Barry Smith
UB Clinical/Research Ethics Seminar
November 20, 2012 http://ontology.buffalo.edu/12/ethicsinformatics-obamacare.pptx
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David Brailer
(first National Coordinator for Health Information Technology)
if patients’ information were shared across health care settings so that personal health information seamlessly followed any patient through various settings of care—$77 billion would be saved annually
“Economic Perspectives on Health Information Technology”, 2005
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Obamacare: “The ‘no-brainer’ of health IT”
• A central pillar of [ARRA’s] mammoth, $800 billion dollar legislation … is devoted to digitizing the nation's medical records and rewiring healthcare for the 21st century, via the $27 billion Health
Information Technology for Economic and Clinical
Health (HITECH) Act.
• health IT … has set the stage for broader healthcare reform, … may just be the most lasting, bipartisan
and transformative piece of the stimulus bill.
Health IT News, TIME magazine correspondent Michael Grunwald, October 1, 2012
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• gaps and duplication in patient care delivery can be reduced or eliminated through proven technologies such as electronic health records, e-prescribing, and telemedicine
• health information technology improves quality by making needed clinical information accessible to all appropriate providers and in a more complete and timely fashion than paper records
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David Brailer, again (from 2005):
• Currently, as soon as a patient arrives at a hospital, a battery of tests is performed … because clinicians have no way of knowing what has already been done.
• Eliminating this inefficiency and frustration through interoperability represents a significant challenge. It does not, however, require magical changes in the business processes or culture of health care to be realized. It is really about obtaining data by calling it up on a computer system rather than waiting for medical records to be delivered.
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“the policy challenge is to get a critical mass of health IT adoption so that this nation can move forward.
The reasoning is that once health IT adoption reaches the 40 to 50 percent range, market forces will take over, because health care IT will become a requirement for doing business.”
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• They “are like the first owners of fax machines. … there is no infrastructure to which an EHR can connect. …
• there are 300 electronic health record products on the market that I know of, and that does not include all the home-grown products.
• Health care providers buy the wrong product virtually all the time. There is no price transparency around products, … .
• Physicians do not know how to contract for these technologies, so they almost always take unnecessary risks in their contracts. And they do not know how to implement them. …
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• Different EHR vendors have financial incentives to thwart interoperability
• Patients move between physicians and hospitals, who use EHR systems deriving from different vendors
• Even where hospitals or wards use the same EHR vendor, their EHR data may not be interoperable
• Even where coders in the same hospital or ward use the same EHR system, they may code in noninteroperable ways
• Interoperability standards are still slapdash
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http://hl7-watch.blogspot.com/
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Eligible health care professionals and hospitals can qualify for more than $27 billion in
Medicare and Medicaid incentive payments available to eligible providers and hospitals https://www.cms.gov/ehrincentiveprograms/.
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EHR incentive payments to Medicare providers
2011 2012 2013
Adopt
2011
$18,000 $12,000 $8,000
2014 2015
$4,000 $2,000
2016
$0
Adopt
2012
---------$18,000 $12,000 $8,000 $4,000 $2,000
Adopt
2013
-------------------$15,000 $12,000 $8,000 $4,000
Adopt
2014
-----------------------------$12,000 $8,000 $4,000
2017
$0
$0
$0
$0
TOTAL
$44,000
$44,000
$39,000
$24,000
Adopt
2015 +
--------------------------------------$0 $0 $0 $0
After
~2018 penalties, in the form of reduced Medicare reimbursements
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• Question: Why do it so quickly, when there are so few trained personnel, and when EHR systems are so bad, and when there are so many systems, and when the systems are not interoperable?
Answer: Magical thinking*
*What, after all, can go wrong?
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Question: In the age of Wikileaks, how do we ensure that success in achieving health IT interoperability will not be accompanied by massive threats to data security?
Answer: HIPAA*
*Big locks on all the doors (which will also make it hard to open the doors from the inside)
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David Brailer, again (from 2005):
• Currently, as soon as a patient arrives at a hospital, a battery of tests is performed … because clinicians have no way of knowing what has already been done.
• Eliminating this inefficiency and frustration through interoperability represents a significant challenge. It does not, however, require magical changes in the business processes or culture of health care to be realized. It is really about obtaining data by calling it up on a computer system rather than waiting for medical records to be delivered.
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Question: In the age of Wikileaks, how do we ensure that success in achieving health IT interoperability will not be accompanied by massive threats to data security?
Answer: HIPAA
*Big locks on all the doors
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CMS (Centers for Medicare & Medicaid Services)
Staged Approach to Meaningful Use
Stage 1: ~2011 Stage 2: ~2013 Stage 3: TBD
1. Capturing health information in a coded format
2. Using the information to track key clinical conditions
3. Communicating captured information for care coordination purposes
4. Reporting of clinical quality measures and public health information
1. Disease management, clinical decision support
2. Medication management
3. Support for patient access to their health information
4. Transitions in care
5. Quality measurement
6. Research
7. Bi-directional communication with public health agencies
1. Achieving improvements in quality, safety and efficiency
2. Focusing on decision support for national high priority conditions
3. Patient access to selfmanagement tools
4. Access to comprehensive patient data
5. Improving population health outcomes
Capture information Report information
Leverage information to improve outcomes

CMS (Centers for Medicare & Medicaid Services)
Staged Approach to Meaningful Use
Stage 1: ~2011 Stage 2: ~2013 Stage 3: TBD
1. Capturing health information in a coded format
2. Using the information to track key clinical conditions
3. Communicating captured information for care coordination purposes
4. Reporting of clinical quality measures and public health information
1. Disease management, clinical decision support
2. Medication management
3. Support for patient access to their health information
4. Transitions in care
5. Quality measurement
6. Research
7. Bi-directional communication with public health agencies
1. Achieving improvements in quality, safety and efficiency
2. Focusing on decision support for national high priority conditions
3. Patient access to selfmanagement tools
4. Access to comprehensive patient data
5. Improving population health outcomes
Capture information Report information
Leverage information to improve outcomes

Examples of Stage 1 Objectives Measure
Maintain active medication allergy list
Record and chart changes in selected vital signs
(height, weight, BP, BMI, growth charts (2-20 yrs.)
Record smoking status for patients 13 years old or older
Implement one clinical decision support rule along with the ability to track compliance to that rule
80%+ of patients
50%+ of patients
50%+ of patients
1 rule
Report ambulatory quality measures to CMS or the
States
Aggregate numerator/ denominator
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• “Projected quality and safety benefits from
MU could be so substantial that nonattainment may be egregious. … failure to meet MU staged thresholds in a timely manner might signify not only second-rate status, but confer an air of third-world competency.”
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Stephen T. Miller and Alastair MacGregor:
Ethical Dimensions of Meaningful Use
Requirements for Electronic Health Records
“The need to bring clinical charting traditions into the electronic format is obvious. Anyone who works in a clinical setting knows that retrieving information from an outdated or otherwise separate chart is burdensome and inefficient.
Having that information in a structured, easily retrievable format is a great boon to both health care professionals and patients.”
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Subcommittee on Technology and Innovation, Nov 14, 2012
• Is "Meaningful Use" Delivering Meaningful
Results? An Examination of Health Information
Technology Standards and Interoperability
US House of Representatives, 2318 Rayburn House Office
Building Washington, DC 20515
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Willa Fields, Healthcare Information and Management Systems
Society and Professor, School of Nursing, San Diego State University
Statement before the Technology and Innovation Subcommittee of
US House of Representatives
Interoperability Status
The impactfulness of electronic health record systems adoption is highly dependent upon health information exchange (HIE), since EHR data can most effectively be useful if it can be exchanged across healthcare delivery systems, EHR vendors, and health information exchanges. HITECH includes elements of information exchange in the Meaningful Use criteria and provides for state investment in health information exchange infrastructure (referred to as HIEs) through the State Health
Information Exchange Cooperative Agreement Program.
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Currently only for VA? Also for military?
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Staged Approach to Meaningful Use
Stage 1: ~2011 Stage 2: ~2013
1. Capturing health information in a coded format
2. Using the information to track key clinical conditions
3. Communicating captured information for care coordination purposes
4. Reporting of clinical quality measures and public health information
1. Disease management, clinical decision support
2. Medication management
3. Support for patient access to their health information
4. Transitions in care
5. Quality measurement
6. Research
7. Bi-directional communication with public health agencies
Stage 3: TBD
1. Achieving improvements in quality, safety and efficiency
2. Focusing on decision support for national high priority conditions
3. Patient access to selfmanagement tools
4. Access to comprehensive patient data
5. Improving population health outcomes
Capture information
Report information
Leverage information to improve

Stage 2 standards (130 pages) https://www.federalregister.gov/articles/2012/09/04/2012-20982/health-informationtechnology-standards-implementation-specifications-and-certification-criteria-for
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3. Scope of a Certification Criterion for Certification
In the Proposed Rule, based on our proposal to codify all the 2014 Edition
EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in
§ 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§
170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security
(§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§
170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below with, as noted in our discussion of “applicability,” an indication if the certification criterion or the specific capabilities within the criterion only apply to one setting (ambulatory or inpatient).
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3. Scope of a Certification Criterion for Certification
In the Proposed Rule, based on our proposal to codify all the 2014 Edition EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in § 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§
170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security
(§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§
170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below with, as noted in our discussion of “applicability,” an indication if the certification criterion or the specific capabilities within the criterion only apply to one setting 29
(ambulatory or inpatient).

3. Scope of a Certification Criterion for Certification
In the Proposed Rule, based on our proposal to codify all the 2014 Edition EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in § 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§
170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security
(§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§
170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below
What can go wrong?
criterion or the specific capabilities within the criterion only apply to one setting 30
(ambulatory or inpatient).

Pressure on hospitals to receive meaningful use payments will cost lives
Sam Bierstock, MD: There is “enormous pressure by the hospitals to force the physicians to use EHRs that are not necessarily very user-friendly and therefore disruptive to their work and to their efficiency,”
• hospital EHRs “are simply not yet adequately intuitive to meet the needs of clinicians.”
• “Most EHRs result in a 20-30 percent decrease in efficiency of emergency room doctors and an increase in the people who leave without being seen due to extended wait times.
• “Providers also face mounting expenses as a result of
HITECH regulations, which … also strengthened security and privacy requirements, “which are complex, costly to implement and poorly understood by the majority of providers”
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Health IT and Patient Safety:
Building Safer Systems for Better Care
Institute of Medicine, November 10, 2011
Recommendations
Current market forces are not adequately addressing the potential risks associated with use of health IT.
All stakeholders must coordinate efforts to identify and understand patient safety risks associated with health IT by … creating a reporting and investigating system for health IT-related deaths, serious injuries, or unsafe conditions
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The Age (Victoria, Australia), January 24, 2011:
• THE state government is considering abandoning Victoria's trouble-plagued $360 million health technology program,
• … The HealthSMART program - five years late and $35 million over budget - is supposed to link computer systems in hospitals and introduce processes such as electronic prescribing.
• But clinical applications are only partially running in just four hospitals, and doctors say patient safety is compromised by inadequate procedures that causes them to duplicate paperwork, chase test results and compete for access to computer terminals.
For more details see: http://www.systemswiki.org/index.php?title=An_Overview_of_Health_Information_Technology_and_Health_Informatics 34

The UK National Program for Health IT (NPfIT)
Conceived in 1998 to bring:
• Lifelong electronic health records for every person in the country.
• Round-the-clock on-line access to patient records and information about best clinical practice, for all NHS clinicians.
• Genuinely seamless care for patients through GPs, hospitals and community services sharing information across the NHS information highway.
• Fast and convenient public access to information and care through on-line information services and telemedicine
• The effective use of NHS resources by providing health planners and managers with the information they need.
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• U.K. Scrapping National Health IT Network after $18.7 billion in wasted expenditure
• NPfIT stunted NHS IT market
• Rotherham: NPfIT has put us back 10 yrs
• NPfIT failures have left NHS IT “stuck”
• NPfIT ‘pushed the NHS into disarray’
• So good, they abolished it twice
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Two Big Brother Awards
– 2000 The NHS Executive—award for Most
Heinous Government Organisation
– 2004 NFPIT - award for Most Appalling
Project because of its plans to computerise patient records without putting in place adequate privacy safeguards.
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over-optimism on the part of Tony Blair and others as concerns the quality of available standards. “If we use international standards, sanctioned by ISO, what, after all, can go wrong?”
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from Richard Granger (Head of NPfIT program):
• “there was some mythology in the Health Informatics
Community that the standards existed, HL7 was mature, and so forth. That was completely untrue.” from UK Computing Research Committee:
• “many of the technologies are new and have not been tested.
• Of the two standards at the heart of the EPR – HL7 v3 and SNOMED-CT – “neither has ever been implemented anywhere on a large scale on their own, let alone together. Both have been criticized as seriously flawed.”
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Why national eHealth programs need dead philosophers:
Wittgensteinian reflections on policymakers' reluctance to learn from history.

Findings
National eHealth programs unfold as they do partly because no one fully understands what is going on.
They fail when this lack of understanding becomes critical to the programs’ mission.
View NPfiT as an “n of 1” case study
But those in charge of national eHealth programs appear reluctant to learn from such studies.
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Secondary users
PAYER patient
Allied health other provider portal
HILS
Imaging lab
PAS
DSS billing
ECG etc
Online
Demographic registries
UPDATE
QUERY
Enterprise
Comprehensive Basic identity
Patient
Record demographics
Clinical ref data
Interactions DS
Clinical models
Local modelling
Online drug,
Interactions DB notifications
EHR terms archetypes
Msg gateway
Multimedia genetics workflow guidelines protocols realtime gateway
Online
Online terminology
LAB
Path lab telemedicine
4.43

The content of EHR systems (and of terminology standards such as SNOMED) develops too slowly to meet the needs of clinical researchers
1. They are functionally outdated
2. They do not allow vital distinctions to be made
(for example between disease and diagnosis)
3. They are run by large committees / business managers
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• To find out what it takes to capture the reality on the side of the patient in a rigorous and effective way
• We will try to work out what is needed to bring about a radical overhaul of these systems, including creation of rigorous and up-to-date ontologies for specific disease domains
•
• which we will violently test in real-world scenarios until we know they work
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Meaningful use regulations will certainly push things forward; they will give rise, in the short term, to much that is good.
The question is, whether they will create a path for the longer term future that will bring lasting value for the wider public.
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END
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