The Indiana University Center for Law, Ethics, and Applied Research in Health Information (CLEAR) was
founded in September 2010, with a generous grant from Lilly Endowment, Inc. The center’s mission is
“To improve health by addressing the ethical, policy, and user issues necessary for enhancing the use of
health information in treatment and research.” During the period covered by this report (January 1,
2013 through June 30, 2013) we have launched four new projects and continued work on three others,
all of which are described below.
CLEAR’s work reflects our growing conviction about the transformative effective of personal data in
healthcare. Every day we are presented with new examples of the ability to use data in creative ways to
achieve dramatic results. Consider just one example: The New York Times reported on March 6, 2013, a
study from the Journal of the American Medical Informatics Association in which search terms alerted
researchers to potentially dangerous drug interactions. Google has been tracking the spread and
severity of flu using search data since 2006. But rather than use “big data” to identify broad trends, such
as flu outbreaks, this new research—a collaboration between Microsoft, Stanford, and Columbia
University—focused on specific drugs and specific, although not identified, individuals.
The research found that people who had searched for the drugs Paroxetine and Pravastatin were about
10 percent more likely to search for terms related to the side effect hyperglycemia, and 30 percent of
those people would search for symptoms relating to both drugs on the same day. As a result of the data,
researchers were able to predict that when the two drugs are taken together they have the effect of
increasing blood glucose levels. The discovery was based on analysis of existing data; no patients were
put at risk or inconvenienced, the cost was minimal, and the relevant research population, rather than
being a few hundred patients in a large clinical trial, included 82 million relevant searches—more than
enough to establish a statistically valid correlation. Most importantly, analyzing the search data provided
the warning earlier than the FDA’s Adverse Event Reporting System and faster than clinical trials that
have been underway since 2010 to test the hypothesis of a possible interaction between the two drugs.
This is only the beginning. Researchers are finding more correlations that allow medical professionals
and individuals to predict who is at risk for which diseases and which tests or therapies are most likely to
be effective (see, for example, Peter Schwartz’s work, described in greater detail below). Angelina Jolie’s
decision to have her breasts and ovaries removed, which she revealed in an aptly-named essay “My
Medical Choice,” in the New York Times on May 14, 2013, was based on genetic testing. But researchers
are discovering many correlations between disease conditions or drug or treatment effectiveness based
on more routine data such as age, weight, and gender. Moreover, massive data sets increasingly mean
that new discoveries will not be limited to human-generated hypotheses, but increasingly can reveal
trends and correlations in data that were never before observable.
All of these promising developments about the use of data to save and improve lives raise critical issues
about how the data should be collected, accessed, shared, and protected. It is these issues that are the
focus of CLEAR’s work. During the period covered by this report, that work increasingly reflects two
trends:
1. We are placing a greater focus on Indiana and on partnerships with Indiana institutions. This is
reflected in initiatives such as the Indiana Health Information Speakers Series, which brings
leading health information experts to Indiana and at the same time provides critical
opportunities for continuing the dialogue among Indiana health information leaders, and the
Indiana Patient Notification Pilot Study, which involves a broad range of Indiana institutions
working together to demonstrate the value of electronically messaging patients a standardized
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patient summary of data from their implanted cardioverter-defibrillators. It is also evident in our
continuing behind-the-scenes efforts to support Indiana healthcare initiatives and institutions
and, as we first described in our last report, to identify and overcome barriers to enhanced
collaboration among those institutions.
2. For that portion of our work that does not focus on the state of Indiana, we are expanding our
efforts internationally. Prime examples are our new project on Big Data Use by Genomics and
Health Informatics Researchers and our continuing work on Identifying and Mitigating Privacy
Risks in Health Research, both of which include European partners, not to mention our new
collaboration with the OECD. This international dimension reflects the growing range of
resources available in other countries, the increased international visibility of CLEAR, and our
continuing desire to work efficiently and avoid duplication wherever possible.
3. We are engaging in more partnerships to expand the range and impact of our projects. Those
partners include the Regenstrief Institute, Fairbanks Institute, IU Health, the IU Center for
Bioethics, Parkview Research Center, Reid Hospital, IHIT, St. Jude Medical, NoMoreClipboard,
Medical Micrographics, NextGen, and a host of other Indiana-based organizations; Centerstone
Research; the International Association of Privacy Professionals; Intel, Microsoft, Oracle, and a
number of other high-tech companies; and the OECD and other partners in France and the
United Kingdom.
As always, we welcome the opportunity to report on our ongoing projects and their impact. This report
details CLEAR’s activities during the period of January 1, 2013 through June 30, 2013. The report is
divided into two parts. The first provides a narrative description of CLEAR’s projects and other major
activities and impact. The second provides a complete catalog of publications, presentations,
partnerships, public outreach, and staff.
When combined with the center’s financial reports, we believe this information provides a
comprehensive picture of both the impact and our stewardship of the exceptional resources committed
by Lilly Endowment, Inc. to these undertakings.
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Part I
CLEAR Projects and Other Major Activities
New Projects
Big Data Use by Genomics and Health Informatics Researchers:
Identifying the “Top Ten” Impediments and Solutions
Project Leader: Eric M. Meslin
The great potential of genomic data comes not from the quantity of bytes, but from the power of
bioinformatics and computational biology to sift through and assemble valuable information in the form
of associations, mutation patterns and related inferences that will help better diagnose, predict,
prevent, and identify relevant targets for curing diseases. Similarly, large electronic health record
systems offer a different but breathtakingly analogous potential for improving the quality of health of
citizens, by reducing medical errors, determining optimal treatment protocols, referral strategies,
queuing, priority setting for technology development or redesigning the organization of healthcare
systems.
It should be no surprise that when these two sources of data are combined, the opportunities for
benefitting patients are considerable. For example, researchers can now study the genotype of patients
and examine their past medical history to better understand whether and to what extent they will
respond to medicines, or to improve the diagnosis and treatment of cancer, heart disease, and obesity,
among other important health conditions. However, to leverage this power requires greater access to
more personal health information combined with well-characterized genetic samples both for
investigative purposes and for use as controls in genome-wide association studies.
To reap the benefits of these technologies will require unprecedented collaboration, cooperation, and
data sharing among individual investigators, teams, and consortia and healthcare institutions. This raises
significant ethical issues, especially about data sharing, which may be one of the least appreciated
impediments to leveraging the power of “big data,” yet is among the most important predictors of
successful, open science. Notably, despite the belief that data sharing is important and valuable, there is
evidence that researchers are still unlikely or unwilling to share theirs. In a recent study, one-third of the
1,329 surveyed scientists did not respond regarding whether they shared their data or not; almost onehalf of the two-thirds who did respond indicated that they did not share their data.
The goal of this new project is to develop a research program focused on improving the policies,
practices, and ethical justifications for fostering more effective use of “big data” by researchers and
health providers. CLEAR will partner with several domestic and international collaborators including the
Regenstrief Institute, IU Health, the University of Toulouse, the French Institut National de la Santé et de
la Recherche Médicale (Inserm), and the European consortium Genotype to Phenotype (Gen2Phen), a
group of more than 10 institutions from across Europe carrying out research with large datasets. The
project will focus on three main activities:

A Critical Review of Literature to summarize existing empirical findings on impediments to
collaboration and sharing and promising solutions.

Researcher Attitudes and Practices. We will survey and interview researchers working in
comparable Indiana and European research consortia (one in health informatics, the other in
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bioinformatics/health) to describe the technological, organizational, economic, legal, and ethical
barriers to sharing big data and whether they have solutions in mind. This will include a survey
of perceived barriers of selected researchers in genomics and health informatics from the U.S.
and Europe, and interviews with a subsection of key informants.

Convening Expert Panels. Once the survey and interviews are complete we will use the findings
to convene a research agenda-setting meeting to identify the “top ten impediments.” We intend
to bring together a group of experts in law, ethics, health information, and genomics to assess
the survey findings and key literature with the aim to identify the most promising areas for
which research would help provide tractable data and proposals for enhancing data sharing. The
meeting would recommend key questions that would catalyze and focus research in this field.
The results of this meeting will be published, and the top priority topics will be targeted for
further research at the grant-writing workshop. Using the case studies identified in the
Literature Review phase, we will identify strategies most amenable to making progress towards
policy, procedure, or guidance.
This project intersects with CLEAR’s prior NIH-funded work on legal impediments to the use of personal
data in health research, and is a critical next step toward ensuring that data are both available for
important research and used consistently with legal requirements and ethical norms.
Indiana Patient Notification Pilot Study
Project Leader: Stan Crosley
CLEAR is participating in a pilot study with Parkview Research Center, Reid Hospital, IHIT, St. Jude
Medical, NoMoreClipboard, Medical Micrographics, and NextGen. The objective of the project is to
demonstrate the value of electronically messaging patients a standardized patient summary of remote
implantable cardioverter-defibrillator (ICD) data captured via a client application on a computer and
transmitted to a hospital EHR. Several secondary objectives include providing essential information for
future ICD to PHR implementation efforts by documenting “lessons learned” in three key areas:
technological development, patient
interaction with data, and clinician
interaction with data, including the
relevant privacy, ethical, and data security
issues.
CLEAR will study the proposed data flows
and mechanisms, the security around the
data flows, and the legal and regulatory
obligations that will apply. We will also
leverage the surveys of state and federal
regulation we completed last year to
make recommendations based on
privacy, data security, and ethical, legal,
and policy grounds.
Initial planning conversations have taken
place and the project is now in the
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development phase, exploring the data paths and the role of each of the participants in the project, and
setting up the technical solutions to enable the transmission and capture of the ICD data. Additionally,
standardization of the data capture and translation into guidance letters is underway. We expect that
there will be subsequent phases of this project that will further develop the model that is constructed in
this initial pilot.
Data Privacy Health Information Institute:
Innovations in Healthcare and the Applied Strategic Considerations for Health Information
Project Leader: Stan Crosley
On November 14, CLEAR and the International Association of Privacy Professionals will host a one-day
conference in Chicago to bring together industry, health care providers, patient advocates and privacy
and data security professionals from throughout the Midwest to address innovations in the collection
and use of health information and the issues that those innovations raise. Topics include: Data Analytics
in Healthcare: Lessons from Other Industries; Biobanks, Pharmacogenomics Data, and Personalized
Medicine: Research, Treatment, and Marketing; Privacy by Design in a Healthcare Model that Enables
Patient Health Outcomes; Patient Access to Device, Sensor, Diagnostics, and Other Real-time Data; and
Big Data in Healthcare: Data from Sensors, Devices, and Apps for Use in Patient Health Outcomes.
The conference is based on a series of cutting-edge case studies that will be addressed by thoughtleaders who are able to apply the principles of the real-life case studies to healthcare and health
information strategy. All four CLEAR co-directors are participating and other speakers are confirmed
from Acxiom, Amgen, CVS Caremark, Eli Lilly and Company, the Fairbanks Institute, Merck, Microsoft,
Oracle, Rite-Aid, and other organizations. The conference reflects CLEAR’s commitment not only to
bridging gaps among different disciplines and between academia and industry, but also to drawing on
the experience of data analytics in fields outside of healthcare to advance the legal and ethical use of
data within healthcare.
On the following day, CLEAR will be hosting an invitation-only workshop for our stakeholders and other
guests to address strategic issues for the center in particular and the productive, responsible use of
health information in general.
Indiana Health Information Speaker Series
Project Leaders: Fred H. Cate and Stan Crosley
This fall, CLEAR will be partnering with leading Indiana health information institutions to host the first in
a quarterly series of distinguished lecturers on health information innovation, law, and ethics. The
speakers will be drawn from government, industry, academia, and the not-for-profit world, and will visit
one or more of those institutions, share an informal meal with representatives of those institutions, and
then give a public lecture on a current topic.
This series serves four purposes:
1. It brings key innovators and experts to Indiana and exposes them to our work;
2. It helps connect Indiana institutions to the speakers’ work;
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3. It provides a valuable outreach opportunity for CLEAR and our partners to engage individuals
and institutions in Indiana in this field; and
4. It creates a regular opportunity for Indiana’s leaders in health information innovation to meet
together in person.
With the permission of the speakers, we intend to make their presentations available via the web as
well, in an effort to further expand the audience for and the visibility of the series.
This project is the most recent incarnation of our Information Issues in Health Innovation (HI4), which
brought together health-related organizations on a quarterly basis to meet with leading experts to
address information-related issues that affect health innovation. As originally envisioned, those one-day
workshops brought together representatives from companies as diverse as 3M, Acxiom, CVS Caremark,
Drinker Biddle & Reath LLP, Eli Lilly and Company, Iowa Health System, IMS, Takeda, and Vitalogix
Consulting LLC in different locations around the country. While support for the workshops was strong,
the difficulty in scheduling meetings became such a significant impediment that we decided to focus our
efforts in Indianapolis and make them part of our ongoing commitment to partnering with, and serving
the needs of, health-related institutions in central Indiana.
OECD Collaboration
Project Leaders: Fred H. Cate and Stan Crosley
We mentioned in our last report that we had been in discussions with the Organization for Economic
Cooperation and Development (OECD) about partnering with its growing efforts around health
information.
At the request of health ministers, the OECD Health Care Quality Indicators Expert Group (HCQI)
launched a project in 2011 to support health ministries in strengthening health information
infrastructure. That project has come to focus on the need to assist countries in addressing risks to
information privacy and developing a global perspective on appropriate data uses and privacy
protections. To help guide this work, the HCQI and the OECD Working Party on Information Security and
Privacy (WPISP) have appointed an Advisory Panel of Experts on Health Information Infrastructure.
CLEAR Co-Directors Fred Cate and Stan Crosley have been appointed to the Advisory Panel and CLEAR is
assisting in the work of the Advisory Panel to develop tools to help the 34 member countries of the
OECD, as well as a number of participating non-member countries, to develop appropriate
Privacy-respectful monitoring and research to improve population health, health care quality and health
system performance.
Continuing Projects
Personalized Risk and Benefit Information Regarding Colorectal Cancer Screening
Project Leader: Peter H. Schwartz, M.D., Ph.D.
We now have ways of calculating people’s personalized risk of developing colorectal cancer (CRC, often
referred to as simply “colon cancer”) based largely on measures that are available in an electronic
medical record. For example, some recent rules for predicting risk of developing CRC in the next 10
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years depend largely on age and body mass index. Unfortunately, nobody knows how to use such
personalized risk calculations, collected from EMR or in other ways, to best improve decision-making
and outcomes. CRC screening is particularly interesting in part because, while screening is
recommended for all individuals at average risk from ages 50-75, there are multiple approved tests.
CLEAR is supporting a pilot project undertaken by Peter H. Schwartz, M.D., Ph.D., to examine the impact
of personalizing risk information for medical decision-making, using CRC screening as a case study. He
and his team have completed their first study, “Pilot Study of Individuals' Responses to Hypothetical
Information about Lifetime Risk of Colorectal Cancer.” They enrolled 600 individuals from an online
panel to provide responses to hypothetical personalized information regarding their risk of developing
colorectal cancer.
Building on their CLEAR-supported study, they also completed an in-clinic study of personalized CRC risk
information, “Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk
Assessment Tool,” funded by the PredictER program (and led by CLEAR Co-Director Eric Meslin). In that
study, they measured the responses of 50 patients to a calculation of their risk of CRC that is provided
by an NCI-approved, online calculator.
Another in-clinic study, also supported by CLEAR, is currently underway. This study collects information
from the EMR and uses this to estimate patients’ CRC risk in the next 10 years. Those estimates will be
compared with additional data we obtain directly from the patients by telephone or at clinic, and will
provide a recommendation on the most appropriate test for them for screening.
Collectively, these three studies are already showing significant progress in understanding how
individuals assess CRC risk indicators, and tools that health professionals can use to prompt appropriate,
rational responses.
Identifying and Mitigating Privacy Risks in Health Research
Project Leaders: Fred H. Cate and Stan Crosley
This project is a novel attempt to identify what precisely we are trying to protect when we talk about
protecting privacy in health research. We are working to create an evidence-based, practical framework
of privacy interests and risks in health research; to assess those risks for demonstrated likelihood of
occurring and impact if they do; and to propose technology, policy, and legal measures for mitigating
those risks when real or educating and clarifying them when not.
This topic is of more than merely academic interest, because concern over privacy—both real and
perceived threats—has proven to be a major impediment to data flows essential to health research. If
research subjects don’t believe their privacy—whatever that means to them—is protected, they will not
participate in studies. Patients will not allow their data to be examined. Researchers will shy away from
potentially valuable research for fear of invading privacy or otherwise becoming embroiled in privacy
controversies. The press will decry actions that violate their understanding of privacy. And, as the
inadequacies of the HIPAA Privacy Rule demonstrate, policymakers will adopt overbroad or misfocused
regulations in an effort to ensure that their conception of privacy is protected.
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Despite the importance of the issue and the gallons of ink that have been spilled over privacy, no one to
our knowledge has created, much less assessed, a precise, workable framework of privacy interests and
risks. That is the goal of this project.
In the period covered by the report, CLEAR has examined thousands of academic and industry studies,
government reports, and press clippings, as well as the focus groups that we conducted as part of our
Protecting Privacy in Health Research project, to identify the range of issues, incidents, and harms
described under the term “privacy.” Building on that comprehensive assessment, we have developed a
series of frameworks that categorize the various interests based on whether they most affect
individuals, institutions, or society, and analyze the likelihood of their occurring and the potential
consequences if they do. Here is a summary slide covering just one element—the potential harm to and
impact on the individual if personal data are revealed:
The next step is to test these frameworks with a diverse group of stakeholders, including patients, to
continue expanding our understanding about what, specifically, the privacy risks are in healthcare, how
frequently they materialize, the harm caused if they do, and the laws or other measures already in place
to prevent those.
Much of the work on this project was being carried out by Alanna Whybrew, who to our great regret left
CLEAR this summer for personal reasons. We are currently looking to fill her position. In the meantime,
we are partnering with Richard Thomas, OBE, the former Data Commissioner of the United Kingdom and
a noted expert on privacy issues in health data, to begin testing these frameworks with industry,
government, and academic experts on risk generally.
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CenterStone Collaboration
Project Leader: Kay Connelly
CLEAR and the CenterStone Research Institute, the research arm of the nation’s largest not-for-profit
provider of mental health services, are collaborating to investigate how information technology can be
used with mental health patients to improve diagnosis and treatment. The collaboration involves three
independent projects, two of which have been completed:
1. CenterStone is a leader in developing and integrating clinical IT systems in the behavioral health
domain. Recently, they had a large effort to make their intake (i.e., new patient) process more
streamlined with their EHR. CLEAR performed a usability analysis of their proposed electronic,
intake system and made specific recommendations for improvement.
2. CenterStone provides training for life skills for patients who are low-functioning due to
behavioral health problems. Life skills training has traditionally been performed one-on-one,
with clients receiving “homework” to complete on their own, such as going to the grocery or
paying their bills. However, there has been no reliable way for life skills teachers to evaluate if
their clients were able to successfully complete their homework, and what specific problem they
may have encountered. CLEAR designed a mobile application to complement the one-on-one
sessions, help clients through their homework, and provide more detailed information to the
teachers about problems clients may have had while performing their homework.
3. One limitation of traditional therapy for conditions such as depression is that patients only see
their therapist once a week (at most). For many conditions, this small level of interaction is
simply no enough. It does not provide the time needed for the therapist to collect important
information about the patient’s current situation, nor does it provide the level of support the
patient requires to deal with their illness. CenterStone and CLEAR are in an ongoing project to
investigate how the use of technologies may facilitate the therapy process by automatically
collecting data the therapist has never had access to before (e.g. sleep quantity and quality), as
well as providing information to patients in real-time that may help them between therapy
sessions.
To date, the CLEAR team has interviews 15 providers to learn about the opportunities and
barriers in using technology with patients with depression. A manuscript with their results is
currently under peer review. CLEAR is now endeavoring to obtain the patient perspective by
interviewing patients. In the future, the combined provider and patient perspective will provide
the foundation for technologies designed specifically for this population.
This work not only assesses the usefulness of such technologies and determines practical applications,
but also is carrying out studies to address important issues about privacy, consent, and the applicability
of health data regulations to such information in an effort to facilitate easier use through a number of
approaches including stakeholder engagement, study groups, and surveys.
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Part II
CLEAR Activities and Indicators
Publications
Cate, Fred H., “Information Security Threats, Policies, and Law in the United States,” 3 Beihang
University Law Review __ (forthcoming 2013).
Cate, Fred H., “Notice and Consent in a World of Big Data,” International Data Privacy Law, vol. 3, no. 2
at 67 (2013) (with Viktor Mayer-Schönberger).
Cate, Fred H., “Government Data Mining,” in David G. Kamien, ed., McGraw-Hill Handbook of Homeland
Security __ (2d ed., 2013) (with Newton N. Minow).
Cate, Fred H., “Face-to-Data—Another Developing Privacy Threat?,” International Data Privacy Law, vol.
3, no. 1 at 1 (2013) (with C. Kuner, C. Millard & D. Svantesson).
Cate, Fred H., “Alan Westin and Privacy and Freedom,” Foreword to the 2013 edition of Alan Westin,
Privacy and Freedom (forthcoming 2013).
Lorenzen-Huber, L., Shankar, K., Caine, K., Connelly, Kay, Camp, L.J., Walker, B.A., and Borrero, L. (2013).
“How in-home technologies mediate caregiving relationships in later life.” International Journal of
Human Computer Interaction. 29 (7), 441-455.
Kutz, D., Kalpana S., and Connelly, Kay. “Making Sense of Mobile- and Web-Based Wellness Information
Technology: Cross Generational Study.” Journal of Medical Internet Research. 2013; 15(5):e83.
Siede, LV and Meslin, EM. La ciencia de los biobancos, ¿un derecho o un privilege? Hacia un Nuevo
contrato social [The science of biobanks, a right or privilege? Towards a New Social Contract], In:
Biotecnologías e Innovación: el compromiso social de la ciensa edited by Elizabeth Hodson de Jaramillo,
Teodor Zamudilo. Bogata, Columbia: Pontificia Universidad Javeriana, 2013: 252-265.
Meslin, EM, Ethical issues in constructing and using bio-banks In. Bioethics, Science, and Public Policy.
Edited by Jonathan Beever and Nicolae Morar, Purdue University Press, 2013: 123-135.
Hendrix, K.S., Carroll, A.E., and Meslin, Eric M., and Downs, S.S. “Indiana Caregivers' Attitudes About the
Use of Newborn Dried Blood Spots for Research.” Academic Pediatrics (in press 2013).
Schwartz, Peter H., Edenberg, E., Barrett, P.R., Perkins, S.M., Meslin, Eric M., and Imperiale, T.F. “Patient
Understanding of Benefits, Risks, and Alternatives to Screening Colonoscopy.” Family Medicine. 2013;
45(2): 83-89.
Meslin, EM, Were, E, Ayuku, D. Taking Stock of the Ethical Foundations of International Health Research:
Pragmatic Lessons from the IU-Moi Academic Research Ethics Partnership. Journal of General Internal
Medicine [published online] 2013: DOI: 10.1007/s11606-013-2456-7.
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Meslin, EM, Blasimme, A, Cambon-Thomsen A, Mapping the Science Policy ‘Valley of Death’ Clinical and
Translational Medicine (in press 2013).
Goodman, K.W. and Meslin, Eric M. “Ethics, Information Technology, and Public Health: Duties and
Challenges in Computational Epidemiology.” In JA Magnusen, Paul Fu, and James Aspevig eds. Public
Health Informatics and Information Systems Springer (in press 2013).
Allen, J., Hulman, D., Meslin, Eric M., and Stanley, F. “Privacy protectionism and harms to health: is there
any redress?” Journal of Law and Medicine (in press 2013).
Presentations
Fred H. Cate spoke on “Surveillance and its Impact,” at the First Friday Call webinar hosted by the Centre
for Information Policy Leadership at Hunton & Williams LLP, on July 12, 2013.
Fred H. Cate spoke on “National Security Surveillance, the Rule of Law, and the Challenge for U.S.
Interests: What Edward Snowden Won’t Tell You” at the Summer Language Workshop (SWSEEL) at
Indiana University, July 11, 2013.
Eric M. Meslin presented “L’assistance a la procreation en Europe et tourisme procreative” ["The
Procreative assistance in Europe and procreative tourism"]. Discussant with Jean-Jacque Rouch,
European Summer School on Health Law and Bioethics « Ecole Européenne d'Eté de Droit de la Santé et
de Bioéthique », University of Toulouse School of Medicine, July 2, 2013.
Fred H. Cate spoke on “The Legal Landscape” at Cybersecurity 2013: Managing the Risk, New York, New
York, July 1, 2013.
Eric M. Meslin presented “The role of research ethics committees”, France-China Symposium, « Ethics,
culture and traditional medicine,”, University of Toulouse, June 28, 2013.
Eric M. Meslin presented « Mise à disposition de données de séquences générées en recherche ou dans
le cadre de séquençage proposé directement au consommateur» ['Availability of sequence generated
through research or proposed sequencing directly to the consumer data], Museum of Natural History of
Toulouse, June 27, 2013.
Fred H. Cate spoke on “Information Security for Fun and Profit” at Mini University at Indiana University,
June 13, 2013.
Eric M. Meslin and Alessandro Blasimme presented a poster “Toward a Theory of Science Policy for
Genetics. [Poster] at the European Society for Human Genetics Annual Meeting, Paris, June 8-11, 2013.
Kay Connelly and Kelly Caine presented a poster entitled “SOLACE: Supporting Older Low-SES Adults and
their Caregivers Electronically,” at the National Science Foundation Smart Health and Well Being PI
meeting in June 2013.
Fred H. Cate co-organized and co-moderated the Data Use and Impact Global Workshop in London, UK,
May 30-31, 2013.
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Stan Crosley participated in the Data Use and Impact Global Workshop in London, UK, May 30-31, 2013.
Eric M. Meslin presented “The future for biomedical collections: ethics, law and social connections in
health-related research. [Panel presentation with AC Campbell, S Grainger], JK Mason Institute for
Medicine, Life Sciences and Law – Anniversary Event, Edinburgh, Scotland, May 28 2013.
Eric M. Meslin presented “Crossing (and Mapping) the Translational Science Policy ‘Valley of Death,’” at
the Institute for Biomedical Ethics, University of Zurich, on May 21, 2013.
Fred H. Cate delivered the keynote address, entitled “The Promise and Perils of Personal Information in
Healthcare,” at the 2nd Annual Western Canada Health Information Privacy Symposium in Winnipeg,
Canada, on May 15, 2013.
Fred H. Cate delivered the keynote address, entitled “The Growing Importance (and Irrelevance) of
International Data Protection Law,” at the 2013 Manitoba Access, Privacy, Security & Information
Conference—Making Connections, at the Office of the Manitoba Ombudsman, in Winnipeg, Canada, on
May 14, 2013.
Eric M. Meslin participated in the “P3G Privacy Summit: Data Sharing, Cloud Computing, and Privacy,” in
Paris on May 3, 2013.
Eric M. Meslin participated in the “ELSI 2.0 Grant-writing Workshop,” in Paris on May 3, 2013.
Fred H. Cate presented the keynote lecture “The Promise and Perils of Personal Information in
Healthcare” at the Monroe-Owen County Medical Society Annual Meeting, in Bloomington, Indiana on
May 2, 2013.
Fred H. Cate spoke by video link to the Board of Directors of the IU Credit Union at its annual retreat of
“Cybersecurity Threats and Policy Issues,” French Lick, Indiana, on April 26, 2013.
Fred H. Cate participated in “Privacy Principles for the 21st Century” at the Privacy Policy Workshop at
Microsoft Corporation, in Redmond, Washington, on April 24, 2013.
Fred H. Cate participated in “Cybersecurity Challenges in Higher Education” at the Internet2 Annual
Members Meeting, Crystal City, Virginia, on April 22, 2013.
Eric M. Meslin presented “Genetics and Society Platform Workshops (Genotoul Societe) « La medecine
basee sur les donnees ? La responsabilite de la communication de resultats et decouvertes fortuites
dans la cadre du diagnostic » April 18 , 2013, Toulouse.
Fred H. Cate served as a panelist on “Accountability Through Attribution: Real Name vs. Anonymity” at
the U.S.-China Internet Industry Forum, hosted by Microsoft Corporation and the Internet Society of
China, in Beijing, China, on April 10, 2013.
Fred H. Cate served as a panelist on “Transforming Society and Bridging Cultural Differences via Online
Services” at the U.S.-China Internet Industry Forum, hosted by Microsoft Corporation and the Internet
Society of China, in Beijing, China, on April 10, 2013.
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Fred H. Cate spoke on “Password Vulnerability and Liability,” at the First Friday Call webinar hosted by
the Centre for Information Policy Leadership at Hunton & Williams LLP, on April 5, 2013.
Fred H. Cate moderated “Effective Data Protection for the 21st Century” at the 2013 International
Association of Privacy Professionals Global Privacy Summit in Washington, D.C., on March 7, 2013.
Stan Crosley served as a panelist on “Effective Data Protection for the 21st Century” at the 2013
International Association of Privacy Professionals Global Privacy Summit in Washington, D.C., on March
7, 2013.
Eric M. Meslin presented in “EU Science: Global Challenges and Global Cooperation,” at the European
Parliament in Brussels, March 5-7, 2013.
Fred H. Cate moderated a panel on “Accountability in Distributed Environments” at Accountability Phase
V—The Essential Elements in Distributed Environments, in Warsaw on February 21, 2013.
Fred H. Cate presented “Is There Any Hope for Cybersecurity?” to the Indiana University Retirees’
Association on February 13, 2013.
Fred H. Cate led a cybersecurity webinar on the “Critical Infrastructure Executive Order,” hosted by the
Centre for Information Policy Leadership at Hunton & Williams LLP, on February 13, 2013.
Eric M. Meslin served as a panel chair on “Data protection in an era of consumer targeted genome
sequencing,” at the Brocher Foundation in Geneva, Switzerland, February 4-5, 2013.
Fred H. Cate co-organized and co-moderated a three-day workshop on Revising the OECD Privacy
Guidelines, sponsored by the Oxford Internet Institute and funded by Microsoft in London, January 2325, 2013.
Kay Connelly presented “PHIT Lab: Pervasive Health information Technologies,” at the Microsoft
Research Home Lab Faculty Think Tank.
CLEAR in the Media
Fred H. Cate was quoted in “FSSA sends alert on info breach.” July 1, 2013. WISH-TV (Indianapolis CBS).
Fred H. Cate co-authored “Should the Feds regulate cybersecurity?” June 26, 2013. The (Newark) StarLedger.
Fred H. Cate was quoted in “After Snowden, a defense of Big Data.” June 19, 2013. The Rutland Herald.
Fred H. Cate was quoted in “In the End, NSA might not need to snoop so secretly.” June 18, 2013. The
Christian Science Monitor.
Fred H. Cate appeared on “More technology means less privacy for users.” June 10, 2013. WTHR
(Indianapolis NBC).
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Fred H. Cate was quoted in “Apps to hide phone records no barrier for government: experts.” June 8,
2013. Times of India.
Fred H. Cate was quoted in “Technology to hide phone records no barrier to government snoops:
experts.” June 6, 2013. Chicago Tribune.
Fred H. Cate was mentioned in “IU joins $2 million cybersecurity effort.” April 24, 2013. Inside Indiana
Business.
Fred H. Cate was quoted in “Four ways to bolster your hacker defenses.” April 4, 2013. Campus
Technology.
Fred H. Cate was quoted in “Former dentist’s office dumps records.” March 22, 2013. Chronicle-Tribune.
Fred H. Cate was quoted in “Mission creep at the TSA?” March 1, 2013. National Geographic Traveler.
Fred H. Cate was quoted in “Executive order could warrant cyber-security response.” February 26, 2013.
Compliance Week.
Fred H. Cate was quoted in “Info governance: crafting and effective data security policy.” February 12,
2013. Compliance Week.
Fred H. Cate was quoted in “Instagram’s changes stir up social media pot.” January 18, 2013. Indiana
Daily Student.
Fred H. Cate was quoted in “Banks warning customers about cyberattacks.” January 7, 2013. WIBC.
Grants
Grants Awarded
PI/Co-PI:
Agency:
Status:
Project Title:
Amount:
Dates:
Fred H. Cate
The Privacy Projects
Awarded
Data Use Workshop
$140,000
05/01/13-08/01/13
PI/Co-PI:
Agency:
Status:
Project Title:
Amount:
Dates:
Eric M. Meslin
Brocher Foundation, Geneva
Awarded
The Governance of International Consortia – Establishing A Proof of Principle for ELSI 2.0
In-kind travel and workshop support
June 2014
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PI/Co-PI:
Agency:
Status:
Project Title:
Amount:
Dates:
Eric M. Meslin
Brocher Foundation, Geneva
Awarded
(BATIR) Bioethics Acting Towards Interdisciplinary Research
In-kind travel and workshop support
One month residency stay 2014
Total amount of grants received by senior personnel during reporting period: $140,000.
Grants Submitted
PI/Co-PI:
Agency:
Status:
Project Title:
Amount:
Dates:
Eric M. Meslin
NSF
Pending (submitted 02/14/13)
Bioethics Acting Towards Interdisciplinary Research (BATIR)
$300,000
01/01/14 – 12/31/17
PI/Co-PI:
Agency:
Status:
Project Title:
Kay Connelly
NSF
Pending (submitted 06/04/13)
REU Supplement: Privacy-Enhanced Technologies to Support Underserved Older Adults
Age in Place
$30,360
06/01/13-08/31/13
Amount:
Dates:
PI/Co-PI:
Agency:
Status:
Project Title:
Amount:
Dates:
PI/Co-PI:
Agency:
Status:
Project Title:
Amount:
Dates:
Kay Connelly
NSF
Pending (submitted 05/28/13)
SCH: EXP: Collaborative Research: SOLACE: Supporting Older Lone Adults and Their
Community Electronically
$394,445
01/01/14-12/31/16
Peter H. Schwartz
Patient-Centered Outcomes Research Institute
Pending (submitted 04/15/13)
Presenting the Comparative Benefits of Colonoscopy and Stool Testing for Colorectal
Cancer Screening
$1,429,976
09/01/13-08/31/16
Total amount of grants submitted by senior personnel during reporting period: $2,154,781
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Management and Personnel
Co-directors:




Fred H. Cate is a Distinguished Professor, C. Ben Dutton Professor of Law, and director of the
Center for Applied Cybersecurity Research (CACR).
Kay Connelly is an associate professor of Informatics and Computing and coordinator of Health
Informatics.
Stanley W. Crosley, the former chief privacy officer for Eli Lilly and Company, is of counsel to
Drinker Biddle & Reath and leads the firm’s Data Privacy and Health Information Governance
team.
Eric M. Meslin is director of the Indiana University Center for Bioethics, associate dean
(Bioethics) in the Indiana University School of Medicine, and professor of medicine, medical and
molecular genetics, public health and philosophy.
Staff










Sheri Alpert is a post-doctoral fellow (100% FTE)
James Boyd is external relations manager (37.5% FTE)
Leslee Cooper is budget and finance manager (50% FTE)
Dara Eckart is administrative director (50% FTE)
Sarah Portwood is executive assistant to Fred H. Cate (33% FTE)
Stephanie Schoneweis is events coordinator (50% FTE)
Peter H. Schwartz is a faculty researcher who also serves as faculty investigator at the Indiana
University Center for Bioethics and assistant professor of medicine in the Division of General
Internal Medicine at the Indiana University School of Medicine. He is lead investigator in the
CLEAR-funded study on Colorectal Cancer Screening.
Drew Simshaw is project manager and policy analyst
Marjorie Young is administrative assistant (50% FTE)
Alanna Whybrew was a research fellow (100% FTE, resigned position May 31, 2013; CLEAR is
currently accepting applications to fill this position)
Hourly Employees
Centerstone Research Institute Collaborative Project
 Harish Bharani
 Robyn Evans
 Meisi Huang
 Carrie Lawrence
Colorectal Cancer Screening Project
 James Baker
 Paul Muriello
 Karen Krall-Schmidt
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Stakeholder Group
Close collaboration with external stakeholders is a key feature of CLEAR and helps to ensure that
projects are original, meaningful, and take advantage of existing work. The stakeholders are also key to
providing access to data, people, and funding that CLEAR otherwise could not.
The members of our formal stakeholders group are:










Joe Alhadeff, Oracle
Peter Cullen, Microsoft
Michael Harrington, Eli Lilly and Company
David Hoffman, Intel
Jane Horvath, Apple
Jana Klopp, Eli Lilly and Company
Nuala O’Connor, Amazon
Deven McGraw, Center for Democracy and Technology
Alison Smith, C-Change
Hilary Wandall, Merck
Conclusion
The projects, publications, presentations, and other activities described in this report would not have
been possible without the exceptional support of Lilly Endowment, Inc. CLEAR is privileged to have the
opportunity to collaborate with others in Indiana and elsewhere to facilitate the reliable availability of
information necessary to improving individual and public health. By addressing the ethical, policy, and
user issues necessary for enhancing the use of health information in treatment and research, we believe
we can help make meaningful progress toward this goal. Moreover, we increasingly believe that the
features that distinguish CLEAR—its interdisciplinary approach, its collaboration with a diverse range of
private and public partners, and its efforts to blend scholarly analysis with practical problem-solving—
are vital to helping expand the impact and reputation of Indiana University and the state of Indiana in
this critical field. We are deeply grateful for the support—financial and otherwise—of Lilly Endowment,
Inc., and we hope that you will not hesitate to let us know if you would like more information about any
of our activities.
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