## AMERICAN HEALTH INFORMATION 

## COMMUNITY MEETING

## October 31, 2006

## \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

## Hubert H. Humphrey Building

## 200 Independence Avenue, SW, Room 800

## Washington, DC 20201

### 

### 

### List of Participants:

### 

> **[Members:]{.underline}**
>
> ** **
>
> •         Secretary Michael Leavitt, Chair
>
> •         David Brailer, Ph.D., Vice-Chair
>
> •         Robert Kolodner, M.D.
>
> •         Robert Cresanti
>
> •         Nancy Davenport-Ennis
>
> •         Colin Evans *(representing Craig Barrett, Ph.D.)*
>
> •         Stephen Finan *(representing Nada Eissa)*
>
> •         Lillee Smith Gelinas, R.N.
>
> •         Julie Gerberding, M.D. *(also represented by Ed Sondik,
> M.D.)*
>
> •         Gail Graham
>
> •         Daniel Green *(representing Linda Springer)*
>
> •         Kevin Hutchinson
>
> •         William Winkenwerder, Jr., M.D. *(also represented by
> Stephen Jones)*
>
> •         Charles Kahn, III                                 
>
> •         Leslie Norwalk
>
> •         E. Mitch Roob
>
> •         Scott Serota *(also represented by Justine Handelman)*
>
> •         Rosi Sweeny *(representing Douglas Henley, M.D.)*
>
>  
>
> **[Presenters:]{.underline}**
>
> •         Alfred Berg  
>
> •         Carolyn Clancy  
>
> •         Kelly Cronin
>
> •         Terry Cullen  
>
> •         Art Davidson  
>
> •         John Glaser  
>
> •         John Halamka 
>
> •         Anthony Hayward  
>
> •         Kathy Hudson  
>
> •         Joel Kupersmith  
>
> •         John Loonsk  
>
> •         John Lumpkin  
>
> •         Jonathan Perlin  
>
> •         Paul Tang  
>
> •         Tony Trenkle  
>
> •         Janet Warrington  

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

### TABLE OF CONTENTS

-   Call to Order: Dr. Brailer

-   Introductory Comments: Dr. Brailer

-   Comments: Robert Kolodner

-   Overview of Personalized Health Care

    -   Gregory Downing, Alfred Berg, John Glaser, Joel Kupersmith

    -   Janet Warrington, Kathy Hudson

-   Overview of Population Health and HIT

    -   Terry Cullen

-   Overview of Clinical Research and HIT

    -   Anthony Hayward

-   Health Information Technology Standards Panel (HITSP) - Standards
    and Interoperability Specifications

    -   John Loonsk, John Halamka

-   Biosurveillance Minimum Data Set

    -   Art Davidson

-   Electronic Health Record Workgroup

    -   Lillee Gelinas, Jonathan Perlin

-   Chronic Care Workgroup

    -   Colin Evans, Tony Trenkle

-   Consumer Empowerment Workgroup

    -   Nancy Davenport-Ennis, Paul Tang

-   Biosurveillance Workgroup

    -   Charles Kahn, John Lumpkin

-   Quality Workgroup

    -   Carolyn Clancy

-   Considerations Across Priority Areas

    -   John Loonsk, Kelly Cronin

-   Public Input

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**[P R O C E E D I N G S]{.underline}**

DR. BRAILER: Okay. Secretary Leavitt is tied up on a phone call and
asked us to go ahead and get started. He will be with us in a couple of
minutes.

So, let me thank you all for coming to ninth meeting of the American
Health Information Community. This promises to be quite a substantive
and important meeting in the work of the American Health Information
Community as is evidenced by the published agenda and the people who are
coming to work with us today.

The Secretary will come and make opening comments. But in the time
we\'re preparing for his arrival, I would like to review the agenda and
to go over a couple of other housekeeping items.

Today's meeting will be broken into three sections. The first is a
discussion of potential, new areas of exploration by the American Health
Information Community. This will be dominated by a discussion of
personalized healthcare, which we started at the last meeting of the
Community. This discussion will set up the question about how does the
American Health Information Community engage the interface between
personalized healthcare and health information technology. And the
panelists who are coming, representing a broad array of stakeholder
views, will help us understand the facets of that question.

That will then be followed by early presentations, meaning very brief
presentations, on population health and health information technology in
clinical research and health information technology, essentially asking
if there\'s interest in having more detailed and complete panel
discussion at a subsequent meeting.

We'll take a break, and after the break we'll come back to perhaps the
most substantive part of the meeting: the action component of this
discussion, which is the acceptance of the health information technology
standards panel recommendations and the biosurveillance minimum data
set.

As you will hear, there\'s been an enormous amount of effort and
attention and work on the part of many people to bring these
recommendations back on the timetable that was laid out in Meeting 5.

After lunch then we will turn to an exercise of visioning and priority
setting. As we've completed the work on the first round of specific
breakthroughs, the work of Workgroups is going to become more expansive,
and this discussion is to help them focus their efforts on what it is
that in 2007 will help us accomplish the most, given the work that\'s
been invested to date.

As I said, it\'s a very substantive agenda, and something that I
appreciate all of you taking time for and investing your time and your
effort, not only in preparation, but here today.

As we look towards the meeting, I just want to go back to the minutes of
the September 12th meeting and ask for comments or corrections to those
minutes?

In absence of that I will ask for a motion to accept them.

Second?

Okay, and opposed?

So the minutes of the September 12th meeting stand approved.

We will ask the Secretary to make his comments when he comes, but in the
interim, to keep us moving on schedule, I'd like to make two other
comments and then we'll move forward with the personalized healthcare
panel.

The first is that I want to add my thank you to Rob Kolodner, who is
sitting at this table in a different capacity than he sat here in the
past. Rob is sitting here, as you know, as the Interim National
Coordinator for Health IT. And I just wanted to say thank you, Rob.
We've been working closely on this transition, and I just want to say
that you've brought both the right tone and the right intelligence to
this job, both for the short‑term and for the long‑term, and I thank you
very much for investing your time in making this a success.

And I know you have got comments to make, but I thought perhaps you
should save for those for after the Secretary, who I think has a much
more eloquent introduction and thank you of you.

With that, let\'s turn to the personalized healthcare panel, and I'll
ask the panelists to come forward. While they\'re doing that, I will
wish everyone a happy Halloween!

\[laughter\]

Those of you who came to the last meeting of the American Health
Information Community know that the Secretary asked us to have
exploration of personalized medicine. And this occurred because of the
huge growth in personalized medicine and genomics towards bringing
information that is necessary for patient care in the future.

And then the obvious question this has raised about how does this affect
the investment that's being made in health information technology? And
at the same time how does the investment made in the nation and health
information technology help advance both the development and application
of personalized medicine?

After a briefing by Greg Downing at the last meeting, the decision was
made to come back with a full panel. And this panel that we've assembled
represents a diverse number of stakeholder opinions, people who will
tell you about different facets of this question.

And the eye that I'd ask you to bring to this is: if we were to charter
a Workgroup in this area, what kinds of direction would we give them,
what kinds of issues would be raised, and do we need a Workgroup at all?

How should the Community engage on this topic? What it that we should
understand? What are the questions that should be asked? This is an area
that obviously will unfold over many years, and our efforts today will
be the beginning of intersecting two critical trends in healthcare.

And with that, let me turn it to Greg Downing, who will be the moderator
of today\'s panel. Greg, thank you for coming.

DR. DOWNING: Thank you, David, and Dr. Kolodner and members of the AHIC
community. On behalf of the Secretary\'s personalized healthcare team,
let me acknowledge that we're \-- very much appreciate the interest and
the input that you've provided to us in response to our discussions on
September 12th. We are pleased to be back with you. We've brought, I
think, more depth and insights into this important matter and the
opportunity that's unfolding in front of us on a daily basis.

We see the abundant evidence on the horizon that the rapid advances in
the scientific understanding of disease and health at the genetic and
molecular level will provide us with a new vista upon which to improve
the quality of healthcare at the individual, patient level. And some of
the significant scientific mileposts that we have passed that are
enabling this future to be considered include the completion of the
human genome project, the advent of molecularly-targeted therapies and
drugs that are aimed at specific genes and proteins, and the remarkable
advances in technologies for imaging, drug development, and diagnostics.

There is \-- this has also provided a new pathway for science and
medicine to make a real impact in the health of Americans in the future,
by enabling the prediction of risk for disease, enabling early
interventions or preemption of the disease processes, and modernized
approaches to disease prevention and the development of highly effective
therapies.

We also see a future in which the personalized healthcare can address
disparities in health outcomes and provide for a safer healthcare system
by anticipating health adverse events on the basis of a biological
response.

This future will not be achievable, however, without the crucial
enabling factors that health information technology provides. The
complexities of science, coupled with the vast amounts of data that are
needed to gain knowledge and inform decision‑making is quite clear.

At the same time as we move forward in this new science, we must keep in
front of our minds its applications and how we use this information and
the technologies in front of us.

How can personalized healthcare be introduced into a system that
encourages healthcare practitioners and healthcare consumers alike to
embrace it rather than fear it? And one of the keys to understanding the
impact and path to the future of the personalized medicine is through
the electronic health record. 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 health IT can
have a direct patient impact through similar strategies applied to
genomic tests data, for example.

Another important key to success in this new age world of science and
technology is the achievement and maintenance of public trust. The
foundation for that trust rests on the ability to use information about
an individual\'s healthcare experiences in ways that benefit the
healthcare system at many levels, yet at the same time does so in a way
that does not harm that individual. What is unique about this time and
place is the focus on genomic information.

Even in situations where information about that patient ‑‑ that patient
is deidentified, genomic information has the capability of identifying
each and everyone of us at the most fundamental level, our genetic code.

Further, and because of laws of nature, and means of which our genetic
code is inherited, this genomic information has information not about
that individual, but also about their relatives and the implications of
that on family members cannot be anticipated at this point, but it\'s a
factor that we must be considering in terms of the rules and ways in
which information is being used.

No other laboratory tests or other types of information have those
characteristics or special considerations. Privacy, security, and
confidentiality are key components of responsible stewardship of medical
information that we must all consider carefully. And to provide more
perspective and breadth on this topic about the underscoring convergence
about transformational, technological forces of our time, we have
assembled an expert panel to provide their views and snapshots of the
elements that they foresee as critical to personalized healthcare.

And at this moment I'd like to introduce them briefly, and then we'll be
prepared to \-- with the presentations.

To my left is Dr. Albert O. Berg, the professor and chair of the
Department of Family Medicine at the University of Washington school of
medicine in Seattle. Dr. Berg is a member of the Institute of Medicine
and serves in many roles in public service, including advisory roles to
the Centers for Disease Control and Prevention and AHRQ. Dr. Berg will
address the perspectives of primary care practice and the use of genetic
tests and applications of electronic health information for clinical
decision support.

He'll be followed by Dr. John Glaser, vice president, and chief
information officer at Partners Healthcare at Harvard and Cambridge. Dr.
Glaser is a scholar in health information management, and senior advisor
for the Deloitte Center for health solutions. Dr. Glaser will speak on
the use of health IT, electronic health record, as a means to accelerate
the translation and integration of genomic discovery science into
healthcare.

At the last meeting you'll recall, we heard from the Veterans Health
Administration about their interest in electronic health information and
integration of genomic information. Dr. Joel Kupersmith is here today as
the chief research and development officer from VHA. Dr. Kupersmith will
talk about his experience for planning for the adoption of genomic test
data into the VA's electronic health records system.

Following him is Dr. Janet Warrington, vice president of emerging
markets and molecular diagnostics at Affymetrix, Inc. Dr. Warrington
provides leadership to a number of public committees on the development
of industry standards for the integration of genomic technologies into
healthcare. Dr. Warrington will address the needs for standards and
emerging medical opportunities for applying technology in genomic-based
diagnostics.

She will be followed by Dr. Kathy Hudson, Director of Genetics and
Public Policy at the Berman Bioethics Institute, and Institute of
Genetic Medicine at Johns Hopkins University. Dr. Hudson will address
will address aspects of public concern and interest associated with
personalized healthcare, including privacy and security issues.

Dr. Brailer.

DR. BRAILER: Thank you, Greg. With that, unless there\'s any other
introductory comments or questions, I would like to turn it back to you,
Greg, to begin with the panel discussion.

DR. BERG: Great, thank you. My name is Al Berg. It's a pleasure to be
here, and I'm especially pleased to be in an auditorium named after John
Eisenberg, friend and mentor, who would have strongly been interested in
these proceedings.

I\'m chair of Family Medicine at the University of Washington. I'm also
immediate past chair of the United States Preventive Services Task
Force, a group making recommendations to clinicians about the preventive
interventions. And I currently chair a new panel sponsored by the CDC to
evaluate genetic tests for proposed use in practice.

And I'll get to that later.

But I'm also a family physician. Along with general internists and
general pediatricians, we comprise primary care in the United States.
OB/GYN on this slide is in parens, because it is sometimes included in
primary care, and sometimes not.

These three core disciplines account for more than half to all visits to
physicians. They are the first contact, personal medical home, provide
continuous and comprehensive care, and also especially in rural areas
take a community and population perspective.

My point here is that whatever we do in HIT and genetic testing, has got
to work in primary care. Because it\'s where most of us as patients
begin when we use medical care services.

Primary care physicians see common problems specializing in breadth and
in the ability to recognize patterns that suggest something unusual
might be going on. It is here in particular that information systems and
decision support offer their greatest potential.

High volume means that support has to be there fast and it has to be
there all the time. Importantly, things in primary care must recognize
that in whole population, rare things are indeed rare. This means that
tests with excellent performance characteristics in research settings
can still wreak havoc in primary care, because many of the positives, in
many cases, most of the positives will be false positives. And it can
take a lot of effort, expense, and patient and family anxiety to get
through it.

Primary care physicians are your ultimate empiricists, relentlessly
practice, and new test intervention must be available, feasible,
acceptable to the patient, it must be accurate and do what it says it
does. It needs to be reproducible and reliable, providing the same
answer or effect each time it is used. Importantly, it must provide \--
it must improve clinical outcomes \-- importantly, it must provide
improved clinical outcomes that patients would actually notice and care
about. And it should do this without increasing costs and without
increasing adverse effects.

Collectively, this list sets quite a high standard. It\'s one reason
that in the example of prevention, for example, with the preventive
services task force that uses these criteria, we give relative few tests
and interventions positive endorsements. We actually recommend against
many tests and interventions that various well‑intentioned enthusiasts
have proposed.

So, what about genetic tests? There are many points that could be made
here. But I want to focus on just so‑called genetic exceptionalism. That
is, idea that genetic information is a different kind of information
than that from other kinds of tests and assessments. We already have
many hundreds of nongenetic tests available that address risk, address
prognosis, address responses to therapy, and have ethical, legal, and
social consequences.

And further, many current electronic records can already accommodate
some test information and intelligently link it to other parts of the
record. Thus, the conclusion among many primary care physicians is: why
the fuss? Although no one denies the potential importance of genetic
information, many in primary care have a wait and see attitude.

The landscape is further complicated by the fact that there are
thousands of genetic tests already available. Many are for single gene,
rare disorders that primary care physicians don\'t deal with. But an
increasing number are for chronic, common diseases and intended to
advise on treatment for common problems. There\'s essentially no
regulation, buyer beware with both direct to physician and direct to
consumer advertising. You have only to enter genetic testing in an
internet search engine to see what I mean. My favorite site is "Who's
Dad?"

Many of us believe that clinicians and consumers need good
evidence-based advice on the use of genetic tests. The model is that of
the US Preventive service task force, which for more than 15 years has
been making evidence-based recommendations about preventive
interventions.

It uses a rigorous process that is transparent and publicly accountable,
and is not tainted by conflicts of interest. It recommends, for example,
routine screening for breast cancer, using mammography, but withholds
judgment on the usefulness of breast self-exam. It reached the
conclusion that there is not enough high‑quality evidence to recommend
for or against prostate cancer screening, and it directly recommends
against screening for some other rare cancers.

The CDC has convened a new panel, called EGAPP, Evaluation of Genomic
Applications in Practice and Prevention to develop methods that will
provide similar, evidence-based advice to clinicians about genetic
testing, and we've just begun the third year of our project.

The CDC is a principal sponsor, but we're participating, or partnering
with ARC evidence centers. The panel is non-regulatory, independent,
non-federal, and multidisciplinary. We went to extraordinary lengths to
minimize potential conflicts of interest, and the processes we are using
are as evidence based as we can make them, transparent and publicly
accountable.

We have six reviews underway, tests for early detection of ovarian
cancer, testing before placing a patient on a particular class of
antidepressant drugs, testing for familial colon cancer, testing to
advise on likely response to treating colon cancer, genetic profiting
for cardiac risk, and breast cancer gene expression profiling.

We have not yet released a recommendation. But I thought I would share
with you our general impressions so far. Basically, the quality and
quantity of evidence has been disappointing. Study designs are weak, we
can't get to some of the evidence because it\'s proprietary. There's
little evidence on benefits and harms, no comparison with current
approaches using non-genetic tests, no testing in typical patient
populations, little information about cost, little information about
ethical, legal, and social issues, particularly for family members. The
effect of genetic testing on family members, by the way, as Greg
mentioned, is one of the areas that is indeed special about genetic
testing, as opposed to other kinds of tests that only tell you something
about the patient, him or herself.

So I conclude that the potential for genetic testing is not in dispute.
It holds get promise.

But I counsel a wait and see attitude from the point of primary care. I
think it is very unlikely there will be much to work with over the next
three to five years. I also believe that current electronic records are
already developing capacity to take advantage of genetic information as
they already do for tests using other technologies. Recall that the
family history is still our best and most widely‑used genetic test, and
every record I have seen gives family history its proper place.

My experience with EGAPP so far, tells me that the single most important
hurdle to get over is this final bullet, the quality of evidence linking
any genetic test to measurable improvements in clinical outcomes in real
populations of patients. And the evidence has to be publicly available
for all of us to see it and to evaluate it.

And thank you for your attention.

DR. BRAILER: Thank you, Dr. Berg. Before we continue I'd like to ask
that anyone that is looking for a place to observe the meeting to be
aware that the overflow room in the lobby auditorium is available with a
video broadcast of this meeting. And so that\'s available on the ground
floor of the building. Thank you.

I will just open it for any brief comments or questions aimed at Dr.
Berg, mostly for clarification or for illumination of his presentation.
Otherwise we will move forward.

John?

DR. GLASER: It\'s a pleasure to be here. I actually have to leave at
10:00, so I don't mean to disappoint you all. So I'll be about half‑way
through my comments at that point, and we'll leave the rest in the
transcript for you to conclude later on here.

\[low audio\]

DR. GLASER: Joel knows exactly what I would say, which is the \-- and
he'll be able to turn the drivel into insight as I leave here.

Anyway, I\'m responsible for the IT activity at Partners Healthcare,
which you may be aware of. It's a large integrated delivery system ‑‑ I
think it\'s a lower case \"I\" up in eastern Massachusetts. We take care
of a lot of people in the course of a year as you can see here. We also
have a fairly substantive biomedical research enterprise, and we are
actively engaged in the training of tomorrow\'s healthcare
professionals.

Now, within Partners, and I think you'll see or hear similar comments
later, it's very clear to us that understanding a patient\'s genome and
the way that that genome interacts with a wide variety of variables is a
critical contributor to both the advances in biomedical research, but
also a critical contributor to our own efforts to ensure that our
physicians continue to make sound and safe diagnostic and therapeutic
decisions here.

So just listing an example of some research questions for which the
genome appears to play a significant role. Ten percent of our asthmatic
patients do not respond well to traditional steroid therapy and wind up
as repeat visitors to the emergency department and frequent
readmissions. Why is that? I mean, why do they fail to respond?

Similarly, as an example of a clinical question, the types of questions
we'd like to be able to help our physicians and other physicians answer,
is if I have high cholesterol, is there reason to believe I do need to
be taking statins or will diet alone do the trick? And there appears to
be a genetic underpinning as a basis for answering that question.

So questions like this, and a whole bunch more that aren't on here are
critical that we answer and critical that we be able to guide our
physicians both for the patients that Partners Healthcare takes care of,
but also for the people in this country and frankly, the people
globally.

Now, in the course of helping all of this research and clinical
activity, there is a non-trivial and relatively diverse IT, or
information technology foundation, which I will touch upon briefly in
the next couple of slides. So really, the core circle is that this is a
collaborative effort that we engage in, in the IS Group with the Harvard
Partners Center for Genetics and Genomics.

You can see, although it may be a little faint to you \-- you\'re better
looking at the print than the slide here. Starting in the lower right
there\'s a series of activities that is helping the investigator
understand the genomic basis of disease to the degree that it exists,
and understanding how a certain set of genetic variants interacts or
works to create a disease or manifestation of a disease. Why does, for
example, Huntington\'s disease, the date of onset have such variability?

So we need we understand why therapies work or don't work in particular
populations.

So going on to the lower left is a series of laboratory activities which
are designed and intended to do the genetic tests, both by those being
ordered by the investigator, and those being ordered by the clinician to
produce a result, an actionable result.

Going up to the top left is the incorporation of those into the
electronic medical record that guide these primary care physician and
the specialist in an ongoing treatment to management of a patient\'s
illness.

And then on the far right is the a creation of databases, which bring
together phenotypic data, along with genotypic data, and some relatively
powerful tools to allow investigators to understand why does this work,
why does this not work, and to pursue a series of biomedical research
questions, but also a series of questions based on the outcomes and
quality of care that we deliver.

Now what I'll do in the next four slides is will take one of these by
each here. This is the first. The acronym at the top, Harvard Partners
Center for Genetics and Genomics, and the IT work that has to be done
here is to create the ability for that laboratory to do genetic testing.
Again, you can see a physician on the top left, it could be a scientist
who works at the laboratory for molecular medicine group and says, this
is the test I'd like to perform. And then there\'s a series of analyses
that are done, a series of bioinformatics methods that are applied to
the results, leading up to, in the sort of middle, to the right there, a
geneticist, a genetics counselor says, given this variance that we have
detected in your patients or your research subject's DNA, this is what
it means.

This may mean that in fact you're at high risk of cardiomyopathy, this
might mean a particular regime for treatment of breast cancer is the
most appropriate regime, but this is what it means. You can see the
interpretation engine being a set of technologies to assist in that
interpretation.

So one sector is dealing with the laboratory functions of genetic
testing and helping that to run smoothly and effectively and things
along those lines.

Next area here, and we \-- as people often do, particularly in the IT
profession, is put screen shots where the print's so tiny you can\'t
tell what\'s up there, but trust me, this is what it\'s really intended
to say.

This is the result that goes into the electronic medical record. So we
have at this point a relatively focused series of activities to rule out
the MR use for about 3300 physicians across the Partners system. And now
in the last year we have begun to add genetic test results along the
variance so that they can understand what the results were, what they
mean, etc. And we're beginning to introduce clinical decision support,
surrounding the notion of genetics.

So, for example, if you order a particular chemotherapeutic regime, we
will test to see whether you've done the genetic tests to determine
whether this is going to be an effective chemotherapeutic regime or
ineffective chemotherapeutic regime.

We're going to begin to do some decision support regarding dosing, both
blood thinning agents and antidepressants to make sure we avoid toxic
situations where there\'s an inadvertent overdose as a result of limited
understanding of the underlying physiology. So incorporating this into
the practice that our physicians engage in.

Next one is here, we bring the data from the MR, which is now in partner
since early forms of this in 1976, just shows you how long it can take
to implement this stuff. And which have now, sort of broadened to
incorporate multiple, several million people and a lot of phenotypic
data. So we extracted from EMR, inpatient systems, et cetera, bring
together either through treatment reasons or for research reasons,
knowledge of genetic, and allow investigators to do, sort of, in
computer, clinical research, clinical trials.

So for example, in this case here, you may not be able to see, but the
database has a mixture of phenotypic and genomic data, and counters,
notes, etc. The question is, why after head traumas do certain patients
have seizures? But not all of them do. And it turns out there's a strong
correlation with the presence of the portion of the genome here, labeled
here, APPOES14 allele, allowing the investigator to target.

We expected these kinds of analysis, so a similar analysis identified 11
genes highly correlated with the aging process. Now there can be a long
way between that knowledge and the treatment of this, or the extension
of longevity here, but nonetheless we believe we can reduce the time and
cost of certain clinical trials and clinical research by two to three
orders of magnitude, which is a nontrivial gain in the discovery process
and we'll have to see how well that plays out in a variety of things
that we do here.

Last one here, and this is the NIH, as you may know, has authorized
seven national centers for biomedical computing. One of them is devoted
to understanding the IT infrastructure necessary to support
investigators looking at the genomic basis of disease, that has an
acronym of I2B2, informatics for integrating biology in the bedside. It
took us several thousands of dollars of marketing research to come up
with that relatively cute acronym, but it works.

But what it's done, is using four investigations, into Huntington's
disease, diabetes, asthma, and hypertension, is \[inaudible\] data that
we have obtained in the routine provision of care to develop the tools
needed by the investigator to be very effective at doing these kinds of
research.

It also deals with some very messy electronic health record data. That
stuff, as you may know, while it may be suitable for clinical use, is
often quite poor for research purposes, and so cleaning up the data,
resolving gaps in data collection, resolving biases of records,
recording by the physicians, so a lot of very hard, naughty, computer
science and bioinformatics problems that come with this terrain here.

Last slide here, while I think we are making good progress, we have
partners in other places across the country, across the globe, there are
\-- we're still quite early, and a whole lot of complicated questions.
Some of which deal with the IT infrastructure and the HR infrastructure
that goes with this. Some are broader, as you can see in the bottom,
that deal with reimbursement issues, privacy issues, how do you train
7,000 physicians to use this kind of testing effectively and know what
to do with the results, et cetera.

It's clear to us that while we would pursue these vigorously, we cannot
do this alone. So we have, in the last several months, reached out to
the University of Utah to have a collaborative development of some of
the technologies here. We've reached out to HL7 to begin work on the
transaction standards for the exchange of genetic test results, began to
reach out to the industry sector, HP in particular to understand a
variety of computational issues that go with this. And last but not
least, reaching out to some of our payers within our region about
reimbursement strategies and care strategies related to all this.

And last but not least, we look forward to reaching out to you all and
being engaged with you all as we advance the cause and the improvement
of the care for our patients. So I thank you.

DR. BRAILER: Thank you, John. Welcome, Mr. Secretary.

SECRETARY LEAVITT: Thank you.

DR. BRAILER: Any questions or comments for John before we move on? John,
I just had one clarification. You talked about structured genomic data.
Is that a structure or a standard that's developed at Partners, or where
does that knowledge base come from?

DR. GLASER: Well, there's a bunch of efforts \[inaudible\] that are
early and there are efforts to standardized a range of genomic proteomic
types of data and test results here.

So, not a Partner standard but there are nascent standards out there
that I think ought to be part of the work that John and colleagues will
continue over the course of the years ahead.

DR. BRAILER: Thank you. Joel Kupersmith.

DR. KUPERSMITH: Thank you very much. I\'m Joel Kupersmith, Chief
Research and Development Officer at the VA. I have been with the VA for
a year and a half and previous to that had previous administrative
positions in academic medicine, including chairman of medicine and dean.
And my research has been in basic and clinical cardiac
electrophysiology, later cost effectiveness analysis and now I write on
health policy.

And what I'm going to discuss are the very first steps and
implementation of a major new initiative for us, the genomic medicine
database of the Department of Veteran's Affairs.

Now to understand this, you have to understand the VA healthcare system.
We are a large system, with a \$34.7 billion budget last year,
5.3 million patients seen last year, 7.6 million enrolled, at least 1400
sites of care, including a substantial outpatient establishment. And
academic affiliations are the underpinning of care at the VA, and
clinician scientists are the backbone of VA clinical care, research, and
culture.

Our patient population is older, sicker, poorer, and loyal. We have less
turnover than private health plans and good adherence to clinical
trials. We also have changing demographics. Now 4.5% women, but in the
future this will be higher and 4.5% still represents over 200,000
individuals.

Now it has generally been considered that implementation of a large
genetic population cohort will considerably advance the field of genomic
medicine. And \[inaudible\] from striking familial diseases and
scattered tests to use in every day 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 its electronic health
record. This has been proposed by a number of individuals here in a
paper by Francis Collins, also by a Secretary\'s Advisory Committee
which issued a report recently.

Our attributes for this cohort are that we are a large healthcare system
with treatments in a variety of settings, a more stable population than
in other sectors. We have a research network that\'s integrated into the
healthcare system. We have an unrivalled electronic health record. We
have vehicles for, and considerable success in translation of research
findings directly into clinical care, and a substantial establishment in
what we call implementation research. And this is, of course, to provide
veterans with state of the art care. And we feel it is a strongly
veteran-centric initiative.

Our first steps in implementing this program is first an establishment
of governance. We have a federal advisory committee, the genomic
medicine program advisory committee consisting of leading authorities,
Frances Collins, \[unintelligible\], it\'s chaired by Dr. Wayne Grody.

We have an internal genomic medicine management committee, which
consists of a regional director, myself, one of the heads of this
initiative, Dr. Timothy O'Leary and the head of clinical care of the VA
in our office. We also have various committees looking at what kind of
genetic testing should be available be now.

We have a pilot project underway via our cooperative studies program,
which is our major clinical trials program. And we have collected over
30,000 specimens, and we have, right now, banking capacity for 100,000.
And we will address a number of issues including consents, financial
needs, and so forth.

We are now ready to broaden this pilot project beyond the cooperative
studies program and beyond the clinical trials framework, and that will
give us considerably more information about consents and various other
factors.

We are looking at project funding. We are looking to enlarge our
capacity in genomics, so we have established through a pharmacogenomics
RFA, pharmacogenomics laboratories, we have methodology RFAs, and other
research funding steps. As an independent process, we are establishing a
central institutional review board which should be in operation in about
a year or less, seven or eight months, and this will, of course, help us
with multicenter trials such as will be necessary in multicenter
studies.

We are developing computer capability to incorporate genomic data, and
looking very seriously at security. I should say that in research in the
VA we have never had a major security breach, but we have, since the
security breach at the VA, we have been considerably increasing our
security.

We are providing for educational needs, we are providing for educational
needs for veterans and our professionals, healthcare professionals
through CME‑type ventures, just beginning this, and looking, as
Dr. Glaser said, and Dr. Berg, at the computerized healthcare record to
provide information in the form of guidelines as perhaps decision trees
with nodes, with advice, references to the literature, and we hope in
the future information from our own database that will help in the care
of the individual patient that the physician or other healthcare
provider is seeing. And we\'re opening discussions with potential
collaborators and with the broader community moving in the same
direction.

And finally, what we consider the gorilla in the room is address the
ethical and privacy standards. We, of course believe, that high ethical
standards and beneficence is crucial. And our main vehicle for this, we
are talking to experts and we are talking to advisory committees. But
our main vehicle is to speak to veterans themselves. I have had
discussions of the leadership of major Veterans service organizations,
and will be setting up focus groups and other ways of getting
information back.

We believe that our practical needs for these kind of answers may serve
as a precedent‑setting construct for others. Thank you.

DR. BRAILER: Thank you, Joel. Any comments, clarifications? With that we
will turn it to Janet Warrington. Janet?

DR. WARRINGTON: Hi, I'm Janet Warrington, and I\'m leading a number of
standards initiatives and that\'s what I'm going to focus on today.

I would like to make the point, however, that personalized healthcare is
actually being practiced today. That treatment decision‑making, dosing,
and timing of treatment is actually, in many instances ‑‑ and there are
some examples here ‑‑ is based on information that's collected using
either clinical chemistry or molecular information. And that a number of
treatments are currently being used that use genomic technology in their
development and/or clinical trials. And so, there are some examples
there.

And I work at a company that ‑‑ it\'s a biotechnology company, that \--
it\'s a genomic technology company and our first FDA-cleared
microarray-based diagnostic test was cleared in December of 2004 with
our diagnostic partner, Roush Diagnostics. And, again, this is another
example of a genomic technology that\'s in use today. And this, again,
informs the decision about which patients are likely to respond to
different types of treatments.

So, we\'re not talking about something in the future. This is something
that\'s actually happening today.

Now, how do we think about this in the development of these diagnostic
tests? At Affymetrix, with our diagnostic partners, we really treat this
information in the same way that you would treat other information, with
clinical utility. You develop the test, so that it\'s focused on a
specific outcome. It\'s a intended‑used based algorithm where you
extract from the genomic information what you need to address a specific
clinical question. And so, what you see here on this slide is, basically
you start with an array that has a lot of information on it, a lot of
genomic information on it, and you can see an image of a scanned array
there. And you develop your algorithms based on the question that you'd
like to address.

So for instance, right now in development we have a leukemia diagnostic
that's in development, it's for the subclassification of leukemias, that
also includes signatures for related disorders that inform clinical
treatment decision‑making and information about infectious disease that
could also be relevant to that patient\'s well‑being.

You don\'t report the entire genome. What you report in the output is a
specific signature that\'s relevant to understanding the probability
that this individual has a subclass or subclasses of leukemia-related
disorders and their infectious disease status with that probability
information.

The other thing that\'s very important about this is that in every
single test, because we can put so much information on that array, we
build in multilevel control information. Manufacturing controls, assay
performance controls, and a like quality. That informs your information
about the data quality that you\'re getting off of that specific test.
And that is included in the output.

With our diagnostic partners, then, we've determined that the best way
to output this information is in an XML output. And it\'s categorical
information with probability information associated with it. So it\'s
not the entire genome, it's not a lot of information that you don\'t
know what to do with. During your development process, during your R&D
and product development process, and your multi-site clinical trials,
you build these reference databases that help you understand what these
signatures are telling you and how they can inform treatment
decision‑making.

So, there is evidence of the need to act now. And that\'s what I'm going
to focus on in the last few minutes here. At Affymetrix alone, one
microarray company, we have over 20 microarray-based diagnostic products
in the pipeline. These are in development with diagnostic partners now.

There\'s also an increased awareness in the value of harmonization
across this industry. There are many, many companies that are producing
tests based on genomic technologies. We all understand that and
appreciate that unless we\'re using the same terminology, the same
metrics for performance, that it will be very difficult for the end user
to really interpret and understand the information. So there's this
increasing amount of clinically relevant genomic information, there's an
increasing cost of development, but there's also an increasing awareness
of working together to develop standard controls and best practice
guidelines.

And this is an example of one of these initiatives. The external RNA
controls consortium consists of 175 stakeholders from 92 organizations
in 14 countries. What would get all of these people working together in
a voluntary effort, committing resources of their own initiative?
There\'s no regulatory recommendation or requirement for doing this.
However, we do have four divisions of the FDA participating in this. The
CDC's participating, the National Institute of Standards and Technology
is participating.

Industry initiated this effort because we all understand that a rising
tide floats all boats.

And that if we really want to get these technologies incorporated into
use in the clinic that we could really all help each other by developing
some consensus on the standard controls that are used, and the best
practice guidelines that are used for applying these technologies in a
clinical environment.

Not only is the FDA participating, but also regulatory bodies from the
UK, Europe, China, and Japan are participating in this effort. This
particular effort is really focused on developing well‑characterized
standard control materials for RNA‑based expression assays. And I'm
proud to say our first deliverable, our first milestone, was the
delivery of a guideline document that was published by the clinical and
laboratory standards institute in August of this year. So, we do have
now a guideline that\'s based on an ANSI accredited process for
developing consensus on guidelines for use in clinical applications.

Another initiative that I would like to bring your attention to that I'm
also leading is the clinical and laboratory genomic and genetics
standards initiative. This, again, is a volunteer organization. There
are 70 participants from 50 organizations in 19 countries, public and
private. We've come together to develop recommendations for
qualification of performance controls for DNA‑based tests.

There's a lot of expertise out there world‑wide. But people haven\'t
really gotten together in a room, shared what they know and developed
any sort of a consensus document around it. So we are really focused on
micro array‑based DNA genetic tests. We're also \-- one of our goals is
to develop a forum for driving the consensus on characteristics and
outputs of algorithms for DNA‑based genomic tests. And we propose to do
that by hosting three meetings worldwide. One in Asia, one in Europe,
one in the United States. Get the stakeholder community together and see
if we can build consensus on the way to move this forward.

So what I'd like to just to make a point about here is that this is
happening now. And if you look at the column on the left, all of the
black print, that\'s a description of what\'s in the pipeline, what's
being developed in the output that we've been developing for these
tests. So, in the top, in the blue box you've got new genomic,
diagnostics, and therapeutics, then you've got how we've been thinking
about electronic medical records, describing this information, putting
it out there in usable output.

On the right hand we have the issues with respect to access and impact
that we\'re all considering and working within the community, working
together, to really put this out there in the right way, in a way that
everyone will be able to take advantage of. Instead of having, you know,
16 or 60 silos worldwide where people are doing it off in their own ways
with no oversight, bringing that community together so that we can work
together and really build a foundation for moving this forward.

So, this is the right time to establish this standardized electronic
medical record infrastructure. And also the required standard controls
and guidelines for these genomic‑based assays. Harmonization benefits
everyone. And doing it early accelerates development, and these
development dollars are more efficiency spent when these standards are
in place.

DR. BRAILER: Thank you, Janet. Any questions or comments before we move
forward?

SECRETARY LEAVITT: I have a question that I'm not sure is best asked now
or later.

But I'm intrigued by the degree to which there are standards development
efforts that are collaborative that are going on intuitively. And I
think the reason that we wanted to have this discussion was to talk
about how the work of this group factors into those other efforts. And
how we can begin to create well‑established standards that integrate
into the things that we\'re doing with respect to electronic health
records and the adoption of the United States government and all of the
other players that are now committing to do that.

I don\'t know if we\'re going to have a conversation about how those are
currently interacting. If \-- I can defer until then, if we're not I'd
like to have one.

DR. BRAILER: We can do it anytime you like.

\[laughter\]

SECRETARY LEAVITT: We have one more presentation. I'd like to hear
Kathy\'s view and I would like to come back and have this conversation.

DR. BRAILER: With that, Kathy Hudson, thanks for being with us.

DR. HUDSON: Thank you for the invitation to be here with you. By way of
background, I\'m a molecular biologist by training and a policy wonk by
genetic predisposition. I've spent the last 20 years doing science and
health policy in Washington, spent seven years as the assistant director
of the Human Genome Research Institute, and with the completion of the
Human Genome Project, went on to found the Genetics and Public Policy
Center at Johns Hopkins where we conduct research, legal, and policy
analysis in order to facilitate sound, evidence‑based policy in the area
of genetics.

And I need the clicker.

FEMALE SPEAKER: Yes, you do.

DR. HUDSON: Thank you.

So there are a number of policy prerequisites for personalized medicine
and a number of them are listed here. I won\'t read them. Those in black
I will touch on very briefly.

The first is public confidence. I think in order to realize the promise
of personalized medicine we need to have a sustained public confidence.
Right now it\'s very clear that large majorities of the American public
approve of genetic testing and technologies for health related
applications, despite the fact there\'s a relatively low level of
genetic literacy.

The American public expects that the government is taking steps to
ensure the safety and accuracy of genetic tests. And large majorities
feel that insurers and employers should not have access genetic
information principally out of fear that that information will be
misused.

And we have a problem with trust. And I'd like to illustrate the problem
we have with trust by sharing with you \-- oops, I skipped over one. Can
I go back? Can you make me go back? No. Forward one. Thank you.

So we've done a number of focus groups with the public talking to them
about advances in science. And in the discussion about discoveries of
genetic variance that are more common in specific racial and ethnic
groups, people immediately started talking about how that information
might be used by the government or by the scientific community in ways
that would be detrimental.

And someone said, hey, that's not a problem. That's not a problem. And
in response, one focus group member said, yes, but you know what,
you\'re a reasonable person. We\'re all responsible people here. But
some of those scientists, because of the science, and because of their
warped minds, they will do something stupid like that. You know they
will.

This mistrust that the public has of the scientific community is
reciprocated by the scientific community. We did a series of interviews
with genetic scientists, and this quote illustrates a very widely‑held
view when asked about what\'s the public\'s role in genetics policy
formulation.

Uniformly, scientists said that they were very concerned about the
public having a role because they simply didn\'t understand. So, there
is a significant distrust on the scientists' part of what kind of role
the public can and should play.

Turning now to the issue of genetic testing quality. By way of
background, as Dr. Berg said, there are a thousand of genetic tests that
are clinically available today with many, many more in the pipeline.

The regulatory status of those varies significantly. A small handful
have been submitted as genetic testing kits to the FDA and have been
reviewed and approved by the FDA, including the kit that Dr. Warrington
mentioned.

FDA has recently asserted its authority over a subset of
laboratory-developed kits, and this has caused quite a lot of
consternation in the community. The Centers for Medicaid and Medicare
Services is responsible for laboratory quality, and that would assure
the analytic validity of laboratory‑developed tasks. And that\'s the
overwhelming majority of laboratory, of genetic tests. And currently I
would argue that CMS oversight of genetic testing in laboratories is
inadequate.

We recently conducted a survey of genetic testing laboratories in the
United States and we found that, reassuringly, overwhelmingly most
genetic testing laboratories are CLIA- certified, but 16% overall, and a
third of the highest volume genetic testing laboratories do not have a
specialty certification.

What\'s a specialty certification?

A specialty is basically a way of creating tailored standards for
particular high complexity tests. So there are specialties for
microbiology, toxicology, infectious diseases, other areas where there
are special concerns about being able to do those tests right. 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, and I think this is unusual in the regulatory world, a
large majority of the genetic testing laboratory directors supported the
creation of a genetic testing specialty at CMS. This is also supported
by a number of important organizations, the Personalized Medicine
Coalition, the American Society of Human Genetics, three advisory groups
to the Department of Health and Human Services and more than 100
companies, including Affymetrix, patient groups and provider
organizations. And so for over a decade we have been thinking hard and
deep thoughts about creating a genetic testing specialty. And in July,
CMS indicated that they were not going to pursue this.

I want to just touch on one of the issues that Dr. Berg mentioned, which
is the need to be able to translate what we know and what we don\'t know
about genetic tests so that it can be effectively used by healthcare
providers. Right now we have an important process happening with EGAPP
and we need to be able to translate the products of EGAPP into specific
clinical practice guidelines for the individual specialties and
subspecialties.

And ‑‑ click ‑‑ lastly, I'd like to touch on the issue of privacy.
Oftentimes people think that genetic information is special and should
be afforded special privacy protections. I think the right approach is,
in fact, the approach that was taken under HIPAA, which is to provide
the same level of protections for all information irrespective of
whether it\'s genetic information or non-genetic information.

We do have some new challenges to privacy, particularly at the
intersection between clinical information and research information,
particularly with the incredible proliferation of biobanks that are
storing a vast number of genetic samples that are linked in one way or
another to clinical information.

And under the current guidelines for the ethical conduct of research,
de-identified samples and records can be used in research without
expressed consent. And the question is whether, in this genomic age, any
of that is truly de-identified and so we, indeed, need to pay additional
information to that.

And then lastly, we need to put in place strong statutory protections
for genetic information.

So in terms of next steps, in terms of public confidence, I think we
need to earn it by demanding transparency across the board of all of the
participants in the personalized medicine revolution. We need to ensure
genetic testing equality by creating a genetic testing specialty under
CLIA, and by rationalizing FDA's approach to genetic tests.

For healthcare providers, we need to ‑‑ I think ‑‑ move the agencies
beyond just funding the research and development to develop these tests,
but beyond that to a sustained mechanism of helping those be translated
into health professional guidelines that can be used in the trenches.

And then lastly, on privacy and misuse. We need to enact statutory
standards and we need to rereview the policies governing the research
use of the de-identified genetic samples. Thank you.

DR. BRAILER: Thank you. Thank you to all of the panelists for coming and
spending time with us.

Mr. Secretary?

SECRETARY LEAVITT: As I indicated in the last meeting we had by
proposing we have this discussion, it\'s clear to me that what we've
talked about today ‑‑ and by the way, I'm very sorry I missed the first
couple of presenters. I did have a chance to review your slides in
depth. And while I don\'t pretend to understand them fully, I gathered
the essence of them. And I am persuaded in aggregate, as I believe all
of you, this much very much part of the future. And that 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, as they say in hockey: skate to where the puck\'s going to
be.

And it would be a shame if we did not anticipate this in our work.

I was intrigued as we went through. The presentations, as I indicated
earlier, with the number of standards efforts that were already taking
place that had intuitively come together. Frankly, we've seen the ‑‑
that phenomenon involved in other parts of electronic health records.
Today later we will have a conversation about HITSP's efforts to scale
down from \-- they had to sort through some 700 standards down to what
we'll consider today. I worry that we will begin to see that happen in
this area if we don\'t begin to work now in developing widespread,
collaborative efforts that will funnel into this broader effort.

So could I just the question of the panelists: 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. And that\'s the first question. The second is: what must we do to
integrate it into our larger effort?

DR. HUDSON: In the initiatives that I have been leading, this question
comes up. And even though there are lots of things to do with respect to
creating standard control materials, developing best practice
guidelines, there is a lot of concern about, then how will this
information be used?

We recognize that these controls are needed, the guidelines are needed
to enable the other. And we also have concern about getting our hands
around the other piece of it.

So just based on my experience in talking with people in this community,
we had a few attempts at trying to get people around the table to
address this issue informally. You can see that we have had some success
with the voluntary efforts in these other areas.

This effort, the electronic medical record initiative area is ‑‑ it\'s
just ‑‑ it has a completely different flavor to it from the perspective
of the enormity of the challenges, and the variety of stakeholders with
differing agendas.

And 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. That 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. And that\'s pretty much where we
left it.

Because it just seemed that it was bigger than any one of us.

SECRETARY LEAVITT: Thank you. John?

DR. GLASER: I think this is \-- you all ought to move all over this
stuff. I don\'t know what the next wave of stuff is for HITSP and what's
sort of lined up on deck. And there\'s a wide range of places you can
apply standards, performance of equipment, whether it's sort of in a
standard way leads to predictable and accurate results, guidelines for,
under what conditions should you order a genetic test and how should
that affect the treatment decisions, but if you just focused on the
data, storing of variants, storing of proteomic information and what are
the standards and the vocabularies for that.

We are doing that now as are others, and there are early efforts, but
obviously if we\'re five degrees off or 50‑degrees off, we\'re
replicating this problem and reducing the surability or the \-- for
research purposes in others.

So 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.

Another area which is a little unusual for the genetics is we have these
tables that say this variant means this. And this guides our doctors and
our people about what to do. But there\'s a lot of discovery going out
there about this variant means this, and the ability to exchange variant
information. And so whether it's developed at Utah or UCSF or University
of Texas, is there are ways to exchange that knowledge base such that
when we see these variants, we are more informed and kept abreast of the
discoveries of others.

So there is, I think the timing is terrific to go out and do this. There
are other early efforts. HL7, for example, in our case is being involved
in this stuff. So, I would encourage this conversation, this community
to proceed in that, again, not knowing what else is on deck for HITSP.

DR. BRAILER: Thank you. Joel?

DR. KUPERSMITH: 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 the providing of beneficent ‑‑ doing this in a
beneficent way.

But we are absolutely delighted to sit at the table for all these
discussions, and since the father of the VA electronic health record is
sitting on that side of the table, Dr. Kolodner, 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. BERG: Just, again, from the primary care perspective, let me comment
that the lack of standard ways of recording this information, electronic
records is not the problem primary care physicians have. The problem
primary care physicians have is the lack of evidence that the tests lead
to clinically important improved outcomes.

So that 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.

SECRETARY LEAVITT: Any other questions or comments for this panel? Yes,
Kevin?

MR. HUTCHINSON: Just one question, and this leads to the primary care
office, also, around technology is, do you find the storage and sharing
of this information to be on top of readily available commercial
platforms, regular relational databases or do you find this as something
that is probably not a product that can be commercialized into a single
family practitioner office as part of an EHR system? So when you\'re
storing this information and trying to share this information and
evaluating the information, is this something that runs on a standard
platform, like a relational database‑type platform?

DR. GLASER: I think, Kevin, we still have a long ways to go. But by and
large, the storage demands of a test result are not significant. The
decision support methods can be different. They are usually
\[unintelligible\] and if then, these are quite \[unintelligible\],
levels so you have different models at play. So we\'re not quite sure
yet how to insert new methods into the usual engines that run behind
these products.

There are displays and we\'re still working with the doctors, how do you
display? So a physicians says, golly, I don\'t know what this test does,
and how do I act on it, et cetera, so how do you convey in just-in-time
fashion?

What it doesn\'t appear to necessitate is a full‑scale re-architecting
of today's products \[unintelligible\]. That doesn't mean it will be
immune from the changes but it doesn't appear to be full‑scale.

On the investigator side, you can get phenomenal amounts of data. I
mean, so you \-- we\'re in the petabyte conversation on a couple of ‑‑
for those of you not IT, that's really big, I mean, like, really big,
just think of it that way.

So, but there storage demands can be very different, and the challenges
to the infrastructure can be much more significant. They don\'t appear
to be draconian. They appear to be, frankly, relatively modest. We'll
have different issues about how do you work with physicians to really
understand the right result and how to interpret and how to act on it,
and with the plans about where should you reimburse and not reimburse on
this kind of stuff. So there are thornier issues there.

DR. KUPERSMITH: Just to follow‑up on the comment on primary care, I
mean, the purpose of our database is to provide the data for primary
care physicians to be able to use this genetic information in their
daily practice. And hopefully there will be an aggregation of studies
and data to do that.

We also have a fair amount of experience and use of the electronic
health record for physician decision support and educational purpose and
other areas and, it of course, is a lot more complicated. And there\'s
sometimes an issue of mother deafness that, or parent deafness, that,
you know, the physician is barraged by too much information. So I think
there are a lot of aspects that we have to be careful.

DR. BRAILER: Other comments, questions?

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? Janet, you mentioned a few. Al,
you mentioned one at least. John, you implied some that sound like
they're more incorporated into existing standards efforts.

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?
Janet.

DR. WARRINGTON: When we jumped into this a few years ago, we \--
Affymetrix \-- thought there must be some such collective activity
happening. And we hosted a meeting, frankly, so that we could inform
ourselves and meet the people who are the experts who are driving this,
to learn about something like that.

And what we found was that there were lots of activities going on, but
no collective information, no report, survey. And, in fact, one of the
outcomes of that meeting in meeting with stakeholders from around the
world, who are very active in the standards community, was the request
and the desire for even a single website 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. So I
don\'t know of any such survey report.

We initiated a website as an outcome of \-- it was an activity of the
CLGGS, to establish a website where people could go to get that kind of
information. And it was associated with Affymetrix initially, but we
really wanted to try to move it to a more neutral site. And I spoke with
a number of people at different institutions in the United States, as
well as other organizations worldwide who are associated with standard
setting efforts. And IFCC eventually offered to host that standards
site. So, I wasn\'t able to get anyone in the United States to support
it. But the International Federation of Clinical and Laboratory
Chemistry offered to host that site. Just as a place where people can go
to get this information or people can deposit their information about
their standard‑setting initiatives.

DR. BRAILER: Mitch.

MR. ROOB: Thank you. Probably the term ‑‑ I guess it\'s on. We\'re very
excited about the opportunity to use the \[unintelligible\] and other
products in diagnosis for the mentally ill. To deal with issues of what
is now a very crude way to discern which drug works best for that
particular individual. Apparently liver functions, other functions
within the different individuals make some drugs appropriate and others
not. And we are hopeful that the \[unintelligible\] holds up promise of
helping us make that determination.

We spend a lot of time in this committee talking about the \-- what I
would refer to as more clinical as opposed to ‑‑ clinical medical care
as opposed to mental healthcare.

And I wonder if any of you can comment where you are with using this
kind of diagnostics for the mentally ill and the developmentally
disabled community and how that plays into issues of dealing with these
chronic conditions.

DR. BERG: Let me comment that I have in my briefcase the draft of EGAPP
report on the \[unintelligible\] amplichip and diagnosing patients with
their first diagnosis of depression, and whether or not they should be
on which SSRI and at what dosage. And without telling you what the
recommendation will say, what I can tell you is that there are no
randomized trials showing that an average patient with a new diagnosis
of depression, if tested with an amplichip leads to a clinically
different outcome in three months or six months or twelve months
compared to a patient that hasn\'t been tested.

Which is not to say it might not be a good idea to test. But that 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.

So amplichip has enormous promise. All of us in primary care hope very
much that tests like it can be helpful in mental health diagnosis,
because a lot of mental healthcare, as you know, is performed in the
primary care setting. But the evidence is disappointing at this point,
in my view.

DR. GLASER: We have, I know at Partners, some more going \-- we can get
the sort of genetic basis, genetic predictability of certain types of
mental health issues.

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. And so both there, and in \[unintelligible\] is to see
whether you can do better predictive initial dosing guidelines again, to
\[unintelligible\] over the risks that go through that.

So I know it is going on, and I don\'t have the specifics here.

MR. ROOB: We seem to disconnect between the clinical medical record and
when I talked to my colleagues in mental healthcare, in getting that
data into the mental healthcare record, there seems to be a big
disconnect there. And I think this panel or some other panel might want
to look at how you get that kind of information into the mental
healthcare record where it seems to be a generation or two behind where
we are in this commission, this committee.

DR. BRAILER: Bill Winkenwerder.

DR. WINKENWERDER, JR.: 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
and what sort of polices are you aware of?

DR. GLASER: I'll speak. 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 it
is probably not standard practice if you leave outside the academic
health center realm. But in this case we keep it in perpetuity.

DR. BERG: I would make one comment. We don\'t destroy things either. But
the technology moves so very quickly that there is a real problem with
just keeping up that the ‑‑ 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. So, being able to take the information that make sure that
even though you don\'t lose it, you've updated it appropriately, I think
is an enormous challenge for the field in the future.

DR. BRAILER: Rob Kolodner?

DR. KOLODNER: Thank you, David. What I'm hearing from the panel is
really the emergence of four different areas that need to be addressed,
and maybe more. But one at the very top is, we need to have more
research and evidence about the practical value of the genomic tests in
clinical practice. And there needs to be more research in order to
identify those tests that, in fact, are ready for widespread clinical
use, although there\'s probably a slightly different threshold for the
use in the academic settings, now.

Below that 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 scale, the technology scale of having to have
standards for storing and representing that data and that we don\'t have
that yet. But the standards for that sound like they're different than
what we have dealt with in the first breakthroughs because it ‑‑ as
opposed to what HITSP was doing, which was harmonizing across existing
standards, right now they\'re not standards that are yet at a point
where they need to be harmonized. We need to bring the groups together
to actually ‑‑ or at least somebody needs to. And if that\'s the
government, then we need to bring the groups together to develop those
standards, which can then go through the HITSP process.

And then finally, overarching all of this is the policy and where the
policy issues and the privacy issues that need to be dealt with as well.

DR. BRAILER: And if I could drill down on the latter point and direct a
question, at least to Kathy, if not to others.

Kathy, you implied that more or less the genomic privacy issues can
largely be dealt with under the existing structures that have been
considering privacy. And let me make it very specific to AHIC.

We have a Privacy and Security Workgroup that is looking at crosscutting
privacy and security issues. And as we think about how to create
structure for evaluating policies in the future, are genomic privacy
issues more akin to themselves or are they truly more like other tests,
in that ‑‑ 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. HUDSON: I think the privacy considerations need to be considered
throughout all of the Workgroups. But 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.

That being said, that doesn\'t really argue that existing protections
are adequate. And I think one of the issues that maybe your Workgroup is
looking at is who is really a covered entity under current regulations?

There are now new companies that are springing up with electronic health
information for you, there are companies that are doing, offering
genetic testing over the internet, and have that information. I don\'t
believe that those are covered entities currently, and the question
would be should we make them covered entities and play by the same
rules?

DR. BRAILER: Al.

DR. BERG: The point of concern in primary care, of course, is the family
members. Especially in family medicine where we often see all family
members. Privacy, 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 very significantly different problem than sharing other kinds of
medical information. That's one of the unique things, I think, about
genetic testing.

DR. BRAILER: And have there been policy discussions or evaluations of
that question to begin proposing answers, or is this still an emerging
question?

DR. BERG: I think \[inaudible\] would probably know better.

DR. HUDSON: 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 so they have
created guidelines for that.

But I would argue that while genetic information, and particularly DNA
test information gives you a new precision, perhaps, that we've known
that things run in families for a very long time. And we've known that
if one family member is at risk, that maybe we should look at the other
family members, as well. So again, I think it's just \-- it's a matter
of degree here and not a totally novel phenomenon.

DR. BRAILER: Joel.

DR. KUPERSMITH: Just on the privacy issue, the sense of our advisory
committee is similar to what Dr. Hudson said, that this should be
treated similarly to others. I'm not sure, though, it's going to be the
sense of our constituency. And I think the two issues are the privacy,
but the most important issue is the use of the information that may be
available. And I think we need a lot of work in that area. That\'s
really where I see us coming down for the future.

DR. BRAILER: Great. Thank you. Kevin Hutchinson?

MR. HUTCHINSON: I have a two‑part question. On standards and on ‑‑ John,
you don\'t need to run off. I\'m just kidding. I know. I\'m just boring
you! Over and over and over.

\[laughter\]

It\'s really a two‑part question. On the standards work that's going on
now, is this through an ANSI accredited standards delivery organization?

And the second part of the question is: one of the work that AHIC
focuses on is on standards and other work is on use cases and that's
where, actually, the Workgroups focus a lot on those use cases. Do you
see, is there a use case that the panel would suggest would be
appropriate for a Workgroup to focus on when looking at this topic?

DR. WARRINGTON: The external RNA controls consortium was initiated by a
group of folks in industry and then everyone was invited to participate.
The National Institute of Standards and Technology is participating. As
I mentioned, four different divisions of the FDA and so on.

Our meetings are announced in the federal register. We try to hold
meetings in Bethesda.

The FDA has generously provided a place for us to have these meetings as
has NIST \[spelled phonetically\]. So everything's published, put out in
the public, and everyone is invited to participate.

The protocol document that was developed for the use of external RNA
controls and expression assays was developed as a CLSI product. So, the
Clinical and laboratory Standards Institute was the harbor for that
document development. And those protocols will be useful with control
materials, like what is being developed by the ERCC.

The control materials that are being tested by members of the ERCC are
being deposited at NIST, Open Access, the sequences have all been
deposited in GenBank \[spelled phonetically\], and all of the materials
have been donated by members of the stakeholder community with no
strings attached.

The ultimate goal is to develop those as a certified reference material
and publish all of the information about their characterization so if
other people would like to develop other materials that are similar to
these, there\'s a reference point.

For the CLGGS, it\'s very similar to that. The focus is more on DNA, but
it\'s open to the public. Anyone who wants to participate is invited to
participate. We\'re really trying to do this in a way that will be just
unquestionable from the perspective of the ways of working and the
methods for moving forward.

Did I answer \-- what was the second question?

MR. HUTCHINSON: Use case.

DR. WARRINGTON: Use case. I think we can probably set up some models
based on the way the external RNA controls consortium work is being
developed. And, in fact, every micro RNA manufacturer has controls but
they all have their own controls. And what we need is some
standardization across the industry. And so, I think you could probably
develop a use case around that model.

DR. BRAILER: If I could just drill down on both Kevin and Rob\'s earlier
point. I think Janet, perhaps to you, but to anyone who would comment.
In addition to the standards being more emerging rather than in need of
harmonizing, it seems like the groups that are developing the standards
have other functions that go beyond information standards.

For example, the use of the tests, research advocacy. There\'s not
something that\'s akin to a standard\'s development organization and the
health information paradigm that is a stand‑alone group that is focused
only on structure and standardizing information; is that right?

DR. WARRINGTON: That\'s right. So for instance, I'm leading both of
these initiatives and it\'s because Affymetrix understands and
appreciates the value of moving this area forward to advance the use of
microarray technology in clinical applications. So, no, everyone
participating in this ‑‑ it\'s the stakeholder community. It\'s regular,
it's representatives from the regulatory agencies because they want
access to this, they want to understand it and they'd like to have a
voice on how these things are developed and produced.

It\'s diagnostic companies and pharmaceutical companies, because this
will help them with their development efforts. And then we have people
from the clinical community who would like to inform and influence the
direction that this takes. So it really cuts across private and public
sector. It\'s government laboratories, academic laboratories, clinical
laboratories, and biotechnology, pharmaceutical, and diagnostic
companies participating.

DR. BRAILER: Okay. Thanks. Julie.

DR. GERBERDING: Point of clarification. 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. BRAILER: I don\'t think it\'s inherent to the data, Julie. I think
the question is one of, is there a set of standards organizations that
are working on health \-- genetic information that can be standardized?
So it's both the maturity of the standards themselves and also whether
or not those organizations are subject to the jurisdiction of HITSP.

And so, you know, 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.

Nancy?

MS. DAVENPORT-ENNIS: Thank you, panelists for your presentation. And
there are just a couple of questions that I have and two remarks that
I'd like to share.

Dr. Warrington, I was particularly fascinated with your discussion of
the external RNA controls consortium, as well as the clinical and
laboratory genomic and genetics standards groups, and the representation
of those entities that are participating in the discussions. I\'m
certain that as open meetings, they are open to patient organizations as
well as to consumers.

But if I might invite you to invite, with special energy and enthusiasm
their participation, I think that as you move forward and once these
initiatives are clearly defined and introduced to America, there may be
a greater support for the task if the consumers feel that they've been
integrated throughout the whole decision‑making.

Dr. Hudson, I think that your remarks are particularly cogent to
consumers. 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.

I commend you for citing the need for strong statutory protections and
it was interesting to hear a number of the panelists cite that indeed,
we do have to look thoughtfully at privacy and security. And we do, at
this time. have an opportunity to supplement the statutory authority
that we have in this regard.

So thank you, again, for citing that in your remarks. You did begin your
comments by saying that for us to be successful with personalized
medicine, that we have to have public confidence. And I think if we can
have answer the global question around how do we secure this information
and protect secondary use, and protect families, then, indeed, we can
build the public trust that's necessary to move this forward.

It\'s very exciting and I thank each of you for your presentations.

DR. WARRINGTON: Thank you, Nancy. I would like to comment that the
Genetic Alliance and the Breast Cancer Coalition have been very involved
and do participate in the meetings, they're invited and they receive our
monthly summaries. But it's \-- I\'m glad you raised that point. It\'s
an important point. And ultimately those are end users and we\'re
engaging end users in these efforts.

DR. BRAILER: Joel?

DR. KUPERSMITH: As stated, we are starting with talking to our
constituents in the Veterans Service Organizations and veterans
directly, and I think it bears watching what develops from that, and
what their concerns will be. Because I think it may say something to the
community at large.

MS. DAVENPORT-ENNIS: And I would agree with you particularly since that
particular population already has a demonstrated desire to serve this
United States.

You may have very ready participation with that community. Thank you.

DR. BRAILER: Kathy?

DR. HUDSON: There was a mention of the proposed study to follow half a
million people or more over a period of time to dissect out the
environmental and genetic contributors to health and disease. And I
think the positioning of the NIH on this is one that we should all
applaud before really even getting down to design specifics. They have
undertaken to hear from the American public about what are the areas of
optimism and concern about such a study. And would they be more
concerned or less concerned about their genetic information versus other
potentially stigmatizing health or behavior‑related information. And so
that has recently gotten underway and should deliver some very important
findings for us.

DR. BRAILER: Lillee?

MS. GELINAS: Just one quick question. I understand the VA genomic
cohort, but is the Department of Defense tied in down in any way to the
work either through governance or participation? I don\'t quite
understand how that works. Because I know in our last meeting you
mentioned that the DOD has a very large bank of genetic information; is
that correct?

DR. WINKENWERDER, JR.: That is correct and we\'re in regular
communication through a variety of forms and Workgroups and, of course,
Rob has worked very closely with Carl Hendricks, our chief information
officer. And so, we\'re learning about the VA's initiative, and we've
got our similar sets of issues. So I think it makes great sense that we
would try to proceed down a similar pathway and take advantage of the
respective experience and skill sets within both our organizations.

DR. KUPERSMITH: Absolutely. And I would add that we are going ‑‑ going
down that path in a number of other areas as well. It\'s not only
genomics but much more than I think has been done in the past.

SECRETARY LEAVITT: Dr. Brailer, I think this has been a very good
discussion. I am persuaded that this is a ‑‑ such a significant part of
the future that 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.

And 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. There will be a series of things that this Workgroup
could do. Dr. Brailer, do you have any thoughts about how we could or
should structure such an undertaking?

DR. BRAILER: Mr. Secretary, just reflecting on this conversation as well
as the last discussion that we had here, it seems to me that there are
five points a Workgroup could pursue if formed by the American Health
Information Community.

This is somewhat different that other Workgroups where the work was so
clear that we could simply go right to developing use cases. So I think
here, I would propose the following five for consideration by the
American Health Information Community.

First, is to survey existing efforts that are developing standards, or
that are influencing the standards for genomics and genetics
information. And to compile that to determine who the constituents are
and what their roles are and where there could be missing constituents,
or where there could be overlapping or duplicative constituents.

Secondly, to propose a role for HITSP and the other related health IT
mechanisms that have been established. The institutions that are
underway to determine is this like every other test or type of
information, or is there, in fact, some unique issues that should be
considered here, either because of the maturity of the standards or
because of their unique characteristics.

Thirdly, to determine and develop a plan for how genomics information
standards could be deployed over the next two years with a particular
emphasis, and obviously with some attention to the longer term.

Fourth, to evaluate the privacy and security considerations, and to work
in collaboration with the Privacy and Security Workgroup in carrying
those forward. So we both have the commonality of other privacy and
security issues, but we do have a group charged to pay particular
attention those family issues or DNA identification issues that could be
quite unique to this information.

And finally, two proposed use cases to actually come forward after this
process with use cases that can help us begin the process that has
worked, I think, relatively well for the Workgroups, to focus on a few
specific things that can help move this agenda forward, whether they\'re
about primary care usage or something that could perhaps on the more
clinical research side, I think that's an open question, to propose
those.

Those seem to be the five areas, Mr. Secretary, that have come from this
discussion to me, that \-- where this Workgroup could make a
contribution that is unique without stepping into the entire universe of
genomics and proposed medicine.

MR. SEROTA: A comment that I'd make \-- I want to make sure we don\'t
lose the comments by Dr. Berg about the utility about the information.

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.

And rather than putting it at the back end, I think it should be at the
front end. I mean 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?

Let's start out with, what is it that would help you in your practice,
and let's build our standards from that end as opposed to building our
standards from the scientific side, or the theoretical side first. I
think we need to start at the practical side. So I'd encourage us to
take to heart Dr. Berg\'s comments and work through \-- I mean, I don't
see Doug, Doug's not here today. He would be waving \-- oh, he is here.
Where\'s the flag for me?

DR. BRAILER: Scott, to that end, and perhaps I could turn this question
back to Al of others, I didn\'t propose that because my sense was that
EGAPP and others are actually looking at those particular questions and
I just didn't want to create a redundancy here.

But if that\'s not the case, clearly that is job one. So Al or others,
could you comment, is the work efficacy \-- does it already have a home
in a Workgroup or elsewhere?

DR. BERG: Let me \--it\'s been wonderful working with the CDC and the
partner ARQ on the EGAPP project. We\'re two years into the project.
We've been able to look at six tests out of more than 1,000 out there.
And even in our wildest dreams we don\'t imagine that EGAPP by itself is
going to be able to address the comment that Dr. Serota made.

We believe that it\'s an important issue that needs to be brought
forward. We hope that our processes can be used by panels other than
EGAPP in order to get through a larger volume of what\'s out there. But
we certainly would agree with the sentiment that, from the primary care
perspective, and from the perspective of any practicing physician,
utility and usefulness and value to the patient is where we need to
start.

DR. BRAILER: So I would take that as an amendment to my proposal. In a
particular way, Scott, which would be that where we look at the proposed
use cases, that the primary attention is given to where, either EGAPP or
others have identified that there is some clinical utility. So we're
starting with our use cases and focusing the overwhelming share of our
attention on what trickles out directly into care. Does that help?

Good.

SECRETARY LEAVITT: You've heard the proposal described. Are there any
other comments with respect to this matter?

Kevin?

MR. HUTCHINSON: Two comments. One would be, and David's laid it out
nicely to make sure that we don\'t have overlap with some of the other
work, and especially the privacy and security issues that go along with
that.

But the proposed role of HITSP, I think, has a certain charter with
looking at harmonizing existing standards that are out there. I struggle
with the role HITSP would play in such a, as you mentioned before, the
maturity level of the standards in this particular space, versus a role
for an NCBHS or some other ANSI accredited organization to identify
standards, work that needs to be done versus the harmonization of
existing standards. That would be a change in charter, almost, of what
HITSP would be doing. That's the one I can't quite put my arms around.

DR. BRAILER: Well, I certainly take that as an important amendment of, I
think, the very rudimentary idea I threw out. That what I think should
be done by this Workgroup is looking at the health IT structures,
whether they are SDOs or HITSP or another body that's underway, that
could include NCBHS or the HIC itself to say here's the role that you
should play.

But to not treat it as an open question that those roles would
naturally, spontaneously come about, maybe this Workgroup needs to think
about who should take point on bringing standards to ground. And perhaps
it's already resolved practically and it just needs a name. Or perhaps
it\'s not. I wasn\'t presupposing that HITSP had any necessary role in
this at this point.

SECRETARY LEAVITT: I would \-- I'd like to suggest in the interest of
time, that we ask the ONCCHIT staff to bring back to our next meeting a
fleshed‑in proposal as to what this should look like, the kind of people
it needs ‑‑ the structure and proposed members and that we can have ‑‑
that will be circulated in advance of our meeting.

We can have a robust discussion as to exactly how this should be
directed. But it appears to me that, at least I'm sensing from you that
there is \-- 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.

Having accomplished that, I believe there is a break scheduled next. Am
I correct?

DR. BRAILER: That\'s right, Mr. Secretary. Until 10:35. Thank you very
much and I appreciate the panel\'s work.

SECRETARY LEAVITT: Thank you.

\[break\]

DR. BRAILER: We'll now resume. We'll now resume with two overviews ‑‑

That\'s all right. You have to do it three times.

We will now continue with two brief overviews of areas that have not
gotten attention at the Community as it relates to health information
technology. One is population health and the other one is clinical
research. And here for these very brief synopses are Terry Cullen from
the Indian Health Service to talk about population health, and Anthony
Hayward, from NIH, to talk about clinical research.

And with that I'll turn it to Terry Cullen.

DR. CULLEN: Good morning. I'm Terry Cullen, I'm a family medicine doc.
I'm also the Chief Information Officer for Indian Health Service. I\'m
here to talk to you today briefly, five minutes, as a presentation from
the Interagency Health IT Policy Council on the need for population
health to be attentive with the AHIC.

As you may be aware, population health is contained in many of the
activities that have already been discussed within the AHIC, use cases
and priority areas. On the slide here what you see is many areas that
are enabled by population health itself. At the current time, however,
as you are aware, the majority of electronic health records focus
primarily on a provider perspective or a patient perspective.

If you go back to the minutes from the last meeting you had, in fact,
Dr. Painter talked about sustainable high value care for all. In his
proposal, he elicited, and in fact acknowledged the need for many health
data sets from a population perspective that are in fact currently not
available within the majority of the electronic health record solutions
within the United States.

The reason for that is that the focus has been primarily been,
appropriately, on the provider, as well as, as we\'re seeing the patient
at the current time. However, in order to enable and facilitate the
gathering, aggregation, evaluation, lots of verbs, use of population
health, the electronic health records themselves need to be designed to
facilitate that.

As was alluded to in the previous discussion, and as we go from the
micro there to the macro here, what we acknowledge in population health
from an electronic health record perspective, is that there probably are
true architectural differences that need to be acknowledged up front
from a health IT perspective.

In addition, the ability to do data modeling, data logic, to have a
metadata registry and to facilitate \[unintelligible\] and/or on the fly
are what need to be incorporated into the electronic health records in
order to get and enable the population health activities you see on the
screen.

The current state of population health IT, as many of you are aware is
primarily through the use of registries. Data populates an electronic
health record; for most people it\'s passively pulled into a registry,
and at that point queries are done on the registry.

However, that limitation, using solely data fields that currently exist
in registries means that we eliminate the robust functionality that we
are embedding in to the current electronic health records solutions.

It is critical, I believe, at this time, to look forward to go to where
the puck is going, to preempt to what Secretary Leavitt said earlier
today, to try to engage and ensure that the design of the current
electronic health records will not only facilitate our ability to do
population health, but in a sense, embed population health knowledge
within the context of the individual patient, and hopefully the provider
that is seeing that patient.

So, as we look forward, we need to look at the patient perspective, the
provider perspective that has been well‑addressed by the current works
of the AHIC. But in addition to recognize the need for the population
health to be, in a sense, the background of what we do. To acknowledge
that if we truly want to look forward to the elimination of health
disparities, the improvement of health status for Americans, we have to
be able to passively acquire that information in health IT solutions.

If we look at the benefits of using health IT, you'll see them up here.
At the current time, we believe that population health IT will
facilitate the monitoring, it will increase effectiveness, and we
believe efficiencies of population health activities.

However, in order to do this, there are many near term opportunities
that need to be addressed. As I previously alluded to, the data
architecture on the back end of the health IT solutions has not been
formally described for how to get at and ensure that the
\[unintelligible\] logic is incorporated and available for population
health activities within the current standards of the electronic health
records.

Clearly there are other issues: privacy and security that can be
addressed through current HIPAA endeavors. However, the need to ensure
that data sets can be pulled passively, used for populations, used for
multidirectional reporting, requires us to work specifically on the
development of these specific needs for the near‑term opportunities.

As you are aware, population health is alluded to in many of the current
cases that the AHIC has taken on: quality, electronic health records,
chronic care. There's already the incorporation of the concept of
population health within those.

However, the need to specifically address what are the architectural
components, what is the data mapping, the previous things I've alluded
to within the electronic health record, to hopefully eventually use them
to help set standards for EHRs in the near term as opposed to the
long‑term, I think present an immediate opportunity for the federal
government.

Thanks!

DR. BRAILER: Thank you, Terry. Why don\'t we continue with Anthony and
then we'll open it up for discussion.

DR. HAYWARD: Good morning. I\'m Anthony Hayward, and I direct the
Division for Clinical Research Resources at the National Center for
Research Resources, which is a component of the NIH. And I'm here, this
morning, to tell you about the relationship between clinical research
and health IT, and why it\'s going to be important to continue to
integrate the two.

The first point I need to make is that clinical research improves
healthcare. Almost all the treatments we currently have available could
do with some sort of improvement, and the role of clinical research is
to make that improvement possible.

My second bullet is an example of a definition of clinical research, and
the important words here are "benefit" because that means provide a
treatment that is better than what is currently available and that
implies comparison. And the things that are compared are data, that's
clinical outcomes data and laboratory data. And they need to be compared
to identify the best treatment, in head to head comparisons.

Now clinical research has brought enormous benefits. And to put the
topic into perspective, it\'s worth considering some examples. We have
seen enormous increases in life expectancy, and that means avoiding
heart attacks and strokes, and we do that by interventions such as
reducing high blood pressure and controlling blood cholesterol levels.
But clinical research has impact in specific diseases, too. And most of
us now know long‑term breast cancer survivors owe that survival to Taxol
and Gleevec having a comparable effect in chronic myeloid leukemia.

Now the medical research behind this is enormously costly. The 2004/5
figure is approaching roughly \$100 billion. Roughly half of that is
spent on human subjects research, that\'s clinical research. Now these
costs, of course, are tiny compared with the cost of delivering
healthcare. And Dr. Zerhouni calculates that the cost savings from
reductions in mortality from coronary artery disease exceed about
\$2.6 trillion.

Health IT has already brought enormous resources and benefits to
clinical research. Principle amongst those, the creation of standards
that allow for structured data flow. And if I were to emphasize anything
that we depend upon, it is the creation and implementation of those
standards.

Electronics really has taken over communication between the principal
parties, so that researchers, healthcare providers, and patients can all
communicate by e‑mail. However, some 60% of clinical trial data and
adverse event reporting is still done on paper, and that paper is faxed.
A very slow and inefficient process.

My third bullet refers to the enormous amount of data that is stored.
And you heard from that earlier from the Partners organization that data
serving is the basis for all of the comparisons that are made. There are
enormous opportunities for health IT in clinical research.

When in my first bullet I say facilitate patient access to clinical
trials, I mean disseminating information about clinical trials for which
a patient might be eligible. And that information needs to go to both
caregivers and to patients so that they can make informed decisions as
to what to do.

And in this respect, my presentation differs from much else you have
been hearing in that this is a two‑way flow. We need information to go
to patients and care providers and that information to come back. We
need better baseline data because it allows for improvements in the
speed with which new treatments can be seen as being better than old
treatments. And better baseline data also allows for more confident
interpretations.

My third bullet makes the point that all participants in a clinical
trial know that they\'re running a small risk, that the new treatment
may have unexpected adverse effects. We want speedier reporting of those
adverse effects, and the dissemination of all experiences across all
research sites, so that we can enhance patient confidence in the
research process.

Participants in clinical research ‑‑ this is my fourth bullet ‑‑ sign
consent forms that sometimes limit the sharing of data, and the uses to
which clinical specimens can be put.

The research enterprise would be enormously facilitated if we could have
automated tracking of these consent instructions and the limitations
that are imposed.

In conclusion, while clinical research has made tremendous contributions
and advances to health care, investments will be much more productive if
we use health IT to integrate the research process with the delivery of
clinical care.

Thank you.

DR. BRAILER: Thank you, Terry and Anthony.

We brought these briefings forward as we've done in the past to be able
to expose the Community to these two very large components of healthcare
that have not gotten the attention at the Community level, population
research, and clinical trials. So that not only did you have a chance to
ask questions but you could give any direction to us in terms of
planning how to bring these topics forward in a more substantive manner.

So we do have a few minutes for discussions, questions and answers, or
any feedback or comments before we move forward with the agenda. Thank
you both very much. The floor is open.

Dan?

MR. GREEN: I guess 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 to be ‑‑ for a EHR to be
useful, you have to capture that information, obviously, in the EHR. Now
some are obviously, available.

Medicaid would be tied to income population \-- income, but in a
clinical setting it wouldn\'t necessarily be so. So, is that what
you\'re talking about? And the issues of privacy, and that sort of thing
surrounding capturing all that additional information, I think is an
issue.

DR. CULLEN: I can respond to that. And 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.

So the current situation, however, for the near term for the AHIC would
be to look at what current data fields are collected, what data fields
may potentially need to be collected in order to do ‑‑ not only at a
community or a performance level, for me as a provider, what are my
diabetic patients doing, but for me, what \-- how do I assess wellness
of my community.

And we know that there are some composite measures that exist, things
like YPLL, Years of Productive Life Lost, things like DALYs, Disability
Associated Life Years that can clearly be calculated from the electronic
health record and used for long-term evaluation of the impact of the
healthcare system.

However, from a smaller ‑‑ from a small microperspective, at the
community level, if I'm caring for my population of 3,000 primary care
patients, what I may want to know is what\'s going on in my community
that influences them? The ability to aggregate the data, assuming the
data is there, which is a very appropriate question, would then enable
us to be able to do longitudinal tracking of the concept of population
health within that population.

So, if these data ‑‑ appropriate data fields, appropriate data logic,
appropriate model gets embedded in the electronic health records that
are released by vendors, what it enables us to do long‑term is address
what is population health at that provider level. So instead of not only
having specific US healthcare disparity reports, health of the American
public, there\'s also that drill‑down into the level where we know it
matters, that patient provider level.

And if you go back to the example that was given during your last
meeting, what that example showed is that when somebody knows that the
amputation rate is the highest of any community, they're apt to do
something about it. If the data isn\'t available for aggregation in a
way that enables them to look at their patients through that venue, it's
possible that that patient may not get the appropriate care. So it
really is a bidirectional flow.

DR. BRAILER: Kevin Hutchinson.

MR. HUTCHINSON: I\'m glad these two topics were able to get on the
agenda. I think they're two very important topics.

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.

The data sets are expanded when you're looking at population health
versus the narrowness of biosurveillance. But 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.

The clinical research and clinical trials, you know, one of the things
that I think is most critical about this area: it\'s not \-- the data
needed for that is not necessarily tracked and included as well as it
should be inside of the electronic health record systems and the ability
to exchange that information. I think actually that ‑‑ you know, this
was pointed out before. The more efficient reporting, realtime tracking,
it does improve the quality of the research, the timeliness of the
research, but also the dissemination of the information of the research.

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 Improvement, you know, programs in Workgroup is that
it brings a whole new audience to the table that could be a driver for
adoption of EHRs.

Because you have a lot of research organizations. And I think it was
mentioned you have \$96 billion that's spent on clinical research and
clinical trials. Now you have another partnership level that could be
created between research organizations and the physician community to
help facilitate another reason why the adoption of clinical technologies
is so critically important. And another ROI factor for the deployment of
technology to support the tracking of clinical research and the
reporting of that around clinical trials.

So I think the two are very closely related, and I like the fact that it
brings a new driver for adoption purposes.

DR. BRAILER: Let me just echo that back and then we'll turn to other
comments.

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?

MR. HUTCHINSON: It is. I see it across a couple of groups: chronic care
as well as EHR are two that come to mind, of the Workgroups that exist.

DR. BRAILER: Could I just ask Terry and Anthony to comment on that and
then we'll turn to other comments?

DR. HAYWARD: I do think that clinical research has a unique focus to it.
It\'s the need, as I was saying, 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. CULLEN: I think in terms of population health and biosurveillance.
And Kevin, I'm not \-- I don\'t want to put words in your mouth. But it
seems to me biosurveillance is a subset of population health. So, from
that perspective, that is fine. I think what we wanted to do ‑‑ the
federal agencies that have been involved in pushing this forward, really
want to ensure that population health is addressed with the recognition,
early detection, bi-directional data flow, data standards that will
allow us to not only capture biosurveillance and early detection but
other issues as they relate to population health would be addressed.

MR. KAHN, III: I think we have some real overlap coming here. One of the
things ‑‑ and I don\'t want to scoop myself later on when we present the
Biosurveillance Workgroup. But 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.

So, I'm not sure what to say about the clinical research side of it. But
I think 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.

But in terms of the kinds of issues, of that communication back and
forth on large chunks of data, that\'s the kind of stuff that we\'re
going to be recommending.

DR. BRAILER: But it sounds like, just to put a sharp point on it, some
of the things that Terry\'s proposing could be outside of the scope of
what you\'re thinking about a recasted Biosurveillance or Public Health
Interfaces Workgroup.

MR. KAHN, III: Oh right. I\'m just saying if you listen to the words she
just used and you look at the priority areas that we've already said in
terms of bidirectional communications and case reporting, and I can\'t
remember all of the words she used, they really are the exact same
language.

DR. BRAILER: I would suggest in the interest of time, then what we do,
is take up this question, Chip, when you do your presentation. And we
remand the clinical trials question back to staff to explore with and to
come back with some options about how we can consider this.

Were there any other comments or questions here? Nancy?

MS. DAVENPORT-ENNIS: I will make my comments very brief in the interest
of time.

Ms. Cullen, thank you for your remarks. I certainly think that \-- I'd
like to bring two points to bear in the discussion.

One is relative to the Alaskan native population. As I look at
population health in the United States, I think that your observation
that perhaps we\'re at a place where we need to be very sensitive to
what fields of data we are collecting that can in turn have a two‑way
data flow that can make a significant difference. Within the Consumer
Empowerment Working group certainly we\'re going to be making
recommendations around data fields for PHRs.

But 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. So, I do think also early
detection is another one of those areas within those special
populations.

And the last point I would like to make, Mr. Secretary, is that 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,
again, one of those populations, and I just have to take a moment to
recognize that population. Thank you.

DR. BRAILER: Rosi?

MS. SWEENEY: A comment that staff is to do your follow up work in terms
of research: I think language is important, and clinical research, not
clinical trials is what we\'re talking about. And 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.

DR. BRAILER: Very good. Thank you both very much and thank you for the
discussion. With that, I will turn to Secretary Leavitt.

SECRETARY LEAVITT: I wanted to acknowledge Dr. Rob Kolodner, who is, of
course, serving as our Interim National Coordinator for Health IT. As
all of you know as his long participation on this group, he brings a
great deal of \-- a great number of assets to this. And, Rob, thank you
very much, for your service and willingness to participate in a new way.
I think it\'s very clear that we have ‑‑ our momentum is increasing.

Rob joins us at a time when we\'re seeing results. I think we\'re
solidifying the process and we\'re pushing the horizon of what we've
accomplished beyond where we had originally set it, evidenced by the
fact that we\'re creating new Workgroups and expanding the work here.
The importance of this work for patients and providers, and for all of
us is no less important today than it was 18 months ago when we started
talking about it.

You will recall that the executive order that established AHIC gave us a
two‑year life that is renewable. I have little question that our
momentum will be such that we'll see that renewal occur. I also want to
remind you that part of our charge is the development of an ongoing
business model that allows our perpetual, our continued function outside
of government. That\'s something I want to keep on our mind.

I have also want to acknowledge that on my desk, as I have told you in
the past, I have a little clock. And it says today 812. That\'s how many
days there are left in this term. Whether \-- no matter who is elected
there will be disruption. And I am resolved that by the time that clock
says zero, that we will have turned this standards crank at least three
times and that we have a very well‑established process that can continue
outside of government, and that does not depend solely on the function
of government to oversee it.

I want to remind you of that because it is I think is crucial ‑‑ our
work is crucial and will continue with Rob\'s current leadership to
drive this process forward. Urgency is a word that\'s used often at HHS
and I'm feeling it, and so if it appears that we\'re driving our work,
that\'s why. This is a very important thing. Lots depends on it.

I'd like to take a moment specifically to acknowledge the hard work
that\'s being done by others outside of AHIC. We\'re going to hear today
from the Health Information Technology Standards Panel, HITSP. It\'s
been engaged in a tremendous task. I referenced it earlier. They\'re
developing a national health standards harmonization process that
involves over 260 health care organizations.

They have also sifted through 700 possible standards, examining them,
testing them, and documenting their work to bring us to the 30 that will
get us another leap closer to the full‑scale interoperability, the pure
vision we talked about in the first meeting we had.

It has involved hundreds of people, more than 12,000 volunteer hours,
I'm told, that have been donated to this effort. The creation of volumes
of documentation about how to use these standards to achieve
interoperability.

I have to confess that I am not technically able to understand
everything that is inside those binders. I've tried. It is a
mind‑numbing level of detail that must be undertaken. But I have come to
not ‑‑ while I don\'t understand it all, I have come to more fully
appreciate what they do. I want to recognize its importance in getting
us where we\'re trying to go. I want to thank HITSP for their
dedication. Thanks to the good work that's been done at HITSP and by the
Office of the National Coordinator and by others, today we\'re going to
be presented with recommendations and harmonizing standards. This
represents the core of our first task.

It\'s time for me to confess, that it turns out as I suggest a lot more
complicated to set standards here than it is to determine what the rail
gauge is on a railroad. While that continues to be a useful metaphor, it
certainly is not one that is complete.

We have now begun to hear the ‑‑ how this ‑‑ began to see how this
engine can perform. There are standards at every point in the queue. And
a plan is in place for keeping standards up to date over time. And more
importantly I think a process is being built to surface the differences
and to resolve them on an ongoing basis. That\'s what AHIC is all about.

Finally, we'll hear today from each of the Workgroups of the directions
\-- we have heard from Workgroups about the directions that we'll have
ahead of us. And I want to just express my satisfaction and my optimism
that we\'re not only going to get the three turns of the crank, we're
not only going to see more health IT systems that are certified, we're
not going to \-- not only see standards begin to harmonize, but we\'re
gaining good momentum and I feel increasingly optimistic that what we're
doing here is leading to a healthcare system that will have lower costs,
fewer medical mistakes, and better quality.

And I want to thank all of you for the work that you\'re putting in. I
note that you are regular attenders and that you are, in fact, putting a
lot of work in that isn\'t seen here. I recognize the work that\'s going
on at the Workgroup level by all of you. And I just want to acknowledge
that and in my role as secretary, thank you for your effort. So, with
that, Dr. Brailer, let\'s proceed with the HITSP presentation.

DR. BRAILER: Great. Thank you, Mr. Secretary. And with that, I will turn
to John Loonsk and John Halamka. And I think it's fair to say, as the
Secretary has already described, what you're about to here, represents
the essence of what the Community is here to do. And the capstone of
today\'s presentation, I have witnessed, is an enormous amount of work
and very intelligent work. And so with that let me turn it to John
Loonsk.

DR. LOONSK: Thank you. Good morning, Mr. Secretary, members of the
Community. We are very pleased to come forward here, representing HITSP,
and bring forward what is a small step in the total number of standards
that need to be considered, but a very large step, if you will, in
moving towards interoperability, perhaps not paperwork reduction.

We\'re going to talk about the context for the work that HITSP has done.
We\'re going to talk about the interoperability specifications, a little
bit about the HITSP process, a little bit about why, what standards were
chosen, what were the controversial issues in this regard, and then also
talk about some of the next steps.

The context for the Health Information Technology Standards Panel were,
like many other processes, was set by the breakthroughs that came from
the American Health Information Community.

Those breakthroughs were converted into use cases, which were an attempt
to very 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 health IT systems.

HITSP itself has been moving forward with three goals. One, the
harmonization of standards to use in that specific context as defined by
those use cases.

Two, to identify gaps and needs, and to then begin to work with
standards development organizations and other members of industry in
filling those gaps.

And three, to develop the kind of specificity necessary as to how to use
those standards specifically to achieve interoperability. And in front
of you we have some examples of that. This is one of the HITSP
interoperability specifications. Though we, in HITSP, have gotten to 30
standards, the specific guidance on how to use those standards to
achieve interoperability is significant and detailed. And I will pass
these around, or at least one of them, perhaps, to save our arms, as we
talk and talk about the specifics of the HITSP endeavor.

Before turning it over to John, I wanted to talk a little bit about the
process that\'s been developed. The Secretary mentioned 12,000 volunteer
hours. This has been a massive undertaking for the members of all
different parts of the health information technology community.

Standards development organizations, payers, providers, the entire gamut
of participation as represented through some 261 different organizations
that are now on the HITSP panel and participating in the process. It is
a very public process. And the process itself has been what we've held
forward as the principal goal of the HITSP work. So during the course of
this year, a process has been developed which includes a board that
focuses on the process aspects and guides the process.

We have HITSP staff that work on advancing the process. But importantly,
we have a number of different technical committees, and we have the
panel itself which executes the process, and which has done the work of
developing and winnowing down the standards, but doing so in a way
that\'s based on strong bylaws, on process and participation, through
support of an excellent parliamentarian, in moving forward in a
consensus‑based fashion. And having the valid HITSP process be held out
as a long‑term activity that can move forward this area.

The standards community at times has sought the perfect rather than the
good enough. This is something that they recognize and has been
well‑recognized in terms of the difficulties at times in coming to
closure on standards. It\'s a very difficult process. It is very
complicated. But, indeed, closure is necessary to move forward. They are
a passionate group, and we can speak to that from experience.

And I must, as I turn this over to John Halamka, commend him on his
reasoned tone and the coordination and leadership that he has shown in
moving forward to this important step. Because the passion is something
that we want to channel. And it has been expressed and I think we are at
a significant step in moving forward and we\'re going to describe that
step to you now.

DR. HALAMKA: Well, thanks so much and good morning. And I\'m very proud
to represent the 261 passionate organizations who have devoted 12,000
hours of their energy to produce the work you see on the table before
you.

About 13 months ago we were assigned these use cases that we'll be
delivering today. The most important aspect of those 13 months was not
the paper that John is about to pass around, but this process that you
see before you. We had to come together as a group of disparate
organizations from payers, providers, standards development
organizations, employers, privacy advocates, the general public, and
agree upon a process that could be used for each of the turns of the
crank that you describe.

Now, the good news is, a turn of the crank was done in just under a
year. So that does imply two more turns are possible. So recognize the
way this happens is you as a group, or your Working groups ‑‑ provide us
with a harmonization request. And that, in this case, of course, has
been the biosurveillance, EHR, and consumer empowerment. Now, in the
future, you may suggest things like genomics or clinical research. That
request, once given to HITSP, is then analyzed by our technical
committees. The technical committees develop, through a very regimented
process, detailed events, actions, and actors to fill out those use
cases with such detail as John has described, there\'s really no
ambiguity as to the scope of the work.

We then take those very detailed use cases and we look at the scope of
standards. Now you heard there were 700 standards in just this first
three use cases that we looked at. There are thousands and thousands of
standards and clearly we need to identify, in a non-emotional way what
are most appropriate standards to fulfill the use case? Now recognize
this isn\'t choosing good and bad standards. It\'s choosing appropriate
for the context of the use case that you give us.

So, we have developed a set of very objective criteria, which I'll share
with you, that reduce it from the passion to a set of objective
criteria. We then figure out within those selected or named standards
where there are gaps and overlaps. We then come up with the clinical
implementation guidance that constrains the standards; it removes some
of the ambiguity. And then we produce these documents, which can be
handed to industry to implement.

And the way I describe this is, imagine you went out and bought the
first version of Microsoft Word. Well, chances are, six months after you
bought that, there would be a service pack. Well, in this similar
fashion, we have finished Version One, and we'll be delivering it to you
today, and we also have a commitment of regular service packs. Six
months from now we'll be back and then yearly thereafter, and we'll
describe that process in some detail.

So this is the way we look at standards. You take 700 and place them
into the funnel, and you and ask: is this standard suitable for a
particular purpose? If the issue is a consumer not having to fill out
the clipboard ever again, and you need to understand demographics, the
medications and allergies, well, is this standard going to help us with
that? And then is there a standards development organization behind it
that can keep it maintained? So if, for example, we all decide that
sharing genomic information is critical to having continuity of care,
well, is the standards organization going to be there year to year to
amend whatever standards exist to include such data elements, and has
that been done in an open, transparent way, that engages all the
stakeholders and the general public?

And, of course, we want to make sure there is good guidance, that there
are products that can be had from these standards development
organizations that will help us implement the standards. As I say, it\'s
more than just dictating, here is a set of data elements. How is a
vendor, how as an employer, a payer, a provider, do you implement those
in a nonambiguous way?

So we look to those standards in the development organizations, and
filter out those that meet those criteria, and then move on to even more
detailed criteria, our tier two or second set which asks, well, if
we\'re going to pick a suite of standards, for example, for consumer
empowerment, we may have to rely on the work products of multiple
standards development organizations. Do they fit together? Do they
interoperate? Are they compatible? Are they generally available for
public use? Now, that doesn\'t necessarily mean free. I mean, we do see,
for example, HHS paid for the use of \[unintelligible\] for the country.
So that's not a specific criteria to rule out.

But we want to make sure they are available, generally accessible, that
all those electronic forms that are necessary for all of our
stakeholders to communicate the nature of the standards and how they\'re
used, are available from development standards organizations.

We were going to look at total costs of implementation of various
standards. That was one element of these criteria we did not get to in
this first round but work that we will do in the future.

Well, let me go into the individual use cases. And tell you about the
controversies. Take you inside the HITSP panel as it deliberated.

Consumer empowerment, I will admit, was one of most challenging use
cases. And it was challenging for the following reason: where might a
consumer get their information? Well, a payer may very well have
information about demographics, certain aspects of claims which may in
fact have medications associated with them.

A hospital may have information about demographics, medications, and
allergies. A small solo practitioner may have similar medications and
allergies. And it may very well be that there are other organizations
like pharmacies or pharmacy benefit managers that may have databases.

Now let's take a look at those constituents. Payers, by HIPAA, must use
X12 standards. That is the HIPAA mandate for administrative
simplification. So in fact, should we go to the entire payer community
and say, I know you spent billions implementing these standards and
HIPAA requires you to use them, but we weren\'t really serious. Or
should we go to the pharmaceutical industry that has spent billions
implementing NCPDP standards and say, no, you must reengineer all your
internal standards. Or hospitals with HL7, or doctors\' offices with a
continuity of care record.

So it was challenging because we had to develop a single, harmonized,
over the wire basis of communication while recognizing we cannot disrupt
the commerce or regulatory requirements like HIPAA and the Medicare
Modernization Act, which have already mandated specific standards.

So, what did we do? We recognized that ongoing efforts by ASTM and HL7
to produce the continuity of care document take into account the best of
several standards of organizations work to date.

In fact, we have taken the best of ASTM, HL7, NCPDP, and X12, and
created a single implementation guide for all of those to be used from
those various stakeholders into a common format between organizations.

Now, let me tell you a bit about more controversy. That particular work,
that continuity of care document is just being finished by ASTM, HL7,
and may be validated next month, and if not next month, certainly in
early 2007.

We asked the question, for consumer empowerment is there any interim
standard that we could pick that would meet the needs of all of these
stakeholders that would be harmonious? Well, what if we just picked just
HL7 for everybody, or just CCR for everybody, or just X12 or everybody?
Well, I think what we discovered in all of our deliberations is there is
no single interim state that would actually be harmonious.

So what we had to do was say, we recognize, we'll take the best of each,
the continuity of care document will provide that convergence, and that
ballot will be done very, very soon, it could be as soon as next month
with HL7, balloting in the next cycle, at the very latest February.

But certainly we can deliver an implementation specification,
interoperability specification that fills in all of the details, all of
the content, all of the vocabularies, and says continuity of care
document has been agreed by consensus by all stakeholders to be the
right answer and we\'re on the cusp of getting there.

So this, I will tell you, of all of those, the most controversial. I
measure this by the sheer number of emails I received. I received over
1700 e‑mails on just this particular interoperability specification, as
compared to just a few hundred on lab, HER, and just a few dozen on
biosurveillance.

The definition of harmony is also an interesting one. Compromise, I
think I've said, is making everyone equally unhappy. But harmony is
everyone in the room agreeing it\'s good enough. These are passionate
people on the standards organizations. They've spent their lives
creating their particular standard. For them to agree, oh, well I will
give a little. I, yes, accept this harmonious consolidation of HL7,
ASTM, NCPDP and X12, was done in our public meeting on September 20^th^
by a consensus of all there. And at the end of the meeting there was not
a single objection heard to this single interoperability specification
based on the continuity of care document.

This interoperability specification, like all of the others we will talk
about today, will be a living document. We've selected the standards,
we've given you implementation guidance. It will continue to be refined,
and we know that in the future there may be new technologies, new
expansions of the use cases; it will require constant vigilance and
maintenance. But the commitment of all HITSP members is, we understand
this is a point in time. We agree, by consensus, that what we've
delivered to you today is good enough, and we will continue to refine it
as a HITSP organization in a multi-stakeholder fashion.

One other challenge about this one was architecture. Now we want to be
careful in HITSP not to dictate how vendors might implement their
systems, or how the federal government or RHIOs or small doctors\'
offices might implement these standards. What I mean by implementation
is, could there very well be a central database for a RHIO that allows a
lot of clinical information about medications and demographics to be
stored for a community? There could be. Or maybe some communities will
decide that centralizing data is too much of a privacy risk, and they
want to keep it in the individual doctors' offices. Our standards should
allow all these permutations of architecture: centralized,
decentralized, and federated. RHIOs or non-RHIOs, doctor's office to
doctor\'s office, doctor's office to patient, hospital to patient,
patient to patient, all these permutations. So in creating these
interoperability specifications we gave enough variability in
architecture.

It could be documents being exchanged with certain contents, it could be
messages being exchanged between a laboratory and a hospital or a
patient. And so I think what we've done, and then we were very careful
is not to lock in the NIN-contractors, the AHIC Working groups and other
stakeholders to a predefined, well, what are we going to connect, how
will it look in the future? I think everybody is pretty comfortable
about that.

Those were our controversies on consumer empowerment.

Let me move on to electronic health records and interoperability for
laboratories. One great challenge here is that a lot has been invested
in HL7, 2.3, that is the current version of HL7 being used in many
commercial laboratories and hospitals and doctors\' offices. Well, we
recognize a desire to have a very robust standard that includes blood
banking information, CLIA compliance, gives us the basis for what you
may ask us to do in the future on genomics exchange.

So there are other versions of HL7 that include more features. Version
2.4, version 2.5. Well, of course a question, just as with consumer
empowerment is if you\'re going to mandate change or upgrade, what you
do with the fact there\'s a large investment in a given standard
already? Where do you go?

E-links, a group that David was very much involved in, California
Healthcare Foundation, put together an implementation guide for the lab
version 2.4 of HL7. Very, very good specification. In fact, we used it
as the very foundation of this work on electronic health record
exchange.

It was quite good; now the one challenge is again, we wanted some blood
banking information and some additional features that were only
available in 2.5. So we had to ask the question: well, what is the
barrier of going from what is today, version 2.3 to 2.4 versus 2.5? And
what we concluded was the barrier of change is really equivalent,
whether you go from 2.3 to 2.4 or 2.3 to 2.5. So let's leapfrog and go
to 2.5, and recommend that as the HITSP approved and harmonized
standard. Leveraging all the good work of E-links, incorporating all of
their guidance, but recognizing that 2.5 holds the greatest promise for
the future.

Again, we achieved harmony on that particular decision. We've provided
both a messaging format and a document format which will enable a
variety of architectures and allow patients and providers and payers and
employers, laboratories, all stakeholders to exchange electronic health
information for laboratory.

Now just quickly, it's not on the slide, but we will be happy to serve
in whatever capacity you decide useful to investigate genomics and their
incorporation into the electronic health record interchange
specification. Certainly, CHI, the Consolidated Health Informatics
Initiative, has already looked at some of the standards, and there is
the human genomics nomenclature that they have declared as a CHI
standard. And I think you wisely suggested this is very much an evolving
and rapidly changing field. And when it comes time for us to look at
gaps and to do any harmonization, we'll be certainly happy to do that.

Biosurveillance. So, biosurveillance, a very complex standard because we
had to gather clinical information, such as laboratory and radiology
reports. We had to gather information about patients that do so in an
anonymized way. We would care more about the fact that David was a
person in San Francisco who had recently visited a rural Chinese chicken
farm and come back with a fever and cough than the fact that it was
David. You want to, from a population health, from a biosurveillance
perspective, de-identify an individual and transmit to public health
agencies, state, local, and national, that information that can be used
for surveillance.

So, we had to think about all aspects of what I just said. How does one
de-identify the data? How does one transmit laboratory information or
codify clinical information that can be used from a biosurveillance
perspective? There are specific vocabularies that need to be considered
and data formats that enable automated sensors to detect trends and
report on them. So substantial bodies of work. Just as the work on
laboratory was informed by the work of E-links, the work of the AHIC
Biosurveillance group, and you'll be hearing from Art Davidson after us,
informed the work of the HITSP biosurveillance team. In fact, it's right
to say that Art\'s work and the AHIC Working group work was foundational
to biosurveillance. And you will in fact find 100% overlap. So that's
the one good thing here is there is total and complete consolidation of
the work between the two organizations without redundancy.

So we have been able to identify a harmonious set of standards for
biosurveillance. But I will tell you, because part of HITSP is
identifying not only harmony, but gaps. That we have declared there\'s a
transaction for anonymizing data. That there is not a specific process,
because, in fact, there are many ways to anonymize data. And what we
said is, here is the data; it can be transmitted in the following way
and to an anonymizer, and come back anonymized. Oh, and, well, what if,
state public health or national public health agencies wish to
re-identify the patient for the purposes of treatment?

Well, again, not quite a standard for that re-identification yet. So we
have been able to be as specific as all the messaging standards, but
recognize there are gaps on how anonymization and re-identification may
be done. And that\'s okay. I mean it may very well, that as industry
develops innovative techniques, that those are absolutely, you know,
innovative and capable of being different as long as the messaging
standards to these anonymizer black boxes are consistent. We can allow
that variability.

Give you an example of the gaps. This one also achieved a complete
consensus. So let me give you a bit of an overview of the work of the
last year. 700 possible standards, 261 stakeholder organizations, 12,000
volunteer hours. On three use cases which then have been reduced to 30
selected standards.

Now, you will see that if you add up the standards and the individual
implementation guides, it adds up to a little more than 30, and that's
because we have tried to reuse across all these use cases, in a very
consistent way, what we would call a component. That is, if there is a
need for a laboratory to be transmitted between providers in EHR or a
need for a laboratory to be transmitted to public health agencies, you
should be able to use the exact same component. Or, we use another term
called transaction package. It includes all of those standards in the
implementation guidance to do that particular activity.

So you'll find that across these three use cases there\'s great
consistency, and you will not find that one suggested one direction for
lab or demographics, whereas another went another direction. We\'re
really reusing in a very common way, a very common framework, those
actions that need to be done in common across these three use cases, so
hence we end up with 30.

Our next steps ‑‑ and this is very key because I really consider today a
milestone for these 261 organizations who are bringing you this body of
work. HITSP has brought to you today Version One. And it is complete and
we encourage what we have delivered today to be forwarded to the
Secretary, to be reviewed by AHIC. We call on industry to take Version
One and begin implementing products, and just as I mentioned this
service pack concept, we may very well in over these 1,000 pages of
documentation, discover when actual products are created that there\'s
ambiguity.

And therefore we want to make sure that these implementation guides are
as clear as possible. So there may be opportunity, not for selecting new
standards, but for refining language that removes any sense of
ambiguity. And that\'s a process that will be continuous. And, again,
you have my commitment that April will be the time in which we have the
next release of these particular use cases. That also gives us the time
to incorporate that continuity of care document that I mentioned was
being validated in either November or early 2007. So that will also be
included.

Very importantly, because the Office of the National Coordinator and
AHIC recognized that the implementation arm of all of this is CCHIT.
That HITSP and CCHIT have formed a Working group so that these
interoperability specifications are incorporated into CCHIT functional
criteria, and CCHIT and HITSP together will develop the time frame by
which products from vendors will be evaluated against those criteria.
We've already sent out a call for nominations. We will have three
members of HITSP, three members of CCHIT, and joint chairmanship between
CCHIT and HITSP on this activity to ensure that we take the next step of
incorporating these into CCHIT's very good work.

So with that I present you both the electronic and paper formats of
these interoperability specifications, and I look forward to your
questions.

SECRETARY LEAVITT: First of all, bravo!

It\'s just not ‑‑ 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?

DR. HALAMKA: Absolutely! And so recognize that the greatest
accomplishment of the last year was developing a process. That process
is now in place. Well, of course, it will continue to be refined. But
because that engine is there it does make this work much more
repeatable.

Now if you look at the way we divide up these interoperability
specifications into what I've mentioned, these components, 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. BRAILER: Colin?

MR. EVANS: John, a comment and a couple of questions. I mean first of
all, obviously, not to echo the fact that this is a mountainous task to
herd the stakeholders here. I was chair of a couple of international
standards organizations for many years in the high‑tech sector and this
task sort of dwarfs that one by an order of magnitude, I think, so
navigating the whole thing is, you know, hats off to you and the whole
team.

You pointed out that touchstone of what you\'re doing was to point to
standards that came from standards development organizations, ANSI
certified or whatever, and I think that shows through a lot of the work
that\'s been done here and it points to an expectation of transparency
and rigor, and sort of maintainability of those standards.

But I think you also pointed to areas where no standards exist. And you
have sort of pointed to industry efforts where people have gotten
together through things like IHE, Integrated Healthcare Enterprise to
essentially recommend sort of what\'s the current state of the art of
assembling these things, but isn't necessarily, you know, in this case,
did not come from a standards organization.

So first of all, I would comment that I would suggest that those areas
that clearly came from an SDO should be marked as such. And those that
didn't, you should indicate which do and don\'t.

But I'd like your comments on how you see that evolving if you've got
things today that are not SDOs, if they become sort of the best
practice, how would they moved to a process that would become
essentially ‑‑ get the kind of discipline and rigor and you also
mentioned the maintainability of the standards organization.

DR. HALAMKA: That's a very, very good question. We recognize what is a
base standard. Well, typically we think of a base standard as coming
from an ANSI accredited standards development organization, such as
ASTM, or HL, NCPDP, X12, et cetera, 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. So we said, yes. We looked to what we
might include in our work, let's first of course, look to those SDOs.
But we can also look at implementation guidance, if it is done in an
open, transparent way, in a way that is maintainable. And leverage what
the industry has done, if by consensus it is considered by the all HITSP
stakeholders to be good work.

Now, I think as Colin might suggest, this is not without controversy.
One, of course, has to recognize that in my role ‑‑

MR. EVANS: I think I might have sent some of 1700 emails...

DR. HALAMKA: Well, exactly. And I may have answered them while I was
climbing Half Dome last summer. And so I recognize that, for example,
where there are differences of opinion between standards development
organizations and implementation guidance that is provided by non-SDOs,
that we get a consensus‑based way through technical committees and
objective criteria have to look at both sides of this.

And as chair I was not allowed to take sides. In fact, I think one of my
proudest accomplishments is that the small organizations thought I was
siding with the big guys and the big guys thought I was siding with the
smaller organizations. That must be the definition of true harmony.

And so my role as chair is to ensure that the pros and cons of each of
these is appropriately considered in an open and transparent fashion,
and to make sure this process is enforced so that people feel quite good
about it.

We have just started to establish a process control board to recognize
that we actually want, almost like an internal audit organization
looking at HITSP processes and making sure they're continuously refined,
if there\'s ever questions about how we've acted.

So I think I'll summarize by saying 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. BRAILER: Great. Thanks. Kevin Hutchinson and then Bill.

MR. HUTCHINSON: I would echo Colin\'s comments. I think the danger ‑‑
and I'm trying to reconcile this with the charter of HITSP, which is to
focus on ANSI accredited SDO organizations. I thought we had established
a baseline that said we shouldn\'t be going down a path, unless it has
an ANSI accredited process or standards come from the process. Because
it\'s great for a snapshot in time, to say this looks good today. But
how do those implementation guides get updated along the way in a
governance process outside of an ANSI organization, and its own
governance to ensure the purity of these standards? Because this is...

First of all, let me commend the work. You know I've said this to you by
e‑mail a hundred times, but this is incredible, 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 standards that have not been vetted
through, or an implementation approach that has not been vetted through
an ANSI accredited standards organization.

We talked about true harmony, but as you mentioned version 2.3
representing labs on AHIC is the widely implemented version. So if we
are going to recommend Version 2.5s, is there a time frame? Talking
about the disruptiveness of payers, you wouldn't go to them and say, now
rip this out and do this. Is there a time frame that we are allowing the
industry to get to 2.5 as part of this certification joint process
between CCHIT and HITSP, or is this, within the next six months, you
must be at 2.5, especially given the Presidential executive order that a
lot of this will fall underneath.

DR. HALAMKA: These are excellent questions. So let me answer in a couple
of ways.

One of the things that we did as a HITSP panel, is we actually reviewed
some recommendations that we did not accept. And that is to your point:
there was the suggestion that we adopt on an interim basis some
standards that had not been widely vetted, approved, gone through
standard SDO processes, and the panel said we understand that that\'s
good work but we really believe that this process that's going on
between HL7 and ASTM is going to result in even better work. So let\'s
not adopt something interim that we don't think is going to get us to
the final state any quicker. So I think you'll find the panel is quite
good at vetting these particular decisions.

When you think about IHE, IHE as an organization, again, I don\'t take
any side of this.

But is writing implementation guides about SDO accredited standards
products? So in that sense, I don\'t think of IHE as ever inventing any
standard. The challenge which you accurately point out is, well what if
HL7 changes its standard? And then IHE has created an implementation
guide based on that. How do we ensure there\'s bidirectional
coordination between the implementation guide writers and underlying
SDOs? And that is actually a set of work we're just taking on.

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. We also have oversight in that
regard. And, John, I don\'t know if you have comments?

DR. LOONSK: 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 industry is moving in that direction, and 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. HALAMKA: Right. HITSP, itself, of course does 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.

You also asked the time frame. Now, CCHIT and HITSP together will have
to work on these time frames. Just as HIPAA had an implementation
schedule and we know that it took a couple of years to get everyone to
use the 4010 X12 standard. One imagines there\'s going to be the gradual
kind of transition to the 2.5 standard and CCHIT and HITSP, I think, can
delineate that well as a group.

DR. BRAILER: Bill Winkenwerder.

DR. WINKENWERDER, JR.: John, great work. And, again, commendation for
just a fantastic product here. My question goes to ‑‑ this is a huge
volume of work and I guess one of the questions I have is ‑‑ goes to the
resources for HITSP and looking forward.

Do you see an ever expanding universe of work to do or is this the big
lump so to speak, and then it sort of cascades down?

And then what are your thoughts regarding the necessary resources and
people and so forth to not only make the process continue to work but
presumably to accelerate it so that the standards can be developed, you
know, more quickly.

DR. HALAMKA: So this is an excellent question. And we did have a Working
group on business sustainability. It was led by Steve Lieber of HIMSS,
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? How many staff do you need to have
internal?

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, that it will be a
balance between funding by government and nongovernment entities. So we
believe there are educational products, that there are tasks we can take
on, stakeholders that may very well be reimbursable, and that we believe
we can maintain a streamlined staff, because we\'re very good at this.
We'll be much more efficient than we have in the past because we will
have defined a lot of the processes.

But nonetheless, I think the question, of course, is how fast can we
proceed, given that the number of people in the standards development
world you'll find, I think, is rather constrained. It\'s not an infinite
set of resources. You'll find that the similar people who are serving on
all the Working groups are also serving in HITSP, are also serving on
CCHIT.

So, one hopes that we will be able to define, say, a six 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. LOONSK: It is, I think fair to say that the rate of change is going
to change itself, too. We've already seen that 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. BRAILER: Let me actually play off of John Loonsk's comment with a
question to John Halamka.

I presume that none of the 30 standards that came forward were approved
and accepted in whole. Meaning only part of any of the standards was
actually stitched into these use cases. If that\'s the case, that has
implications as we go through three, four, five turns of the crank for
the SDO ecosystem itself. How the standards organizations come to mature
under this kind of a process. Do you have any thoughts about that, or
has there been discussion about how SDOs themselves evolve under a HITSP
guided framework?

DR. HALAMKA: First, you\'re quite correct that one of the aspects of the
implementation guides is that they constrain variability. You take an
SDO's whole standard, and you say, these pieces implemented as such are
what constitute interoperability specification, so they are all subsets,
you are correct.

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. Because, I think, as you've described, the last
thing that we want as we develop into new domains like genomics, that
there's now going to be de novo overlaps developed going forward. Might
HITSP be that coordinator of the ecosystem that ensures that the work
across SDOs and stakeholders is appropriately coordinated. So I
certainly look forward to that, and our foundation committees, as I
mentioned, we're really thinking through some of those ecosystem issues.

DR. BRAILER: Thank you.

SECRETARY LEAVITT: We will have other opportunities, and we'll see you
regularly with this kind of report and we're delighted by that and
appreciative of it.

We need to act as a group to advance these to the secretary. And I will
notify you that I'll receive them with pleasure.

Would there been an objection to advancing them?

MS. GRAHAM: Gail Graham, Department of Veterans Affairs. I just wanted
to make a, kind of one clarification here that these are advanced for
implementation testing, and not for straight to implementation. Just
that point of clarification.

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.

MS. GRAHAM: And I just want to \-- so, VA, for example, we'd be happy to
participate in the testing but going right straight to production is
just what I want to clarify. That even in industry or government we
would go through a testing period in that interim during that time
frame.

SECRETARY LEAVITT: It seems to me \-- recognizing you're addressing the
question to them. But let me just ‑‑ I mean, I think what you\'re
raising is to what extent will these need to be used in the
implementation of the President\'s executive order. And I think that\'s
a subject that needs to be discussed. Probably not here. But it does
need to be discussed and obviously we will.

Yes, go ahead. Rosi.

MS. SWEENEY: 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 not dissimilar to how we've approached performance measures and
clinical practice where we've said, yes, performance measures can be
used but they ultimately have to go through the AQA and the NQF process.

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.

DR. BRAILER: Could I just, Rosi, clarify that? Or ask John to do that.
Because I think 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. HALAMKA: That is correct.

DR. BRAILER: So your comments, Rosi, are really about the implementation
guide and the question here is really one of what is the vetting
standard, or the vetting process for implementation guidance, and
perhaps that's something that HITSP could go back and look at, and come
back to us with, because I think this is being developed in realtime, is
that fair?

DR. HALAMKA: Right. Underlying all this work is the work of ASTM, HL7,
NCPDP, X12, \[unintelligible\] et cetera, there are implementation
guidance elements from IHE that are also included but they are based on
all these SDO vetted and approved and validated standards.

DR. BRAILER: Are there circumstances under which you would bring back to
us a named standard that did not come from SDO?

DR. HALAMKA: There are no such circumstances.

MR. EVANS: Eight of the 30, IHE, which, I mean, eight of the 30 are
implementation guide rather than SDO standards.

DR. HALAMKA: They're implementation guides of SDO standards.

MR. HUTCHINSON: Is there variation for interpretations of those
standards, correct?

DR. HALAMKA: So there are constraints on an existing underlying base
standard that came from an SDO. So it's saying, of this particular base
standard, we are using these pieces of it. We\'re constraining it,
removing some of the variability. But the underlying standard, of
course, is purely an SDO product.

MR. HUTCHINSON: That would be my only concern is that \-- we are, and
maybe it\'s just language, because it\'s saying recommended standards.
But if you look into these recommended standards, some of them are
standards that have gone through an SDO organization. Some of them are
implementation guides or interpretations of those standards getting to
the point that Colin was making, Rosi was making with respect to an
implementation guide very different than an actual standard.

It might be better to look at the standards that are underlying the
guides as what's being recommended, because in this particular instance
having \-- and IHE has done some great work, but its vendors that have
gotten together to work on a demonstration project with respect to the
implementations of certain standards. I\'m concerned going forward how
we work at that organization that\'s not an SDO organization, and how we
actually implement that and keep their implementation guides in
compliance with an ANSI accredited SDO organization.

SECRETARY LEAVITT: May I say that all three or four of these comments
are good comments and they reflect the fact that we\'re putting a first
effort on the table and we\'re going to learn as we go.

But we are going to move forward. And recognizing that you have not been
able to ‑‑ that you have not opted to make the perfect enemy of the good
which we appreciate from this point forward, we'll likely make a mistake
or two. But we will keep driving forward and learning from it.

So, we'll look forward to ‑‑ I would just like to ask if there\'s any
objection to formally advancing these now to the department?

Bill.

DR. WINKENWERDER, JR.: Again, 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.

SECRETARY LEAVITT: 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. And we congratulate
you and I think a round of applause for HITSP is appropriate.

\[applause\]

DR. LOONSK: One hundred sixty-one organizations so ‑‑

SECRETARY LEAVITT: So multiply it by 260 and that was it.

DR. BRAILER: We have one other standards recommendation to process
before we let you eat lunch. And that is the recommendations from the
Biosurveillance Data Steering Group regarding their minimum data set.

DR. DAVIDSON: Good morning.

DR. BRAILER: Art, thanks for coming.

DR. DAVIDSON: Mr. Secretary and members of the Committee, on behalf of
the Biosurveillance Data Steering Group and my co-chair, Marty Lavincher
\[spelled phonetically\], I want to thank the American Health
Information Community and the Biosurveillance Workgroup for this
opportunity to present our findings and the support provided to conduct
our work.

I am Arthur Davidson, a family physician and public health practitioner
from Denver Health, a vertically integrated safety net organization in
Denver, Colorado.

The work we were charged to complete operates at the interface of
personal and public healthcare. Speaking on behalf of the group I want
to provide both perspectives with more than 25 years as a family
physician, and 20 years experience directing public health informatics
at Denver Public Health.

Your charge and that of the Biosurveillance Workgroup was to define a
process that builds capacity and in turn permits a biosurveillance
system to work throughout the nation. As such, it opens opportunities
but also creates challenges that I hope to point out as we discuss the
slides that follow.

This work would not have been possible without the concerted effort of
the committee, numerous experts who provided testimony and the support
from the Office of the National Coordinator. Thank you, again, for
permitting us to present our findings.

Our broad charge was clear. We're seeking something that would be
functional within one year, capable of reporting from many different
data sources, and was repeatable of a daily basis. These functionalities
help drive our feasibility definition. We saw the minimum
biosurveillance set that was achievable within one year, and
incorporates data from many sources and leverages current health
messaging infrastructures.

Another more specific charge was to define requirements necessary for
multijurisdictional biosurveillance programs. Probably the output of
greatest significance was not the actual list of data elements, but the
effort by our group to describe the context in which exchange might
occur. Iteratively developed, the pre-conditions document, or Appendix A
in your handout is where our group repeatedly refined our interpretation
of the environment. Here we enumerate requirements as identified through
contact with our expert witnesses, our group deliberations, and comments
from reviewers or colleagues.

The group articulated our guiding principles or assumptions as a work to
complete the specific charge building on previous work of the HITSP
technical committee, as John described.

The next slide, please. This slide \-- oh thank you. I'll control it
here? Thanks.

This slide and the following described the process our group utilized to
build the minimum biosurveillance data set. There were many drivers,
inputs, processes and fortunately, a few final outputs for us to review
today. What is essential for the Community to recognize that our efforts
were focused solely on biosurveillance. Our thoughts were shaped by a
biosurveillance definition developed by the association of state and
territorial health officials.

Biosurveillance is not the comprehensive package of disease control and
reporting activities that happens everyday in communities across
America. This work is in adjunct to those activities. Any
biosurveillance system will be insufficient to replace those activities.
Our task was to find the minimum data necessary to detect an event, to
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.

This figure describes our group process using the requirements and
recommendations we present today, starting in the upper left and working
down the left column we received a list of potential minimum data set
elements, and solicited expert input regarding each element and its
feasibility from a data source perspective.

Feasibility, based on our charge, was defined as meeting a short‑term
goal of data transmission within one year. All work was performed with a
constant eye on the HITSP technical committee and their efforts, with an
explicit goal of remaining concordant. An ad hoc group of experts
performed a gap analysis based on a representative sample of five of the
fifteen national planning scenarios by the Department of Homeland
Security; additional data elements are were identified.

Using a paper that described 33 public health information network
functional areas required for emergency response, our group reviewed,
validated, and selected some for biosurveillance purposes. Now starting
at the lower right, our deliberations identified seven functional areas
that the minimum biosurveillance data set would address in the first
year, short‑term phase. And these are referenced in your Appendix D.

Multiple crosswork efforts compared functional areas with proposed data
elements that confirm the value of each element. The ad hoc group, HITSP
technical committee, expert testimony, and our group deliberation shaped
the development of 18 preconditions considered as our requirements
document.

Finally the group reviewed each data element for one year feasibility
and any filtering requirements. And the final product is in the upper
right hand corner, is the minimum biosurveillance data set, which is
Appendix B in your packet.

In response to our charge, we have the following recommendation: we
recommended that the community adopt the minimum biosurveillance data
set to promote simultaneous data sharing across jurisdictional
boundaries for public health purposes. As our group defined what was
needed and feasible based on review of past efforts and expert
testimony, we recommend 58 valuable data elements.

We recognize that not all of the data elements can be easily obtained.
For some, much work needs to be completed. Low prevalence of some
technologies and standards, or in some cases, incompletely developed or
adopted standards may delay getting to the full 58. Given our
feasibility estimates, we believe only 31 of the listed 58 would be
available in the short‑term. That is defined as less than one year, in
25% of all reporting sites.

Having accepted your charge, and the challenge to the Biosurveillance
Data Steering Group, we have presented to you a list of data elements
for us to move forward. The real challenge, however, is that going from
a paper list to functionality is a very large leap and not necessarily
easy to accomplish. While collecting these data is doable, we must work
on a short‑term implementation plan that focuses our effort. There are
many factors that need to be more fully understood to make this
practical and valuable at all jurisdictional levels.

After all of the work we did to collect the data presented in the
document, it became clear we needed a recommendation that helped define
the scope of what a biosurveillance effort really entails. The costs and
resources to establish this will be significant, and all stakeholders
and partners should have an opportunity to contribute to the
operationalization of these recommendations.

Of concern to our group was going from the \"what,\" that is the simple
list of data elements, to the method, or the \"how,\" a minimum
biosurveillance program would happen. Given our limited time span, the
group could not fully address the question of \"how.\" However, this is
precisely the step that needs further exploration and elaboration.

What are the functional and nonfunctional requirements for such a
biosurveillance system? How should the system behave for each
jurisdiction with access to the data?

How should the system leverage the knowledge, skills, responsibilities,
and authorities at the local and state public health agencies? What
tools need to be developed for local and state data users to maximally
benefit and to permit this system to actually synergize and enhance
traditional public health surveillance efforts?

Our group did identify many concerns in the preconditions document,
Appendix A, as a starting point for both functional and nonfunctional
requirements. A particular question to many of us in the field is how
this potentially costly biosurveillance effort relates to another
critical initiative from the Department and the Office of the National
Coordinator, promotion of HIT adoption, and ultimately establishment of
the nationwide health information network.

What RHIO activities would support efforts to create this minimum data
set, and how can the implementation of the minimum data set help support
the development of RHIOs? If these two efforts, biosurveillance and
RHIOs, are not brought together, we run the risk of duplication of
efforts and competing demands with limited resources in local
environments.

How should the multiple jurisdictions interact? What are the roles and
authorities? What are the consequences and responsibilities of alarms,
either false or true? And do local and state agencies have the person
power to mount an appropriate response to all alarms?

A major nonfunctional requirement is implementation costs. Our group
provided very preliminary cost estimates for parts of these systems at
the back of Appendix B. The total cost estimates are high and
implementation burden may be extreme for less IT experienced data
sources.

The group believe that initial cost estimates warrant further
exploration, confirmation, and evaluation, by comparing various
implementation methods. While we defined a data set, we also uncovered
multiple implementation issues: cost effective strategies need to be
determined to minimize the impact on healthcare providers and clinical
care partners. Some facilities may quickly adapt to these reporting
needs, while others may be more challenged. Finding resources and
creating a comprehensive plan that may involve incremental progress
should be a priority if this data set and a biosurveillance system are
to become a reality.

Our group felt it necessary to filter data for privacy concerns and to
maintain a clear purpose for data use. Transparency of purpose will
engender greater consumer confidence and support for these data flows.
Our obligation is to assure only required data elements are shared. As
such, we propose a filtering mechanism for some of the data elements.
For instance, in date of birth. Do we really need the day of the month?
Or can we just get by with month and year? And a variety of others that
I can go through if necessary. And they're elaborated in Appendix B.

Due to the potential expense, the need to incrementally expand this
undertaking and ultimately synergize this effort with a broader
nationwide health information network, a periodic, structured evaluation
should be undertaken by a federal agency. The committee has suggested
CDC as the best qualified to lead that effort, with active input from
stakeholders including other federal agencies and partners from across
the healthcare spectrum.

Our nation needs to ensure the efforts have ongoing value. Those
involved in building the systems need to hear feedback, be accountable
for their actions, and reflect on whether we are meeting our objectives.
Lessons need to be collected and analyzed, modifications made, and a
process of reevaluation performed to assure resources are properly
utilized and purpose is clear as we encourage others who are moving to
adapt HIT to participate and invest in this biosurveillance effort.

There is insufficient time here today to fully address all 18
preconditions in Appendix A. I encourage each of you to scan that
document and gain from our collective wisdom. This document provided
comfort and grounding as we endeavored to meet our challenge. It allowed
us to place our effort in a context, set some rules, guiding principles,
expectations and clearly articulate our assumptions. It evolved
iteratively over this past several months.

Obviously, there are some tensions between local, state, and federal
jurisdictions. We heard that clearly in the testimony. If this is to be
a successful effort, it is best that we keep those tensions in the
forefront and deal with them as we proceed. Our local and state public
health officials have responsibilities and authorities that must be both
carried out and enforced. We need to be sure that limited public health
resources are not inadvertently redirected to strictly biosurveillance
efforts that impede local and state officials from performing
surveillance and disease control activities as expected within their
jurisdictions. While we build a biosurveillance system we must
simultaneously preserve traditional comprehensive public health
investigatory roles and responsibilities.

On this final slide, we present a summary from our balloting process for
functional areas that a biosurveillance system should address. Based on
33 defined functional areas, we selected these seven as guiding our
effort.

Just as the community suggested, we focused on early event detection,
outbreak management, and countermeasure and response administration. The
data elements selected are directly tied to the subbullets listed here.
I encourage the members of Community to review Appendix D if you have
further questions about a review and results.

On behalf of the entire Biosurveillance Data Steering Group and my
co-chair, Marty Lavincher \[spelled phonetically\], who is unable to
join us today, I want again to thank you the Community and the
Biosurveillance Workgroup for this opportunity to assist in the effort
to build a biosurveillance system of value to local, state, and federal
agencies.

The work of the staff at ONC, our expert testimony, the HITSP technical
committee, and your confidence in our group\'s capacity to return with
these recommendations in response to your charge have made this effort
possible.

We're pleased to have contributed to this effort and hope our
presentation and multiple appendices describe a suggested next step. We
have done our best to estimate what the data set should look like, what
are potential cost implications for implementing the data set, and
provide a series of recommendations for you to consider as you move
forward.

With that I will stop. And I believe there is some time for some
questions or suggestions or comments. Thank you.

SECRETARY LEAVITT: Thank you. That was a very thoughtful report and
concisely given. The tensions you alluded to are evident. And I think
the worry that I have had from the beginning that I believe you very
effectively surfaced is that we would develop a public health
infrastructure that would be independent of that which we are doing with
respect to our broader health care system.

And I think you've taken a significant step toward surfacing the issues
that are necessary to resolve as we move forward in the context of this
larger tension. That it goes beyond the technical. It\'s ‑‑ I think it
was in many respects invented in 1787 at the Constitutional Convention
and we\'re still arguing about it. And in the context of a new
information age, it\'s actually a fascinating part of federalism.

I'd like to ask for comments. Dr. Gerberding, I'm interested in
particular in or your comments and then we'll move to adoption of the
report.

DR. GERBERDING: Thank you. I think I have a sense of all of the work
that went on behind this ‑‑ probably don\'t have an accurate and
complete sense. But I know it's been heroic and we really, 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.

I guess my question is probably more contextual. And that is how this
biosurveillance initiative which is really a subset of population health
data requirements is going to link to the other Workgroup, because in a
sense we\'re all trying to do the same thing, get population level
information for making better policy decisions, and better public health
decisions, better resource allocation decisions. And 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. DAVIDSON: Well, I will be happy to answer that. From the perspective
at the local level ‑‑ and I am the principal investigator on ARC
contract for the Colorado RHIO and I believe that Lynn Dierker was here
at the last meeting. Our effort to build a RHIO in Colorado.

We look at biosurveillance as a subset of population health measures. We
consider that we have four lines of business. One of them is population
health. And it sits underneath that rather than being its own. That\'s
the point I was trying to make a little earlier: that there is
opportunity here to have RHIOs be supportive of biosurveillance and
biosurveillance to be supportive of RHIOs, rather than \-- and we can
call it RHIOs for today.

I don\'t know what the proper term is. But it\'s that these efforts
happen at the local level. And 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. To not divide
one way do this, so now I have to go ahead and send this information to
these organizations while with these others I'm using some different
standards, different techniques, and different technologies. We really
want these to converge.

DR. BRAILER: Julie, if I could speak to the procedural nature of the
question. 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. But to the question that we talked about in the earlier part
of the meeting, it is our hope we will then cast what this population
health/biosurveillance/public health apparatus looks like, and is it
lumped together or is it split apart? But that's separate and apart from
this quick hit that this group did. So I think we'll take that up after
lunch and hopefully we'll leave with a very clear posture of how we move
forward.

DR. GERBERDING: I really look forward to that. I think \-- it's the same
people that we're talking about, it\'s the same source of information,
right. I would just add there may be ways in which the head start that
we have in some of the biosurveillance activities could help support the
RHIO and the population health engagement, because, again, it\'s the
same process.

DR. BRAILER: Right. Chip.

MR. KAHN, III: I just wanted to remind everyone, and I think Art's group
did an incredible work in a short time. The reason for this group was it
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.

SECRETARY LEAVITT: And the urgency is still there, the threat is still
there. And this has, in fact, I think moved that discussion
substantially forward. And I want to express, again, appreciation of the
group.

If there are no other questions we are at the point where we would ‑‑
I'd like to see this adopted and advanced to the department. Are there
any objections?

Hearing none, I will declare a consensus and we will advance these as
written.

And thank you very much, Art, and with that I think we\'re prepared to
break until 1:15.

DR. BRAILER: That\'s right.

SECRETARY LEAVITT: Thank you.

DR. BRAILER: Thank you.

\[break\]

DR. BRAILER: Thank you. I\'d like to recognize Rob Kolodner.

DR. KOLODNER: Thank you very much, David. And Mr. Secretary, thank you
for the warm welcome earlier today.

I really feel honored to serve as the Interim National Coordinator for
Health IT, and to have the opportunity to contribute to the goal of
having most Americans have an electronic medical record by 2014. And a
key step towards that achievement is the development and nationwide
implementation of the Interoperable Health IT Infrastructure, and what
we have been working on during this time of the AHIC. As everybody
knows, HHS and ONC have been working very, very hard toward that goal
for the past two years, 18 months, and I\'m excited to be part of the
leadership team now that will strive to achieve it.

Now, because of the Herculean job that the first national coordinator,
David Brailer did, this is a hard act to follow. And you really did move
veritable mountains within HHS organization, in order to accomplish what
you did, in order to ‑‑ in such a short period of time. And it was much
than anyone imagined was really possible.

And in addition to establishing the office, you really initiated the
critical visionary constructs that we\'ve heard alluded to today, the
certification commission for Health IT and the healthcare IT standards
panel, HITSP. And most importantly, communicated very effectively that
vision and ‑‑ of both the Secretary and the President for the health
information technology and its potential to vastly improve the US
healthcare system.

At this point, I see my job, as the interim national coordinator, is
very simple, it\'s to not mess it up, but also to make sure that I help
ONC and the AHIC through our staffing to move forward the activities.
And today\'s meeting clearly represents a key point that ‑‑ the end of
the first turn of the crank for the first set of activities, use cases
and standards to use for the system certification; and the beginning of
the next. That\'s what we\'re going to be getting into very shortly, is
what do we need to do to turn that crank again, with the expert advice
from the community.

One of the things also is to work with the HITSP and others so that we
have a continuous flow of new activities, rather than the \[inaudible\]
type effect that we had, so that we can, in fact, be able to handle a
growing volume of the standards and activities moving forward. And as we
heard with John Halamka, the question is what is that capacity, and how
quickly can we move forward?

Most importantly, we need to make sure that the activities that we\'re
focusing on are the ones that give us the most leverage. And I think in
particular, we need to foster innovation and creativity throughout the
country in very many groups, and what we\'re doing should represent the
floor, and not a ceiling, for the activities that are related to the
interoperable health IT infrastructure.

We have evidence of continued movement forward, we have a new contract
that was awarded just very recently to advance the emphasis on the
state-based activities that we heard about in previous AHIC meetings, a
contract to the National Governors\' Association, and the creation of
the state alliance for E‑health, and that state alliance is really a
forum through which governors, and elected state officials and other
policy makers are working together to identify HIT policies and best
practices. And they also will be working with experts in the public and
private sector to develop real world HIT solutions and model practices.

Now, we recognize the importance of including all stake holders in our
common agenda to achieve this interoperable transformation of
healthcare, and my emphasis with ONC will be to build the broad
inclusive alliances with other stakeholder organizations to enable
continued success in their national initiative, and these alliances
include our work with the private sector, with other internal HHS
agencies, and across the federal government departments such as VA and
DOD, Office of Personal Management Commerce, and others.

And Mr. Secretary, to acknowledge that we have a limited time and we
need to achieve that, you\'ve pointed out the number of days that we
have left. I understand that that clock that you have really may be more
of a spreadsheet, and the problem with a spreadsheet is that it doesn\'t
give you the minutes and the seconds, so I have here a clock that shows
that we currently have 811 days, 21 hours, 34 minutes and counting down
from 36 seconds, that you might have to make sure that you can keep
track of achieving our goal.

SECRETARY LEAVITT: Can you buy these in bulk?

DR. KOLODNER: I think you can get them real cheap after the Y2K, but ‑‑.

DR. BRAILER: Thank you, Rob. And ‑‑ thank you, Rob. We\'re now returning
to really a part of the AHIC that\'s not been done before, or was not
been done since we started, which is really trying to understand the
journey that we\'re going to take through these use cases, through these
priority areas. And to set these up, we\'ve had all of the Workgroups,
in addition to their other work of bringing forward the substantive
recommendations, be thinking about where their priority areas are, and
how that fits into the broader vision that each is challenged with.

And what you\'re going to hear today are six presentations that lay out
five different sets of priority areas, one from each Workgroup, and then
a capstone presentation that sets up the discussion from a cross‑cutting
perspective.

Let me describe it this way. Each Workgroup is looking within their own
charts to say where are the priority areas? What is it that we see being
the sequence of events, or the major steps, that help take us from these
narrow breakthroughs that we\'ve now approved the standards for today,
to the much broader vision that\'s been laid out.

However, we recognize that any process that creates Workgroups or
committees necessarily creates potential silos, so staff has taken a
separate level of analysis to look across the Workgroups to understand
where there are commonalties, where there are ‑ to use the term you\'ll
hear later today ‑- clusters, or groups of areas that cross the
Workgroups, so that the AHIC, in the end, can govern the end points, not
necessarily the tasks of the Workgroups.

This is a very complicated conversation to have. There are many moving
parts. Those of you that have looked at these spreadsheets know that
they are dizzying with respect to the details, but I think they are a
fair representation of how much work there is to do. We have made our
best efforts to try to make this as compartmentalized and as logical as
possible to walk through.

And over the course of the next two hours, we would like to leave this
with any input and sense of ideas or disagreements that the AHIC has
with where we\'re going forward. This is not a formal action for
approval that has to be taken at this point, but it will begin guiding
the work of the Workgroups going forward.

So with that, let me first turn to Lillee, who will present on behalf of
the Electronic Health Record Workgroup. And I will ask all of the
speakers today, for the purposes of people that are viewing elsewhere,
just to identify yourself, your organization, so people can have a
chance to acquaint themselves with the speakers as we go forward.
Lillee?

MS. GELINAS: Thank you, Dr. Brailer, Secretary Leavitt, members of the
Community, I\'m Lillee Gelinas. I\'m vice‑president and chief nursing
officer for the VA Inc., the other VHA, I guess you could say.

I\'m going to acknowledge my co-chair, Dr. Jonathan Perlin, who is not
here today, in outstanding work in the commitment of our Workgroup
members. I would tell you that in taking this charge of creating a
vision for the electronic health record work, the passion for the work
and the sense of urgency from the Secretary really drove a lot of our
discussions.

We heard a lot of public testimony from multiple stakeholders, including
those who have built EHRs, those who have researched the use of EHRs,
those that have used EHRs in their practice, and those that have
researched the multiple issues related to EHR use that has fueled our
work.

I\'d like to note that in the future, the Workgroup has said that it
will be a priority to look at consumer perception as our key next step.
As a reminder, our broad charge, what are we trying to accomplish to
make recommendations to the community on ways to achieve widespread
adoption of certified electronic health records, minimizing gaps in
adoption among providers.

Now, this was our vision for the future, a person-centric healthcare
system. And what we meant by that was that the electronic health record
would be available anywhere, everywhere; that quality of care could be
assessed across a continuum of services and demonstrated to meet patient
needs and expectations. That that care would be coordinated across the
entire team, and that there would be significant patient engagement.
There would be genomic information which informed patient care.

But we also saw extensive provider use and access to electronic health
information in both the public and the private sectors. We see
widespread use of interoperable HIT throughout the entire healthcare
system, building on the outstanding work of HITSP that we heard today.
We have an expectation that health IT is embedded in the fabric of the
healthcare system. Right now, we have many, many fibers that need to be
woven into a fabric.

We also need new reimbursement systems, because the entire healthcare
system, and particularly the testimony we heard in our Workgroup, it was
clear that we understand that current reimbursement processes support
fragmentation and focus on illness rather than wellness. The gap,
therefore, is enormous.

Now, where are we today? In one word, the clipboard. That\'s it. Any
questions? The clipboard. And I really want to acknowledge Secretary
Leavitt\'s vision, which resulted in the President\'s August executive
order as a critical step forward in dealing with the number of issues
that we have on this slide. And I think everyone in this room, everyone
watching these proceedings would know that there is nothing new here.

But we did want to make one point, that the low levels of EHR adoption
at this point is actually a good thing, because now with the outstanding
work of HITSP, that was just presented today, we now have the
opportunity to accelerate interoperability and adoption.

And I\'d like to note also that 50 percent of reimbursement to hospitals
in the private sector is federally based, and it\'s based on episodes of
care in individual settings by individual providers. So that employer
based public fee for service type reimbursement is an area that really
does need to be addressed shortly.

Now, what about our interim state so that the perfect doesn\'t trump the
good? We still see, by 2014, a provider centric healthcare system, that
there will be much more patient engagement, and that there would be
demonstrated improvement in safety, quality, and transparency. That
widespread adoption of EHRs will have occurred by then.

We also had discussion around how the Katrina after action report, and
the reality of the situation in the gulf coast last year, may actually
have illuminated the issues in why we need to have urgency around
reaching the interim state.

Incremental availability of interoperable health information we believe
will also be in the interim. We also see strong demand for HIT functions
and incentives for new models of reimbursement. Now, I will tell you,
there was a lot of discussion around what would be around those new
models of reimbursement. Is it pay for performance, or should we say no
pay for poor performance? But we opted not to go there for purposes of
this report. Just know that there was tremendous robust discussion about
reimbursement enabling this work.

As noted on the previous slide, we do anticipate incremental
availability of interoperable health information over the next few
years, and when considering the interoperability data elements that make
EHRs valuable to clinicians, these ten types of clinical information
were considered most important with respect to exchange among
clinicians. And I won\'t read them, but we went through quite a
deliberative process to reach these priorities.

Key barriers to implementing these priorities, I think we have all
talked about them in the last year. Patient identification, and I would
like to note that we need an accurate and reliable patient
identification absent a national patient identifier, very important
caveat there.

In terms of laboratory results, relief from current restrictive
laboratory results data sharing under current CLIA and state laws have
to be addressed. Clinical encounter notes, radiology reports, anatomic
pathology results, preservation of the necessary clinical content in
these textual documents, while structuring data to be machine readable
and interoperable is important. And, of course, family history and
health factors, policies, guidance, and protections related to the
inclusion of other family members\' health history in the patient\'s
record. And then finally, immunizations, policies, and guidance would be
needed for secondary uses of data for public health reporting, just as
we heard from that biosurveillance data task force.

Now, critical elements for reaching the interim state. I just want to
acknowledge that Dr. Perlin and I actually wanted to go here a year ago,
and we\'re very excited that we\'re finally going to be making
recommendations to you, after the first of the year, in these five
critical areas.

Financial business model that supports physician and hospital adoption
and the maintenance of EHRs. The business case for health IT is one of
the largest issues in the private sector, and we are ready to address
it. Incremental technological progress towards interoperability and
usability. Mitigation of the medical legal liability that rises from
accessing and maintaining large amounts of clinical information.
Confidentiality, privacy and security guidelines that we\'ve all talked
about up to this point.

But I really want to address this fifth area, which is organization and
cultural change in both the workforce and in patient populations with
respect to new and different approaches to the use of health IT. Both
consumers and providers need to truly understand the value and actually
want electronic health records.

Again, I want to emphasize that our Workgroup will be making
recommendations to you in these areas in the very near future.

So if I could summarize what our current state is, the clipboard. What
our interim state by 2014 needs to be, the keyboard. Thank you.

SECRETARY LEAVITT: Well done.

MS. GELINAS: Was that crisp enough, Dr. Brailer?

DR. BRAILER: Lillee, that exceeded my expectations. Thank you. With
that, the floor is open for any questions, clarifications or discussion
caveating that we will have a more capstone discussion after all of
these presentations, so there are certain issues I might ask to be held
off, if they start crossing areas.

Lillee, I\'ll start. You mentioned the adoption gap which was an area of
great concern to me when I was in government. Will I assume that these
five areas will have recommendations that will specifically address the
adoption gap ‑‑

MS. GELINAS: Absolutely.

DR. BRAILER: ‑‑ as opposed to being a separate area of its own right?

MS. GELINAS: We\'re considering adoption, as you know, a large part of
our broad charge. And with the outstanding work that HITSP presented
this morning, a lot of our specific charge for our Workgroup has been
addressed, which we\'re thrilled about. When we think about a year ago,
when AHIC first came together in October, think about where we were and
where we are now. But Dr. Perlin and I have very much wanted to really
close that gap on where we are and where we need to be, through adoption
strategies. And we would be considering not only effective strategies,
but implementation strategies. There is a big difference. We can come up
with all the strategies in the world, but implementation is where the
rubber hits the road.

DR. BRAILER: Okay, great. Thank you. Next we have ‑‑ I lost my notes
here. Colin Evans, please.

MR. EVANS: Thank you. My name is Colin Evans. I\'m director of policy
and standards for healthcare at Intel. I\'m representing Craig Barrett
here today, who has been very active particularly in this Workgroup for
all sorts of reasons, and I\'m co‑presenting this with Tony Trenkle,
representing the other co‑chair from CMS.

The broad charge of what we\'re trying to accomplish in the chronic care
arena is summarized here on the screen. Recommendations to deploy
solutions for remote patient monitoring and patient to doctor, as well
as doctor-to-doctor communication. There are a couple of reasons why ‑‑
I think we all know this, but stating the obvious, there are two main
drivers to why we\'re concerned about chronic care.

One is we\'re concerned about it, the same reason that certain subset of
the population is concerned about robbing banks. This is where the money
is. You know, 80 percent of spending in the healthcare system goes on
chronic care. And the second reason is that 90 percent of that care is
essentially self‑administered. When people are, due to a chronic
illness, particularly in the case of co-morbidities, they are
essentially doing that alone; they\'re measuring their blood sugar,
they\'re taking their pills, they\'re looking after their weight,
they\'re taking take care of their diet, you know, on their own. So
these are systems that are not ‑‑ in‑hospital systems need to be
improved, but ways that of actually enabling individuals to engage.

So there are two things that are really the main drivers for this. One
is the technology that puts patients themselves in different settings,
not in the clinical setting; and secondly, to facilitate efficient
patient-doctor communications. They are the two planks of this whole
thing.

Our vision for the future, and I think this will be sort of a repeating
theme as we go through this. There will be many sort of opportunities
for sort of discussion into weaving themes, and I\'ll even mention these
presentations are constructed for that very purpose.

We should be person focused in the delivery of healthcare in the chronic
care arena so that people can get care and deliver care in the home,
work, school, on vacation, while traveling, any setting that they
particularly need to. There is a recurring theme here about
reimbursement, whilst we pay for today, events, when you visit a doctor,
these systems that deal with people in different settings, we define
ways of getting the right macro outcome without dealing with some of the
micro financials.

Anybody with even one chronic care, almost, but certainly if you\'ve got
co‑morbidities, you\'re likely dealing with multiple providers and
different types of providers, so that coordination either has to be
created as a provider to provider link, or better yet, make sure that
all the providers can communicate with the patient in some consistent
form.

And patient engagement is also integral to the care process. We heard
testimony repeatedly from different angles at the Chronic Care Workgroup
about models that seemed to work, and they all worked when patients are
engaged in their care, themselves, and can actually see a benefit, and
see an easy way of engaging the technology.

Our vision for the future. Obviously, the technology should be usable by
anybody. The demographics of chronic care also imply an older community,
so, you know, maybe through time, those of us who are young enough to
use technology will become old enough to use it later, but at the moment
the population is not necessarily technology savvy, so that\'s one of
the barriers. Affordability is obviously a question. Portability, both
physically and logically, in the sense of being able to take information
around. The systems have to be compatible with the provider IT systems
and devices. This data has to come from somewhere.

Bi‑directional communication is very important. This is as much about
the patient receiving care instructions as it is about them providing
information to their caregiver so they can be monitored. It has to
enhance the relationship between the provider and the patient.

In this case, the opportunity for remote monitoring in many ways is
that\...

\[low audio\]

MR. TRENKLE: I\'m Tony Trenkle. I\'m the director of the Office of
E‑health Standards and Services at CMS. And without repeating what Colin
said, I do want to make just a couple major points, and I think it will
also tie to the consumer empowerment discussion that Paul will be
starting in just a few moments.

When we look at where we\'re at in 2014, I think it\'s kind of an
interim state. We still have a provider centric healthcare, but
hopefully a lot less fragmented than it is today. A lot of that will
depend on the widespread availability and use of interoperable health
information.

We certainly will see differences in reimbursement, which we won\'t get
into here today, David, but we\'ve certainly discussed these before,
outcome based, but certainly promoting the use of communications and
removed monitoring for the chronic care population. And then finally, as
Colin mentioned a few moments ago, the bi‑directional electronic
communications.

These are pretty consistent critical components, not only what was
discussed with the EHR, but also in our initial specific charge we
discussed these; the business model, secondly, the interoperability, the
user friendly, secure, and affordable technologies that kind of, once
again, get into the consumer empowerment area with engaged consumers.

Assurances of confidentiality, privacy and security which ties very
closely with the AHIC Workgroup on confidentiality, privacy, and
security. The liability that Lillee spoke about a few moments ago, and
certainly most importantly, work force and organizational changes.
Changes in workflow, that\'s certainly been a topic we\'ve spent a lot
of time on with our Workgroup, looking how we can really begin to
integrate a lot of these communications and monitoring technologies into
the overall work flow.

So the near term priorities that we\'ve focused on is basically related,
once again, to the communications and monitoring. Communications between
the clinician and patient, but also between the various clinicians. The
vital sign monitoring, the lab monitoring, and device monitoring, all
these are tied into interoperability and also building the use cases as
well. And the longer term, obviously, fall into pretty much the same
categories, just the next kind of iteration of that.

So I think to kind of sum up the overall ‑‑ I think Lillee says hers was
the clipboard. Ours is probably the telephone, at this state, and really
moving towards more different types of technologies to do
communications, whether it be secure messaging. And then finally, also
moving into more remote monitoring, not only when the person\'s
condition becomes chronic, but as Colin said, even before that. And,
which, of course, ties in very nicely with Paul and the personal health
records and the consumer empowerment.

MS. DAVENPORT-ENNIS: I\'m Nancy Davenport‑Ennis, and the co‑chair of the
consumer empower Working group, and it is my privilege, this afternoon,
to introduce to you a special person that we have invited to actually
deliver to you the results of the Working group over the past several
weeks, around the consumer empower recommendations that we would like to
advance.

I\'d like to introduce to you, this afternoon, Dr. Paul Tang, who is the
vice‑president and chief medical officer of the Palo Alto Medical
Foundation in California. The very significant piece of this is that
they have 700 physicians in this multi-specialty group, 330 of them
today are involving EHRs that they introduced in 1999. In 2002 they also
introduced tandem PHRs that are integrated within their system.

And at this point, about 40 percent of all primary care patients that
come in to this particular facility are immediately engaged in PHRs and
EHRs, and so we think that he is a magnificent person to deliver to you
this information. I'd also like to share with you three credentials that
we find to be outstanding to represent the voice of the consumer. He is
a current board chairman of the American Informatics Association that is
headquartered in Bethesda. He is a member of the National Committee on
Vital and Health Statistics, and he is also a member of the Board of the
Institute of Medicine Board of Healthcare Services.

So Dr. Tang, we welcome you as an internist, we welcome you as an
electrical engineer, and we welcome you as one who has been doing this
for 22 years. Thank you.

DR. TANG: Thank you, Nancy. Mr. Secretary, Dr. Brailer, members of the
Community, I\'m very happy to present the report of the consumer
empowerment Workgroup. You charged us to make recommendations to
Community on how we could gain widespread adoption of these records,
PHRs. What\'s the approach to take from where we are today, to where we
might be in the future, to 2014.

So let\'s start with where we are today. The first challenge really is,
well, they don\'t really know about this technology. Maybe 40 percent of
folks keep personal health information at home, largely on paper. Very
few keep it in electronic form, or even know that these products exist.

If you were on the graphic to look at the right‑hand side, that\'s to
the right of the wall of Babel, you might say that\'s probably the space
where vendors should apply these products, and in fact, there are maybe
70 or as many as 100 of these products around. The problem is they are
very low uptake. Why is that? Probably a lot because of that activity
going on right there, which is that the consumers would have to enter
the data in manually and maintain it. So whereas they might be very
motivated, initially, to enter that data, and sort of play around with
it and see what they can get out of it, very quickly they get tired of
that.

So ‑‑ and we also don\'t have communication between the patients and
their healthcare team. A contrast to that, to the left of the wall of
Babel, where we do have a lot of data, and, in fact, a lot of that is
available electronically. But because of that wall, they can\'t talk to
each other. Hopefully, after using the standards that got passed this
morning at HITSP, we\'ll be in a better position. But right now, they
can\'t talk to each other.

We have a little \[inaudible\] from the left, going to the right, and
that\'s primarily with patients who are seeing physicians in an
integrated delivery system, such as the VA, or Kaiser, or Palo Alto
Medical Foundation. They can ‑‑ those patients can get access to the
same record that their physicians have. And most of that information is
in one place.

So from there, we can learn what the benefits are, and they are
enormous. So we\'ve created an active partnership or a co‑pilot in their
care. Unfortunately, that segment of the population is very small,
because that data is tethered to any one organization.

Now, add to that, that there is a lack of sustainable business model,
and you get a bottom line where few very Americans, maybe a handful or
less percent of Americans, have access to one of these things that has
the full array of data in it.

Where would we like to be? We would like to create some kind of
comprehensive consumer experience, rather than just transaction where
you get sick care, it\'s really a health experience. And that would put
the patient at this center, or the consumer at the center, the PHR is
not an end but a means; so that the patient can gain access to the data,
the knowledge, and the people he or she needs in order to maintain and
improve their health.

That means we need wide‑spread adoption of PHRs, which can provide the
following: One is comprehensive longitudinal sort of virtual record of
their data that pertains to their health and healthcare, the data.
Secondly, they need, in understandable format, what knowledge they need
in order to understand their health data and to act upon it. Third, they
need tools ‑‑ they don\'t need just to be talked at, but they need tools
to help them change their health behavior. And finally, they need to
reach out and have easy communication tools so they can keep in constant
contact, not only with their healthcare team, but also other caregivers.

And before they are willing to share this data, they will need the
privacy protections that all of us alluded to. These protections need to
follow the data as it traverses the NHIN.

What are the components of that vision? Well, the first is something we
dealt with a lot this morning. Those are the interoperable technical
standards, such as those in terminology, or the ability, the methods to
exchange health information and make it portable, and the security
provisions to make sure that we identify each person on both ends of the
wire.

The second component really is interoperable policies. So when an
individual signs up and forms an agreement with the entity gathering
data, he or she goes ‑‑ does that willingly, with the understanding that
there are certain things you can and can\'t do with that data.

That protection of data needs to follow the ‑‑ that protection needs to
follow the data and transcend a local institution or state. Similarly,
they ‑‑ they are, at the same time, authorizing certain things to be
done with that data. That should also follow the data. And licensure is
another kind of requirement that transcends the state boundaries.

As a component of EHRs, and I know Lillee says it\'s a half full
situation where we wish that we won\'t have too many people using it now
so we can take care of the interoperable standards, so now we\'re just
asking her to play catch up and get them all connected so that ‑‑
because the EHRs have a lot of the data that the patients would like to
have, and both parties would like to share access to the same data. And
this data, then, would ride on sort of the interstate highway that\'s
being laid as the NHIN.

What would be ‑‑ there are several key enablers, and a big role for the
federal government to help advance these. One is the public education,
so in a sense, we started out by saying, one of the challenges is people
don\'t really even know this exists, what the benefits are. Maybe we
need some public service announcements that really cover what it\'s
like. Unfortunately, it\'s very much like a try it, you\'ll like it kind
of technology. You really have to experience what would care in a
relationship be with your healthcare team that doesn\'t just revolve
around sick care. I hear Smoky the Bear is unemployed at the moment, so
maybe we can take advantage of him.

He would also have to educate ‑‑ well, sort of assure and ensure that
the public\'s trust, from a privacy protection, would be met, because
that\'s the only way it\'s going to go to ‑‑ it\'s going to be acquired
and be shared across this NHIN.

The next piece is just like you\'re trying to reduce the risk of
providers purchasing an EHR; I think we also, likewise, have to provide
some kind of assurance to patients that this, indeed, is a qualified
product that not only delivers the kinds of functionality that can
benefit you, but also cares that the policies protect the data. So some
‑‑ potentially some kind of certification for core PHR functions would
be important.

We go, again, back to the EHR where we really need to see that
disseminated, we really need to see the data flow from one provider to
another, so that it can be shared with the patient as well. And
automatically populate the PHRs.

And finally, since we said that some of the benefit accrues from the
knowledge about the data, and knowing what to do next; then there needs
to be some kind of qualifying standards, perhaps, for consumer focus
educational information, somewhere besides just searching for things on
the Internet where they can get information.

Priorities, on the left side we have sort of immediate or near‑term
priorities. Just like there is a transparency called for for quality
measures and for pricing, patients would like the transparency of their
own data. So there is three kinds of ‑‑ although this is not an
exhaustive list, there is three categories of near‑time priorities.

One is the transparency of things in their record, like lab test
results, their diagnoses, prescriptions, their medications. Another kind
of enticing functionality would be the convenience function, and that\'s
what\'s represented by the administrative features, being able to order
a prescription renewal, schedule an appointment, get their claims
benefits list.

And then the third category would be sort of reminders. It\'s a mixture
of the two. So what are my health maintenance things that I\'m due for?
Could be a pap smear, mammogram or colonoscopy. Now, not every reminder
would be as refreshing as or well desired as the next, but anyway, that
is an important function ‑‑ feature of their health.

And subsequently we have online consultation at the top. We recognize
that it may be required for many of the other benefits, such as chronic
disease management. It was put on the right side because ‑‑ probably the
reimbursement situation, because it would be hard to demand people to do
this without any formal compensation for their professional service.

Summaries of the healthcare encounters, endorsed educational
information, decision support to help patients act on, in an informed
way, on their data, and capturing health outcomes, like the SF 36, like
adverse events and medical errors.

So we come back to recap to this circle, where we show the patient as
having access to tools that give them ‑‑ that improve their access to
data, knowledge, and the people they need to engage in keeping healthy
and overcoming illness.

The words in red talk about the three things to deal with immediately
and that is having the interoperable standards to move data around, to
have the privacy protections follow the data, and to have some way of
perhaps certifying core functions so the consumer can be protected.
Thank you.

DR. BRAILER: I think next is Chip Kahn from Biosurveillance.

MR. KAHN, III: And I\'ll be presenting with John Lumpkin from Robert
Wood Johnson Foundation, who has extensive background in the area of
public health practice, and what I\'m going to do is define ‑‑ talk
about our mission, define the problem, let John describe the long term
vision, where we want to get to, the end stage, and then I\'ll come back
and conclude with a couple of our immediate near‑term priorities. Let me
advance here.

Our initial mission really was to determine how to take advantage of
informational tools for monitoring and management in the public health
area at the various levels of public health authority, which obviously
are county ‑‑ or regional, state and federal. And we respond to that,
and well described this morning, that group's immediate response to this
mission.

But as we went beyond our immediate mandate, we explored the problems in
public health regarding this issue of electronic communication,
electronic record keeping, and concluded that the issues for public
health, that were relevant to the AHIC, surrounded the lack of
connectedness between public health, and the lack of ‑‑ or the
idiosyncratic connectedness of public health entities, generally with
clinical care and the ‑‑ those who were providing care and meeting the
patient ‑‑ meeting the populations that are affected by disease and
illness.

And that even though there were varying levels of use of health IT
across the country in public health, that basically it was idiosyncratic
and unconnected, and that in terms of getting immediate information to
the Secretary to exercise his authority, there were issues there. And in
terms of split authority regarding enforcement, there were all kinds of
different venues, which probably are a major obstacle to bringing this
together, because of all the different entities wanting to guard their
enforcement rights as well as keeping each other informed.

I think the issue we focused on was how can we best inform everyone at
all levels, whether it was county, state and federal. The enforcement
issues can be handled by others, obviously, as time proceeds. So we
basically divided the world of public health into functions that related
to information where HIT might be helpful, advances the AHIC could
recommend, and we then set some priorities; and basically came down to
four areas. Case supporting, bio‑directional communications, response
management and adverse events recording.

In each of these areas, there is an obvious link between clinical care
and public health entities, as well as our desire to make sure that all
the public health entities, up and down the line; local, state and
federal, simultaneously got the information they needed to play their
role on the enforcement and regulatory side.

So that\'s how we settled on these as our areas to explore. These ended
up being our priorities. And now in terms of a vision of the future,
I\'ll hand it off to John and let him take it from there.

MR. LUMPKIN: Thank you. Let me start off by saying that ‑‑ and put a
little flesh on these bones. Before I came to the Robert Wood Johnson
Foundation, I was state health director in the State of Illinois. In
1999, in November, there was a case in a small town in Illinois, which
doesn\'t really need to be mentioned, but a patient died of invasive
group A strep, beta hemolytic strep, the flesh eating bacteria that the
media talks about in the nursing home. Another patient died, and then
another patient died, and then another patient died, and over a period
of three months, ten patients died before the first report came to the
State Health Department.

When we investigated we identified two nursing homes, and there seems to
have been some contamination. We recommended antibiotic treatment and
prevention. And the outbreak stopped. But ten people had died.

Now, why did it take three months for this report to come? Was it
because the physicians in this community didn\'t care about their
patients? Nothing could be further from the truth. Was it the fact that
what we\'re dealing with were very busy clinicians? And I\'ll tell you,
in the State of Illinois, there are 60 diseases that are required to be
reported, and in the 12 years that I was state health director, there
was not one year that I could name every one of those 60 diseases. So
the challenge facing these physicians, who were providing care, was how
to figure out what to report in order to prevent this outbreak.

And so when we talk about a future, we talk about connectivity between
public health and healthcare systems, that local state and federal
agencies are getting the data they need to be able to identify outbreaks
and to prevent disease. And that the infrastructure and policies have to
be in place to enable data aggregation at the appropriate levels.

So at the local level for the county health department in that area,
they needed to know the name of that patient who got sick and who died.
They needed to know where they lived, and they needed to know what the
problem was so that they could do their intervention. But at higher
levels, we didn\'t need to know the same level of detail. What we needed
to know was what was going on so we could martial resources to that
community.

So the first area that we talked about is case reporting. And we need
rapid standardized case reporting across states, because microbial
organisms don\'t recognize state boundaries, and in many cases, people
don\'t recognize state boundaries because, you know, in southern
Illinois, people went to Kentucky, they went to Missouri, they went to
Indiana for healthcare. So you have to recognize that these systems have
to follow the patients, that the case criteria can then be implemented
into the electronic health record. There needs to be interchange.

Now, let me emphasize this point, because I\'m going to go back to my
story. You can\'t rely on a laboratory, which does most of the case
reporting now, to detect an outbreak of invasive group A strep, because
strep is not, in and of itself, a reportable disease. It\'s only when
you have that forum that becomes rapidly invasive. So it has to be a
case definition that would identify these cases, not just a laboratory
result.

And that means the ability of an electronic health record to have
transmitted to it a case definition, so that after there is an index
case number one, people in those communities can say, hey, this case
meets that case definition, I need to notify public health, push a
button, and the electronic health record sends the kind of information
they need.

And so this is a representation not only of case reporting, but also
bi‑directional communications. So when that doc sees a patient, who may
have this disease, they will know ‑‑ or who visited that nursing home or
worked in that nursing home, they would know that this is an active case
that\'s being investigated by public health, and I should give this
patient antibiotics.

And without that communication between the electronic health record and
the public health system, they wouldn\'t be able to make that kind of
decision, because they wouldn\'t have the right information. And part of
the problem of the healthcare system, providing information to public
health, has been it\'s been a one‑way street. They send stuff in, and
then they never hear anything back. Bi‑directional means we begin to
have a much more interactive system, and there is a benefit for both
parties.

The third area that we looked at is response management, and this is a
very complicated area, but let me make it fairly simple. If there were
to be an event in my current home state of New Jersey, and resources
were needed from New York, Pennsylvania, and Delaware, which are the
contiguous states, how do we coordinate that response? The systems that
states are starting to implement, from place to place, to try to
coordinate how to manage resources need to be able to interact. There
needs to be common standards, means of communicating.

And then we have to think about what if? And those of us in public
health spend a lot of time thinking about what if? This system needs to
manage someone who is confined to their home, as we saw with the SARS
outbreak. How do we manage them? How do we make sure that they get the
medications they need? How do we make sure that they get food and other
kinds of things? That\'s what the response management system would do in
this future.

And then finally, adverse reporting. Cases need to be reported,
sometimes when a device malfunctions or a drug has an adverse
interaction, and these things can be detected much quicker if we were to
pool this sort of data. So this is the vision. So let\'s talk about some
of the key enablers.

First is that we need to ensure that public health is at the table when
regional health information exchange discussions are occurring. Because
the cost of getting engaged, at that point, is relatively cheap. But if,
after these exchanges have been developed, and electronic health record
is developed, and public health says, oh, by the way, you do remember
that you\'re required by law to report, and there is no interchange
standard, the cost to implement this sort of interaction becomes very
expensive.

When I was public health director, I talked to laboratory folks who had
electronic systems. They received the samples, they sent electronic
samples back to the clinician, and then they hired somebody to then take
a hard copy of that laboratory result, write it down in state forms and
mail it to us.

There is a cost associated with participating in the public health
system that can be significantly reduced. And that becomes the business
case. The business case, then, is by leveraging the work done by Public
Health Informatics network, to identify requirements, standards and
certification, and to work with HITSP and CCHIT.

And I can tell you when I was chair of the National Community for Vital
and Health Statistics, I was taught this very important lesson. SDOs
don\'t develop standards unless there is a business case, and I think
the business case can be very clear. It\'s not because they want to do
it. It\'s because they\'re customers. Providers are required by law to
make these reports. So let\'s make it easy for them to do it, so the
public health system can do their job.

And then finally, open participatory processes. We establish this in
systems for certification of the public health system, so they are
certified to show that they can have implemented the standards
correctly, that they are interoperable and that they have the function
that\'s needed. And now back to Chip.

MR. KAHN, III: Just to conclude, taking ‑‑ trying to meet vision that
was outlined by John, we have taken each of the four areas that we\'re
focusing on with some very specific projects. In the case of case
reporting, we want to work on national standards so the definitions are
the same. And we want to work on an architecture, a strategy for an
architecture of how the electronic case reporting can be done from the
developing EHRs.

In terms of bio‑directional communications there, we need standards, and
we need to develop a system for alerts going back and forth between the
clinical care ‑‑ clinical care and public health, and then back to
clinical care.

In terms of response management, we\'re looking at the design of a pilot
for a sharing hospital utilization data, as well as how to best
integrate commercial sector supply chain and distribution response in a
public health emergency; and finally, in terms of adverse event
reporting, we want to develop national standards, and identify candidate
systems for consolidation of that information.

So if you put this together with the vision, what we want to reach, it
seems to me what we\'re talking about here is collecting information
that can be acted upon, both from a regulatory and policy standpoint
from policy makers at the state, local, and federal levels, and at the
same time, getting information back to clinicians so they can act in
terms of taking care of patients.

So I\'ll just conclude on this thought, that from our view, the title,
which was very relevant at the beginning of our process of
biosurveillance for this Workgroup, I\'d suggest something more like
public health clinical care interface; because what we\'re really
talking about here is the interaction between public health and clinical
care, using all of the tools of electronic health records that we\'re
going to develop in HIT, and hopefully, bringing about a standardization
that makes it seamless for providers to get the word up to the system,
and for the system to get the word back to providers.

DR. BRAILER: And Chip, if I might add, as part of that naming
convention, I think we have to go back and look at the charge, and make
sure we bring back a charge that is more overlapping these objectives.

MR. KAHN, III: I completely agree with that, David, and I think in terms
of our broad charge, not to say that Art\'s group completely fulfilled
it, but I think it moved it ‑‑ moved us very far in that direction. And
what we discovered, when we explored this sort of whole field, we came
up with our assessment of current state, our vision, and then our
conclusions; and I think it goes way beyond the issue of simply
immediate information the Secretary needs.

DR. BRAILER: So maybe at the next meeting we could have those
recommendations for that.

SECRETARY LEAVITT: Sure. And I feel good about the change in both the
description and the name, I think that\'s a smart thing to do, and I
think it does build on what we heard this morning, in terms of the
fulfillment of that task. So I hope we can include that in our
discussion next month.

DR. BRAILER: Okay, great.

Carolyn?

DR. CLANCY: So if Lillee's was the clipboard, then mine will be F7. So
essentially, our broad charge is very long, but let me just say,
Mr. Secretary, what we\'re trying to accomplish here, I think, is an
essential component of your vision and our shared vision, for a value
based healthcare system.

All of us have recognized, and our group is officially chartered by the
Community on August 1st of this year, that our current strategies for
collecting and aggregating data on quality and clinical performance are
simply not scalable. Lillee Gelinas mentioned seeing a nurse sitting
with a pile of charts after hours, and I think we all have our own
stories.

Now, the interesting thing, of course, is that there are providers who
make investments in electronic health records, thinking that they will
buy a product which has a functionality such that they can hit F7 and
upload these quality measurements, and for the most part, that is not
the case. Where there are solutions that exist, they have to be
programmed very specifically, and where they are programmed, they are
customized and not consistent across healthcare settings.

So in the long run, we\'re trying to focus on two areas, how do we make
quality assessment and reporting scaleable, at the same time making sure
that we use that same functionality to give clinicians and healthcare
organizations feedback in realtime.

So the broad charge, Mr. Secretary, gets back to what you were saying
this morning, about trying to skate to where the puck will be. Based on
all of the work of the other Workgroups, and I think a lot of work
that\'s happening in healthcare right now, we know the system will
change and we\'ve got to be skating to that future, even as we are
addressing real problems right now.

In the very short run, that is to say the imperfect world that we
currently reside in, we\'re going to be making recommendations to this
community that specify how certified health information technology can
capture, aggregate and report data for a core set of ambulatory and
patient quality measures.

That sounds a tad more straightforward than it is. It turns out a lot of
these measures haven\'t been specified to make that happen, but we have
a terrific Workgroup, and I do want to recognize the co‑chair, Rick
Stevens, who is from the Boeing Cooperation, and I think brings new
meaning to the word urgency, and I\'ll leave it at that, which is really
good.

So to date, we\'ve just gotten started. We\'ve had two meetings, and I
think we have just finished introductions, and Rick wanted to get right
into the business case, which turns out to be pretty interesting. It\'s
both about what is the business case for quality, in our current
reimbursement system, which is really a steep hill to climb.
Superimposed on that, what\'s the business case or value added for IT,
to make it easier to report on an improved quality of care? But we are
attempting to take that on now.

We have agreed that the core set of measures we\'re going to start with
come from the hospital, and ambulatory quality alliances, the starter
set of measures, and we have been educating ourselves about the HIT
certification process and so forth.

Some emerging principles I just wanted to share. One is that we are
going to identify solutions, but not prescribe those solutions. We
recognize that an emerging market will come up with innovations, and we
don\'t want to foreshadow those or foreclose those. We\'re going to
apply a requirements approach focused on the standardization and
discreet capture of data elements critical for reporting. And at the
same time that we\'re focused on reporting, we also want to make sure
that those same data elements can be used to give clinicians and
healthcare organizations feedback in a timely fashion.

To put this in context right now, where the hospitals are reporting
publicly on quality of care, and have been doing so for a couple of
years, it\'s nine months from the time they submit their data to the
time it\'s posted on a website, which does not facilitate improvements.
And we know that there is an array of solutions that may be necessary to
decrease the burden of data collection.

Clearly, from the conversations and presentations you\'ve heard thus
far, it\'s clear the reporting on quality is just one of several
secondary uses for clinical data, which says to me that we can leverage
a lot, and identify points of synergy with the other Workgroups.

The solutions here are likely to require some interesting collaborations
between disciplines of folks who don\'t necessarily always find each
other immediately. And by that I mean vendors, clinicians, people who
know something about human factors, healthcare organization leaders, and
so forth, to make sure that the solutions that are developed are usable
and will be used.

And we also recognize that in the current world, given the current rate
of adoption, which Lillee has presented us a glass half full, we know
that we\'re going to be living in a highbred world for the next few
years, where I do believe that an increasing number of clinicians and
hospitals will be adopting certified electronic health records. At the
same time, others are going to need to be relying on electronic claims
data enriched by the breakthroughs coming out of the work done by this
community.

So our priorities in the near term are to, again, automate the data
capturing and reporting to support a core set of AQA and HQA measures,
always keeping our eye on providing timely feedback and enabling data
aggregation.

We start our visioning exercise tomorrow, and we\'ll look forward to our
interactions between the various Workgroups. And just to depict that
somewhat visually, it\'s very clear, you could hear John Lumpkin talking
about the real need for bi‑directional communication and sharing of
information between public health and care delivery.

Similarly, I think the kinds of information that consumers are going to
want, that we\'re talking about, are under the guise of consumer
empowerment, are also likely to be a substantial overlap with our
efforts; and it's clear, I think that there is a nice synergy between
the electronic health record group, and the quality Workgroup, because
the sooner this functionality is part of certified products, I think
that adds more to the impetus and incentive for physicians to adopt
these products.

So let me thank you for your attention and say that I look forward to
continuing our work.

DR. BRAILER: Thank you all very much, and thank the Workgroups and all
the participants for very, very hard work to bring us to this date. Let
me now say to hold everything you\'ve heard, because before we go to
discussion, we\'d like to have the capstone presented by the ONC
directors.

DR. KOLODNER: What we wanted to do is have the directors move up and
crowd at the table nearby. And while they\'re getting placed, maybe I
can go ahead and start, since I\'ll do the first slide or two.

As you heard from David earlier, one of the issues is we\'ve got a lot
of information here. We\'ve got very active Workgroups, dedicated
individuals and ‑‑ who have been spending long hours to identify what\'s
important in their area, what are the priorities, what\'s the vision for
the future. And the question is, how do we handle this mass of data?

So first of all, for the visioning, what we want to acknowledge is that
that will help us to develop what we don\'t have yet, which is a
priority road map for the AHIC, that is, taking the information in, and
helping to lay out not just the next step, which is all that we\'re on,
but, you know how can we lay this out, both these technical activities
and the priorities of the policies, and some of the issues that ‑‑ such
as the privacy that have been identified.

And so we will be developing this from the input from the visioning. And
that will allow the AHIC Workgroups to focus on their identified
priorities and issues, but do so in a coordinated fashion.

And if I don\'t have a clicker here, if somebody can advance the slide
to the next slide. Thank you.

The road map will also inform the next steps for the national agenda,
and this is where I was saying it feeds not only the use cases, but the
use cases that also then deal with policy, and other issues that we need
to deal with.

The use cases, themselves, have been used to identify needs for
architecture and data harmonization, confidentiality and security which,
as you know, we formed a new cross-cutting Workgroup, pulling those out
from the different groups. And then things like certification in new
policies. Next slide, please.

Now, many priorities ‑‑ that\'s the visioning. In terms of the
priorities that you heard laid out today, many of them were expressed by
the Workgroup, and clearly, the number of priorities is more than the
bandwidth that we have right now for the next turn of the crank. So what
we\'re looking at is how do we take that set of priorities, how do we
get ready to feed additional use cases and additional issues and
policies in, and how do we use that 80/20 rule to identify the next set
of priorities that may cross cut across the different groups, in order
to ‑‑ to identify the ones that we can next take that will get us the
farthest on this next go round.

And so we\'re looking for overlaps that were across the different
Workgroups, and relationships between the different priorities that are
there, rather than risking stove piping and going forward with the
individual priorities of each of the Workgroups. So that\'s what you
will see us put forth as a strategy for how do we make sense of this
mass of information.

One other bit of information that we\'re also adding in, and that is the
gaps that were identified by both HITSP and by CCHIT. So it\'s the
priorities of the Workgroups, and for those use cases that have gone
through, the contracted Workgroups out there, the HITSP and CCHIT, the
things where as they got the use cases, they saw that there were gaps
that existed.

At this point, let me turn it over to John Loonsk.

DR. LOONSK: So as David suggested, a dizzying number of priorities, and
we really, in analyzing these priorities, thought that there needed to
be some common construct for how to look at them. And the initial
attempt at that was to take the existing use cases that were developed,
the EHR lab results, the consumer empowerment \[unintelligible\]
medication history, bio‑surveillance, add in the emergency responder
EHR, and as we were analyzing those, and the priorities that came from
the different working groups, it seemed to fall into three logical
constructs, three perspectives. And we use perspectives in use cases to
emphasize how things look to a particular group. It doesn\'t mean that
these are the only perspectives that would be represented in the use
cases, but there are three prominent perspectives that helped to
organize the material.

I think you heard, in the recent presentations, some of those common
themes; themes of secondary use, themes of a consumer experience or
consumer perspective, and there are certainly themes of the provider
perspective throughout that. And those were the three that seemed to
elevate above some of the other activities, in terms of most immediate.

So what we did was take those three perspectives and put your
priorities, as represented through the different working groups, into a
view from those perspectives. And this large chart, that we\'ll talk a
little bit more about, is really a way of looking at those priorities,
looking at the commonalities, and trying to consider this additional
organizing principle of what the high level perspectives are, so that we
can make the next use cases be coherent, not stove piped, and leverage
the different needs across the different activities.

So I think the first item is that we have suggested that these three
perspectives may be the common principles for, or common construct for
how some of this can be viewed; and that might be something that you
want to refine, you want to add to over time. But from our perspective
and analysis, that\'s the first thing that came forth.

DR. BRAILER: I\'d like to stop there with any discussion that\'s related
to these perspectives in that there are significant value statements
being made by the perspectives that are brought, how they are chosen,
and clearly, the attempt was not made to represent every stakeholder in
healthcare, and have their perspective, but to represent some of the key
polarities that come through, as this dance that John described has
happened.

These are not organizational statements. It\'s not that we expect to see
organizational structures around consumer provider secondary use. These
are management tools to help us understand how we have been complete, or
where we have gaps, with respect to this. It\'s a way to pull together
this information in a way that we can make sense of it.

So if there is any comments from the directors or discussion here, now
would be a time to have them, because everything that flows from this
will be built upon these perspectives.

Ed, did you have a comment?

DR. SONDIK: I guess I had a question on the secondary use. Because it
does seem as if a great deal of the secondary use is represented in the
other two perspectives. So I wondered if you could talk about that a
bit. I would have thought there wouldn\'t be overlap, if you will.

DR. LOONSK: Well, I think no matter how you slice this, there is
substantial overlap between the different activities, and ‑‑

DR. SONDIK: I didn\'t mean overlap between the activities, because I
actually thought that Carolyn's chart, at the end, was really terrific,
the Venn diagram which really, I think, really capsulized everything.
But in terms of the different perspectives, secondary makes it seem so
secondary, and yet it\'s represented, in large part, among the two
primary ones, if you will.

DR. LOONSK: I think that the ‑‑ terminology aside, because secondary use
does have certain attributes to it that may not be ideal in the longer
term, but the terminology aside, that when you\'re looking at data, in
the context of not using them for immediate healthcare provisions, but
that there are other processes that need to work on those data, that it
does endow the activity with a different perspective. And that\'s what
seemed to fall out.

And you can look at biosurveillance, some of the quality work, certainly
some of the broader public health activities, some of the research
activities, as all having attributes in the secondary use realm. And
again, it\'s not intended to say that everything has to be pigeonholed
into this. It\'s a way of looking at it that I think is simplifying in
some respects, because it allows for us to leverage some of the
commonalities around these different areas against each other as we move
forward with the use cases.

DR. KOLODNER: One of the things on the spreadsheet that we may want to
point out is we had a column also that existed as AHIC, and that that
was bringing forth the feedback that we received in anticipation of
meeting from the AHIC members tin in terms of what were the important
areas. And what you see is that it in fact highlights many of the things
that we\'re seeing elsewhere. So we started with a spreadsheet without
any highlighting. The elements are the same in all three of the sheets.
And then from a particular perspective, highlighted within that
perspective, what seemed to be important cutting across the columns. And
we even recognized that there is a 3D component to that, that is, there
are elements in each perspective that may be in common with highlighted
areas across the perspectives as well.

So again, what we\'re trying to identify, or one of the things that rise
up to the top, that have enough commonality and are identified either in
different perspectives or in different columns, that if we were to move
forward on activities that advanced that area, it would, in fact, pull a
lot of things forward. It wouldn\'t just be one small amount, but it has
that 80/20 component to it.

DR. BRAILER: So Rob, just to make it very practical, where a gray item,
an item is gray in all three of these perspectives, that would be part
of that \[inaudible\] 20. Right?

DR. KOLODNER: Yes.

DR. LOONSK: So as Rob has suggested, each column is a listing of the
priorities from the Working groups. There are issues at the bottom, but
the general sense is that the higher properties should be nearer the
top. That there is a column for the AHIC priorities, as coming from this
group in your review of the Working groups, and then there is a column
that has HITSP and CCHIT, because from their perspectives, there are
pieces that they need to add.

So what we did was, we went through ‑‑ we tried to put these different
priorities, this dizzying array of properties into a table so that you
could look at them. And then we highlighted, in yellow, and in gray,
those that related to the perspective. So if you look at the consumer
perspective, everything that\'s highlighted is very related to the
consumers\' view on this process moving forward.

The gray areas are intended to represent the things that we think we can
potentially write in to the next step use cases, to the second round of
use cases as they come forward. And this is an area where there is an
effort, there is ‑‑ the development of the use cases will allow some to
move in more easily than others. But we wanted to put this in front of
you to get from you ‑‑ to give the gestalt of what seems to be leveraged
from each other into that view. And I think as you\'ll see, that the ‑‑
in aggregate, more can be done if we leverage the activities off the
different Working groups to accomplish that.

So as you see, that there is ‑‑ predominantly, the highlighting is at
the top, and there is an effort here to respect the working groups\'
priority setting, but to try to coordinate it into these perspectives so
that we can move forward.

DR. BRAILER: John, could you describe some of the reasons that something
moves from a yellow to a gray classification, or from a high priority to
an actionable high priority, I think, if I could paraphrase what\'s
listed here?

DR. LOONSK: And if you look at the slide, there are clearly some areas
that work across the different Working groups, and if we point to lab
results, for example, they are prominent in several different Working
groups. They are prominent in several different perspectives. And even
if it\'s low, lower on chronic care than it is in consumer empowerment,
it\'s high enough in these various areas that it probably should rise to
the top as something that\'s elevated and advanced. So when you look at
these lists, there are actually these different clusters of activities
that cross these different Working groups that are important to elevate.

And in terms of identifying those that are here, some of them are those
that have already been looked at, to some degree; but the others seem to
be the evident next steps in regard to both the prioritization of the
working groups, and this leveraging across, and connection between the
different activities.

MS. CRONIN: So while we are going to be discussing the priorities for
infrastructure developments of these use cases that will guide the work
of the Nationwide Health Information Network Consortia in the next year,
the Health IT Standards Panel and the Certification Commission, we also
need to be thinking about what the Workgroups are working on, and
recognize the important issues that they are taking on in the context of
their broad charge. And they include the business case, work flow, legal
issues that have already been specified by several of the presentations
earlier today, and then also the cross cutting, privacy, confidentiality
and security issues.

Some of the specific issues that are related to the priority areas that
have already been noted, both in the May recommendations and in some of
the issues that have been discussed at the Workgroup, and documented in
the spreadsheet that we are currently reviewing, include regulatory
evaluators for the sharing of lab results, both to patients and to
providers, integrating electronic health records, personal health
records, remote care monitoring, and case reporting into the normal
delivery of care into the work flow of an office. And also the need for
clear and practical policies and practices on secondary uses of clinical
data.

So it\'s important for us to keep these in mind. We don\'t want to be
talking just about infrastructure development as we prioritize and as we
develop a road map; that we\'re really trying to take an integrated
approach to everything that we need to be accomplishing as we move
forward.

So what are our next steps? We hope, over the next hour or so, to get
input from all of you. We have some specific questions that we posed
yesterday that we\'ll be now discussing. Those include what are we
missing? Out of the gray highlighted areas, in each perspective, do you
think we\'re basically touching on the things that are most important to
advance in the second round of use cases? And are there any specific
considerations for the Workgroups, as we move forward, that we have not
noted already today, that we should be working on? And then lastly, is
there anything that we have currently thought that we might try to
accomplish in this second round of use cases, or in the near term for
the Workgroups, should they be considered perhaps further down the road,
because we\'re trying to take on too much at this point in time?

We also plan to initiate the development of these use cases after this
meeting today, but have two rounds of public comment so that we continue
to get more input, and really shape these, based upon not only the input
from AHIC and the Workgroups, but from the broader communities. So we
end up with use cases that really do represent what we think is going to
be the right set of priorities and accomplishments in the near term.

We also expect to be developing this high level road map, both for the
use cases for infrastructure development, and for the overall work of
the AHIC, so that we have a coordinated approach across all of our
Working groups in all of the work that we plan to take on over the next
year or more.

And then we also expect to be instituting a new process for reviewing
properties on a somewhat regular basis, perhaps every six months, as Rob
referred to before. We want to make this continuous and iterative, and
one that could be handled appropriately, and allow for broader public
input, as necessary; and also keep more of a steady state to all of our
processes, where we don\'t have a huge influx of a whole new set of
priorities that are, perhaps, difficult for everyone to consider fairly
and carefully, and once every year. We\'d like to make this more of a
steady state as we move forward.

So with that, I\'ll turn it over back to Dr. Brailer.

DR. BRAILER: Thanks, Kelly. I just have two comments. For those of you
that have watched the nuances of AHIC and ONC, as they have danced
towards the place we are, one of the things that you would notice is
that often we have only been one small step ahead of where we need to be
for contractual purposes with CCHIT, or HITSP or NHIN. And this exercise
is one to really break that mold, to get us out ahead of this process
for 811 days plus.

So that we\'re not being dictated by the short‑term needs that ONC has
to be able to fulfill its own contract oversight so that the contractors
can do their work. And so this effort is a little abstract, and I think
part of what people might be feeling is, what am I supposed to comment
on? It\'s midway through the process. And this is a chance for AHIC to
shape the overall directions and contours of this, because we did not
want to come back to you with a finished product, with 11 bullet points
saying, here is our draft candidates for what we\'re going to do next,
and here is how they play out over the next couple of years, without
anyone saying we had a chance to discuss it.

So what you\'re seeing is a work in progress. It\'s built upon all the
Workgroup discussions that we\'ve had to date, in terms of kind of
working backwards from a 2014 intermediate state back to the so whats.
You see an enormous amount of commonalities across these areas, and this
is a reality, and this is part of what the AHIC ultimately has to do, is
to make sure that there is one game, there is one process, even though
it\'s being parcelized into many component pieces.

So there are questions that have been posed to you, that we\'ll pose to
you now, but at this point, the floor is really open for discussion
about what should or should not be a priority, or about the methodology
or process that\'s brought us here that will carry us forward. Because
you will see many versions of this every year or half year as we go
forward. Colin?

MR. EVANS: Thanks David. That\'s helpful. I mean I\'m struggling a
little bit, trying to figure how to deal with this data set, and figure
out what you would actually do with it, when you get the comments from
‑‑ some guidance as to what would be most useful in terms of comments.
You want us to sort pass judgment on whether these cost cutting
varieties still make sense? Because to me, setting priorities, certainly
in the place I work, implies not just what the most important thing is,
but what the least important thing is, and therefore, the more likely
thing you stop doing, in order to focus on something else.

So you\'ve got two vectors here. You\'ve got a vector of taking the work
you\'ve already done, taking the first turn of the crank, and figuring
out what it takes to actually focus on making some of that become
actionable and actually have impact.

And the second factor, figuring out what the next wave of use cases is
that we\'re on the existing process to go and work on it. To me they
seem potentially in conflict. If you put direct resources onto worrying
about the next set of use cases, does that mean we\'re actually
directing our attention or the ONCs\' attention away from focusing on
actionable ‑‑ you know, my instinct on these things is let\'s, you know,
deep root some of the existing work as a higher priority than perhaps
starting new stuff that could be a distraction.

But then, again, I don\'t really have a good feel for the resource that
we\'re prioritizing here to know whether we can do both. I mean if we
can do both, then of course, but it seems to me that 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, and
focus on stuff that ‑‑ I\'d certainly err on the side of making what
we\'re doing already impactful before on taking new stuff that\'s
potentially speculative. So guidance on what would be useful input
\[inaudible\].

DR. BRAILER: Let me respond to that, and first, 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.

So we\'re not in the steady state. I think you might have a discussion a
year from now, which is we have about maxed out the amount of volunteer
effort that we\'re going to get. Let\'s now just start working within. I
think there is a sense that it\'s expanding, but I don\'t want to add
numbers to it, but it\'s not doubling, you know. So maybe it\'s just
getting bigger. So it\'s a little bit hard to do that. It\'s very
different than the corporate setting, to some degree, where we know what
finite resources that we have.

But I think the two key variables in this discussion come from how did
this list get percolated? You see a list of all of the elements, the
line items of what have been said are important. It\'s just fixed. It
came from data collection Workgroups, et cetera. You\'ve seen this.

The elements that make things go to the top of this are how many things
are seen as actionable, to your point, which is a point of discussion,
itself, is that the criteria that\'s the most important, very much
driven by the needs of making sure HITSP, and CCHIT and the other
institutions that are being created, are busy and working at their
maximum effort towards the goals that are here.

And secondly, how often something lines up as a priority across these
three stakeholder perspectives, thus coming back to the question John
raised, that these three perspectives are artificial constructs. They
give us a lens to try to break the model to decide where things are
common or not. And those might not be the right ones, they might be the
right ones, they might be too few.

So the total of those two really boil up to what comes out of the other
end that we say we\'re going to be working on. And the document you\'ll
see at the next meeting will be very much, I think, the shrink wrapped
version of here\'s the 12 or ten or eight things. So I think those
things are worth discussion.

SECRETARY LEAVITT: 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. And we
would ‑‑ I think we need to contemplate that as a possibility.

DR. BRAILER: And I think to that end, Mr. Secretary, there is really an
unknown number of contingencies that aren\'t even stated here that could
shift this, and so, you know, that\'s why I think this is seen in the
end as not a top down once and for all list. We can\'t give that level
of certainty, the Workgroups or the contractors, but a process to be
revisited.

SECRETARY LEAVITT: I\'m going to have to leave to get an airplane, so
I\'ll just jump ahead and ask if you\'ll help me understand, when we\'re
going to go through this discussion and the process, and I see what
I\'ve heard you describe as we\'re going to see a lot of this worksheet
over the years, and over the months, and that it will change, and I
think it\'s a very important planning construct, and I like the way I
can see it all here, and I\'m beginning to understand it.

Do you anticipate that we\'ll make some decisions on what we can deploy
at the next meeting, or the meeting after that? Or when do you see us
actually selecting, albeit not a final list, but at least an initial
list to get people deployed?

DR. BRAILER: First to your comment, this list will change in two ways.
The elements on the list will change as the universe of what\'s
considered expands, for instance, the genomics discussion today.
Secondly, the sense of actionability or priority will change because of
reasons that you describe, the nonlinear factors or just the linear
evolution. And so this list will change. The decisions that need to flow
from this will happen beginning after this meeting. Decisions have to be
made in ONC about certain guidance to contractors by the end of the
fiscal year, so they\'re close, and, you know, they\'ll be playing out
this month and next month.

To that end, members of the Community have seen precursors of this
document and this document. There has been a lot of back and forth
discussion. In many ways, what\'s presented here presents, in a public
recap, what has been being discussed for some time.

But this would continue to evolve. 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.

SECRETARY LEAVITT: Using that information we\'ll then begin to deploy
contractors and resources as we have ‑‑

DR. BRAILER: And Workgroups, et cetera. But that result should be able
to be walked back to these, if you would, genetic groups, so where that
came from, so there is no misstep.

Kevin.

MR. HUTCHINSON: So with that said, there is obviously, across a lot of
this, labs and meds continue to come up, and as the most important data
element items; but to Lillee\'s point, she mentioned previously about
adoption, and you get down in ‑‑ I notice that there are ‑‑ the
Workgroup issues are here as well.

But 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? Or like business case issues, like we
just discussed, with clinical research, or clinical trials, or other
types of programs that could expand the business case for adoption? And
other great topics that were brought up today, that could actually
expand the business case for adoption of EHR systems. But those aren\'t
on here as workflow ‑‑ Workgroup issues. So I just want to see if
that\'s missing, or just not intended to be on here.

DR. BRAILER: It\'s a good question. Those were not intended to be on
here. 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.

The other thing is that remember, 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. And I
know many of those incorporate these elements, regardless of where they
stand with respect to the charter. So ‑‑ but these line items, I think,
are open with respect to what else needs to be put on them.

SECRETARY LEAVITT: Could I pick up on the adoption piece? I mean that
clearly is a subject that we have to deal with, but I think David is
right. I would like to see AHIC focus on any technical or ‑‑ 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. There has been a
lack of certainty in the marketplace as I\'ve been around the country.
I\'ve been to, I guess, 13 or 14 medical societies in the last two or
three weeks, and I\'ve had lengthy conversations with them about
adoption, and I\'ve, on occasion, reflected a story about a young
student who has just graduated, and going to Tennessee, who said, \"I've
heard your speech on health IT, I buy it, I just want to know one thing.
What system should I buy?\" And I was very pleased to be able to tell
him, just make sure it has the CCHIT seal of approval, and you\'ll be on
a pathway.

It\'s clear to me that there are physicians all over America, who have
been asking that precise question. He said, \"I can only afford to do it
one time,\" and they've been waiting. So if ‑‑ and I think in
significant measure, by developing what ‑‑ the certification process,
and driving this process forward, we\'re giving people substantial
comfort that there is an end game here, and, of course, I think a lot of
Congressional action will begin to provide incentive, if, in fact, any
solution is arrived at, the physician reimbursement rate issue, either
in the short term or long term.

I\'m of the belief that some part of that is going to play very heavily
on this subject. That will add impetus. I think the fact that we now
have 17 percent of the physicians in the country who have been through
early adoption, and that we\'ve worked through that problem, that\'s
very much driving this. So I\'m of the perspective that we\'re going to
see a substantial increase in adoption happen.

And there will be a big debate in Congress about whether or not the
federal government ought to be putting money into it, or how it should
be paid for, et cetera, et cetera. Our job is to make certain that there
are no technical barriers that stand in the way of those other things
happening.

DR. BRAILER: Lillee?

MS. GELINAS: A quick question. When we mention adoption, I know my
learning curve serving on AHIC has been enormous, and I have been
encouraged by seeing that there is a segment in healthcare in the United
States that is interoperable, and that\'s the Veteran\'s Administration.
And I just ‑‑ when we talk about this notion of technical, I hope that
our VA colleagues that I don\'t know enough about, 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.

There is much to learn from that, and I know in our EHR Workgroup, it
has been great having Dr. Perlin as the co‑chair with me, because he can
inform those discussions. We have other Veteran\'s Administration staff
on the Workgroup to help us inform those discussions.

But it would seem, as a part of this, I do get confused a little bit
when I look at all this. Does this all apply universally to every
healthcare entity in the United States, or are we only talking about a
segment? I\'m not suggesting that we answer that today. I\'m just trying
to get my arms around how big is this thing and are there best practices
already out there that can inform this work and not have us reinvent the
wheel.

SECRETARY LEAVITT: Again, my sense is that\'s what the work of this
group is to determine. And 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 ‑‑ 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.

DR. SONDIK: I think in John\'s ‑‑ one of John\'s slides, he showed the
clustering of these elements, and I think looking at it that way, that
will really inform the technical side of this, because we\'ll see a
number of dimensions of it by looking at it that way, in other words,
across the areas at the top, consumer empowerment, chronic care and so
forth, and then looking at those issues. When I look at them,
individually, it seems as if I don\'t see the technical barriers, but I
think if we look at them more jointly, if you will, from the fact that
they\'re going to be used in different ways, then I think it will become
more evident.

So I really look forward to seeing that, and I\'m assuming that you\'ll
be ‑‑ am I correct that you\'ll be coming back with sort of an analysis
of this based on that clustering idea?

DR. LOONSK: 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, as Kelly
said, and then to move on down. But I think to hearken back to some of
the discussion, this allows us some of the flexibility to move forward
in terms of leveraging the work that\'s already been going on, but there
still is a need for some of the specificity, as you heard, relative to
the standards activity, that without the specificity of context, they
can\'t do their work.

DR. BRAILER: And again, I would emphasize, Ed, that 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. And so you
will have that, it will be at the next meeting, but already after this
discussion the wheels will be turning in ONC for various things that
they have to do of their own right. Chip?

MR. KAHN, III: To Colin\'s point, and then to your point, I think in
some ‑‑ I understand that it\'s very ‑‑ and to your point, it\'s very
hard to quantify what resources we have, because it\'s not simply the
contracts. It\'s an army of people out there, or organizations that
could be brought to bear in any one of these things. But just in looking
at the mass of it, I still sort of wonder whether ‑‑ and maybe it\'s the
next meeting or the meeting after, and let me just offer a suggestion,
that somehow could there be some waiting, which would obviously be
subjective, of what massive resources ‑‑ you know, what\'s ‑‑ maybe
there\'s just a number, you know, this is like a nine and this is like a
five, in terms of the amount of effort it would take to actually get
this done. Because it seems to me that ‑‑ you know, we want to get all
this done, but we\'re not going to get all of this done, I don\'t think.

And maybe one ‑‑ if there was just something ‑‑ some way of assessing
not just the financial resources, but just sort of 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, you know, then it\'s just a value judgment of whether this or
that is more important for reaching all these goals we\'re talking
about, and at the end of the day, you know, I can make arguments either
way, and it\'s still a zero sum game in terms of the amount of energy,
money and whatever there is out there that will make these use cases, or
these projects that underlie these happen. So I just wonder if there is
some way to weight it so you can make some judgment.

DR. BRAILER: It\'s a very interesting question, because, you know, there
are, as you know, well established even kind of two by two tables of how
big an opportunity is versus how hard you have to work to get there, and
you always stay up in the upper right quadrant in those.

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. Some hospitals would engage in, some
health plans would, some of the technical community would, public
health. 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. We
could certainly go back and look at that.

MR. KAHN, III: I\'m assuming you could weight voluntary effort, in some
way. Maybe you can\'t, but it would seem to me you would have to do that
to make the ‑‑

DR. BRAILER: \[Inaudible\] and they're not fungible poles, that you
could ‑‑ if you chose project A or project B, they draw from separate
walls of resources, so they\'re not really exclusive.

MR. KAHN, III: So it's not zero-sum game, it still is a game \-- there
are still aspects of it that are zero sum.

DR. BRAILER: And partially, we can\'t measure that very well either.

DR. KOLODNER: I think one of the things to be aware of is this is ‑‑
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.

Now, while the standards and the use cases, which allow this to identify
some standards, while those go through to those next phases, we still
have additional opportunities to put in some new use cases, to use this
early part of the mechanism, to identify some further standards that can
move through the process, so we\'re still learning. We\'re still
refining.

We still don\'t know how expandable that is or whether, in fact, as
people get excited, we\'ll find new individuals that haven\'t been part
of the experience now coming in and coming forth. We\'ll see how that
plays out.

At this point, we need to be very careful. We need to not do anything
that jeopardizes getting the first set of activities that we have
started to the finish line, and to deliverable product that is now being
used. We\'ve got the NHIN activities that we haven\'t talked about
today, to have an opportunity to begin actually allowing some of these
early systems to connect to one another and get us some early winds from
that interoperability.

So there is a number of other pieces that are coming together. And I
think that while being careful that we\'re making progress, we need to
take the next step, and ‑‑ because we\'re continuing to refine this
process, probably through the second and even the third turn of the
crank that we\'re going to be doing. But it will get better, and better,
and faster as we do that.

DR. BRAILER: Any other comments at this point? Colin?

MR. EVANS: A couple of comments, I don\'t know if it\'s useful or not or
not, but it seems to me, looking at this, that there are some of these
things that we've observed, not just this yellow and gray stuff, but I
think there are some Workgroups that have natural affinities chronic
care and consumer empowerment seem to be ‑‑ sort of empower the
consumer, PHR oriented, whereas the biosurveillance and EHR seem to me
at least be clusterable. I mean those together would be useful.

And I think to me it seems a little bit dangerous to look too much at
the cross-cutting, 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 given a higher priority to picking,
you know, the minimum subset of things required to make the base set of
recommendations in each of the Workgroups is actually get implemented
rather than focus too much on the horizontal and then miss the vertical
end.

DR. BRAILER: And again, 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 finding ‑‑ 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.

SECRETARY LEAVITT: Your point, though, Colin, is a very good one. I have
this suspicion that I\'ve already suggested, 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, adoption ‑‑ 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.

There is a value in that occurring, because in every case, we talk about
adoption as being a critical element of it. If that\'s the moment that
drives adoption, we ought to be looking at a vertical axis ‑‑

\[Low audio\]

SECRETARY LEAVITT: ‑‑ that\'s right, to drive that one home, and we can
work on some of the other vertical axes later, or columns. I think
that\'s a very, very important point.

DR. BRAILER: Any final comments? Anything else from ONC staff that you
need at this point?

MS. CRONIN: It would be helpful to have a clarification that we do want
to either consider within this particular round of priorities, anything
related to either clinical research or population health. We did hear
from roughly half of you, over the last week, that 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.

DR. BRAILER: Okay. Kevin.

MR. HUTCHINSON: I think ‑‑ because I know I gave feedback prior to
actually the meeting, and what I get a sense of the discussion today is
biosurveillance and population health can kind of come together into one
as we move forward in \'07. 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, you know, 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.

DR. BRAILER: Chip?

MR. KAHN, III: I just think ‑‑ and I agree with Kevin\'s point about
population health, but I think in terms of the other ‑‑ I can think of
some places it might fit, and I think, at this point, my bias would be
to try to take new topics like that, and if it could fit, let\'s fit it
rather than start a whole new group and a whole new process, and ‑‑ you
know, you could argue EHR would be for a home for it. I mean there are a
lot, but I think the first charge ought to be, can we fit it into our
current model. If we can\'t, than obviously we need a new Workgroup, but
I think we need to go through that exercise.

MS. CRONIN: I think we wanted specifically to hear from you whether or
not we should be considering it for these next use cases, so we can come
back to you with some options on how to handle clinical research and
population health within the current constructs or the current working
groups, but for the use case development, do we consider these
priorities to be in or out at this point?

DR. BRAILER: So taking these piecemeal, is there objection to merging
the population health topic into this being restructured or expanded
Workgroup formerly called biosurveillance? If there is no objection to
that, then, Chip, I think 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.

I think that clinical research question, notwithstanding, is one of
the ‑‑ you know, my overall feeling, as we started the discussion from
Anthony earlier today, was that despite the magnitude of it, we don\'t
have a lot of experience in this group, or in the health IT community
dealing with it, and I\'d hate to take a huge step and misstep.

So 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 are we missing?

So I don\'t want to wait for that discussion, which probably wouldn\'t
be until January or February to be able to get started. On the other
hand, I don\'t want to just suddenly change our process because it\'s an
unknown. Will that work? So could you bring back a clinical research
element to any and all of the use cases that you think are relevant? Any
opposition to that, Ed?

DR. SONDIK: Back to secondary again, just one more time. There is a lot
to words.

DR. BRAILER: It\'s now tertiary.

DR. SONDIK: \[Inaudible\]. I think rather than ‑‑ it just bothers me. It
seems to me that it will somehow be downplayed. And yet if you look at
what\'s there, particularly if we expand the scope of biosurveillance,
combine it with population, it\'s very important, and it\'s another very
critical partner to all of this. I think it\'s the ‑‑ I\'m not quite
sure what to call it, but it\'s sort of the system side. It\'s the
people who are responsible for quality, for example, and overseeing a
particular area. And I think it\'s important. So I\'m not sure the right
word at this point, at this hour, but perhaps others who are more
creative can come up with one.

DR. BRAILER: But my suspicion is, when we take away the nomenclature
issues, it\'s a deeper issue than just the name. There is a real
question here about how much is quality in public health, and population
health, and the oversight and administration of the healthcare system
really relying upon the same data artifacts that flow out of the patient
care process, and I don\'t think they do. And I think there is a
question within that about what is the real intent by these secondary
uses of data. And Rob, I think maybe you have an answer?

DR. KOLODNER: The main thing is that the word \"secondary\" doesn\'t
mean second class. I mean it really runs something that was a
perspective that will be addressed. And some of the things about
anonymizing the data, and aggregating the data, I think are issues that
come up in that particular perspective that don\'t come up in some of
the other perspectives. So we are ‑‑ that\'s where we would pick up some
of the quality and population that are important, but that have a
different outcome in terms of aggregate data.

DR. SONDIK: I guess what underlies my statement is that I see the
information coming from this as not solely, if you will, healthcare. 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. BRAILER: I think it\'s fair to say that it\'s easy for all of us to
understand and to use, as a management tool, a consumer perspective or a
provider perspective; even though in provider, there are various
perspectives. 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. Dan?

MR. GREEN: 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 healthcare
system, but do you also mean payers? Do you include the secondary
consumers; parents, for instance? Just what ‑‑ policy decision makers. I
would like to see a better ‑‑ a clearer definition, at least one clearer
to me.

MS. CRONIN: 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.

And then for biosurveillance, it\'s secondary use of clinical data
that\'s captured originally at the point of care, and then shared with
public health for public health purposes. Now, there are broader uses
which have been touched on, both by Dr. Collins\' presentation this
morning, and through clinical research that are both secondary uses of
data, again for two different purposes. Population health being sort of
a broader construct serving many purposes, including the monitoring of
health status.

So I think when we go back and start to evaluate both the broad charge
of the biosurveillance Workgroup, as it\'s renamed, and all the other
secondary uses, we can be considering, from a societal perspective,
perhaps, what all these data could be doing for us.

DR. BRAILER: So 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. Any further comments here? Nancy.

MS. DAVENPORT-ENNIS: Thank you. Just to ‑‑ I think whether we examine
the worksheets that we have from a cross-cutting perspective, or whether
we examine them from the vertical perspective, there is one fundamental
area that as we focus on technical barriers to adoption and moving
forward, and if we needed to implement immediately, what can be in the
way. Doesn\'t matter which section you go into. There is reference to
the need to be able to have a patient identifier, a system of
authentication that would allow access, and through the system of
authentication that allowed access, there could be a process that could
help to ensure the issue of security.

And I\'m trying to approach those from a technological perspective this
afternoon, and not from the legislative evaluation of HIPAA. And so I
think technologically, if that\'s their charge, this afternoon, that we
want to look at that, both vertically and cross-cutting.

I\'d also like to say a closing comment, if I may have permission to do
that this afternoon. 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.

DR. BRAILER: Sounds as close to a final comment as I\'ve heard. Thank
you. And with that, let me thank the panelists, and the staff, and the
people who have worked so hard. This is the beginning of a process. You
will hear more, but I think we have accomplished the goal of giving
direction to staff, so they can continue executing on the contracts in
other work. Thank you.

With this, the floor is open for public comments. If you do have one,
please approach a microphone. I will ask that your comments be brief and
be noncommercial in nature. As people are coming to the microphones,
I\'ll just, again, thank everyone for this work to date, and we\'ll be
looking forward to more. And I think we have ‑‑ please.

MR. MERTZ: Hi, Dr. Brailer.

DR. BRAILER: Hi, how are you doing, Al?

MR. MERTZ: Hi. I\'m Alan Mertz, president of the American Clinical
Laboratory Association, and pleased for this opportunity to comment to
the Community. My comments, today, specifically address the ongoing work
of the Health Information Technology Standards Panel or HITSP.

While we are generally supportive of the standards harmonization efforts
that HITSP is undertaking, and agree that as in general, its
recommendations should be given deference where matters under the scope
of its responsibilities are concerned, some of HITSP\'s work is
fundamentally flawed.

By recommending standards, which 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 the
feasibility and pursuit of perceived technical progress.

In particular, we would like to direct your attention to the use case of
laboratory results and HITSP\'s recommendation today, to utilize HITSP
ISO1. This seemingly innocuous recommendation, if adopted, will actually
create new roadblocks, despite existing efforts to address the creation
of uniform results reporting standards.

It\'s our belief, at the American Clinical Lab Association, that vendors
have dominated this process, and as such, HITSP ISO1 reflects a
specification used by vendors in Europe that do not adequately
accommodate the practical realities of lab result reporting today in the
United States.

HITSP ISO1 is based on integrating the healthcare enterprise laboratory
technical framework, IHE. This specification recommends use of HL7
version 2.5. Even though the vast majority of U.S. applications use HL7
versus 2.3, and to a lesser extent, version 2.4, the EHR lab
interoperability and conductivity specifications for e‑link
specifications calls for HL7 version 2.4.

The cost and time required for healthcare providers to upgrade their
systems and processes to the HITSP specification would be substantial,
and only the largest healthcare providers in the US, hospitals and
laboratories, would be even remotely capable of conforming to this
standard, albeit at a considerable cost.

The adoption of e‑links, a specification developed in a multi
stakeholder collaborative process, under sponsorship of the California
Healthcare Foundation, would be far more preferable than adoption of
HITSP\'s vendor-driven 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 lab reporting specification that can be adopted as
an industry standard, thereby eliminating the need for clinical
laboratories and ambulatory EHR systems to define a new \[inaudible\]
interface that\'s implemented.

As I mentioned, e‑links is based on HL7 version 2.4, in large part,
because of the ongoing adoption of that version by laboratories and EHR
vendors. The laboratories and vendors who work together to develop
e‑links valued feasibility as much as technical progress.

By contrast, few, if any providers, including laboratories, have adopted
HL7 version 2.5, and implementing the version that HITSP is currently
suggesting would be significantly more costly, take much longer to
adopt, and create numerous operational difficulties for all providers.

E‑links is currently being utilized successfully here in the United
States. Five demonstration projects are taking place in large and small
physician group practices in California, among them Cedar Sinai,
Humboldt, Del Norte.

Participating laboratories include Lab Core, Quest Diagnostics, St.
Joe\'s Hospital, and the UC San Francisco Hospital, among others.
Alternatively, the HITSP specification is not currently in use in the
United States. For these reasons, we recommend that you reject the HITSP
recommendation and consider a means to leverage the e‑links
specification. The certification commission has already recognized its
use in the initial and second drafts of its 2007 interoperability
criteria, and we urge the Community to do the same.

We thank you for this opportunity to comment.

DR. BRAILER: Thank you, Allen. Could you make sure a written copy of
your comments are given to staff, if you have one?

MR. MERTZ: We will.

DR. BRAILER: And same for anyone. Please.

MS. SERKES: Good afternoon. I\'m Kathryn Serkes on behalf of the
Association of American Physicians and Surgeons. I want to thank the
Committee for again opening up their meetings to public comment.

I have just some brief comments on this issue of technology versus
policy, and a couple of weeks ago at the NHIN, Simon Cohen, the chair of
the NCBHS wisely pointed out that in all of the discussions about the
technology, that the issue of policy, policy, policy keeps coming up. So
what I would like to reiterate to you, that it is not so much the
technology that is holding our physicians back and our members back for
adoption, it is the policy questions that still remain to be answered.

And as I should point out, the Association of American Physicians and
Surgeons, is physicians in all specialties, but our \[inaudible\] small
group and solo practitioners. So I think in many cases these discussions
that you have, we are likely to be the laggers in terms of the adoption.
So our concerns always come back to this.

And certainly, cost is an issue, as the Secretary pointed out, but some
of our guys are hesitant to adopt, because of cost issues, but it\'s our
perspective, then, that the policy needs to drive the technology. Which
is going to drive? Is the technology going to drive the policy, or is
the policy going to drive the technology? And that the business models
will be based on the policy decisions, and then that\'s going to be the
long term factor in the cost for our guys.

So let me give you an example. The secondary use certainly is a primary
concern for our members, and that\'s a policy decision. Also, the
privacy is of utmost importance, as a policy decision.

Let me give you an example of something that really is ‑‑ that initially
seems like an example of a technological issue, but is a policy issue;
and that\'s the issue that keepings coming up of granularity. What
information can be ‑‑ which information and to whom can that information
be shared? So that there has to be a ‑‑ the technology has to be
available to handle it in different ways, but there also needs to be the
policy decision about how much will be made available and must be made
available?

So we see ‑‑ and obviously, the granularity is something that\'s
certainly going to drive the cost factor, and the education based ‑‑ the
level of education for the end users.

And then the fourth area that\'s of a policy concern for our guys is
that many of our members are trying to, if you will, declare
independence from the third party payment ‑‑ third party influences on
the practice of medicine, the influence on the clinical practice of
medicine. And this is seen ‑‑ they are concerned that the inclusion of
the EHR being linked to the payment issue again will pull them back into
the third party vortex, which is what they\'re trying to pull away from.

So again, I will echo the concerns, and I see that certainly in the
Workgroup issues, you have ‑‑ you talk about the policy, and outline
like the need for the policy for the secondary use, and we echo those
and certainly hope that that is something that you can keep addressing,
and keep in the forefront as you go along. Thank you very much.

DR. BRAILER: Great. Thank you very much.

MR. LEARY: Dr. Brailer, my name is Tom Leary, Director of Federal
Affairs for HIMSS. I have just two observations from today. First, given
the conversation around coordinated next steps, and for the AHIC, it
seems like an obvious next step would be to more closely coordinate your
efforts with the government and health sector coordinating councils
around infrastructure protection \--

\[low audio\]

\-- They can learn a lot from participation and from observing this
Community, and from collaborating with you. Secondly, just speaking on
behalf of HIMSS members, I appreciate the Secretary\'s comments about
volunteers, participation in the HITSP process, and the whole issue of
volunteer burn‑out is reality for our members.

One small suggestion would be to possibly have the Secretary\'s comments
made available so that we can send it to our members who participated,
who weren\'t able to be part of these proceedings today. Thank you.

DR. BRAILER: Thank you, Tom. Any other public comments?

With that, let me thank you all for participating in the ninth AHIC
meeting. Before we close, I want to give a special call out of thanks to
three people.

The first is the person you\'ve met who is behind me, Judy Sparrow, who
is the director of the AHIC who has just done an admiral job. Thank you,
Judy.

\[Applause\]

Also, and perhaps more importantly, behind the curtain over here, Gloria
Cohen and Matt McCoy have driven the AHIC since nearly the beginning,
and they have been self‑less and quiet and unassuming, and yet they have
made everything happen for us. So thank you two very much as well.

\[Applause\]

And we stand adjourned. Thank you.

\[Whereupon, the meeting adjourned at 3:30 pm\]