the-age-of-ebola/ Being able to introduce anonymization methods into practice to ensure data custodians are willing to share data for public health purposes is important in the age of such epidemics as Ebola. The efficiency with which we track and investigate outbreaks is directly related to the spread of the disease. There is an urgency to get access to data. And it is not always health data that is important. Ongoing public health surveillance systems would allow rapid detection of and reaction to outbreaks. But this can only happen if privacy concerns that currently act as a barrier are addressed. Privacy does not have to be an obstacle, but it is an issue that needs be dealt with upfront when these surveillance systems are put into place. We cannot take for granted that data custodians are willing to share their data, even when there is an outbreak, as we saw during H1N1. Thomas R. Frieden (Director, U.S. Centers for Disease Control and Prevention; Administrator, Agency for Toxic Substances and Disease Registry) September 2012 “Non-Communicable Diseases and the New Global Health” http://www.cfr.org/diseases-noncommunicable/non-communicable-diseases-newglobal-health/p35310 Really, let me say one thing about the problem and one thing about the solution. Noncommunicable diseases are sometimes mischaracterized as diseases of affluence because we have the concept that as people get richer, they do more unhealthy things, and these diseases follow. But actually, I think these are fundamentally diseases of poverty. They're diseases of poverty because in most countries, not only do they disproportionately affect the poor, but they perpetuate poverty in individuals, in families, in communities and, perhaps most importantly, in countries. Noncommunicable diseases are an enormous drag on economic development, on health care systems, on workplace productivity. And so they have enormous economic implications for individuals, families, communities, work sites and countries. The global burden of disease has really shifted. For the first time in human history, we have more people living in cities than in rural areas. We have more people who are overweight than underweight. We have more deaths among adults than among children. And we also have more people dying from noncommunicable diseases in poor countries than in rich countries, with higher rates of noncommunicable diseases in poor countries than rich countries. In fact, in poor countries, half of all deaths from noncommunicable diseases occur before the age of 70. In rich countries, it's about a quarter of all deaths from noncommunicable disease before the age of 70. So these are huge differences, and now non-communicable diseases kill more people than communicable diseases, about two-thirds of all of the world's deaths, and that burden is not only high, but it is increasing and on a trajectory to increase even further. Mass health surveillance is good – its key to medical effectiveness and drug development Freedland 14 (Jonathon Freedland is the Guardian’s executive editor. He also writes for the NYT and New York Review of Books. He won the Orwell special prize for journalism and the columnist of the year in What the Papers Say. “We now trust no one with our data – not even our doctors” 1/31/14 http://www.theguardian.com/commentisfree/2014/jan/31/nhs-medical-data-trust-doctors-edwardsnowden)///CW If you thought someone snooping around your emails and listening to your phone calls was bad, imagine them looking at your medical records. The private realm may be ever-shrinking – in an age when we reveal so much of ourselves online and when we know the eavesdroppers of the NSA and GCHQ are never far away – but if there's one thing we'd want to keep behind high walls, it's surely the intimate histories of our mental and physical health.¶ So there can be little surprise that privacy campaigners are recoiling at the expansion of NHS England's data collection, which from this spring will take in information from the place where most people experience the NHS: their GP's surgery. Until now, the NHS in England kept the stats from hospital visits but not from those day-to-day encounters with your local doctor. As 26.5m leaflets pop through letterboxes, explaining the new "care.data" project, groups such as medConfidential.org are urging patients to opt out in the name of basic privacy. One survey found that up to 40% of GPs plan to keep their own personal records out of the scheme. My first, unreflective instinct would be to stay out too – and others will surely feel the same way. Indeed, the appeal of that stance says much about the times we live in, both online and in the physical world.¶ For one thing, less than a year after Edward Snowden's revelations of mass surveillance, the notion that our medical records will remain closely guarded, viewed only by those doctors and scientific researchers who need to see them, arouses instant scepticism. Sure, we think. They said the same about our emails. After Snowden, many will assume that if the authorities want to know whether we are HIV-positive or once suffered from depression, they'll be able to find out with just one click. As medConfidential's Phil Booth told the FT: "Everyone agrees medical research is a good thing but, after the NSA scandal, people are getting wise to the dangers of these massive data sets." [paywalled link]¶ It doesn't even have to be that sinister. It wasn't that long ago that government ministers were apologising from the floor of the House of Commons after Revenue & Customs mislaid two discs containing the names, dates of birth, national insurance numbers and, where relevant, bank details of 25 million people. What, one wonders now, is to stop the geniuses who brought us that disaster messing up again, except this time losing not our tax details but the stories of our lives and bodies?¶ Advertisement¶ Campaigners worry too about who might want to take a look at all that info. Won't the big drug companies be desperate to pore over that information, the better to profit from our frailties? And if private health and life insurance companies get access to that data, won't they start charging higher premiums if they know what once took us to see the doctor?¶ Given all those worries, you can see why some want to opt out. And yet that first, gut instinct might be wrong. It's not just that the vast bulk of the information will be rendered anonymous, with individuals blurred out in all but the most controlled circumstances, or that there are strict rules in place over access to this information. Nor even that there is an explicit declaration that this data will not be shared with insurance or marketing companies – so no prospect of a Strepsils ad popping up on your screen just after you've seen your GP over a sore throat.¶ Rather, it's the great gain that this information will provide. Small, clinical studies only tell you so much. Sometimes it's mass data you need. It was mass information that disproved the link between MMR and autism, or that spotted the connection between Thalidomide and birth defects, or between smoking and cancer. Ethically you can't conduct trials on pregnant women or children, so you're reliant on knowing what's happening in the population. If you can know that swiftly and at scale, you can act faster and more effectively. As the leaflet popping through the door puts it: "Better information means better care."¶ The pragmatic truth is that this logic extends even to the private drug companies. Like it or not, it's through pharmaceutical companies that new medicines are developed: they're the ones who fund the trials, turning research into medication. As Nicola Perrin of the Wellcome Trust, which strongly backs care.data, put it to me: "If we want access to the best possible drugs, the drug companies need access to the best possible information."¶ There is a principle at stake here too. In a subtle piece for the Socialist Health Association, Prof Dave Byrne recalls the traditional method of teaching medical students, in which a senior doctor on a wardround would urge them to look at and learn from real-life individuals and their treatment: care.data is just a hi-tech version of that process, says Byrne, gathering together doctors' experience of treating patients. Viewed this way, our individual experience of treatment – suitably anonymised – is not our private property, even if it should remain private. Those who treated us have the right to use that experience to benefit others, to help the collective good.¶ But anonymity is the key. None of these arguments in favour of care.data works unless we can be sure those rules on access hold firm and that the identity of individual patients remains concealed – and not easily hacked as some currently fear. And yet online anonymity remains vexed. All too often it seems we don't have it when we should, whether through data loss or NSA-style state intrusion. At the same time, we have too much anonymity when we shouldn't: witness the social media trolls and abusers, or phoney, astroturf campaigners, able to stay hidden when they would surely shrivel if exposed to the daylight and forced to reveal their true identities.¶ The larger obstacle confronting this new scheme goes beyond the virtual realm. It is a change that is infecting almost every aspect of our shared lives: loss of trust. So the government can issue guarantees of privacy protection and our first thought is of missing discs, GCHQ eavesdroppers or perhaps hacked phones. Too many institutions have been exposed as having betrayed their unspoken promises, whether it's MPs, the security services, the police, the banks or the BBC.¶ For many years the NHS stood alone, immune to this trend, doctors topping every index of trust. But thanks to Mid-Staffs and scandals like it, the NHS too has been found wanting. Which is why a good idea like a project to share our broad, unnamed data can face such resistance. We take nothing on trust these days – not even the word of a doctor. Medical Research Extensions Even the current minimal protections provided by HIPAA drastically impede research Steinberg and Rubin 9 (Mindy Steinberg and Elaine Rubin. Steinberg is a program associate at the Association for Academic Health Centers. Rubin is the vice president for policy and program at AAHC. “The HIPAA Privacy Rule: Lacks Patient Benefit, Impedes Research Growth.” 2009. P. 1-2. http://www.aahcdc.org/Portals/0/pdf/AAHC_HIPAA_Privacy_Rule_Impedes_Research_Growth.pdf)//// EMerz The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), a regulation designed to protect the privacy of health information, continues to have a negative impact on the nation’s research enterprise, according to the latest survey of academic health center research administrators and principal investigators by the Association of Academic Health Centers (AAHC). Since the 2003 implementation of the Privacy Rule (45 CFR 160, 164), studies have shown that it has imposed barriers to research at academic health centers, the nation’s major research institutions, thus slowing the pace of research, increasing the costs, and significantly hindering participation of individuals in important research studies. Research was not intended to be governed by the HIPAA Privacy Rule, but neither was it exempted from the regulation. However, the new constructs and restrictions on information mandated by the Rule have had untold consequences for the conduct of research and the advance of science and discovery in the United States. Despite repeated efforts by the research community to highlight the negative consequences of the HIPAA Privacy Rule, policymakers have made little attempt to address the Rule and consider options to remedy the situation. With the U.S. facing critical socioeconomic challenges, including an aging population and the desire for new treatments and cures for disease and illness, it is essential that policymakers reexamine the HIPAA Privacy Rule. The AAHC called for changes to the HIPAA Privacy Rule and recommended options to address these critical research issues based on evidence from a limited number of focus groups conducted with researchers throughout the country in 2007.4 This year, to broaden its information base, the AAHC developed a questionnaire that was administered online to 102 members of the AAHC’s executive leadership group of Vice Presidents for Research as well as other senior leaders (e.g., legal counsel and chief compliance officers) who are members of the Vice Presidents for Research Workgroup on HIPAA. The vice presidents for research were also asked to forward the survey to 2-4 principal investigators at their institution in the interest of including the perspective of researchers along with that of senior research administrators. Privacy legislation destroys scientists’ motivation to conduct research- it’s too expensive with protections in place Steinberg and Rubin 9 (Mindy Steinberg and Elaine Rubin. Steinberg is a program associate at the Association for Academic Health Centers. Rubin is the vice president for policy and program at AAHC. “The HIPAA Privacy Rule: Lacks Patient Benefit, Impedes Research Growth.” 2009. P. 3. http://www.aahcdc.org/Portals/0/pdf/AAHC_HIPAA_Privacy_Rule_Impedes_Research_Growth.pdf)//// EMerz In short, the majority of survey respondents believe the HIPAA Privacy Rule had a significant negative impact on the scope, pace, and costs of research. The greatest concern was expressed about the negative impact on the costs of research. Respondents also indicated they were aware of research studies that were stopped or never pursued because of Privacy Rule related problems. The negative perceptions of research leaders are especially significant. The HIPAA Privacy Rule imposes another limitation on America’s ability to fulfill the promises of new science. A lack of interest in scientific careers, and decreased federal funding of research when coupled with the HIPAA Privacy Rule, create a burdened and troubled environment for the future.8 That turns case- patients health will be worse off if there are more barriers to DNA research Steinberg and Rubin 9 (Mindy Steinberg and Elaine Rubin. Steinberg is a program associate at the Association for Academic Health Centers. Rubin is the vice president for policy and program at AAHC. “The HIPAA Privacy Rule: Lacks Patient Benefit, Impedes Research Growth.” 2009. P. 3. http://www.aahcdc.org/Portals/0/pdf/AAHC_HIPAA_Privacy_Rule_Impedes_Research_Growth.pdf)//// EMerz The problems with the HIPAA Privacy Rule are extensive and are likely to be even broader than the survey suggests. Furthermore, there is no clear evidence that the Rule is achieving its intended purpose in the research arena. Given the longstanding history of the Common Rule in research, it would be most expedient and effective to exempt research from the HIPAA Privacy Rule and to defer to the Common Rule. The Common Rule — an essential safeguard that has worked successfully — has been responsible for ensuring the protection of research participants’ safety and privacy for more than 30 years. The negative impact of the HIPAA Privacy Rule on research ultimately translates into negative consequences for patients, with more terminally ill patients missing out on the opportunity to participate in clinical trials that have the potential to save their lives. To remedy this threat to research and the American people, revision of the HIPAA Privacy Rule is imperative. The AAHC recommends that research be exempt from the HIPAA Privacy Rule and that it be solely governed by the Common Rule. Furthermore, the AAHC recommends a revision of the Common Rule to incorporate more explicit standards for the privacy of health information and to augment the protections of the Common Rule to accommodate new technologies and guard against new threats to patient safety and privacy Privacy-based critiques fail and undermine research Hannson et al 12 (Mats, Centre for Research Ethics & Bioethics at Uppsala University; Bengt Simonsson, Department of Medical Sciences at Uppsala University; Nils Feltelius, The Swedish Medical Products Agency; Joanna Forsberg, Centre for Research Ethics & Bioethics at Uppsala University; Joerg Hasford, Institut for med Informationsverarbeitung, “Medical registries represent vital patient interests and should not be dismantled by stricter regulation,” July 2012, The International Journal of Cancer Epidemiology, Detection, and Prevention, p. 3-4)//JL 3. Registries criticized for threatening privacy Accordingly, vital patient interests are in the balance in association with the EUTOS for CML and other similar registrations and data-sharing efforts. However, within the ethics and legal literature collaborations between medical registries of this kind are seen as controversial because they pose a potential threat to the individual privacy of the patients. Mark Rothstein has recently argued that collection and use of large quantities of health information create a substantial challenge for protecting the privacy of patients and research subjects that is accentuated when biological samples are involved [8]. De -identification, he suggests, does not solve the problem since the process of removing identifiers implies that someone will actually have to do it thus representing an intrusion in private matters. It has also been claimed that re-identification may be possible by using publicly available databases, provided that one have access to reference samples [9]. Rothstein suggests that rules about de-identification are insufficient for privacy protection and need to be comple- mented with rules about notice provisions to patients, such as informed consent, strategies for opt-out, and giving individual patients a degree of control over the use of data and, where relevant, biological samples. 4. The critique fails for four reasons In light of the experience with the EUTOS for CML registry we believe that Rothstein’s argument fails for four reasons. 1. Rothstein foresees criticism of his proposal for leading to selection bias in research, delaying the introduction of new treatment and safety procedures in medicine, but he claims that at present there is an ‘‘insufficient empirical basis to assert that adding some level of privacy and autonomy protection to deidentified health information and biological samples will invariably and unreasonably disrupt biomedical research’’ (p. 8). However, as has been argued by several, inclusivity and universality are the keys to successful registry research [10,11]. There is a price to be paid since all requirements for informed consent, opt-out, re-consent, etc. imply that the registry will be affected both by those included and those not included. The likely result is incomplete information and data bank bias that will prevent researchers from tracking success and failure of treatment and drug efficacy and safety. The immediate victims of this will be the patients, with those suffering from rare diseases like CML paying the highest price. There are several examples of bureaucratic ethical review procedures and requests for consent that seriously jeopardized the possibility of doing biomedical research, at the end exposing patients to increased risks [12,13]. There are recent assessments available of the cost in lives caused by hurdles related to information and consent procedures [14]. 2. Rothstein acknowledges that research concerns should not be dismissed lightly, but, he continues: ‘‘On the other hand, the interests of patients and the public also deserve respect and consideration’’ (p. 8). His argument for privacy relies, as stated, on a perceived dichotomy between the clinical researcher on the one side with the patient and the public at the opposite side, a normative description of the relationship that is questionable. This dichotomization seems to be a rather common phenome-non [15]. As Dixon-Woods et al. have recently argued, the ethical, legal and sociological accounts of medical research that influence the policy debates describe research as operating in opposition to the norms and interests of the general public and of the patient [16]. Based on empirical studies in a pediatric oncology research context they were, in contrast to this alleged dichotomy, able to show how sentiments of coalition and partnership characterized the relationships between the patient families, their doctors and the researchers. 3. Rothstein argues for the need of increased protection of privacy and autonomy based on these interests as fundamentally protected by constitutional law. Wendy Mariner argues in a similar vein for the need of limiting intrusion into medical privacy and has suggested that a constitutional challenge could dismantle cancer registration [17]. Health is regarded as an important concern but must sometimes give way to inherent principles of law, e.g. protection of privacy [18]. That privacy is a vital interest of citizens and democratic societies is not controversial. However, the values that are associated with a secluded life are all kinds of social value [19]. They presuppose and acquire their meaning only in a context where various kinds of social relationships with other individuals are involved. To be banished to seclusion on a desert island, certainly implies that one will be left in peace, but it is not the kind of situation which people wishing to protect their private life, strive for. Individuals, as far as their own personal matters are concerned, have an interest in being left in peace but they also wish to participate in the possibilities that are available to citizens in a society. This includes having access to new medical knowledge attainable only when personal medical data is recorded and shared within the format of large well-managed registries. In order to further strengthen his argument Rothstein suggests that autonomy is only one aspect of the broader concept of ‘‘respect for persons’’ (p. 8) and that this should imply closer regulation of registry research. However, patients have interests also at the end of the research line, e.g. in new possibilities to follow up the effects of medical drugs with regard to treatment response and adverse reactions, and if they became aware of the costs of stricter regulation undermining the possibilities of participating in the development of scientific knowledge they may be more likely to feel disrespected. 4. Rothstein is critical of partnership with commercial interests in association with biomedical research, something not uncommonly questioned by ethicists and lawyers [20]. However, we suggest that partnership between academic and commercial partners is essential for making progress in medical research and is intrinsic to concerns about assessment of drug efficacy, safety and effectiveness. This claim does not imply that one should be naı¨ve. For the benefit of patients sharing of data should go in both directions, also when a pharmaceutical company enjoys a monopoly. Potential conflicts of interest may arise and should not be taken lightly. The increasing collaboration between industry and patients’ organizations should be considered. However ELN provides an interesting example of how doctors and researchers may be able to collaborate with the pharmaceutical industry while preserving their own integrity. A working party has just started a controlled trial in order to find out when treatment of CML patients with TKI should be stopped because the patient will not benefit from prolonged treatment with the drug. Such a study may, arguably, not be in the best (economic) interest of the drug companies. HIPAA’s protections of individual health records have prevented vital research Pritts 13 (Joy L. Pritt. “The Importance and Value of Protecting the Privacy of Health Information: The Roles of the HIPAA Privacy Rule and the Common Rule in Health Research.” 2013. P. 1-2 http://iom.nationalacademies.org/~/media/Files/Activity%20Files/Research/HIPAAandResearch/PrittsPr ivacyFinalDraftweb.ashx)//EMerz The privacy of personal information, and of health information in particular, continues to be a vexing issue in the United States. As more and more health information is computerized, individuals express concern about their privacy and that they are losing control over their personal health information. To help allay public concerns, federal rules governing the use and disclosure of health information were promulgated under the Health Insurance Portability and Accountability Act (known as the HIPAA Privacy Rule). While the HIPAA Privacy Rule does not directly regulate researchers, it does restrict the manner in which health care providers may use and disclose health information for health research. Health researchers have been critical of the HIPAA Privacy Rule since its inception, concerned that it would interfere with valuable research. Various research organizations and others have requested that the Rule be revised to lessen its effect on research. Most recently, an Institute of Medicine (IOM) committee was formed and charged with reviewing the impact of the Privacy Rule on health research. This paper was commissioned by that committee, the IOM Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule. Disease Turn - Military Surveillance key to check tick-based disease outbreaks --- specifically likely on military installations Peterson et al, masters in entomology qualifications of other authors: Medical Entomologist/epidemiologists, 2015 (Wade, “Tick-borne disease surveillance”, published in U.S. Army Medical Department Journal, jan-march edition, Academic OneFile)//roetlin Tick-borne diseases (TBDs) represent some of the world's most rapidly expanding arthropod-borne infectious diseases. (1) (p1) In the United States, ticks are responsible for more human disease than any other arthropod group. The incidence and the number of pathogens transmitted by ticks are increasing. For example, Lyme disease is now the most commonly reported arthropodborne illness in the United States. (2) Anaplasmosis, ehrlichioses, and rickettsioses are also on the rise. (1) (p1) In most parts of the world, TBDs are potentially serious health threats to troops, civilian employees, and residents at military installations. (2) (p6) Companion animals and military working dogs (MWD) are also at risk in areas where ticks and TBDs are endemic or emerging. Risk of TBD increases with the introduction of exotic tick species into new areas and the expansion of historical tick ranges. One example of exotic ticks that effects the United States is Boophilus annulatus and B microplus, also known respectively as the cattle fever tick and the southern cattle tick, that were imported here by Spanish colonists who brought tick-infested cattle and horses with them. These ticks transmit a severe disease to cattle called Texas fever or cattle fever that caused enormous losses to the US cattle industry in the past. Present efforts to keep this tick out of the United States exist as the Cattle Fever Tick Eradication Program. (3) Nilgai antelopes, native to India, Nepal, and Pakistan, that were released into southern Texas are also hosts to the cattle fever ticks, posing a threat as maintenance hosts of cattle fever. (4) There are many other examples of exotic tick introductions from migratory birds, exotic and wildlife species, and domestic animals. (5) Changes in climate may also alter the geographic distribution of tick vectors, and in turn, cause a change in the currently recognized demographic patterns, seasonality, and incidence of TBDs. (1) (p61) For example, the range of the Gulf Coast tick (Amblyomma maculatum) has historically been along the Gulf of Mexico and southern Atlantic coast as far north as South Carolina, and extending approximately 100-150 miles inland. However, resident populations of these ticks are now established in Arkansas, Oklahoma, and Kansas, (6) and they have been collected on the east coast as far north as Delaware and Maryland. (7) Another example is the lone star tick (A americanum) which has moved northward as far as Maine and westward into central Texas and Oklahoma. (8) Incidental introductions of these ticks, and the diseases they carry beyond endemic regions, occur with increasing frequency. This is likely due to the feeding of immature ticks on migrating birds, and the transportation of tick-infested livestock and wildlife into new areas. (6) These introductions may also come from pets belonging to people who move from one area to another. In addition, suburbanization has contributed to the increase in TBD transmission in North America by bringing people and their pets close to ticks and by creating new tick habitat. (9) In the northeastern United States, the highest risk for Lyme disease occurs around the homes of those who have been infected. (10) As communities continue to expand into tick habitat, and people are encouraged to enjoy outdoor recreation and pursue activities such as urban farming, the risk for peridomestic exposure to ticks and TBDs may increase. The National Notifiable Disease Surveillance System (NNDSS) of the Centers for Disease Control and Prevention (CDC) maintains a list of diseases that are considered to be of public interest by reason of their contagiousness, severity, or frequency. The 7 TBDs on the NNDSS list are shown in the Table. Many of these diseases, which are caused by closely related tick-borne pathogens, can also be acquired internationally. There are also many TBDs that can be acquired abroad that do not occur in the continental United States. In addition to transmitting disease, ticks can cause irritation, pain, and swelling at attachment sites, otoacariasis (invasion of the auditory canal), paralysis, allergic reactions, and anaphylactic reactions. (11) Heavy infestations of ticks on animals can cause debilitation due to blood loss. Direct effects from TBDs include troop and MWD morbidity and mortality. There are also many indirect effects, such as illness of dependents or Department of Defense (DoD) civilian personnel, and related healthcare costs. Both types of effects can be mitigated through aggressive surveillance, public education, and prevention/control programs, together with prompt diagnosis and treatment. (2) (p6) TICK BIOLOGY AND DISEASE TRANSMISSION Ticks are grouped into 2 separate families. Family Ixodidae, also called hard ticks, have 4 developmental stages: egg, larva, nymph, and adult. The latter 3 each take one large blood meal and then molt to the next stage, or lay eggs in the case of the adult. Hard ticks have mouthparts with recurved teeth that allow them to firmly anchor themselves to hosts while feeding with the assistance of a cement-like substance secreted by the salivary glands. This allows them to feed for extended periods of time that can vary from 2 to 12 days or longer, depending on species, life stage, and gender. Family Argasidae, also called soft ticks, have the same 4 developmental stages, but most have multiple nymph stages. Soft ticks have mouthparts that allow them to hold fast to their host, as hard ticks do, but they do not secrete cement. Although some soft ticks can remain attached to the host for several days, (11) (p501) others can complete a meal within minutes to hours. (12) This is still much longer than other bloodsucking arthropods such as mosquitoes, and is one of the factors that contribute to their high vector potential because it increases the likelihood of pathogen ingestion and allows them to secrete large amounts of host-derived fluid and salivary secretions, which contain pathogens, back into the host. Other factors that make ticks efficient disease vectors include a highly sclerotized body that protects them from environmental stresses, high reproductive potential, and a long life span (compared to other blood feeding arthropods). Although the majority of TBDs are transmitted during normal feeding activity, they can be transmitted by other routes as well, including through regurgitation and feces. Argasid ticks can also release pathogens through excess liquid excreted from the coxal glands located adjacent to the first segment (coxa) of the front legs. (11) (p512) Adding to their efficiency as vectors, the larvae and nymphs are very small. The presence of an immature tick on a host often goes unnoticed, enabling the tick to feed to repletion and drop off without detection, which increases the likelihood of pathogen transmission. Ticks can also transmit more than one pathogen at a time. For example, Ixodes ticks can simultaneously or sequentially infect their hosts with Borrelia burgdorferi, Anaplasma phagocytophilum, and Babesia microti. (1) (p61) Co-infections with these pathogens have been reported from wild and domestic animals, including dogs, as well as humans. These infections can result in more severe and longer illnesses and can complicate diagnoses. (1) (p493) Ticks are also effective disease reservoirs. In some species, pathogens can be transmitted from the adult female to its offspring (transovarial transmission) and from one developmental stage to the next (transstadial transmission). Infected ticks can also transmit viruses to uninfected ticks while feeding simultaneously on an uninfected host. (11) (p512) Therefore, they can maintain and transmit infections even if they have not fed on an infected host. SURVEILLANCE Surveillance is the process of determining the presence of vectors and pests, estimating their general population levels, and determining if pathogens of concern are present in the population. It gives quantifiable data on which to base control and education programs and is the starting point in the prevention of any arthropod-borne disease. The analysis and interpretation of information gained from surveillance is the basis for developing quantitative and qualitative risk assessments that can be used to predict the occurrence of pest outbreaks or vector-borne diseases. (13) (p7) Various methods can be used to describe disease risk. One commonly used index is called the Entomologic Risk Index (ERI), an indicator of the number of infected ticks that a person might come into contact with over a set distance. The ERI is calculated as the number of infected ticks collected over a 1,000-meter drag (described below). Accurate ERIs are obtained by testing ticks for pathogens to determine tick infection rate. Public health officials can use indices like the ERI in public education efforts and to determine if, when, and what control measures should be implemented. (13) (p7) That collapses military readiness Peterson et al, masters in entomology qualifications of other authors: Medical Entomologist/epidemiologists, 2015 (Wade, “Tick-borne disease surveillance”, published in U.S. Army Medical Department Journal, jan-march edition, Academic OneFile)//roetlin Ticks are one of the major vectors of disease that threatens military personnel, families, and civilian employees on US military installations. (25) The presence of tickborne disease in military personnel, including our military working animals, may result in the loss of training days, decreased force strength, and may adversely affect unit readiness and effectiveness. Tick-borne disease also affects DoD civilians and the families of our troops. Soldier and unit readiness may be affected when family members and companion animals are sickened by TBDs. The information gained from tick surveillance regarding tick vectors, disease incidence, and pathogen prevalence is invaluable. It allows medical personnel to educate personnel regarding tickbite and TBD recognition and prevention. Tick surveillance information also enables leaders to make decisions regarding the application of safety and control measures during training and operations to prevent TBDs. As with any disease, prevention of TBDs is highly preferable to treating the short- and long-term consequences once they occur. (1(p155)) Readiness solves lashout Jack Spencer, 2k, Research Fellow in Nuclear Energy Policy at The Heritage Foundation's Roe Institute for Economic Policy Studies. “The Facts About Military Readiness” Sep. 15, 2k. accessed July 31, 2010 http://www.heritage.org/Research/Reports/2000/09/BG1394-The-Facts-About-Military-Readiness// Military readiness is vital because declines in America's military readiness signal to the rest of the world that the United States is not prepared to defend its interests. Therefore, potentially hostile nations will be more likely to lash out against American allies and interests, inevitably leading to U.S. involvement in combat. A high state of military readiness is more likely to deter potentially hostile nations from acting aggressively in regions of vital national interest, thereby preserving peace. Disease Turn – A2 Privacy Aggregated data is good – doesn’t hurt privacy and facilitates effective treatment Hannson et al 12 (Mats, Centre for Research Ethics & Bioethics at Uppsala University; Bengt Simonsson, Department of Medical Sciences at Uppsala University; Nils Feltelius, The Swedish Medical Products Agency; Joanna Forsberg, Centre for Research Ethics & Bioethics at Uppsala University; Joerg Hasford, Institut for med Informationsverarbeitung, “Medical registries represent vital patient interests and should not be dismantled by stricter regulation,” July 2012, The International Journal of Cancer Epidemiology, Detection, and Prevention, p. 3-4)//JL Development of medical registries with sharing of data is intrinsic for the protection of patient benefits and patient safety. If, linked to the medical record, and used also for clinical decision making in dialogue with the patient the benefit and legitimacy of clinical registries might increase even more. The patient in our view should have the right to quality assured medical treatment and care and the clinicians and hospitals should have a corresponding duty to document relevant quality measures for long term follow up of treatment. There is a well-recognized duty to document at the individual patient level but today there is a lack of systematic collection and analysis of aggregated registry data. It was objected by one reviewer that registries for quality assurance are seldom considered a problem from a data inspection point of view, because the exact use of data is clearly specified at outset and the registries are used for the same, usually repetitive quality assurance analyses while research implies that new questions are being raised as science develops. However, there is an increasing awareness of the need for aggregated data for quality assessments and drug efficacy/safety assessments. Recent developments in genomics in fact blur the traditional line between quality assurance and research through the rapidly increasing possibilities to identify genotypes as well as environmental factors regulating the treatment benefit/risk scenarios. It is actually strange that the demand of mandatory quality assurance that is common in so many other areas in society is not implemented as rigorously in health care where lives are at stake each day. Furthermore, in order to assure the patient the best medical treatment available at each time research based on those registries is necessary and should in principle be approved and supported. From the patient’s perspective there is no conflict between the interest of documentation in a medical record, the interest of follow-up and long-term assessment through medical registries (whether local, national or collaborative on a global level) and the interest of receiving the at each moment best available treatment based on research. This, we believe, holds not only for rare diseases like CML but also for all medical treatment. Registries don’t hurt privacy and are key to solve diseases – empirics prove Hannson et al 12 (Mats, Centre for Research Ethics & Bioethics at Uppsala University; Bengt Simonsson, Department of Medical Sciences at Uppsala University; Nils Feltelius, The Swedish Medical Products Agency; Joanna Forsberg, Centre for Research Ethics & Bioethics at Uppsala University; Joerg Hasford, Institut for med Informationsverarbeitung, “Medical registries represent vital patient interests and should not be dismantled by stricter regulation,” July 2012, The International Journal of Cancer Epidemiology, Detection, and Prevention, p. 3-4)//JL The EUTOS for CML Registry clearly illustrates the benefits of aggregated, long-term clinical data for the assessment of drug effectiveness, in particular for orphan diseases but the same logic applies to all diseases, i.e. the more standardized, relevant and validated data available in quality registries, the better. Although values such as autonomy and privacy are important and should be safeguarded, it must be kept in mind that these registries exist for the good of patients and therefore it seems inconsistent and even unethical to hinder their optimal utilization. Transparency and safeguarding personal integrity are necessary to preserve trust but rules and legislations to protect integrity should not prevent the development of registries and performance of clinical trials in both national and transnational collaborations. That would be detrimental to vital patient interest of reaping the benefits of collaborating with others. Systemic data collection over a wide range of health issues is inevitable and required for a wide range of issues --- the plans reversal is bad --- it’s a linear case turn Gostin, an internationally recognized scholar in law and public health, professor of Law at Georgetown University; Professor of Public Health at the Johns Hopkins University; and the Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities, 2001 – (Lawrence, “Health Information: Reconciling Personal Privacy with the Public Good of Human Health”, published in Healthcare Analysis vol 9, A health care system supported by data on almost any relevant subject, accessible to a diverse and significant number of users, is an integral part of the vision for the health care system. Plans for the systematic collection, storage, use, and dissemination of a huge volume of uniform data sets in electronic form are already under way and have an aura of inevitability. This new health information infrastructure is the subject of reports published by the Congressional Office of Technology Assessment (Congressional Office of Technology Assessment, 1993, 1988, 1986), the General Accounting Office (Information Management and Technology Division, General Accounting Office, 1993a, 1993b, 1991), the National Academy of Sciences (Donaldson and Lohr, 1994), the Department of Health and Human Services (Task Force on Privacy, U.S. Dep’t of Health and Human Servs., 1993; Task Force on the Privacy of Private Sector Health Records, U.S. Dep’t of Health and Human Servs., 1995), the Physician Payment Review Commission (Physician Payment Review Comm’n, Annual Report to Congress, 1994, 1993, 1992) 322 and the Centers for Disease Control and Prevention.1 The U.S. Department of Health and Human Services issued final regulations on health information privacy in 2001 (Gostin, 2001). Contrary to the assertions of some privacy advocates, powerful reasons exist for the broad collection and use of health data. High quality data are needed to help consumers make informed choices among health plans and providers, to provide more effective clinical care, to assess the quality and cost effectiveness of health services, to monitor fraud and abuse, to track and evaluate access to health services and patterns of morbidity and mortality among under served populations, and to research the determinants, prevention, and treatment of disease. Surveillance is key to solve economy—saves money, resources, and labor Mirza et al 13 (Nabila, Tera Reynolds, Michael Coletta, Katie Suda, Ireneous Soyiri, Ariana Markle, Henry Leopold, Leslie Lenert, Erika Samoff, Alan Siniscalchi, and Laura Streichert researchers and analyists for OJPHI, “Steps to a Sustainable Public Health Surveillance Enterprise A Commentary from the International Society for Disease Surveillance” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3733763/ July 2013 JM) Recognize systematic and ongoing public health surveillance as a core public health function that is essential for population health, economic stability, and national security. Public health surveillance data is the foundation of public health programs and is required for a number of purposes, including: to demonstrate the size and impact of the public health problem being addressed by a program; to identify the population groups to which additional prevention efforts should be directed; to determine whether the problem is growing in size or abating; to provide feedback to data providers; and as part of an overall program evaluation strategy. The significant health impacts and economic costs of disease outbreaks illustrate the critical importance of effective public health surveillance and rapid response, as well as the cost of inaction [11]. Table 1 provides examples of the health and financial burdens posed by some naturally occurring and intentional infectious disease outbreaks. The values reported in Table 1 do not fully reflect additional indirect costs of diseases and their potentially crippling effects on a community, nor do they address costs that are underreported/ unreported due to lack of data. Higher rates of illness, for example, can lead to lower worker productivity [11], while premature mortality can reduce the size of the labor force, both of which have economic ramifications. There is growing evidence that these economic and societal costs can be mitigated by surveillance systems that are stable; a stable system provides the best foundation for identifying whether the problem being addressed is getting bigger or smaller or disproportionately affecting a section of the population, etc., while still allowing flexibility to provide useful information quickly about emerging issues. The optimum mix of stability and flexibility will depend on the purpose(s) of surveillance and the particular health condition under surveillance. For example, in the case of SARS, an effective surveillance system has the potential to decrease the size of an epidemic by one-third and the duration by 4 weeks, with significant cost savings [25]. Another study found that the early detection of an outbreak of highly infectious bacterial meningitis saved approximately $2 for every dollar invested in infectious disease surveillance [26]. Yet another evaluation of surveillance practice found that technological improvements in a sentinel influenza-like illness (ILI) surveillance system in Virginia saved over $9,500 (1,992 hours) in staff-time during the 2007-2008 influenza seasons [27]. Ongoing surveillance can also inform the design and evaluation of prevention and intervention programs in order to control the escalating costs associated with chronic diseases in the U.S. and abroad [28]. Some experts forecast that chronic disease prevention programs could save up to $48.9 billion per year by 2030 [29], while others predict applying electronic medical record implementation and networking to the prevention and management of chronic disease will exceed the currently projected $81 billion in annual savings [30]. Bioterror Links More surveillance is key to solve the aff impacts White House 12 (The White House, from the President of the United States Barak Obama, “NATIONAL STRATEGY FOR BIOSURVEILLANCE” https://www.whitehouse.gov/sites/default/files/National_Strategy_for_Biosurveillance_July_2012.pdf July 31 2012 JM) national biosurveillance enterprise is a national security imperative. Our ability to detect quickly and a potential incident of national significance that affects human, animal, or plant health is of paramount importance. Rapid detection and enhanced situational awareness are critical to saving lives and improving incident outcomes, whether the result of a bioterror attack or other weapons of mass destruction (WMD) threat, an emerging infectious disease, pandemic, environmental disaster, or a food-borne illness. Beyond our need to protect domestic interests, and because health threats transcend national borders, the United States also plays a vital role within an international network of biosurveillance centers across the globe. For years, there have been dedicated A well-integrated, characterize efforts to promote and strengthen biosurveillance capabilities. There exists a strong foundation of capacity arrayed in a tiered architecture of Federal, State, local, tribal, territorial, and private we seek to leverage distributed capabilities and to add value to independent, individual efforts to protect the health and safety of the Nation through an effective national biosurveillance enterprise. A key to improving all-hazards incident management is to focus efforts on collecting, analyzing, and disseminating information to facilitate timely decisionmaking, whether a health incident is a naturally occurring phenomenon, accidental, or deliberate in nature. From capabilities. We can strengthen the approach with focused attention on a few core functions and an increased integration of effort across the Nation. In these fiscally challenging times, the individual, to primary care providers, to hospital practitioners, to state and local health officers, to Federal entities responsible for health emergency response, to the President of the goal is to achieve a wellintegrated national biosurveillance enterprise that saves lives by providing essential information for better decisionmaking at all levels. Our Strategy is to integrate and enhance national biosurveillance efforts to answer specific key questions that guide decisionmaking in times of crisis; enable more rapid detection and foster improved situational awareness by further extending a dynamic, distributed national network of expertise and capabilities; and put into practice new thinking to facilitate decisionmaking processes in conditions of significant ambiguity. This enhanced national biosurveillance capability will be applied broadly to identify and understand potential human, animal, or plant health impacts resulting from chemical, biological, radiological, and nuclear (CBRN) and environmental incidents, as well as influenza and United States, there exists an imperative to identify incidents early and to make decisions swiftly to save lives, even amidst great uncertainty. The other public health trends, all of which may also be leveraged in the service of global health efforts. We must be resolved to strengthen life-saving biosurveillance capabilities within our existing resources. We can do this by leveraging more effectively our existing national network of expertise and capabilities, and through targeted enhancements that provide benefits across the enterprise. There are no higher priorities than the health, well being, and security of the American people. Outbreak reaction plans require the necessary data in real time to work effectively [Lindsey Thomas, Professor @ UC Santa Barabara “Pandemics of the future: Disease surveillance in real time” 2014] In 2013, the World Health Organization (WHO) published a document on the 2009 H1N1 influenza pandemic entitled Evolution of a Pandemic. This document traces the disease outbreak from April 2009 to August 2010 and documents how the WHO responded to the crisis. The document particularly emphasizes the importance of preparedness plans to mitigating the effects of the pandemic: it claims that investment “in developing national and regional pandemic preparedness plans” by WHO member nations had “paid major dividends” and that these plans “helped make the world better prepared to cope with public health emergencies” (WHO 2013a: 9, 43). Such plans involved the “active surveillance of diseases and public health events” and rapid response to “unexpected, internationallyspreading events” (WHO 2013c). Active surveillance and rapid response are important features of what’s known as global health security, which emphasizes preparing for pandemics before they occur through the adoption of international frameworks for pandemic response. These frameworks, or preparedness plans, allow public health officials to react quickly, in real time, to mitigate the effects of pandemics when they occur (Lakoff 2007). Global health security can be seen as part of a larger program of preparedness, a security paradigm that emphasizes planning for future catastrophic events in the present. Preparedness, which moved to the center of United States national security policy after September 11, 2001, has also been adopted by international organizations like the WHO in order to secure against potentially catastrophic pandemics. It is one among several modes of what Ben Anderson has called “anticipatory action”: these modes, which also include precaution and preemption, are all security paradigms that focus on making possible futures available in the present (Anderson 2010; also see Grusin 2010). Preparedness emphasizes institutional readiness and emergency management, treating a variety of potential catastrophic threats—terrorist attacks, hurricanes, pandemics—under the same rubric. Because the probability and severity of such catastrophes cannot be calculated, preparedness focuses not on trying to prevent such events but rather on preparing officials and experts for their eventual emergence. A variety of techniques and technologies make such preparation possible. For global health security, this has involved not only the creation of international preparedness plans, but also of international disease surveillance systems that monitor emerging infectious disease outbreaks. These systems allow public health officials to collect and manage huge amounts of data on disease outbreaks as they occur. Such systems attempt to harness the power of big data to get ahead of the catastrophic pandemic that is coming, not necessarily in order to prevent it from happening (because we can’t), but rather to better deal with its effects (de Goede and Randalls 2009; Lakoff and Collier 2010). Health surveillance exists for a reason --- terror results in unique risks to public health that this surveillance remedies --- specifically checks against bioterror Gostin, an internationally recognized scholar in law and public health, professor of Law at Georgetown University; Professor of Public Health at the Johns Hopkins University; and the Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities, November 2001 – (Lawrence, “Public Health Law In An Age Of Terrorism: Rethinking Individual Rights And Common Goods”, published on HealthAffairs vol 21 no. 6)//roetlin The balance between individual interests and common goods needs to be recalibrated in an age of terrorism. Public health agencies should have a robust infrastructure to conduct essential public health services at a level of performance that matches evolving threats to the health of the public. This includes a well-trained workforce, electronic information, surveillance, and laboratory capacity. This paper explains modern efforts at public health law reform: a Model Public Health Statute and the Model State Emergency Health Powers Act (MSEHPA), which has been enacted wholly or in part by nineteen states and the District of Columbia. Next, the paper shows why existing public health laws provide a weak foundation for public health practice. Finally, the paper offers a systematic defense of MSEHPA, which has galvanized the public debate around the appropriate balance between public goods and individual rights. PROLOGUE: Following the 2001 anthrax attacks, an outbreak of concern about the inadequacies of the public health infrastructure caught the nation in the grip of a profound ambivalence about what we expect from government. For the past twenty years distrust of public institutions has severely dampened public health spending and so dominated the political landscape that even the Institute of Medicine’s stern warning about deterioration of the infrastructure in 1988 did not generate renewed investment. Then, in the wake of the anthrax scare, the refrain suddenly became, “Why aren’t we better prepared?” The following essay by legal scholar Lawrence perform its essential functions, the public health system needs legal authority to act. Yet most of its statutory foundations, which lie primarily in the domain of state government, have not been updated for half a century. Even before last fall’s terrorist attacks, efforts were under way to develop new model laws for the states. The focus of the model legislation is to confer enough authority that public health agencies can mount adequate preparations, obtain information, and act in an emergency to protect those who are threatened. But some sacrifice of personal rights and freedoms is necessary to achieve this end, and these legal initiatives have been controversial. “In a country so tied to rights rhetoric..., any Gostin suggests that our collective confusion about public health goes deeper than dollars. To proposal that has the appearance of strengthening governmental authority was bound to travel in tumultuous political waters,” Gostin concludes. Three Perspectives that follow Gostin’s paper highlight the extent of the disagreement that still exists, nearly a year after the model law was last revised. Gostin is ideally suited to clarify the difficult issues involved. He is a professor of law at Georgetown University; a professor of public health at the Johns Hopkins University; and director of the Center for Law and the Public’s Health, which drafted the Model State Emergency Health Powers Act at the request of the Centers for Disease Control and Prevention. In defense of a model act that was written to bring public health law into the modern age. Public and scholarly discourse in the late twentieth century became highly oriented toward “rights.” The political community stressed the importance of individual freedoms rather than the health, security, and well-being of the community. The salience of individualism could be seen on both sides of the political spectrum. The ideological left favored a set of personal interests, principally autonomy, privacy, and liberty. This meant that individuals should be free to make choices, restrict the flow of health information, and have unfettered movement, without regard to the needs and desires of the wider community. The ideological right favored a set of proprietary interests, principally the freedom to contract, conduct business, use and develop property, and pursue a profession. This meant that entrepreneurs should be permitted to engage in free enterprise without the fetters of, for example, occupational health and safety regulations, inspections and products liability, zoning and nuisance abatements, and licenses. In this civil and property rights society, the tone has been distinctly antigovernment. The State has been perceived as inefficient, bureaucratic, and burdensome. Citizens have opposed taxation and broad health and welfare spending as well as oppressive regulation. From a funding perspective, this has meant that health dollars have been allocated primarily to advanced biotechnology and health care, which serve the needs of individual patients, particularly those who can afford private health insurance. Funding for traditional prevention and population-based services represents only a small fraction of health spending, estimated at around 1 percent at the state level and less than 5 percent at the federal level.1 As a result of chronic underspending, the public health infrastructure is badly deteriorated.2 Public health agencies lack the capacity to conduct essential public health services at a level of performance that matches the constantly evolving threats to the health of the public. Critical components of that infrastructure include a well-trained workforce, electronic information and communications systems, rapid disease surveillance and reporting, laboratory capacity, and emergency response capability.3 The public health law infrastructure is equally deficient. The law establishes the mission, functions, and powers of public health agencies. Yet public health laws are highly antiquated, after many decades of neglect. Very little consideration has been given to modernizing these laws to reflect advances in public health practice and constitutional law. Reform of public health law is essential to ensure that public health agencies have clear missions and functions, stable sources of financing, adequate powers to avert or manage health threats, and restraints on powers to maintain respect for personal rights and liberties. The balance between individual interests and common goods needs to be recalibrated in an age of terrorism. The attacks on the World Trade Center and Pentagon on 11 September 2001 and the subsequent dispersal of anthrax spores through the U.S. postal system reawakened the public to the importance of public health, safety, and security.4 The president’s 2003 budget reflects changing priorities, with an influx of funding to prevent and respond to bioterrorism.5 However, even in this budget, disproportionate funding is devoted to biotechnology rather than to basic prevention and population-based services.6 Bioterrorism – Link Uniqueness Current electronic system effective—economy, disease prevention and treatment Freudenheim 12(Milt, reporter for the NY times, “Fast Access to Records Helps Fight Epidemics” http://www.nytimes.com/2012/06/19/health/states-using-electronic-medical-records-to-track-epidemics.html?_r=0 6/19/12 JM) health departments around the country have long scrutinized data from local hospitals for indications that diseases like influenza, tuberculosis, AIDS, syphilis and asthma might be on the rise, and to monitor the health consequences of heat waves, frigid weather or other natural phenomena. In the years since 9/11, this scrutiny has come to include signs of possible bioterrorism. When medical records were maintained mainly on paper, it could take weeks to find out that an infection was becoming more common or that tainted greens had appeared on grocery shelves. But the growing prevalence of electronic medical records has had an unexpected benefit: By combing through the data now received almost continuously from hospitals and other medical facilities, some health departments are spotting and combating outbreaks with unprecedented speed. More than one-third of the nation’s 5,000 Public acute care hospitals now use electronic medical records, and the share of primary care doctors using them has doubled to 40 percent in the last two years, said Dr. Farzad Mostashari, the technology’s spread is helping “officials faced with events of public health significance to know sooner, act faster and manage better,” said Dr. Seth Foldy, a senior adviser to the Centers for Disease Control and Prevention. In February, public health officials in Michigan noted an increase in electronic reports from clinical laboratories Obama administration’s national coordinator for health information technology. The indicating E. coli cases in several counties. Eleven patients were identified, including six who were hospitalized. In less than a week, officials had enough evidence to warn the public that the infection appeared to be linked to clover sprouts in food at the Jimmy John’s sandwich chain, said James Collins, director of the communicable diseases division at the state’s Department of You can see it happen in real time and zero in on the cause faster,” said David A. Ross, director of the Public Health Informatics Institute, a nonprofit organization that helps write digital standards. “That can save both lives and money.” In Massachusetts, the data are being used to prevent hepatitis infections. Medical labs transmit more than 100,000 electronic reports annually to the state health department. Names are confidential, though available to certain medical personnel. The agency’s software sorts through the reports and every year identifies more than 1,500 cases of hepatitis B for follow-up. Infected women ages 14 to 44 get special attention. Health officials alert their medical providers to infections; they in turn identify anyone who is pregnant or recently gave birth. Their newborns are vaccinated and then monitored. Without that prompt protection, those babies risk lifelong infection with hepatitis B and its Community Health. The chain quickly removed the sprouts, and by April, the 11-state outbreak was over. “ consequences, liver disease, cirrhosis and cancer. With paper records, locating at-risk babies would take weeks or months, said Kevin Cranston, director of the infectious disease bureau at the Massachusetts Department of Public Health. “That would be too late to be of benefit to the newborn,” he said. Although the C.D.C. recommends prompt hepatitis B vaccination for all When the H1N1 flu pandemic broke out in 2009, Wisconsin laboratories generated thousands of positive H1N1 test results, said Dr. Foldy, who was then chief medical officer of the Wisconsin Health Information Exchange. “We were able to route this electronically into our case management system to alert public health nurses,” Dr. Foldy said. “Because we were getting near real-time information from hospitals, we could see that even with the large numbers of emergency room visits for flulike symptoms, very few were being admitted as inpatients,” he added. This provided an early glimpse of how the pandemic was rising and then declining. Public health officials in Marion County, Ind., were among the first to sound the all-clear in the flu outbreak by tracking the drop in cases from electronic reports from hospitals and laboratories, forwarded by the Indiana Health Information Exchange. More than 150 health information exchanges are now operating or being set up across the country. (These differ from the insurance exchanges mandated under the Affordable Care Act.) Each exchange receives electronic medical data from clinical laboratories, hospital admissions offices and emergency rooms and relays it to relevant public health agencies. newborns, nationally, four in 10 did not get that protection, according to an agency report last year. Health care providers are required to provide pertinent data electronically to local and state public health officials, who feed into a national digital network coordinated by the C.D.C. in . Using an electronic records registry, the Urban Health Plan, a network of clinics in the South Bronx and Queens, was able to triple its caseload of mostly young, low-income asthma patients to 8,100. “We are in the heart of asthma country,” said Dr. Atlanta Samuel De Leon, a lung specialist who is Urban Health’s chief medical officer. His group compared spending per patient with a Medicaid managed care plan in the city that did not then have For children, we saved about 39 percent of the cost of care. For adults, savings were in the 25 percent range,” he said. New York City health officials began using electronic medical records six years ago. After reviewing the incoming medical data, city health department officials recently electronic monitoring. Using its record system to keep tabs on its patients, Dr. De Leon said, Urban Health was able to reduce emergency room visits and hospital admissions. “ discovered that smoking rates are a little higher in Staten Island than in the other boroughs. Now, instead of sending trainers on routine visits to every primary care doctor to help them learn to use electronic records to improve care, the visits are concentrated to help those physicians whose patients need it most. “ We can identify and monitor trends in high-priority diseases and health problems by geography and groups,” said Dr. Amanda Parsons, a deputy commissioner at the city’s Department of Health and Mental Hygiene. “We can tell where things are improving or getting worse. Bioterrorism – Impact Uniqueness Synthetic biology makes bioterror inevitable- creates means and motive Rose, 14 -- PhD, recognized international biodefense expert [Patrick, Center for Health & Homeland Security senior policy analyst & biosecurity expert, National Defense University lecturer, and Adam Bernier, expert in counter-terrorism, "DIY Bioterrorism Part II: The proliferation of bioterrorism through synthetic biology," CBRNePortal, 2-24-14, www.cbrneportal.com/diy-bioterrorism-part-ii-the-proliferation-of-bioterrorism-through-syntheticbiology/, accessed 8-16-14] In Part I of this series, we examined how the advancement of synthetic biology has made bio-engineering accessible to the mainstream biological community. Non-state actors who wish to employ biological agents for ill intent are sure to be aware of how tangible bio-weapons are becoming as applications of synthetic biology become more affordable and the probability of success increases with each scientific breakthrough. The willingness of non-state actors to engage in biological attacks is not a new concept; however, the past biological threat environment has been subdued compared to that of conventional or even chemical terrorism. The frequency and deadliness of biological attacks has, thankfully, been limited; much of which can be attributed to the technical complexity or apparent ineptitude of the perpetrators developing biological weapons. Despite the infrequency and ineffectiveness of biological attacks in the last four decades, the threat may be changing with the continued advancement of synthetic biology applications. Coupled with the ease of info rmation sharing and a rapidly growing do-it-yourself-biology (DIYbio) movement (discussed in Part I), the chances of not only , more attacks , but potentially more deadly ones will inevitably increase .¶ During the last half century terrorist organizations have consistently had an interest in using biological weapons as a means of attacking their targets, but only few have actually made a weapon and used it. The attraction is that terrorist activities with biological weapons are difficult to detect and even more difficult to attribute without a specific perpetrator claiming responsibility. Since 1971 there have been more than 113,113 terrorist attacks globally and 33 of them have been biological. The majority of bio-terrorism incidents recorded occurred during the year 2001 (17 of the 33); before 2001 there were 10 incidents and since 2001 there were 6 (not counting the most recent Ricin attacks). The lack of a discernable trend in use of bio-terrorism does not negate the clear intent of extremist organizations to use biological weapons. In fact, the capacity to harness biological weapons more effectively today only increases the risk that they will successfully be employed.¶ The landscape is changing : previously the instances where biological attacks had the potential to do the most harm (e.g., Rajneeshees cult’s Salmonella attacks in 1984, Aum Shinri Kyo’s Botulinum toxin, and Anthrax attacks in the early 90’s) included non-state actors with access to large amounts of funding and scientists. Funding and a cadre of willing scientists does not guarantee success though. The assertion was thus made that biological weapons are not only expensive, they require advanced technical training to make and are even more difficult to effectively perpetrate acts of terrorism with. While it is difficult to determine with certainty whether the expense and expertise needed to create biological weapons has acted as a major deterrent for groups thinking of obtaining them, many experts would argue that the cost/expertise barrier makes the threat from biological attacks extremely small. This assertion is supported by the evidence that the vast majority of attacks have taken place in Western countries and was performed by Western citizens with advanced training in scientific research.¶ In the past decade the cost/expertise assertion has become less accurate. Despite the lack of biological attacks, there are a number of very dangerous and motivated organizations that have or are actively pursuing biological weapons. The largest and most outspoken organization has been the global Al Qaeda network, whose leaders have frequently and passionately called for the development (or purchase) of Weapons of Mass Destruction (WMD). The principal message from Al Qaeda Central and Al Qaeda in the Arabian Peninsula (AQAP) has included the call to use biological WMDs to terrorize Western nations. Al Qaeda has had a particular focus on biological and nuclear weapons because of their potential for greatest harm. Osama Bin Laden, Ayman al-Zawahiri and Anwar al-Awlaki have all called for attacks using biological weapons, going so far as to say that Muslims everywhere should seek to kill Westerners wherever possible and that obtaining WMDs is the responsibility of all Muslims. Before the US-led invasion of Afghanistan, Al Qaeda had spent significant funds on building a bio-laboratory and had begun collecting scientists from around the world; however, the Afghanistan invasion and subsequent global War on Terrorism is thought to have disrupted their capabilities and killed or captured many of their assets. Despite the physical setbacks, this disruption does not appear to have changed the aggressive attitude towards obtaining WMDs (e.g., more recently U.S. Intelligence has been concerned about AQAP attempting to make Ricin).¶ The emergence of synthetic biology and DIYbio has increased the likelihood that Al Qaeda will succeed in developing biological WMDs . The low cost and significantly reduced level of necessary expertise may change how many non-state actors view bio logical weapons as a worthwhile investment. This is not to say that suddenly anyone can make a weapon or that it is easy. To the contrary making an effective biological weapon will still be difficult, only much easier and cheaper than it has been in the past.¶ The rapid advancements of synthetic bio logy could be a game changer , giving organizations currently pursuing biological weapons more options, and encouraging other organizations to reconsider their worth. Because the bar for attaining bio logical weapons has been lowered and is likely to continue to be lowered as more advances in biological technology are made, it is important that the international community begin to formulate policy that protects advances in science that acts to prevent the intentional misuse of synthetic biology. Disregard for this consideration will be costly. A successful attack with a potent biological weapon, where no pharmaceutical interventions might exist, will be deadly and the impact of such an attack will reverberate around the globe because biological weapons are not bound by international borders. Doctor-Patient Trust - Data Breach Inevitable Patient-Doctor relations low now Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB Healthcare information systems are largely viewed as the single most important factor in improving US healthcare quality and reducing related costs. According to a recent RAND study, the USA could potentially save $81B annually by moving to a universal Electronic Health Record (EHR) system (Hillestad et al., 2005). Not surprisingly, recent government initiatives have pushed for wide-scale adoption of universal EHR by 2014 (Goldschmidt, 2005). Yet, IT spending in healthcare sector trails that of many other industries, typically 3–5% of revenue, far behind industries like financial services where closer to 10% is the norm (Bartels, 2006). Anecdotal evidences from recent years suggest that a lack of adequate security measures has resulted in numerous data breaches, leaving patients exposed to economic threats, mental anguish and possible social stigma (Health Privacy Project, 2007). A recent survey in the USA suggests that 75% of patients are concerned about health websites sharing information without their permission (Raman, 2007). Possibly, this patient perception is fuelled by the fact that medical data disclosures are the second highest reported breach (Hasan and Yurcik, 2006). In response to these increasing threats to health information and privacy, new regulations at both the state and the federal level have been proposed in the USA, e.g., Health Insurance Portability and Accountability Act (HIPAA). Medical identity theft is an expanding issue that current legal protections fail to prevent Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 8-10 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz With a legislative requirement to notify a data subject of a data breach, the data custodian’s duty is triggered upon loss of control of the data, making a breach notification rule the definitive downstream protective model. Breach notification laws proliferated because of the dramatic increase in identity theft.27 Although all federal agencies are subject to a robust breach notification policy,28 federal legislation to cover private parties has been proposed but not yet passed.29 In contrast, and in the decade following California’s 2002 example, forty-six states and the District of Columbia have enacted breach notification laws.31 More recently attention has turned to medical identity theft.32 It has been argued that medical identities are highly valued by criminals because of the comprehensive data that are contained in, for example, a stolen electronic medical record (EMR).33 A 2006 report from The World Privacy Forum focused attention on the issue,34 and in 2009 the Office of the National Coordinator for Health Information Technology (ONC) commissioned a study on the subject from Booz Allen Hamilton.35 Today both HHS’s Office of Inspector General36 and the Federal Trade Commission 37 web sites have information pages concerning medical identity theft. According to a 2012 Ponemon Institute study, 52% of health care organizations experienced one or more incidents of medical identity theft. The 2013 Survey on Medical Identity Theft (also conducted by the Ponemon Institute) estimated a 19 per cent increase in medical identity theft victims year-to-year.39 Relatively few states include health data within their definition of the personal information subject to breach notification. Others, true to the US sector-based approach to privacy regulation, exclude data covered by, say, HIPAA or the Gramm-Leach-Bliley Act of 1999 (GLBA).41 HITECH introduced two closely related breach notification regimes. The first, introduced by section 13402, requires HIPAA covered entities and HIPAA BAs to provide notification following a breach of “unsecured protected health information.”44 The second, courtesy of section 13407, imposes a similar duty on vendors of personal health records (PHR) 45 and their third party service providers 46 with regard to “Unsecured PHR Identifiable Health Information.”47 Rulemaking authority and enforcement are vested in the HHS regarding the former and the (Federal Trade Commission) FTC regarding the latter. The regulation of PHRs is a limited (but ultimately unsuccessful) attempt to expand health data protection from a narrow sector provider based model (e.g., information held by a covered entity) to a data-type based model. Unfortunately it stopped short of a broad datatype model (e.g., by protecting the data itself held by any data custodian), limiting the custodian cohort to PHR providers.49 It is an interesting question why HITECH added a breach notification data protection model. Certainly medical identity theft was being raised as an issue.50 As likely this rethinking of the approach to data protection may have been triggered by the expansion of personal health records services offered by non-health companies such as Google Inc.51 Maybe the HITECH architects could not agree on a way to open up the broader and established HIPAA model to apply to nontraditional custodians of health data (BAs aside) and so had to settle on a new but limited data protection model as the legislative alternative. Notwithstanding, the result was that HITECH authorized regulatory activity by the FTC that would mirror the work of HHS in the more narrowly defined, traditional health space. Ironically, however, by the time HITECH was passed the PHR business was slowing and Google Health, the PHR poster-child, soon would be closed.52 Healthcare data breaches are inevitable Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB These attackers may have resources ranging from modest financial backing and computing skills to a well-funded infrastructure. Additionally, the nature of the threats typically depends on the technical capability of the attackers. Moreover, with the growing underground cyber economy (Knapp and Boulton, 2006), an individual possessing adequate financial resources and with the intent to acquire data may be able to buy the services of sophisticated hackers to breach healthcare data. Government Access to records greatly expands the risk of data disclosure Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB Although health information privacy has been widely discussed in the social science and business press (Etzioni, 1999), the academic literature lacks systematic investigation to identify and classify various sources of threats to information privacy and security. Recent policy-based studies (such as NRC, 1997; Rindfleisch, 1997) broadly categorise privacy threats, or source of information security, into two areas: 1 organisational threats that arise from inappropriate access of patient data by either internal agents abusing their privileges or external agents exploiting a vulnerability of the information systems 2 systemic threats that arise from an agent in the information flow chain exploiting the disclosed data beyond its intended use (NRC, 1997). Organisational Threats: These threats assume different forms, such as an employee who accesses data without any legitimate need or an outside attacker (hacker) that infiltrates an organisation’s information infrastructure to steal data or render it inoperable. At the outset, these organisational threats could be characterised by four components: motives, resources, accessibility and technical capability (NRC, 1997). Government will leak private data Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB Recent studies suggest that the broad spectrum of organisational threats could be categorised into five levels, listed in increasing order of sophistication (NRC, 1997): • Accidental disclosure: Healthcare personnel unintentionally disclose patient information to others (e.g., e-mail message sent to wrong address or inadvertent web-posting of sensitive data). • Insider curiosity: An insider with data-access privilege pries upon a patient’s records out of curiosity or for their own purpose (e.g., a nurse accessing information about a fellow employee to determine possibility of a sexually transmitted disease or medical personnel accessing potentially embarrassing health information about a celebrity and transmitting it to the media). • Data breach by insider: Insiders access patient information and transmit it to outsiders for profit or revenge. • Data breach by outsider with physical intrusion: An outsider enters the physical facility either by coercion or forced entry and gains access to the system. • Unauthorised intrusion of network system: An outsider, including former employees, patients, or hackers, intrudes into an organisation’s network from the outside to gain access to patient information or render the system inoperable. Systemic Threats: Etzioni (1999), in discussing the ‘limits to privacy’, observed that a major threat to patient privacy occurs, not from outside of the information flow chain, but from insiders who are legally privileged to access patient information. For example, insurance firms may deny life insurance to patients based on their medical conditions, or an employer having access to employees’ medical records may deny promotion or terminate employment. Patients or payer organisations may incur financial losses from fraud including upcoding of diagnoses or for rendering medically unnecessary services. They cant solve --- technological advances make illegal dissemination unpreventable Ruebner and Reis, professor former professor of law at The John Marshall Law School, 1/1/2004 – (Ralph, Leslie, “Hippocrates to HIPAA: A Foundation for a Federal Physician-Patient Privilege, 77 Temp. L. Rev. 505 (2004)”, published in the Temple Law Review at The John Marshall Law School)//roetlin HHS commented on the inherent conflict between technology and privacy, in particular, the connection between the increasing use of interconnected electronic information systems in the health care context and the loss of health information privacy. 6 3 In doing so, HHS emphasized the fact that advances in technologies used to collect and disseminate patient health information have "reduced or eliminated many of the financial and logistical obstacles that previously served to protect the confidentiality of health information and the privacy interests of individuals." 6 4 Simply, the pervasiveness of and access to medical information in electronic form creates the likelihood that such information will be wrongfully disclosed or used in a manner that may harm the patient. 6 5 Technological advancements in information systems "may provide a reason for institutionalizing privacy protections in situations where the risk of harm did not previously justify writing such protections into law." 6 6 Heath information data breaches inevitable now – triggers all aff links New York Times April 2015 “Patients' Medical Records Under Threat From Data Breaches” http://www.nytimes.com/aponline/2015/04/14/health/ap-us-med-breached-health-records-.html Your private medical information is under threat. That's according to a study that found almost 30 million health records nationwide were involved in criminal theft, malicious hacking or other data breaches over four years. The incidents seem to be increasing. Compromised information included patients' names, home addresses, ages, illnesses, test results or Social Security numbers. Most involved electronic data and theft, including stolen laptops and computer thumb drives. The study didn't examine motives behind criminal breaches, or how stolen data might have been used, but cyber-security experts say thieves may try to use patients' personal information to fraudulently obtain medical services. Cases that didn't involve malicious intent included private health information being inadvertently mailed to the wrong patient. Hackings doubled during the study, from almost 5 percent of incidents in 2010 to almost 9 percent in 2013. Hackings are particularly dangerous because they can involve a high number of records, said Dr. Vincent Liu, the lead author and a scientist at Kaiser Permanente's research division in Oakland, California. "Our study demonstrates that data breaches have been and will continue to be a persistent threat to patients, clinicians, and health care systems," Liu said. The study appears in Tuesday's Journal of the American Medical Association. A JAMA editorial says there's evidence that the incidents are leading some patients to avoid giving doctors sensitive information about their health, including substance abuse, mental health problems, and HIV status. "Loss of trust in an electronic health information system could seriously undermine efforts to improve health and health care in the United States," the editorial said. Patients should be alert to cyber threats, including "phishing" emails from hackers posing as doctors, hospitals or health insurance companies, said Lisa Gallagher, a cybersecurity expert at the Healthcare Information and Management Systems Society. Those messages require clicking on a link to get information, and patients should instead should call the purported sender to verify whether the email is legitimate, she said Patients should also double check doctor bills and other insurance company information. "Don't throw away your explanation of benefits. Take a look at them," Gallagher said. "If you see care that wasn't provided to you, or dates and names of providers that don't make sense, go to the provider and report that." For the study, Liu and colleagues analyzed an online database regulated by the U.S. Department of Health and Human Services and containing mandated reports of breaches in health information protected by federal privacy law. Over the four years, 949 data breaches were reported across the country. The numbers climbed annually, from 214 in 2010 to 265 in 2013. Nearly 60 percent involved theft. Doctor-Patient Turst – Privacy Not Key Patients don’t actually expect privacy Appari and Johnson 10, ( Ajit, Eric, Tuck School of Business, “Information security and privacy in healthcare: current state of research,” Dartmouth, 4, 2010, http://www.ists.dartmouth.edu/library/501.pdf)//IB Bansal et al. (2007) developed a set of constructs based on utility theory and prospect theory as antecedents of trust formation and privacy concern that impact users’ personal disposition to disclose their health information to online health websites. In particular, they reported that users’ current health status, personality traits, culture, and prior experience with websites and online privacy invasions play a major role in users’ trust in the health website and their degree of privacy concerns. On the other hand, in a mail-based survey with adult patients in England, Campbell et al. (2007) found that about 28–35% of patients are neutral to their health information – such as age, gender, ethnicity, reason for treatment, medical history, personal habits impacting health, type of treatment obtained, side effects of treatment – being used by physicians for other purpose. Only about 5–21% of patients, however, expected to be asked for permission to use their information by their physicians. Similarly, only about 10% of the patients expected to be asked for permission if their doctors used their health information for a wide variety of purposes, including combining data with other patients’ data to provide better information to future patients, sharing treatment outcomes with other physicians, teaching medical professionals and writing research articles about diseases and treatments. No internal link – patients don’t care McCarthy 15 (Kevin McCarthy covers healthcare tech and policy regulations, “Why EHRs do not harm the doctor-patient relationship” 6/3/15 http://www.nuemd.com/news/2015/06/03/ehrs-do-not-harm-doctor-patient-relationship) It's no secret that the road to widespread implementation of electronic health records has been a difficult one for some clinicians. While large providers may have had the capital to throw at a problem like staff training and new equipment purchases, small practices were faced with financial and operational issues that, while challenging, proved not to be as unsolvable as some critics had predicted. According to the U.S. Centers for Medicare and Medicaid Services, over 447,000 providers have implemented and been compensated for EHR systems in their offices.¶ Now that EHR software has become a large part of the medical industry, experts have turned their gazes back to an issue that dominated the discussion when federal agencies first started pushing the platform as reform alternative. The question of how EHRs affect the physician-patient relationship can seem simple at times - more screens separating clinicians from their patients can only seem wrong - but, as EHR Intelligence explained, the underlying factors may point to a different and more positive interpretation for EHRs in the workplace.¶ Office manners¶ The doctor-patient relationship goes all the way back to the days when house calls and personal physicians were only the domain of the super wealthy. Today, every patient has a right to expect their doctors to be open, polite, informative, and, most of all, confidential. Such a natural relationship fosters trust between both parties, and when outpatient treatments are the only ones possible, this level of mutual respect is necessary for both sides to move toward a positive care outcome.¶ However, with the rise of EHRs, especially on mobile devices, creating a meaningful doctor-patient relationship isn't as easy as it used to be. In an interview with EHR Intelligence, James Avallone, director of physician research for Manhattan Research, explained that EHR use is most certainly up, but its impact on the personal dynamics between patients and doctors is much less clear.¶ "Whether it is too much or too little, it is difficult for us to say from our perspective," Avallone said. "In the past four to five years, we have seen a fair share of complaints in terms of the efficiency of EHRs and how [they are] changing bedside manners for physicians overall. I do think we are starting to see some efficiencies come about in terms of efficient use of these platforms and that includes at the point of care. It is certainly something that physicians are getting used to as it becomes more ingrained in their day-to-day behaviors. They have had more time to streamline workflow and that is something that we are seeing in terms of how these devices are being used at the point of care."¶ Avallone noted that research from a recent Manhattan study found that 66 percent of physicians self-reported as being more efficient with their EHRs than in the past. While part of this may be due to a greater sense of familiarity with the product and how to fit it into workflows, EHR vendors have also caught up with the trends of the day by developing software that intuitively meshes with physicians' daily tasks.¶ A minor annoyance¶ While EHRs may be an easy target for opponents of the technology, studies show that EHRs are not a top concern among physicians who are worried about losing the trust and goodwill of their patients.¶ According to a 2013 study published in Health Affairs, only 25.8 percent of physicians reported that EHRs were threatening the doctor-patient relationship. Administrative burdens like the ICD-10 transition and HIPAA compliance regulations, on the other hand, were noted by more than 41 percent of those surveyed. ¶ If industry experts are truly concerned about protecting the quality of the doctor-patient relationship, then EHR software should not be the primary focus. Instead, it should be highlighted during discussions with patients to show them just how powerful it can be. From there, patients may not care so much about the time doctors spend inputting their information into a piece of software that could save their lives. Healthcare privacy is not key to trust Dan Munro (Writer for Forbes and Quora specializing in healthcare related topics) November 2014 “Trust Trumps Privacy In Battle For Patient Health Data” http://www.forbes.com/sites/danmunro/2014/11/09/trust-trumps-privacy-in-battle-for-patient-healthdata/ There’s no shortage of advocates on behalf of the “free your health data” movement. The keywords, of course, are “ your,” “health data” and “free” (as in donating your health data for the global benefit of clinical research). The latest demand was an article that appeared last week in Wired ‒ You Should Share Your Health Data: Its Value Outweighs The Privacy Risk by Beth Seidenberg, MD (a partner at the venture firm Kleiner Perkins Caufield & Byers). Dr. Seidenberg’s medical credentials are definitely compelling (including Chief Medical Officer of Amgen AMGN -0.82%), but it’s always a red flag to me when a total stranger (especially one with medical credentials) boldly demands that I “should” do anything online ‒ with my health ‒ which includes my health data. While Dr. Seidenberg’s demand is noble in the conclusion that we can all benefit from the clinical research, her argument is based squarely on the false premise that privacy is the largest gating factor in the reluctance of consumers (or patients) to share their health data. I’m sure that privacy is a reason for many, but it’s certainly not for me. I know just how easy all health data can be breached ‒ and wrote about it earlier this year when I logged onto the network of a 300+ bed hospital using just a browser and my desktop PC (here). It’s not that the electronic door to the hospital was unlocked ‒ or even open. There was simply no door at all. The only thing missing was a banner ad saying “Click here for free health data.” The larger trend for health data breaches (including this year’s 2nd largest ever ‒ 4.5 million by CHS) is alarming. But risk of data breach ‒ cloaked as ‘privacy’ ‒ is not the issue. At least it’s not mine. The issue I see is much larger ‒ trust. Given the importance of getting this priority right, it’s really tone deaf for anyone anywhere to demand that we do anything with our personal health data. Dr. Seidenberg’s demand makes sense, of course, because the interests of venture capitalists are well aligned with many commercial interests in healthcare ‒ much of which has been optimized around revenue and profits ‒ not safety and quality. The lack of trust I see is clearly evident in countless stories of courageous patients, battling openly (almost entirely at their own expense) for access to their health data. Privacy issues (and HIPAA) are often cited as the legal reason for prohibiting access, of course, but that’s just an excuse. Absent data security (clearly evident) there is no privacy and the real reason masquerading behind these false claims isn’t privacy protection ‒ it’s revenue protection. This isn’t just hospitals. The data battle for many patients encompasses medical device manufacturers, pharmaceutical companies and electronic health record vendors too. Our collective rights as patients are entirely secondary ‒ if at all. Here’s one example that appeared just yesterday in the New York Times ‒ Medical Records: Top Secret (by Elisabeth Rosenthal). The story outlines the continuing case of Mr. Drier ‒ a patient Ms. Rosenthal wrote about previously who was billed $117,000 after a 3‒hour neck surgery. Mr. Drier’s efforts to get his health record (for ongoing management of his health condition) resulted in this summary: The six-week ordeal included requests that needed to be made via regular mail, numerous phone calls, consent forms and an estimate for copying fees that totaled $100. This was topped off by an actual visit to the hospital by Mr. Drier, who sat in an office until he had paper documents in hand. The problem is enormous ‒ and longstanding. The above example is simply one case that highlights what little progress we’ve made in the course of 5 years. I reference that timeframe because this last September marked the 5‒year anniversary of Dave deBronkart’s battle cry at the Medicine 2.0 event in Toronto. He opened his keynote with this slide. Working with his physician ‒ Dr. Danny Sands ‒ he was finally able to download his health record electronically. The data that came into view, however, was largely based on billing records and loaded with inaccuracies (including the fact that an x‒ray from 2003 identified him as a 53 year‒old woman). He summarized his experience with transferring his health data into Google GOOGL +1.71% Health (now defunct) this way: In other words, the data that arrived in Google Health was essentially unusable. Dave deBronkart ‒ Imagine someone had been managing your data, and then you looked ‒ April, 2009 Hugo Campos is another example. Hugo continues to work tirelessly on getting access to the data from the cardiac defibrillator inside his own chest. His TEDxCambridge talk highlights his dilemma and his ongoing battle with Medtronic MDT -0.73% for access to the data his own heart generates ‒ again to manage his own health. Like other device manufacturers, Medtronic believes they should own the data ‒ and patients who actually generate the data have no legal rights. The ICD device collects a lot of data about its own function and about the patient’s clinical status. It’s a pretty complex little computer, but unfortunately, none of this very valuable data is made available to the patient who originates it. The best we can do is get a print-out or a hardcopy of an interrogation report (typically at 6 or 12 month intervals). These reports are designed for doctors ‒ not really for patients ‒ so a lot of patients are discouraged from even getting this information. It’s hard to read.” Hugo Campos ‒ TEDxCambridge 2011 Earlier this year, I wrote about Anna McCollister‒Slipp and her battle with the data that she needs to manage her Type 1 diabetes. So I have all of this incredible information literally 24/7 – not just from my prescription medical devices – but also from my Fitbit, from a Bluetooth blood pressure monitor, from my digital scale and from a variety of different iPhone apps that are used for nutrition tracking etc. None of it connects. They’re all in completely different data streams, and even though each of them provides something that would be an incredibly vital element for me to truly understand how to manage my disease, how to predict when I need to change insulin in response to exercise, or stress, or schedule changes, or whatever the case may be – I can’t get that information all in one place. Even though it’s electronic – even though it’s all downloadable in one form or another – it’s all on different platforms, different computing systems and it doesn’t work together. Anna McCollister‒Slipp ‒ The View Of Digital Health From An Engaged Patient These are just a few examples ‒ there are millions more ‒ most of which will remain forever silent for reasons of personal privacy (or embarrassment) and they all exist because the business models don’t support sharing data with the people who create it in the first place ‒ patients. Venture capitalists are notably absent when it comes to funding any patient‒centered solutions because there’s simply no way to avoid the first question ‒ who pays? Healthcare needs our clinical (and genetic) data for the purpose of advancing diagnosis and treatment of disease. I get that. What’s hard to believe is the misaligned priority of demanding our health data in advance of important efforts to break down the impenetrable barriers of our own access ‒ to our own data. Tone deaf may be a harsh characterization, but if it doesn’t apply here ‒ where does it? There is no question that all this data has enormous value, but getting the priority right makes all the difference in establishing trust. As Dr. Peter Diamandis suggested in his keynote at CHIME earlier this month, “privacy is dead.” Whether he’s right or not is immaterial. Trust most certainly isn’t dead ‒ and that trumps privacy everywhere. Especially in healthcare. Beth Seidenberg (M.D. general partner with Kleiner Perkins Caufield & Byers) November 2014 “You Should Share Your Health Data: Its Value Outweighs the Privacy Risk” http://www.wired.com/2014/11/on-sharing-your-medical-info/ Single issue focus under patient-physician trust is flawed - key issues constantly shift Steven Pearson and Lisa Raeke (Center for Ethics in Managed Care, Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass) 2000 “Patients' Trust in Physicians: Many Theories, Few Measures, and Little Data” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1495476/ The importance of trust in patient-physician relationships is not questioned, but our understanding of it has depended largely on the passionate thoughts and anecdotes of physicians who cherish the special bond they feel with their patients. For practicing clinicians and for those who teach medical students and residents, the elements of physician behavior that foster trust can continue to reflect the instincts of physician-theorists: competence, compassion, reliability, integrity, and open communication. A widely accepted empirical conceptualization and understanding of trust is yet to come. In recent years, other complex and once believed intangible concepts, those of “satisfaction”24,25 and “health status,”26,27 have yielded to rigorous qualitative and quantitative research, and investigators and policy leaders now have standardized instruments with which to measure these concepts in a wide variety of health care settings. Although attempts to operationalize patient-physician trust are in their infancy, with models emerging recently through the effort of investigators such as Kao and Safran, a refinement and convergence of techniques may soon allow trust to be measured and discussed as routinely and rigorously as many other elements of health care. For patient-physician trust to be strengthened, our ability to measure the mediators and outcomes of trust must mature. However, a single measure of patient trust is unlikely to achieve long-lasting predominance, nor should it. The evolving nature of the health care system will continue to cast new light on patient-physician relationships. There will be new threats to trust that appear on the horizon, while other threats will be perceived to fade in importance. Much as the threat of overly paternalistic physicians provided the chief concern in the 1970s, researchers are now more interested in measuring patients' concerns about physicians' conflict of interest in the setting of strong financial incentives. As the focus of measures of trust have evolved, from the earliest measure of Dedrick and Anderson to the latest measure of Kao et al., measures of patientphysician trust must also continue to evolve to address changes in the health care system and in how our society views the key elements of trust. Doctor-Patient Trust - Uniqueness Doctor-Patient trust high now Gregory Giroux (writer for Bloomberg Business News) July 14, 2014 “Doctors Running for Congress Ditch Suits for White Coats” www.bloomberg.com/news/2014-07-14/doctors-running-for-congressditch-suits-for-white-coats.html It’s no accident: polls show nurses and doctors are among the most trusted people in America. Politicians are among the least trusted. All three commercials for Monica Wehby, an Oregon Republican seeking to unseat Democratic Senator Jeff Merkley, have shown her in a hospital setting. “As a pediatric neurosurgeon, I know firsthand how devastating Obamacare is for Oregon families and patients,” Wehby said in one of her ads, which was interspersed with footage of the candidate in surgical scrubs. The “Grey’s Anatomy” backdrop comes as Republicans seek to gain control of the U.S. Senate and, with their House majority counterparts, pass a law repealing 2010’s Affordable Care Act. The quest is gaining urgency as Americans become more accepting of the law. Republicans need a net gain of six seats for a Senate majority. Fifty-three percent of Americans oppose the law, though just 32 percent say it should be repealed, according to a Bloomberg National Poll last month. Fifty-six percent say they want to keep Obamacare with “small modifications.” Wardrobe Messaging The latest wardrobe preferences for political ads also put distance between some candidates and the unpopular Congress they are seeking to join. About 82 percent of Americans say nurses have a “high or very high level” of honesty and ethical standards, the top spot among 22 professions rated in a December Gallup survey. Pharmacists were tied for second at 70 percent, and medical doctors were tied with military veterans for fourth at 69 percent. Medical professionals have high approval ratings because people view them as “primary care-givers,” said Frank Newport, Gallup’s editor-in-chief. Doctor-Patient Truest – Uniqueness o/w Link Doctor-Patient trust is at an all-time low – suspicion is deep-rooted and privacy doesn’t solve Fiaz Fazili (M.D., King Fahad Hospital Medina La Munawarah Kingdom Of Saudi Arabia, Surgery; Minimal invasive and acute acre) June 16, 2015 “A Lost Trust” http://www.greaterkashmir.com/news/opinion/story/189486.html Medicine still is a noble profession. To most of us, medicine is more than a job of care providing- putting patients' interest first. Unfortunately, in quest of big business, nobility of noble this profession is vanishing, and the doctor-patient trust is running all time low. Sadly, there is a general perception in public that the ethics of medical profession have degenerated, Doctors are accused of not attending to patients with same zeal and compassion as it used to be. Contrarily, in their own private clinic attitudes often are different. There is a conflicts of Interest. Is your doctor paid to promote a drug or device? Are doctors prescribing what is best for you? Today, patients, or their relatives carry a lot of prejudice and preconceived notions when they enter a doctor's chamber for consultation; a mindset of suspicions that doctors also behave like businessmen. Recognition and avoidance of conflicts of interest represent a core issue of professionalism, and are well covered in State and Indian medical council bye-laws of, as most of our doctors are honest, follow the rules, avoiding situations in which the interest of the doctor is placed above that of the patient. Honesty is a major concern in medical ethics and carries an important value for a medical practitioner where doctor is perceived as a messiah – a healer. Quality of care varies dramatically between individual doctors and hospitals, but those differences are invisible to patients. Whether it is a systemic failure, lack of uniformity in standards of care, organizational disarray, trust deficit or attitude problem. A number of common problems arise within the 'expectation zone', environment, and circumstances. Valley medicos often cry insecurity, seek action and protection from concerned authorities. Isn't it time to lift the veil on this sad reality for finding some important remedial measures to restore the dignity, honor and trust of overwhelming majority of the doctors who don’t succumb to kickbacks or other lucrative incentives from pharmaceutical companies, who are unwilling to prescribe a drug, or implant a device, refusing facilitation for conferences, symposiums and research? Generalizing a statement, doctors fleecing patients in their private clinics or nursing home, is a myth in our valley when you compare similar circumstances outside the state. Agreeably, there might be a few even in our state who disgrace the profession, as there are in any profession but factually majority of doctors are altruistic. I don't say that all doctors are like priests, not driven by a greed. Some among us do resort to practices that are unethical practices to make money. This menace once limited to corporate hospitals is now infiltrating the state administered hospitals through these dishonest elements who need to be identified and let the writ of law take its course. My humble appeal goes to public and patients for change in perception, don’t look through tainted glasses on this profession. Our dedicated, intelligent health care staff need recognition of for the hard work they do. Doctor-Patient Trust – A2 Disease Impacts Status quo solves – antifolates – breakthroughs have already happened and are going to trials Colin Poitras (writer for the UConn Today) July 23, 2014 “Possible Breakthrough in Battle Against Drug-Resistant Diseases” http://today.uconn.edu/blog/2014/07/possible-breakthrough-in-battleagainst-drug-resistant-diseases/ In the war against drug-resistant diseases and so-called “superbugs”, the family of bacteria known as CREs are a particularly nasty bunch. The bacteria, whose scientific name is carbapenem-resistant Enterobacteriaceae – include notorious strains of E. coli and Klebsiella and are a constant health concern in hospitals and nursing homes, where the germs breed in ventilators, catheters, and intravenous lines. CREs have been flagged as an “urgent threat” by the Centers for Disease Control and Prevention because of their strong resistance to antibiotics and easy transmission between humans. Some CRE bacteria are resistant to all known antibiotics. The mortality rate is high. As many as 50 percent of patients infected with CRE bacteria die because there is no drug to fight them. But two UConn scientists may be gaining new ground against the public health threat. Professors Amy Anderson and Dennis Wright, along with their students in the School of Pharmacy, have developed a group of drug compounds that appear to be particularly effective against CREs in early tests. A lead is a preliminary molecule that shows promise and is poised for further development. The potent compounds – part of a group of drugs known as antifolates – were a long time coming for the two, who have been searching for effective treatments for drug-resistant diseases like MRSA, E. coli, and Klebsiella pneumoniae for more than 10 years. Working with drug-resistant strains is particularly challenging for researchers, as the diseases constantly morph and evolve to fend off attacks to kill them. “It has been a holy grail to kill these types of CREs,” says Anderson, a professor of medicinal chemistry and interim head of the Department of Pharmaceutical Sciences. “These (CRE) bacteria have an extra thick, tight membrane meshed with proteins that makes it very hard for drugs to penetrate. We’ve spent years trying.” After testing hundreds of different compounds, delicately altering each one’s chemical structure with the hope of finding the magic recipe that would serve as a CRE knockout blow, Anderson and Wright recently started seeing positive results in one particular group. ‘Our goal was to inhibit a certain enzyme in the bacteria so it can’t function and the bacteria can’t survive,” Anderson says. “When we finally got a very potent inhibition of the enzyme, that was definitely a eureka moment.” The pair recently received a five-year, $2.7 million grant from the National Institutes of Health to further study these compounds and prepare them for clinical trials. Together, Anderson’s and Wright’s labs have received more than $10 million in federal research support since they began working on the project. Wright, a professor of medicinal chemistry, synthesizes the new drugs; Anderson evaluates them and determines the atomic details of how they interact with their intended target . “We want to make compounds that are potent inhibitors of the growth of the bacteria and at the same time are safe, with good drug properties, so down the line they will be effective when used at a clinic,” says Wright. At this stage in the research, Anderson and Wright are trying to learn more about the physical and chemical processes that allow their compounds to penetrate the armor-like coating around CREs when so many others have failed. Understanding why their compounds are working may allow them to apply the same biological chemistry to different compounds that could be used to fight other persistent infections. Associate professor of pharmacy practice Jeffrey Aeschlimann from UConn Health is helping with the CRE drug characterizations. University of Montana professor of chemistry Nigel Priestley is assisting with testing in early animal pre-clinical trials. “Right now, what makes our compounds attractive is that they seem to have a very low rate of resistance,” says Wright. “We’ve made compounds that are very hard for these CREs to fend off.” Recently discovered fungus Catholic Online July 2014 “How one fungus may stop superbugs” http://www.catholic.org/news/health/story.php?id=56093 Scientists at McMaster University in Ontario discovered a compound that instantly turned off a gene in several harmful bacteria that made them highly resistant to treatment with a class of antibiotics used to fight so-called suberbug infections. There are still thousands of children who need just one light in the darkness. Aspergillomarasmine A (AMA), was the compound that was found in a soil sample extracted from a common fungus found in soil and mold. Antibiotic resistance is a growing public-health threat. Common germs such as Escherichia coli (E. coli) are becoming harder to treat because of increasing immunities to common antibiotics. In the United States alone, some two million people are infected with antibiotic-resistant diseases, and around 23,000 die as a result, according to information released from the Centers for Disease Control and Prevention (CDC). The World Health Organization (WHO) has called antibiotic resistant a threat to global public health. Using the compound, the Canadian team was able to disarm a gene-New Delhi Metallo-beta-Lactamase-1 (NDM-1) that has become the WHO's number one enemy since it was discovered in 2009. , "Discovery of a fungus capable of rendering these multidrug-resistant organisms incapable of further infection is huge " said Irena Kenneley, a microbiologist and infectious disease specialist at Frances Payne Bolton School of Nursing at Cleveland's Case Western Reserve University. "The availability of more treatment options will ultimately save many more lives." Squo solves Anne Trafton (writer for the MIT News Office) September 21, 2014 “Battling superbugs” http://newsoffice.mit.edu/2014/fighting-drug-resistant-bacteria-0921 In recent years, new strains of bacteria have emerged that resist even the most powerful antibiotics. Each year, these superbugs, including drug-resistant forms of tuberculosis and staphylococcus, infect more than 2 million people nationwide, and kill at least 23,000. Despite the urgent need for new treatments, scientists have discovered very few new classes of antibiotics in the past decade. MIT engineers have now turned a powerful new weapon on these superbugs. Using a gene-editing system that can disable any target gene, they have shown that they can selectively kill bacteria carrying harmful genes that confer antibiotic resistance or cause disease. Led by Timothy Lu, an associate professor of biological engineering and electrical engineering and computer science, the researchers described their findings in the Sept. 21 issue of Nature Biotechnology. Last month, Lu’s lab reported a different approach to combating resistant bacteria by identifying combinations of genes that work together to make bacteria more susceptible to antibiotics. Lu hopes that both technologies will lead to new drugs to help fight the growing crisis posed by drug-resistant bacteria. “This is a pretty crucial moment when there are fewer and fewer new antibiotics available, but more and more antibiotic resistance evolving,” he says. “We’ve been interested in finding new ways to combat antibiotic resistance, and these papers offer two different strategies for doing that.” Cutting out resistance Most antibiotics work by interfering with crucial functions such as cell division or protein synthesis. However, some bacteria, including the formidable MRSA (methicillin-resistant Staphylococcus aureus) and CRE (carbapenem-resistant Enterobacteriaceae) organisms, have evolved to become virtually untreatable with existing drugs. In the new Nature Biotechnology study, graduate students Robert Citorik and Mark Mimee worked with Lu to target specific genes that allow bacteria to survive antibiotic treatment. The CRISPR genome-editing system presented the perfect strategy to go after those genes. CRISPR, originally discovered by biologists studying the bacterial immune system, involves a set of proteins that bacteria use to defend themselves against bacteriophages (viruses that infect bacteria). One of these proteins, a DNA-cutting enzyme called Cas9, binds to short RNA guide strands that target specific sequences, telling Cas9 where to make its cuts. Lu and colleagues decided to turn bacteria’s own weapons against them. They designed their RNA guide strands to target genes for antibiotic resistance, including the enzyme NDM-1, which allows bacteria to resist a broad range of beta-lactam antibiotics, including carbapenems. The genes encoding NDM-1 and other antibiotic resistance factors are usually carried on plasmids — circular strands of DNA separate from the bacterial genome — making it easier for them to spread through populations. When the researchers turned the CRISPR system against NDM-1, they were able to specifically kill more than 99 percent of NDM-1-carrying bacteria, while antibiotics to which the bacteria were resistant did not induce any significant killing. They also successfully targeted another antibiotic resistance gene encoding SHV-18, a mutation in the bacterial chromosome providing resistance to quinolone antibiotics, and a virulence factor in enterohemorrhagic E. coli. In addition, the researchers showed that the CRISPR system could be used to selectively remove specific bacteria from diverse bacterial communities based on their genetic signatures, thus opening up the potential for “microbiome editing” beyond antimicrobial applications. To get the CRISPR components into bacteria, the researchers created two delivery vehicles — engineered bacteria that carry CRISPR genes on plasmids, and bacteriophage particles that bind to the bacteria and inject the genes. Both of these carriers successfully spread the CRISPR genes through the population of drug-resistant bacteria. Delivery of the CRISPR system into waxworm larvae infected with a harmful form of E. coli resulted in increased survival of the larvae. The researchers are now testing this approach in mice, and they envision that eventually the technology could be adapted to deliver the CRISPR components to treat infections or remove other unwanted bacteria in human patients. “This work represents a very interesting genetic method for killing antibiotic-resistant bacteria in a directed fashion, which in principle could help to combat the spread of antibiotic resistance fueled by excessive broad-spectrum treatment,” says Ahmad Khalil, an assistant professor of biomedical engineering at Boston University who was not part of the research team. High-speed genetic screens Another tool Lu has developed to fight antibiotic resistance is a technology called CombiGEM. This system, described in the Proceedings of the National Academy of Sciences the week of Aug. 11, allows scientists to rapidly and systematically search for genetic combinations that sensitize bacteria to different antibiotics. To test the system, Lu and his graduate student, Allen Cheng, created a library of 34,000 pairs of bacterial genes. All of these genes code for transcription factors, which are proteins that control the expression of other genes. Each gene pair is contained on a single piece of DNA that also includes a six-base-pair barcode for each gene. These barcodes allow the researchers to rapidly identify the genes in each pair without having to sequence the entire strand of DNA. “You can take advantage of really high-throughput sequencing technologies that allow you, in a single shot, to assess millions of genetic combinations simultaneously and pick out the ones that are successful,” Lu says. The researchers then delivered the gene pairs into drug-resistant bacteria and treated them with different antibiotics. For each antibiotic, they identified gene combinations that enhanced the killing of target bacteria by 10,000- to 1,000,000-fold. The researchers are now investigating how these genes exert their effects. “This platform allows you to discover the combinations that are really interesting, but it doesn’t necessarily tell you why they work well,” Lu says. “This is a high-throughput technology for uncovering genetic combinations that look really interesting, and then you have to go downstream and figure out the mechanisms.” Once scientists understand how these genes influence antibiotic resistance, they could try to design new drugs that mimic the effects, Lu says. It is also possible that the genes themselves could be used as a treatment, if researchers can find a safe and effective way to deliver them. CombiGEM also enables the generation of combinations of three or four genes in a more powerful way than previously existing methods. “We’re excited about the application of CombiGEM to probe complex multifactorial phenotypes, such as stem cell differentiation, cancer biology, and synthetic circuits,” Lu says. Its already got a patent – will be scaled up for commercial and national needs now Kenneth Ma (Lawrence Livermore National Laboratory) October 7, 2014 “Bio researchers receive patent to fight superbugs” https://www.llnl.gov/news/newsreleases/2014/Oct/NR-14-10-3.html Superbugs, or antibiotic-resistant bacteria, have been on the rise since antibiotics were first introduced 80 years ago. That's because these germ-fighting agents have lost their punch from being overprescribed and misused, allowing bacteria pathogens to develop immunities against them. As a result, superbugs sicken nearly 2 million Americans each year and roughly 23,000 people die annually from these infections, according to the Centers for Disease Control and Prevention. Many more people die from other conditions that are complicated by antibiotic-resistant infections. Lawrence Livermore National Laboratory scientists have figured out a way to reverse this trend by developing novel antibiotics that effectively kill superbugs. They were recently issued a patent for producing antimicrobial compounds that degrade and destroy antibiotic-resistant bacteria by using the pathogen's own genes against it. Their approach can be used to fight superbugs such as antibiotic-resistant E. coli, Salmonella, Campylobacter, Methicillin-resistant Staphylococcus aureus (MRSA), Bacillus anthracis and many others. Antimicrobial compounds available today are designed to treat a host of bacteria, not target specific ones. While this is effective in the short term, bacteria are able to modify themselves over time to prevent a number of antibiotics from inhibiting their growth, rendering the antibiotics useless. To prevent this, the LLNL team created a process to discover new antibiotics designed to eradicate targeted bacterium responsible for a specific infection. Their technique uses computational tools and genome sequencing to identify which genes inside a bacterium encode for lytic proteins that can be used to kill it. Lytic proteins are enzymes that normally produce nicks in cell walls that allow cells to divide and multiply. But used in high concentrations, these enzymes cause rapid cell-wall degradation and cell rupture, a process known as lysis. Lytic proteins circumvent any defenses that bacteria have developed against today's broadly focused antimicrobials. Once genes encoding lytic proteins are identified in a bacterium, Lab researchers synthesize those genes and produce the lytic proteins in a laboratory setting. They are then experimentally introduced to the cell walls of targeted pathogens to destroy them. "We knew about these proteins because they were primarily coded and identified in bacteriophages, virus particles that attack bacterium and make copies of themselves," said Matthew Coleman, a member of the LLNL research team. "Bacteriophages need a way to get out of the bacteria once they make enough copies. So they encode a lytic protein, called an endolysin that breaks down the cell wall, causing the cell to die. The wall is what gives the cell its strength." The team's unique discovery was the existence of lytic proteins that are not associated with bacteriophages. They learned that bacteria themselves encode their own versions of these lytic proteins, which they use under tight regulatory control to remodel their cell wall during cell division. Tight regulatory production means that lytic protein is not overproduced because too much of it will kill the cells. The team conducted lab experiments that show lytic protein produced by bacteria killed pathogens more effectively than lytic protein produced by bacteriophages. LLNL's resources allowed the team to sequence genomes within a few weeks to obtain information on new pathogens, unknown bacteria species and even species yet to be sequenced. This data helps the team determine which genes encode lytic proteins and reproduce those proteins in large quantities to eliminate targeted pathogens. So far, the team's novel approach has been extremely effective in lab testing. In CDC experiments, the LLNL-produced lytic protein killed 100 percent of Bacillus anthracis cells, the bacterium that causes anthrax. "We can isolate these genes to support the development of effective antimicrobial agents for commercial and national needs," Coleman said. Multi-drug resistance is unlikely- Combination therapy Cobey el al. 15, (Gabriel G. Perron, R. Fredrik Inglis, Pleuni S. Pennings and Sarah Cobey, Evolutionary Applications, “Fighting microbial drug resistance: a primer on the role of evolutionary biology in public health,” 23 MAR 2015, http://onlinelibrary.wiley.com/doi/10.1111/eva.12254/full)//IB The shortage of new antibiotics motivated the search for novel strategies to manage resistance evolution. For therapy showed that some antibiotics have nonlinear inhibitory activities when used together (King et al. 1981; Yeh et al. 2009). Extensive phenotypic screens revealed that many classes of antibiotics could inhibit the effects of other antibiotics given their modes of activity (Yeh et al. 2006), often caused by regulatory example, combination conflicts in the expression of the antibiotics’ cellular targets (Bollenbach and Kishony 2011) or by reductions in bacterial growth rates (Ocampo et al. 2014). Subsequent studies have shown that such interactions could modulate resistance evolution (Yeh et al. 2009): Multidrug resistance is unlikely to evolve against sets of antibiotics that inhibit each other's activity, as resistance evolution to one antibiotic would expose the bacterium to the full efficiency of the second antibiotic (Michel et al. 2008). However, additional clinical trials are required to see whether this finding can be put into practice. Alt Cause – Laundry List Series of factors affect the doctor-patient relationship and trust Goold and Lipkin 99 (Susan Dorr Goold, MD, MHSA, MA, Received from the Division of General Medicine, University of Michigan Medical Center, Ann Arbor, Mich. AND Mack Lipkin, Jr., MD, New York University Medical Center, New York)(“The Doctor–Patient Relationship: Challenges, Opportunities, and Strategies”, J Gen Intern Med. 1999 Jan; 14(Suppl 1): S26–S33. doi: 10.1046/j.15251497.1999.00267.x)//ASMITH A series of organizational or system factors also affect the doctor–patient relationship. The accessibility of personnel, both administrative and clinical, and their courtesy level, provide a sense that patients are important and respected, as do reasonable waiting times and attention to personal comfort. The availability of covering nurses and doctors contributes to a sense of security. Reminders and userfriendly educational materials create an atmosphere of caring and concern. Organizations can promote a patient-centered culture,29 or one that is profit- or physician-centered, with consequences for individual doctor–patient relationships. Organizations (as well as whole health care systems) can promote continuity in clinical relationships, which in turn affects the strength of in those relationships. For instance, a market-based system with health insurance linked to employers' whims, with competitive provider networks and frequent mergers and acquisitions, thwarts long-term relationships. A health plan that includes the spectrum of outpatient and inpatient, acute and chronic services has an opportunity to promote continuity across care settings. The competition to enroll patients is often characterized by a combination of exaggerated promises and efforts to deliver less. Patients may arrive at the doctor's office expecting all their needs to be met in the way they themselves expect and define. They discover instead that the employer's negotiator defines their needs and the managed care company has communicated them in very fine or incomprehensible print. Primary care doctors thus become the bearers of the bad news, and are seen as closing gates to the patient's wishes and needs. When this happens, an immediate and enduring barrier to a trust-based patient-doctor relationship is created. The doctor–patient relationship is critical for vulnerable patients as they experience a heightened reliance on the physician's competence, skills, and good will. The relationship need not involve a difference in power but usually does,30 especially to the degree the patient is vulnerable or the physician is autocratic. United States law considers the relationship fiduciary; i.e., physicians are expected and required to act in their patient's interests, even when those interests may conflict with their own.9 In addition, the doctor–patient relationship is remarkable for its centrality during lifealtering and meaningful times in persons' lives, times of birth, death, severe illness, and healing. Thus, providing health care, and being a doctor, is a moral enterprise. An incompetent doctor is judged not merely to be a poor businessperson, but also morally blameworthy, as having not lived up to the expectations of patients, and having violated the trust that is an essential and moral feature of the doctor–patient relationship.31 Trust is a fragile state. Deception or other, even minor, betrayals are given weight disproportional to their occurrence, probably because of the vulnerability of the trusting party (R.L. Jackson, unpublished manuscript). Alt Cause – Staff/Expertise Budget cuts and staff shortages short-circuit all health surveillance Edward Richards (Harvey A. Peltier Professor of Law and Director, Program in Law, Science, and Public Health at the Paul M. Herbert Law Center, Louisiana State University) 2009 “DANGEROUS PEOPLE ,UNSAFE CONDITIONS T HE CONSTITUTIONAL BASIS FOR PUBLIC HEALTH SURVEILLANCE” The Journal of Legal Medicine, 30:27–50, http://biotech.law.lsu.edu/Articles/ULGM_A_369622_O.pdf The Constitution grants broad authority for public health surveillance. As long as public health authorities do not use administrative searches as a subterfuge for criminal law searches, the courts will uphold these searches when they are conducted either pursuant to an area warrant or through the regulated industries exception to a warrant requirement. Surveillance, however, is just the first step in protecting the public health and safety. Surveillance data must be combined with good epidemiologic analysis, and then become the basis for public health interventions. There have been few abuses of public health administrative searches. Public health authorities, if anything, have been too reticent to use proper surveillance techniques. Although some of this reticence is because of con- cerns about being seen as violating individual rights, most of it stems from lack of staff and other resources. 113 Despite the push on public health preparedness since the terrorist attacks on September 11, 2001, health departments around the United States continue to suffer budget and staff cuts. The impacts of these cuts are exacerbated by legislatures pushing ever-increasing responsi- bilities on health departments without providing the budgets or staff to carry out these new tasks. 114 The hardest issue for public health policy makers is to avoid pressures to transform public health agencies into extensions of the Department of Homeland Security. As we have seen from the adoption of Draconian emergency powers laws, it is more difficult to maintain a balance between individual rights and community protection than to attempt to satisfy political pressures by swinging wildly between extreme positions. Staff and expertise shortages take out the aff Bernard Choi (Injury Prevention Research Centre, Medical College of Shantou University, Shantou, China and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada) 2012 “The Past, Present, and Future of Public Health Surveillance” Scientifica Volume 2012 (2012), Article ID 875253, 26 pages http://dx.doi.org/10.6064/2012/875253 To avoid fragmentation in national surveillance efforts [107, 144], there is a need for federal agencies to provide national facilitation to foster interstate and intercounty collaboration. Central guidance can lead to coordination across states and counties, interstate technology transfer, and opportunity to learn from the successes and failures of other localities. Needless expense, unnecessary development time, and failure to rapidly share information on innovative systems can be avoided [205]. No attempt to meet the current challenges in public health surveillance will succeed unless it recognizes the fundamental importance of providing and maintaining a cadre of highly trained and motivated public health professionals in every local health agency in the country [5]. To use surveillance information to better prioritize, plan, deliver, and evaluate programming, public health staff must possess the required knowledge and skills. While it is neither feasible nor necessary for all staff to receive postgraduate academic training, a greater proportion of the public health workforce will need to acquire the knowledge and skills necessary to effectively understand and use surveillance concepts and techniques. Public health surveillance systems must be strengthened by (1) allocating resources, including human resources, for the effective use of health surveillance data and tools and (2) recognizing the need for existing staff to acquire new skills [77]. Alt Cause – Commercialization/Pharma Alt causes – commercialization of health and Ebola Collins 14 (Sam P.K. Collins is a health reporter for ThinkProgress. He previously provided general news coverage of the D.C. metropolitan area for the Washington Informer, and wrote reports of President Barack Obama’s activities as a White House press pool reporter for American Urban Radio Networks. Sam holds a master’s degree in public policy, and a bachelor’s degree in journalism and mass communication from George Washington University. “American’s Don’t Trust The Medical Profession” 10/23/14 http://thinkprogress.org/health/2014/10/23/3583625/americans-skeptical-doctors/)///CW Americans count among the least trusting of the medical profession, according to an international health care survey. The findings, which appeared in a recent issue of the New England Journal of Medicine, show significant levels of suspicion of doctors, especially among those who make less than $30,000 annually.¶ Researchers studied public health polls dating back four decades, including one conducted by a consortium of universities between 2011 and 2013 during which people in 29 countries answered survey questions. In that poll, 58 percent of Americans said they trust the medical profession, placing the United States in 24th place with Croatia.¶ “It fits with decades of data on the American public’s trust in institutions, in general,” Michael Gusmano, a scholar at the Hastings Center, a Garrison, N.Y.-based research institute that focuses on health care, told WebMD.¶ Skepticism of the medical profession hasn’t happened without any reason. Experts point to unequal access to health care and the “commercialization” of American medicine as key factors at play in that damaged relationship. Some people say that members of the medical field often seem more concerned about protecting their financial interests than caring for patients, especially those from less affluent backgrounds.¶ Big Pharma has historically tried to influence the advice that doctors give patients, something that may make Americans wary of the field in general. In exchange for their endorsement of prescription medications, physicians receive free samples and gifts that include coffee mugs emblazoned with the drug company’s logo, tickets to sporting events, expensive dinners, and trips to exotic destinations. At the peak of Big Pharma’s profitable relationship with the medical industry in 2007, more than 100,000 representatives made visits to more than 650,000 physicians across the country.¶ This can sometimes have a direct effect on patients. A Centers for Disease Control and Prevention (CDC) study in August, for example, found that doctors in hospitals with a strong black patient base encouraged breastfeeding to expectant mothers at a rate 15 percentage points less than that of their white counterparts, due in part to a relationship between the facility and manufacturers of baby formula.¶ Americans’ mistrust of the medical industry has been on full display in the weeks since American Ebola patient zero Thomas Eric Duncan died in a Dallas hospital.¶ Days after CDC officials assured Americans that the disease would spread no further, two nurses who treated Duncan tested positive for Ebola. Many of the nurses who had direct contact with patient zero before he succumbed criticized the medical establishment, saying nurses at Presbyterian Hospital in Dallas treated Duncan for days in an open space in the emergency room under constantly changing protocols and without sufficient protective gear.¶ The controversy has discouraged some Americans from trusting what CDC officials are saying about the United States’ ability to contain the virus. According to one recent poll, nearly half of Americans don’t think their local hospital could safely treat an Ebola case.¶ That has facilitated the spread of panic about Ebola — anxiety that may pose a bigger threat to Americans than the virus itself. Instead of listening to federal health officials, many Americans have looked to sensationalized media reports and reckless words of commentators and politicians as indicators of Ebola’s impact in the United States.¶ There are other examples of how some Americans’ mistrust of the medical profession undermines public health. An increasing number of parents are skipping or delaying their children’s recommended vaccination, due in part to a belief that the injections cause autism and other sicknesses. Members of the scientific community beg to differ, especially since vaccinations in the last two decades have prevented nearly 700,000 deaths. But the parents who choose to delay their kids’ vaccines don’t trust scientists’ opinions on the subject.¶ The study recently published in the New England Journal of Medicine does have another significant finding: Even when Americans are skeptical of the medical industry as a whole, they do trust their own doctor. So information about things like Ebola and vaccinations might need to come from those immediate sources rather than national spokespeople. Genetics Surveillance – Data Leaks Inevitable Impossible to keep genetic data anonymous – data leaks inevitable Gina Kolata (Medical reporter for the New York Times) June 2013 “Poking Holes in Genetic Privacy” http://www.nytimes.com/2013/06/18/science/poking-holes-in-the-privacy-ofdna.html?pagewanted=all&_r=0 For years now, a steady stream of research has eroded scientists’ faith that DNA can be held anonymously. The first shock came in 2008, when David W. Craig, a geneticist at TGen, a research institute in Phoenix, and his colleagues imagined a theoretical problem. Suppose you are trying to learn what percentage of intravenous drug users are infected with hepatitis, and you collect DNA from discarded needles and amass it in a database to look for signs of the virus in the genetic material. Is there any way, they wondered, to find a particular person’s DNA is in this soup of genes? Most researchers would have said the task was impossible, worse than looking for a needle in a haystack. But Dr. Craig and his colleagues found a way to do it, exploiting the four million or so tiny, and usually inconsequential, differences in DNA letters between one individual and another. With their method, using the combinations of hundreds of thousands of DNA markers, the researchers could find a person even if his or her DNA constituted just 0.1 percent of the total in the mix. So explosive was the finding that Dr. Craig deliberately chose to write about it only very technically. The N.I.H. understood what he had accomplished, though, and quickly responded, moving all genetic data from the studies it financed behind Internet firewalls to prevent the public or anyone not authorized from using the data and, it was hoped, to protect the identities of research subjects. But another sort of genetic data — so-called RNA expression profiles that show patterns of gene activity — were still public. Such data could not be used to identify people, or so it was thought. Then Eric E. Schadt of Mount Sinai School of Medicine discovered that RNA expression data could be used not only to identify someone but also to learn a great deal about that person. “We can create a profile that reflects your weight, whether you are diabetic, how old you are,” Dr. Schadt said. He and a colleague also were able to tell if a person is infected with viruses, like HPV or H.I.V., that change the activity of genes. Moreover, they were able to make what they called a genetic bar code that could be used to identify a person in a number of DNA databases. Then, this year, in perhaps the most disturbing exercise, Yaniv Erlich, a genetics researcher at the Whitehead Institute, used a new computational tool he had invented to identify by name five people from their DNA, which he had randomly selected from a research database containing the genes of one thousand people. Experts were startled by what Dr. Erlich had done. “We are in what I call an awareness moment,” said Eric D. Green, director of the National Human Genome Research Institute at the National Institutes of Health. Research subjects who share their DNA may risk a loss of not just their own privacy but also that of their children and grandchildren, who will inherit many of the same genes, said Mark B. Gerstein, a Yale professor who studies large genetic databases. Even fragments of genetic information can compromise privacy. James Watson, a discoverer of DNA’s double helix shape, had his genes sequenced and made the information public — except for one, the sequence for ApoE, a gene that has a variant linked to an increased risk of Alzheimer’s disease. Researchers noticed, though, that they could still figure out if Dr. Watson had that variant by examining the DNA on either side of the gene he had removed. They did not reveal whether he had it. With so many questions about the privacy and security of genetic data, researchers wonder what research subjects should be told. Leaks and identification of study subjects will never be completely avoidable, said George Church, a Harvard geneticist. And as much as investigators might like to find a way to keep genetic data secure and private, he does not think there is an exclusively technical solution. “If you believe you can just encrypt terabytes of data or anonymize them, there will always be people who hack through that,” Dr. Church said. He believes that people who provide genetic information should be informed that a loss of privacy is likely, rather than unlikely, and agree to provide DNA with that understanding. Other researchers say the idea is not farfetched, and some suggest that scientists be licensed before they are given access to genetic databases, with severe penalties for those who breach privacy. “My fear is not so much that someone will take everyone’s genomes and put them on the Web,” Dr. Gerstein said. “It is that a graduate student in some lab somewhere will naïvely post bits of genomes on his Facebook page. The idea is that before he could get access to genomes, he would be taught he can’t do that. And if he did he would lose his license.” The amount of genetic data that has been gathered so far is minuscule compared with what will be coming in the next few years, Dr. Altshuler noted, making it important to address the problems before the data deluge makes them worse. “We see substantial issues,” he said. “We want to have serious discussions now.” Genomic data breaches happen all the time- the health system does not have enough protections in place to secure private genetic information McEwen et al 13 (Jean E. McEwen, Ethical, Legal, and Social Implications Program, Division of Genomics and Society, National Human Genome Research Institute, National Institutes of Health,Ethical, Legal, and Social Implications Program, Division of Genomics and Society, National Human Genome Research Institute, National Institutes of Health. Joy T. Boyer, Senior Program Analyst, and Kathie Y. Sun, Program Analyst. “Evolving Approaches to the Ethical Management of Genomic Data.” February 28, 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665610/)//EMerz The genetic studies and test protocols that dominated the field 15–20 years ago were generally highly targeted, and tended to view the risks to participants or patients (apart from the physical risks associated with blood drawing) as straightforwardly informational [17–19]. Thus, consent materials in use prior to the mid-2000s, if they mentioned non-physical risks at all, tended to focus on the potential for breach of privacy, with insurance and employment usually listed as the two areas of main concern [20–22]. Data security measures of the time were, by today’s standards, remarkably “low tech,” often consisting of little more than coding samples and data and storing samples and data in locked freezers and cabinets. Still, consent forms, if they addressed the issue at all, typically described the risk of a security breach as low; at the time that assessment seemed reasonably accurate, predating as it did the development of massive, web-accessible genomic databases and expanded data sharing norms. Early consent forms rarely addressed the issue of whether individual findings from studies would be returned to participants [20, 21]. The usual default presumption was that they would not be [23], because most findings emanating from studies of the time interrogated only limited regions of the genome, so the likelihood of generating incidental findings (apart from occasional evidence of undisclosed adoption or misattributed paternity [24]) was relatively low. Another feature of early consent forms was their characteristically narrow scientific scope [8, 20, 21]. Most described only the immediate study for which samples were being collected or the specific disease being analyzed; although the possibility of sharing with close collaborators working on the same disease was sometimes mentioned, obtaining broad consent to an unspecified range of future uses was the exception, not the norm. Often, consent documents were simply silent about plans for any future sharing, and in such cases, the absence of an explicit prohibition against sharing was generally interpreted (or, at least over time came to be interpreted) as tacit permission to share [23]. In 1994, long-percolating concerns among bioethicists about the practice of using stored, linkable samples without obtaining new consent from those from whom they had been obtained culminated in the publication of a highly influential paper that recommended against continuing this practice [25]. Following this recommendation, consent documents gradually began to be written with greater specificity about whether, with whom, and for what purposes, samples and data would be shared. In practice, however, the recommendation was often interpreted as applying only to prospectively collected samples. Thus, as was recently called to public attention in a best-selling book, archived samples collected under widely varying and sometimes questionable consent conditions – and cell lines derived from such samples - are often still being used today. Genetic Surveillance – No Impact There’s no impact to genetic discrimination- their evidence is just rhetoric Begley 4 (Sharon Begley. Senior health & science correspondent at Reuters. “Bill Seeking to Ban DNA Discrimination Isn't Really Necessary.” February 6, 2004. http://www.wsj.com/articles/SB107595572756521572)//EMerz When it comes to genetic discrimination, there is a yawning chasm between rhetoric and reality. As law professor Henry Greely of Stanford University puts it, "Genetic discrimination is a much greater threat in people's fears than it is in reality, today or in the foreseeable future....Failure to ban [it] will not make the sky fall, [or] the employment markets crumble." Genetic discrimination means being denied employment or health insurance (or being charged more for it) as a result of testing positive for a gene that raises your risk of developing a disease such as cancer or Alzheimer's. Since at least 1990, it has been cast as the dark underbelly of the human genome project, which dutifully set aside 3% to 5% -almost $100 million -- of its annual budget to study such ethical, legal and social issues. Francis Collins, director of the project, has called genetic discrimination "a vexing problem" and praised the Senate's "important" bill. The emperor, however, is wearing skivvies. Just as genome enthusiasts, and much of the media, have hyped the medical benefits of decoding humankind's double helix, so they (and we) have grossly overstated the threat and the reality of genetic discrimination. If you probe beneath the anecdotes, evidence of genetic discrimination melts away. Bioethicists and genetic counselors, for instance, say they've heard of people being fired or denied health coverage after testing positive for a risk gene, but concede they know of no such patients firsthand. When they do offer an actual case, it turns out that the discrimination was based not on a predictive genetic test (finding a genetic variant that raises the risk of cancer, perhaps) but on family history or actual symptoms of, say, the blood disorder hereditary hemochromatosis. That may be medical discrimination, but it isn't genetic discrimination as usually understood. In an effort to get beyond anecdote, a 2000 study examined the effect of state laws barring genetic discrimination in health insurance. To their surprise, Mark Hall and Stephen Rich of Wake Forest University in Winston-Salem, N.C., found that states with such laws had no fewer cases of genetic discrimination than states without them. Why? Because you can't have fewer cases than zero, and zero is about how much genetic discrimination the study turned up. "We found almost no cases of health insurers asking for or using the results of predictive genetic tests," Prof. Hall says. "The laws have so little impact because almost no genetic discrimination is occurring," as morerecent studies confirm. Dawn Allain, president of the National Society of Genetic Counselors, agrees: "We haven't seen any real cases of genetic discrimination." Health insurers have little financial incentive to set rates based on predictive genetic tests, Prof. Hall explains. For group coverage, it's much simpler to tote up last year's costs and factor in inflation. For individual coverage, people change carriers so frequently that even if they develop a disease 15 years down the road, as a genetic test might predict, it will likely be on another insurer's dime. Although the warnings of bioethicists (including, Prof. Greely sheepishly admits, "an earlier version of myself") haven't come true, some now argue that we need federal legislation for symbolic reasons, to protect people from even the theoretical risk of genetic discrimination. This "what harm does it do?" argument is OK, says William Nowlan, chief medical officer of the National Life Insurance Co., Montpelier, Vt., who has written widely on the myth of genetic discrimination. But then let's admit that the Senate bill addresses a problem that exists solely in the public's imagination. As far as I can tell, the bill's only real benefit would be to allay the fears of people who reject genetic tests in the belief that a positive result could make them uninsurable and unemployable. That's a worthwhile goal. But it comes at a cost. By enshrining genetic status in federal law, we reinforce the widespread and pernicious belief that DNA is destiny. It isn't. Risk genes for common diseases aren't like those for the exceedingly rare Huntington's or Tay-Sachs, where carrying the gene means you definitely will get the disease. Instead, risk genes are low in what biologists call "penetrance:" They increase your chance of developing the disease, but to nothing like 100%. In one fascinating 2000 study, Swedish scientists calculated that genes account for less than half of the risk of developing 11 common cancers. The cancers with the highest genetic component, the study found, are prostate (42%) and colorectal (35%). A woman's risk of getting breast cancer if her identical twin does is only 13%. Supporters of the genetic discrimination bill should make clear that what they want to guard against is no more than a theoretical risk. They should make equally clear that the risk genes they're so worried about are not all they're cracked up to be. Even if genetic surveillance contains invasive information, it doesn’t require much protection- few people are qualified to read DNA Lauss et al 13 (Georg Lauss, Arndt Bialobrzeski, Matthias Korkhaus, Karoliina Snell, Johannes Starkbaum, Andréa E. Vermeer, Jukka Weigel, Herbert Gottweis, Ilpo Helén, Jochen Taupitz, Peter Dabrock. “BEYOND GENETIC PRIVACY PAST, PRESENT AND FUTURE OF BIOINFORMATION CONTROL REGIMES.” 2013. http://private-gen.eu/uploads/media/PRIVATE_Gen_FINALREPORT_2013_01.pdf)//EMerz Ultimately, some genetic information might merit special treatment because it has a number of characteristics which, although they may be individually present in respect of other forms of information, are present to a high degree in the case of genetic information and combine to give it a special status in some contexts. [p.31] The report emphasizes the importance of context. Genetic information might not always be sensitive in itself. What makes genetic information – and arguably information in general – sensitive is its context and the way a piece of information is combined with other information. Since information about a person or a state of affairs takes on meaning only if it is put into a social context and if it is combined with other information, it was even be argued that genetic information is even better protected from widespread third-party misuse than other types of (medical) information because it requires a high level of expert knowledge and expert resources to “read” it and interpret it in meaningful ways. In a certain sense, it has a comparably high legibility threshold [24]. Moreover, empirical research has shown the likelihood that genetic information and its related research may be seen as problematic, but it appears that people perceive other types of information as being sensitive, as well, and that their concerns revolve around the concrete context in which data and materials are used and the intention behind a particular inquiry Genetic Surveillance Good - Crime Genetic research base is key to solving violent crimes and exonerating criminals [David H. Kaye, Penn State Law “Trawling DNA Databases for Partial Matches: What is the FBI Afraid of?” 2009] Across the globe, many countries have established DNA databases-collections of computer-searchable records of the DNA profiles of suspected or convicted offenders.' England started the first national criminal DNA database in 1995.2 In the United States, the state and federal databases as combined in the National DNA Index System (NDIS) hold over seven million short tandem repeat (STR) profiles from convicted offenders as well as a growing number of people who were merely arrested or detained. 3 When investigators recover a DNA sample from the scene of a crime, they can search these databases to discover if any of the recorded profiles match. Such "cold hits" from these database trawls have led police to serial rapists and murderers who have long eluded detection. 4 Indeed, even dead men have been "accused" through this technology. 5 In addition, database trawls have considerable potential to solve common property crimes.6 In one case, an observant police inspector in Finland noticed a dead mosquito in a stolen vehicle. 7 The mosquito's body contained human blood from its last meal. Testing the blood against Finland's database yielded a DNA profile match, giving the police a likely suspect.8 At least 10,000 people are wrongfully convicted annually for crimes they didn’t commit – the plan stop the exoneration process and is a helping hand in human rights abuse [Shaun King “An exoneration happens every three days in America. What this really says about our justice system” March 24th 2015] According to the National Registry of Exonerations at the University of Michigan, 1,569 men and women in the United States, most of them African American, have been completely exonerated after being wrongfully convicted and sent to prison. The number of people exonerated for wrongful convictions actually broke a record high in 2014 with 125 exonerations, including six people who were actually on death row awaiting execution. Less than every three days in our country, some man or woman is released back into society after spending a tragic portion of their life behind bars for a crime they never committed. Few injustices can compare to the horror of spending one hour in prison for something you didn't do. Ricky Jackson of Ohio spent 341,640 hours, or 39 years, behind bars before he was exonerated. Just a teenager when he was convicted, he was nearly a senior citizen when he was released. Jonathan Fleming was serving the 25th year of a 25-year sentence when he was finally exonerated after a wrongful conviction. Glenn Ford, on death row for 30 years in Louisiana, was 64 years old when he was released and was exonerated. Stricken with lung cancer, he was only expected to live a few more months. One study determined that nearly 10,000 people are likely to be wrongfully convicted for serious crimes annually. Another study estimates that as many as 340 people are likely to have been executed in the United States before they were properly exonerated. This is a travesty. Anyone who says otherwise is sick. Jump below the fold for more. But the conversation should not end at our conclusion that these wrongful convictions are a travesty. It appears, though, that an entire section of America refuses to believe that police or prosecutors can ever do any wrong at all. Except they do. Often. Detective Louis Scarcella of the NYPD is accused of framing suspects, forcing fake confessions, and using the same single eyewitness for multiple murders. Many men who were wrongfully convicted under his watch have recently been exonerated and 50 of his cases are under review. Chicago has now been called the "false confession capital" as more and more details are uncovered on how the city's police officers are torturing men and women to confess to crimes they didn't commit. They were so good at it, in fact, that Detective Richard Zuley was brought from Chicago to Guantanamo Bay to directly oversee one of the most brutal torturing operation in modern history. The prosecutor of Glenn Ford, shipped off to death row at Angola State Prison in Louisiana in 1984, now openly admits that he was "sick ... arrogant, judgemental, narcissistic and very full of myself" when he sought the wrongful conviction of Ford, who spent 30 years of his life in one of the most brutal prisons in the world. Four police officers in Fort Lauderdale, Florida, were just caught sending texts to one another about "killing nigg*rs" and giving them the "early death penalty." This is not okay. It's wrong. Our justice system is altogether broken. This brokenness, though, must not be understood in some abstract way. It's broken because the people leading it are often sick, disturbed racists who care very little for those on the receiving end of their sickness. It's not good enough to simply give wrongfully convicted men an insufficient check and an apology. We must repair the broken system so these instances go away for good. Genetic surveillance stops crime Lindey 11 (Brooke, reporter for CTV news Vancouver, “Could a new technique catch a serial rapist in B.C.?” http://bc.ctvnews.ca/could-a-new-technique-catch-a-serial-rapist-in-b-c-1.597435 1/18/11 JM) A contentious DNA analysis that helped snag one of America's most notorious suspected murderers could be used in the hunt for a serial rapist in Vancouver, according to a lawyer who pushed to have it approved south of the border. DNA evidence has linked a single unknown man to three sex assaults in Vancouver, and police say he could be responsible for five more unsolved cases. But the genetic evidence taken at the scene of the assaults doesn't match anyone in the national DNA databank, and police have been left to plead with the public for tips. Vancouver police made a public appeal for help on Thursday, but five days later, there are no new leads. In the U.K. and some parts of the U.S., police would have had one more option before hitting a dead end. That's because laws in those places allow investigators to search for partial matches in the offender DNA databank and identify possible family members of unknown criminals. "Using familial DNA searching, you can continue to try and solve a case when those other steps have failed," said Rockne Harmon, a retired California deputy district attorney and one of the technique's biggest proponents. "We do know that crime seems to run in families for complicated reasons." Privacy advocates have lobbied against allowing the new technique in Canada, arguing that it submits relatives of convicted offenders to unfair genetic surveillance. But thanks to familial DNA searching, Los Angeles police were able to identify Lonnie Franklin Jr. as a suspect in the brutal "Grim Sleeper" killings -- the murders of at least 10 people over 25 years. When investigators compared genetic samples taken from the scenes of the Grim Sleeper murders with California's offender DNA database, there were no exact hits, but investigators were able to create a list of about 150 close matches -- potential family members of the vicious murderer. Analysts then compared the Y sex chromosomes from those 150 people with the Grim Sleeper's, and found a match so close, the offender had to be either the father or the son of the serial killer. As it turns out, Franklin's son had recently been arrested, and swabbed for DNA. When police followed the elder Franklin to a restaurant, they were able to take a sample from his cup, and found a perfect match for the Grim Sleeper's DNA. Familial DNA searching is currently not permitted in Canada, and in the U.S., only California and Colorado allow it, although Virginia appears to be on the brink of approval. Harmon was the driving force behind California's decision to allow the unique searching technique, and he says that Canada should consider it, too. "Why would you have a law that would keep you from something that can solve crimes?" he told ctvbc.ca. "It'll help make the world a safer place."’ Solvency – Circumvention Federal oversight can’t minimize health surveillance- the biggest offenders are private businesses that use big data Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 13-16 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz Big data is so named because of its unprecedented volume and for its “complexity, diversity, and timeliness.” Big data refers not only to the collection and storage of extremely large data sets but also the data mining and predictive analytic routines that process the data, the latter being understood as “[t]echnology that learns from experience (data) to predict the future behavior of individuals in order to drive better decisions.”74 Essentially big data is the latest type of business intelligence (BI), or, to frame it slightly differently, the latest BI analytics are what extract value from big data. 75 Not surprisingly, MBA-speak business jargon dominates the space. Thus, according to Gartner, Inc., “‘Big data’ is highvolume, -velocity and -variety information assets (sic) that demand (sic) cost-effective, innovative forms of information processing for enhanced insight and decision making.”76 It is important not to underestimate one of these three properties—high-variety. Big data does not use structured databases (or at least is not as reliant on them as previous generation systems such as credit reporting) but is capable of absorbing high-variety data. Data sources (or data pools) continually change and expand; yet big data is seems adept at digesting them. As described in a recent report by the Centre For Information Policy Leadership, While traditionally analytics has been used to find answers to predetermined questions, its application to big data enables exploration of information to see what knowledge may be derived from it, and to identify connections and relationships that are unexpected or were previously unknowable. When organisations employ analytics to explore data’s potential for one use, other possible uses that may not have been previously considered often are revealed. Big data’s potential to yield unanticipated insights, the dramatically low cost of information storage and the rapidly advancing power of algorithms have shifted organisations’ priorities to collecting and harnessing as much data as possible and then attempting to make sense of it.77 The analytics of big data seek to predict the behavior not only of populations or cohorts but also of individuals. In Predictive Analytics: The Power to Predict Who Will Click, Buy, Lie, or Die, computer scientist Eric Siegel explained the distinction as follows: Forecasting makes aggregate predictions on a macroscopic level. How will the economy fare? Which presidential candidate will win more votes in Ohio? Whereas forecasting estimates the total number of ice cream cones to be purchased next month in Nebraska, predictive technology tells you which individual Nebraskans are most likely to be seen with cone in hand.78 In the context of health information the business intelligence grail is to identify and exploit a patient’s differential health status. According to Neil Biehn with such segmentation “organizations can more easily identify anomalous buying behavior and make intelligent product and offer recommendations that are statistically more likely to be purchased. Biehn continues, “If two customers are alike but not buying the same products, the data analysis can advise which opportunities the sales team might be missing,” concluding “[t]his is the type of Big Data viability that moves the needle in the real world.”79 The privacy implications of individuated big data analysis are profound. Beyond the expropriation or “using” objections to such data collection and processing, such as Commissioner Brill’s critique quoted at the beginning of this article,80 the computer modeling of predictive analytics predicts a world of dehumanizing “data determinism,” described by FTC Chairwoman Edith Ramirez as the judgment of persons “not because of what they’ve done, or what they will do in the future, but because inferences or correlations drawn by algorithms suggest they may behave in ways that make them poor credit or insurance risks, unsuitable candidates for employment or admission to schools or other institutions, or unlikely to carry out certain functions.”81 Finally, there is the “Doomsday” scenario—a big data breach. The industrial scale datawarehousing model is the antithesis of the “silo” model of data storage used in the pre-information age. The lack of data liquidity (with all of its informational disadvantages) inherent in that model meant that there was little profit or harm in an isolated security breach. The opposite is true with big data storage. However, there are reports that big data brokers are not immune from the same security breaches that are plaguing other businesses.82 Individuals willingly give up their health records by using non-protected mediumsmeans state legislation can’t solve Terry 14 (Nicolas P. Terry. “Big Data Proxies and Health Privacy Exceptionalism.” 2014. P. 19-21 https://www.ftc.gov/system/files/documents/public_comments/2014/01/00004-89091.pdf)//EMerz Ironically one of the greatest threats to an individual’s health privacy is . . . the individual. One of the first examples of theretofore HIPAA-protected data migrating to HIPAA-free space was during President George W. Bush’s administration at a time when the slowing of the administration’s provider-curated EMR program coincided with the launching of PHR platforms by Google and Microsoft.96 As a result the HITECH Act architects attempted to protect for the first time health data that migrated from a protected to an unprotected (or marginally protected) zone. However, they chose to do so with a swiftly outmoded, downstream breach notification model.97 In the interim different (and unregulated) technologies have emerged that encourage patient rather than provider curation of health data. The most obvious example is the federal government’s “Blue Button” technology that allows patients to download their records to their own devices. The “Blue Button” approach to patient access and hence control of their health data has become a rallying cry for many (if not all) patient privacy advocatesand has been encouraged by President Obama’s administration. 101 Indeed, then ONC National Coordinator Farzad Mostashari announced a Blue Button Mash-Up challenge to build software for patients designed to combine their downloaded Blue Button information with other data sources.102 At root such patient curation of health data bespeaks autonomy and is symbolic of patient ownership of the data. However, it fails to take into account one practical limitation—the canonical version of the record will remain in the provider’s control – and one legal limitation— that only the provider-curated copy is protected by HIPAA-HITECH. In contrast, the patient-curated “copy” attracts little meaningful privacy protection. Well-meaning privacy advocates should think carefully before promoting this autonomy-friendly “control” model until data protection laws (not to mention patient education as to good data practices) catch up with patient curated data. A similarly dichotomous result is likely as the medically quantified self develops. The quantified-self movement concentrates on personal collection and curation of inputs and performance. 103 Obviously, health, wellness and medically inflected data will likely comprise a large proportion of such data. A similar, if less formal, scenario is emerging around health and wellness apps on smartphones and connected domestic appliances such as scales and blood pressure cuffs. 104 Smartphones are crammed with sensors for location, orientation, sound and pictures that add richness to data collection.105 And there is ongoing and explosive growth in the medical apps space that seeks to leverage such sensors. More and more we are going to demand control of information about ourselves and generate medically inflected and core health data about ourselves. These processes will in most cases lead to medically inflected data that exists outside of the HIPAA-HITECH protected zone. Circumvention inevitable- police legally collect DNA all the time Scherr 13 (Albert E. Scherr. Professor of Law, University of New Hampshire. “Genetic Privacy & the Fourth Amendment: Unregulated Surreptitious DNA Harvesting.” 2013. P. 448-449. http://georgialawreview.org/wp-content/uploads/2015/02/Download-PDF-V47-I2-Scherr.pdf)//EMerz So why does the law regard genetic privacy issues in criminal and civil contexts differently? Why do surreptitious-DNA harvesting practices by private parties get appreciably more legal scrutiny than such practices by police? One broad-brush answer is that society places more value on the public-safety goal of solving crimes than on the needs of amateur genealogists, divorce lawyers, and genetic researchers. That broad-brush answer is unsatisfactory. Current Fourth Amendment jurisprudence on surreptitious harvesting creates an all-or-nothing dynamic. If a putative suspect—one for whom the police have some reasonable suspicion but not enough for a search warrant—abandons his DNA in a public place, the police can do with the sample what they will, without limitation. The police can do the same for a suspect for whom they have only a hunch. They can also do the same for someone for whom they have no suspicion, including a victim or a witness. They can do so without a suspect’s, a witness’s, or a victim’s consent or knowledge. If surreptitious DNA harvesting is not a “search” under the Fourth Amendment, the police can do whatever they want with anyone’s DNA. Solvency - Alt Causes Too many alt causes Outdated legal codes THEIR AUTHOR Gostin, an internationally recognized scholar in law and public health, professor of Law at Georgetown University; Professor of Public Health at the Johns Hopkins University; and the Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities, November 2001 – (Lawrence, “Public Health Law In An Age Of Terrorism: Rethinking Individual Rights And Common Goods”, published on HealthAffairs vol 21 no. 6)//roetlin The public health law infrastructure is equally deficient. The law establishes the mission, functions, and powers of public health agencies. Yet public health laws are highly antiquated, after many decades of neglect. Very little consideration has been given to modernizing these laws to reflect advances in public health practice and constitutional law. Reform of public health law is essential to ensure that public health agencies have clear missions and functions, stable sources of financing, adequate powers to avert or manage health threats, and restraints on powers to maintain respect for personal rights and liberties. Underfunding and infrastructure THEIR AUTHOR Gostin, an internationally recognized scholar in law and public health, professor of Law at Georgetown University; Professor of Public Health at the Johns Hopkins University; and the Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities, November 2001 – (Lawrence, “Public Health Law In An Age Of Terrorism: Rethinking Individual Rights And Common Goods”, published on HealthAffairs vol 21 no. 6)//roetlin As a result of chronic underspending, the public health infrastructure is badly deteriorated.2 Public health agencies lack the capacity to conduct essential public health services at a level of performance that matches the constantly evolving threats to the health of the public. Critical components of that infrastructure include a well-trained workforce, electronic information and communications systems, rapid disease surveillance and reporting, laboratory capacity, and emergency response capability. Faulty allocations and income inequality THEIR AUTHOR Gostin, an internationally recognized scholar in law and public health, professor of Law at Georgetown University; Professor of Public Health at the Johns Hopkins University; and the Director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities, November 2001 – (Lawrence, “Public Health Law In An Age Of Terrorism: Rethinking Individual Rights And Common Goods”, published on HealthAffairs vol 21 no. 6)//roetlin In this civil and property rights society, the tone has been distinctly antigovernment. The State has been perceived as inefficient, bureaucratic, and burdensome. Citizens have opposed taxation and broad health and welfare spending as well as oppressive regulation. From a funding perspective, this has meant that health dollars have been allocated primarily to advanced biotechnology and health care, which serve the needs of individual patients, particularly those who can afford private health insurance. Funding for traditional prevention and population-based services represents only a small fraction of health spending, estimated at around 1 percent at the state level and less than 5 percent at the federal level.1 Solvency – A2 Judicial Modelling No court influence now Liptac 08, (Adam, New York Times US, “U.S. Court Is Now Guiding Fewer Nations,” September 17, 2008, http://www.nytimes.com/2008/09/18/us/18legal.html?pagewanted=all)//IB But now American legal influence is waning. Even as a debate continues in the court over whether its decisions should ever cite foreign law, a diminishing number of foreign courts seem to pay attention to the writings of American justices. “One of our great exports used to be constitutional law,” said Anne-Marie Slaughter, the dean of the Woodrow Wilson School of Public and International Affairs at Princeton. “We are losing one of the greatest bully pulpits we have ever had.” From 1990 through 2002, for instance, the Canadian Supreme Court cited decisions of the United States Supreme Court about a dozen times a year, an analysis by The New York Times found. In the six years since, the annual citation rate has fallen by half, to about six. Australian state supreme courts cited American decisions 208 times in 1995, according to a recent study by Russell Smyth, an Australian economist. By 2005, the number had fallen to 72. The story is similar around the globe, legal experts say, particularly in cases involving human rights. These days, foreign courts in developed democracies often cite the rulings of the European Court of Human Rights in cases concerning equality, liberty and prohibitions against cruel treatment, said Harold Hongju Koh, the dean of the Yale Law School. In those areas, Dean Koh said, “they tend not to look to the rulings of the U.S. Supreme Court.” The rise of new and sophisticated constitutional courts elsewhere is one reason for the Supreme Court’s fading influence, legal experts said. The new courts are, moreover, generally more liberal than the Rehnquist and Roberts courts and for that reason more inclined to cite one another. Another reason is the diminished reputation of the United States in some parts of the world, which experts here and abroad said is in part a consequence of the Bush administration’s unpopularity around the world. Foreign courts are less apt to justify their decisions with citations to cases from a nation unpopular with their domestic audience. “It’s not surprising, given our foreign policy in the last decade or so, that American influence should be declining,” said Thomas Ginsburg, who teaches comparative and international law at the University of Chicago. Aversion to Foreign Law The adamant opposition of some Supreme Court justices to the citation of foreign law in their own opinions also plays a role, some foreign judges say. “Most justices of the United States Supreme Court do not cite foreign case law in their judgments,” Aharon Barak, then the chief justice of the Supreme Court of Israel, wrote in the Harvard Law Review in 2002. “They fail to make use of an important source of inspiration, one that enriches legal thinking, makes law more creative, and strengthens the democratic ties and foundations of different legal systems.” Surveillance K Links Trying to curtail the medical surveillance state starts from the wrong position— ignoring the interaction between the self and the collective body leads to reinforcing the biopolitics of the state and recreates the impacts of the 1AC through risk calculations Baur and Olsen 9 (Susanne, professor at the University of Copenhagen, and Jan, professor at University of Copenhagen, “Observing the Others, Watching Over Oneself: themes of medical surveillance in society” file:///C:/Users/Jessi/Downloads/3252-5562-2-PB.pdf 2009 JM) This paper is an attempt to explore the reconfiguration of space, body and gaze in recent biomedicine. The constellations of the body and the medical gaze and their location in space were closely intertwined with specific epistemologies of medical science and practice at different historical periods. Michel Foucault localized the birth of the clinic in the spatialization of disease and bodies, which took place with the structuring of hospitals according to nosological categories (Foucault 1963). Inspired by Foucault’s analyses of the clinical space, David Armstrong coined the term ‘surveillance medicine’ as ‘a significant alternative model to hospital medicine and pathology, which emerged during the 20th century around the observation of seemingly healthy populations’ (Armstrong 1995: 393). Medical thinking in terms of surveillance embraces probabilistic rationality and prediction, which have continuously proliferated in medical research and in public health, for instance in early diagnostics or decision-making in the clinic and in preventive medicine. Drawing on examples from clinical diagnostics on the one hand and population health surveillance on the other hand, we explore recent reconfigurations of the clinical gaze in western biomedicine. In these recent forms of diagnostic monitoring an augmented space of digital visualization and statistical data, an abundance of numbers and images is created and the clinical gaze is being delocalized. In large-scale epidemiological studies, health data from whole populations are used for risk calculations that inform policy making. Both the body and society are governed by data analyses and numerical profiling; interventions are made in a rationality of prevention at ever earlier stages. This paper thus refers to developments that take place within western biomedicine and are products of the latter; in a global perspective, however, there remains a digital divide in terms of access and availability of information technologies. Our themes – monitoring the patient-body and population surveillance – can be read as representing both poles of biopower, in the sense the term has been introduced by Foucault: the gaze is directed both upon the individual body and the self as well as upon the collective ‘population body’. Taking up these two poles of biopower, we explore the digitized and transparent individual patient body of the clinic on the one hand and the epidemiological databases originating through public health surveillance practices on a population scale on the other hand. In doing so, we pay particular attention to the more distributed forms of contemporary surveillance, which go beyond the classic spatialization of the body in the clinic and the accounts of Jeremy Bentham’s panopticon (Foucault 1975). Drawing on surveillance studies, we take inspiration in the concept of panopticism and synopticism, as proposed by Thomas Mathieson (1997). In other words, we are asking about who is observing and who is being watched. What constellations between individuals, bodies and data do we encounter in the worlds of biomedicine and epidemiology? Which specific modes of knowing do such digital assemblages bring about? What is the location of the body and knowledge on the body – is it still in the macroanatomic body or rather on the hard drive or in population databases? How do imaging and visualization techniques mediate medical procedures, clinical and political decisionmaking? What kinds of body and control practices do we face with the data avalanches of imaging techniques and databasing in the health sector? In exploring these questions, we will examine selected biomedical sites and contexts in which surveillance is at work – often as taken-for granted and widely accepted if not desired practice. By exploring the effects of surveillance from perspectives situated in the cultural studies of medicine, this article attempts to expose the digital reconfiguration of the body as object of medical monitoring and intervention. Health monitoring relies on statistics that are informed by the biopolitical state—their evidence is predicated off of skewed data epistemes have constructed to support themselves Baur and Olsen 9 (Susanne, professor at the University of Copenhagen, and Jan, professor at University of Copenhagen, “Observing the Others, Watching Over Oneself: themes of medical surveillance in society” file:///C:/Users/Jessi/Downloads/3252-5562-2-PB.pdf 2009 JM) Monitoring population health has a long tradition in demography, government statistics and social policy; in 18th century political arithmetic, population thinking, probability theory and the field of political economy were closely entangled (Desrosières 1998). The production of population data has long been intertwined with biopolitical frameworks, e.g. of central state governance, life insurance and actuary reasoning. The panoptic constellation of monitoring and managing a collective ‘population body’ continues to play a central role in contemporary concepts and practices of evaluation and governance. In public health, surveillance, as defined by Alexander Langmuir, means ‘the continued watchfulness over the distribution and trends of incidence through the systematic collection, consolidation and evaluation of morbidity and mortality reports and other relevant data’ for purposes of prevention of disease or injury’ (Langmuir 1992). Epidemiologist Alfredo Morabia described surveillance as the ‘bedrock of public health’ (Morabia 2000: 22); securing generation and access to valid data is critical in epidemiologic research. Survey and monitoring techniques bring about statistical entities and make them perceptible; subsequent data visualization works as a tool for inspection of multiple aspects ‘at a glance’, similar to techniques of mapping. A survey is an act of viewing, examining and inspecting; the term ‘survey’ originated in 19th century land surveys and geology (Converse 1987). Different from land surveys for the mapping of geographical space, the data patterns visualized in epidemiology refer to multiple levels and diverse contexts. The extent and modalities in which data are collected has differed between countries; often so-called ‘routine data’ such as demographic data on births and deaths (‘vital statistics’) are collected for the entire population. The Nordic countries maintain central population registries which allow record linkage between different sectors (for example population registries, social services and health care data). Health research relies heavily on data from these routine administrative monitoring techniques as well as on the data recording systems of health-related registries. Registry research has become a sub-discipline in epidemiologic research in the Nordic countries (Mortensen 2004). Further, specific epidemiological studies are usually conducted for representative samples of the population, for example longitudinal follow-up studies or cross-sectional surveys. Health surveys among representative or random samples of the population are used to gain quick ‘comparative snapshots’ of the population’s health. Not only has the anatomic atlas of the macroanatomical body been replaced by a statistical and digitized body; at a population level health and disease are documented for instance in national cancer atlases, as done for example in Denmark since the 1970s. Visual mapping as part of descriptive epidemiology creates new epistemological infrastructures; the surveillant gaze takes up these new data patterns as grids of orientation, in which one is able to navigate. More than a metaphor the visual episteme plays is key to design and display of health statistics. Alluding to the objectivity effects of photography, Catherine Waldby has described epidemiological surveillance as an imaging process that is conceived to provide ‘accurate photographs of population health’ (Waldby 1996: 99). Graphs, charts and tables visualise and spatialize data; they mediate research design and risk communication. While as part of state administrative procedures, routine data are recorded and stored to evaluate health and disease at the population level, it is also new forms of accountability that drive the implementation of monitoring and evidence-based decision-making; these in turn nurture the need for documentation, visibility and transparency. This data hunger of quality management has contributed to the vast bureaucracies that accompany medical practice and health care systems. The plan fails – only questioning broader surveillance structures solves Whetton 13 (Suzanne, Lecturer at University of Tasmania, “Health informatics discourses and the use of personal health information: Which piper, which tune, who pays?”, July 2013, University of Tasmania, http://eprints.utas.edu.au/17110/2/whole-Whettonthesis.pdf)//JL The health informatics community has the option of continuing to participate in discussions within the parameters established by the privacy framework, or it may go beyond these parameters to challenge the dominant approach to personal health information management and, in doing so, address issues beyond a private trouble/public interest level. To adopt this form of critique would mean exploring alternative approaches to conceptualizing information management issues. It would mean challenging the representation of the privacy framework as neutral. It would also mean identifying links between the collection of personal health information and broader social practices and power relations in Australia. Such a challenge would ‘invoke broader questions of social control and warn of the dangers of the creeping surveillance society’ (Bennett, 2011, p. 485). It would explain this creeping surveillance society in terms of disciplinary power and control not only of some individuals and groups but of the population as a whole. The willingness to critique is increasingly imperative as the Australian Government progresses its plans for an Individual Health Identifier (IHI) and a Personally Controlled Electronic Health Record (PCEHR). As health information networks expand to intersect with other personal information networks, creating the potential for new, more widespread and more intrusive forms of surveillance, it becomes even more imperative that the health informatics community participate in the critical debate. Biopolitical disease surveillance sets the stage for the militarization of health and society – culminates in authoritarianism Youde 10 (Jeremy Youde is a professor of Political Science at the University of Minnesota Duluth, “BIOPOLITICAL SURVEILLANCE AND PUBLIC HEALTH IN INTERNATIONAL POLITICS” p. 31-34)///CW The other major concern about the increased surveillance associated¶ with biopolitics focuses on overly militarized responses. As we¶ redefine infectious disease as a security threat, critics have warned¶ that governments may inappropriately rely on traditional security¶ apparatuses to address the problem. Deudney raised a similar concern¶ with the environment. If environmental degradation is deemed a¶ security threat that concerns national and international stability, it¶ may lead political leaders to call on military forces to confront the¶ threat. Militaries may be useful for traditional threats, but they may¶ be poorly equipped to respond to environmental degradation or¶ infectious disease.73¶ Militaries can and do play a role in biopolitical surveillance. Some¶ of this is concentrated on the members of the armed forces. Military¶ commanders have an obvious interest in ensuring that their forces are¶ healthy and able to respond to situations as they arise. The military¶ often creates its own parallel public health infrastructure specifically¶ for its members. Like any other public health system, the military¶ seeks to monitor, treat, and prevent illnesses. However, those same¶ capabilities can be extended to monitor civilian populations. Militaries¶ may have laboratory and diagnostic capabilities beyond those of traditional¶ public health organizations. They may also have the logistical¶ and organizational capabilities to facilitate rapid deployment in epidemic¶ regions and the communication technologies to communicate¶ with WHO officials in a timely manner.74 Indeed, in developing¶ countries, the military may be the only organization with these capabilities.¶ Such an extension of military capabilities into decidedly nonmilitary¶ realms raises fears of the militarization of society. Chretien et¶ al. suggest that some governments have essentially turned the provision¶ of public health services and disease surveillance over to military¶ forces “by providing health services for civilians in remote areas and¶ reporting military surveillance data to the ministry of health.”75 This¶ extends the role of the military into a more prominent place within¶ the domestic arena.¶ The connections between military forces and public health are not¶ limited to developing countries. Within the United States, much of the¶ global infectious disease surveillance system is linked to the Department¶ of Defense (DoD). In the 1990s, the U.S. government established the¶ Global Emerging Infectious Surveillance and Response System (GEIS).¶ The system set up mobile laboratories that could quickly respond to¶ disease outbreaks around the world. Interestingly, GEIS comes under¶ the administrative aegis of the DoD, not one of the diplomatic or¶ humanitarian bureaucracies in the government. “Their location in the¶ DoD, as opposed to the United States Agency for International¶ Development (USAID) or Center for Disease Control (CDC) demonstrates¶ how seriously the United States views the response to infectious¶ disease as a key national security strategy.”76 Surveillance becomes¶ inextricably linked with the military and the deployment of military¶ personnel in foreign countries. Fears arise that this could cloud the¶ state’s response, leading to rely too heavily on military, as opposed to¶ health, means. It also could potentially place the military in a strong¶ position for ensuring and regulating the population’s health.¶ Pandemic influenza preparations have further stoked fears about¶ the links between biopolitical surveillance and the role of the military.¶ In 2005, U.S. President Bush released the document National¶ Strategy for Pandemic Influenza. The document focuses on preparedness,¶ surveillance, and containment. This strategy calls upon government¶ officials at the local, state, and federal government to develop¶ mitigation strategies, build greater lines of communication between¶ officials, and collaborate with international partners. To contain an¶ outbreak, the strategy acknowledges that military capabilities may be¶ used domestically to provide additional medical facilities and to¶ engage in “infrastructure-sustainment activities.”77 Bush expanded¶ upon the military’s potential role during a press conference. He¶ remarked:¶ If we had an outbreak somewhere in the United States, do we not then¶ quarantine that part of the country, and how do you then enforce a¶ quarantine? When—it’s one thing to shut down airplanes; it’s another¶ thing to prevent people from coming in to get exposed to the avian¶ flu. And who best to be able to effect a quarantine? One option is the¶ use of a military that’s able to plan and move.78¶ Some have seized upon this potential role for the military as proof¶ that governments are using the threat of an infectious disease outbreak¶ to introduce an overly militaristic response that could border¶ on martial law. The United States’ pandemic influenza program specifically¶ carves out a special role for the military in providing medical¶ services, enforcing quarantines, and ensuring continuity of government¶ and economy. Some critics of this program have argued that it¶ essentially allows for the declaration of martial law.79 Greger argues¶ that using the military to institute some sort of quarantine, as he suggests¶ the National Strategy for Pandemic Influenza allows, would¶ serve only to increase stigmatization and discrimination. This would¶ drive people further away from medical attention and exacerbate an¶ epidemic.80 Irwin Redlener, the dean of Columbia University’s¶ Mailman School of Public Health, called the militarized aspect of the¶ government’s response “extraordinarily draconian” and equated it¶ with martial law.81¶ More bombastically, Michael Osterholm, an advisor to the U.S.¶ government on its pandemic flu preparations, paints the following¶ doomsday scenario:¶ Border security would be made a priority, especially to protect potential¶ supplies of pandemicspecific vaccines from nearby desperate countries.¶ Military leaders would have to develop strategies to defend the¶ country and also protect against domestic insurgency with armed¶ forces that would likely be compromised by the disease.82¶ He goes on to discuss the fallout from the government’s failure to¶ properly securitize pandemic influenza:¶ Someday, after the next pandemic has come and gone, a commission¶ much like the 9/11 Commission will be charged with determining¶ how well government, business, and public health leaders prepared the¶ world for the catastrophe when they had clear warning. What will be¶ the verdict?83¶ Osterholm’s prognostication envisions widespread looting and the need¶ for roaming militias to ensure access to drug supplies as he envisions¶ millions of people dying. He speaks strongly about the need to protect¶ our borders to prevent people from coming to the United States to get¶ America’s drugs. This also suggests that pharmaceutical manufacturing¶ capabilities may become a national security issue, as could access to¶ antiretroviral drugs in developing countries. Garrett notes that pharmaceutical¶ patent protections are stoking anti-Western sentiments in¶ some countries, threatening to create greater problems.84¶ These concerns about the role of the military in responding to a¶ disease outbreak get to the very heart of surveillance. Fears have arisen¶ about the potential for overt coercion going hand in hand with¶ increased government surveillance in public health. Government officials¶ have linked increasing adherence with universal standards embodied¶ within increased health surveillance with a loss of sovereignty,¶ attempts to weaken the state, and domination by Western states. ***Impact Framing*** No War - General No risk of global war – economic costs, democracy, treaties, interdependence and multiple other reasons check conflict escalation [John Aziz, former economics and business editor @ The Week. “Don't worry: World War III will almost certainly never happen” 2014] Next year will be the seventieth anniversary of the end of the last global conflict. There have been points on that timeline — such as the Cuban missile crisis in 1962, and a Soviet computer malfunction in 1983 that erroneously suggested that the U.S. had attacked, and perhaps even the Kosovo War in 1999 — when a global conflict was a real possibility. Yet today — in the shadow of a flare up which some are calling a new Cold War between Russia and the U.S. — I believe the threat of World War III has almost faded into nothingness. That is, the probability of a world war is the lowest it has been in decades, and perhaps the lowest it has ever been since the dawn of modernity. This is certainly a view that current data supports. Steven Pinker's studies into the decline of violence reveal that deaths from war have fallen and fallen since World War II. But we should not just assume that the past is an accurate guide to the future. Instead, we must look at the factors which have led to the reduction in war and try to conclude whether the decrease in war is sustainable. So what's changed? Well, the first big change after the last world war was the arrival of mutually assured destruction. It's no coincidence that the end of the last global war coincided with the invention of atomic weapons. The possibility of complete annihilation provided a huge disincentive to launching and expanding total wars. Instead, the great powers now fight proxy wars like Vietnam and Afghanistan (the 1980 version, that is), rather than letting their rivalries expand into full-on, globe-spanning struggles against each other. Sure, accidents could happen, but the nobody in power wants to be the cause of Armageddon. But what about a nonnuclear global war? Other changes — economic and social in nature — have made that highly unlikely too. The world has become much more economically interconnected since the last global war. Economic cooperation treaties and free trade agreements have intertwined the economies of countries around the world. This has meant there has been a huge rise in the volume of global trade since possibility is incredibly remote. More importantly, World War II, and especially since the 1980s. Today consumer goods like smartphones, laptops, cars, jewelery, food, cosmetics, and medicine are produced on a global level, with supply-chains criss-crossing the planet. An example: The laptop I am typing this on is the cumulative culmination of thousands of hours of work, as well as resources and manufacturing processes across the globe. It incorporates metals like tellurium, indium, cobalt, gallium, and manganese mined in Africa. Neodymium mined in China. Plastics forged out of oil, perhaps from Saudi Arabia, or Russia, or Venezuela. Aluminum from bauxite, perhaps mined in Brazil. Iron, perhaps mined in Australia. These raw materials are turned into components — memory manufactured in Korea, semiconductors forged in Germany, glass made in the United States. And it takes gallons and gallons of oil to ship all the resources and components back and forth around the world, until they are finally assembled in China, and shipped once again around the world to the consumer. In a global war, global trade becomes a nightmare. Shipping becomes more expensive due to higher insurance costs, and riskier because it's subject to seizures, blockades, ship sinkings. Many goods, intermediate components or resources — including energy supplies like coal and oil, components for military hardware, etc, may become temporarily unavailable in certain areas. Sometimes — such as occurred in the Siege of Leningrad during World War II — the supply of food can be cut off. This is why countries hold strategic reserves of things like helium, pork, rare earth metals and oil, coal, and gas. These kinds of breakdowns were troublesome enough in the economic landscape of the early and mid-20th century, when the last global wars occurred. But in today's ultra-globalized and ultra-specialized economy? The level of economic adaptation — even for large countries like Russia and the United States with lots of land and natural resources — required to adapt to a world war would be crushing, and huge numbers of business and livelihoods would be wiped out. In other words, global trade interdependency has become, to borrow a phrase from finance, too big to fail. It is easy to complain about the reality of big business influencing or controlling politicians. But big business has just about the most to lose from breakdowns in global trade. A practical example: If Russian oligarchs make their money from selling gas and natural resources to Western Europe, and send their children to schools in Britain and Germany, and lend and borrow money from the West's financial centers, are they going to be willing to tolerate Vladimir Putin starting a regional war in Eastern Europe (let alone a world war)? Would the Chinese financial industry be happy to see their multi-trillion dollar investments in dollars and U.S. treasury debt go up in smoke? Of course, world wars have been waged despite international business interests, but the world today is far more globalized than ever before and well-connected domestic interests are more dependent on access to global markets, components and resources, or the repayment of foreign debts. These are huge disincentives to global war. But what of the militaryindustrial complex? While other businesses might be hurt due to a breakdown in trade, surely military contractors and weapons manufacturers are happy with war? Not necessarily. As the last seventy years illustrates, it is perfectly possible for weapons contractors to enjoy the profits from huge military spending without a global war. And the uncertainty of a breakdown in global trade could hurt weapons contractors just as much as other industries in terms of losing access to global markets. That means weapons manufacturers may be just as uneasy about the prospects for large-scale war as other businesses. Other changes have been social in nature. Obviously, democratic countries do not tend to go to war with each other, and the spread of liberal democracy is correlated against the decrease in war around the world. But the spread of internet technology and social media has brought the world much closer together, too. As late as the last world war, populations were separated from each other by physical distance, by language barriers, and by lack of mass communication tools. This means that it was easy for war-mongering politicians to sell a population on the idea that the enemy is evil. It's hard to empathize with people who you only see in slanted government propaganda reels. Today, people from enemy countries can come together in cyberspace and find out that the "enemy" is not so different, as occurred in the Iran-Israel solidarity movement of 2012. More importantly, violent incidents and deaths can be broadcast to the world much more easily. Public shock and disgust at the brutal reality of war broadcast over YouTube and Facebook makes it much more difficult for governments to carry out large scale military aggressions. For example, the Kremlin's own pollster today released a survey showing that 73 percent of Russians disapprove of Putin's handling of the Ukraine crisis, with only 15 percent of the nation supporting a response to the overthrow of the government in Kiev. There are, of course, a few countries like North Korea that deny their citizens access to information that might contradict the government's propaganda line. And sometimes countries ignore mass anti-war protests — as occurred prior to the Iraq invasion of 2003 — but generally a more connected, open, empathetic and democratic world has though, may be that the made it much harder for war-mongers to go to war. The greatest trend, world as a whole is getting richer. Fundamentally, wars arise out of one group of people deciding that they want whatever another group has — land, tools, resources, money, friends, sexual partners, empire, prestige — and deciding to take it by force. Or they arise as a result of grudges or hatreds from previous wars of the first kind. We don't quite live in a superabundant world yet, but the long march of human ingenuity is making basic human wants like clothing, water, food, shelter, warmth, entertainment, recreation, and medicine more ubiquitous throughout the world. This means that countries are less desperate to go to war to seize other people's stuff. But the tendency toward inertia is strong. It is clear at least that the incentives for world war are far lower than they were in previous decades, and the disincentives are growing. The apocalyptic visions of a new world war between nations or empires that three generations of children have been raised into continue to diminish. Empirics prove that mutually assured destruction prevents war because all actors are rational and nuclear war is fundamentally unwinnable Tepperman 9 (Jonathan Tepperman is an editor, writer, and analyst working on international affairs. He was appointed Managing Editor of Foreign Affairs—the magazine published by the New York–based Council on Foreign Relations—in February 2011. Tepperman has a BA in English Literature from Yale University and law degrees from Oxford and NYU. He is Vice Chairman of the Halifax International Security Forum and a Fellow of the New York Institute of Humanities. “How Nuclear Weapons Can Keep You Safe” 8/28/9 http://www.newsweek.com/how-nuclear-weapons-can-keep-you-safe-78907)///CW The argument that nuclear weapons can be agents of peace as well as destruction rests on two deceptively simple observations. First, nuclear weapons have not been used since 1945. Second, there's never been a nuclear, or even a nonnuclear, war between two states that possess them. Just stop for a second and think about that: it's hard to overstate how remarkable it is, especially given the singular viciousness of the 20th century. As Kenneth Waltz, the leading "nuclear optimist" and a professor emeritus of political science at UC Berkeley puts it, "We now have 64 years of experience since Hiroshima. It's striking and against all historical precedent that for that substantial period, there has not been any war among nuclear states."¶ To understand why—and why the next 64 years are likely to play out the same way—you need to start by recognizing that all states are rational on some basic level. Their leaders may be stupid, petty, venal, even evil, but they tend to do things only when they're pretty sure they can get away with them. Take war: a country will start a fight only when it's almost certain it can get what it wants at an acceptable price. Not even Hitler or Saddam waged wars they didn't think they could win. The problem historically has been that leaders often make the wrong gamble and underestimate the other side—and millions of innocents pay the price.¶ Nuclear weapons change all that by making the costs of war obvious, inevitable, and unacceptable. Suddenly, when both sides have the ability to turn the other to ashes with the push of a button—and everybody knows it—the basic math shifts. Even the craziest tin-pot dictator is forced to accept that war with a nuclear state is unwinnable and thus not worth the effort. As Waltz puts it, "Why fight if you can't win and might lose everything?"¶ Why indeed? The iron logic of deterrence and mutually assured destruction is so compelling, it's led to what's known as the nuclear peace: the virtually unprecedented stretch since the end of World War II in which all the world's major powers have avoided coming to blows. They did fight proxy wars, ranging from Korea to Vietnam to Angola to Latin America. But these never matched the furious destruction of full-on, great-power war (World War II alone was responsible for some 50 million to 70 million deaths). And since the end of the Cold War, such bloodshed has declined precipitously. Meanwhile, the nuclear powers have scrupulously avoided direct combat, and there's very good reason to think they always will. There have been some near misses, but a close look at these cases is fundamentally reassuring—because in each instance, very different leaders all came to the same safe conclusion.¶ Take the mother of all nuclear standoffs: the Cuban missile crisis. For 13 days in October 1962, the United States and the Soviet Union each threatened the other with destruction. But both countries soon stepped back from the brink when they recognized that a war would have meant curtains for everyone. As important as the fact that they did is the reason why: Soviet leader Nikita Khrushchev's aide Fyodor Burlatsky said later on, "It is impossible to win a nuclear war, and both sides realized that, maybe for the first time."¶ The record since then shows the same pattern repeating: nuclear-armed enemies slide toward war, then pull back, always for the same reasons. The best recent example is India and Pakistan, which fought three bloody wars after independence before acquiring their own nukes in 1998. Getting their hands on weapons of mass destruction didn't do anything to lessen their animosity. But it did dramatically mellow their behavior. Since acquiring atomic weapons, the two sides have never fought another war, despite severe provocations (like Pakistani-based terrorist attacks on India in 2001 and 2008). They have skirmished once. But during that flare-up, in Kashmir in 1999, both countries were careful to keep the fighting limited and to avoid threatening the other's vital interests. Sumit Ganguly, an Indiana University professor and coauthor of the forthcoming India, Pakistan, and the Bomb, has found that on both sides, officials' thinking was strikingly similar to that of the Russians and Americans in 1962. The prospect of war brought Delhi and Islamabad face to face with a nuclear holocaust, and leaders in each country did what they had to do to avoid it. No War – Nuclear Winter Nuke war is unlikely – conventional weapons are prioritized and there is no impact to nuclear winter Brian Dunning (co-founded and was chief technology officer for Buylink, technical editor for FileMaker Advisor Magazine, hosted and produced Skeptoid: Critical Analysis of Pop Phenomenon, winner of the 2010 Parsec Award for "Best Fact Behind the Fiction Podcast".[14] In August 2010 he received an award recognizing his contributions in the skeptical field from the Independent Investigations Group (IIG) during its 10th Anniversary Gala) 2011 “Nuclear War and Nuclear Winter” http://skeptoid.com/episodes/4244 Other cataclysmic events have proven that the nuclear winter scenario is not at all far-fetched. The eruption of Mt. Pinatubo in the some 17 million tons of particulates into the upper atmosphere that caused global temperatures to drop by about a degree for several months. Sunlight dropped by 10%. This temperature drop did not, however, have any long-term effect on agriculture. Pinatubo was only a blip compared the the K-T extinction event of some 65 Philippines, also in 1991, threw million years ago, when a theorized asteroid hit us with one hundred million megatons of destructive force, lighting virtually the entire world on fire. The evidence of this is called the K-T boundary, a layer of clay found all around the world. Sunlight was reduced by 10-20% for ten years, which caused a massive cascading extinction of species from plants to herbivores to carnivores. But we shouldn't expect anything like this to happen from a nuclear war. Times continue to change, including the nature of warfare. Nations no longer stockpile the megaton class weapons popular in the 1950s and 1960s; typical yields now are a fraction of a megaton. The United States' conventional capability is now so good that it can effectively destroy an entire nation's ability to wage large-scale war overnight, using only conventional weapons. But that doesn't mean the nuclear forces are no longer needed. Should a superpower strike first against the United States with nuclear weapons, the response would more than likely be nuclear, bringing Mutually Assured Destruction into play. But what about a small nation striking first? What about nukes in the trunks of cars parked in major cities? In the modern era, it's much less clear that any superpower would necessarily have anyone to shoot back at. And so, while the nuclear winter scenario is a good prediction of the effects of a worst-case scenario, when all the variables are at their least favorable, the strongest probabilities favor a much less catastrophic nuclear autumn; and even those effects depend strongly on variables like whether the war happens during the growing season. A bomb in Los Angeles might result in history's worst firestorm, while a bomb in the mountains of Pakistan might create no fires at all. The simple fact is that there are too many unpredictable variables to know what kind of climate effects the smoke following nuclear fires will produce, until it actually happens. Obviously we're all very mindful of the many terrible implications of nuclear combat, and if it ever happens, the prospect of a nuclear autumn will likely be among the least of our concerns. The physicist Freeman Dyson perhaps described it best when he said "(TTAPS is) an absolutely atrocious piece of science, but I quite despair of setting the public record straight... Who wants to be accused of being in favor of nuclear war?" Nuclear winter can’t be proven—their studies are politically biased AIP (American Institute of Physics) 2011 “Wintry Doom” https://www.aip.org/history/climate/Winter.htm Atmospheric scientists were well-placed to take up the question of smoke from a nuclear war. Measurements like Crutzen's of the effects of soot and the like had greatly advanced since the 1975 study. Richard Turco and others, working on the dinosaur extinction problem, had developed a computer model of a haze-filled atmosphere, and it had occurred to them that dust lofted by the explosions of a nuclear world war might have effects comparable to the dust from an asteroid impact. Meanwhile the surprising observation that a giant dust storm was cooling the atmosphere of Mars had inspired two more scientists, James Pollack and Brian Toon, into new calculations of dust effects. This led them into work with Carl Sagan on how the aerosols emitted by volcanic eruptions could affect climate. Now these scattered scientists joined forces to calculate the consequences of an exchange of hydrogen bombs. Their ominous conclusion was that the sooty smoke from burning cities could bring on a "nuclear winter" — months or even years of cold so severe it would gravely endanger living creatures.(8) The scientists did this work mainly for public consumption. When they announced their results in 1983, it was with the explicit aim of promoting international arms control. Surely the likelihood that all-out nuclear war was literally suicidal would persuade nations to reduce their arsenals? As a side effect, the studies helped to improve scientific understanding of how aerosols could affect climate.(9) The computer models were so simplified, and the data on smoke and other aerosols were still so poor, that the scientists could say nothing for certain. Critics, mostly people opposed to nuclear disarmament, quickly pointed out the deficiencies. In the mid 1980s, detailed studies confirmed that a nuclear war would probably alter global climate temporarily. But as Schneider and a coauthor explained in a widely read article, it was not likely to bring an apocalyptic winter, but it would bring a damaging "nuclear fall." (According to more recent research, smoke following even a limited, regional war would probably dim sunlight enough to kill many more people through starvation than would die directly under the bombs.)(10) No War - A2 Irrational Actors Even the wildest leaders are deterable – if Mao and Stalin didn’t start a nuclear war then nobody will Tepperman 9 (Jonathan Tepperman is an editor, writer, and analyst working on international affairs. He was appointed Managing Editor of Foreign Affairs—the magazine published by the New York–based Council on Foreign Relations—in February 2011. Tepperman has a BA in English Literature from Yale University and law degrees from Oxford and NYU. He is Vice Chairman of the Halifax International Security Forum and a Fellow of the New York Institute of Humanities. “How Nuclear Weapons Can Keep You Safe” 8/28/9 http://www.newsweek.com/how-nuclear-weapons-can-keep-you-safe-78907)///CW Nuclear pessimists—and there are many—insist that even if this pattern has held in the past, it's crazy to rely on it in the future, for several reasons. The first is that today's nuclear wannabes are so completely unhinged, you'd be mad to trust them with a bomb. Take the sybaritic Kim Jong Il, who's never missed a chance to demonstrate his battiness, or Mahmoud Ahmadinejad, who has denied the Holocaust and promised the destruction of Israel, and who, according to some respected Middle East scholars, runs a messianic martyrdom cult that would welcome nuclear obliteration. These regimes are the ultimate rogues, the thinking goes—and there's no deterring rogues.¶ But are Kim and Ahmadinejad really scarier and crazier than were Stalin and Mao? It might look that way from Seoul or Tel Aviv, but history says otherwise. Khrushchev, remember, threatened to "bury" the United States, and in 1957, Mao blithely declared that a nuclear war with America wouldn't be so bad because even "if half of mankind died … the whole world would become socialist." Pyongyang and Tehran support terrorism—but so did Moscow and Beijing. And as for seeming suicidal, Michael Desch of the University of Notre Dame points out that Stalin and Mao are the real record holders here: both were responsible for the deaths of some 20 million of their own citizens.¶ Yet when push came to shove, their regimes balked at nuclear suicide, and so would today's international bogeymen. For all of Ahmadinejad's antics, his power is limited, and the clerical regime has always proved rational and pragmatic when its life is on the line. Revolutionary Iran has never started a war, has done deals with both Washington and Jerusalem, and sued for peace in its war with Iraq (which Saddam started) once it realized it couldn't win. North Korea, meanwhile, is a tiny, impoverished, family-run country with a history of being invaded; its overwhelming preoccupation is survival, and every time it becomes more belligerent it reverses itself a few months later (witness last week, when Pyongyang told Seoul and Washington it was ready to return to the bargaining table). These countries may be brutally oppressive, but nothing in their behavior suggests they have a death wish. Yes War - General Nuclear war is possible – India, Pakistan, China, North Korea, and terrorism Duz 14 (Sergei Duz is a writer for the Voice of Russia, “Nuclear war more likely than ever: threat comes from South Asia and nuke terrorists” 1/2/14 http://sputniknews.com/voiceofrussia/2014_01_02/Nuclear-war-more-likely-than-ever-threat-comes-from-South-Asia-andnuke-terrorists-1915/) The main reason for this is the ongoing erosion of the non-proliferation regime, experts say. The Non-Proliferation Treaty has been continuously bashed as "unfair," but it is in fact the exclusive geopolitical environment and ensuing nuclear responsibility of a handful of states that has so far kept mankind away from the total wipeout.¶ The theory of reciprocal deterrence wasn’t there all the time. A long two decades after the A-bomb was invented, the powers who had it in their arsenals thought of it as fair game, a weapon you could actually use in a conflict, rather than a deterrent.¶ The Cuban Missile Crisis came as a wakeup call. It brought home the danger of nuclear weapons and led to the non-proliferation regime as conceived by the socalled "nuclear club," which included the Soviet Union, the US, Britain, France and China. Under the NPT, only countries that made and set off a nuclear bomb prior to January 1, 1967 were granted the status of a nuclear power. Washington, London and Moscow were the first to sign the treaty in 1968, with Paris and Beijing committing themselves to it years later. But all of the signatories abided by the rules.¶ Those times have passed. NPT controls have become so loose and new nuclear powers so numerous, there’s no counting them anymore. India, Pakistan, Israel and North Korea have never even applied for "nuclear club" membership. On the contrary, they created their own shadow club with no rules. The official club with all its nukes poses less threat to the human race than this bunch of neophytes. Volatility has spread, though South Asia plays a separate role in it.¶ "Some South Asian countries have a full arsenal of nukes," says Pyotr Topychkanov, a senior researcher at the International Security Center of the Institute of World Economy and International Relations at the Russian Academy of Sciences. "They have enough nuclear warheads and vehicles. They have only one equal in the Middle East, which is Israel. Iran has no nuclear weapons yet."¶ "The same is true of North Korea, which has weapon-grade fissile nuclear materials. They have built and tested explosive devices, but it’s still a long way to fully-fledged nukes for them."¶ "The countries that really cause concern are India, Pakistan and China. China and Pakistan are longtime partners, including their nuclear agenda. India borders on China and Pakistan and is certainly aware of this partnership. It doesn’t have faith in either. Were a conflict to spark off, it would be trilateral and include not only India and Pakistan, but India, Pakistan and China."¶ About 30 to 40 countries are on their way towards nuclear status. Many of them are inches away, like Germany, Japan and Canada, who could have had an A-bomb long ago – but simply didn’t wish to. The Sunni Saudi Arabia has hinted it will make a bomb the moment the Shiite Iran lays its hands on one.¶ The principle of uncontrolled nuclear proliferation was formulated back in 1965, when Pakistan’s foreign chief Zulfikar Ali Bhutto said: "There’s a Christian bomb, a Jewish bomb and now even a Hindu bomb. It’s high time we got a Muslim bomb."¶ Nuclear terrorism is yet another problem. Terrorists can’t make a nuke. But they do know how to pit countries and eventually provoke them to an inadequate response. There’s no lacking of short-sighted politicians who can take that last step, for instance Republican Senator Steve Buyer who nudged the government after 9/11 to nuke Tora Bora caves, instead of sending a task force to Afghanistan.¶ In that sense, the threat of a full-scale nuclear war has transformed into the menace of a local nuclear conflict, or even a string of them. You shouldn’t be lulled by their seeming locality though, since a precise nuclear strike will be felt globally, says PIR Center Internet Project Director Andrei Baklitsky.¶ "A nuclear conflict will have dramatic consequences for all of us, because nuclear weapons are weapons of mass destruction. They are not selective. A nuclear attack in the Middle East would be most tragic, first of all, because of its huge oil fields, and a burning oil field is a big trouble. Secondly, any strike on the Middle East will skyrocket oil prices across the world and plunge the global economy back into an even worse economic crisis that before.¶ The consequences of using an A-bomb in an Indo-Pakistani conflict would be just as grave for these densely populated countries, driving millions of refugees out of their homes and turning agriculture lands into barren wastes."¶ Unfortunately, the world is home to many paradoxes. Despite a drop in amounts of nuclear weapons worldwide, the collapse of the bipolar world has made the risk of a manmade apocalypse palpable. Nuclear war is possible – accidents and poor risk calculation Gobry 14 (Pascal-Emmanuel Gobry is a writer and fellow at the Ethics and Public Policy Center. His writing has appeared at Forbes, The Atlantic, First Things, Commentary Magazine, The Daily Beast, The Federalist, Quartz, and other places, “The end of nuclear deterrence” 12/12/14 http://theweek.com/articles/441584/end-nuclear-deterrence)///CW Since the end of the Cold War, the public mind has pretty much forgotten about the existence of nuclear weapons, except in the Middle East. And yet, they still exist — thousands and thousands of them, ready to destroy all of human civilization several times over. In response, a new nuclear disarmament movement is getting underway.¶ This week, I attended the Vienna conference on the Humanitarian Impact of Nuclear Weapons. (Full disclosure: one of the sponsoring organizations, the Nuclear Threat Initiative, invited me all expenses paid.) The conference was striking in describing the utter, absolute destruction that can be caused by nuclear weapons.¶ I came in as a supporter of the doctrine of nuclear deterrence, which says that the world's major power-brokers should have nuclear weapons as a way of preventing a new world war. Advocates of this doctrine point to the Cold War, which never went hot, as a success for deterrence.¶ But supporters of disarmament — including the Red Cross, Pope Francis, and, believe it or not, Henry Kissinger — say that's wrong. These are serious, sober-minded people, not just pie-in-the-sky activists, and they say that deterrence doesn't work in a multipolar world. Instead, the presence of nuclear weapons just creates an incentive for more proliferation, as small countries try to one-up their regional adversaries.¶ What's more — and this was the most striking thing at the conference — they point to the risks inherent in the existence of nuclear weapons. History has recorded many close calls in which nuclear weapons were almost fired. (This, in turn, could have led to a nightmare scenario where an accidental strike is met with a riposte, triggering Armageddon.) For example, in 2007, six U.S. nuclear warheads went missing because of a bureaucratic mistake. Then there's the story of the U.S. nuclear missile launch officer with the drug problem.¶ If this stuff can happen in the U.S., which has the oldest, best-funded, and most sophisticated nuclear force, one shudders to think about what might be going on in Russia or Pakistan. Given the way human nature and technology works, advocates warn, it is not a matter of if, but when a catastrophic accicent will occur. The only solution is simply to ban nuclear weapons for good.¶ This is where I started rethinking my position. A lot of research has shown that human brains are wired in such a way that it is very difficult for us to rationally process risks that have a very low probability but a very high cost. This is essentially what caused the 2008 financial crisis: a very low risk was treated as non-existent, so that when the event occurred, the system collapsed. This is exactly the kind of risk we are talking about with nuclear weapons. Peace isn’t inevitable – framing it as such increases the risk of conflict by altering threat perceptions Jehangir 12 {Hamza, Research Associate on a National Priorities Research Project (Texas A&M – Qatar), Masters of Arts, International Relations and Globalization (University of Salford, UK) and Bachelor of Social Science, International Relations (SZABIST, Islamabad, Pakistan), “Realism, Liberalism and the Possibilities of Peace,” E-IR, 2/19, http://www.e-ir.info/2012/02/19/realism-liberalism-and-thepossibilities-of-peace/} When Plato said that only the dead have seen the end of war, his remarks echoed the history of his time. War was all too often of an occurrence in ancient Greece, so much so that it might’ve been considered a necessity in some cases but a menace in others. From Plato’s time to the contemporary period of political science and international relations theorizing, philosophers and theorists have been primarily concerned with discovering human nature, its role in social and political life as well as ways and means of giving meaning to human life. Peace has been central to this process of inquiry and thought which has led humanity to its present condition. Theories of peace and war have been central to this cognitive exercise. However, in the last three centuries, relations between nation-states have taken the central stage. Theories have come to light which illuminate our understanding of how nations interact, what causes them to go to war, what motivations might they have to establish peace and how these causes and motivations might be managed to reach a stage where peace is not “an armistice in a war” as Thucydides (431BCE) stated but “a virtue, a state of mind, a disposition for benevolence, confidence, justice” as Baruch Spinoza (1670) considered it to be. Nonetheless, there are still considerable obstacles that remain in the pursuit of peace. Theorists have outlined them and literature has shed light on these hurdles whereas in some cases the pre-occupation with peace has also led towards a more hostile state of international affairs amongst nations as well as peoples. Yes great power war – realism, fear of worse alts, failed political processes, violent human nature – their evidence twists definitions to exclude our scenarios Lyon 14 {Rod, director of the strategy and international program at the Australian Strategic Policy Institute, executive editor of The Strategist, “No, Great Power War Isn’t Obsolete,” The Diplomat, 8/22, http://thediplomat.com/2014/08/no-great-power-war-isnt-obsolete/} August has seen a wave of reflection on major war. It’s a question we seem to revisit every time the key anniversaries of WWI and WWII roll around, but especially this year because its the 100th anniversary of the outbreak of WWI. Some pundits are keen to draw parallels between 1914 and 2014—though on its face it’s not apparent to me why 2014 should be more like 1914 than 2013.¶ Academic strategists familiar with their disciplinary history will know that the issue of whether major war’s obsolete received a detailed coverage back in Survival magazine in the late 1990s. To save readers the trouble of digging through their archives, one contributor, John Mueller, argued that it was obsolete—gone the way of slavery and dueling—while others wrestled partly over how to define obsolescence and even more over how to define major war. Was the Vietnam War “major?” Was the Cold War a “war?” Michael Mandelbaum argued that perhaps major war was just a poor policy option nowadays—because of the steep rise in the costs and the thin rewards for success.¶ It’s intriguing that the question about the obsolescence of war is typically qualified by the adjective “major.” No one seems particularly keen to claim that nasty little wars—in particular, nasty little wars in faraway places— are obsolete, perhaps because they patently aren’t. From memory, Mueller didn’t want to call those conflicts “wars,” though; he saw those more as “opportunistic predation” (That’s the reason the cover of his book, The Remnants of War, features an image—from the Balkan conflict in 1991—of a thug swigging from a bottle.)¶ Then 9/11 came along and sideswiped that whole debate. The nasty little wars of the 1990s didn’t stay in faraway places. A superpower got up and marched off to war—albeit a war against al Qaeda, its supporters, and all its works. Somewhere along the line the mission became conflated with a host of other problems, and Washington ended up obsessing about the Global War on Terror for longer than it probably should have done. But Washington’s behavior at least answered one question related to the Big One: did great powers still go to war? Yes. Now, the question still unanswered—unanswered since 1945 if you think major war has to be hot; unanswered since 1991, if you think major war can be cold—is whether or not major powers still go to war with each other.¶ Psychologist Steven Pinker has recently argued that the better angels of our nature are making us turn away from violence. I’m not wholly convinced by his argument—the better angels of our nature seem pretty militant to me, and always have been. (See Ephesians, 6:12.) But academic research from a few decades back suggests that great-power wars against each other aren’t common. Jack Levy in his research on war in the international system between 1495 and 1975 found only nine of what he would call “world wars”—wars where almost all great powers were involved. Much more commonly, he found “interstate wars”—113 of which engaged a great power.¶ I cite those figures to underline two points. First, if world wars are rare, maybe we don’t need special explanations to say why there hasn’t been one since 1945 (hot) or 1991 (cold). Second, that definition of major war is still a problem.¶ Let’s put aside the academic arguments and look straight at the case that most worries us. Is a great-power war between the U.S. and China possible? I think we could answer that question directly: possible, yes; likely, no. Great powers, especially nuclear-armed ones, don’t go to war with each other lightly. But sometimes wars happen. And they aren’t accidents. They’re about international order. They’re about, as Raymond Aron said, the life and death of states. And the principal reason for fighting them is that not doing so looks like a worse alternative.¶ Moreover, the paths to war—including rare major-power war—are not reserved solely for conventionally-armed states. Where both powers are nuclear-armed we should expect a conflict, even one at the lower rungs of the escalation ladder, to be fought with a high degree of political control, and an understanding that the objectives of the conflict are limited. Naturally, it would help if both sides shared a common understanding of where the firebreaks were between conventional and nuclear conflict, and already had in place a set of crisis-management procedures, but it’s possible that neither of those conditions might exist. (Neither would prevent a war, but both would provide a better sense of the likely escalation dynamics of a particular conflict.) Indeed, it’s because major war is possible that we retain such a keen interest in war termination. Unconstrained escalation doesn’t lead to a happy place. Yes War – A2 Interdependence Trade doesn’t solve war – empirics prove it only applies for two Western nations Hafner-Burton and Montgomery 12 (Emilie M. Hafner-Burton PhD is a professor at the University of California, San Diego. Alexander H. Montgomery is Department Chair and Associate Professor of Political Science at Reed College. He has a B.A. 1996, Physics, University of Chicago. M.A. 1999, Energy and Resources, University of California at Berkeley. M.A. 2003, Sociology, Stanford University. Ph.D. 2006, Political Science, Stanford University. He has published articles on dismantling proliferation networks and on the effects of social networks of international organizations on interstate conflict. His research interests include political organizations, social networks, weapons of mass disruption and destruction, social studies of technology, and interstate social relations. “War, Trade, and Distrust: Why Trade Agreements Don’t Always Keep the Peace”)///CW Many before us have been skeptical of the claim that interdependence promotes¶ peace among states. It is well understood that international institutions can have¶ adverse effects on conflicts among member states, mismanaging crisis situations¶ and worsening conflict intensity (Gallarotti, 1991), or producing rivalry among¶ states due to their relative social positions (Hafner-Burton and Montgomery,¶ 2006). We are nevertheless among the first to directly tackle the principal claims¶ supporting the liberal thesis that trade institutions dampen conflict, and to propose¶ an explanation for why conflict often characterizes outcomes.¶ This is important because we observe significant instances of violent conflict4¶ between PTA members: the 1990s alone included border clashes between¶ Armenia and Azerbaijan, members of the Commonwealth of Independent¶ States (CIS); the outbreak of war in the Great Lakes, with foreign involvement¶ in the Democratic Republic of Congo from Angola, Namibia, Rwanda, Uganda,¶ and Zimbabwe, all members of the Common Market for Eastern and Southern¶ Africa (COMESA); the Iraqi invasion of Kuwait and violent border clashes¶ between Egypt and Sudan, all members of the Council of Arab Economic Unity¶ (CAEU); and fighting between India and Pakistan, members of the South¶ Asian Association for Regional Cooperation (SAARC). North and South¶ Korea frequently are involved in violent incidents; both are members of the¶ Global System of Trade Preferences Among Developing Countries (GSTP). A¶ majority of these disputants are also members of the WTO. Powers contends¶ that in Africa, 16% of all militarized international disputes registered by the¶ Correlates of War data from 1950 to 1992 occurred between PTA members¶ (Powers, 2003, 2004). These examples show clearly that members of the same¶ trade institution can and do conflict, that conflict often breaks out into violence,¶ and that commerce is frequently not enough to keep the peace. They stand in¶ sharp contrast to the liberal expectation that trade institutions dampen conflict¶ through an increase in trust.¶ Trade institutions do increase repeated contact between members; however,¶ contact does not necessarily build trust or a sense of community. The lessons of¶ European integration theory suggest that building community through upgrading¶ the common interest between PTA members requires a minimum level of homogeneity:¶ a pluralist social structure, a high level of economic and industrial development,¶ and ideological similarity (Haas, 1960). Security communities are also¶ most likely to develop through economic relations among Western nations, as ¶ even the most institutionalized forms of integration in the developing world cannot be said to create the mutual identification at the core of the concept ¶ (Bearce, 2003). Although evidence suggests that economic integration has led to¶ the formation of a collective identity and trust among member states of the¶ European Union over time, it is well understood that ‘‘democratic features of liberal¶ democracies enable the community in the first place’’ (Russett and Oneal,¶ 2001: 166). The liberal argument that trade institutions dampen conflict by building¶ trust among leaders to overcome commitment problems consequently chiefly¶ applies to the Western world of advanced democratic nations. Yet the overwhelming¶ majority of trade institutions manage trade between partners that include at¶ least one developing or nondemocratic state, and there is no evidence to show¶ that these institutions build trust over asymmetrical distribution of gains.¶ Boehmer, Gartzke, and Nordstrom cogently argue that states that belong to many¶ different international institutions may have a greater number of international¶ interests to competitively defend and a greater array of opportunities to enact¶ aggressive behavior in defense of those perceived interests (Boehmer et al., 2002).¶ We extend this argument one step further; trade institutions create and shape¶ states’ interests, affecting not only the number of potential issues for dispute, but¶ also establishing conditions that can lead to distrust. Institutions do this by placing¶ states in social positions of power within international relations, which shape¶ expectations for behavior by defining which issues are legitimate for contestation¶ via military means and enable states to coerce, bribe, reward, or punish each¶ other. We address this possibility in the next section. Leaders value short-term benefits of aggression over long-term economic harms – economic MAD fails Solomon 15 (Jon Solomon is a writer at Information Dissemination, a naval information blog. He is citing Eric Lorber and Jacquelyn Schneider. Eric Lorber is a PhD candidate in Political Science at Duke and a JD candidate at the University of Pennsylvania Law School. His research focuses on civil-military relations, the use of force against non-state actors, and the credibility of security guarantees. He has been a fellow at the Duke University American Grand Strategy Program, worked for the RAND Corporation, and is currently an adjunct staff member at the Institute for Defense Analyses. Jacquelyn Schneider is a PhD student in Political Science at George Washington University. Her research focuses on the intersection of national security, technology, and political psychology and covers a diverse range of topics from intelligence to unmanned technologies to cyber policy. She has won awards for Best Graduate Student Paper at both the International Studies Association Annual Meeting (Foreign Policy Section and International Security Studies Section) and the Southwestern Social Sciences Association Annual Meeting and is a two-time award winner of the AFCEA National Intelligence Writing Contest. She holds a B.A. in Economics and Political Science from Columbia University and a M.A. in Political Science from Arizona State University. “The Fallacy of “Mutually Assured Economic Destruction” 4/24/15 http://www.informationdissemination.net/2015/04/the-fallacy-of-mutually-assured.html)///CW In an excellent War on the Rocks article last week, Eric Lorber and Jacquelyn Schneider argued that economic sanctions cannot serve as standalone deterrents against aggression by another state. They noted in particular how prospect theory and credibility considerations affect the utility of threatened economic punishments as a deterrent within an opponent’s decision-making: ¶ “…while these new, sophisticated sanctions often cause medium- and long-term damage to a country’s economy, the prospect of such damage may not deter aggressive actors from taking immediate actions contrary to U.S. interests. For example, in the case of Russia, while the sanctions have certainly taken a toll, the Russian economy, when supported by capital reserves, is sufficiently resilient to put off the worst impacts of the sanctions for a few years. In the short-term, however, Russia has been able to annex Crimea and exercise significant influence in rebel-controlled areas deep in Eastern Ukraine. Thus, while the prospect of economic damage may loom down the road, this risk may be insufficient to deter an aggressive actor from pursuing short-term benefits...¶ …Likewise and in the Russia context, given the discord among European Union member states about how to respond to additional Russian aggression, Russia may not believe that the United States and the European Union will impose additional, extremely painful sanctions on the country, and therefore may not be deterred from engaging in additional destabilizing action in Ukraine.” ¶ They conclude that a defender must understand “the aggressive actor’s intentions and motivations” in order to determine whether deterrence by economic punishment is likely to succeed:¶ “Policymakers in Washington need to do better than conclude that ‘these sanctions will cause economic pain, therefore they will deter.’ Rather, they must analyze whether the particular sanctions on the table will influence a malicious actor’s decisionmaking.”¶ In other words, the opponent’s leaders’ political objectives and perceptions of the strategic circumstances (including pressures stemming from domestic popular passions) are central variables in determining a deterrence policy’s probable efficacy.¶ While all deterrence policies face this challenge to some degree, it tends to especially impact deterrence by punishment. The amount of threatened pain must significantly exceed the opponent’s discomfort with continuing to honor the status quo. A threat of certain national economic catastrophe is not sufficient if opponent’s leaders value some other political objective more highly or suffer from exceptional ‘strategic desperation.’ Japanese leaders proved that exact point in their decision for war during the late summer and early fall of 1941.¶ This does not change if a threatened economic catastrophe would affect both the aggressor and the defender. This is the premise behind ‘mutually assured economic destruction,’ a concept rooted in the longstanding idea that the likelihood of war between competing states decreases as their economic interdependence increases. In theory, two competing countries should be mutually restrained by the risk of devastating their entwined economies. One does not have to look that far back into history to see the fallacy in this thinking: the aggressors in both World Wars valued other objects more highly than the prospects of economic disaster (to the extent economics factored into their calculus at all). Trade doesn’t solve war Martin et. al. ‘8 (Phillipe, University of Paris 1 Pantheon—Sorbonne, Paris School of Economics, and Centre for Economic Policy Research; Thierry MAYER, University of Paris 1 Pantheon—Sorbonne, Paris School of Economics, CEPII, and Centre for Economic Policy Research, Mathias THOENIG, University of Geneva and Paris School of Economics, The Review of Economic Studies 75, 2008) Does globalization pacify international relations? The “liberal” view in political science argues that increasing trade flows and the spread of free markets and democracy should limit the incentive to use military force in interstate relations. This vision, which can partly be traced back to Kant’s Essay on Perpetual Peace (1795), has been very influential: The main objective of the European trade integration process was to prevent the killing and destruction of the two World Wars from ever happening again.1 Figure 1 suggests2 however, that during the 1870–2001 period, the correlation between trade openness and military conflicts is not a clear cut one. The first era of globalization, at the end of the 19th century, was a period of rising trade openness and multiple military conflicts, culminating with World War I. Then, the interwar period was characterized by a simultaneous collapse of world trade and conflicts. After World War II, world trade increased rapidly, while the number of conflicts decreased (although the risk of a global conflict was obviously high). There is no clear evidence that the 1990s, during which trade flows increased dramatically, was a period of lower prevalence of military conflicts, even taking into account the increase in the number of sovereign states. Yes War – A2 Deterrence Deterrence fails – correlation isn’t causation and complex situations mean nuclear war is always possible – prefer magnitude to probability Pelopidas 15 (Benoît Pelopidas is a lecturer (assistant professor with tenure) in international relations at the University of Bristol (Global Insecurities Center) and an affiliate of the Center for International Security and Cooperation at Stanford University. He has been awarded two international prizes for his research, from the International Studies Association and the James Martin Center for Nonproliferation Studies. His research focuses on the global politics of nuclear vulnerability, cases of near-use of nuclear weapons, and lessons learned from global nuclear history and French nuclear policies. His is currently completing an edited volume on the experience of the Cuban missile crisis worldwide as an early set of experiences of global nuclear vulnerability and its implications for security, responsibility, and alliance dynamics. “Challenging the Assumptions of Classical Nuclear Deterrence Theory: The War That Must Never Be Fought” 3/12/15, can be downloaded at http://www.hoover.org/research/challenging-assumptions-classical-nuclear-deterrence-theory)///CW We cannot know for sure what caused the absence of great-power wars¶ over the last seventy years.17 We are left with dueling counterfactuals and¶ the need to bet and trust.18 The opponents of the goal of a world without¶ nuclear weapons create a false dichotomy between what we know for¶ a fact and what we hypothesize. On the one hand, they argue, is the hard¶ fact of the nuclear peace; on the other hand are other hypotheses or counterfactual¶ reasonings. But the nuclear peace is not a fact. It is a hypothesis¶ trying to link two observable facts: the existence of nuclear weapons in¶ the world since 1945 and the absence of war between the United States¶ and the Soviet Union during the same period. The fact is that the idea of¶ the nuclear peace and competing explanations share the same status: all¶ are hypotheses, requiring a rerun of the history of the last seventy years¶ without nuclear weapons to see whether war would have broken out. The¶ nuclear peace hypothesis is no less a counterfactual than its rivals.19 It¶ faces the challenge of proving a negative. In these circumstances, faith in¶ the nuclear peace becomes a bet or a matter of trust.20¶ Moreover, we know that complex and tightly coupled systems like¶ nuclear weapons are doomed to fail eventually, even if the frequency of¶ failure is very low. This is because their complexity and tight coupling¶ don’t allow for anticipating and testing of every possible failure.21 Given¶ this epistemological challenge, which relies ultimately on the trust one¶ puts in one potential cause of peace at the expense of the others and on¶ the expected timing of nuclear versus non-nuclear disasters, at least one¶ question arises: is seventy years a high enough standard of evidence for¶ us to surrender our fate to nuclear weapons forever?22 Multiple factors complicate nuclear deterrence Lyon 15 (Dr Rod Lyon is a Fellow - International Strategy. Rod was most recently a Senior Analyst with ASPI. He has previously lectured in International Relations at the University of Queensland where he taught courses on conflict, international security, and civil-military relations. His research interests focus on a range of problems associated with global security, nuclear strategy and Australian security. He previously worked in the Strategic Analysis Branch of the Office of National Assessments between 1985 and 1996. As a Fulbright scholar in 2004, he was a visiting research fellow at Georgetown University in Washington DC, researching a project on the future of security partnerships in the postSeptember 11 environment. He was appointed to the National Consultative Committee on International Security Issues in April 2005. “The New Dilemmas of Nuclear Deterrence” 7/3/15 http://thediplomat.com/2015/07/the-new-dilemmas-of-nuclear-deterrence/)///CW With nuclear modernisation programs under way across a range of countries, Russia asserting its right to deploy nuclear weapons in the Crimea, NATO reviewing the role of nuclear weapons in the alliance, and a recent report in the US arguing for a more versatile arsenal of tactical nuclear weapons, it’s clear the world’s revisiting an old problem: how to build effective nuclear deterrence arrangements.¶ Since the end of the Cold War, thinking about deterrence issues has been mainly confined to the academic and think-tank world. But policymakers are now having to re-engage with those issues. And the problem has a new twist: we no longer enjoy the luxury of a bipolar world. Indeed, as Therese Delpech observed in her RAND monograph Nuclear deterrence in the 21st century, nowadays ‘the actors are more diverse, more opaque, and sometimes more reckless’.¶ Done properly, deterrence is a contest in threats and nerve, or—to use Thomas Schelling’s phraseology—‘the manipulation of risk’. (The chapter so titled in Schelling’s Arms and influence is a great starting point for anyone wanting to think through the broader deterrence problem.) That helps explain why some thought the concept ‘ugly’. It’s hard to make a policy threatening massive damage to societies and civilians sound noble and aspirational. Still, the bad news is that the alternatives are worse. And if deterrence is going to remain the dominant approach in nuclear weapon strategy, we need to fit the strategy to the contemporary geopolitical environment.¶ Historical experience of the deterrence problem is greatest in relation to two competing superpowers, separated by intercontinental distances, endowed with the resources to manage challenges, and both knowing well the costs of major war. We’ve had relatively little experience of nuclear deterrence in contests between giants and midgets (US v North Korea), between established and fast-rising powers (US v China), and amongst players in a multipolar system. Even our understanding of the role nuclear deterrence plays in relations between regional rivals (think South Asia) remains under-developed. It’s entirely possible that the old superpower deterrence model might not fit those new challenges well. Indeed, maybe the old model doesn’t even fit the US–Russian strategic relationship well these days: Russia’s no longer governed by a sclerotic CPSU.¶ Some years back INSS’ Elaine Bunn (now a senior official in the Obama administration) wrote a paper unpacking the notion of ‘tailored’ deterrence introduced in the 2006 Quadrennial Defense Review. True, deterrence has always been characterized by particular strategic wrinkles, but Bunn’s paper was an attempt to bring those wrinkles to the fore in relation to the possibility of a nuclear-armed North Korea, Iran, or transnational terrorist group. Her exploration of three different forms of tailoring—tailoring to specific actors and specific situations; tailoring capabilities; and tailoring communications—helps to illustrate the growing complexity of the deterrence challenge.¶ It now seems likely that we’re headed back into a set of complicated deterrence debates. A strategy that might make sense in one strategic setting—for example, a degree of restraint by a giant engaged in a conflict with a midget—might well risk flagging unintended messages in another. In the giant–midget case, almost any crossing of the nuclear threshold by the giant risks imposing a set of desperate choices on the midget’s leadership, and desperate choices tend not to be good ones.¶ Deterrence in the context of an established power versus a fast-rising power has a different wrinkle. One effect of a deterrence-dominated world is to reward passivity over initiative. As Schelling notes, in the world of the arthritic, passivity tends to be the default choice. But fast-rising powers aren’t arthritic. Turning one aside from a revisionist agenda will probably be more challenging than deterring another established player.¶ Multipolarity brings its own wrinkles, including a more mixed set of adversarial relationships, asymmetrical contests, inadvertent signalling, and third-party exploitation of bilateral rivalries. Capability issues become more vexed: actors require the capabilities to deter and defend against another, but also the residual capabilities to remain a player in other contests. The pressure must surely be towards larger rather than smaller arsenals. And reputational issues become more dominant: just as Margaret Thatcher fought the Falklands War in part to show the Soviet Union that the West wouldn’t buckle in the face of force, so too players in a multipolar nuclear world will want to show resolve in one contest because of its implications for others.¶ Finally, and perhaps most controversially, deterrence turns upon a credible threat to cross the nuclear threshold if push comes to shove. During the 1960s the US advocated a doctrine of flexible response, arguing for a model of deterrence that would fail in small packets rather than in one catastrophic breakdown. Notwithstanding the giant–midget problem outlined above, there’s usually good sense behind such a doctrine: it makes deterrent threats more credible, avoids global annihilation in any initial crossing of the nuclear threshold, maintains a degree of ‘intra-war deterrence’ from the options still on the table, and optimizes prospects for negotiated war termination. But historically the doctrine invited questions about the relative balance between usability and credibility in US nuclear policy—questions buried rather than resolved by the end of the Cold War.¶ Tailoring, messaging, usability, credibility, and thresholds: I suspect policymakers will soon be thinking about all those questions again, across a range of deterrence relationships.¶ Asymmetry of multipolar world takes out deterrence theory Goodby 15 (James E. Goodby has served in the US Foreign Service, achieving the rank of Career Minister, and was appointed to five ambassadorial-rank positions by Presidents Carter, Reagan, and Clinton, including ambassador to Finland. He taught at Georgetown, Syracuse, and Carnegie Mellon Universities and is Distinguished Service Professor Emeritus at Carnegie Mellon. Ambassador Goodby has worked with former Secretary of State George Shultz at Hoover since 2007. He is a research fellow at the Hoover Institution and a senior fellow with the Center for Northeast Asia Policy Studies at the Brookings Institution.¶ He was a Distinguished Service Professor at Carnegie Mellon University from 1989 to 1999 and is now a professor emeritus. Selected for the US Foreign Service through competitive examinations in 1952, Goodby rose to the rank of career minister in the Senior Foreign Service and was given five presidential appointments to ambassadorial rank, including ambassador to Finland (1980–81). During his Foreign Service career he was involved as a negotiator or as a policy adviser in the creation of the International Atomic Energy Agency, the negotiation of the limited nuclear test ban treaty, START, the Conference on Disarmament in Europe, and cooperative threat reduction (the Nunn-Lugar program).¶ Goodby’s awards include the Presidential Distinguished Service Award, the State Department’s Superior and Distinguished Honor Awards, and the Commander’s Cross of the Order of Merit of Germany. He was named a Distinguished Fellow of the US Institute of Peace in 1992. He was the recipient of the inaugural Heinz Award in Public Policy in 1995. In 1996, he was awarded an honorary doctor of laws degree by the Stetson University College of Law. “The New Dilemmas of Nuclear Deterrence” 7/3/15 http://thediplomat.com/2015/07/the-new-dilemmas-of-nuclear-deterrence/)///CW During the Cold War, nuclear deterrence was essentially a US-Soviet calculation.¶ After the Cold War, China began to loom larger in US planning,¶ but the premise that deterrence was essentially a bilateral interaction¶ remained. In the future, situations that are not demonstrably bilateral may¶ become the norm. Even now, but especially in the event global nonproliferation¶ efforts fail to meet current challenges, the nuclear deterrence¶ calculations of the United States and other states armed with nuclear¶ weapons will have to be based on a much more complex set of global¶ and regional dynamics.¶ In such a system, if nuclear weapons were used or even if their use¶ were threatened, there would be an action-and-reaction effect that might¶ involve several nations, not just two as in the Cold War paradigm. For¶ example, the alert status of nuclear delivery systems probably would be¶ changed to a higher level of readiness by several nations. There might¶ be movements of air and naval forces equipped with nuclear weapons.¶ A great deal of ambiguity can be expected in the event of a nuclear¶ explosion as to which nation had detonated a nuclear weapon. Once¶ nuclear weapons attacks occurred, terminating the war could be difficult.¶ Conceivably, three or four nuclear-armed states could become engaged¶ in hostilities that might have originated with just one nation initiating a¶ nuclear attack. The dynamics of nuclear conflict in the Middle East, South¶ Asia, or Northeast Asia would require qualitatively different deterrent calculations¶ from those the five Non-Proliferation Treaty nuclear weapons¶ states have been accustomed to making.¶ “Catalytic” nuclear war was one of the worries of the Kennedy and¶ Johnson administrations. It meant that the United States could become¶ engaged in a nuclear war because a nuclear-armed US ally had used¶ a nuclear weapon and their common adversary, the Soviet Union, had¶ decided to use nuclear weapons in response. Those worries would also¶ figure in a complex world of perhaps fifteen or so nuclear-armed states,¶ which would also include the unknown capabilities of terrorist groups¶ and the likelihood that cyber-mischief would accompany any nuclear¶ attack. How does one measure strategic stability in such a situation? Luck, not deterrence, accounts for nuclear peace Pelopidas 15 (Benoît Pelopidas is a lecturer (assistant professor with tenure) in international relations at the University of Bristol (Global Insecurities Center) and an affiliate of the Center for International Security and Cooperation at Stanford University. He has been awarded two international prizes for his research, from the International Studies Association and the James Martin Center for Nonproliferation Studies. His research focuses on the global politics of nuclear vulnerability, cases of near-use of nuclear weapons, and lessons learned from global nuclear history and French nuclear policies. His is currently completing an edited volume on the experience of the Cuban missile crisis worldwide as an early set of experiences of global nuclear vulnerability and its implications for security, responsibility, and alliance dynamics. “Challenging the Assumptions of Classical Nuclear Deterrence Theory: The War That Must Never Be Fought” 3/12/15, can be downloaded at http://www.hoover.org/research/challenging-assumptions-classical-nuclear-deterrence-theory)///CW Luck is too often taken as a confirmation that nuclear deterrence¶ kept the peace.28 But luck should not be misread as successful deter-¶ rence.29 More accurately, as Thomas Schelling noted, leaders of nuclearweapon¶ states can make threats that “leave something to chance”30—¶ recognizing that things could spiral out of control and nuclear weapons¶ could be used even if they do not intend to use them—to make¶ those threats more credible. But including luck in a successful deterrence¶ strategy, as if you could control it, is both a conceptual confusion¶ and a retrospective illusion.31 Luck was on our side this time, but¶ this is not a consequence of purposeful action. For example, during the¶ night of October 26–27, 1962, at the height of the Cuban missile crisis,¶ an American U-2 spy plane strayed into Soviet airspace over the Arctic.¶ Soviet fighter jets scrambled to intercept the U-2 while F-102 interceptors¶ were sent to escort it home and prevent Soviet MIGs from freely entering¶ US airspace. Given the circumstances, the F-102s conventional air-to-air¶ missiles had been replaced with nuclear- tipped ones and their pilots¶ could decide to use nuclear weapons. According to Scott Sagan in The¶ Limits of Safety, “the interceptors at Galena were armed with the nuclear¶ Falcon air-to-air missiles and, under existing safety rules, were authorized¶ to carry the weapons in full readiness condition in any ‘active air defense’¶ mission.”32 Fortunately, the spy plane turned back and the Soviet jets held¶ their fire.33 There are many other instances in which deterrence cannot¶ account for favorable outcomes.34 Robert McNamara was direct about the¶ role of luck during the Cuban missile crisis:¶ According to former Soviet military leaders, at the height of the crisis,¶ Soviet forces in Cuba possessed 162 nuclear warheads, including at¶ least 90 tactical warheads. [And the United States. was not aware¶ of that at the time.] At about the same time, Cuban President Fidel¶ Castro asked the Soviet ambassador to Cuba to send a cable to Soviet¶ Premier Nikita Khrushchev stating that Castro urged him to counter¶ a U.S. attack with a nuclear response. Clearly, there was a high risk¶ that in the face of a U.S. attack, which many in the U.S. government¶ were prepared to recommend to President Kennedy, the Soviet forces¶ in Cuba would have decided to use their nuclear weapons rather than¶ lose them. Only a few years ago did we learn that the four Soviet¶ submarines trailing the U.S. Naval vessels near Cuba each carried¶ torpedoes with nuclear warheads. Each of the sub commanders had¶ the authority to launch his torpedoes. The situation was even more¶ frightening because, as the lead commander recounted to me, the¶ subs were out of communication with their Soviet bases, and they¶ continued their patrols for four days after Khrushchev announced the¶ withdrawal of the missiles from Cuba. The lesson, if it had not been¶ clear before, was made so at a conference on the crisis held in Havana¶ in 1992. . . . Near the end of that meeting, I asked Castro whether he¶ would have recommended that Khrushchev use the weapons in the¶ face of a U.S. invasion, and if so, how he thought the United States¶ would respond. “We started from the assumption that if there was¶ an invasion of Cuba, nuclear war would erupt,” Castro replied. “We¶ were certain of that. . . . [W]e would be forced to pay the price that¶ we would disappear.” He continued, “Would I have been ready to¶ use nuclear weapons? Yes, I would have agreed to the use of nuclear¶ weapons.” And he added, “If Mr. McNamara or Mr. Kennedy had been¶ in our place, and had their country been invaded, or their country¶ was going to be occupied . . . I believe they would have used tactical¶ nuclear weapons.” I hope that President Kennedy and I would not have¶ behaved as Castro suggested we would have. . . . Had we responded¶ in a similar way the damage to the United States would have been¶ unthinkable. But human beings are fallible [emphasis added].35¶ This fascinating account shows how lack of information, misperception,¶ and ideology could have led to disaster if we had not been lucky. But¶ false information, lack of information, and misperceptions were not the¶ only reason why luck was the decisive cause of the positive outcome of¶ the Cuban missile crisis. Limits of safety, limits of command and control,¶ and organizational problems also have to be taken into account. As Scott¶ Sagan wrote:¶ Many serious safety problems, which could have resulted in an accidental¶ or unauthorized detonation or a serious provocation to the¶ Soviet government, occurred during the crisis. None of these incidents¶ led to inadvertent escalation or an accidental war. All of them,¶ however, had the potential to do so. President Kennedy may well have¶ been prudent. He did not, however, have unchallenged final control¶ over U.S. nuclear weapons.36¶ Most-recent studies show that sloppy practices in nuclear weapons¶ management have occurred at all levels of decision-makers, leaders,¶ nuclear safety and security teams, and top-level military personnel in¶ most nuclear-weapon states. They also show the limits of learning from¶ past sloppy practices. Confidence in perfect nuclear safety is still a matter¶ of wishing for the best and relying on luck.37 One telling example¶ of this occurred at Minot Air Force Base in North Dakota in 2007. This¶ offers a well-documented case of multiple sloppy practices and suggests¶ the limits of learning after the incident was identified. On August 29–30,¶ 2007, six US nuclear-armed cruise missile warheads were mistakenly¶ flown to Barksdale Air Force Base in Louisiana. They had been placed by¶ mistake under the wings of a B-52; the weapons had not been guarded¶ appropriately during a thirty-six-hour period. Had the plane experienced¶ any problems in flight, the crew would not have followed the proper¶ emergency procedures.38 After this widely publicized case of sloppy¶ practices,39 US Secretary of Defense Robert Gates emphasized the need¶ for responsibility in handling nuclear weapons: “The problems were the¶ result of a long-standing slide in the Service’s nuclear stewardship. . . . For¶ your part, you must never take your duties lightly. There is simply no room¶ for error. Yours is the most sensitive mission in the entire US military.”40¶ Change and improvement were supposed to follow, but even on the base¶ where the incident took place and where the Secretary of Defense came¶ to give his speech, it was necessary to repeat the order to leave no room¶ for error. In April 2013, one officer from the 91st Missile Wing at the same¶ Air Force Base in North Dakota was punished for sleeping on the job¶ while having the blast door open behind him. (Sleeping wasn’t prohibited¶ on a twenty-four-hour shift, but leaving the blast door open was.) He was¶ one of two missile officers sanctioned that year for such a fault and he¶ told his superiors that it wasn’t the first time.41 Air Force officers told the¶ Associated Press that such violations of the safety procedures had happened¶ more often than just in the two documented cases.42 The limits of¶ safety, the limits of command and control, and the persistence of sloppy¶ practices even in the US nuclear forces suggest that the role of luck is¶ likely to have been even more important than we can document here.¶ three different groups) of the payload installed in those cruise missiles, those procedures¶ were not followed.” The quotes for the account of this particular accident are¶ taken from the unclassified account available in the February 2008 report from the¶ Defense Science Board Permanent Task Force on Nuclear Weapons Surety, entitled¶ Report on the Unauthorized Movement of Nuclear Weapons.¶ There are no reliable records of nuclear weapons accidents or close calls¶ in most nuclear-weapon states. A2 Tepperman Tepperman’s thesis ignores complexities and accidents – expert consensus Shaw 9 (Douglas B. Shaw serves as the Associate Dean for Planning, Research, and External Relations at the George Washington University’s Elliott School of International Affairs with a concurrent appointment as an Assistant Professor of International Affairs. Doug previously served as Director of Policy Planning in the Office of the President at Georgetown University, on the U.S. Department of Energy’s Nuclear Material Security Task Force, at the U.S. Arms Control and Disarmament Agency, and in leadership roles for a number of nongovernmental organizations including Physicians for Social Responsibility, the Lawyers Alliance for World Security, and the Institute on Religion and Public Policy. Doug holds a Ph.D. in international relations from Georgetown University and has lectured on nuclear nonproliferation and disarmament on four continents. “Newsweek misrepresents nuclear weapons scholarship” 9/1/9 http://nukesonablog.blogspot.com/2009/09/newsweek-misrepresents-nuclear-weapons.html)///CW Jonathan Tepperman’s thesis in his September 7th Newsweek article “Why Obama should Learn to Love the Bomb” that “a growing and compelling body of research suggests that nuclear weapons may not, in fact, make the world more dangerous” badly misrepresents the state of scholarship on this crucial topic.¶ First, Tepperman references a handful of scholars to make his argument while dismissing the majority who disagree with him. George P. Shultz, William J. Perry, Henry A. Kissinger, and Sam Nunn opposed this view in two op-eds in the Wall Street Journal and other leading scholars and practitioners participated in a 2007 conference at Stanford University, now memorialized as a 500-page volume, Reykjavik Revisited. Scores of experts are summarily excluded from Tepperman’s article.¶ Second, Tepperman suggests a robust understanding of how deterrence relates to today’s challenges where none exists. Nuclear deterrence scholar Sir Lawrence Freedman observed a “lost generation” of nuclear weapons specialists in remarks at the Elliott School of International Affairs this spring and Commander of the U.S. Strategic Command, General Kevin Chilton, observed this summer “we have allowed an entire generation to skip class, as it were, on the subject of strategic deterrence.” More scholarship is needed to translate “nuclear optimism” and other Cold War concepts into the Twenty-first Century.¶ Third, in over 2,700 words on deterrence, not one of them is “accident.” This is a catastrophic flaw in characterizing scholarly debate on nuclear weapons. Kenneth Waltz, cited by Tepperman as “the leading nuclear optimist” underlines this point by co-authoring a book titled The Spread of Nuclear Weapons: A Debate Renewed with Stanford University’s Scott Sagan who has done decades of careful scholarship to demonstrate the relevance of accidents to nuclear deterrence.¶ Tepperman’s “iron logic” of deterrence is undermined by a more unstable plutonium logic that can only be understood by the combined lights of physics, engineering, political science, economics, and at least more than a dozen other disciplines that James Doyle of Los Alamos National Laboratory argues constitute “nuclear security science.” The nuclear future ahead of us is long, imperfect, and badly in need of more research and more informed public debate.¶ A2 Empirics Their empirics argument is historically false Pelopidas 15 (Benoît Pelopidas is a lecturer (assistant professor with tenure) in international relations at the University of Bristol (Global Insecurities Center) and an affiliate of the Center for International Security and Cooperation at Stanford University. He has been awarded two international prizes for his research, from the International Studies Association and the James Martin Center for Nonproliferation Studies. His research focuses on the global politics of nuclear vulnerability, cases of near-use of nuclear weapons, and lessons learned from global nuclear history and French nuclear policies. His is currently completing an edited volume on the experience of the Cuban missile crisis worldwide as an early set of experiences of global nuclear vulnerability and its implications for security, responsibility, and alliance dynamics. “Challenging the Assumptions of Classical Nuclear Deterrence Theory: The War That Must Never Be Fought” 3/12/15, can be downloaded at http://www.hoover.org/research/challenging-assumptions-classical-nuclear-deterrence-theory)///CW The limits of nuclear deterrence as a peacemaker23¶ Critics of abolition portray a world without nuclear weapons as warprone¶ and believe that nuclear weapons are a necessary and sufficient¶ cause for great-power peace. This is only the latest instance of an idea¶ that has repeatedly been proven wrong, since at least 1860: the expectation¶ that the unprecedented destructiveness of a new weapon system¶ and the threat of its use will put an end to war. This was wrong for dynamite,¶ submarines, artillery, smokeless powder, the machine gun, and poison¶ gas.24 Was nuclear deterrence a necessary and sufficient cause for¶ peace among great powers? Most critics of the idea of a world without¶ nuclear weapons maintain that it was. They argue that the nuclear-armed¶ states never fought a war against each other.25 This can now clash between China and Russia26 and, more¶ recently, the 1999 Kargil crisis between India and Pakistan show that¶ the conventional wisdom that a nuclear-armed state cannot be attacked¶ is historically inaccurate. Moreover, nuclear-armed states have been¶ attacked by non-nuclear-weapon states on multiple occasions. US troops¶ were attacked by Chinese forces in 1950 in Korea and by Vietnamese¶ forces in the 1960s and 1970s; Israel was attacked by Syria and Egypt¶ in 1973 and by Iraq in 1991; and in 1982, Argentina invaded the British¶ be proven¶ wrong. The 1969 border Falkland Islands.27 This narrows down the claims for nuclear weapons¶ as peacemakers. More importantly, even this narrower claim needs¶ to be reexamined taking into account two facts: (1) avoidance of several¶ nuclear disasters was due to luck and cannot be explained by¶ nuclear deterrence; and (2) deterrence as a strategy has favored more¶ risk-prone strategies and in some cases made war possible instead of¶ preventing it. High-Magnitude, Low Probability = Good High magnitude, low probability events first Bostrom 13 [Nick, Philosopher and professor (Oxford), Ph.D. (LSOE), director of The Future of Humanity Institute and the Programme on the Impacts of Future Technology, of course, he’s also the inaugural recipient of “The Eugene R. Gannon Award for the Continued Pursuit of Human Advancement,” “Existential Risk Prevention as Global Priority,” Global Policy, Vol 4, Issue 1, http://www.existentialrisk.org/concept.html] existential risk is one that threatens the premature extinction of Earth-originating Although it is often difficult to assess the probability of existential risks, there are many reasons to suppose that the total such risk confronting humanity over the next few centuries is significant. Estimates of 10-20% total existential risk in this century are fairly typical among those who have examined the issue, though inevitably such estimates rely heavily on subjective judgment.1 The most reasonable estimate might be substantially higher or lower. But perhaps the strongest reason for judging the total existential risk within the next few centuries to be significant is the extreme magnitude of the values at stake. Even a small probability of existential catastrophe could be highly practically significant (Bostrom 2003; Matheny 2007; Posner 2004; Weitzman 2009). Humanity has survived what we might call natural existential risks for hundreds of thousands of years; thus it is prima facie unlikely that any of them will do us in within the next hundred.2 This 1. The maxipok rule 1.1. Existential risk and uncertainty An intelligent life or the permanent and drastic destruction of its potential for desirable future development (Bostrom 2002). conclusion is buttressed when we analyze specific risks from nature, such as asteroid impacts, supervolcanic eruptions, earthquakes, gamma-ray bursts, and so forth: Empirical impact In contrast, our species is introducing entirely new kinds of existential risk — threats we have no track record of surviving. Our longevity as a species therefore offers no strong prior grounds for confident optimism. Consideration of specific existential-risk scenarios bears out the suspicion that the great bulk of existential risk in the foreseeable future consists of anthropogenic existential risks — distributions and scientific models suggest that the likelihood of extinction because of these kinds of risk is extremely small on a time scale of a century or so.3 that is, those arising from human activity. In particular, most of the biggest existential risks seem to be linked to potential future technological breakthroughs that may radically expand our ability to manipulate the external world or our own biology. As our powers expand, so will the scale of their potential consequences — intended and unintended, positive and negative. For example, there appear to be significant existential risks in some of the advanced forms of biotechnology, molecular nanotechnology, The bulk of existential risk over the next century may thus reside in rather speculative scenarios to which we cannot assign precise probabilities through any rigorous statistical or scientific method. But the fact that the probability of some risk is difficult to quantify does not imply that the risk is negligible. Probability can be understood in different senses. Most relevant here is the epistemic sense in which probability is construed as (something like) the credence that an ideally reasonable observer should assign to the risk's materializing based on currently available evidence.4 If something cannot presently be known to be objectively safe, it is risky at least in the subjective sense relevant to decision making. An empty cave is unsafe in just this sense if you cannot tell whether or not it is home to a hungry lion. It would be rational for you to avoid the cave if you reasonably judge that the expected harm of entry outweighs the expected benefit. The uncertainty and error-proneness of our first-order assessments of risk is itself something we must factor into our all-things-considered probability assignments. This factor often dominates in low-probability, high-consequence risks — especially those involving poorly understood natural phenomena, complex social dynamics, or new technology, or that are difficult to assess for other reasons. Suppose that some scientific analysis A indicates that some catastrophe X has an extremely small probability P(X) of occurring. Then the probability that A has some hidden crucial flaw may easily be much greater than P(X).5 Furthermore, the conditional probability of X given that A is crucially flawed, P(X|¬A), may be fairly high. We may then find that most of the risk of X resides in the uncertainty of our scientific assessment that P(X) was small (figure 1) (Ord, Hillerbrand and and machine intelligence that might be developed in the decades ahead. Sandberg 2010). Possibilistic thinking best for decision-making Clarke 5 [Lee, member of a National Academy of Science committee that considered decision-making models, Anschutz Distinguished Scholar at Princeton University, Fellow of AAAS, Professor Sociology (Rutgers), Ph.D. (SUNY), “Lee Clarke's Worst Cases: An Interview with Lee Clarke,” UChicago press, http://www.press.uchicago.edu/Misc/Chicago/108597in.html] Why focus on worst cases? They probably won’t happen, right? Why not focus on scenarios that have a greater degree of probability? Lee Clarke: One of the main ideas in Worst Cases is that we can use possibilistic thinking to balance probabilistic thinking. Over the past couple of hundred years probabilism has come to be thought of as the only way to reason rationally. But I think that it sometimes makes perfectly good sense to take worst case consequences into account when people are making decisions. For example, the chances of getting into a commercial airline crash are extremely low. People who fly know that, and that’s why they’re willing to defy gravity every day. But they also know what happens if the plane gets into serious trouble at thirty thousand feet. That’s worst case, possibilistic thinking. It is reasonable to worry about both. It is true, in a sense, that worst cases probably won’t happen. Still, as the political scientist Scott Sagan has said, things that have never happened before happen all the time. Just think of Chernobyl or 9/11. They had a low probability of occurring at any given time, but who would say now that we should have ignored them? It’s the same kind of thing as when you buy life insurance. Is it likely that you will die today? Probably not. But if you have life insurance you’re actually betting the insurance company that, in fact, you will die today. Is that irrational? Not at all. We say that people who don’t buy life insurance are irresponsible. Question: Consequentialism Good Public Health surveillance requires consequentialist framing- public health outweighs minor violations of rights most of the time Petrini 13 (Carlo Petrini. Unità di Bioetica, Presidenza, Istituto Superiore di Sanità.“Ethics in Public Health Surveillance.” 2013. P. 352. http://www.scielosp.org/pdf/aiss/v49n4/v49n4a05.pdf)EMerz The ethical problems posed by public health surveillance have been specifically addressed in numerous studies in the past, and various factors have led to an increase in this interest in recent years, including the diffusion of new and unforeseen epidemics and a greater awareness of and sensitivity towards the issues involved [57]. The checklists shown above can help to assess the compatibility of public health surveillance programmes with ethical principles. One of the major problems highlighted by these tools is the fact that, given the virtual impossibility of obtaining informed consent, programmes for public health surveillance frequently necessitate an infringement of the principle of autonomy. Today it is widely accepted that “Overriding individual autonomy must be justified in terms of the obligation of public health to improve population health, reduce inequities, attend to the health of vulnerable and systematically disadvantaged persons, and prevent harm. In addition, data elements collected without consent must represent the minimal necessary interference, lead to effective public health action, and be maintained securely” [15]. Returning to Childress and co-authors, they suggest five useful “conditions intended to help determine whether promoting public health warrants overriding such values as individual liberty or justice in particular cases”. These conditions encapsulate the key criteria referred to in the various checklists. They are: effectiveness; proportionality; necessity; least infringement; public justification” [55]. In summarising the criteria listed above it may also be helpful to refer to a proposal formulated by the noted biolaw expert Lawrence Gostin on the spread of Severe Acute Respiratory Syndrome (SARS). His concise proposal makes a suitable and practical conclusion: “Coercive measures, which violate individual rights, are acceptable when: - the risk to public health is demonstrable; - the intervention is likely to be effective, cost-effective, not overly invasive, fairly distributed; - the process for pursuing intervention is just and publicly transparent” [58]. Utilitarianism Good Adopt a framework of public health utilitarianism – this avoids the traditional trap of sacrificing the few for the many but maintains the best possible consequences Gostin 10 (Lawrence O. Gostin has more qualifications than any other card put out in the past 30 years. He is University Professor, Georgetown University's highest academic rank conferred by the University President. Prof. Gostin directs the O'Neill Institute for National and Global Health Law and was the Founding O'Neill Chair in Global Health Law. He served as Associate Dean for Research at Georgetown Law from 2004 to 2008. He is Professor of Medicine at Georgetown University, Professor of Public Health at the Johns Hopkins University, and Director of the Center for Law & the Public's Health at Johns Hopkins and Georgetown Universities. Prof. Gostin is the Director of the World Health Organization Collaborating Center on Public Health Law & Human Rights. He also serves on the WHO Director-General's Advisory Committee on Reforming the World Health Organization. In 2007, the WHO Director-General appointed Prof. Gostin to the International Health Regulations (IHR) Roster of Experts and the Expert Advisory Panel on Mental Health. In a 2012 systematic empirical analysis of legal scholarship, independent researchers ranked Prof. Gostin 1st in the nation in productivity among all law professors, and 11th in in impact and influence. “Public Health Law, Ethics, and Human Rights: Mapping the Issues” http://www.publichealthlaw.net/Reader/ch1/ch1.htm)///CW The application of general ethical principles to public health decisions can be difficult and complicated. Since the mission of public health is to achieve the greatest health benefits for the greatest number of people, it draws from the traditions of utilitarianism or consequentialism. The “public health model,” argue Buchanan (2000) and his colleagues, uncritically assumes that the appropriate mode of evaluating options is some form of cost-benefit (or cost-effectiveness) calculation— the aggregation of goods and bads (costs and benefits) across individuals. Public health, according to this view, appears to permit, or even require, that the most fundamental interests of individuals be sacrificed in order to produce the best overall outcome.¶ This characterization misperceives, or at least oversimplifies, the public health approach. The field of public health is interested in securing the greatest benefits for the most people. But public health does not simply aggregate benefits and burdens, choosing the policy that produces the most good and the least harm. Rather, the overwhelming majority of public health interventions are intended to benefit the whole population, without knowingly harming individuals or groups. When public health authorities work in the areas of tobacco control, the environment, or occupational safety, for example, their belief is that everyone will benefit from smoking cessation, clean air, and safe workplaces. Certainly, public health focuses almost exclusively on one vision of the “common good” (health, not wealth or prosperity), but this is not the same thing as sacrificing fundamental interests to produce the best overall outcome.¶ The public health approach, of course, does follow a version of the harm principle. Thus, public health authorities regulate individuals or businesses that endanger the community. The objective is to prevent unreasonable risks that jeopardize the public’s health and safety— e.g, polluting a stream, practicing medicine without a license, or exposing others to an infectious disease. More controversially, public health authorities often recommend paternalistic interventions such as mandatory seat belt or motorcycle helmet laws. Public health authorities reason that the sacrifice asked of individuals is relatively minimal and the communal benefits substantial. Few public health experts advocate denial of fundamental interests in the name of paternalism. In the public health model, individual interests in autonomy, privacy, liberty, and property are taken seriously, but they do not invariably trump community health benefits.¶ The public health approach, therefore, differs from modern liberalism primarily in its preferences for balancing— public health favors community benefits, while liberalism favors liberty interests. Characterizing public health as a utilitarian sacrifice of fundamental personal interests is as unfair as characterizing liberalism as a sacrifice of vital communal interests. Both traditions would deny this kind of oversimplification. Bioethics in the context of health surveillance requires that the government value public health over individual interests Childress 2 (James Childress. University Professor and the John Allen Hollingsworth Professor of Ethics at the University of Virginia. “Public Health Ethics: Mapping the Terrain.” 2002. P. 171. file:///C:/Users/Emily/Downloads/Childress_et_al-2002The_Journal_of_Law,_Medicine_&_Ethics.pdf)//EMerz In view of public health’s goal of producing net health benefits for the population, this meaning of public is very important. In measurement and analysis, the “numerical public” reflects the utilitarian view that each individual counts as one and only one. In this context, ethical analysis focuses on issues in measurement, many of which raise considerations of justice. For example, how should we define a population, how should we compare gains in life expectancy with gains in health-related quality of life, and whose values should be used in making those judgments? Second, public is what we collectively do through government and public agency - we can call this “political public.” Government provides much of the funding for a vast array of public health functions, and public health professionals in governmental roles are the focal point of much collective activity. In the United States, as Lawrence Gostin notes, government “is compelled by its role as the elected representative of the community to act affirmatively to promote the health of the people,” even though it “cannot unduly invade individuals’ rights in the name of the communal The government is a central player in public health because of the collective responsibility it must assume and implement. The state’s use of its police powers for public health raises important ethical questions, particularly about the justification and limits of governmental coercion and about its duty to treat all citizens equally in exercising these powers. In a liberal, pluralistic democracy, the justification of coercive policies, as well as other policies, must rest on moral reasons that the public in whose name the policies are carried out could reasonably be expected to accept.I Third, public, defined as what we do collectively in a broad sense, includes all forms of social and community action affecting public health - we can call this “communal public.” Ethical analysis on this level extends beyond the political public. People collectively, outside of government and with private funds, often have greater freedom to undertake public health interventions since they do not have to justify their actions to the political public. However, their actions are still subject to various moral requirements, including, for instance, respect for individual autonomy, liberty, privacy and confidentiality, and transparency in disclosure of conflicts of interest. Using a cost benefit analysis to address health surveillance is key to balance conflict of interests Childress 2 (James Childress. University Professor and the John Allen Hollingsworth Professor of Ethics at the University of Virginia. “Public Health Ethics: Mapping the Terrain.” 2002. P. 171. file:///C:/Users/Emily/Downloads/Childress_et_al-2002The_Journal_of_Law,_Medicine_&_Ethics.pdf)//EMerz Conceptions of morality usually recognize a formal requirement of universalizability in addition to a substantive requirement of attention to human welfare. Whatever language is used, this formal feature requires that we treat similar cases in a similar way. This requirement undergirds casuistical reasoning in morality as well as in law. In public health ethics, for example, any recommendations for an HIV screening policy must take into account both past precedents in screening for other infectious diseases and the precedents the new policy will create for, say, screening for genetic conditions. Much of the moral argument will hinge on which similarities and differences between cases are morally relevant, and that argument will often, though not always, appeal to general moral considerations.* We can establish the relevance of a set of these considerations in part by looking at the kinds of moral appeals that public health agents make in deliberating about and justifying their actions as well as at debates about moral issues in public health. The relevant general moral considerations include: producing benefits; avoiding, preventing, and removing harms; producing the maximal balance of benefits over harms and other costs (often called utility); distributing benefits and burdens fairly (distributive justice) and ensuring public participation, including the participation of affected parties (procedural justice); respecting autonomous choices and actions, including liberty of action; protecting privacy and confidentiality; keeping promises and commitments; disclosing information as well as speaking honestly and truthfully (often grouped under transparency); and building and maintaining trust. Several of these general moral considerations especially benefiting others, preventing and removing harms, and utility - provide a prima facie warrant for many activities in pursuit of the goal of public health. It is sufficient for our purposes to note that public health activities have their grounding in general moral considerations, and that public health identifies one major broad benefit that societies and governments ought to pursue. The relation of public health to the whole set of general moral considerations is complex. Some general moral considerations support this pursuit; institutionalizing several others may be a condition for or means to public health (we address this point later when we discuss human rights and public health); and yet, in particular cases, some of the same general moral considerations may limit or constrain what may be done in pursuit of public health. Hence, conflicts may occur among these general moral considerations Utilitarianism Bad Health care should use a deontological approach – the ends don’t justify the means MM 07 (Morning’s Minion is a Catholic blog, “Utilitarianism in Health Care” 8/23/07 http://vox-nova.com/2007/08/23/utilitarianismin-health-care/)///CW On all three grounds, she argues that social justice considerations do not support a transfer from the young and healthy to the old and sick on social justice grounds. As I read this, I felt there was something very wrong with her reasoning. Personally, I am in favor of single payers systems, and on the record as saying so. But I’m the first to admit that there are valid Catholic arguments against single payer systems. There is nothing intrinsically evil about choosing to fund health care in a different manner.¶ But still, at least from a Catholic perspective, there is something fundamentally flawed in McArdles’s reasoning. Here is the problem: it treats social justice not from the point of view of the common good, but from an individualist ethic ultimately derived from utilitarianism. Like all teleological philosophies, it is only outcomes that matter, and these outcomes are defined in terms of maximum utility, or happiness (utilitarianism is of course, a special application of consequentialism). The main problem, of course, is that it takes no account of whether an act is inherently right or wrong, irrespective of consequences. This kind of thinking arose directly from the Enlightenment, and a flawed concept of rationality based on what can be demonstrated empirically. As Pope Benedict noted, in a world based on calculations, it is the calculation of consequences that determines what should be considered moral and immoral.¶ I think this manner of thinking owes as much to Thomas Hobbes as it does to classic utilitarians like Bentham. It was Hobbes who, more than anybody else, led to the idea of social contracts overtaking the common good as the object of policy. Hobbes did not see humanity as an organic community underpinned by the common good; he saw instead a collection of individuals all seeking mastery over each other, necessitating some form of “social contract” to keep the peace. The individual is everything, the community, nothing. It follows naturally that social common good stems from the dignity, unity and equality of all people, not some mechanical calculation. It refers to justice flows from the aggregation of individual happiness, rather than an organic conception of the common good. But the “the sum total of social conditions which allow people, either as groups or as individuals, to reach their fulfilment more fully and more easily”. It is the social and community dimension of the moral good. While it is underpinned by the dignity of the human person, it is not an individualist ethic; rather, it recognizes that there is no fulfilment if the individual does not recognize that he or she exists “with” others and “for” others.¶ To see the bankruptcy of the contracts approach to justice, consider abortion. Clearly, the unborn are not agents that can participate in a social contract. Clearly, their welfare must therefore be discounted, and subjugated to the welfare of others, who are proper contracting agents. It is this notion that underpins the pro-abortion position today, and it stems from a failure to understand the encompassing and organic nature of the common good.¶ Back to health care. McArdle engages in a classic utilitarian calculus to argue that social welfare is not increased by a transfer from the young and healthy to the old and sick. It’s all about individuals, and “welfare” is limited to wealth. Whereas the right to health care is regarded by the Church as basic to the common good, the utilitarian approach instead sees only a collection of individuals out for themselves, and therefore largely responsible for their own health care. Within this individualist ethic, a social contract can indeed justify redistribution, but this is based on extremely limited characteristics, such as luck and personal worthiness. Nowhere in sight is the core principle of solidarity, a “a firm and persevering determination to commit oneself to the common good”. Nowhere is the idea that our interdependence coupled with the right to health care may call for the young and healthy to look after the needs of the old and infirm, irrespective of circumstances. And that is what troubled me most about McArdle’s reasoning. Evaluate the debate through the lens of personalism – utilitarianism alone fails but combining it with an ethic for constant respect for a human’s dignity solves Petrini and Gaintoti 08 (Carlo Petrini PhD is with the Bioethics Unit, Office of the President, Italian National Institute of Health, Rome, Italy. Sabina Gainotti works at The National Center for Rare Diseases in Rome and focuses on Qualitative Social Research, Quantitative Social Research, and Ethics. “A personalist approach to public-health ethics” http://www.who.int/bulletin/volumes/86/8/08-051193/en/)///CW Philosophical theories are also applied to bioethics and public-health ethics. In public health, some positions are more common: positions based on outcomes (utilitarianism), positions focused on rights and opportunities (Kantian theories), views that emphasize sociality and solidarity (communitarianism).1 Utilitarianism asserts that decisions should be judged by their consequences, in particular by their effect on the total sum of individual wellbeing. Following this view, public-health policies must be aimed to produce “the greatest happiness of the greatest number”.35 This approach is very intuitive in public health but has some limitations. Difficulties arise for example in the measurement of wellbeing which can be defined with reference to an individual’s personal experiences or to more objective and measurable components, e.g. quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs).36 However, the most important critique to utilitarianism is grounded on the view that it easily leads to unfairness and to the sacrifice of individual rights and freedoms to warrant the public utility.37 Individual rights and freedoms are the main good to be preserved in Kantian theories. Kant argued that human beings ought to be treated with respect, as ends in themselves, not as means to another individual’s ends.38 This assertion has important consequences in publichealth policies, but is not without ambiguities. Indeed two kinds of liberalism can be drawn: libertarians and egalitarians.39 Libertarians believe that only negative rights deserve protection to warrant individual freedom. By contrast, egalitarian liberals argue that the right to choice is meaningless without adequate resources. Respectively, the two perspectives entail a minimal or, vice versa, a strong state intervention for the sake of individual health.¶ Critics of utilitarianism and liberalism point out that these theories neglect the collective dimension of public-health ethics that is strongly valued in communitarianism. Communitarianism values highly the social dimension of health-care policies and involves visions of the appropriate social order and the virtues that will maintain such an order in a particular community. However, a basic question in communitarianism is: who decides what is virtuous? Every community could define its own norms or, by contrast, a single form of good society may serve as a reference for all communities. Ethics-of-care feminism can also be mentioned. Ethics-of-care proponents argue that real people live in families and real caring relationships are not impartial, impersonal or equal. Health-care policies must hence consider the factual dimension of caring, which is mostly carried out by women, and must be more supportive towards caring roles.39 All the outlined theories in our view may offer a contribution to a continuing discussion about how to deal ethically with public-health matters and how to organize society. What is missing in these theories is a clear definition of the concept and value of the human person: a primary point in personalism.¶ From traditional philosophy to personalism¶ Personalism may offer some compensation for the conflicts and shortcomings of principlism. For reasons of comprehensiveness, it might be useful here to mention its most elementary, and possibly obvious, aspects. Personalism should not be confused with individualism, which considers auto-decisions as the main (or only) constitutive feature of person. Personalism is based upon our common shared human nature. It takes as its primary ethical principle that all human beings deserve respect. A human is the only being capable of self-reflection and comprehension of the meaning of life.40¶ The principles of ontologically- based personalism in bioethics may be summed up as follows:31the defence, intangibility and sacredness of human life; the therapeutic principle whereby any intervention on life is justified only if it has a therapeutic purpose; the freedom and responsibility principle, where freedom recognizes respect for life as its objective limitation; the sociality and subsidiarity principle, consisting of the achievement of common good through individual well-being.Some consider the traditional value of the person as a cumbersome dimension. Hence some modern thinkers focus on the individual but not on the person. Post modern philosophers not only dissolve the concept of person but also that of subject.41 Excessive positions like these are also present in bioethics. Still bioethics, especially when applied to clinical and experimental issues, is generally attentive to the individual person. The problem arises in defining the person and the moment when he/she begins and ends, from the status of the human embryo to the dignity of the dying. Personalism strongly emphasizes the need to protect the weakest and the sickest persons in society. In a personalistic view, the being and dignity of the person are fundamental and inalienable values. Moral actions can thus be measured in respect of the person’s being and dignity.42 This can be stated through a formulation that is similar to the second Kantian imperative: the person “should never be treated as a simple means, as an instrument that can be used for the purpose of achieving any other end: on the contrary, the person should be treated as an end, or – more specifically – respecting, and in some cases promoting, its own ends”.43 In Kant’s philosophy, however, this imperative has a negative connotation.44 Personalism does not simply exclude negative behaviours but requires positive attitudes.¶ Personalism and its application to public health¶ When applied to public health, personalistic principles include a set of duties which derive from respect of the person. These include respect of the individual’s autonomy, the safeguard of confidentiality within a collective and potentially depersonifying framework, the effort to guarantee equity and equal opportunities for everyone in the allocation of health-care resources.45,46 Personalism is not opposed to other ethical theories as it can have both points in common and divergences with them. In a personalist view, for example, the consequentialist-utilitarian approach can certainly be part of a public-health policy as long as the lives and well-being of individuals are preserved.47¶ Respect for individual rights and freedom is also an essential requisite of human coexistence if it comes with regard to the “correct exercising” of freedom that is bonded to respect for life. In public health there might be cases where freedom must be sacrificed to the advantage of the common good. A minimum limit however should never be exceeded and decisions should never heavily penalize a person’s living conditions. If the wellbeing of the community is at stake, personalism does not exclude “moderate patronizing.” Gerald Dworkin defines patronizing as “the interference with a person’s freedom of action for reasons which exclusively refer to the wellbeing, good, happiness, needs, interests or values of a person who is subjected to the coercion”.48 A moderate form of patronizing is justified both in serious or emergency circumstances (such as during epidemics where persons need to be isolated to prevent the spread of a disease), and in routine conditions where the subject may not be in full charge of the situation and hence it becomes necessary to force certain behaviours (such as the compulsory wearing of seatbelts).¶ Cautionary policies based on the precaution principle are also significant in terms of public-health ethics. When scientific data are contradictory or quantitatively scarce, it is possible to appeal the precautionary principle. This principle shows the need for making temporary decisions that may be modified on the basis of new facts that eventually become known.49¶ Some authors have singled out the precautionary principle as one fundamental value in public-health ethics, alongside justice, transparency and the choice of the least restrictive alternative for people’s autonomy.50 Special importance has been attached to the precautionary principle by European ethics.51 Its relevance is also underlined by the Italian Committee on Bioethics and the Pontifical Council for Justice and Peace, with reference to the ethics of social and collective problems and to environmental issues.52,53 Personalism strongly values principles of sociality and solidarity. However, the individual’s good is the basis for common good. The social dimension of personalism, which was highly emphasized at the beginning of the 1920s, contributed to the renewal of classical personalism and the foundation of the modern personalism of Emmanuel Mounier and Jacques Maritain.54,55¶ Utilitarian framing of health surveillance is flawed- it overlooks individual health issues and autonomy Rubel 12 (Alan Rubel. Ph.D., Department of Philosophy, University of Wisconsin-Madison; J.D., magna cum laude, University of Wisconsin Law School Assistant Professor. “Justifying Public Health Surveillance: Basic Interests, Unreasonable Exercise, and Privacy.” 2012. P. 9-10. https://kiej.georgetown.edu/home_files/22.1.rubel.pdf)//EMerz Parmet provides some important guidance in applying this perspective to assessing the health of populations when she compares and contrasts the population perspective with utilitarianism. In her view, utilitarianism provides some support for the population perspective insofar as it is a maximizing theory. The difference between the two is that the good to be maximized on the population perspective is much narrower—health within a defined group instead of utility among all individuals (2009, p. 15). However, the view that the population perspective, and hence public health generally, “seeks to maximize group health” (Parmet 2009, p. 16) is problematic. The comparison with utilitarianism shows why. Utilitarianism is a moral theory that is consequentialist, welfarist, and sum-ranking: it is concerned with the consequences of actions (rather than with, for example, virtues or respect for autonomy), the consequence that matters is individual welfare, and the best state of affairs is the one in which the aggregate welfare of all relevant individuals is maximized. The population perspective mimics utilitarianism insofar as it is consequentialist and sumranking (i.e., maximizing) and differs only in that the consequence that matters is health within a population (presumably measured in terms of qualityadjusted life years, disability-adjusted life years, or the like). The problem comes in using the population perspective to determine policy. It is true that public health interventions can at times be justified insofar as they can maximize health within a population in cases in which individuals acting alone or along with health care providers would fail—consider the efficacy of public sanitation measures relative to individual efforts to drink clean water absent such measures. But if our guiding principle is health maximization, interventions at the individual level will be justified if they do in fact increase aggregate health. The state of affairs with such an individual intervention will rank ahead of the state of affairs without it. In other words, a sum-ranking view fails to distinguish individual and population health and therefore is liable to opt for individual health interventions on the grounds that they increase population health, independently of whether they comport with individuals’ own senses of good. A related problem is that a consequentialist view that maximizes the particular good of health within a population will necessarily subordinate nonhealth interests. Some individual behaviors decrease aggregate health only insofar as the decision-maker’s health decreases (e.g., avoiding doctors, being sedentary, not flossing). Surely, though, some efforts to change those behaviors would be unwarranted on the grounds that people are within their rights to engage in them.7 Thus, coercive measures to increase aggregate health require at least some justification to override individual autonomy. That justification might be the negative effects of individual behaviors on others’ health, sufficient risk to individual health to warrant strongly paternalistic actions, or something else altogether, but simple appeal to marginal increase in aggregate health would not suffice. Utilitarianism is bad in the context of public health surveillance – substitutes individual welfare for state affairs Rubel 12 (Alan Rubel. Ph.D., Department of Philosophy, University of Wisconsin-Madison; J.D., magna cum laude, University of Wisconsin Law School Assistant Professor. “Justifying Public Health Surveillance: Basic Interests, Unreasonable Exercise, and Privacy.” Kennedy Institute of Ethics Journal, Volume 22, Number 1, March 2012, pp. 1-33 (Article). John Hopkins University Press, DOI: 10.1353/ken.2012.0001. Card from P. 9-11. )//ASMITH Although the research/practice distinction fails to provide an adequate guide for resolving conflicts between public health surveillance and privacy, another approach, which takes the proper scope of public health into account, may be more promising. Just how to understand the term “public health” is the subject of significant debate. For instance, there is a question as to whether factors that affect health—such as education, homelessness, and human rights—are constitutive of public health (Rothstein 2002). Nonetheless, for the purposes of this article, it is promising to begin with the traditional view that public health should be understood as population health. The Institute of Medicine states that public health is what a society does “collectively to assure the conditions for people to be healthy” (Committee for the Study of the Future of Public Health 1988, p. 19; Rothstein 2002, p. 145). A full articulation of this kind of view comes in a recent book by Wendy Parmet. Parmet offers an account of public health that centers on what she calls the “population perspective.” According to this view, health is understood from a social or community perspective, and the “health of populations qua populations is an important goal of social life” ( 2009, p. 14). Parmet provides some important guidance in applying this perspective to assessing the health of populations when she compares and contrasts the population perspective with utilitarianism. In her view, utilitarianism provides some support for the population perspective insofar as it is a maximizing theory. The difference between the two is that the good to be maximized on the population perspective is much narrower—health within a defined group instead of utility among all individuals (2009, p. 15). However, the view that the population perspective, and hence public health generally, “seeks to maximize group health” (Parmet 2009, p. 16) is problematic. The comparison with utilitarianism shows why. Utilitarianism is a moral theory that is consequentialist, welfarist, and sum-ranking: it is concerned with the consequences of actions (rather than with, for example, virtues or respect for autonomy), the consequence that matters is individual welfare, and the best state of affairs is the one in which the aggregate welfare of all relevant individuals is maximized.6 The population perspective mimics utilitarianism insofar as it is consequentialist and sumranking (i.e., maximizing) and differs only in that the consequence that matters is health within a population (presumably measured in terms of quality-adjusted life years, disability-adjusted life years, or the like). The problem comes in using the population perspective to determine policy. It is true that public health interventions can at times be justified insofar as they can maximize health within a population in cases in which individuals acting alone or along with health care providers would fail— consider the efficacy of public sanitation measures relative to individual efforts to drink clean water absent such measures. But if our guiding principle is health maximization, interventions at the individual level will be justified if they do in fact increase aggregate health. The state of affairs with such an individual intervention will rank ahead of the state of affairs without it. In other words, a sum-ranking view fails to distinguish individual and population health and therefore is liable to opt for individual health interventions on the grounds that they increase population health, independently of whether they comport with individuals’ own senses of good. A related problem is that a consequentialist view that maximizes the particular good of health within a population will necessarily subordinate nonhealth interests. Some individual behaviors decrease aggregate health only insofar as the decision-maker’s health decreases (e.g., avoiding doctors, being sedentary, not flossing). Surely, though, some efforts to change those behaviors would be unwarranted on the grounds that people are within their rights to engage in them.7 Thus, coercive measures to increase aggregate health require at least some justification to override individual autonomy. That justification might be the negative effects of individual behaviors on others’ health, sufficient risk to individual health to warrant strongly paternalistic actions, or something else altogether, but simple appeal to marginal increase in aggregate health would not suffice. Fortunately, there is a better way to interpret public health from the population perspective and using it to guide action, which I refer to as the basic interests approach, following a framework developed by Alex London (2003).8 Even though one natural interpretation of population health—the one Parmet explicitly makes and which Mark Rothstein argues is implicit in other accounts—is aggregative and sum-ranking, it need not be (Rothstein 2002, pp. 145–46; Parmet 2009, p. 16). A different approach is to see public health as securing a set of interests that is public in the sense that the interests are shared by all members of a society, just in virtue of the fact that they are reasonable, rational persons.9 To see why, it is useful to consider John Rawls’s understanding of primary goods. People in a modern, liberal democracy have widely diverging interests and projects. Some people will want opportunities for certain types of athletic recreation, others will seek intensive religious experiences, still others will look to intellectual or artistic projects, and many will order their lives around interest or social groups. Often these will conflict. For example, creating the opportunity for people to play baseball on a new field might undermine others’ opportunity to hunt in the location where the field would be placed, and vice versa. That is exactly as we would expect in a pluralistic society. These interests are personal interests. However, the existence of such a society requires social cooperation, which on Rawls’s view demands that citizens in the society be able to exercise two moral powers: the ability to form and revise a conception of the good (i.e., to be rational) and the ability to form a sense of justice and what is right and hence the ability to abide by fair terms of cooperation (i.e., to be reasonable) (1996, pp. 301–2). Based on this conception of a citizen, Rawls posits that each citizen has a number of fundamental interests (or primary goods) regardless of his or her particular conception of the good and personal interests. Among these are basic rights, liberties, and opportunities, and social bases for self-respect. They also include certain “natural goods,” among them health, which are only partly a function of the basic structure of society (1999, p. 54). The important point here is the idea that there are basic interests that every person in a society would want more of, and those interests must be treated as basic in a liberal, pluralistic society. Being deprived of the basic goods undermines persons’ ability to form their own conceptions of the good and to be reasonable such that they can abide fair terms of social cooperation. Moreover, restriction of a person’s basic interests (e.g., deprivation of basic rights and liberties, curtailment of opportunities, imperilment of health) gives rise to a claim on the rest of society to ameliorate these restrictions. Utilitarianism justifies viewing people as only valuable for their contribution to larger society which justifies discrimination and destroys value to life Hunnell 15 (Dr. Denise Jackson Hunnell is a Fellow of Human Life International. She graduated from Rice University with a BA in biochemistry and psychology. She earned her medical degree from The University of Texas Southwestern Medical School. She went on to complete a residency in family medicine at Marquette General Hospital, Marquette, Michigan. She also teaches anatomy and physiology at Northern Virginia Community College Woodbridge Campus. Other affiliations include the American Academy of Family Physicians, The Catholic Medical Association, and the National Catholic Bioethics Center. She received her certification in health care ethics from the National Catholic Bioethics Center in 2009. “When Utilitarianism Designs a Healthcare System…” http://www.truthandcharityforum.org/when-utilitarianism-designs-a-healthcare-system/)///CW Ezekiel Emanuel, the architect of President Obama’s signature health care legislation, has penned a provocative piece published in The Atlantic and entitled Why I Hope to Die at 75. In this essay he argues that people over the age of 75 are a drain on society and it would serve the common good if they would just die sooner rather than later. He is very clear that he is not advocating for euthanasia or assisted suicide. But what he is doing is laying the groundwork for age-based rationing of health care.¶ It must be understood that Dr. Emanuel is a utilitarianist. He believes that the value of a person lies in his contribution to the economic structure of a society. Non-contributors are worth less than those who are economically productive and are therefore entitled to less of the community resources, including health care.¶ Nurse_in_geriatryEmanuel argues that age associated declines in mental-processing speed and creativity make older individuals a burden. He notes that most great scientists, writers, composers, and artists have made their most significant contributions by the time they are in their late forties or early fifties. He declares that it is a rare individual who still has the intellectual capacity to produce great work past the age of 75, so we should stop striving for longevity at that point and refuse all life-prolonging medical care.¶ It is quite disturbing to read his cold assessment of those with even the most minor disabilities associated with age. He has no respect for the elderly enjoying their golden years and pursuing avocations instead of professional excellence:¶ The American immortal, once a vital figure in his or her profession and community, is happy to cultivate avocational interests, to take up bird watching, bicycle riding, pottery, and the like. And then, as walking becomes harder and the pain of arthritis limits the fingers’ mobility, life comes to center around sitting in the den reading or listening to books on tape and doing crossword puzzles. And then …¶ Of course, many of us would counter his arguments with a discussion of the non-economic benefits the elderly provide. I have had the good fortune to know several centenarians in my lifetime. They provided a window to the past that could not be captured in any history textbook. I think of my relationships with several of my grandparents and great-grandparents who lived well past the age of 75 and know that my life was immeasurably enriched by these encounters with my elders, even when they were challenged by infirmities and disabilities. I hope to similarly influence my own grandchildren.¶ Ezekiel Emanuel discounts any value to familial relationships. In fact he states, “Our living too long places real emotional weights on our progeny…there is much less pressure to conform to parental expectations and demands after they are gone.” His further explanation of this reveals a prideful, self-centered motivation. He is concerned that if he lives past the age of 75, he will be remembered as a burden instead of as someone who was vibrant and a joy to be around.¶ After laying out his arguments for why life after age 75 is just not worth living, Emanuel goes on to outline the health care policy implications of his position. After the age of 75 he advocates for virtually no health care. No screening tests, no treatment for cancer, no flu shots, no antibiotics. Palliative care to keep the elderly comfortable is all that he sees as reasonable.¶ Here is where Emanuel errs most dramatically. He is judging the patient as to his worthiness for treatment, instead of judging the treatment as to its worthiness for the patient. There is no question that there are many medical tests and treatments that are not appropriate for patients over the age of 75. Following cholesterol levels, screening mammograms in asymptomatic women, screening colonoscopies for colon cancer are all tests that can be discontinued by this age. However, the reason is not that patients over the age of 75 are not valuable enough to receive this medical care. It is that the burden these tests impose on the elderly is not justified by the expected benefit of these tests. Decisions about the appropriateness of any medical test or intervention need to be made on an individual basis, taking into account the specific burden to benefit analysis for a given treatment in a given patient. Arbitrarily declaring that all those over the age of 75 are unworthy of anything but palliative medical care is unjust ageism.¶ Caring for an elderly relative can present physical, emotional, and financial challenges. But facing these challenges is an opportunity for great spiritual growth. We are better people and create a better society when we generously love and care for those with infirmities and disabilities. Through their lives, the elderly generously offer us the opportunity to cultivate virtue. As Pope Francis said, “A population that does not take care of the elderly and of children and the young has no future, because it abuses both its memory and its promise.”¶ Emanuel explicitly rejects such thinking as existential nonsense:¶ Many of us have suppressed, actively or passively, thinking about God, heaven and hell, and whether we return to the worms. We are agnostics or atheists, or just don’t think about whether there is a God and why she should care at all about mere mortals. We also avoid constantly thinking about the purpose of our lives and the mark we will leave. Is making money, chasing the dream, all worth it? Indeed, most of us have found a way to live our lives comfortably without acknowledging, much less answering, these big questions on a regular basis. We have gotten into a productive routine that helps us ignore them.¶ I actually feel sorry for Ezekiel Emanuel that he cannot see the value of human life in any terms other than economic productivity . How sad that he does not cherish the rich dimensions the elderly add to our lives. We learn from their experiences, their faith, and, yes, even their suffering. The question before us in American health care policy is whether or not we will value each human life from the moment of conception to the moment of natural death and treat each individual according to his individual needs. Or, will we follow the utilitarian approach and declare whole classes of the population as economically unproductive and therefore unworthy of medical care? Social injustices worsen health- recognizing human rights is a step in the right direction that allows us to make effective policy changes Childress 2 (James Childress. University Professor and the John Allen Hollingsworth Professor of Ethics at the University of Virginia. “Public Health Ethics: Mapping the Terrain.” 2002. P. 177. file:///C:/Users/Emily/Downloads/Childress_et_al-2002The_Journal_of_Law,_Medicine_&_Ethics.pdf)//EMerz We have noted potential and actual conflicts between promoting the good of public health and other general moral considerations. But it is important not to exaggerate these conflicts. Indeed, the societal institutionalization of other general moral considerations in legal rights and social-cultural practices generally contributes to public health. Social injustices expressed in poverty, racism, and sexism have long been implicated in conditions of poor health. In recent years, some evidence suggests that societies that embody more egalitarian conceptions of socioeconomic justice have higher levels of health than ones that do not.20 Public health activity has traditionally encompassed much more than medicine and health care. Indeed, historically much of the focus of public health has been on the poor and on the impact of squalor and sanitation on health. The focus today on the social determinants of health is in keeping with this tradition. The data about social determinants are impressive even though not wholly uncontroversial. At any rate, they are strong enough to warrant close attention to the ways conditions of social justice contribute to the public’s health. Apart from social justice, some in public health argue that embodying several other general moral considerations, especially as articulated in human rights, is consistent with and may even contribute to public health. For example, Jonathan Mann contended that public health officials now have two fundamental responsibilities - protecting and promoting public health and protecting and promoting human rights. Sometimes public health programs burden human rights, but human rights violations “have adverse effects on physical, mental, and social well-being” and “promoting and protecting human rights is inextricably linked with promoting and protecting health.”2’ Mann noted, and we concur, that, ultimately, “ethics and human rights derive from a set of quite similar, if not identical, core values,” several of which we believe are captured in our loose set of general moral considerations.22 Often, as we have suggested, the most effective ways to protect public health respect general moral considerations rather than violate them, employ voluntary measures rather than coercive ones, protect privacy and confidentiality, and, more generally, express rather than impose community. Recognizing that promoting health and respecting other general moral considerations or human rights may be mutually supportive can enable us to create policies that avoid or at least reduce conflicts. While more often than not public health and human rights - or general moral considerations not expressed in human rights - do not conflict and may even be synergistic, conflicts do sometimes arise and require resol~tion.~~ Sometimes, in particular cases, a society cannot simultaneously realize its commitments to public health and to certain other general moral considerations, such as liberty, privacy, and confidentiality. We have tried to provide elements of a framework for thinking through and resolving such conflicts. This process needs to be transparent in order to engender and sustain public trust. Disease Outweighs Disease is the greatest impact- more people die from disease than all wars combineddisease spread is the root cause of structural prejudice and the biggest threat to security Selgelid 9 (M.J. Selgelid. Center for Applied Philosophy and Public Ethics (CAPPE), The Australian National University, Canberra, Australia. “Public Health: Pandethics.” 2009. http://www.sciencedirect.com/science/article/pii/S0033350608003314)//EMerz The ethical importance of infectious diseases is partly revealed by the fact that their consequences are almost unrivalled.1 Historically, they have caused more morbidity and mortality than any other cause, including war.2 The Black Death eliminated one-third of the European population over the course of a few years during the mid 14th Century; tuberculosis killed 1 billion people from 1850 to 1950; the 1918 flu killed between 20 and 100 million people; and smallpox killed between 300 and 500 million people during the 20th Century alone, i.e. three times more than were killed by all the wars of that period. Infectious diseases are currently the biggest killers of children and young adults, and the continuing threat of infectious diseases is revealed by the emergence of many new infectious diseases during recent decades [including human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), Ebola, severe acute respiratory syndrome (SARS) and avian influenza], the growing problem of drug resistance and the spectre of bioterrorism. Second, infectious diseases raise difficult ethicophilosophical questions of their own. Although measures such as surveillance, mandatory treatment and vaccination, isolation and quarantine may sometimes be important to the protection of public health, they may each involve infringement of basic rights and liberties, i.e. the right to privacy, informed consent to medical intervention, and freedom of movement. Given that most deny that either the goal to promote public health or the goal to protect individual rights and liberties should always take absolute priority over the other, a difficult ethical question is how to strike a balance between these two types of goals in cases of conflict. Third, the topic of infectious disease is closely connected to the topic of justice. Malnutrition, dirty water, overcrowded living and working conditions, lack of sanitation and hygiene, poor education, and lack of access to health care make poor people more likely to become infected and more likely to suffer poor outcomes when infection occurs. As bad health, in turn, exacerbates poverty, a vicious cycle promotes both poverty and disease. Fourth, infectious diseases are prone to promote fear, panic, stigma, discrimination, and emotional and irrational decision and policy making. Fifth, and finally, infectious diseases pose threats to security. Security dangers are associated with fast-moving infectious disease outbreaks that overwhelm response capacity and cause chaos. In 2007, the World Health Organization described pandemic influenza as ‘the most feared security threat’,8 and former US President George W. Bush suggested that a military response may be necessary in the event of a flu pandemic. Security may also be jeopardized for economic reasons in the case of slower-moving epidemics. HIV/AIDS, for example, has brought numerous African societies to the verge of economic collapse. Historical studies reveal that factors such as high infant mortality, low life expectancy and decreasing life expectancy – especially salient in sub-Saharan Africa at present, largely as a result of HIV/AIDS – are among the most reliable indicators of societal upheaval. Prefer a focus on non-communicable chronic diseases Zarocostas 10 (John Zarocostas is a Geneva-based independent international correspondent and broadcaster, with more than 20 years experience in covering international global issues, including world health, development and humanitarian issues. His news dispatches have been published in The Lancet, The BMJ, McClatchy Newspapers, the International Herald Tribune, The National Law Journal, The New York Times, The Straits Times, Lloyd's List, The Canberra Times, The Globe & Mail, The Times, The Irish Times,The Journal of Commerce, and the South China Morning Post. “Need to increase focus on non-communicable diseases in global health, says WHO” http://www.bmj.com/content/341/bmj.c7065)///CW Governments worldwide need to increase the priority given to fighting non-communicable diseases especially in the poorest nations, the World Health Organization says.¶ The sense of urgency by WHO is driven by the high and projected increases in the prevalence rates of non-communicable diseases—cardiovascular diseases, cancers, diabetes, and chronic lung diseases.¶ These four major groups of diseases share four risk factors—tobacco use, unhealthy diet, physical inactivity, and the harmful use of alcohol.¶ Ala Alwan, WHO’s top official for non-communicable diseases and mental health, said, “The reason for the focus on these four major group of diseases is because they are responsible for about 80-85% of mortality due to chronic diseases, and because they also share the same risk factors.”¶ Dr Alwan told reporters the magnitude is increasing globally. Non-communicable diseases are currently responsible for 60% of all deaths, or more than 35 million deaths every year, of which 80% occur in low and middle income countries.¶ Up to 25% of deaths from non-communicable diseases occur in people under 60 years of age, he said.¶ “They are not only an enormous health problem, but they are also a problem that has very negative socioeconomic consequences,” he added.¶ Dr Alwan said that according to mortality estimates in all regions except Africa more than 50% of deaths are caused by non-communicable diseases and among these, the leading cause of death is cardiovascular disease.¶ The WHO predicts that global mortality from noncommunicable diseases will increase by 17.6% during 2006 to 2015; by more than 24% in some regions such as Africa, and by 23% in the Western Pacific and South East Asia.¶ The treatment and health care for people with non-communicable diseases is also expensive, and increasing, Dr Alwan said. In poor populations a substantial proportion of families with a relative with cancer or heart disease will experience catastrophic expenditure, which will drive the family below the poverty line.¶ “We see higher levels of risk factors like tobacco, and overweight and obesity in the lower social-economic class[es] and we also see the highest prevalence of diabetes occurring in developing populations,” he said.¶ Dr Alwan, a former minister of health of Iraq, also highlighted that non-communicable diseases are “largely preventable if we address risk factors with tobacco control, address unhealthy diet and physical inactivity.”¶ He said international efforts to implement a global strategy to control and prevent noncommunicable diseases is leading to the development of indicators similar to the millennium development goals together with a monitoring mechanism. Greater priority needs to be given to non-communicable diseases in health and broader development agendas, he said.¶ Dr Alwan added that the private sector, including the food and beverages industries, also has to provide some solutions. These include responsible marketing, especially for children, and a greater emphasis on more healthy products. Prefer chronic disease – media creates a bias toward ISIS and nuclear war Fisher 14 (Max Fisher is a writer at Vox, “Threats to Americans, ranked (by actual threat instead of media hype” 8/17/14 http://www.vox.com/2014/10/17/6988377/threats-to-americans-ranked-ebola-isis-russia-furniture)///CW Americans are inundated with media coverage and politicians warning them of dire threats: Ebola, the Islamic State of Iraq and Syria (ISIS), the war on Christmas.¶ The truth, though, is that the most-hyped threats are often not actually that threatening to Americans, while larger dangers go mostly ignored. That should tell you something about how our political system and media can distort threats, leading Americans to overreact to minor dangers while ignoring the big, challenging, divisive problems — like climate change — that we should actually be worried about.¶ ¶ An actual poll featured on Fox News (Nick Martin)¶ Obsessing about possible threats is something of a beloved national past-time here in America, which is objectively one of the safest places on Earth, so we want to help you do it right. Here, then, is a highly un-scientific and incomplete ranking of threats to the United States — sorted by the current danger to Americans, worst-case danger to Americans, and how freaked out you should be.¶ 9) Ebola¶ Threat to Americans: If you are an American in West Africa in close proximity with Ebola victims, the threat is moderate. If you are an American health worker in the US assisting an Ebola victim or someone who frequently comes into physical contact with one, the threat of infection is minor if you use proper protective equipment. Otherwise, the threat is pretty close to zero.¶ Worstcase scenario: The outbreak could get much worse in West Africa, but even in that scenario the disease will remain unlikely to affect many Americans outside of the region.¶ How freaked out should you be: If you have loved ones in Liberia, Sierra Leone, or Guinea, it is not unreasonable to urge them to take all possible precautions. Otherwise, you would do better to worry about the other items on this list.¶ ¶ A health worker demonstrates Ebola treatment practices in London (Dan Kitwood/Getty)¶ 8) Your own furniture¶ Threat to Americans: According to a report by the Consumer Product Safety Commission, just under 30 Americans are killed every year by "tip-over," which is when "televisions, furniture, and appliances" fall onto their owners. The report also found that over 40,000 Americans receive "emergency department-treated injuries" from tip-over every year.¶ Worst-case scenario: This is America. We can always find ways to make a bigger, heavier, deadlier TV.¶ How freaked out should you be: Council on Foreign Relations scholar Micah Zenko found that tip-over kills about as many Americans per year as terrorism does, and injures many more. In theory, then, you should be just as freaked out by tip-over as you are by terrorism. Based on the fatality rate, you should be much more freaked out about tip-over than you are about Ebola.¶ 7) ISIS¶ Threat to Americans: Presently, the threat to Americans outside of Iraq and Syria is extremely low, as ISIS has no demonstrated intent or capability to launch such an attack. And since 2001, the US has gotten much, much better at preventing terror plots.¶ Worst-case scenario: ISIS does control a giant stretch of territory, boast thousands of fighters (some with Western passports), earn lots of oil revenue, and field heavy US-made weapons seized from the Iraqi army. Oh, and it now has access to rotting but still-deadly chemical weapons. They could decide to use those resources to try to attack the US, or could allow other terrorists to use their territory as a safe haven.¶ How freaked out should you be: Not very. If ISIS decides to turn its attention to attacking the US, the prospect it might succeed is real, but remote. And even if it did pull off a successful attack, it would almost certainly kill only a small fraction of the number of Americans that guns and cars are virtually certain to kill every single year.¶ ¶ Smoke from a battle between Iraqi Kurds and ISIS (SAFIN HAMED/AFP/Getty)¶ 6) The flu¶ Threat to Americans: The flu kills thousands of Americans every year, many times more people than Ebola. The elderly and infirm are especially at risk.¶ Worse-case scenario: An especially bad outbreak in 2004 killed 48,000 Americans.¶ How freaked out should you be: If you're elderly, very young, or immunosuppressed, you should get a flu shot or nasal spray immediately. (Even if you're not, you should still get off your lazy butt and get a flu shot, unless you are some kind of monster who doesn't care about herd immunity.) But if you're young and otherwise healthy, you'll probably be fine even if you do catch the flu.¶ 5) World War III breaking out in the Baltics¶ Threat to Americans: No one wants a global thermo-nuclear war between the West and Russia, including Vladimir Putin. But his meddling in Baltic NATO countries like Estonia, which the US and Western Europe are committed to defend, could inadvertently trigger what we avoided throughout the Cold War: open military conflict between the major nuclear powers. Both Putin and President Obama have threatened as much to try to scare one another out of acting aggressively.¶ Worst-case scenario: Russia does in Estonia what it did in Ukraine, that snowballs into war between Russia and the US/NATO, and the nukes start falling.¶ How freaked out should you be: To be very clear: the odds of this happening are extremely low. But the danger is real enough that everyone is taking it seriously (Russia is holding major nuclear exercises). If it did happen, it would be many, many times worse than every other item on this list combined.¶ ¶ Russian tanks in a military parade in St. Petersburg (OLGA MALTSEVA/AFP/Getty)¶ 4) Climate change¶ Danger to Americans: Potentially dire. The greatest near-term harm may be from a rise in extreme weather events. Over the next 100 years, that could include deadly heat waves, droughts, flooding, and a rise in sea levels that would affect coastal cities.¶ Worst-case scenario: The world is trying to limit the global temperature rise to 2°C, because any more than that is considered dangerous. A temperature rise of 4°C would cause "substantial species extinctions" and "large risks to global and regional food security," as well as rising sea levels, according to the Intergovernmental Panel on Climate Change. In other words, a total catastrophe.¶ How freaked out should you be: If you care about the world your kids and grandkids will grow up in, pretty freaked out. Averting disaster requires immediate, massive, global cuts to carbon emissions. With the US and China particularly dragging their feet, it may simply be too late.¶ 3) Guns¶ Danger to Americans: Guns kill more than 30,000 Americans every year, about as many deaths as caused by motor vehicles. But only about one in three of those deaths is a homicide. A few thousand are from accidents but most are due to suicide.¶ Worst-case scenario: We have already chosen to live in a society with the world's highest gun ownership rate and some of its loosest gun control laws, so the worst-case scenario is pretty much here. Still, gun deaths per year are on the rise.¶ How freaked out should you be: It all depends on whether you see America's uniquely permissive gun laws as worth the trade-off. But you — and, yes, your children — are at risk, regardless of your views about gun regulations.¶ ¶ A customer inspects a totally legal AR-15 assault rifle at a gun store in Wendell, North Carolina (Chuck Liddy/Raleigh News & Observer/MCT via Getty)¶ 2) Traffic accidents¶ Danger to Americans: Very high. About 34,000 deaths in 2011 (the last year with complete data), more than one in four of all deaths related to unintentional injures.¶ Worst-case scenario: Drunk driving. Don't do it.¶ How freaked out should you be: The motor vehicle death rate is declining, but getting in your car is still dangerous. Stay alert and don't drink.¶ 1) Heart disease and cancer (tie)¶ Danger to Americans: The number-one and number-two killers in the US, collectively responsible for just over 50 percent of all American deaths.¶ Worst-case scenario: These could become even deadlier as Americans get unhealthier. Heart disease correlates with rising obesity. Cancer rates also correlate with obesity, smoking, and other unhealthy practices.¶ How freaked out should you be: The odds are that one of these two things will kill you, so you should be thinking about this. The good news: it's pretty easy to reduce that risk by making healthy lifestyle choices and screening regularly for cancer. Much easier for any given American, at least, than combatting West African Ebola outbreaks or Middle Eastern terrorist groups. Extinction- engineered pathogens Sandberg, 8 -- Oxford University Future of Humanity Institute research fellow [Anders, PhD in computation neuroscience, and Milan Cirkovic, senior research associate at the Astronomical Observatory of Belgrade, "How can we reduce the risk of human extinction?" Bulletin of the Atomic Scientists, 9-9-2008, thebulletin.org/how-can-we-reduce-risk-human-extinction, accessed 813-14] The risks from anthropogenic hazards appear at present larger than those from natural ones. Although great progress has been made in reducing the number of nuclear weapons in the world, humanity is still threatened by the possibility of a global thermonuclear war and a resulting nuclear winter. We may face even greater risks from emerging technologies. Advances in synthetic biology might make it possible to engineer pathogens capable of extinction-level pandemics. The knowledge, equipment, and materials needed to engineer pathogens are more accessible than those needed to build nuclear weapons. And unlike other weapons, pathogens are self-replicating, allowing a small arsenal to become exponentially destructive. Pathogens have been implicated in the extinctions of many wild species. Although most pandemics "fade out" by reducing the density of susceptible populations, pathogens with wide host ranges in multiple species can reach even isolated individuals. The intentional or unintentional release of engineered pathogens with high transmissibility, latency, and lethality might be capable of causing human extinction . While such an event seems unlikely today, the likelihood may increase as biotechnologies continue to improve at a rate rivaling Moore's Law. Emerging diseases and bioterrorism are comparatively the largest impact Milne 4 – Formerly a practicing veterinarian in New Jersey and Maryland, Dr. Milne attended Johns Hopkins University in 1987-88 where he earned a master's degree in public health with a concentration in epidemiology. For six years, he worked for the New Jersey Department of Health in risk assessment as well as legislative and regulatory review, and finally served as Emergency Response Coordinator. Dr. Milne joined Tufts University's Center for the Study of Drug Development in 1998 as a Senior Research Fellow, after graduation from law school. His research interests include the evaluation of regulatory initiatives affecting the pharmaceutical and biotechnology industries, and incentive programs for the development of new medicines for neglected diseases of the developing world. Dr. Milne is currently Assistant Director at the Center and a member of the bar in New Hampshire (Christopher, “Racing the Globalization of Infectious Diseases: Lessons from the Tortoise and the Hare,” 11 New Eng. J. Int'l & Comp. L. 1) Although we have faced planet-killing events such as nuclear brinkmanship during the Cold War and mega-meteors colliding with earth in prehistory, the most imminent threat is one we face everyday from the globalization of infectious diseases. Leading authorities in government, medical institutions, and schools of public health have been ringing the warning bell for over a decade about the major threats to global public health. 2Link to the text of the note infectious diseases in the developing world, drug resistant bacteria, and the problem of multiple HIV strains, remain unaddressed. The public health community lacks answers to key scientific questions for an AIDS vaccine, and needs to press harder on research for a tuberculosis (TB) vaccine, a process which could take twenty to fifty years. 3Link to the text of the note Experts believe that the threat warning level has risen from orange to red, comparing the circumstances favoring a pandemic today to the "Perfect Storm," due to the continuing increase of worldwide antimicrobial resistance, diminished U.S. capacity to recognize and respond to microbial threats, and the likelihood of intentional releases of biological agents.¶ The sources of this public health challenge derive from a panoply of emerging and re-emerging natural plagues, Threats such as thirty of which have been recognized just in the last few decades with thirteen occurring in North America. 4Link to the text of the note According to Anthony Fauci, Director of the National Institutes [3] of Allergies and Infectious Diseases (NIAID), emerging diseases are defined as ones that have not been previously recognized, such as acquired immunodeficiency syndrome (AIDS) or severe acute respiratory syndrome (SARS). Comparatively, re-emerging disease has usually been in existence for a long time but has changed location, as did the West Nile Virus. Dr. Fauci considers bioterrorism to be a part of the continuum of emerging and re-emerging diseases, and points out that when it comes to bioterror: "The Worst Bioterrorist May be Nature Itself." 5Link to the text of the note¶ Infectious diseases with the potential to be global killers come in two basic forms: the "slow epidemic," taking months or years to reach pandemic status, with an insidious onset and long latency, that resists treatment - the archetypical example being AIDS, 6Link to the text of and the "fast epidemic," rapidly spreading from country to country, typically aerosol-borne, with fairly quick onset, and high mortality and morbidity - most recently manifested in pandemic SARS. 7Link to the text of the note Both forms have potential uses as bioweapons, although most of the counter-terror attention focuses on the SARS-like diseases.¶ Part II of this article will discuss the scenarios for a the note global pandemic presented by SARS, AIDS, or bioweaponized incarnations - what they have done, what they could do, and why it is so hard to stop them. Part III will describe the scope of the public health problem, particularly the globalization factors that serve as enablers of the pandemic potential of these diseases, as well as a host of ill-defined "x" factors that have served to further complicate the dynamics of dealing with these global killers. Part IV will consider solutions to the problem by discussing what we have versus what we need. Part V will present recommendations for how government, pharmaceutical and biotechnology industries, as well as international non-governmental organizations can be part of the solution. Lastly, Part VI provides a conclusion.¶ "Ring around the rosie, pocket full of posies,¶ Ashes, ashes - we all fall down!" - According to legend, a children's rhyme dating from the time of the plague in medieval Europe.¶ II. Scenes from a Plague¶ SARS has been compared to the bubonic plague of the Middle Ages, but the Black Death was not a "fast epidemic" due to the limitations of its [4] mode of transmission, as well as the modes of medieval transportation. While SARS is somewhat comparable to flu epidemics of the last century and to the putative bioterror agents of today, AIDS has the dubious distinction of being closer to the experience of the Black Death. However, unlike that ancient pandemic, which was more limited temporally and geographically, AIDS is embarking upon what, Dr. Peter Piot, executive director of UNAIDS, refers to as a "true globalization phase." 8Link to the text of the note¶ A. Black Death Redux¶ The superlatives used to describe the public health impact of AIDS never seem to be exhausted. One commentator noted that AIDS will soon exceed the death toll of the Bubonic Plague, making it the most "numerically lethal pandemic" the world has ever known. 9Link to the text of the note The World Health Organization (WHO) refers to it more prosaically, but with similar notoriety, as the "toughest health assignment the world has ever faced." 10Link to the text of the note Even after twenty years, AIDS is still something of a medical and scientific conundrum. Diversity of the virus increases with duration of infection, further complicating drug treatment. 11Link to the text of the note Vaccine development is similarly complicated due to existence of ten major genetic types or clades of HIV-1, each with a distinct geographical spread. 12Link to the text of the note¶ What we do know is that AIDS is caused by an infection with the human immunodeficiency virus (HIV), transmitted through unprotected sex, sharing hypodermic needles, transfusions of contaminated blood, or from mother to child during pregnancy, labor, delivery, or breast-feeding. The virus attacks the immune system by infecting white blood cells, known as CD4+ cells, making it difficult for the body to fight off infections. AIDS itself is considered the final stage of HIV disease. 13Link to the text of the note Without treatment, HIV will progress to full-blown AIDS within nine to eleven years, and is usually fatal within two years after that point. 1