**Meeting Report**

**American Health Information Community**

**October 31, 2006**

The American Health Information Community (AHIC), a federally chartered
commission formed to help advance President Bush's call for most
Americans to have electronic health records (EHRs) within 10 years, held
its ninth meeting on October 31, 2006, at the Department of Health and
Human Services (HHS), 200 Independence Avenue, SW, Washington, DC,
20201.

The purpose of the meeting was to bring together Community members to
continue discussion of steps toward ways to achieve its mission of
providing input and recommendations to HHS on how to make health records
digital and interoperable, and assure that the privacy and security of
those records are protected in a smooth, market-led way. The meeting's
discussions focused on: (1) an overview of personalized health care, (2)
overviews of population health and health information technology (HIT)
as well as clinical research and HIT, (3) a discussion of Health
Information Technology Standards Panel (HITSP) standards and
interoperability specifications, (4) a presentation on a biosurveillance
minimum data set, and (5) AHIC Workgroup perspectives on visioning and
2007 priority areas.

HHS Secretary Michael O. Leavitt chairs the Community. The remaining 17
members, selected by Secretary Leavitt, are key leaders in the public
and private sectors who represent stakeholder interests in advancing the
mission of the Community and who have strong peer support. Members serve
two-year terms.

A summary of the discussion and events of that meeting follow.

**Call to Order**

Joining Secretary Leavitt counterclockwise around the table were:

**David Brailer, MD, PhD,** Vice Chairman, AHIC

**Robert Kolodner, MD,** Interim National Coordinator for Health
Information Technology

**Gail Graham,** Director of Health Data at the Department of Veterans
Affairs, Veterans Health Administration (VHA)

**Kevin Hutchinson,** CEO of SureScripts

**Leslie Norwalk,** Acting Administrator, Centers for Medicare and
Medicaid Services (CMS)

**Daniel Green,** Deputy Associate Director, Center for Employee and
Family Support Policy, Office of Personnel Management (OPM) (Mr. Green
represented Ms. Linda Springer, Director, OPM)

**Julie Gerberding, MD,** Director of the Centers for Disease Control
and Prevention (CDC), U.S. Department of Health and Human Services (Dr.
Gerberding was represented by Dr. Ed Sondik, Director of the National
Center for Health Statistics, for part of the meeting)

**William Winkenwerder, Jr., MD,** Assistant Secretary of Defense for
Health Affairs (Dr. Winkenwerder was represented by Stephen Jones, DHA,
Principal Deputy Assistant Secretary of Defense for Health Affairs, for
part of the meeting)

**Lillee Gelinas, RN, MSN,** Vice President of VHA, Inc.

**Scott Serota,** President and CEO of the Blue Cross Blue Shield
Association (Justine Handelman, Director of Federal Relations at the
Blue Cross Blue Shield Association, represented Mr. Serota for part of
the meeting)

**Charles N. (Chip) Kahn III,** President of the Federation of American
Hospitals

**Nancy Davenport-Ennis,** founder of both the National Patient Advocate
Foundation and the Patient Advocate Foundation

**Colin Evans,** Director, Policy and Standards, Digital Health Group,
Intel (Mr. Evans represented Craig Barrett, PhD, Chairman of the Board,
Intel)

**Stephen Finan,** Senior Economist, U.S. Treasury (Mr. Finn represented
Nada Eissa, Deputy Assistant Secretary, U.S. Treasury)

**Robert Cresanti,** Under Secretary of Commerce for Technology, U.S.
Department of Commerce

**Rosi Sweeney,** American Academy of Family Physicians (AAFP) (Ms.
Sweeney represented Dr. Douglas Henley, Executive Vice President, AAFP)

**E. Mitchell (Mitch) Roob,** Secretary of the Indiana Family and Social
Services Administration

# Introductory Comments

Secretary Leavitt was absent for the start of the meeting; in his
absence, Dr. Brailer served as Chair and welcomed Community members to
the meeting. After reviewing the agenda, Dr. Brailer recognized Dr.
Robert Kolodner, who was named as the Interim National Coordinator for
Health Information Technology.

# Approval of September 12, 2006, Meeting Minutes

Minutes from the September 12, 2006, AHIC meeting were distributed and
reviewed by Community members. A motion to accept the minutes with no
changes was made, seconded, and approved unanimously.

**Overview of Personalized Health Care**

Dr. Brailer introduced this panel by reminding Community members that
there has been tremendous growth in personalized medicine and genomics
towards bringing information that is necessary for patient care in the
future. How does this affect the investment that is being made in HIT?
At the same time, how does the investment made in the nation and HIT
help advance both the development and application of personalized
medicine? Dr. Brailer asked Community members to consider whether AHIC
should charter a workgroup in this area, and if so, what direction that
workgroup would take. He also asked members to suggest ways in which
AHIC as a whole can address the concept of personalized medicine within
the context of the Community's mission. Following these comments, Dr.
Brailer introduced the panel's Chair, Dr. Gregory Downing, Program
Director, Personalized Health Care, HHS.

Dr. Downing reminded Community members that this panel was convened in
response to initial discussions on the subject of personalized health
care that took place at the previous AHIC meeting. There is abundant
evidence on the horizon that the rapid advances in the scientific
understanding of disease and health at the genetic and molecular levels
will provide new opportunities to improve the quality of health care at
the individual/patient level. Some of the advances that are enabling
this future include the completion of the human genome project; the
advent of molecularly targeted therapies and drugs aimed at specific
genes and proteins; and advances in technologies for imaging, drug
development, and diagnostics. This progress has fostered new approaches
for predicting disease risk, enabled early interventions or preemption
of disease processes, and modernized approaches to disease prevention
and the development of highly effective therapies. Dr. Downing added
that the future of personalized health care holds promise for addressing
disparities in health outcomes and providing for a safer health care
system by anticipating adverse health events on the basis of a
biological response. This future will not be achievable, however,
without the enabling factors that HIT provides.

Dr. Downing noted that one of the keys to understanding the impact and
future direction of personalized medicine is through the EHR, explaining
that organized, consistent, and structured approaches to information
management can present data in an interpretive fashion that answers
questions rather than leaving more to chance. The successes that AHIC
has achieved in other areas of HIT can have a direct patient impact
through similar strategies applied to genomic test data, for example.
Another important key to success is achieving and maintaining public
trust. The foundation for that trust rests on the ability to use
information about an individual's health care experiences in ways that
benefit the health care system at many levels, yet does so in a way that
does not harm that individual. Privacy, security, and confidentiality
are key components of responsible stewardship of medical information
that must be considered carefully.

## Using Genetic Information at Ground Level: The Perspective of Primary Care

Dr. Alfred Berg, Professor and Chair of the Department of Medicine at
the University of Washington School of Medicine, discussed the
perspectives of primary care practice and the use of genetic tests and
applications of electronic health information for clinical decision
support. He noted that primary care includes family medicine, general
internal medicine, general pediatrics, and obstetrics and gynecology.

These areas of medicine account for more than one-half of all office
visits to physicians in the United States (approximately 471,000,000
visits in 2004). Dr. Berg emphasized that whatever policies are set
forth regarding HIT and genetic testing they must work in the primary
care arena, because that is where most patients begin when using medical
care services.

Primary care physicians see common problems and specialize in having a
breadth of knowledge and expertise. They recognize the patterns that
suggest the unusual, and need information systems and decision support.
From the primary care doctor's perspective, a new test or intervention
must: (1) be available, feasible, and acceptable to the patient; (2) do
what it says it does; (3) be accurate and reproducible; (4) improve
clinical outcomes that patients would notice and care about compared
with current practice; (5) not increase adverse effects; and (6) be cost
effective. In terms of genetic testing, Dr. Berg explained that primary
care physicians are skeptical of the concept of "genetic exceptionalism"
(i.e., the idea that genetic information is a different kind of
information than that from other kinds of tests and assessments). Many
non-genetic tests in current use produce the same kinds of information
promised by genetic tests, such as risk, prognosis, and response to
drugs and other therapies. In addition, many current EHRs already can
accommodate test results (genetic or otherwise), and intelligently link
them to other parts of the record. Dr. Berg commented that although
there is no denying the potential importance of genetic information,
many in primary care have a "wait-and-see" attitude.

There are thousands of genetic tests already available---many of which
are for single-gene, rare disorders that primary care physicians do not
deal with. However, an increasing number of these tests are aimed at
chronic, common diseases and are intended to advise on treatment for
common problems. There is essentially no regulation of these tests,
which are marketed using both direct-to-physician and direct-to-consumer
advertising. Clinicians and consumers need good, evidence-based advice
on the use of genetic tests. Dr. Berg described the U.S. Preventive
Services Task Force, which for more than 15 years has been making
evidence-based recommendations about preventive interventions. The Task
Force uses a rigorous process that is transparent and publicly
accountable, and is not tainted by conflicts of interest.

The CDC, in partnership with the Agency for Healthcare Research and
Quality's (AHRQ) Evidence-Based Practice Centers, has convened a new
panel, the Evaluation of Genomic Applications in Practice and Prevention
(EGAPP), to develop methods that will provide similar, evidence-based
advice to clinicians about genetic testing. EGAPP has just begun its
third year. The panel is non-regulatory, independent, non-federal, and
multidisciplinary. EGAPP currently has the following six reviews
underway: (1) testing for early detection of ovarian cancer, (2) testing
before placing a patient on an antidepressant drug, (3) testing for
familial colon cancer, (4) testing for response to treatment for colon
cancer, (5) genetic profiling for cardiac risk, and (6) breast cancer
gene expression profiling. EGAPP has not yet released a recommendation,
and has found thus far that the quantity and quality of evidence
supporting testing in typical practice settings is disappointing. Study
designs generally are weak, some potentially important data are
proprietary, and there are few data on potential benefits and harms. In
addition, there are no head-to-head comparisons with current practice,
these tests are not evaluated in typical patient populations, and there
is little information about cost and cost-effectiveness compared with
current practice. Finally, there is no information regarding ethical,
legal, and social implications, especially for family members.

Before ending his presentation, Dr. Berg discussed the following
conclusions:

-   Genetic testing to assess risk or guide therapy holds great promise.

-   There is a need to recognize the importance of appropriateness in
    primary care settings.

-   New tests and technologies must improve on what is currently
    available.

-   There will likely be few examples of genetic tests that meet
    standards for common use in typical practices in the next 3-5 years.

-   Many current EHRs can already link test information to other parts
    of the record.

-   There is a tremendous need for more and better quality research on
    effects of testing on clinical outcomes (good and bad), with the
    results made publicly available.

Support for Structured Genetic Results in the EMR and Clinical Research
Infrastructure\
at Partners HealthCare

During this presentation, Secretary Leavitt joined the meeting and
resumed his role as Chair.

Dr. John Glaser, Vice President and Chief Information Officer at
Partners HealthCare as well as a Senior Advisor at the Deloitte Center
for Health Solutions, discussed the use of EHRs as a means to accelerate
the transition and integration of genomic discovery science into health
care. He described Partners Healthcare as a large, integrated delivery
system that has a fairly substantive biomedical research enterprise. Dr.
Glaser commented that it is clear that understanding a patient's genome
and the way that it interacts with a wide variety of variables is a
critical contributor to both advances in biomedical research as well as
to efforts to ensure that physicians continue to make sound and safe
diagnostic and therapeutic decisions.

Dr. Glaser presented a list of research questions for which the genome
appears to play a significant role. Examples of research questions
include: (1) Why do some patients with asthma respond to steroid
treatment while others do not? (2) Why do some patients with diabetes
have few complications even with "poor" control whereas others with
"good" control have severe complications? Examples of clinical questions
include: (1) Can a patient lower their cholesterol through diet alone,
or should they start on an anticholesterol drug immediately? (2) Should
a 40-year old with mild heart failure be put on the transplant list
right away because he has a genetic cardiomyopathy that will worsen
rapidly?

Dr. Glaser explained that supporting Partners Healthcare's research and
clinical activities is a diverse IT foundation. At the core of this
foundation is a collaborative effort between Partners IS Department and
the Harvard Medical School Partners Healthcare Center for Genetics and
Genomics (HPCGG). This collaboration undertakes work to help
investigators understand the genomic basis of disease to the degree that
it exists, and understand how a certain set of genetic variants
interacts or works to create a disease or manifestation of a disease.
The collaboration also includes a series of laboratory activities
designed to carry out the genetic tests (both those being ordered by the
investigator, and those being ordered by the clinician) to produce an
actionable result. Those results then are incorporated into electronic
medical records (EMRs) that guide primary care physicians and
specialists in ongoing treatments to manage patients' illnesses. The
Partners/HPCGG collaboration also includes creation of databases that
bring together phenotypic data, genotypic data, and tools to allow
investigators to understand why this approach does or does not work, as
well as to pursue a series of biomedical research questions and
questions based on the outcomes and quality of care delivered.

Dr. Glaser described the HPCGG IT infrastructure as well as the patient
genetic profile module in the EMR. Within the EMR, identified variants
are represented in the CDR in structured form. Reference information
related to the test performed also is retained. Dr. Glaser and his
colleagues currently are working on establishing clinical decision
support rules targeting this information.

Dr. Glaser noted that the NIH has authorized seven national Centers for
Biomedical Computing. One of them, the National Center for Biomedical
Computing's Informatics for Integrating Biology at the Bedside (i2b2) is
devoted to understanding the IT infrastructure necessary to support
investigators examining the genomic basis of disease and the informatics
for integrating biology in the bedside. i2b2 is creating an
infrastructure for a merged genomic and phenotypic data repository and
analyses tools.

Dr. Glaser described a number of challenges associated with IT support
of personalized medicine. In terms of infrastructure and applications,
there are a number of issues, such as: (1) To what degree can patient
care data be leveraged to support research on the genomic basis of
disease? (2) How does one structure, store, and "operate" genomic and
proteomic data and transactions? (3) What are the methods needed for
processing these data? (4) How different will clinical systems be in 10
years? Similarly, with regard to implementation and care improvement,
there are a number of questions, such as: (1) What is the impact on the
safety, quality, and efficiency of care? (2) Will the discovery process
be accelerated significantly? (3) What steps are needed to manage
privacy? (4) What are the new issues in approaches to practice?

Dr. Glaser closed his presentation by noting that Partners Healthcare
has formed a collaboration with the University of Utah to develop some
of these technologies. Partners also is collaborating with HL7 to begin
work on the transaction standards for the exchange of genetic test
results. Other collaborative endeavors with industry and payers also are
underway.

Department of Veterans Affairs Genomic Medicine Database: First Steps in
Implementation of a Major New Initiative

Dr. Joel Kupersmith, Chief Research and Development Officer at the
Department of Veterans Affairs (VA), discussed planning for the adoption
of genomic test data into VA's EHR system. He explained that the VA
system is large, with a \$34.7 billion budget and 5.3 million patients
seen last year. The system has 7.6 million enrollees, and at least 1,400
sites of care. Dr. Kupersmith noted that academic affiliations are the
underpinning of care at the VA, and clinician scientists are the
backbone of VA clinical care, research, and culture. The VA's patient
population is older, sicker, poorer, and loyal compared with other
patient populations. The system also has less turnover than private
health plans and demonstrates good adherence to clinical trials.

Dr. Kupersmith discussed the need for a genomic population cohort
project. It has generally been considered that the implementation of a
large genetic population cohort will considerably advance the field of
genomic medicine. This advance likely would be accompanied by a move
towards use in everyday practice. The VA has the capacity to create such
a cohort for the benefit of veterans and the nation, and it intends to
collect genetic information from all consenting veterans and link it to
their EHRs. This activity has been proposed by a number of individuals,
and was printed in an article appearing in the journal *Nature*
(*Nature*, 429:475-477; May 2004). The VA has a number of attributes
making it attractive for creating this cohort, including: (1) a health
care system with a large population treated in a variety of settings,
(2) a research network integrated into the health care system, (3) an
unrivaled EHR, (4) vehicles for and considerable success in translation
of research findings directly to clinical care, and (5) the provision of
state-of-the-art care.

The first step in implementing this program is establishing governance.
The VA is guided in these efforts by a federal advisory committee, the
Genomic Medicine Program Advisory Committee. Internally, the VA has
created the Genomic Medicine Management Committee. Other various
committees are contributing as well. There is a pilot project underway
via the VA's Cooperative Studies Program (VA's major clinical trials
program). More than 30,000 specimens have been collected, and there is
capacity to bank approximately 100,000 specimens. The pilot project is
ready to be expanded beyond the Cooperative Studies Program.

The VA is looking to enlarge its capacity in genomics, and has
pharmacogenomics laboratories through a pharmacogenomics Request for
Applications (RFA). The VA also has issued methodology RFAs and is
examining other research funding measures. A central institutional
review board is being developed and should be in operation within 1
year; this board will provide assistance with multicenter trials. The VA
is developing the computational capability to incorporate genomic data
into EHRs while assuring security. The Department also is providing for
the educational needs of its professionals and of veterans through
continuing medical education-type ventures, and is beginning to look at
the possibility of using the EHR to provide information in the form of
guidelines (e.g., decision tree nodes with advice, literature
references, etc.). Additionally, there are open discussions ongoing with
potential collaborators and the broader communities moving in the same
direction.

Dr. Kupersmith noted that a significant challenge tied to these
implementation steps are ethical and privacy standards. Maintaining high
ethical standards and beneficence is critical, as is holding open
discussions with stakeholders. Communication with veterans themselves
also is key to these efforts. Dr. Kupersmith concluded his remarks by
stating that the VA's practical needs for these kinds of answers may
serve as a precedent-setting construct for others.

Integration of Genomic Technologies in Clinical Practice: Development of
Standard Controls\
and Best Practice Guidelines

Dr. Janet Warrington, Vice President of Emerging Markets and Molecular
Diagnostics at Affymetrix, Inc., addressed the need for standards and
emerging medical opportunities for applying technology in genomic-based
diagnostics. She noted that there are examples of personalized health
care in practice today. In many instances, treatment decisionmaking
(e.g., dosing and timing) is based on information collected using either
clinical chemistry or molecular information. In addition, a number of
treatments currently in use are based on genomic technology.

Dr. Warrington noted that Affymetrix and its diagnostic partners treat
genetic information the same way they treat other information---with
clinical utility. She described the process for developing genetic-based
diagnostic tests, using the example of the Roche Amplichip™, the first
U.S. Food and Drug Administration (FDA) cleared microarray-based
diagnostic test. The test provides clinically useful information from a
genomic assay, with an automated analysis that includes a quality check
with standard controls. The test features automated interpretation by
signature comparison to a controlled reference database, with XML output
that provides categorical with probability information to the end user.

At present, Affymetrix alone has more than 20 microarray-based
diagnostic products in the pipeline; evidence of the need to act now in
fostering the integration of these technologies in clinical practice.
These products bring with them an increased awareness of the value of
harmonization of terminology, controls, protocols, best practice
guidelines, and electronic information management systems. Unless the
same terminology and metrics for performance are used, it will be very
difficult for the end user to interpret and understand the information
gained from these various tests. There is an increasing amount of
clinically relevant genomic information, an increasing cost of
development, and an increasing recognition of the need to work together
to develop standard controls and best practice guidelines.

An example of an initiative to form collaborations to develop these
standard controls and best practice guidelines is the External RNA
Controls Consortium, which includes 175 stakeholders from 92
organizations in 14 countries. There is no regulatory recommendation or
requirement for this initiative; however, four Divisions of the FDA are
participating in the Consortium, as are the CDC and National Institute
of Standards and Technology. In addition, regulatory bodies from Europe,
China, and Japan are participating. The External RNA Controls Consortium
is focused on developing well‑characterized, standard control materials
for RNA‑based expression assays. The Consortium's goals are to: (1)
develop well-characterized standard controls for multiple genomic
technology platforms (e.g., reverse-transcriptase polymerase chain
reaction); and (2) develop protocols for multiple applications,
research, and clinical laboratory use. The Consortium's first
deliverable was a guideline document on the use of external RNA controls
published in August 2006 by the Clinical and Laboratory Standards
Institute.

A similar activity underway is the Clinical and Laboratory Genomic and
Genetic Standards Initiative---a volunteer organization with 70
participants from 50 organizations in 19 countries who represent
industry, government, and academia. This Initiative has the following
goals: (1) make recommendations for qualification of performance
controls for microarray-based DNA genetic tests, and (2) develop a forum
for driving consensus on characteristics and output of algorithms for
microarray DNA-based genomic tests.

Dr. Warrington reminded AHIC members that widespread adoption of
integrated EMRs requires consensus on standard controls and best
practices. She emphasized that now is the right time to establish a
standardized EMR infrastructure as well as the required standard
controls and guidelines for these genomic‑based assays. She noted that
harmonization benefits patients, physicians, test and drug developers,
regulatory bodies, and trade and commerce. Creating standards early in
the process accelerates development; development dollars in turn are
more efficiently spent when standards are in place.

## Policy Priorities for Personalized Medicine

Dr. Kathy Hudson, Director of the Genetics and Public Policy Center at
Johns Hopkins University, discussed aspects of public concern and
interest associated with personalized health care, including privacy and
security issues. She explained that the Genetics and Public Policy
Center at Johns Hopkins conducts research, legal, and policy analysis to
facilitate sound, evidence‑based policy in the area of genetics. The
following are prerequisites for personalized medicine: public
confidence, a robust research pipeline, quality assurance for genetic
tests and paired treatments, providers equipped with tools, quality
linked to payment, outcomes tracked over time, and strong privacy
protections.

In terms of public confidence, Dr. Hudson stated that large majorities
of the American public approve of genetic testing and technologies for
health-related applications, despite the fact that there is a relatively
low level of genetic literacy among the public. Few data exist on how
much the public needs to know about the science to make informed health
decisions and on the correlation between literacy and support. Dr.
Hudson commented that Americans expect that the government ensures the
safety and accuracy of genetic tests. The large majority of Americans
feel that insurers and employers should not have access to genetic
information, principally out of fear that their information will be
misused. There are issues related to trust, both from the public's
perspective as well as from the scientists' viewpoint.

Dr. Hudson discussed the issue of genetic testing quality. The
regulatory status of these tests varies greatly. The FDA has reviewed
and approved only a handful of genetic testing kits, and recently
asserted its authority over a subset of laboratory-developed kits, which
caused some consternation, because the CMS is responsible for laboratory
quality, and that would assure the analytic validity of
laboratory‑developed tasks. Dr. Hudson commented that current CMS
oversight of genetic testing in laboratories is inadequate.

The Genetics and Public Policy Center recently conducted a survey of
genetic testing laboratories in the United States and found that
overwhelmingly, most genetic testing laboratories are Clinical
Laboratory Improvement Amendments (CLIA) certified, but 16 percent
overall, and one-third of the highest volume genetic testing
laboratories, do not have a specialty certification. Dr. Hudson
explained that there is no genetic testing specialty presently, and
therefore, no ability to tailor rules for quality assurance over and
above the minimum standard required under CLIA. Interestingly, she and
her colleagues found that a large majority of the genetic testing
laboratory directors support the creation of a genetic testing specialty
at CMS. This is also supported by a number of other organizations, such
as the Personalized Medicine Coalition, the American Society of Human
Genetics, three advisory groups to HHS, and more than 100 companies,
including Affymetrix, patient groups and provider organizations. Despite
reiterating its commitment to create a genetic testing specialty for
almost a decade, CMS made a decision in July 2006 not to pursue creating
a genetic testing specialty.

There are more than 1,000 genetic tests clinically available today, with
many more under development. Despite their utility in aiding clinical
decisionmaking, relatively few guidelines for genetic testing have been
developed by health care provider organizations. There is a need to
increase the evidence base for many tests, and a sustainable system of
supporting health professional organizations is needed to develop
evidence-based guidelines (e.g., for tests reviewed by EGAPP).

In terms of privacy, Dr. Hudson suggested that the approach taken under
the Health Insurance Portability and Accountability Act be adopted
(i.e., provide the same level of protections for all information,
irrespective of whether it is genetic information or non-genetic
information). There are some new challenges to privacy, particularly
where clinical information and research information intersects,
especially in light of the proliferation of biobanks storing vast
numbers of genetic samples that are linked to clinical information.
Under the current guidelines for the ethical conduct of research,
de-identified samples and records can be used in research without
expressed consent. Strong statutory protections are needed for genetic
information.

Dr. Hudson closed her presentation by suggesting the following next
steps:

-   Earn public confidence by demanding transparency and encouraging
    engagement.

-   Create a CLIA genetic testing specialty.

-   Rationalize FDA's role in genetic testing.

-   Create a funding mechanism for organizations to develop
    evidence-based practice guidelines.

-   Enact statutory protections against discrimination.

-   Carefully re-review policies governing use of de-identified samples.

## Discussion Highlights

"This is very much part of the future. As we begin developing an
infrastructure for standards on electronic health records, we need to be
contemplating this in the context of where we're going to be ending
up...it would be a shame if we did not anticipate this in our work." --
Secretary Leavitt

"What is your view of the current state of standard setting with respect
to electronic health records as it relates to the collection and storing
of this kind of data? That's the first question. The second is: what
must we do to integrate it into our larger effort?" -- Secretary Leavitt

"The conclusion, that I've drawn and other people in the community I've
worked with have drawn, is that this is the perfect place for the
government to lead. It would be very difficult for any one individual in
industry to really pull together the people who need to be pulled
together to make this happen."\
-- Dr. Hudson

"There's a wide range of places you can apply standards...it's not just
the data; it's the transaction that comes in from another genetic
testing lab to our place and it will affect our care. So it's the
transactions for moving these results back and forth...I think the
timing is terrific to go out and do this." -- Dr. Glaser

"We are just starting in these efforts in setting up our own internal
mechanisms to look at standards as well as the ethical privacy issues
and doing this in a beneficent way...I think that we can certainly enter
into some very interesting and significant discussions on this, since we
are ahead in some ways, and we are catching up in others." -- Dr.
Kupersmith

"From the primary care perspective, many of the medical records that we
already have have the capability of recording information that
intelligently allows us to link test results to a clinical decision. The
problem we have is that we don't have test results yet that can reliably
be linked to clinical decisions that improve outcomes without increasing
adverse effects." -- Dr. Berg

"Is there a survey that has been completed or that is underway of the
various standard‑setting activities in the government or in the private
sector regarding genomics information? Has this been undertaken? Do we
have something we can look to that can help guide thinking about how
this gets set up for future evaluation?" -- Dr. Brailer

"We hosted a meeting so that we could inform ourselves and meet the
people who are the experts who are driving this...we found that there
were lots of activities going on, but no collective information, no
report, survey... one of the outcomes of that meeting...was the request
and the desire for even a single Web site that people could go to to
find out what's going on in the standards community, what initiatives
are underway and how people could participate in those
initiatives...just as a place where people can go to get this
information or people can deposit their information about their
standard‑setting initiatives."\
-- Dr. Warrington

"At this point there are no high‑quality randomized trials showing that
the average patient entering that clinical decision‑making cascade can
be relatively certain of a better outcome." --Dr. Berg

"We are actually going to be starting a trial on SSRI dosing, and
largely to see whether we can use the chip set to get to a more stable,
initial dose faster, and avoid some of the bouncing around that can
occur in the clinical setting." -- Dr. Glaser

"We seem to disconnect between the clinical medical record and...in
getting that data into the mental health care record...this panel or
some other panel might want to look at how you get that kind of
information into the mental health care record where it seems to be a
generation or two behind where we are in this committee." -- Mr. Roob

"Could any of you comment with respect to any policies that you're aware
of in any of your organizations or for those of you particularly that
are maintaining databases with respect to the retention or destruction
of information of the personalized information?" -- Dr. Winkenwerder

"Our policy is we do not destroy, ever. And largely for research
purposes to the degree that an investigator wants to go back perhaps
over very long periods of time and do this. That is probably not
standard practice if you leave outside the academic health center realm.
But in this case we keep it in perpetuity." -- Dr. Glaser

"We don't destroy things either. But the technology moves so very
quickly that there is a real problem---many of the tests that have
entered the research literature are no longer being provided by the
manufacturers. So, that by the time we get it into the record, it
quickly becomes outdated." -- Dr. Berg

"What I'm hearing...is the emergence of four different areas that need
to be addressed...We need to have more research and evidence about the
practical value of the genomic tests in clinical practice...We have got
to have quality checks regarding the test methods because we need to
make sure when a test result is reported, that it is reproducible and,
in fact, means the same thing each time. Then further down the
technology scale is having to have standards for storing and
representing that data...And then finally, overarching all of this
\[are\] the policy and privacy issues that need to be dealt with." --
Dr. Kolodner

"We have a Privacy and Security Workgroup that is looking at
crosscutting privacy and security issues...Should we charge the existing
group to look at genomic questions, or would a Genomics Personalized
Medicine Workgroup want to take these up on their own right?" -- Dr.
Brailer

"I think the privacy considerations need to be considered throughout all
of the Workgroups. I would argue that we don't want to segregate, or
treat differently, genomic information. What we're really leaning
towards here is trying to integrate this information into medical care.
And so, I think we need to keep it as a part of the routine medical
record." -- Dr. Hudson

"The point of concern in primary care is the family members. Especially
in family medicine where we often see all family members. What do you do
with a genetic test performed on a family member that may have
implications for another family member, where there's some disagreement
about whether to share the information? It's a significantly different
problem than sharing other kinds of medical information. That's one of
the unique things, I think, about genetic testing." -- Dr. Berg

"The medical professional groups have looked at the issue of what is the
responsibility of the individual healthcare provider when he or she
knows something that may affect family members. And they have created
guidelines for that." -- Dr. Hudson

"I appreciated what Dr. Berg said about not having genetic tests
exceptionalism. And it's a little confusing to me why this wouldn't
already automatically be part of HITSP. Is there something about these
genetic data different than the current charge in authorities that HISTP
has on its plate?"\
-- Dr. Gerberding

"I think the question is one of: is there a set of standards
organizations that are working on genetic information that can be
standardized? It's both the maturity of the standards themselves and
also whether or not those organizations are subject to the jurisdiction
of HITSP. I don't think we can answer that question here. But an
appropriate next step might be to look at that and determine what those
roles should be." -- Dr. Brailer

"I think consumers do indeed have a sense of concern that for
themselves, if they've been personally diagnosed with an illness, having
the genetic information is very important for them as it relates to
future treatment and protocol options. But at the same time there is a
concern about their heirs and the other family members and likewise a
genuine concern of how is the genetic information going to be used in
terms of secondary research and processes." -- Ms. Davenport-Ennis

"Our work at AHIC would not be complete, in fact, it would be hampered
in the future by not beginning to contemplate these issues as a
significant part of our work. I would be inclined to see AHIC form a
Workgroup that could begin to deal with issues and incorporate the work
of other groups that are already engaged." -- Secretary Leavitt

"It seems to me that there are five points a Workgroup could
pursue...First, is to survey existing efforts that are developing
standards, or that are influencing the standards for genomics and
genetics information...Secondly, to propose a role for HITSP and the
other related health IT mechanisms that have been established...Thirdly,
to determine and develop a plan for how genomics information standards
could be deployed over the next 2 years...Fourth, to evaluate the
privacy and security considerations, and to work in collaboration with
the Privacy and Security Workgroup in carrying those forward...And
finally, two proposed use cases to actually come forward after this
process that can help us begin the process that has worked relatively
well for the Workgroups, to focus on a few specific things that can help
move this agenda forward." -- Dr. Brailer

"I\'m very concerned about us investing incredible resources, efforts,
and energies into developing protocols and standards without looking at
what the end game is here. What will ultimately be the use of the
information? Who do we expect to use it? I would argue that primary care
physicians would be the first line of folks that we need to have the
ability to use this information. And ensure that whatever we're
developing and designing is going to have ultimate utility to that
group...I think we need to structure standards and structure protocols
in such a fashion that they will have immediate utility to the primary
care physicians rather than structure all of this and then go to the
primary care physicians and say 'okay, we have this, now how are you
going to use it?'" -- Mr. Serota

"I'd like to suggest in the interest of time, that we ask the ONC staff
to bring back to our next meeting a fleshed‑in proposal as to what this
should look like...it appears to me that...there would be no objection
to the development of such a Workgroup. Hearing no objection, I'm going
to declare a consensus on that point, and we'll direct staff as
indicated and in our next meeting, we'll be in a position to finalize
its development, but we'll clearly move forward in that direction." --
Secretary Leavitt

# Overview of Population Health and HIT

**Interagency Health IT Policy Council Population Health Workgroup --
Priority Areas**

Dr. Terry Cullen, Chief Information Officer for the Indian Health
Service, noted that population health is contained in many of the
activities already being discussed by AHIC in the use cases and priority
areas. She explained that HIT-enabled population health activities will
permit more complete, efficient, and timely: (1) improvements in
population health status through clinical performance measurement using
longitudinal health data linked with external data sources; (2)
measurement and reduction of health care disparities; (3) identification
and management of emerging health conditions; (4) assessment,
intervention, and evaluation of the impact of appropriate interventions
for populations at increased risk for certain disorders; (5) clinical
performance improvement; (6) population health research; and (7)
dissemination of population health information. Dr. Cullen reminded AHIC
members that at the last Community meeting, Dr. Michael Painter
discussed sustainable, high-value care for all and acknowledged the need
for many health data sets from a population perspective that currently
are not available within the majority of the EHR solutions within the
United States. One major reason for this is the fact that the focus of
EHRs has been, appropriately, primarily on the provider and the patient
at the current time.

Current HIT use for population health management typically is limited to
information obtained from registries. As such, data populates an EHR, in
most cases it is passively pulled into a registry, and at that point
queries are done on the registry. However, the limitation imposed by
solely using data fields that currently exist in registries means that
the robust functionality being embedded in to the current EHR solutions
are eliminated. Improving the health status of American populations
requires a robust HIT solution that supports population health
management---Dr. Cullen explained that it is critical to engage and
ensure that the design of current EHRs facilitates the ability to do
population health activities and embed population health knowledge
within the context of the individual patient.

Dr. Cullen described the following benefits of using HIT:

-   Facilitate identification of at-risk patients/populations.

-   Facilitate monitoring of population health status and population
    health prevention and improvement.

-   Enable information exchange between appropriate partners.

-   Identify HIT requirements needed for population health management.

-   Increase effectiveness and efficiencies of population health
    management in federal and private sectors.

Dr. Cullen concluded her remarks by identifying near-term opportunities
in a number of areas, including: patient/population identification,
identifying crucial data elements, privacy and security, storing and/or
retrieving longitudinal patient data, de-identifying and reusing data,
data mapping, integrating other data, and multi-directional reporting.

**Overview of Clinical Research and HIT**

Dr. Anthony Hayward, Director of the Division for Clinical Research
Resources at the National Center for Research Resources, NIH, discussed
the relationship between clinical research and health HIT, and why it is
important to continue integrating the two. Dr. Hayward emphasized that
clinical research improves health care, and defined clinical research as
the study of a drug, biologic, or device in human subjects with the
intent to discover potential beneficial effects and/or determine its
safety and efficacy. Clinical research has yielded enormous benefits,
and is the basis for all improvements in treatments, both preventive and
symptomatic. Examples include antihypertensives reducing stroke risk,
and the drugs Taxol and Gleevec improving patient outcomes among those
with breast cancer and chronic myeloid leukemia, respectively.

The expenditures associated with clinical research are very high. In
2004/5, biomedical research expenditures in the United States were
approximately \$96.2 billion. Roughly one-half of that is spent on human
subjects research (i.e., clinical research). These costs are minute
compared with the cost of delivering health care. Dr. Hayward noted that
NIH Director Dr. Elias Zerhouni has estimated that the cost savings from
reductions in mortality from coronary artery disease exceed \$2.6
trillion.

HIT already has brought enormous resources and benefits to bear on
clinical research, foremost among them being the creation of standards
that allow for structured data flow across both the research and care
process. HIT also provides for communication among providers, patients,
and researchers that partially support outcome and adverse event
reporting (although much of this is still paper based). Existing
databases serve as data warehouses for clinical findings and laboratory
results, and for patient, family, and medication histories. However, the
data need to be standardized to be comparable across clinical sites and
across the research community.

Opportunities for health information technology in clinical research
include:

-   Facilitating patient access to clinical trials.

-   Supporting better baseline data for comparisons.

-   Increasing the speed of adverse event identification and reporting.

-   Tracking human subject consents.

-   Establishing common vocabularies and anonymization of human subject
    information.

Dr. Hayward concluded by noting that although clinical research has made
tremendous contributions and advances to health care, investments will
be much more productive if HIT is used to integrate the research process
with the delivery of clinical care.

## Discussion Highlights

"I would like a little better understanding of what is meant by
"population health." Are we talking about populations based on race,
sex, age? Clinical or chronic disease? Income? National origin? All of
those things? And if so, in order for an EHR to be useful, you have to
capture that information, obviously, in the EHR. Some are obviously
available." -- Mr. Green

"The answer would hopefully, in the long‑term be yes. What we know is
that the indicators of health are affected by many things that
traditionally have gone beyond what we currently collect. As I call it,
the 'beyond hemoglobin A1C phenomena.'" -- Dr. Cullen

"The category of population health seems to me to fit a lot in what
we're doing around biosurveillance, in the sense that biosurveillance
could be even a subset of population health, because you're looking at
the same entities that are needing to exchange information....I can see
where those two things are aligned with one another from the
organizations that are involved and the need for the exchange of
information... What I like most about the clinical research and clinical
trial category being included, either as a focused part of EHR Workgroup
or as a focus of our Chronic Care Workgroup is that it brings a whole
new audience to the table that could be a driver for adoption of EHRs."
-- Mr. Hutchinson

"More or less as we would consider structuralizing these directions,
I've heard you say that perhaps biosurveillance could be expanded to
include a broader population on health perspective, one element of which
is biosurveillance. But secondly that clinical trials be incorporated
into each of the Workgroup's domains rather than creating a subgroup
unto itself for that. Is that fair?" -- Dr. Brailer

"It is. I see it across a couple of groups, Chronic Care as well as EHR
are two that come to mind."\
-- Mr. Hutchinson

"I do think that clinical research has a unique focus to it. It's the
need for two‑way data flow. And above all, the need to see clinical
research as permeating most clinical care so that the efficiency of the
research process can be improved. I wouldn't have thought that diluting
it out amongst all Workgroups would necessarily be the ideal way to
proceed. I think that certainly the impact is going to be felt across
all Workgroups. But one might do better to have at least a community
that was focusing primarily on clinical research." -- Dr. Hayward

"I think we have some real overlap coming here...I think the
Biosurveillance Workgroup needs a new name. Because if you look at the
near-term projects, even besides the ultimate vision, some of the things
Terry mentioned are already on our agenda and it really is sort of a
public health-clinical care interface Workgroup in terms of the kinds of
projects we're talking about...in terms of a good bit of what Terry
covered, that's really covered, to some extent, by our near-term and
long‑term agenda in the current Workgroup. But we'd have to sort of
array everything to see where other issues would fall." -- Mr. Kahn

"I think there may indeed by an opportunity to look at data fields such
as family histories and life style choices, that we do see have a
particular bearing and a very high incidence of certain types of
diseases in certain special populations...As we look at Alaskan Natives,
many who are being treated for chronic, debilitating and
life-threatening conditions are required to leave communities, travel
great distances, and live in secondary locations for extended periods of
time. And have a very diverse group of caregivers and medical providers
during that process. If there is any population that can really be
advantaged by a strong EHR and PHR system that is one of those
populations." -- Ms. Davenport-Ennis

"One of the hopes of the extrapolation of HIT throughout the health care
system is to have research in more different practice‑based settings to
get better outcomes, so I think it's a very important point, and I'm not
sure it should be in all the Workgroups but maybe it merits one on its
own, so I look forward to the staff work. I think it's very important
that the group looks at it." -- Ms. Sweeney

**Comments From the Secretary, HHS**

Secretary Leavitt was not present for the opening portion of the
meeting, and took a few moments to provide his introductory comments
following the discussion related to population health and HIT. He first
acknowledged Dr. Kolodner, who has moved from serving as a Community
member to Interim National Coordinator for Health Information
Technology. Secretary Leavitt noted that AHIC is pushing the horizon of
what it has accomplished beyond where it was originally set, as
evidenced by the fact that new Workgroups are being formed and the work
is being expanded. The Executive Order that established AHIC set forth a
2-year cycle that is renewable---Secretary Leavitt indicated that he is
confident that this renewal will occur by the end of the first 2-year
cycle. He also reminded Community members that part of AHIC's charge
includes the development of an ongoing business model that allows for
AHIC's continued function outside of the government. Secretary Leavitt
also noted that as of this meeting, there are 812 days left in the
current administration. He expressed his resolve to have three more
rounds of standards pass through the Community with the refinement of a
well-established process that can continue outside of the government and
not rely solely on the government to oversee it.

The Secretary acknowledged the hard work being done by others outside of
AHIC, particularly by those associated with HITSP, which is developing a
national health standards harmonization process that involves more than
260 health care organizations. HITSP volunteers have sifted through 700
possible standards, and after examining, testing, and documenting them,
have identified 30 standards that will move this field closer to
full-scale interoperability. More than 12,000 volunteer hours have been
given to this effort so far. Secretary Leavitt also recognized the time
and contributions of AHIC members and the staff of the Office of the
National Coordinator for Health Information Technology, thanking them
for their expertise, dedication, and efforts.

**First Round of Standards Harmonization: HITSP Interoperability
Specifications**

In discussing the first round of standards harmonization results, Dr.
John Loonsk, Office of the National Coordinator for Health Information
Technology, first described the context of the work that HITSP has
carried out, including the interoperability specifications, the HITSP
process, what standards were chosen, and next steps. The context for
HITSP was set by the breakthroughs that came from AHIC. These
breakthroughs were converted into use cases, which were an attempt to
specifically set the context, describe the processes, and describe some
of the data needs necessary for data and technical standards in moving
forward with interoperability for HIT systems. HITSP itself has been
working towards the following three goals: (1) harmonization of
standards to use in the context as defined by AHIC use cases, (2)
identify gaps and needs, and to begin working with standards development
organizations and other members of industry to address those gaps, and
(3) develop the specificity necessary to use those standards
specifically to achieve interoperability.

In describing the standards harmonization process, Dr. Loonsk noted that
HITSP represents a partnership of public and private stakeholders
operating through a neutral and inclusive governance model. HITSP
utilizes a bylaw-based, consensus-based process. A consensus process is
used with success for the majority of HITSP Technical Committee
decisions---a voting process is used only when the consensus process
fails---when voting is used, a quorum consists of 50 percent of the
voting Technical Committee members, and 66 percent of those casting a
vote must agree for a vote to pass. One vote is allowed per
institutional member "representative on record" or regular participant.
Dr. Loonsk noted that there are 261 registered HITSP organizations, and
re-emphasized the importance and value of the estimated 12,000 volunteer
hours contributed by HITSP members to date.

Dr. John Halamka, HITSP Chair, reminded Community members that about 13
months ago, HITSP was assigned use cases. Over those 13 months, HITSP
has developed a process including a large group of disparate
organizations that includes payers, providers, standards development
organizations, employers, privacy advocates, and the general public. The
first set of standards were processed through HITSP in just under one
year, implying that two more rounds are possible during the current
administration. Dr. Halamka reviewed the following eight major
harmonization process steps developed and utilized by HITSP: (1)
receiving a harmonization request; (2) conducting a requirements
analysis; (3) identifying candidate standards; (4) resolving gaps,
duplications, and overlaps; (5) selecting standards; (6) constructing
interoperability specifications; (7) conducting an inspection test; and
(8) releasing and disseminating interoperability specifications.

The standards required to support each major use case event were
organized within an agreed-upon standards taxonomy. The standards
selected for inclusion in the pool were examined using "HITSP-approved"
tier 1 harmonization readiness criteria. Standards in the pool then were
considered for inclusion in the interoperability specifications by
application of the tier 2 harmonization readiness criteria. The tier 2
standards readiness criteria include five components: (1) suitability,
(2) compatibility,\
(3) preferred standards characteristics, (4) standards development
organization and process, and (5) total costs and ease of
implementation.

Following these comments, Dr. Halamka described the scope, standards,
and issues/remedies associated with the following three use cases:

**Consumer Empowerment -- Registration and Medication History**

-   Scope: As part of a personal health record, this interoperability
    specification addresses two key areas:\
    (1) the patient's registration data, and (2) their medication
    history.

-   Standards: Thirteen "named standards" were identified to support
    this interoperability specification, and five separate constructs
    were developed. Approximately 170 pages of implementation-level
    guidance were developed to support the specific use of these
    standards to achieve interoperability.

-   Issues and Remedies: There is a need for a patient summary record
    within the technical environment of care providers, pharmacies, and
    health plans. Steps to address this include: (1) supporting and
    leveraging the existing HL7-ASTM harmonization initiative, (2)
    introducing new electronic links without replacing the existing
    links, and (3) promoting architectural independence.

**Electronic Health Records - Laboratory Results Reporting**

-   Scope: This interoperability specification is relevant to clinical
    care providers who wish to have laboratory test results and
    laboratory interpretations electronically available for patients for
    whom they are providing care.

-   Standards: Ten "named standards" were identified to support this
    interoperability specification, and 12 separate constructs were
    developed. Approximately 250 pages of implementation-level guidance
    were developed to support the specific use of these standards to
    achieve interoperability.

-   Issues and Remedies: There is a lack of harmonization among data
    interoperability standards, including vocabulary, laboratory, and
    other messaging standards. Steps to address this include: (1)
    accommodating both laboratory message transaction and document
    sharing approaches, and (2) selecting standards with wide coverage
    to address gaps and provide mapping between standards to address
    overlaps.

**Biosurveillance**

-   Scope: This interoperability specification includes the transmission
    of essential data from ambulatory care and emergency department
    visits, utilization, and laboratory result data from electronically
    enabled health care delivery and public health systems in a
    standardized and anonymized format, to authorized public health
    agencies with less than one day lag time.

-   Standards: Twenty-four "named standards" were identified to support
    this interoperability specification, and 16 separate constructs were
    developed. Approximately 400 pages of implementation-level guidance
    were developed to support the specific use of these standards to
    achieve interoperability.

-   Issues and Remedies: There is a need to maximize data sources and
    provide stringent data management to ensure proper routing,
    security, privacy, and timely reporting. Steps to address this
    include: (1) supporting any variant of architectural environments,
    and (2) selecting full options of standards to maximize data and
    information exchange.

Dr. Halamka summarized that in the last year, 700 possible standards
were considered by 261 stakeholder organizations. Representatives from
these organizations spent about 12,000 volunteer hours on these three
use cases, and have reduced the 700 possible standards to 30. He
emphasized the large degree of consistency across the three use cases.

Dr. Halamka stated that HITSP has approved three Version 1 sets of
standards and implementation guidance (or interoperability
specifications). He noted that the Panel now calls on industry to begin
the implementation process for these interoperability specifications,
during which HITSP will work with implementers to test the specifics of
the implementation guidance. HITSP also has asked that AHIC recommend
these standards and implementation guidance to Secretary Leavitt. HITSP
will return to AHIC at least yearly with updates to the interoperability
specifications. Because HITSP just released the Version 1
interoperability specifications, HITSP will return to AHIC no later than
April 2007 with Version 2 updates for recommendation to the Secretary.
Dr. Halamka explained that in the coming months, HITSP will seek to
include a harmonized summary record standard into the interoperability
specifications. HITSP also will work with the Certification Commission
for Healthcare Information Technology (CCHIT) to establish
interoperability specifications in the CCHIT criteria via the joint
CCHIT/HITSP Working Group.

## Discussion Highlights

"I don't have words to tell you how profoundly important I think this is
in the process. I do have a question: as you see more use cases, will
there be an adoption curve here where they get easier because you've got
standards that you've agreed upon, that you can now build on? Will this
get any easier as you go?" -- Secretary Leavitt

"Absolutely. And so recognize that the greatest accomplishment of the
last year was developing a process. That process is now in place \[and\]
will continue to be refined. But because that engine is there it does
make this work much more repeatable. If you look at the way we divide up
these interoperability specifications into...these transaction packages,
I think we'll discover, for example, for clinical research, wouldn't it
be great if the laboratory transaction package that we use for doctors
and patients was also used by researchers? And so one would hope there's
going to be a very high degree of reusability across these new use cases
and that we'll we will be able to accelerate this work." -- Dr. Halamka

"You pointed out that touchstone of what you're doing was to point to
standards that came from standards development organizations... But I
think you also pointed to areas where no standards exist...I would
suggest that those areas that clearly came from an SDO should be marked
as such...You should indicate which do and don't." -- Mr. Evans

"Typically, we think of a base standard as coming from an
ANSI-accredited standards development organization...but we also had to
consider sometimes there are implementation guides that take those
standards as they come from SDOs and constrain them, because there may
be too much ambiguity in a standard as it's published. So we also
included in our set of base standards implementation guides from
organizations like IHE, and IHE does not suggest that it is an
ANSI-certified SDO, it's not creating standards at the base level. It is
creating implementation guidance." -- Dr. Halamka

"Where there are differences of opinion between standards development
organizations and implementation guidance that is provided by
non-SDOs...we will leverage the strengths of the SDOs, take work
products from industry, and bring them in to technical committees where
they can openly vetted, and by consensus, choose the best of what we
get." -- Dr. Halamka

"This is incredible work. But when we get down to the individual details
and now that we're making recommendations for the passage of Version
One, my concern is we actually would be recommending an implementation
approach that has not been vetted through an ANSI-accredited standards
organization."\
-- Mr. Hutchinson

"I think you'll find the panel is quite good at vetting these particular
decisions... We've created some foundation committees, we're calling
them, to work on some of these basics of how as a whole environment of
people working on standards, SDOs, implementation guide writers, and
industry, do we ensure that good coordination. HITSP has a very
important role in not only creating these, but ensuring they're
maintained going forward." -- Dr. Halamka

"I think it's fair to say that the industry is trending towards
standards development organizations, or their like, managing this level
of implementation guidance. So I think that this is an important
step...The role that HITSP is taking here is really ensuring that it's
available, though it will readily step out of the infinite detail work
of implementation guidance where they are available and readily usable.
And I think that's the direction the industry will head." -- Dr. Loonsk

"HITSP, itself, of course does not want to be an SDO. And when we can
look to an SDO and say 'we need this particular use case satisfied, you
maintain it, and we will reference it in an implementation guide,'
that's really the best approach." -- Dr. Halamka

"We did have a Working group on business sustainability... and asked the
question how can HITSP continue on past a 100% government funding kind
of resource set? We asked the question, given the harmonization that
we've described in those multiple steps, how can we be the most
efficient about it? And of course, we worry about volunteer burnout;
12,000 volunteer hours, companies that gave up employees for weeks at a
time, will that be sustainable? The end result, as the model suggests,
is that it will be a balance between funding by government and
nongovernment entities." -- Dr. Halamka

"We'll be much more efficient than we have in the past because we will
have defined a lot of the processes... one hopes that we will be able to
define, say, a 6 month to year‑long turn of the crank process by which
we can deal with two or three use cases and do that in a sustainable
way. And my prediction is it will be an ongoing process that will last
many years. We'll do it faster; we'll do it cheaper. But it will not be
done in my lifetime, because there are so many domains to explore." --
Dr. Halamka

"The standards development community has contributed substantially to
this effort and has also thought about how they will play in the future.
And I think as they accept some of the activities including
implementation guidance, development, and such that we can see an
expansion of scope of accomplishment, of throughput, even if HITSP's
role may become smaller in terms of more of a coordinating role and less
of the 'doing' role." -- Dr. Loonsk

"One of the aspects of the implementation guides is that they constrain
variability. You take an SDO's whole standard, and...these pieces
implemented as such are what constitute interoperability specification,
so they are all subsets. It requires that the SDOs have much better
coordination amongst themselves and the stakeholders and we believe that
HITSP can serve in that coordination role." -- Dr. Halamka

"In the life cycle of a standard, one releases the standard, and of
course it's used by industry, and then that implementation guidance
about the standard is refined. So we are bringing these to you today, as
I say, Version One, they're going out to the industry to begin
implementation with the notion that come April, we will have refinements
based on their early experiences." -- Dr. Halamka

"I wasn't sure what the response was about making the distinction
between those that have gone through an SDO and those what have not.
Because I think that's very important. This is embryonic work in the HIT
area...And I think we'd feel more comfortable if there were an
understanding that the goal was for standards to go through SDOs. And I
understand the need to get these out there now in a quick timeline. But
we're really not comfortable, not having that distinction made and not
having that ultimate goal that we do want an SDO process." -- Ms.
Sweeney

"This is a very important point. There are 30 standards that are being
proposed here and the sense that I've gotten through my background in
due diligence and or discussions is that these is standards are set and
we don't expect that implementation testing will in any way change the
bundle of standards you've come back to us with. The implementation
guide itself may change as we get better evidence about what works and
where it's ambiguous or silent. So the standards, the 30 standards have
all come from standards development organizations?" -- Dr. Brailer

"That is correct." -- Dr. Halamka

"Are there circumstances under which you would bring back to us a named
standard that did not come from SDO?" -- Dr. Brailer

"There are no such circumstances." -- Dr. Halamka

"We urge adoption of these standards today, and moving forward. But I do
want to echo the concern about the need to do some testing over a period
of time. We don't anticipate that being a long period of time, but just
to have an effective implementation from the federal side." -- Dr.
Winkenwerder

"The President's Executive Order does contemplate that need. And in
terms of its implementation I acknowledge it. I think all of us are
saying we will move forward. This is a function of not 'if,' it's a
matter of what the process is and we will work that out internally.
Hearing no objection, but a good comment, I will declare a consensus and
these will be advanced for Department's assistance."\
-- Secretary Leavitt

**Biosurveillance Minimum Data Set Presentation**

Dr. Arthur Davidson, a family physician and public health practitioner
from Denver Public Health, a vertically integrated safety net
organization in Denver, CO, noted that the Biosurveillance Data Steering
Group's broad charge was to make recommendations to the Community so
that within one year, essential ambulatory care and emergency department
visits, utilization, and laboratory result data from electronically
enabled health care delivery and public health systems can be
transmitted in a standardized and anonymized format to authorized public
health agencies within 24 hours. The Steering Group's specific charge
was to identify the requirements for data from ambulatory care,
emergency departments, and laboratories necessary for
multijurisdictional biosurveillance programs. These requirements will
build upon previous work completed by the AHIC Biosurveillance Workgroup
and the HITSP Biosurviellance Technical Committee (HITSP-TC).
Recommendations that specify these requirements also will refine and
supplement the work of the HITSP-TC.

Dr. Davidson described the process used by the Biosurveillance Data
Steering Group to build the minimum biosurveillance data set. He
emphasized that the group focused solely on biosurveillance as defined
by the Association of State and Territorial Health Officials.
Biosurveillance is not the comprehensive package of disease control and
reporting activities that happens every day in communities across
America---any biosurveillance system will be insufficient to replace
those activities. The task of the Biosurveillance Data Steering Group
was to find the minimum data necessary to detect an event, create
situational awareness, and support outbreak management and
countermeasure and response administration. The minimum biosurveillance
data set is much less inclusive than data required for routine public
health surveillance, case reporting, and crucial disease control
activities carried out daily in local and state jurisdictions.

The Biosurveillance Data Steering Group has recommended adoption of 58
valuable data elements, with the realization that not all of the data
elements can be easily obtained. Given the group's feasibility
estimates, it is believed that 31 of the 58 data elements will be
available in the short term (defined as being available in 25 percent of
all reporting sites in less than one year). Although collecting these
data is feasible, a short-term implementation plan is needed, and many
factors need to be more fully understood to make this practical and
valuable at all jurisdictional levels.

Dr. Davidson discussed the following recommendations from the
Biosurveillance Data Steering Group:

-   Recommendation 1.0: The Secretary of the U.S. Department of Health
    and Human Services should adopt the minimum biosurveillance data set
    to guide data collection in biosurveillance programs that involve
    the simultaneous sharing of clinical data from health care providers
    to authorized local, state, and federal public health agencies.

-   Recommendation 1.1: By September 2007, the U.S. Department of Health
    and Human Services, in collaboration with state and local
    governmental public health agencies, should work with clinical care
    partners to implement the short term minimum biosurveillance data
    set and enable simultaneous data access to local, state, and federal
    public health entities for biosurveillance purposes.

-   Recommendation 1.2: By March 2007, the U.S. Department of Health and
    Human Services, in collaboration with state and local governmental
    public health agencies, and clinical care partners, should evaluate
    implementation models, costs, and determine availability of
    resources and establish a plan to effect a short-term minimum
    biosurviellaince data set implementation.

-   Recommendation 2.0: Public health agencies and partners who
    implement the short-term minimum biosurveillance data set should
    filter out some components of the following data elements as
    appropriate: date of birth, age, zip code, and diagnosis/injury
    code.

-   Recommendation 3.0: CDC should, no less than annually, involve
    local, state, and federal public health agencies and clinical care
    partners in a minimum biosurveillance data set monitoring process
    for biosurveillance usefulness, and make appropriate modifications
    as evidence develops to support such modifications.

## Discussion Highlights

"We really do appreciate the time and energy, and the thought of
everyone that contributed. And I think it's a terrific starting place.
It's realistic, it's doable. I think we can move ahead as you've
suggested in the timeline that you've proposed...How is this
biosurveillance initiative, which is really a subset of population
health data requirements, going to link to the other
Workgroups?\...While this happens to focus on some specific utilities
that are of an urgent nature, the transactional nature is basically the
same. And so should we be thinking about these more as parallel
processes rather than two separate streams of activity?" -- Dr.
Gerberding

"We look at biosurveillance as a subset of population health
measures...Until we try to leverage all the local resources toward this
improved interoperability across those communities and with federal
agencies, we're going to lose the real sense of commonality. I think
that's what we want to happen at the local level...We really want these
to converge." -- Dr. Davidson

"Upon this report, this Workgroup actually sunsets. It is done with its
very specific charge. We didn't view this Workgroup having a life after
this, unless it made a recommendation that it continue to do this work."
-- Dr. Brailer

"\[This\] was the Biosurveillance Workgroup's way of responding to the
Secretary's concern that he needed certain kinds of information fast and
we needed to be able to facilitate that through our process here, and
that's why they were tasked as they were. And now I think that we've got
this great, sort of, body, we can sort of figure out how it flows back
in. But I think it was incredibly important that they worked as fast as
they did, and I think we achieved your objective that you set out." --
Mr. Kahn

**Comments From the Interim National Coordinator for Health\
Information Technology**

Dr. Kolodner noted that a key step toward achieving the goal of having
most Americans with an EHR by 2014 is the development and nationwide
implementation of the interoperable HIT infrastructure, which has been a
major focus of AHIC, ONCHIT, and HHS. He added that AHIC now will place
a major emphasis on what needs to be done to push the second round of
standards through HITSP's process. Working with HITSP to facilitate a
continuous flow of activities and manage a growing volume of standards
also is a priority. Most important, Dr. Kolodner indicated, AHIC needs
to ensure that the activities it focuses on are the ones that provide
the most leverage. AHIC's activities should represent a floor, not a
ceiling, for the efforts that are related to the interoperable HIT
infrastructure. The importance of including all stakeholders in AHIC's
common agenda to achieve this interoperable transformation of health
care is well recognized. Dr. Kolodner indicated that his emphasis with
ONCHIT will be to build the broad, inclusive alliances with other
stakeholder organizations to enable continued success in their national
initiatives---these alliances include AHIC's work with the private
sector, with other internal HHS agencies, and across the federal
government.

**Visioning and 2007 Priority Areas -- Workgroup Perspectives**

Dr. Brailer introduced this series of presentations by explaining that
each of the AHIC-chartered Workgroups was asked to come to this meeting
having thought out their substantive recommendations, their priority
areas, and how they fit into each Workgroup's respective vision. Leaders
from each of the Workgroups were asked to present these findings, which
should help move from narrow breakthroughs to a much broader vision. In
addition to these Workgroup reports, ONCHIT staff undertook a separate
level of analysis to look across workgroups to understand the clusters
of areas that cut across the various Workgroups.

## Electronic Health Record Workgroup

Community member Ms. Lillee Gelinas, Vice President and Chief Nursing
Officer for VHA, Inc., noted that the EHR Workgroup heard a great deal
of public testimony from multiple stakeholders, including those who have
built, researched, and/or used EHRs in practice. A future priority of
this Workgroup is to examine consumer perception. Ms. Gelinas reminded
Community members that the broad charge for the EHR Workgroup is to make
recommendations to the Community on ways to achieve the widespread
adoption of certified EHRs, minimizing gaps in adoption among providers.

This Workgroup's vision of the future includes: (1) a person-centric
health care system, (2) widespread use of interoperable HIT, and (3) new
reimbursement systems that support improved outcomes achieved through
virtual care. Today, however, there is a provider-centric health care
system, low levels of EHR adoption, minimal interoperability, a low
demand for HIT, and employer-based/public fee-for-services
reimbursement. Ms. Gelinas commented that the low level of EHR adoption
today may actually be a positive, from the standpoint that with the
HITSP work that was presented earlier during this meeting, there is now
the opportunity to accelerate interoperability and adoption.

In 2014, Ms. Gelinas explained that the Workgroup envisions an interim
state that has a provider-centric health care system, although one with
widespread adoption of EHRs with incremental availability of
interoperable health information, a strong demand for HIT functions, and
incentives or new models of reimbursement. The Workgroup identified 10
types of clinical information that were considered to be most important
with respect to health information exchange among clinicians. Those
types of information are: (1) patient identification, (2) medication
list/allergies, (3) laboratory results, (4) problem list, (5)
clinical/encounter notes, (6) anatomic pathology results, (7) vital
signs, (8) family history/health factors, (9) radiology reports (not
including images), and (10) immunizations.

Key barriers to EHR adoption include the need for an accurate and
reliable patient identification system and relief from current
restrictive laboratory results data sharing under current CLIA and state
laws. Additional barriers include preserving the clinical context and
structuring data to be machine readable and interoperable as related to
clinical encounter notes, radiology reports, and anatomic pathology
results; and creating policies and guidance related to immunizations for
secondary uses of data for public health policies.

Ms. Gelinas described five critical elements for reaching the interim
state she touched on previously. Those elements will be the focus of a
set of five recommendations that the EHR Workgroup will present to AHIC
early in 2007. Those elements are:

-   Creating a financial/business model that supports physician and
    hospital adoption and the maintenance of EHRs.

-   Fostering incremental technological progress towards
    interoperability and usability.

-   Mitigating of the medico-legal liability that rises from accessing
    and maintaining large amounts of clinical information.

-   Establishing confidentiality, privacy, and security guidelines.

-   Promoting organizational and cultural change in both the workforce
    and in patient populations with respect to new and different
    approaches to the use of HIT.

## Chronic Care Workgroup

Colin Evans, Director of Policy & Standards, Digital Health Group at
Intel, presented in place of Dr. Craig Barrett, Co-Chair of the Chronic
Care Workgroup. Mr. Evans noted that the broad charge of the Chronic
Care Workgroup is to make recommendations to the Community to deploy
widely available, secure technology solutions for remote monitoring and
assessment of patients, as well as patient-related communication between
clinicians. He noted that there are two primary drivers pushing concern
in the area of chronic care. One is that 80 percent of spending in the
health care system occurs in the area of chronic care. The second is
that 90 percent of that care is essentially self-administered. The
Chronic Care Workgroup's efforts have been focused on the technology
that puts patients in different settings outside of the clinical
setting, and facilitating efficient patient-doctor communications.

The Workgroup's vision for the future involves a person-focused health
care system that involves care available anywhere and any time, with new
reimbursement systems that support improved outcomes achieved through
virtual care and care coordinated across multiple providers and provider
types. Patient engagement will be integral to this envisioned care
process, which should be usable by anyone and accommodate persons with
disabilities, affordable, portable, compatible with provider IT systems
and other devices, enhance provider/patient relationships, and provide
real-time continuous physiologic information. In addition, the future
system should include bi-directional communication with pharmacies,
laboratories, health care advocates, and other providers, as well as
provide remote monitoring of symptoms before they become chronic. Mr.
Evans contrasted this vision of the future by explaining that the
current health care system is provider-centric and fragmented, with: (1)
care sought in offices, clinics, laboratories, and hospitals; (2) care
across multiple providers that is not coordinated; (3) a lack of
reliable, secure, and affordable HIT available in the home, school, and
office settings that can communicate with care providers; (4) unit
reimbursement for most ambulatory services; and (5)
employer-based/fee-for-service reimbursement.

AHIC member Mr. Tony Trenkle, Director of the Office of E‑Health
Standards and Services at CMS and Chronic Care Workgroup Co-Chair, noted
that an interim state can be reached by 2014. This interim state could
feature less fragmented, provider-centric health care with widespread
adoption of a limited number of interoperable remote services, remote
services that are reimbursable under specific circumstances, and
bi-directional communication between providers and patients. Mr. Trenkle
outlined the following critical components for reaching such an interim
state:

-   A sustainable financial/business model for provider and patient use
    of interoperable monitoring devices and communications between the
    clinician and the patient.

-   Interoperable, user-friendly, secure, and affordable technologies.

-   Assurances that confidentiality, privacy, and security can be
    preserved.

-   Mitigation of medico-legal liability that may be associated with
    virtual/remote care.

-   Organizational/workforce changes to accommodate virtual care.

The Chronic Care Workgroup identified key enablers in financial;
technological; confidentiality, privacy, and security; medico-legal; and
cultural areas. The Workgroup also identified near-term priorities,
including: (1) improved communications between the clinician and the
patient, which are critical for assuring accurate and timely guidance;
(2) vital sign monitoring (e.g., for weight); (3) laboratory monitoring
(e.g., for blood glucose in patients with diabetes); and device
monitoring (e.g., spirometry---asthma can be managed at home, in school,
and at work). Mr. Trenkle also presented some longer-term priorities in
the areas of vital sign monitoring (e.g., blood pressure, cardiac rate
and rhythm, and pulse oximetry); laboratory monitoring (e.g.,
anticoagulation levels); and other device monitoring (e.g., motion,
medication adherence).

## 

## Consumer Empowerment Workgroup

Community member Nancy Davenport-Ennis, founder of both the National
Patient Advocate Foundation and the Patient Advocate Foundation and
Co-Chair of the Consumer Empowerment Workgroup, introduced Dr. Paul
Tang, Vice President and Chief Medical Officer of the Palo Alto Medical
Foundation, who presented the Consumer Empowerment Workgroup's findings.
The Palo Alto Medical Foundation includes 700 multispeciality
physicians, 330 of whom use EHRs/PHRs. Approximately 40 percent of all
primary care patients at this facility are immediately engaged in PHRs
and EHRs.

The Consumer Empowerment Workgroup's broad charge is to make
recommendations to the Community to gain widespread adoption of a PHR
that is easy to use, portable, longitudinal, affordable, and consumer
centered. The critical components that support widespread adoption are
functionality, interoperability, consumer awareness, and business
models. Dr. Tang noted that very few people know about this type of
technology. Up to 40 percent of patients keep personal information at
home, mostly on paper---very few keep this information in an electronic
form, or even know that products to do so exist. Although stand-alone
PHRs are available, uptake is poor, in large part because they involve
manual entry of data, lack an interface with clinical data sources, and
lack communication tools. It is hoped that adoption of the standards
passed through HITSP will improve communication between patients and
their health care providers.

It is hoped to create some type of comprehensive consumer experience,
with the PHR serving not as an end, but as a means, so that patients can
gain access to the data and the caregivers they need in order to
maintain and improve their health. The end-state vision includes
widespread adoption of PHRs supporting health and wellness, with: (1) a
comprehensive, longitudinal "record" about an individual's health
acquired from all relevant sources; (2) timely, understandable,
context-sensitive health information from trusted sources; (3) tools
that support an empowered consumer taking an active role in managing
his/her health; and (4) tools to facilitate communication with the
health care team and caregivers. This vision also includes uniform
privacy protections for personal health information that follow the data
and give patients control of their personal health information. The
Consumer Empowerment Workgroup identified components needed to reach
this end-state vision. They include interoperability technical
standards, interoperable policies, widespread adoption of interoperable
EHRs, and a Nationwide Health Information Network (NHIN) that
facilitates sharing of personal health information to authorized users
under the control of consumers.

Dr. Tang highlighted the following key enablers for accelerating the
adoption of PHRs, noting that the federal government can play a
significant role in helping to advance many of them:

-   Public education about PHRs from trusted sources.

-   Comprehensive privacy protection for portable personal health
    information.

-   Certification for core PHR functions, interoperability, security,
    and access control.

-   Greater adoption of EHRs and electronic prescribing systems among
    providers.

-   Automated population of PHRs with clinical data from multiple
    sources employing interoperability standards.

-   Development of standards for consumer-focused, evidence-based
    educational information and decision support tools.

Near-term priorities for driving PHR adoption can be focused in the
areas of laboratory results, lists of conditions and allergies,
prescription refills and renewals, administrative features, and
reminders for patients. Subsequent priorities include online
consultation, summaries of health care encounters, endorsed educational
information, decision support, and patient health outcomes. Dr. Tang
summarized by suggesting that there is a need to provide patients with
tools that improve their access to data, knowledge, and the providers
they need to engage in keeping healthy and overcoming illness. Immediate
needs include having interoperable standards in place to move data, have
privacy protections follow the data, and certifying core functions so
that consumers can be protected.

## Biosurveillance Workgroup

Community member Mr. Charles Kahn, President of the Federation of
American Hospitals and Co-Chair of the Biosurveillance Workgroup,
reminded AHIC members that the Biosurveillance Workgroup's broad charge
was to make recommendations to the Community to implement the
informational tools and business operation to support real-time
nationwide public health event monitoring and rapid response management
across public health and care delivery communities and other authorized
government agencies. Today, public health agencies are not
interconnected. Only a small proportion can receive electronic data from
clinical care or public health partners, and silos of data exist in
clinical and public health systems. There is a poorly articulated
business case for data/information exchange between public health and
clinical care at present, despite legal requirements for this exchange.
Furthermore, public health programs and IT support are separated in most
states, and the emphasis on information systems sometimes is inadequate.
Mr. Kahn noted that today, case reporting typically is manual and
passive, but notifiable disease reporting varies across states. Although
bi-directional communications technologies exist at present, standards
and infrastructure are under development and not yet complete. In terms
of response management, there are variable degrees of application use
and integration, including supporting outbreak investigations, tracking
countermeasures, and linking to response registries. Finally, adverse
event reporting today typically is manual, voluntary, passive, and
supported by disparate systems.

Mr. John Lumpkin of the Robert Wood Johnson Foundation described the
Biosurveillance Workgroup's end-state vision. In this vision with regard
to connectivity between public health agencies and health care systems,
local, state, and federal public health agencies can share data
seamlessly with clinical care and each other. Infrastructure and
policies are in place to enable data aggregation at appropriate levels
of public health to monitor population health trends, disease outbreaks,
and medical product safety. There is rapid, standardized case reporting
across states, with case criteria integrated into EHR decision support
algorithms. As such, the EHR prompts clinicians when a diagnosis matches
a reportable disease and sends an electronic report that is approved by
the clinician. There are integrated public health and clinical care
communications; public health communications deliver value to clinicians
that incentivizes providers to communicate on a routine basis with
public health.

Mr. Lumpkin continued that this end-state vision, as envisioned by the
Biosurveillance Workgroup, includes a response management component with
integrated applications to support: (1) outbreak investigation, (2)
countermeasure administration and tracking, and (3) ongoing visibility
of supply and demand for critical resources. There is an established
linkage between the point of care EHR and registry data with emergency
management systems, and improved access to and tracking of
isolation/quarantine cases, patient data for those displaced from usual
site of care, and disaster case management services. This vision also
includes standardized and consolidated adverse events reporting as well
as automated EHR prompting and report filing for medical products.

Mr. Lumpkin presented four key enablers for achieving this end state:

-   Public health involvement in health information exchange (HIE)
    efforts.

-   Leveraging work done by the Public Health Informatics Network.

-   HITSP and CCHIT inclusion of requirements for public health
    surveillance and response.

-   An open, participatory process for certification of public health
    information systems.

Mr. Kahn summarized by noting that the Workgroup envisions some specific
projects to tie these efforts together. With regard to case of case
reporting, this would involve working on national standards to develop
consistent definitions. Another project would involve developing an
architecture for how electronic case reporting can be done from the
developing EHRs. In terms of bi‑directional communications, standards
are needed, as is a system for alerts going back and forth between
clinical care and public health. With regard to response management, one
project would involve the design of a pilot for sharing hospital
utilization data, as well as how to best integrate commercial sector
supply chain and distribution response in a public health emergency.
Lastly, in terms of adverse event reporting, national standards need to
be developed, and candidate systems for consolidation of that
information need to be identified. Mr. Kahn concluded by noting that the
title of this Workgroup should be changed to reflect the group's
modified focus. He suggested the name "Public Health-Clinical Care
Interface."

## Quality Workgroup

Dr. Carolyn Clancy, AHRQ Director and Co-Chair of the Quality Workgroup,
reminded AHIC members that the Workgroup's broad charge was to make
recommendations to AHIC so that HIT can provide the data needed for the
development of quality measures that are useful to patients and others
in the health care industry, automate the measurement and reporting of a
comprehensive current and future set of quality measures, and accelerate
the use of clinical decision support that can improve performance on
those quality measures. The broad charge also calls on the Workgroup to
make recommendations for how performance measures should align with the
capabilities and limitations of HIT. The Workgroup's specific charge
(i.e., what the Workgroup is trying to accomplish in the near term) is
to make recommendations to AHIC that specify how certified HIT should
capture, aggregate, and report data for a core set of ambulatory and
inpatient quality measures. Dr. Clancy explained that the Quality
Workgroup is focusing on making quality assessment and reporting
scaleable while at the same time ensuring that the same functionality is
used to provide clinicians and health care organizations feedback in
real time.

The Quality Workgroup was chartered in August of 2006, and has held two
meetings to date. Progress thus far has included an examination of the
business case for quality in the current reimbursement system as well as
the business case or value added for IT to make it easier to report on
an improved quality of care. The Workgroup has reached agreement that
the core set of starter measures will come from the Hospital Quality
Alliance (HQA) and the Ambulatory Care Quality Alliance (AQA). The
Workgroup also has conducted and environmental scan and has reviewed the
HIT certification process.

Dr. Clancy described a series of emerging principles for the Workgroup,
including:

-   Identify specific solutions for data aggregation and reporting, but
    not prescribing these solutions.

-   Apply a requirements approach focused on the standardization and
    discrete capture of data elements critical for reporting.

-   Focus on accountability, transparency, and improvability, helping
    clinicians obtain feedback in real time.

-   Recognize the necessity of developing an array of solutions for
    decreasing the burden of data collection.

Additional principles include recognizing that quality reporting is one
of several secondary uses for clinical data, the solution will require
the skills of many, and the development/evolution of market competition
and collaboration will be a significant enabler. Dr. Clancy identified
four priorities in the near term: (1) automate data capture and
reporting to support a core set of AQA clinician-focused quality
measures, (2) automate data capture and reporting to support a core set
of HQA inpatient quality measures, (3) provide feedback to providers in
real or near-real time, and (4) enable data aggregation. Next steps for
the Quality Workgroup include continued exploration of the broad and
specific charges, development of recommendations for the specific charge
and priority areas, and taking part in a visioning exercise to guide and
inform the Workgroup's future activities. Dr. Clancy concluded her
remarks by presenting a Venn diagram illustrating how the Quality
Workgroup overlaps materially with other AHIC efforts relative to the
Consumer Empowerment, Electronic Health Records, and Biosurveillance
Workgroups.

## Perspectives and Clustering of AHIC Priorities

Dr. Kolodner noted that a priority roadmap for AHIC will be developed to
describe when areas and issues will be considered and to allow AHIC
Workgroups to focus on their identified priorities and issues in a
coordinated manner. The roadmap also will inform next steps for the
different processes of the national agenda, including use cases that
detail needs for architecture, data harmonization, confidentiality and
security, certification, and policy consideration. Dr. Kolodner
explained that many priorities have been identified by AHIC Workgroups
and others---not all issues can be addressed at one time, and there is
overlap and relationships between the different priorities. There is a
need to avoid "stovepipe" activities where there are opportunities to
share and connect. There also is a need to address process gaps with
HITSP and the CCHIT.

Dr. Loonsk explained that a coordinating structure for future use cases
has been developed with three high-level perspectives: (1) the consumer
perspective, (2) the provider perspective, and (3) a secondary use
perspective. The priorities from the existing use cases, as developed by
AHIC Workgroups, have been put into this structure, in an effort to
examine these priorities, their commonalities, this additional
organizing principle of what the high level perspectives are, so that
AHIC can make the next use cases coherent and leverage the different
needs across the different activities. A spreadsheet illustrating this
structure was presented and distributed to Community members. Dr.
Brailer noted that there are significant value statements being made by
the perspectives that are brought and how they were chosen---the attempt
was not made to represent every stakeholder in health care and have
their perspective, but to represent some of the key polarities that come
through. He also emphasized that these are not organizational
statements; rather, these are management tools to help understand where
activities have been completed and where there are gaps.

On the spreadsheet, Workgroup priorities and issues are arranged in
columns corresponding to each of the three AHIC Workgroups, EHRs,
Quality, AHIC, CCHIT, and HITSP. Areas highlighted in yellow represent
an inclusive list of priority areas and issues related to perspective
(consumer, provider, or secondary use). For example, with regards to the
consumer perspective, everything that is highlighted is very related to
the consumers' view on this process moving forward. Areas highlighted in
gray indicate priority areas and issues that are part of a perspective
that AHIC will try to write up into the next step use cases. Priorities
that relate to, or depend on, each other are clustered across workgroups
and perspectives---clustered items may influence the importance of the
priorities.

Ms. Kelly Cronin, ONCHIT, noted that there are important common issues
across the Workgroups that are being considered within the context of
their respective broad charges. These include the business case, work
flow, legal issues, and issues related to privacy, confidentiality, and
security. Some of the specific issues related to the priority areas
include regulatory barriers for provider and patient access to
laboratory results; EHR, PHR, remote care monitoring, and case reporting
integration in work flow; and the need for clear policy and practices
for secondary uses of clinical data. Ms. Cronin noted that next steps
involve: (1) obtaining AHIC comments on cross-linked priorities at this
meeting, (2) initiating the development of the next round of use cases,
(3) continuing to have the Workgroups address important issues for their
broad charges, (4) developing the high-level roadmap for infrastructure
development and AHIC activities, and (5) reviewing priorities at AHIC in
approximately six months.

In reviewing and discussing the spreadsheet, AHIC members were asked to
consider the following discussion questions from the consumer, provider,
and secondary use perspectives:

-   Are the most important priority areas (highlighted in gray, bold
    text) captured to advance interoperability in the second round of
    use cases?

-   Are there any important considerations for the Workgroups as they
    continue to address both their broad charges and these priority
    areas?

-   Are there any highlighted gray areas that should be considered for
    the third round of uses cases or later in the Workgroup process?

Before opening the floor for discussion, Dr. Brailer commented that one
additional purpose of this exercise to develop a roadmap is to break the
mold of AHIC/ONCHIT being only one small step ahead of where they need
to be for contractual purposes with CCHIT, HITSP, or NHIN. This will
allow AHIC to not be dictated by the short-term needs ONCHIT has to be
able to fulfill its own contract oversight. He emphasized that this is a
work in progress, built on all of the Workgroup discussions that have
taken place to date.

**Discussion Highlights**

"The resource pressure would imply that there are some ugly choices we
might have to make in order to slow things down or, in fact, not take
things on...I'd certainly err on the side of making what we're doing
already impactful before on taking new stuff that's potentially
speculative." -- Mr. Evans

"With respect to the resources that are being triaged or prioritized
here, it's really an unknown quantity, because while clearly ONC has
resources, and the agencies have resources that apply to this, the real
pool of resources that this is prioritizing is the work of volunteers.
And we don't know how elastic that pool is or how expansible, but
clearly, there is a real sense that we can't go radically faster or
broader at the same time, without taxing the voluntary resources that
you've already heard so much about." -- Dr. Brailer

"There is another component, and that is external factors that have
nothing particularly to do with logical sequence or way to do this. For
example, Congress could pass legislation that accelerated the need for a
means of collecting quality information, and it could have a timeframe
on it that would be a year or less." -- Secretary Leavitt

"There is really an unknown number of contingencies that aren't even
stated here that could shift this, and that's why I think this is seen
in the end as not a 'top down once and for all' list...but a process to
be revisited." -- Dr. Brailer

"This list will change in two ways. The elements on the list will change
as the universe of what's considered expands...Secondly, the sense of
actionability or priority will change because of reasons that you
describe, the nonlinear factors or just the linear evolution\...The
decisions that need to flow from this will happen beginning after this
meeting...I do expect that at the December 12^th^ meeting, that the ONC
staff will bring back the 'so what?' that comes from all of this
discovery and say, 'here are our stated directions, here is what's
underlying them, and here's how we go forward.' So this abstraction, if
you would, comes down to a very concrete set of actions steps." -- Dr.
Brailer

"If you get into the adoption for future projects of those workflow
issues or workflow groups, are we going to focus on clearing those
roadblocks for adoption, like the discussion we've had previously on IRS
with payer programs that are trying to distribute funds to physicians to
deploy and adopt EHR systems, but aren't able to because they can't get
nonprofit status?" -- Mr. Hutchinson

"This effort is being driven by the charter of AHIC, which does not
exclude those, but gives those a diminished status with respect to the
work here...this exercise was intended to not replace the set of
recommendations that are already slated to come back here from the
Workgroups within the next two meetings. This was really seen as giving
guidance to what happens after that, and one of the things we made very
clear in this visioning exercise was to not stop, slow down, or change
the short‑term recommendations that are due." -- Dr. Brailer

"I would like to see AHIC focus on any technical barriers to adoption.
There is a robust debate that's taking place outside this room, that
we're all involved in, and we all have different perspectives on, and in
many cases we'll share the perspectives. But I think our focus here
ought to be in eliminating technical barriers to adoption. I'm of the
belief that adoption is about to see a dramatic upswing, I think in
significant part, because of the work of AHIC" -- Secretary Leavitt

"I have been encouraged by seeing that there is a segment in healthcare
in the United States that is interoperable, and that's the Veterans
Administration...I hope that our VA colleagues...are informing our work,
because I have been enormously impressed in the VA system, and see that
the adoption lag is really in the public sector." -- Ms. Gelinas

"There are some very good examples of systems that have achieved a high
level of interoperability, but only within their own system, and our job
is to figure how to get the 83 percent of small practitioners, who
haven't achieved that yet. Ours is to make certain that the large
systems, particularly hospitals who have and now want to share that and
help small practitioners, that when they do it, they do it in a way that
weaves into the larger vision. So I think when we talk about the
technical barriers, this is not a technology problem. It's a sociologic
problem and a coordination problem. And I'm convinced with enough time
and enough focus, we'll get there." -- Secretary Leavitt

"One of the next things you can expect is some prototype/proto‑use cases
that will be high level, and the process that was engineered around the
emergency responder EHR is the one that we're thinking about, where
there is a high level projection of what the use case would be, and then
there is an opportunity for comment." -- Dr. Loonsk

"In the end, what we look at in terms of use cases or action steps might
be pretty self‑evident, but we felt it was very important that we not
just know what we're doing, but why we're doing it, and build up a
public methodology, a public legacy of process, because many people do
look to the AHIC to say, make these overarching priority decisions, so
the industry can work in sync as they have done in many times."\
-- Dr. Brailer

"If there was just some way of assessing not just the financial
resources, but all the resources that it would take to actually
accomplish one of these things, even if we just see the plans, it gives
you something to sort of get a hold on. Otherwise, it's just a value
judgment of whether this or that is more important for reaching all
these goals...I just wonder if there is some way to weight it so you can
make some judgment." -- Mr. Kahn

"The problem that we had in going through that kind of a cost analysis
is depending on what the goal is, different pockets of resources become
available, because so many different constituencies in the market care
about some problems and not others...And so we really had a hard time
trying to ultimately add up whose cost it was, and it became a really
difficult exercise. But we could certainly go back and revisit that,
again in the spirit of building up a methodological process to make
valuable decisions." -- Dr. Brailer

"We're doing something that hasn't been done before. We said we're going
to be learning as we go. This was the first set of things that are
through, but we're not to the point where we've finished incorporating
them into a certification process and delivering that and having them
purchased. That's still a part of the learning that we haven't yet
experienced." -- Dr. Kolodner

"It seems a little bit dangerous to look too much at the cross-cutting
\[priorities\], because I'd hate to be in a situation where we've
actually done a fabulous job of building some horizontal capability, but
actually not being able to do all of what is necessary to do any one of
these Workgroup things. To me, I'd give a higher priority to picking the
minimum subset of things required to make the base set of
recommendations in each of the Workgroups actually get implemented
rather than focus too much on the horizontal and then miss the vertical
end." -- Mr. Evans

"I would caution that this is not an organizational tool. We are not
telegraphing a desire to change the Workgroups or their approach towards
these perspectives. It's really a tool for us to try to break those
assumptions and make sure that we're not relying too much upon those
silos that get created. And I think one of the takeaways from this is
exactly that, that, in fact, these groups are large enough that they can
really get big pieces that seem to fit elsewhere into others as well."
-- Dr. Brailer

"I have this suspicion...that Congress is going to take actions that
will make it in the financial interest of physicians to collect
information, and there is going to be a substantial interest in
automating that process. And when that occurs, there will be a great
hunger for adoption. A lot of people are going to be buying systems, and
if those systems don't do what they want, that's a problem." --
Secretary Leavitt

Following these remarks, Secretary Leavitt excused himself from the
meeting. Dr. Brailer served as Chair for the rest of the meeting.

"Most of you thought that it would be best to consider specific
priorities within clinical research and population health during future
reviews or considerations of priorities, and not now. But I think it
would be best to get all of you to make a determination on what you'd
like to do with respect to both clinical research and population
health." -- Ms. Cronin

"I would still make the strong case for clinical research, whether it is
a separate group or not a separate group. It seems to be a big business
driver as associated with an EHR use case or underneath chronic care or
even quality. It's hard to say where it actually would fit in the
structure that we have today, but I think that individual one could end
up being a big business driver for driving adoption uses of health IT."\
-- Mr. Hutchinson

"Is there objection to merging the population health topic into
this...expanded Workgroup formerly called 'Biosurveillance?" If there is
no objection to that, then we'll be looking for the name and charter
that goes with that, and clearly, we already have a bunch of proto‑use
cases to feed into that...perhaps the first discovery effort should be
trying to find where there is a clinical research aspect to the use
cases or questions that are being contemplated within the Workgroups,
and then we can come back as AHIC and decide, through the vehicle of
another broad multi-person panel presentation, what \[we are\] missing."
-- Dr. Brailer

"I see the information coming from this as not solely, if you will,
health care. But I think what we also get from this is health status.
And when we look at it that way, then I see it as really quite critical
to how we look at health, overall." -- Dr. Sondik

"I will ask ONC to go back and look at the secondary uses, and to come
back with something even deeper than a name change, really a rationale
for why that's a management tool and how we use it, or perhaps parsing
it apart more. Again, in the spirit of building a toolbox, we can manage
our process. It's a good starting point, but I think your points are
fair, that we need to look more deeply." -- Dr. Brailer

"I'd like to see also what's in and out of secondary use. I'm not real
clear on that. I get the feeling that you're talking about public
health, and oversight, and management of the health care system, but do
you also mean payers? Do you include the secondary consumers; parents,
for instance? I would like to see a clearer definition." -- Mr. Green

"The purposes of what we put together for today, we were driven by just
the Workgroup charges and their deliberations, so for quality
measurement and reporting, clearly the clinical data that's being
captured for that would be used on a secondary basis when it's
aggregated and analyzed, and then reported either back to providers or
to the public." -- Ms. Cronin

"I think the direction stands for ONC to come back with a more fully
parsed out or rationalized classification of secondary use of data as
this process goes forward." -- Dr. Brailer

"I cannot tell this body of members of AHIC how exciting it was for me,
representing the consumer voices in the United States, to see this body
support the HITSP recommendations this afternoon. And with that support,
I think that I would have also an additional invitation that I would
like to extend. And that is, that while all of us may look at that and
feel there are other alternatives, or perhaps different processes
available, as members of AHIC, I hope that we can all set aside any
personal independent views of the world and encourage our constituents
to be very supportive of adopting and integrating the standards that
have been established by HITSP, so that, indeed, we can have a genuine
measurement opportunity for integration into the country." -- Ms.
Davenport-Ennis

**Public Input Session**

**Speaker Number 1­ --** Mr. Alan Mertz, President of the American
Clinical Laboratory Association (ACLA), commented on the ongoing work of
HITSP. He suggested that although the ACLA is generally supportive of
HITSP's standards harmonization efforts, some of the Panel's work is
flawed. Mr. Mertz stated that by recommending standards that are not
being utilized by providers today in the United States, despite the
existence of other suitable standards that are more widely adopted,
HITSP is sacrificing feasibility in pursuit of perceived technical
progress. In particular, Mr. Mertz explained that HITSP's recommendation
to utilize HITSP/IS-01, if adopted, will create new roadblocks, despite
existing efforts to address the creation of uniform results for
reporting standards. ACLA believes that vendors have dominated this
process, and that HITSP/IS-01 reflects a specification used by vendors
in Europe that do not adequately accommodate the practical realities of
laboratory result reporting today in the United States.

Mr. Mertz explained that the cost and time required for health care
providers to upgrade their systems and processes to the HITSP
specification would be substantial, and only the largest health care
providers in the United States would be capable of conforming to this
standard, at a considerable cost. He indicated that the adoption of
E‑Links, a specification developed under sponsorship of the California
Healthcare Foundation would be preferable than adoption of HITSP's
recommendation for laboratory results reporting. E‑Links facilitates the
delivery of electronic clinical laboratory results to clinicians in the
office setting by providing a precise and generally applicable
laboratory reporting specification that can be adopted as an industry
standard. E-Links is based on HL7 Version 2.4, while HITSP/IS-01 is
based on HL7 Version 2.5, which few providers and laboratories have
adopted. Mr. Mertz stated that implementing HITSP/IS-01 would be
significantly more costly, take much longer to adopt, and create
numerous operational difficulties for all providers.

Mr. Mertz noted that E‑Links currently is being utilized successfully in
the United States, while the HITSP recommendation is not. He further
recommended that AHIC reject the HITSP recommendation and consider a
means to leverage the E-Links specification. The Certification
Commission has already recognized the use of E-Links in the initial and
second drafts of the Commission's 2007 Interoperability Criteria, and
Mr. Mertz urged the Community to do the same.

**Speaker Number 2 --** Katheryn Serkes of the Association of American
Physicians and Surgeons (AAPS) emphasized that it is not as much a
matter of technology holding physicians back with regard to adoption of
HIT, it is more a matter of policy questions that have yet to be
answered. Many AAPS members are physicians in small groups and solo
practitioners, who are likely to be laggers in terms of adoption. Cost
is an issue, and from AAPS's standpoint, policy should drive the
technology, rather than technology driving policy. The secondary use is
a primary concern for AAPS members, as is privacy---both are policy
decisions. Ms. Serkes gave the example of trying to determine what
information can be shared, and with whom. The technology must be in
place to handle this issue, but there also needs to be policy decisions
in place directing what and how much information will be made available.
Many AAPS members are trying to become independent of third-party
influences on the clinical practice of medicine and are concerned that
the inclusion of the EHR being linked to payment will obstruct this
independence.

**Speaker Number 3 --** Tom Leary, Director of Federal Affairs at the
Healthcare Information and Management Systems Society (HIMSS), noted
that given the discussion of coordinated next steps, an obvious next
step for AHIC would be to more closely coordinate its efforts with the
government and health sector coordinating councils around infrastructure
protection. On behalf of HIMSS members, he noted with appreciation
Secretary Leavitt's comments regarding volunteers, especially volunteer
participation in the HITSP process. Mr. Leary commented that the issue
of volunteer burnout is a reality for HIMSS members. He asked that the
Secretary's comments be made available so that they can be distributed
to HIMSS members who have participated in these activities but were
unable to attend this AHIC meeting in person.

## Closing Remarks

Before adjourning the meeting, Dr. Brailer recognized and thanked Judy
Sparrow, Director of AHIC, as well as Gloria Cohen and Matt McCoy, for
all of their efforts and support for the Community.