## AMERICAN HEALTH INFORMATION 

## COMMUNITY MEETING

## JANUARY 23, 2007

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

## U.S. Department of Veterans Affairs

## The G.V. "Sonny" Montgomery Veterans Conference Center

## Room 230

## 810 Vermont Ave., NW, Washington, DC 20005

### 

### 

### List of Participants:

### 

**[Members:]{.underline}**

** **

-   Secretary Michael Leavitt, Chair

-   Robert Kolodner, M.D. Acting as Vice-Chair for part of meeting

-   Secretary James Nicholson, Department of Veterans Affairs

-   David Brailer, Ph.D., Vice Chair *(participated via conference
    call)*

-   Craig Barrett *(also represented by Brian DeVore)*

-   Robert Cresanti *(represented by Bettijoyce Lide)*

-   Nancy Davenport-Ennis *(also represented by Gail McGrath)*

-   Julie Gerberding *(represented by Steven Solomon)*

-   Gail Graham

-   Douglas Henley, M.D.

-   Kevin Hutchinson

-   Charles Kahn, III

-   John Menzer

-   Leslie Norwalk *(also represented by Tony Trenkle)*

-   E. Mitch Roob

-   Scott Serota *(also represented by Justine Handelman)*

-   Lillee Smith Gelinas, R.N.

-   Linda Springer (*represented by Daniel Green)*

-   Phillip Swagel *(represented by Nada Eissa and Adele Morris)*

-   William Winkenwerder, Jr., M.D. *(also represented by Carl
    Hendricks)*

> **[Presenters:]{.underline}**

-   Linda Kloss

-   Kelly Cronin

-   John Glaser

-   Stephen Parente

-   Victoria Prescott

-   John Loonsk

-   Rose Marie Robertson

-   Blackford Middleton

-   John Lumpkin

-   Carolyn Clancy

-   Jodi Daniel

-   Paul Feldman

-   Richard Stephens

-   Brian Kelly

-   J. Marc Overhage

-   Ginny Wagner

-   Robert Cothren

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**TABLE OF CONTENTS**

-   Call to Order: Secretary Leavitt

-   Introductory Comments: Secretary Leavitt

-   Comments: Dr. Brailer and Dr. Kolodner

-   State-Level Health Information Exchange (HIE) Recommendation

    -   Linda Kloss

-   Health Information Exchange Business Models

    -   Kelly Cronin, John Glaser, Stephen Parente, Victoria Prescott

-   AHIC Priorities and 2007 Use Cases

    -   John Loonsk, Rose Marie Robertson, Blackford Middleton, John
        Lumpkin, Carolyn Clancy

-   Comments: Secretary Nicholson

-   Confidentiality, Privacy, Security Workgroup Recommendations

    -   Jodi Daniel and Paul Feldman

-   Consumer Empowerment Workgroup Recommendations

    -   Nancy Davenport-Ennis and Rose Marie Robertson

-   Quality Workgroup Update

    -   Carolyn Clancy and Richard Stephens

-   Biosurveillance Workgroup Update

    -   Charles Kahn and John Lumpkin

-   Nationwide Health Information Network (NHIN) Prototype Architecture
    Demonstrations

-   John Loonsk, Brian Kelly, J. Marc Overhage, Ginny Wagner, Robert
    Cothren

-   Public Input

[P R O C E E D I N G S (8:30 A.M.)]{.underline}

SECRETARY LEAVITT: I think there is no reason we should not begin. I
call the meeting to order. I think I've got a microphone coming \-- can
we turn the microphones on, please?

Good morning. I'd like to thank all of you for being here. This is our
second meeting in a row where we've been impacted by unusual
circumstances. The last time, of course, a trip to China caused me to
have to call in and many of you did, too. We had a virtual meeting.

Today, the preparation for the President's State of the Union address
has caused us to move from our usual meeting place to the VA. And I want
to thank the Department of Veteran's Affairs for their accommodating us.
This is quite an innovative setup. \[Laughter\] For those of you who
maybe weren't aware, we're being watched from the gallery above, and so
you might want to continue on your best behavior. But we deeply
appreciate them allowing us to be here.

I'd also like to thank Secretary Nicholson, who will join us a little
later for hosting the meeting, and making it comfortable. Most of all, I
want to thank them for agreeing to let Dr. Kolodner continue to
participate as the Interim National Coordinator, and, of course, to you
for, Rob, for your willingness to continue that service. You've given it
a lot of energy and continue to, and your experience is obviously paying
a great benefit to the country in this way.

The VA has a history of being among the pioneers of the use of health
IT, and your successes in improving patient care, as a result, are no
small measure as to why this group has focused so much on accelerating
the adoption.

I mentioned before, the other reason that we're at the VA is the
President's State of the Union address tonight. This address is a moment
that allows us all to reflect on the year past and the year moving
forward. It's an important speech, because it offers an opportunity for
us to, as a country, step back and then focus.

By coincidence, I might add, AHIC began its work a little over a year
ago. Since that time, I've talked often about the need for us to work
with urgency. I think it's safe to say we have worked with urgency and
will continue to. We're on a path that I believe is producing quick
results. It's important for us to see how the work is adding up to a big
picture in national health IT.

At HHS, we put together a brief report on these accomplishments \-- I
think it's very well put together. I want to thank those who were
involved in it. The report is available both in the room today, and also
it will be on the website this afternoon.

Today we have a full meeting planned. First, I'd like to acknowledge
that there are several Workgroups that have been presenting
recommendations to AHIC today. It's worth noting that I have officially
accepted, as Secretary of HHS, the Interoperability Specifications for
Health Information Technology Standards Panel that the AHIC recommended
in October.

Second, we'll be viewing demonstration prototypes today of the National
Health Information Network. What we've learned from the development of
these prototypes will help us move forward into the next phase of the
initiative. That'll be connecting and expanding them, to begin forming
the network of networks that we're working toward developing on a
nation-wide scale.

Third, we're going to talk today about priorities for AHIC going
forward. Before we move on, I would like to officially welcome John
Menzer here, who is the Vice-Chairman of Walmart; and John, we are
delighted to have you here in person today.

And I'd now like to say to Dr. Brailer \-- I'm hoping he's able to hear
us from Japan. Are you there, David? Are we going to connect up with Dr.
Brailer? Who's managing that call?

DR. BRAILER: Mr. Secretary. Hello.

SECRETARY LEAVITT: Oh, good, good. Thank you, David. I don't know \-- I
suspect it's the middle of the night there?

DR. BRAILER: It's actually late evening, so I think we're perfectly
offset.

SECRETARY LEAVITT: Good.

DR. BRAILER: Thank you very much, and I'm here, Mr. Secretary, because
obviously the important things that are happening in today's meeting,
and rather than acting as your co-chair at the meeting today, I'll be
just providing support to the discussion and to the content that's being
presented today.

SECRETARY LEAVITT: Very good. Then we will move on with the agenda, and
Rob, are you going to lead that discussion?

DR. KOLODNER: Yes. I'll be introducing the first panel in just a second.
What I did want to do with this, as you see from this room, we're having
probably the most complex technical support in terms of being able to do
the NHIN prototypes, and I want to thank the contractors for working
hard into the night to set up the room, and Vernette Roberts, who has
been really just superb in helping to work through all of the logistics
in making this \-- making it a success, for us to be able to be here
today. So with that, I look forward to a very full and productive
meeting.

We've got lots of recommendations that we'll be talking about in setting
the priority for the next round of standards, and that will be later on
this morning, and then seeing the demonstrations this afternoon. So with
that, if we could have the first panel come up to the front.

DR. BRAILER: Robert, better approve the December 12th minutes, also.

DR. KOLODNER: Thank you very much, David. Is there a motion to approve
the minutes that have been distributed?

SECRETARY LEAVITT: There is a proposal to approve the minutes. Would
there be any who would object to the approval of the minutes? Hearing no
objection, I would declare consensus, and we'll move forward.

DR. KOLODNER: And joining us for the first presentation is Linda Kloss.
Linda, welcome.

MS. KLOSS: Good morning. Good morning to you, to Mr. Secretary, and to
members of the Community. This is an interesting place to be seated.
\[laughter\] I'm happy to be here to kick off what I think is a very
important agenda that you have today, and happy to have the opportunity
to present what I think are some very important recommendations that
have come forward from the State Level Health Information Exchange
Project.

I'm here representing the steering committee of that project, and in the
spirit of that project, will do my best to be both brief but also
passionate about the importance that we place on the recommendations we
bring before you today.

You will recall that we've been here twice before to give you progress
reports on this project. Our first deliverable was a workbook, "Guide to
Key Issues: Options and Strategies for State Level Health Information
Exchange."

We also presented, at that time, a final report of consensus work done,
both in field research and through interaction with not only members of
the steering committee, but other states. And in December, at the
teleconference, we presented three of the four Phase Two reports.

We talked about our recommendations for State Level Health Information
Exchange in coordination with major federal initiatives, health
information exchange, and coordination with quality and transparency
initiatives, and Medicaid and health information exchange initiatives.
And you'll hear from our final group of researchers on financially
sustainable health information exchange in just a few moments.

So Phase One, Phase Two. And you actually asked us to be bold in our
recommendations, and so what I'm going to present are the results of our
steering committee stepping back, looking at what they learned in Phase
One and Phase Two, and trying to encapsulate this in recommendations for
action.

Again, I remind you of the members of our steering committee. They
represented nine states, plus the National Conference for State
Legislatures; and they have been a passionate group, very committed to
thinking broadly about the needs of moving our agenda forward, advancing
value-driven healthcare. And that's the spirit in which we present these
recommendations.

You may recall that when we gave you a progress report in September, we
came forward with five recommendations, that we needed mechanisms to
promote strategic synergy among states, and between states and Federal
Government, salient financial models for sustainable HIE. You'll be
talking more about that this morning. Engage in leverage, public and
private payers. We did do a deliverable on Medicaid and State Level HIE.
Advancing the understanding of how state policymakers and governmental
agencies should be involved, and vehicles to support, acknowledge, share
as progress in the states moves forward at a very quick pace.

Having gone through our second phase, then, we've refined and broadened
the scope of recommendations, and that's what I'll go through now. We
essentially, as a steering committee, offered four overarching
recommendations to the Community and to the Secretary. They are really
presented with a spirit of encouraging useful and healthy debate about
how health information exchange transparency and transformation should
fit together, and how states can be successful partners.

Specifically, we recommend, and we address recommendations for bringing
HIE and quality transparency together; looking at the design of the
successor to the current AHIC configuration, taking action to ensure
vital state efforts are convergent, and using the power and convening
capability of the Federal Government to ensure that \-- or to help
states succeed. They're not timid recommendations, and again, they're
offered by our steering committee in the spirit of encouraging useful
and healthy debate.

I'll address each recommendation, and then, perhaps, Mr. Secretary,
you'll decide whether you want to discuss it at the time or you want me
to continue.

Recommendation Number One calls on the Federal Government to consolidate
or to coordinate the oversight of federal health IT, and quality, and
transparency initiatives under this Community. We believe, and as we've
studied health information exchange, all of these organizations have a
mission of quality, and certainly quality in transparency requires
access to information. So what we're talking about here is consolidating
the information management process, practices, policies, under this
Community.

Health information exchange and quality transparencies initiatives must
be brought together, because we believe that they share the goals, and
we need some sensible information management policies and practices.

It's a critical moment in time. Efforts are ramping up. There is a lot
of fragmentation, which we documented and described in our report; and
we ask that you consider how to bring this together under the Community.

Specifically, create incentives for innovation and cost effective
coordination, and we do mean of \-- principally information practices in
the first instance, fund research on models for capture, aggregation or
access to data, ownership issues, appoint representatives of health
information exchange organizations to Quality Workgroups, deliberately
help bring these groups together, and study sustainable business models
for HIEs that supply aggregate data for quality measurement and
reporting.

So that, essentially, is our first recommendation. And we've shown this
diagram before. Again, it's not intended as a complete model, but it is
to say that there are certain information management practices,
strategies that need to be in place to make HIE and quality an efficient
process that really uses data wisely.

And this is \-- was a model that was put forward. We acknowledge it
needs more work, but health information exchange organizations generally
are capturing, collecting, exchanging information; and health
information exchange organizations may also have a role in data
aggregation or data provision, and we need that better process
understanding of the relationship between these efforts.

So with that, I'll stop. And that really is the sum and substance of our
Recommendation Number One.

SECRETARY LEAVITT: Would you like to discuss Recommendation One, and
then \-- or would you like to go through all of them and come back? Why
don't we go through all of them and then come back?

MS. KLOSS: Our second recommendation, and we did touch on this in
December, was that the \-- that we encourage the Secretary to begin
convening, and looking at what the successor to this group should be as
a public/private entity; and again, the steering committee acknowledges
that this has been such an effective vehicle. It's spotlighted needs,
tasking work, and we are conveying, I think what we all know, is that
this kind of coordination is going to need to continue for decades.

How do we convene multi-stakeholder coordination that will carry us with
the right authority and the right representation? So as specific
organizations under that, we encourage you to design \-- to charge the
design group with looking forward, not unlike what we do in
organizations where succession planning is an ongoing effort.

And then secondly, the steering committee urges you to reintroduce an
updated, revised 2004 framework for strategic action that more fully
reflects the efforts of the states in that picture. A lot has changed
since 2004, with the National Health Information Network, and the work
of RHIOs and health information exchanges. So that picture needs
revision. So that's Recommendation Number Two.

And we did offer, and we do explain in our letter that you have been
provided a copy of, at least an initial glimpse of this. And we do see
the need for some standing committees, looking at the perspectives of
the legal regulatory health information exchange care delivery impact,
population health standards and certification. We don't claim that this
is the final picture. It's just a placeholder to depict that this is an
ongoing need, and needs to be formalized.

Recommendation Number Three. It's the steering committee's belief that
each state will need a consolidated public/private health transformation
governance mechanism that includes health information exchange, as well
as quality and transparency.

In our first deliverable, the workbook we described, and spent a lot of
time on, "Governance, Governance Models," it seemed to be working for
states that were successfully convening public/private, and having now
looked at what's going on in states with quality initiatives, the
recommendation is that the scope of work, of the public/private health
transformation governance entity, whatever that is \-- and you'll notice
the sub-recommendation is to do more definitional work on that \--
should include both HIE and quality, and transparency efforts within
states.

So we want to build on the work that we've done to describe governance
in the workbook, and move forward with models, authority, core roles,
fill that description out. We do encourage AHIC to appoint a new state
Workgroup, as a formal liaison to this organization, to support the
ongoing need for state level learning community. Best practices are
changing very quickly, and insert \-- deliberately insert the state
perspective into the work of all the Workgroups. That's Recommendation
Number Three.

And our final recommendation is that to the degree possible, under
statute, we call on the Federal Government to help support the
transformation and the ability of the states to succeed at being a key
part of this national network.

So we do recommend specifically that the state Workgroup that would be
convened under AHIC, would develop criteria, and suggest and recommend
mechanisms for any potential funding that may be possible from the
Federal Government. Grants are helpful, but they're not sustainable for
state-level HIE, and we'll talk more about that in the next panel.

So if there is a formal way to make this more of a continuing part of
the fabric, we would recommend that. Leadership regarding Medicare and
Medicaid, and their support for state level HIE quality and
transparency, and we offered some specific recommendations in that
regard at the December meeting. Identifying any possible funding
mechanisms and the process for advancing the criteria as states continue
to evolve. That's our final recommendation.

And again, I reiterate that you encouraged our State Level Health
Information Exchange Committee to think big. They did. They thought in
the spirit of accelerating progress. It's a very key point in time where
we need not uniformity, but we need some clear vision of how the states
fit in, some closer connections, some formal connections, aligning the
parts. Certainly looking ahead at what will be a decade of work, and a
process of system learning, where we're continuing to learn in advance
best practices.

SECRETARY LEAVITT: Thank you, Linda. I'd like to have a discussion on
all four recommendations. We'll invite all of you to comment.

I would like to ask on Recommendation One, do you view the federal role
as being \-- when you talk about the Federal Government having a role,
are you thinking that they should be the organizer of this, or are you
thinking they are the long term overseer? You use oversight, but do you
have a \-- did the group have a vision that this would be a shaping that
we would nurture, and then let fly, or do you see us maintaining let fly
with a cord back?

MS. KLOSS: Well, we certainly saw the need for nurture, and we saw the
need for some ways to make recommendations on what the baby steps should
be going forward now, and then learning further as we go. We certainly
stopped short of \-- and perhaps use of the word oversight was not the
correct word, but we saw the Federal Government, and particularly AHIC,
as convening some real discussion about how we go forward with less
divergence, less opportunity for solutions that are going to need to be
melded back together again.

We shared, I think, a picture at the last meeting of the number of
reporting requirements there are now on providers throughout the
country, different quality mechanisms, and we know there needs to be
some standardization. So we are looking for some convener to make sure
we move at standardization.

SECRETARY LEAVITT: There is a little bit of tension, there seems to me,
between the idea of designating a successor to AHIC, as a public/private
organization, and then the idea of federal funding and using it as an
oversight. Can you talk about that?

MS. KLOSS: You know, I think we do envision it being public/private, and
that certainly there needs to be a strong role for the government in
this. It's not completely private. So we didn't propose specific
mechanisms, but we did propose that as a major payer, and a major
purchaser of healthcare, certainly the Federal Government could \--
there might be a role for advancing the efforts in the states.

SECRETARY LEAVITT: Let's have some more discussion. I have other
thoughts about it, but I don't want to dominate the questioning. Yes,
Chip.

MR. KAHN: I'm not sure I really understand the link between the words at
the top of the recommendation in bold, and the 1.1, 1.2, 1.3, 1.4.
Because if you read the top, it implies that sort of everything that's
being done at AQA, HQA, what's sort of carrying out the federal law
through CMS, what private payers are doing, would all be sort of swept
under here.

And I guess my position would be, and I'm sort of curious about this, I
really believe in HIT, and I believe in \-- we've got to have some
connectivity, but I see that as the vehicle, not the substance, of
collection of data, and aggregation of data for transparency, for
accountability, for quality assurance. And so all these would be tools,
but it's going to be resting in other places, whether it's the payers,
or whether it's the \-- these other entities that will use the IT as a
tool.

And I think for me, this recommendation confuses the two, and in some
ways I think it's distracting. It could be distracting, because I think
we're going to have enough trouble figuring out how to make IT a
successful tool, which it's not right now, and it's really a far piece
from. All the inconsistencies and problems with reporting you're talking
about, you know, are there, whether it's paper or IT, and we haven't
really figured out, I don't think, how to use IT to really make it
effective for reporting, much less have it play the kind of role that it
would play here, I think.

MS. KLOSS: I would ask you to look at these recommendations as having
not IT, not technical underpinnings, but really governance and
coordination underpinnings. So what is common across them is the notion
that the work now, that state level health information exchange
initiatives are doing, are often disconnected from what quality and
transparency efforts may be in the state.

And, you know, we say nothing about the technology. We really talk about
the governance. It is, for the most part, the same public/private
leadership that needs to come together around both, and so we're really
suggesting that this is a governance challenge. I certainly agree with
you that health IT is the tool, but what the state \-- what the
committee was really saying is that we've got some governance
disconnect, and we were really trying to look at that.

SECRETARY LEAVITT: Thank you. Lillee?

MS. GELINAS: Thank you, Mr. Secretary. Do you want to say something?
Sure.

SECRETARY LEAVITT: If you'd like to comment, let's use the standard on
the side system.

MS. GELINAS: That's a good idea. In this unusual room, and we'll still
get the job done.

SECRETARY LEAVITT: That's right.

MS. GELINAS: I want to comment about 1.1, perhaps, and this notion of
cost effective coordination. Several AHIC members had the tremendous
opportunity to have a deep dive into AHLTA yesterday, at Walter Reed
Army Medical Center. And it was phenomenal.

And we've had the ability to have that same deep dive into the Veteran's
Administration IT system. There has got to be a way, cost effective
coordination between public and private sectors, when there's \--
there's there there. It's not vaporware, it's alive and well. And the
idea of aggregating that data for quality and transparency seems to be
fairly simple.

And Dr. Winkenwerder, you could probably comment on that, but I think
that all of us that were there yesterday were just amazed. This notion
of the private/public partnership has got to be put on steroids if we're
going to achieve the President's vision, as quickly as we can. So this
notion of 1.1, I'm supportive of that.

Perhaps the way to really get this going is this idea of the oversight
group to figure this out, what this needs to be, because I don't know if
we're going to figure it out today. We can have some good comment, but
it does seem that there needs to be a solid successor to AHIC.

AHIC has been a phenomenal success by many, many measures, by many, with
putting people around the table that never, ever before, were ever
together around the table. So the second point I want to make is just in
support of some governing group that figures this out and brings a
recommendation to us that fleshes this out a little more.

SECRETARY LEAVITT: Thank you. Kevin, and then Scott.

MR. HUTCHINSON: I want to thank Linda for the information, because I
think what she's bringing to light is what we're experiencing in just
trying to deploy even medication management electronic prescribing in
the states.

There are dozens of states with activities going on today. There are
probably a dozen that have some semblance of organization around their
efforts. Many of them, at least eight to nine states that are \-- have
stated goals now, of a certain percentage of prescriptions they want to
go electronically by the end of this year, and by the end of next year,
in the same timeline that AHIC has established to see action.

I think that the disconnect between the two is the states are, in fact,
looking for, and I think oversight is the word that we're all struggling
with, because it's really a national coordination versus an oversight
type of function, because I think the value that Lillee brings up about
AHIC has really been about bringing these topics to the table.

The enormous number of volunteers, on a private level, that have worked
on these Workgroups, whether it be CCHIT, or HITSP or the other
Workgroups, is really what's moved the ball forward. Bringing these
state activities into this coordination role, whether it's the Federal
Government, as it's listed here playing that role, or whether it's
really the public/private partnership playing that national coordination
role, I think that's the only disconnect I have with the recommendation,
because I would agree with Chip, if you look at the sub-bullets, it
really is about this national partnership between public and private.
And if we could modify that language, I think the recommendation is
good, if it's a coordination role.

SECRETARY LEAVITT: Thank you. Scott?

MR. SEROTA: My comments are along the same lines, and I also would
compliment Linda on the work of this group. It was really terrific. But
I really question whether we want to bring quality and transparency
initiatives, which already have an established protocol in process,
together into this milieu, or whether we want to let them flourish in
their own space.

If we were to bring them in here, I think that we would have to have
probably some discussions about the make-up of AHIC, because I think we
would need more clinical \-- a heavier clinical dose, if we're going to
be venturing into approving and reviewing quality standards. And I think
it would take AHIC perhaps in a direction that was not intended.

So my advice would be to proceed with these recommendations, but,
perhaps, back the quality and transparency piece of this, at least out
for further discussion, and clarify precisely what's meant by those
words, before we move forward.

SECRETARY LEAVITT: Bill?

DR. WINKENWERDER JR: Let me also say that from our perspective, at the
Department of Defense, and as a federal participant in this process, we
think \-- I think it's been a great success, for the reasons that Lillee
and others have said. It has brought people together to share
understanding of what's going, and to take note of that.

And also, I think it's propelled all of us forward at a quicker \-- much
quicker pace, and we have been able to agree upon things, and it's been
a little \-- you might think bringing something like this together is a
little awkward, and there have been those moments, but it's moved things
forward, importantly.

Also, I agree with Lillee about the cost effective approach that we need
to think about, how to not reinvent the wheel, and certainly, in our
society where the government and the private sector both appropriately
play a big role in healthcare, there is going to be some redundancy. But
it would be nice if we could avoid duplicating things, and taking
advantage of what's already known. We stand ready to share on that
front, and I know the VA does as well.

I agree with Scott's comments about the role of this group being
principally a convener, and a national coordinator, and not \--
consolidation of oversight is a pretty strong pair of words, because it
implies almost regulatory authority. And I'm not sure that's what we
want to do here with this group, although your office does have that
authority, and it's been exercised through the executive order and so
forth, on transparency. So \-- and I agree that there is other places
where the quality and transparency efforts reside pretty effectively
today. So those are some of my thoughts.

SECRETARY LEAVITT: Linda, would you like to respond?

MS. KLOSS: I would. I do understand the intricacies of the quality job,
the quality measurement job, and I believe that we will probably need
new mechanisms. And some of this work has come out through some projects
that AHRQ is doing now, to start looking at measured development and
standardization of measurement. And we certainly hadn't envisioned that
all of that work would come to AHIC. That's a very specialized set of
functions.

But from a policy in a directional standpoint, and encouraging sound
information processes, we think that these two areas, two critical
areas, health IT and HIE can't be disconnected. And you've seen that,
because you have a Workgroup on quality and have brought that as part of
the AHIC.

And we're just supporting that need, and suggesting that that same kind
of coordination needs to be occurring at the state level. And it's not,
and a nod from this group could help a lot with that, because a lot of
states are, you know, developing now new governance mechanisms to handle
this. And the HIEs are over here, and how is this going to come
together?

So I think principally, again, our focus is clarity in the role of
states, and replicability of the vision that we've had at this group, to
allow that to happen in the states.

SECRETARY LEAVITT: Thank you. Doug, and then I want to move to
Recommendation Two.

DR. HENLEY: I, too, have been struggling with this recommendation, Mr.
Secretary, particularly as it relates to the quality and transparency
comments related to it. But Linda's last comments have helped clarify
that.

It seems to me at the AHIC, at the Community level, the connection that
we have to the quality and transparency initiatives that are occurring
at the federal level, exist by virtue of the Workgroup that we have
working on the quality standards, by which the measures can be reported
in an electronic fashion, by embedding those standards in electronic
health record technology through the certification committee and so
forth. And, of course, Dr. Clancy helps co-chair that Workgroup, and
Carolyn is also intricately involved in the HQA and the AQA, et cetera,
as it should be.

What Linda \-- so at the federal level, I think we've got that dealt
with very well. I think what Linda has brought to the forefront is at
the state level, that degree of connectivity between state related
quality initiatives and HIT may not exist as well as it does at the
federal level.

And so is there a role for this body to encourage better coordination at
the state level, which may not be as robust and as rich as it is at the
level that we work at here federally? So I certainly would endorse that
degree of coordination, but again, consolidation and oversight may be
too strong terminology.

SECRETARY LEAVITT: Okay, thank you. Good comments. Let's now go to
Recommendation Two. Comments from the group on Two? I would just say
that my vision on this has been from the beginning, that we would see
AHIC have a private/public successor.

I'll start leaning into Three here a bit. I clearly believe there needs
to be a counterpart to AHIC at the state level, and we need to find a
way to consolidate the efforts that are happening at states, and then
coordinate what's happening among states with what's happening at AHIC.

In my mind, I have envisioned that that would be a chartering model,
where there were \-- where states formed their consolidated effort, and
received some kind of charter from whatever the successor organization
is.

Now, I think the question that's been raised today earlier is whether or
not the quality effort, which frankly has a similar kind of vision,
whether or not there is a coordinated vision or a consolidated vision.

There is a \-- in my work in other settings, I've noted that there is a
tension often between the people who manage the IT, and the people who
manage the enterprises. And oftentimes, if the IT is the dominant \-- if
the IT managers are the dominant force, then the management of the
enterprise tends to follow what the computer programmers say is
possible, as opposed to the enterprise managers saying, "This is what I
need, you figure out a way to get it done."

And there is a nice \-- while there is a tension, and often some
duplication, having them separate is important. The quality, in some
respects, appear to me to be more about the enterprise \-- I think this
is what Chip was saying, that the enterprise is quality. The mechanism
to get there is health IT.

And whether or not that is best accomplished with a blended
organization, or whether it's important to have that tension, or it may
be that there needs to be \-- one needs \-- to be chartered in one,
you've got to agree to be somehow in compliance with the other. That
may, in fact, be the way that ends up being.

Linda, do you want to comment on that?

MS. KLOSS: I would just add one comment, that I think where the heads of
the state health HIEs that we've worked with here at the table, they
would suggest that their vision of health information exchange, and its
importance as a transformation mechanism, is \-- goes beyond IT. That
is, when we look at the mission of these organizations, it's about
quality, and it's about advancing change and improvement in healthcare.
In some ways, it's one part of the flow.

So however that tension and collaboration is achieved, I think it's
really important that it be achieved, because as exchange of information
to enable a patient care visit today, you know, what happens with that
information? Do we collect it all over again two weeks from now to
support a quality mission, or do we look for some really intelligent
ways that are privacy and security protecting to use information smartly
for these purposes? So I \--

SECRETARY LEAVITT: Mitch?

MR. ROOB: Thank you, Mr. Secretary. As the head of a state-wide HIT
operation, those comments are terrific, but we're trying to connect
Indianapolis to Evansville, and the quality piece, we're not anywhere
doing that yet.

And so we're really about \-- at least in the states that I'm familiar
with, have a much more \-- a much less idealistic view of this, a much
more practical view of what they need to achieve in the near term,
because you can't get to the quality piece that you're talking about,
until you get the connectivity that is still troublesome for many
states.

And so I'm not \-- it does not concern me that if we deal with quality
and transparency in a different format than here, because we have \-- at
least in our little state, we are really still dealing with the bits and
bytes of moving data across various and sundry networks.

SECRETARY LEAVITT: Kevin?

MR. HUTCHINSON: \[inaudible\] \...consolidating the discussion of item
number \-- Recommendation Two and Three kind of into one discussion. On
Recommendation Two, I think obviously we're going to need to have that
discussion, or a Workgroup that would look at this going forward. I just
question the timing, if '07 or early '07 is the right time right now to
convene that. Because I think we want to take advantage of all the
learnings we can possibly do, to lay out how this will go forward, and I
think '07 could be a year where we'll see a lot of activity in this
particular space that could have learnings that we would want to do to
move that forward. Maybe end of '07 or early '08 is the right timing to
look at the successor organization.

On Recommendation Number Three, I think the challenge, from a governance
perspective, is to find balance that we even struggle with at an AHIC
level, is governance making sure that we're not squeezing off
innovation. Because in many instances, what we've seen, from even the
state level organizations, and the activities they've had in deploying
HIT programs, is associated with being creative in their approach, being
creative in incentivizing their positions, or being creative in how
they're deploying.

Now, obviously a lot of the work that we're doing at the standards
level, with HITSP, and the certification level, and other things that
the federal level is helping those organizations in their deployment,
because they're not having to take on those tasks. But at a state level,
there definitely needs to be a coordination of governance, and some
assistance and guidance in that, but we need to find that fine balance,
not to squeeze off innovation.

SECRETARY LEAVITT: Can I just \-- I think my urgency meter on the \-- I
have a little clock on my desk, and I think it's at 728 days today,
which tells me that before it reaches zero, I'd like to have the
successor established. I'd like to have the ongoing funding mechanism
secure. I'd like to have the \-- whatever consolidated effort at the
state level, operating with a business model that will sustain it.
Because if we go through the change there, without that accomplishing, I
think the chances of it happening diminish some, because there will just
be a break in momentum.

And there is no \-- so the question of when do we do that, it seems to
me we \-- in order to accomplish all those things, we need to have a
chance to build them, and let them work a while so we can refine them,
and make certain that the other things that happen, the private \-- the
private/public successor will have to operate for a while so they can
begin to spin off whatever chartering, or whatever connecting mechanism
is there, and have it in place.

So while it does seem like we're moving this along, I think there is an
urgent reason to do it, to make certain that we have it going with the
momentum necessary.

DR. WINKENWERDER, JR.: Just a question, point of information. Does AHIC,
today, have a charter limit, time limit \--

SECRETARY LEAVITT: It does. We have a two-year limit, but it's
renewable. I think it's two. Can somebody \-- two years.

DR. WINKENWERDER, JR: So it ends at December of '08 or January \--

SECRETARY LEAVITT: That's right. But we can renew it, but the idea has
been always to create a successor. And we'll talk about potential
business models in our next discussion.

If there is not any more comment on Two or Three, I would like to talk
about Four, and I'd like to begin the conversation by saying that it's
\-- we look at federal funding streams as being secure. On the other
hand, they can, literally, with a vote of 218 people on \-- at the end
of a night, you can end up with nothing. And I think that is less
secure, in many respects.

I also don't \-- one of the worries I have is that none of this
conversation has really \-- we've not defined, yet, what I think needs
to be a fairly broad role for the private sector. And I worry that if
it's just about federal funding, that it creates a dependence; it
creates a lack of involvement.

And so I want to ask the question \-- well, I'm making the statement. I
think there is \-- that the motto here ought to be create, fund, and
spin out. And it's not inconceivable to me at all, that in order to
accomplish this, both the birthing of the successor, and the
consolidation of the state counterparts, that we could use some federal
money to provide seed capital. But it ought to be that purpose, and the
condition of getting the seed capital ought to be the creation or an
existence of an ongoing business model that will perpetuate it beyond
that seed capital.

I'd like to get your reaction to that idea, and whether or not it's
completely inconsistent with Four or \--

MS. KLOSS: Well, it certainly is in line with our 4.1 where we reflect
that work would need to be done to understand what the criteria would be
for transformation entity, and that would be a precondition for
certainly any funding.

SECRETARY LEAVITT: Other comments or thoughts about Four? David, or Dr.
Brailer, are you able to hear this conversation? Would you like to
comment?

DR. BRAILER: Thank you, Mr. Secretary. I have been following, and first
to speak to your question about Four, I think the seed capital concept,
particularly subject to the criteria that you described, is very
consistent with the direction we've gone.

But it does raise the question about who sets those criteria, and I
think the answer to that is very much embedded in the other three
recommendations that Linda has raised; that today, regardless of whether
we have a quote, governing, or an oversight mechanism, we don't even
have a communication mechanism between the federal and state efforts, as
they're beginning to form. And I think establishing a means of
communication between AHIC, or somebody like AHIC, and these efforts
that are in the fledgling level in the states, can help us.

But I would hope we would go beyond that to be able to have these
criteria becoming well-known, not only for the governance and
sustainability of the actual mechanism of information exchange, which
we're coming to with the business model discussion, but secondly, to the
value that it brings in terms of quality, or value, or transparency.

And we're moving in that direction, all the pieces are there, but I
would hope that you would all, to get there much faster \-- because in
your linear pathway, you laid out having everything up and running with
plenty of time for it to become \-- come to equilibrium before the end
of your caulk. We need to do that in 2007, which means we need to make
decisions in, say, two months or so, I think, to be able to have that
done.

So I would hope we would get some of these structural decisions made so
we can then turn to what those criteria are, so those could become
inputs, not unlike what you've done with these standards inputs into the
decisions that you've made recently with respect to the acceptance of
the AHIC recommendations.

SECRETARY LEAVITT: I'm trying to think. We started operation in the fall
of '05.

DR. BRAILER: That's correct.

SECRETARY LEAVITT: And we had \-- so a two year charter, which would
take you to the fall of '07, and if we were to begin looking at the
successor being in place in advance of that \-- the need to renew the
charter, that's a timeframe that, to me, seems at least a reasonable
objective. I'm \-- go ahead, David.

DR. BRAILER: Sorry, Mr. Secretary. Yes, and I think we should be
cautious about our language with respect to successor. Remember that
AHIC provides two functions, many functions, but two important
high-level functions.

One is to provide a formal legal mechanism for advice into the
government, and I think many people who have watched AHIC, have
commented that that mechanism for getting input and advice into the
government, around these transformational things, could potentially last
for a long time. There is \-- you know, we have other means, like NCVHS,
but nothing that takes this health transformation strategy to this
level.

But the second issue that \-- or the second value or function that AHIC
provides is providing a mechanism for convening coordination and
communication, is I think what we're talking about, quote, spinning off,
or putting out into a sustainable entity. And so really, these could
move hand in hand. We could think of a longer-term AHIC agenda for
advice, but establish that mechanism within that year period.

SECRETARY LEAVITT: It seems important to remind ourselves, I think, of
two things. The reason AHIC has the capacity to do this is first of all,
it does \-- as it's currently constituted, it is a group that advises
the Secretary.

The corollary to that is that the reason that has value is because of,
essentially, the executive order, which says the Secretary will have the
capacity to link the buying power of the Federal Government into it.

Then we're adding to that by coordinating the buying power of the
Federal Government with the buying power of many other organizations,
both government and public. So \-- or private rather. So that's where
this actually gets the energy to create change.

And I don't think that's lost, in any way, by creating this successor
organization, where the government \-- where the Federal Government
becomes \-- because the Federal Government is still going to have its
influence by virtue of its power as a purchaser, and as a way to
influence and join with others. And the Secretary, whoever it is, will
still have that ability.

The government will need to continue as a participant, in whatever the
successor organization is, and will undoubtedly play large in that
effort. But the \-- nothing is diminished by getting this out, getting
it formed, and so forth. I also think it creates the mechanism, then, to
begin chartering these state counterparts.

DR. BRAILER: Something that AHIC really can't do.

SECRETARY LEAVITT: That's right. Right now AHIC is a federal advisory
committee. Its whole purpose is to advise, but if we're able to then
create a successor, it can both continue to advise, and begin to act as
the conduit to these state entities. I think that's the vision.

And I see a complementary vision happening on the quality side. And it
is, in my mind, very much an open question as to where those \-- how
those two interrelate. And it's something that I need to spend more
time, and will be seeking more advice on from you and from others. Doug?

DR. HENLEY: I have been thinking a bit more, Mr. Secretary, about
Recommendation Number Four, and would just posit these two thoughts.

First of all, with the recent Medicare legislation about pay for
performance, as part of Medicare reimbursement starting in July, I
suspect \-- I know CMS is working on that now, in terms of how to
implement that. A very tough timeline to get done by July 1st, as I'm
sure Leslie knows.

But while most of the discussion around that legislation has focused on
clinical performance measures, and that's important in terms of how that
program might work, we could also, at this level, with your strong
support, could focus not just on clinical performance measures, but
structural measures as well, i.e., implementation of a certified HIT, of
a certified EHR, electronic health record could qualify, perhaps, for
that component of that law. The statute has already been approved.

So some creative thinking around that in '07, not just in '08, I think
would be a very important way where the Federal Government, under
statute, could fund that type of transformation.

Now, looking beyond that, and I'm sure all of us are frustrated by the
\-- what I will refer to as somewhat arcane inability of CVO and OMB to
project savings for efficiency in the system in the future. And I think
there are \-- there is a body of research that would suggest, again,
that implementation of certified EHRs, PHRs, et cetera, can bring huge
cost savings to everybody, not just the Federal Government, but the
private sector as well. And yet we can't get over this hurdle of
thinking of everything as new money versus simply redistributing money
that's already in the system. And we've got to somehow get over the
present inefficient way of projecting those financial impacts,
especially as it relates to the federal sector.

So that doesn't relate to current statute, but it certainly could
relate, perhaps, to some future need for statute changes that would
allow that to occur. And I think you, sir, could \-- Mr. Secretary \--
could have tremendous influence over that process over the next two
years.

SECRETARY LEAVITT: Thank you. Let's go to Mitch, and then Chip, and if
you could hold yours to about two minutes each, I'm going to summarize
for Two, and then we'll move on to the next presentation.

MR. ROOB: Thank you, Mr. Secretary. I think if you look at
recommendation four as the Federal Government being a large payer, it
might be, as opposed to a granter of money; and I would encourage Leslie
and the other folks at CMS to articulate that vision to the states
through the MMIS and MITA infrastructure.

And I think that that is, frankly, not well understood, not effectively
gotten that word out to states yet in terms of how that would operate.
And that's a missed opportunity, at least to date.

MS. KLOSS: That is addressed quite well in the task report on the
Medicaid role in State Level HIE, so I would recommend that you look at
that specific set of recommendations.

MR. ROOB: Thank you.

SECRETARY LEAVITT: Chip?

MR. KAHN: I sort of had reticence in the first recommendation regarding
the role that was envisioned there in the bold text regarding AHIC. I do
think that we are at a point at which statute is needed to define these
relationships, which I think \-- which is implied here.

And if we don't, regardless of the good intentions of everyone to try to
get something going from here, I'm concerned that it may not be lasting,
because there is just nothing like law to make things happen, and
obviously, to secure them over time.

Second, I'm concerned that, as Doug was talking about what's happened in
the Medicare legislation, that in a sense, the pay for performance is
downstream from all the conversation we're having here, and it's
already, you know, moving towards the ocean. And all the things we're
talking about here that would make the processes to make that work in a
way to help not just be another burden, is being lost, or \-- in terms
of what we're doing.

And that's why I think the legislation is needed, to link together
everything that needs to be done on this side with all that, that
Congress has decided to do on the other side, which I don't think they
understand the implications for what we're talking about for what they
have basically required in terms of provider reporting and physician
reporting. We can say it's voluntary, but you know, it's voluntary like
taxes are voluntary, from my standpoint.

SECRETARY LEAVITT: Rob, I'm going to ask you to make your comments, and
then I'd like to sum up.

DR. KOLODNER: Actually, this will be after.

SECRETARY LEAVITT: Oh, okay. Then let me sum up. Chip, first to your
comments.

I expect that at some point Congress will legislate on this. There is
nothing like the right law, not just a law. And I view what we're doing
is in the absence of their legislation, which I think we are shaping in
a way that will be very productive for them, because hopefully, what
they will begin to do is find legislative language to describe what we
have made to work, as opposed to reinventing something that would be
ethereal, and respond to either the economic or the philosophic
interests of one group or another who could guide them. So in the
absence of legislation, we ought to be driving as hard and as fast as we
can, not to outrun them, but to simply guide what would be prudent.

What I believe our discussion leads us to today, and I don't propose
this as a decision, I propose it as essentially defining the state of
our conversation, would be recognition that the question of the
interrelationship between quality and health IT is still an open
question, and requires more thought. That we do intend to \-- to move
forward with the creation of a public/private successor, and that our
objective would be to accomplish that in advance of the two year
authorization of this body.

That we would view \-- and we'll be looking at business models in our
next discussion, as to how those could work. That one of the first
orders of business of that successor organization would be the creation
of state counterparts, with the means of chartering, or some other link
that would facilitate coordination and communication.

And lastly, that the \-- that a condition of that chartering would need
to be a sustainable business model, and a condition of the successor
would be a sustainable business model, and while the \-- it's possible,
I suspect, that some federal component could be a piece of those,
because we would be a participant, both at the state and at the federal
level \-- or at the state level and at the national level, it would be
\-- it would \-- it should not be viewed as simply a creature of federal
appropriation.

Is that a statement people could feel comfortable with in terms of our
general direction? Craig?

MR. BARRETT: Is it fair to interpret that, that we're effectively say
yea to Recommendation Two as a precursor to considering any of the other
recommendations?

SECRETARY LEAVITT: I think that's probably a fair statement, yes.

MR. BARRETT: I heartily concur with that summary, in that case.

SECRETARY LEAVITT: I haven't teed this up today to be a final
recommendation, but I do think those who are taking the minutes ought to
acknowledge \-- I hope that was noted as a summary, and the general
agreement of the participants also acknowledged, and it may be that our
next meeting we'll want to formalize that.

Linda? To you, thank you. And to your colleagues who put a lot of time
and effort into this, we express our gratitude. We expect it will not be
the last time you're here.

MS. KLOSS: Thank you so much.

SECRETARY LEAVITT: Thank you.

DR. KOLODNER: Linda, certainly you succeeded in doing what you said you
wanted to do, a healthy discussion. As the next panelist is coming up to
talk about the business models, let me just make a couple of comments.

First of all, you'll note that for our agenda this morning, there is no
break. We have a full agenda, therefore, if you need a break, please
take it at your own timing.

Also, for the next meeting of the AHIC, the 12th meeting, it is being
moved from March 6th to March 13th, so if people will note that on their
schedules. And at that meeting we expect to have a focus on
confidentiality, privacy, and security issues, with updates from a
number of groups, including recommendations from several of the
Workgroups that are not making recommendations at this particular
meeting.

So as the next panel is coming into place, I will turn the mic over to
Kelly Cronin. This is the discussion about Health Information Exchange
Business Models, and Kelly, if you will take it from there and introduce
our group as they speak.

MS. CRONIN: Thank you. Good morning, Mr. Secretary, members of the
Community. I just wanted to open this panel discussion up with some
brief orientation to two contracts that \-- two projects, mechanisms
that have been used to fund some exploratory work on business models for
health information exchange, the first coming from the four nationwide
health information network consortia contracts. They recently delivered
to ONC their own cost and revenue models that are based on their ideas
around what a viable business model would be for health information
exchange from a service provider perspective. So we'll have a brief
overview of those.

It's important to keep in mind that they are assuming that, as we all
have been discussing, that the NHIN will be a network of networks, so a
business model has to work for individual networks, whether they be at a
regional level, or they, perhaps, service a broader catchment area or
perhaps even the nation, if it's for medications or for labs. But that
the business model discussion you'll hear is really focused at the
network or subnetwork level.

We'll also be getting a review of another project that was funded from
the state Health Information Exchange Project. There was a good review
of what's currently working in the field. So for health information
exchanges that are operational, that are currently making money, how are
they making money, and what can we glean from them, and what
recommendations could be made in terms of a potential path forward
towards sustainability.

So with that, I'll introduce our three panelists. Dr. John Glaser, who
is the vice-president and CIO of Partners HealthCare, will be giving a
relatively brief overview of a lot of work that went on across \--
before NHIN consortia, on their cost and revenue models, including a
brief summary of the services that they could offer, some common themes
and differences across these models, in addition to some marking
conditions that will be necessary to achieve financial sustainability.

And then we'll hear from Steve Parente. He's an economist from the
University of Minnesota, who has worked with the office over the last
few years in a variety of capacities in advising us on economic issues.
He will give us more of the economic perspective, more of a global
market view of how to achieve financial sustainability for health
information exchange.

And then we'll end with Vicky Prescott, who is our primary investigator
on the state HIE project, and led the work, with the advice of both John
and Steve on the regional and state health information exchange
financial sustainability analysis. And she'll, again, give a recap on
the real world experience to date, based upon five operational health
information exchanges, and give some recommendations on what would be
likely initial and viable secondary services to consider.

DR. GLASER: Mr. Secretary, members of the Committee, it's a pleasure to
be here. Interesting physical arrangement. It looks like a dinner table
with microphones, but \-- \[laughter\] But it's a pleasure, pleasure to
be here in that regard.

I will keep my comments brief and try to encapsulate a very
sophisticated and comprehensive set of work that was done by the four
NIH \-- NHIN contractors. There will be a lengthier discussion this
Friday amongst the community and the contractors in which we'll explore
these issues in more detail.

Nonetheless, the critical attribute of the NHIN is that it's financially
sustainable, and which sort of obviously means that it provides services
that are deemed to have value by stakeholders and willingness to pay on
their part.

As part of the demonstrations, as you folks are aware, there was a
request, to the four contractors, that they develop revenue and cost
models that would illustrate potential sustainability approaches, and
I'm going to give some summaries of those analyses which were received
about two weeks ago; give you some overall comments and observations
about them.

Just a little bit \-- a couple slides of reminding us all of what we're
talking about, is that the intent of the NHIN writ large is to
facilitate the exchange of health information across constituencies,
across geographies, both to ensure that as the patient or the consumer
seeks healthcare, that their data is accessible to those who are
delivering care to them, and those folks that are delivering care to
them are in a position to make the best clinical decisions that can
possibly be made here.

As Kelly mentioned, a couple of shared assumptions and concepts which
guide this. One is that it is a network of networks. In other words,
there will be geographically based networks, such as found in Indiana
and eastern Massachusetts. There will be, as the term is often used,
nongeographic networks which traverse geographies. For example, Kevin,
in the work that SureScripts does, focuses on pharmacies and providers,
and is not particularly bound to a particular geography. And the NHIN is
the glue that brings maybe several hundred of those networks together in
an interoperable fashion.

Second assumption is that there is no particular bias or assumption
about the types of organizations; public, private, some blend of the
two, or perhaps multiple organizations that deliver these services.

And the third, sort of assumption, which brings the third and the fourth
bullet together is that you can imagine, and we'll see in a slide, and
as you are aware, the NHIN can provide an array of services.

Nonetheless, within that array, and you could argue how much is in the
NHIN versus at the local level, or in the nongeographic level,
regardless, there is a core \-\-- my apologies for drifting away from
the microphone \-- that ought to be present in all NHINs, either as a
capability or an ability, and particularly here is that regardless,
there is a sort of mandatory ability to exchange records, to provide
necessary security, and to route transactions, upon which one can add
services which might be of interest to the local level, but that it
becomes sort of an optional portion, or an approach to the delivery of
an NHIN.

Here is an example of a diagram you can see - we won't go through all of
these \-- that as, for example, a sort of core service is the secure
transport of data, another core service is the ability to locate a
record, regardless of whether Mrs. Smith's records are in Boston,
Massachusetts or Phoenix.

On top of which, and perhaps on the lower part are some services that
one could consider optional at the NHIN level, although they could also
exist at the local level, EHRs, PHRs, the ability to aggregate data, as
Linda was mentioning, and perform both research and public health and
care improvement types of analyses here.

Now, I want to commend the four contractors. Very impressive pieces of
work that they delivered. So those of you \-- I can't see you, I'm sure
you're all up above eating peanuts and popcorn. But nonetheless, nice
piece of work, and very nicely done. It was impressive to read, both the
thoughtfulness and the skill that went into these.

In particular, what is impressive is the challenge that they faced. They
were asked to come up with definitions of services, different approaches
to governing this, determining who would pay what, which sectors of the
healthcare system would do that; for a very complex IT infrastructure
which has no historical precedence. It's not like you can say, well, we
learned this here and that there, et cetera, and that will work and that
won't work. There is a fairly \-- you know, sort of white board largely
exists here, which both helps you, but also hurts you at a level in
putting this together here.

They also had to assume, and make a number of assumptions of what would
the EHR adoption rate be in the years ahead. If the adoption rate
increases very little in the next five years, then it's highly
problematic that an NHIN is financially sustainable. So you have to make
certain assumptions about the adoption. You have to make certain
assumptions about why will people connect. What will be, quote, in it
for them to go off and to connect?

So they had to make a wide array of assumptions about the progress that
we will make in this country in HIT adoption, and the effective use, and
also the movement to progressively improve quality and efficiency of
care.

And then they developed all these models which has lots of variables,
and lots of assumptions, and put it all together into a fairly coherent
and very thoughtful piece of analysis. So a number of hurdles they had
to overcome in the course of doing the work that they did.

A couple of broad comments here. They were very different models that
came across, and they ranged from a model that was, frankly, very thin
at an NHIN level, that, in fact, there is nothing in, in NHIN, other
than standards and conventions which must be adhered to if we're going
to exchange data between participating networks. But there is no
servers, perhaps no nothing in the middle, other than those standards
that exist here.

We needed something of which there was a fairly substantive core. There
were services, there was a governance structure, there were things that
had to be kept up 24/7, and things along those lines.

Other aspects of the business model, is to what degree it was run by the
private sector, to what degree was a public/private sector, and in the
very thin model, it could be simply a public sector statement of
standards and monitoring of those, et cetera, within which the free
market operated here.

Very different, which gives us lots of opportunity to look at different
models, and to make judgments, and to try and to learn about which
models are the more viable models. It makes the challenge, perhaps,
harder, because all of these models, at this point, could be deemed
equally viable. There is not enough history to judge one as being more
viable than the other.

They also had varying different revenue strategies. For example, who
would provide the capital funding necessary to get it off the ground?
Well, in the very thin model, not a whole lot of capital needed, and so
that's a fairly straight forward question. On the other hand, when you
get into more substantive capital, you can make an assumption about,
again, private versus public sector, the degree to which that is run off
of subscription fees on an ongoing basis, et cetera.

So very different. And again, that will make for a remarkably
interesting conversation on Friday, and in the years to come as we begin
to really experiment with these.

All of these models projected break even within eight years. And I want
to be careful, and be \-- sort of a little caveat about that, lest you
go off and start popping your money down, knowing that you'll break even
in seven years here. What the cost revenue models proposed was the cost
of the NHIN. What was not being discussed was the cost of the HR
adoption by providers, hospitals, physicians, et cetera.

What was not inherently being discussed was the costs of the geographic
networks or the nongeographic networks, so the individual costs that a
RHIO might bear, or that SureScripts or RXHub might bear. It was the
cost, assuming those expenses were being laid out, what would be the
incremental cost, largely to provide the interoperability. Not quite
sure across all, but nonetheless, this is not the full cost of a highly
interoperable system across the country here.

The other, as you can see, that the near term to seven years, near term
in a very thin model, it doesn't cost a lot, so in theory, you can break
even relatively quickly, and so that is a distribution on the thin side,
and where there is more in the middle, that would take a little bit
longer time to go off and do this.

All of them were cautious, and appropriately so in their assessment of
the breakeven, in that sustainability did require several preconditions
or conditions to exist that would, in effect, create this market. You've
got to be mindful, this market does not largely exist at scale, at this
point.

It has to be created over time by a lot of the work that you all are \--
or we are collectively, as an industry, discussing here. We'll come back
to that in another slide here. But let me give other comments here.

All of the models had a fairly active role for government, a variable
role, and with different folks putting different emphasis on different
aspects of this, at a minimum as has been done and started, and I
commend you all on the development standards and certification, that for
things to connect, standards have to exist, obviously. And I think
that's been part of the AHIC understanding for a long time.

As also various aspects of the formation of policy, and policy regarding
a range of things; for example, privacy and security. And then you can
move into the areas \-- the sort of second two bullets were, to varying
degrees, the Federal Government is a contributor of capital, to get this
off and to run, and using its purchasing power, as mentioned before,
both as a provider, an insurer, but also as an employer, can I arrange
its arrangements with those who deliver care to incent, and to cause
moving along these lines.

The only thing I thought was particularly interesting was the last
bullet here, is often enough at maturity. And so once you get past the
early transaction costs, and there were some comments earlier about the
need to get the transactions moving before you can get into sort of
second generation and third generation of using this data, is that
maturity, use of data, accounted for often 50 percent of the revenue
stream for public health purposes, research purposes, looking at care
patterns, analyses, et cetera.

And we'll come back to this in a second, but obviously there is a huge
\-- at this point, realizing how embryonic and immature we are in our
understanding of the sustainability of this, that this is viewed as a
critical contributor to that.

These are the conditions. And these are the conditions, frankly, that
are not new to any of us sitting at this table, or having these
conversations; that for the NHIN to truly become a sustainable activity,
we have to make good progress on all of these things. And to the degree
we don't make good progress on all of these things, the NHIN is highly
problematic as a sustainable, privately funded or largely privately
funded, undertaking.

So we have to make sure, for example, that the RHIOs of the world become
viable and sustainable, in and of themselves, because there has to be
something in the participant networks. The participants have to exist.
And to have an ongoing sort of concerns. So they have to \-- and that's
early, as you all know. We're still not out of the woods on making sure
that that occurs.

There have to be reasons why the participants would conform to the
standards of the NHIN. It's not \-- they could decide, and it's a
reasonable concern and say, hey, listen, the care exchange is local.
It's where 95 percent of it occurs. We're going to make sure the locale
is interoperable, and do that, but we're not sure why we ought to
deviate or change our agenda to connect with \-- Lord knows whether a
patient from LA really does show up in Boston, or how often that occurs.
And so there ought to be some rational for doing that.

It's also a factor of trust. While we in Boston have our own skirmishes
and battles, we do know each other, and it's \-- we don't know those
guys in LA. And so it's the devil you know versus the devil you don't.
So there's a trust issue that goes \-- and a complexity issue that goes
with that.

But making sure that there is reason and rationale, while the local
efforts would conform to these things. Long discussions on the
incentives, and I frankly think, in my own experience at Partners
HealthCare \-- this may be a cynical view on the part of some of our
physicians \-- but they view an EHR as a disruptive effort to erode
margin. That's fundamentally its contribution to their practice here.
And so we have to continue to make work, or to continue to make stride
on rewarding high quality care and efficient care which will require
these investments.

We're not there as a country, and it's uneven across the board, let
alone the exchange of data, and sort of the broad externalities,
although important contributions to healthcare in our future in medical
research it does bring. So that needs work.

The rest you understand; the sufficient base of the EHR adoption, 20
percent, or 24 percent is still small enough that if you were to go out
and query on Mrs. Smith, you would be \-- have big gapping holes, and
you might write off using this particular activity.

Per the interest and effort of looking at secondary uses of data,
obviously some guidance about appropriateness of that, a range of things
that would need to be sort of thought about, if that is to be broadly
encouraged, and that where it takes up to make sure that that is very
effective here.

Last question, and again, I apologize for the speed with which I deliver
this essential report, the phenomenal work of others. I didn't add any
value to this whatsoever here. But nonetheless, there are some series of
open questions, and these are questions that will be with us this year,
next year, and I frankly think for the duration of my professional
career; is what do we continue to have to do, both in the public and in
the private sectors, to facilitate progress that this adoption occurs.

There are complex tradeoffs that were illustrated in the various
business models. So what is the sort of business tradeoff between having
a very rich set of services at the core, versus a very thin set of
services. If it's thin, then those services are delivered at a local
level, either geographic or non-geographic. And the business tradeoffs
are unclear about that kind of activity.

Similarly, the business tradeoff at a local level of saying, I need to
conform to certain standards and support, cross-region, non-geographic
interoperability. What am I surrendering in doing that? What cost do I
incur? What value do I receive, et cetera. And those need further
explorations, et cetera.

The other is we propose \-- I don't think there is a lot of working
knowledge about the effectiveness of these various revenue models and
cost models, and those above and beyond experience need some further
analysis on top of the work that was done.

And then the last point, because of its prominence, is the \-- how
viable is that? There is \-- and again, having earned our own sort of
scar tissue in this regard, within our efforts within eastern
Massachusetts; on one hand, very attractive, very appealing to have this
data and to explore research and this, that, and the other.

On the other hand, there is some nontrivial privacy and anonymization
questions that go with this. And frankly, the data can be crummy. And
you can find severe limitations on \-- you think you can do this, but
there is not a chance because of the uneven quality of recording, gaps
in the data, biases on the part of the reporting physicians, et cetera.
So it can be startling to learn what the reality is on this type of
data. So if it is to be a viable, and perhaps a centerpiece of the
viability of this stuff, perhaps some further thought on making sure we
have a relatively sober and thoughtful assessment of the utility of
that, and that we're in a reasonable effective position to address the
series of issues that will accompany that.

So that is it, in terms of my assessment of the work, and again, I look
forward to the discussions on Friday with the folks, and look forward to
the continued discussions on this particular topic. And so thank you.

SECRETARY LEAVITT: \[Low audio\] \...Friday, again? I heard you refer to
that.

DR. GLASER: I guess you weren't invited, Mr. Secretary. I'm sorry.
\[Laughter\]. It's an oversight on our part.

It is the \-- I'm not sure if I have the official term, the NHIN
symposium, so there are \--

MS. PRESCOTT: It's another public meeting. It's the third open forum
that we'll have on the NHIN, and all of Friday morning will be devoted
to this subject.

MR. PARENTE: Good morning. My name is Steve Parente. I am actually a
professor in the finance department at the University of Minnesota, and
since \-- one luxury of being in a business school is you get to
consult, openly. So I am also representing my consulting operation, HSI
Network LLC.

Actually, this morning as I was driving over here, I was trying to sort
of put pieces together of this odyssey, that this has been on for a
while, and I was startled to find my original name tag when all this
started two years ago, in July of 2004. And I was even more startled
because I didn't own this suit then, so\... \[laughter\] I'm not quite
sure how that occurred. I need to talk to somebody at home.

I am an economist by training, and also health services researcher. I
have worked with health data for a great number of years. I also teach,
actually for the last 12 years, both for Johns Hopkins and the
University of Minnesota, courses in health information technology and
the business proposition of it. So all of this entire subject is just
wonderful for me.

Actually, this is like a great day, because there is this, and then
there is also the announcement of sort of the \-- you know, you have
fantasy football. This is sort of fantasy economics, if you will, of the
President's proposal for tax deductions in health insurance. I hope it
works.

What I'd like to do is give you just a brief overview of how an
economist might look at this, and really answering a question which is:
Does this work in terms of economics? Does health IT work in terms of
economics?

I think that there has been a lot of literature that's been written on
the case studies, and the values, and the return on investment, but
there is a broader question here, and as you'll see as we get into this
\-- a little bit of the punch line, the answer is generally pretty
favorable.

So let me just sort of step you into what this is. And it's favorable in
two things. I should mention. One is that you can make a return on this,
and there are opportunities for public and private partnership. And
furthermore, the opportunities on the private sector are rather
substantial. And that needs to be recognized, and embraced more broadly
than maybe it has been today.

So first, I'll just make sure we're on the same framework of what is
financial sustainability, and certainly a checklist, then talking about
economies of scale and scope. Both are critical for this to be
successful.

I want to mention the notion of how this can generate a public good and
what is, if you will, the prerequisites for it to generate a public
good, and what potentially some federal impetus could be. And then the
economic incentives for innovation in this field. That's something
that's typically in the academic literature. And it should get out more,
talk, because there is \-- actually for healthcare, it's actually a
pretty unique proposition that you don't typically see that makes it a
compelling case. And finally, talking about some areas to have
sustainable revenues in the long run.

Sustainability is really, you know, from an economics perspective, just
can this enterprise break even? Does marginal revenue equal marginal
cost? Can it continue on into the long term? There's lots of factors to
go into this. In many respects, this is really an entrepreneurial
venture, but with other complexities, because of essentially some
aspects of a market failure, where not necessarily the capital is always
there to get to the next level.

The size of the enterprise matters; the time to achieve sustainability,
as John mentioned, also matters quite a bit. The source of the revenues,
how sustainable those revenues matter as well.

Things that aren't talked about as much is the barriers to entry in
intellectual property component of this. Barriers to entry is the one
way where this is essentially \-- essentially the profit component. When
I teach in a business school now, and we talk about barriers to entry,
it's a very different discussion if I teach in a public policy setting
where it's like these barriers to entry will restrict the market. We
have a market failure. Whereas if I turn around to my MBAs and say,
"Look for as many barriers to entry as you can," that's what patents do.
That's what licensing does, because that's how you profit. We have to
somehow fit those things together in health IT.

And then there is obviously the technological opportunities and
constraints. The desire for health IT is actually a 40-year endeavor.
The first time computers looked like they had a chance at doing this,
but it's been taking a long time for it actually to reach fruition.

And then also keeping in mind technological progress, and actually,
redundancy. There is a lot of turnover in this field, and that's what I
think has calloused many folks, who have been in it for those 30 years.

So a little bit of theory. As an economist and teaching in a classroom
setting, I'm going to watch for eyes glazing, so \-- David Brailer has
given me very specific instructions here.

DR. BRAILER: I'm enjoying this, Steve. Thanks.

\[Laughter\]

MR. PARENTE: Thank you, David.

\[Low audio\]

MR. PARENTE: Yeah, I know. Eric Brynjolfsson from MIT, and Loren Hitt
from the University of Pennsylvania, had a wonderful conceptual model
developed in the 1990s; and to summarize this article, one thing that
they talked about was what are the three different values of health IT?

One of the most obvious ones we have talked about all the time is
productivity. Can we reduce medical errors? Can we be faster at what
we're doing? Can we get back and see more patients in an office setting?

Another one that is articulated that, you know, we don't like to talk
about because there is this sort of cultural biases \-- and I'm in
Minnesota now but originally from the east coast \-- and the notion of
profit. You have to sort of say it in like hushed whispers in Minnesota.
But profit is an incentive here for IT, not just health IT.

And then finally, the one that actually relates to the public good
creation is consumer welfare. The example I use for my students is, you
know, think of doing a literature review, say even 15, 20 years ago.
That would mean going to something called a library. It would mean
opening up something called a card catalog. It's kind of scary. These
things don't exist any more. Whereas today, they can just sort of go to
Google, they can go to their online resources, they can have a
literature review done from essentially their dorm room in a span of
about five or ten minutes.

Now granted, your opportunity costs, when you're a student, aren't that
small, but if you're actually operating an enterprise \-- I mean I
remember working on Project Hope ten years ago, that's what we had our
RAs do. They would sort of go to Bethesda and hang out for a day or two.
That doesn't happen as much anymore. That's a consumer welfare gain from
information technology that we all benefit from. We're essentially
getting something for a price that's far less than what we were
originally willing to pay.

So turning to these issues of economies of scale and scope. The scale
economy really gets to looking at a single product and saying, over a
long period of time, will you essentially get the objectives of what
you're looking for? So in the applications of, say, medical error,
reduction, getting higher productivity, say for clinical messaging
systems; those systems, in the longer run, are designed to give you
these productivity gains, and Vicky will talk about, and others, that
basically are pretty proven in lots of case examples.

And the point of these things is that this higher productivity gains
gives you more resources. It lets you do more. Hopefully, it will let
your physicians, if you're in an office practice, see more patients,
which could be more revenue. And that these savings will be actually
long-run savings. It has to be that or else it's just not worth it. It's
going to be to much of a burden.

Economies of scope work the same way, except the efficiencies you're
looking about here are in the bundle. A lot of times we don't talk about
the bundle. We talk about individual things like clinical messaging,
EHR. There is a task list of things that we need to do. But think about
it. In combination, these things do complement each other, and they can
achieve even greater benefits in terms of return on investment for
whatever the adopting firm happens to be.

And finally, to the public good issue. Really, this is a code for
economist-speak of network externalities. There are externalities in
economics that are positive and negative, you know. One I use, sort of
self-deprecating, in class, the notion of medical \-- actually cardiac
drug research, sort of leading to sort of animal testing that shows that
if you apply it on the skin, you know, hair grows. Now, granted,
unfortunately, when Rogaine came out, I was in graduate school. I
couldn't afford it. You've seen the result.

\[Laughter\]

So that was a positive externality, I suppose. For this system, we see
so many things that are possible by having a network system that is put
into place.

Shared clinical data, in many respects it's a profitable sustainable
thing, but it's exactly the type of technology we need in case of a
national emergency. Katrina helped sort of prove this. I mean there were
these technologies that were fledgling. Just two or three years ago they
were tapped, to try to make access to data, when we didn't have anything
at all known about these folks that were in dire straits.

So the question is how do you optimize this public good? First of all,
you look for as many things you get in scale and scope economies as you
can. Why? Because they're going to survive longer. They're going to be
more sustainable.

And then the other key is to actually actively balance this public and
private investment ROI, and here's where I want to get a little more
real about this, and actually respond to something that the Secretary's
comments earlier about this issue about the tradeoffs in public and
private. I actually wrote this down. Create, fund, and spin out. I like
that.

And the last bullet really gets at this issue. The question is, how
strategically do you put the public investment to sort of move these
things along? If there has been a hang-up about moving to the next
level, where essentially the private sector looks at this as too much
risk, essentially the public sector's role, then, is to mitigate that
risk to provide essentially bridging capital to go to the next level.
It's a very difficult high wire act to go at, because what you want is
the private sector to pick up the slack and keep on running thereafter.
So identifying those things are important.

One thing that is of concern is that in some of the reports we've seen
back, that John's reported on, seven to eight years out is what people
are saying is how long the breakeven point is going to be. But for most
of us who have worked, and seen things in venture capital, the window is
usually three to five years. So there is a clear gap actually right
there in terms of where the public investment could be to actually get
us past that point of more private sector investment.

In terms of the incentives for innovation, this is actually the part
that also came out of the Brynjolfsson and Hitt work. This is really
kind of interesting. The standard assumption in IT is that it can yield
profits \-- excuse me, it cannot yield profits. It only reduces cost.
And working with hospital administrators over the years, this was \--
even insurance executives \-- the sense was this is just going to reduce
costs. We'll take the man or woman out of the machine, and things will
sort of move things along.

This assumption is not true if an industry has high barriers to entry.
The medical field or medical industry has massive barriers to industry.
That's what medical school, for example, is about, or patent regulations
for pharmaceuticals, or just the information asymmetry from \-- for
example, my wife's a physician. She knows far more than I know about
what's really going on just inside my body. And because of that,
healthcare, with these barriers, there is an opportunity not just to
control costs, but to profit as well.

Health IT is an enabler of this. I mean this gets back to the consumer
welfare argument. If you know that you can find out what medical
technologies, by a review of your medical records, not by guessing, is
going to give you the best bang for your buck for future innovations,
you might be willing to pay a lot of money for that. But yet the
infrastructure we're talking about building here might be able to
generate that for almost, you know, 10 cents on the dollar for what you
thought that value would be.

So how do we look to these things? The best case for sustainable
revenues \-- actually, I'm going to be an economist here and focus on
the glass that's empty, half empty. The bottom part of this, the less
advantageous revenues for sustainability, and this is \-- these are
really independent comments.

I've seen, over the last year or two, almost sort of like a \-- I
apologize for this term \--feeding frenzy, both in terms of public money
and private money and foundation money, to look at health IT
opportunities. And this is a somewhat jaded view, having worked in a
contract research organization and still do, to a certain extent. This
is the hot flavor of the day.

I don't think that's going to make a sustainable business model. And we
have to be kind of honest about this. Because grants for quality
improvement and IT prototypes won't get you past the next step. The
venture capital has to come from outside sources, or at least be put
into different pieces.

The stuff that is sustainable, where you actually see business models,
and insurance companies, and providers working as user fees; where
physicians feel these are staple things that they have for their
practices, where you have subscription fees, where people have no issue
paying those subscription fees. You do see some examples of those
services. And things are bundled together.

So in summary, to get the value out of sustainability, obviously seek
those long run efficiencies. Those are economies of scale. Look for
multiple revenue sources, or look for companies that have multiple
revenue sources. This really is an entrepreneurial thing.

And getting back to one of the bullets that's toward the bottom, there
is a lot of redundancy and technological, if you will, slow down, or at
least changes that can affect your entire business model. This is the
case with any business enterprise. You need to have multiple sources,
whether it be in different provider sources \-- and also keep an eye out
for future technologies that either have profit incentives attached to
them, or are just cheaper to operate in the longer run.

So in closing, I thank you for letting me share these comments. I tried
to make them a little less academic, but I think that the good news
about this is that there certainly is an economics case for this, both
in terms of profit, as well as getting the private sector involved to
create the public good we would like to see. Thank you.

MS. PRESCOTT: Good morning. I'm Vicky Prescott. Thank you for the
opportunity to share with you the results of the ONC study that was
geared to identifying and analyzing health information exchange services
that have achieved financial sustainability.

The project \-- at the beginning of the project, we had to define what
the parameters were for inclusion in the study, so we had to first
define HIE, health information exchange. It's really used as an umbrella
term for several different types of specific exchanges of clinical
and/or administrative data.

Move closer to the mic. Okay. Sorry, I had to follow instructions. Two
mics. That's great.

HIE services, we had to define that, basically, because it could
encompass several different things. For service, we're looking at a
service, not necessarily an entire organization, but really, just the
specific service and its financial sustainability. It's not limited,
necessarily, to State Level Health Information Exchange Services; but
it's supposed to be the exchange of information between multiple
stakeholders, not just one or two. And it's not merely just the increase
in use of EHRs or telemedicine. So we focused on really services that
would have those criteria.

The financial sustainability, how do you define that? Well, that's sort
of difficult, because some of these projects have started a long time
ago, some of them are more new; so basically, it's having sufficient
revenue for ongoing operations. And we weren't able to include startup
costs in some of that analysis because of the data availability.

Just an overview of what we're going to cover today. I'm just going to
provide a description analysis of five different specific HIE services
that were found to be useful, and some recommendations for health
information exchange initiatives, getting started, and some overall
observations.

The first service is clinical messaging. It's what we call clinical
messaging. It's the delivery of electronic clinical results, such as lab
results, to \-- from the source system, from like the lab system, to the
intended recipient, for instance, the ordering physician.

The key rationale for this is the return on investment is easy to
understand. The doctors only have to log in to one system to see the
results. And the hospitals like it because of the decreased costs of not
having to have a department to deliver the results to the clinicians. It
also establishes connections between clinical data providers and
physician offices. And you don't need to know who the patient is,
basically. You don't have to create a master patient index. You just
need to know who the doctor is to be able to deliver the message to
them.

The clinical relevance of the data, of course, is important. Lab results
are very important for the physician to know in a quick manner. Also,
the test results are received much faster than the typical fax or mail
service that's provided today.

Now, who pays for this type of service? What we found in the study was
that the hospitals and/or labs would be willing to pay for this service.
The doctors do not pay.

The next service that we looked at was medication history service;
electronically sharing the patient's medication history that's obtained
from multiple data sources, with the clinician or the institution that's
treating the patient. This is attractive to hospitals to help them
comply with the JCAHO medication reconciliation requirements that they
have to do.

It's also useful because of the eligibility and formulary functions that
are typically included in a medication history type project, and those
can, of course, reduce drug costs for the patient, the payer, and also
increase sufficiencies in that regard.

Also, the data is very relevant to clinical care. It's very important to
know what Mrs. Jones' meds were, because she won't remember them, and
other medications could indicate other conditions that they \-- the
person might have that could impact the treatment regimen. And, of
course, avoiding adverse drug events and other things like that.

And another good thing about this particular project is that some
sources of medication history, for instance RXHub, have been pooled, so
you wouldn't have to connect as many interfaces to be able to get a good
bolus of data to be able to be useful for treatment of the patient.

So who pays for this service? Once again, we found that the hospitals
were paying for this service based on the number of patients that were
matched in the data.

The next project that we looked at was e-prescribing, which automates
the process for the clinician to prescribe medications for patients by
electronically delivering the prescription to the retail pharmacy or the
mail order service.

The key rationale for this is it's reducing the physicians' and the
pharmacies' administrative expenses, because of increasing the
legibility of the prescription and processing refills. It's just quite a
bit easier to do that. It also has a positive impact on many
stakeholders. The payers, the doctors, the patient, the pharmacies.

This project also would, or could, include, or should include the
medication history component that we just talked about, which we already
went over, and also the eligibility formulary needs to be \-- or should
be included \-- is very beneficial to be included in there as well. And
that needs to be done \-- you know, the doctor needs to know what the
formulary is before he orders the drug. So that whole bolus of different
functions would be considered under the e-prescribing.

Also, there are some hurdles, of course, to implementing any kind of
e-prescribing. Some of the examples were really critical mass of
pharmacies need to be covered. Critical mass of medication history needs
to be available. And the software has to be one that physicians are
willing to use. And the workflow changes are not insignificant.

You also need to map the data to standard vocabularies to be able to be
useful; and to be able to do the formulary function, you have to be able
to map it to the category of data, to help the physician choose the
drug.

Now, who pays for this? In the study that we did, the e-prescribing
delivery network actually pays the health information exchange a portion
of the fees it receives from the pharmacies. So that has \-- that was
the business model that was found there.

The next project is the sharing of the patient's clinical data at the
time and point of care. It's gathering the electronic clinical
information, the medication history, lab results, diagnoses, things like
that, from multiple sources on a patient when the patient actually
presents for care, for instance, in an emergency department. It's a very
high value to treatment of a patient, avoids errors, reduces duplication
of tests and procedures, and improves the continuity of care for the
patient.

A standardized repository of clinical data can also serve to benefit
other entities, other constituents such as public health, researchers,
eventually Pharma, and the addition of clinical decision support and
reminders functionality can also further treatment and quality of care
for the patients.

Of course, once again, there are implementation challenges that include
the fact that it's a very large-scale project to undertake something
like this. You also need a sophisticated master patient index so you map
the data that's \-- that is for that patient, to that patient. And it is
difficult to project the value across different stakeholders, and hence,
there is a hesitancy to invest in such \-- in a project such as this.
The standardization of data is also needed to be of any real value for
this type of work.

Who pays for this? Well, there is only one example of that in Indiana,
and we do have long-term funding, from a philanthropic foundation, that
has funded this, because it does view it as a public good. There is also
some revenue from research grants, because we do have data to do
research on, but primarily we're funded through the public good support.
And some other HIEs are trying to look at models where it's more of a
subscription model, but there's no actual examples of that, that we know
of, in existence.

The final one is quality measurement reporting. This is where you would
share healthcare information clinical data and claims data between
multiple different sources for the purpose of quality measurement. That
can support provider quality initiatives and also serve as a basis for
determining incentives to the providers from the payers. The benefits
and the rationale for this is to have a consistent set of quality
measures. That the payers recognize the improvements and efficiency in
quality of care, they'll have more influence by banding together to come
up with a set of standard quality measures. And providers only have to
comply with one set of measures, as opposed to today. And they will also
receive information, themselves, on their own patients, and incentives
to help them improve. As quality increases, of course the patient
receives better outcomes.

So, of course, the implementation challenge is there is \-- the biggest
one is that you need a critical mass of data. You can't do this kind of
a project on Day One. You also need a critical mass of participation
with enough payers and enough providers to be able to make it worth your
while of going to this trouble and setting this up. Also, you need
consensus on the quality metrics, how to analyze them and who has access
to the results.

Standardization of the data is essential. You can't do it without that.
And, of course, the master patient index is needed. Who pays for this?
The payers pay a per member, per month type of charge to the HIE to
collect, and aggregate, and produce these reports. The payers also give
financial incentives to the physicians as part of the program. They use
it as a basis \-- the information collected as a basis for the pay for
performance, pay for value type programs that are out there.

So the recommendations that came out of this project for health
information exchanges; basically the number one recommendation is to
leverage any infrastructure that's built on any data that's collected,
because reuse of the data is what's important to be able to build on
top, build services on top of this infrastructure.

No one particular service is going to generate all the revenue that's
necessary to build this kind of infrastructure. And it's also key to not
building continued silos of data, but to reuse the data for purposes
that are acceptable to the community.

And I have to be the lawyer and say the disclaimer on these
recommendations. Local circumstances and market conditions are really
going to dictate where the HIE initiative should focus its initial
efforts. These recommendations are a generalization, and a particular
region may be more favorable than others to this type of \-- a
particular type of HIE service. And also, in addition, state laws could
affect the viability of the plan services, and they have to be carefully
reviewed and understood. I should have read that really fast like
lawyers do in commercials.

\[laughter\]

But the recommendations are, for your initial services, the ones that
are a little bit less complex, is to do clinical messaging, and/or
medication history. Some of the examples there, the initials there are
clinical messaging during the study; we found that HealthBridge in
Cincinnati, Inland Northwest Health Services in Spokane, and Regenstrief
Institute in Indiana, health information exchange, basically Indiana, is
also doing that. Medication History is Indiana.

Also, the recommended later services, the more complex services are
e-prescribing, sharing patient clinical data at the point of care, and
really, lastly, would be quality measurement, because it's really \--
you really have to have enough data to be able to make it useful. So\...

Overall observations. There is really no single approach to financial
sustainability. All the projects that we studied were pretty diverse.
Market factors are not well understood. There were some enablers found.
The history of collaboration was helpful in the community. Self-interest
of a critical mass of participants to come together for economies of
scale, as Stephen talked about. Strong leadership from the provider
community, and fragmentation of the market, but not too much
fragmentation, to make it too difficult to have too many interfaces
you'd have to pay for to come together. And payer reimbursement
incentives are always helpful.

Common challenges were found throughout these \-- the projects,
underestimating the size and scope of some of these projects, and the
intricacies and complexities, as John alluded to earlier, of the data
itself, and the quality of the data you're going to receive from the
data sources.

A critical mass of participants is necessary, and a critical mass of
data is necessary for a lot of these projects. And collaboration is
required, and some of these entities really have not collaborated
before, so depending on your history in the community, that could have
an impact.

Also, workflow change resistance by providers in institutions could be a
factor, and also IT staff of the stakeholders, they have other
priorities. This might not be a major priority for them, so that might
cause some delays in implementing.

But the bottom line, as Dr. Brailer wanted me to end with a positive
note, and \-- that there are sustainable models, even though we haven't
\-- you know, don't have a huge amount of them, but there really are
some sustainable HIE models out there. Thank you.

SECRETARY LEAVITT: I would reference four \-- or three excellent
presentations, and I'm anxious now to have some conversation about them.
And Craig?

MR. BARRETT: If you excuse the pun, this is a very clinical presentation
of the topic, and in my mind, it leaves out one of the participants in
the whole process. It's very process oriented, and server oriented, or
service provider oriented, and leaves the customer out entirely.

Even Southwest Airlines allows you to book a seat online. Why? Because
the customer demands it. And the nature of the whole presentation is
really, what is convenient for the service provider, not is what
convenient for the customer or the patient. And if anything is going to
drive this, I think it's going to be customer demand is going to drive
this, which I hope far exceeds any of your expectations in the
implementation of this process.

And I'm just wondering if any of you have any comments in this
direction, because most of your comments are aligned towards the
clinical ROI of the implementation, the \-- who pays for this service;
but as soon as the customer starts demanding that either you do this or
I'm gone, I think this whole process accelerates dramatically. And all
of your clinical ROIs get thrown out on the basis. It's the matter of
staying in business.

You have a couple of business folks at the table today who, if we took
this attitude toward servicing our customers, we would be out of
business, period.

DR. GLASER: I think that's a fair comment. I think obviously we are all
better served by a customer that demands that, but the point is today,
they don't. And so the investments, today, are largely being driven by
those who write the checks, in my case Partners HealthCare, who turn to
their constituencies, and we make sure that that both improves the
quality of care and the efficiencies, et cetera.

We find that the \-- in our own assessment of the patient or the
customer, their demands on us are not here today. We need to move them
there, but if we're writing the checks in fiscal year '07, the major
driver, at this point, is still the provider to the degree, the employer
in the plans. So I think you're absolutely correct, but if \-- today I'm
not sure that the customer is quite the voice that we might like them to
be.

MR. BARRETT: Well, the customers come in two categories, obviously. It's
the individual or it's the payer or the customer, And obviously, the
individual, today, within this system, has essentially no voice, because
he's a single individual against this massive system.

So probably the pressure from the customer has to come from the customer
who pays the bill, which is either the employer, or the Federal
Government. Neither of those voices have been particularly loud in this
instance, and they probably need to be much louder. We're starting to
see some momentum in those areas. But if that momentum grows, I think
most of your analysis has to be kind of turned on its head, because it's
going to be a customer-driven perspective, and not a provider-driven
perspective.

SECRETARY LEAVITT: Craig, do you have any thoughts? I have long felt
that the leaven in the loaf would be customer demand, individual
patient, and if you could unleash that, that it would begin to drive all
of us. Do you have any thoughts about how that can be accomplished?

MR. BARRETT: Well, unfortunately, I think the individual customer driven
demand is held captive by the fact that his employer has an insurance
provider, who has this administrative bureaucracy which throttles that
demand and channels people in directions. But if the employer, for
example, starts to say, "I'm only going to do service with business who
provide this capability," then that's a much louder voice, because the
employer, you know, an Intel, or a Walmart, or anybody around the table
here, who spends a billion dollars a year, has a much bigger voice than
the individual who spends a few thousand dollars a year. So it has to be
an integrated voice, from my perspective.

SECRETARY LEAVITT: Bill, and Gail and Chip.

DR. WINKENWERDER, JR: I just would like to agree strongly with Craig's
comments about the customer driving this. In our case, I think we're, at
the Department of Defense, a unique example, because we're both an
employer, and a provider and a payer. We're all of those, and maybe that
has something to do why we, you know, saw that this made sense early on,
and believed, without all the ROI. We did no ROI. We just said this
absolutely has to be done, because it's a requirement of our business.

Secondly, I think we are generating some customers who will have demand
out of our beneficiary population of roughly 10 million, and out of the
VA of another five or so million. There's a lot of people out there now
beginning to expect that \-- you know, that this is the way you get your
care. They've got more information. Their provider has more information,
has better information, and I think the other thing that I commend the
VA on is demonstrating the quality difference. And, you know, I think
it's coming, but it's not \-- it could come faster. And that will \--
once customers get it, individuals, I think it will happen very quickly.

SECRETARY LEAVITT: I'm curious to ask Rob, and Stephen and others, at
this table who have had \-- who have had experience with some component
of this that would be so robustly adopted, or accepted by consumers,
that they would demand it. What part of this \-- of the service \-- of
the items that Victoria talked about would have the best chance of
having consumers just revolt, and demand that it be provided? I mean
recognizing that there are some barriers to that, but if you were \--
what part of this would have the best chance for that?

DR. KOLODNER: I think what \-- one of the things that we're seeing,
certainly the VA experience, is that personal health record where people
start saying, "You know, I want my own copies of my records, or
electrons," and beginning to say, "Okay," as a consumer empowerment
group did, "Let's start with medication history. And by the way, if
you're giving the laboratory to my provider, how about if I have a copy,
because the next provider, in another state when I'm traveling or
something may not have it."

So we have seen this sense of involvement, which is \-- has certainly
been described by others, in terms of the engagement of the patient as
being an enabler. And whether that will take off, and what rate that
will take off, certainly some entities around the table have put forth
some of those solutions, and others are exploring as well. That that may
be what ignites the consumer, in a broad sense, to begin taking more
responsibility for their health, and the engagement in the healthcare
system, to begin coming in and expecting their provider, or the services
that their provider turns to, to provide them connectivity.

DR. WINKENWERDER, JR.: Always I would add to that, I would say people
like making their appointments, medical appointments online. You were
referencing the Southwest, but we are doing now about three-and-a half,
four percent of all of our appointments. That's a low number, but to my
knowledge, it's the highest of anybody, anywhere. People are making
their appointments online. We have people in Iraq making appointments
when they get back to the United States, online.

SECRETARY LEAVITT: Interesting. Steve?

MR. PARENTE: As a provider working in the VA with the EHR, I want to
second Rob's comments. I think the patients are very much looking for
the opportunity to help, or to control \-- to have greater control over
their health information. The knowledge that they gain from having
access to the results of the information that we have about them, as
providers, is something that they very much want.

In the past, the system \-- as Craig has said, it's a mystery. We
control the information, the patient doesn't have access to it. They
are, in a sense, at the mercy of the system. They are extremely
appreciative and very desirous of having the opportunity to control the
information, and that's very important to them.

SECRETARY LEAVITT: When you say control, you mean to access?

MR. PARENTE: Access. That it's in their possession as well as in our
possession.

SECRETARY LEAVITT: I can get access to my medical information in a way
that's convenient to me.

MR. PARENTE: Exactly.

SECRETARY LEAVITT: Craig, did you want to comment on that?

MR. BARRETT: Well, I was just going to second the issue of not just
making appointments online, but the thought of not always having to go
sit in the waiting room at the doctor's office for communication with
the doctor, I think is a huge opportunity for the system for efficiency
and customer service. Basically just electronic communication with the
doctor.

SECRETARY LEAVITT: I think we said Gail, and then Chip.

DR. BRAILER: Mr. Secretary?

SECRETARY LEAVITT: David, then we'll come to you, unless \--

DR. BRAILER: Thank you.

SECRETARY LEAVITT: Thank you.

MS. GRAHAM: Two points. One is, I just wanted to follow up on your
point, Mr. Secretary, that there is a demand out there right now for
services for information. Patients are clamoring to get their own
information. We see that. So I think the demand is there. I think there
is a lot of frustration, because once you're into the medical system
with a health problem, it's very difficult to get your own information.

So I think that's one issue. But another issue that I didn't hear in the
presentations, and I think it's certainly worth discussing, is who owns
the data; and with this data, what stake does the consumer have in that?
Can the consumer give permission, or should we expect that the consumer
will always give their permission to release data, or is there certain
data that would be public anyway? But I think it's certainly worth \--
if data is going to be bought and sold, then it's certainly worth the
discussion, I think.

SECRETARY LEAVITT: Thank you. Chip? Then we'll go to \-- Kevin, then
David.

MR. KAHN: I think this discussion is artificial. I mean I think first in
terms of big systems like \-- with all due respect to the Defense
Department system or the VA system, there you've got individuals caught
up in a big system; and I think the relationship and the information may
be quite different. I know from my own experience, I go to the doctor,
and he hands me a piece of paper with all the test results. So I have my
test results.

But the point I guess I want to make here, if you look down the HIE
recommendations, it's the money. I mean whether it's on the patient's
side or on the provider's side, there is no money for clinical
messaging. Doctors don't get paid if they get online \-- I mean I have a
great relationship with my doctor, but he is not going to give me his
e-mail address, and we're not going to talk on e-mail, because that's
time, and he doesn't get paid for it. Now, you can say, I could demand
that of him, but how much can I really demand that of him when I'm
insured?

And I think if we go down all of these issues \-- you go to
e-prescribing. I mean it makes a lot of sense; but in terms of the
workflow, it's so complicated for small physicians offices to do it, to
sort of transfer to it, and there's really nothing in it for them. There
is \-- other than providing better service, there is no money there. The
money is for the insurers if there is more ordering of generics and
things.

So I think the problem here is the money flow, and we can talk about the
consumer all day, but at the end of the day, the consumer in healthcare
tends to be passive; because the fact is they rely on a third party
payer, and the customer doesn't have the same relationship with the
provider that you do in other markets. I think it's a unique market, and
either the money's got to flow differently, or something has got to be
shaken to really build these relationships. Otherwise, I think we're not
going to make that much progress on these fronts.

Now, you can go in and say, doctors have to e-prescribe. Medicare could
say, "We ain't going to pay you unless you e-prescribe." And actually,
that would get a lot of attention of doctors. They would start doing it.
And there are things that can be done regulatorily. But from the
patient's standpoint, it's a very peculiar environment, and most of the
patients are paper oriented, too. Most seniors are paper oriented.

I think in terms of making appointments and things it would be great,
but then you've got to have the software, and you've got to have the way
to do it. The question is, for the average physician, is that
infrastructure going to be there? Big groups can do it. Hospitals could
do it. But I think the problem is the flow of the money.

SECRETARY LEAVITT: Kevin, then David. Then I'm going to go to John. And
I just heard something hit the table, and I think \-- \[laughter\]

MR. HUTCHINSON: The original question of what has an impact, of these
things listed here, what can have an impact. And trigger off of Craig's
comments as well, it's about the customer; and the customer is an
integrated voice between the consumer and the employer. And if you
really look at the things that we're discussing, the customer being the
patient, it's about the inconvenience of healthcare, if you were to
start. Cost and quality, probably in the overall scheme of things with
patients, is not the number one item, it's the inconvenience of
healthcare that we \-- that gets their most attention.

With employers, it's about costs, and with costs, it's about quality. If
you combine and you look at the items that are listed here, and I'm not
sure where some of the data came from, some of the research; but going
back to e-prescribing \-- and with all due respect to my colleague,
Chip, I have to disagree with the money issue on e-prescribing.

One of the things that we've seen is the initial reaction of the
physicians is, in fact, who is going to pay me to do this? But once they
start getting their refill requests electronically, from all the
pharmacies in their area, going back to the data in here that says one
of the hurdles is to mass pharmacies, you have 95 percent of all
pharmacies in the United States certified on a network, and you have
two-thirds of the pharmacies in the U.S. live and exchanging
prescriptions in the entire U.S. You're starting to hit mass scale. That
means in many areas across this country, you have 80 and 90 percent of
the pharmacies in those geographies that are doing electronic
prescribing.

What that means to physicians is that they're getting 80, 90 percent of
their refill requests electronically into a single application. What is
money to physicians is time, and what they are saving in that refill
process is time, which enables them to make more money off of seeing
more patient visits.

Getting back into the employer's focus, this activity with the
pharmacies and the physicians also allow the ability for medication
adherence and compliance, which drives quality, which lowers cost. If
you can keep medication \-- patients on medications for particular
conditions, you can avoid duplicate lab tests, and duplicate office
visits, emergency room visits, and other things like that.

The medication management, going back \-- and I know we're going to get
to the use cases this afternoon; but the medication management process
is primed and ready to really be driven across this country, with
respect to improving the convenience of care for patients. The
prescriptions are ready when they walk into the pharmacy to pick them
up, because they're sent electronically. When refills are requested,
they go online to a website, or they dial into their pharmacy's IBR,
they enter a prescription number. The system checks to see if a refill
\-- authorization is needed. It automatically sends it to the physician.
They reply back. No human hands have touched it since the patient
entered their information. Now you're talking about a live, automated
process. You've improved convenience, you've improved quality, because
you've improved the medication adherence and compliance.

And so in my opinion, in knowing this space with respect to where the
pharmacies are, where the payers are, where the physicians are, it is a
disruption in workflow, initially, in implementing these systems,
without a doubt. But when they see the value of getting these refill
requests in a physician's office in an automated fashion, it does save
them time, which brings in more money.

SECRETARY LEAVITT: I'd like \-- let's go David, John \--

DR. BRAILER: Thanks, Mr. Secretary. I have a comment and a question for
the panel. The comment is in response to your challenge about the
question of where are consumers on this, and I'll call everyone's
attention to a really, very interesting Zogby poll that was published, a
poll of Texans. And so if we take the risk of generalizing from Texans
to the U.S., notwithstanding, the two highest ranked preferences that
this sample that was done last week reported; number one was 73 percent
of the respondents wanted e-prescribing. They felt that this had
significant benefits to them in terms of the actual just handling the
prescription process, the denials, et cetera.

Second was virtual visits to the doctor, 42 percent. Those were the only
two very large ones. But, you know, this is a random sample of just
adults, in Texas, who had just remarkably high numbers, more than double
what we saw a year ago, if this could be generalized to a national
level; about what they want, and how they view health IT as part of
their landscape of health access.

SECRETARY LEAVITT: Thank you. The time we have allotted for this
discussion is over, but I want to ask John, and then Craig, and then
Doug if they would make brief comments so that we could, then, move on.
I think it covers \-- is quite related to this one.

MR. MENZER: Thank you. I think there can be a big impact on educating
the patient, and then the patient on their ROI, or their return on
investment. And as you know, last year, Walmart introduced the \$4
generic drug program. And our theme was to put price back in the
equation, price for the customer. And we received tremendous response.
We've had a dramatic change in behavior, not only in the customers, but
in the industry. So I think working back to the patient and the customer
can have dramatic results, and it can move very, very quickly.

SECRETARY LEAVITT: Thank you. Craig and then Doug.

MR. BARRETT: My response is going to be mostly emotional. \[laughter\]
But I just think we are tremendously underestimating the capability of
the doctors in the United States, if we don't think that they can put
routine, everyday, Quicken, Amazon.com, Worldwide Web technology into
their offices. Frankly, if my doctor can't put that into his office, I
have no interest in visiting that doctor.

SECRETARY LEAVITT: Doug? With that...

\[laughter\]

DR. HENLEY: \...in American physicians, and quick frankly, I agree with
him. The whole research that was done, for example, by the Future of
Family Medicine Project two years ago, future of internal medicine,
future of pediatric projects \-- they all occurred about the same time
\-- was the fact that the healthcare environment, in this country, needs
to become patient centered, not provider centered.

And, in fact, I'll just use the example of my colleagues and family in
medicine, we're approaching 35 percent adoption of EHRs in the absence
of financial incentives to do so. So that is occurring. But we do need
to \-- I'll go \-- my colleague, Chip, is correct in the sense that the
way that we pay for healthcare, in this country, needs to change.

That's not asking for new dollars in the system. It's a redistribution
of the dollars that are already there. There is abundant research that
shows, if you connect individuals to a medical home, that quality goes
up, and costs go down. This country does not incentivize by the way we
finance healthcare, be it in the public or private sector, connecting
patients with that medical home in an organized fashion, that
incentivizes that asynchronous communication by e-mail, or electronics,
not just the face to face visit. We still pay for widgets, not for
caring for people. And we need to rethink that, not with new money, but
a redistribution of money that's already in the system.

SECRETARY LEAVITT: Thank you. Robust, good discussion. I learned a great
deal from it. Thank you to our panelists. I wish we had more time to
pursue this. I have some thoughts or questions, as I know others do, but
we're going to move to our next discussion on priorities. Thank you.

DR. KOLODNER: Okay. With that panel, thank you very, very much. And as
the discussion revs up, we now move on to the time when we're going to
discuss, again, the AHIC priorities so that we can guide this next set
of scenarios or use cases that we can use for Round Two of the standards
development.

Remember that Secretary Leavitt did accept the recommendations we had
from the October meeting for the standards for Round One, and now this
discussion is to help us step through and identify those things that we
should be using and developing, or identifying for Round Two.

And as the panelists are getting into place here, this, as you recall,
is continuation of a discussion we started in October. We showed you a
matrix at that time where we took the various recommendations and
visioning by the Workgroups that have been reporting to us, and put them
together in a way that rather than going into the next round by stove
piping the recommendations from each of the Workgroups, what we did was
look across the Workgroups to cluster their various priorities and
recommendations in a way that was meaningful.

And at this point, let me \-- ready to get started? We'll go ahead and
I'll turn the mic over to John Loonsk, who will lead the panel, and talk
about the various perspectives that we use to cluster, as well as the
initial feedback from the AHIC members that we can use as the starting
point for discussions forward. John?

DR. LOONSK: Thanks, Rob. With me, today, I have representatives of some
of the Working Groups of the American Health Information Community,
including Rose Marie Robinson, Blackford Middleton, John Lumpkin and
Carolyn Clancy.

As Rob indicated, we're here to talk about AHIC priorities and about the
use cases, which are a manifestation of those priorities that we use to
move forward this complicated apparatus of the national agenda. The use
cases are really detailed descriptions of what needs to be accomplished
to have a system, or in this case many systems, work together to advance
to a common goal.

We have been using the high level use cases of the \-- of the national
agenda, not to talk about a specific system, but particularly to talk
about the ways in which different systems need to work together at a
high level. We have been trying to represent the priorities of the
Community in those use cases in terms of moving forward with this
agenda.

The use cases strive to provide enough detail that they can be used for
standards harmonization, but also for architecture specification, and
they have been an important part of the work that will be demonstrated
later this afternoon, in terms of the Nationwide Health Information
Network prototype architectures; and will also be demonstrated Thursday
and Friday, Nationwide Health Information Network Forum, in terms of the
types of activities that can be carried out, and how they can be.

They also feed into the certification process, and they have provided an
opportunity to get specific about certain policy issues for
considerations as well. So they basically provide several different
purposes for the different aspects of the agenda.

From the standpoint of this year, we had the American Health Information
Community Working Groups present over 120 different priorities and
issues. There is a lot to attend to. And what we've tried to do is take
the recommendations from the Working Groups, as represented on the
left-hand side of this slide, and cluster them, as best we can, to think
about how they logically go together, how they can work together and
synergize. And we had a discussion on this at the November Community
meeting. And then to offer forth possibilities for the next step use
cases.

And this is the way those possibilities have come together. On the top
of this slide, you'll see the existing use cases, so in the consumer
domain, consumer empowerment, registration and medication history. As
we've clustered these together, they have logically fallen into these
three broad domains; consumer, provider, population.

In the provider domain, we have the existing electronic health records
and lab use case that was worked in this last year, and we always have
the emergency responder, EHR, which is about supporting emergency
response activities, which has been finished, and will definitely feed
into the next round of this agenda.

In the population domain, we have the biosurveillance use case. So what
we are here to talk about today, and hopefully to come to closure on,
are choices for three more use cases to feed the next round of the
activities. And as they have broken down, we have polled you on your
priorities for these three different categories.

First, in the consumer domain, the possibility of supporting remote
monitoring, remote consultation, or consumer access to additional
clinical information. In the provider domain, the area around medication
management, or the area around referrals and transfer of care. And in
the population domain, the possibilities of quality, of public health
case reporting, or public health response and emergency response
management.

So what we hope to do, with this session, is have each of our Workgroup
representatives go through a little bit of the background for these
different options, describe a little bit about what's in them, and
what's not in them. We hope to get as many of the Community priorities
into the next step use cases we can. We can't guarantee it. There are a
lot of priorities being expressed, and we can't certainly cover the
waterfront in terms of what each of those priorities are.

But this is a logical construct, and we'd like each of our presenters to
tell you a little bit about these different options. And then after
we've gone through these presentations, I think we'll return to the
results we got from you, in terms of your feedback as to priorities; and
then, hopefully, have discussion and come to conclusion.

So first, I'd like to turn to Rose Marie, who can talk about the
consumer empowerment options.

DR. ROBERTSON: Thanks, John, and Mr. Secretary, thank you for the
opportunity to be here. I think this is an excellent place to start,
actually, because my bias, both as someone who has practiced in
cardiology for many years in an academic setting, and now as a
representative of the public and patients through the American Heart
Association, it does seem to me that getting it right from the point of
view of the consumer is really what we're all about; that there are many
reasons for this Community to exist. But the key one is to improve the
health of the public.

And the consumer use case choices that were brought together, in fact,
all focus on ways to improve that. And you can't read them on this
slide. I'll go through those options. Let me just say that a key piece,
for all of them, is having adequate privacy and security, safeguards,
and we'll hear a lot more about that this afternoon.

Talking about remote monitoring, as one of the first choices. There is
no question that any of us who have taken care of patients recognize the
huge shift there is when you move from the hospital setting, where you
have minute to minute, hour to hour, at least day to day information
about a huge number of parameters about your patient. And then suddenly
the patient goes home, and they got home a lot earlier than they used to
when I was an intern. And all of a sudden, your information really
shifts. Now you're lucky if you get information weekly, or sometimes
monthly, and sometimes you don't get any information at all, until the
patient comes back. The patient needs to be managed in that setting, and
you don't really have the information you need to do it often. Sometimes
you do, but often you don't.

So the concept of getting that information and having that available
would be a tremendous benefit. And that could include really simple
things like vital signs, blood pressure, heart rate, weight, and very
complicated things, like laboratory data. One of the device companies
recognized, several years ago, that by virtue of pace makers, and
defibrillators and planting defibrillators, that what they really had
were thousands and thousands of patients walking around with computers
that monitored some aspect of their healthcare, and that that could be
expanded hugely to monitor other aspects. So that area of technology is
going to grow extensively.

Already this would provide things that are clearly a priority for the
Community. And the limitations have to do, to some extent, with the data
you can put into the system, so that we can get information through
ambulatory blood pressure monitoring and through other devices.
Sometimes that information is of high quality, sometimes it's
interoperable, and sometimes it's not. So limited interoperability is an
issue.

In addition, there are concerns about medical/legal constraints and
risks in terms of providing remote care. On the other hand, physicians
provide that remote care based on information that you get through the
telephone, much less information that you could get in this better way.
So there are some real potential benefits here.

Let's turn to remote consultation. I think we heard already, in the
comments before, that the concept of having to go and do that, that
office visit, is a real barrier to people getting care. You know, we
have a fast food nation. Maybe we should have a fast health nation,
where you can, in fact, get the information you want, perhaps get the
medications you want and you need in a quicker way.

This certainly would address important priorities for the Community. It
would be done via structured e-mail, in many circumstances. The idea of
providing that information for the public would be key, getting
information from their physician, or their healthcare provider, or their
healthcare provider's office; and being reminded, and even, perhaps,
educated about the next things to do, has great potential to improve
healthcare. It needs to be studied more, but it has great potential.
Again, there are medical/legal risks and concerns that would have to be
dealt with, but it seems that they could be dealt with.

The personal health record, currently, is not integrated with physician
office workflow. We've heard a lot about that. But, of course, patient
calls aren't so well integrated with the workflow, either. And there is
no reason to think that using the personal health record couldn't make
that better. Even for something as simple as the question you forgot to
ask before you left the doctor's office, or something as complicated as
a potential side effect of a new medication, or is this medication
actually doing what the doctor intended it to do; or complex things,
like observations you might make about yourself, that you'd like the
doctor to know about.

So there is the potential for this to improve care as well. The quality
of the data going into it is not yet certain. The integration with the
work flow is an issue, but you can imagine that putting together choice
A and choice B, remote monitoring and remote consultation, could provide
a very robust answer to things that need to \-- need to happen to
improve consumer empowerment and consumer healthcare.

The third choice we'll finish here, is consumer access to clinical
information. This is one, I think, that many people would favor. It
clearly builds on the current use case regarding registration
information and medication history, to add other information, to add
laboratory results. Some people get that lab result pretty quickly from
their physician. I think there are a lot of people who don't get handed
those lab results, and who make many phone calls, and weeks and months
later, still don't have the information.

The concept of having your health problems listed so that you and the
provider know what they are, and the next provider might know what they
are as well, medications, allergies. It's easy to see how that list of
priority areas could improve healthcare.

The access to this is one issue. Control of it and being able to
transfer it to another provider is quite important. And we actually
heard testimony of examples where this has been quite helpful, again
from the Department of Defense on the Healthy Vet System. A veteran with
complex medical problems, who became ill in another city, found it
difficult to communicate because of his medical problems; but the access
to his health information, the fact that he could get that to those
providers, certainly improved his care, and he believes saved his life.
So the ability to have that information available can really be quite
critical in healthcare.

The Workgroup issues that came up regarding this one are of concern, but
\-- because they are not all solved, but solving them would help us take
important next steps. So the fact that there is not currently sufficient
prepopulated clinical data, and there is limited patient access, we have
to solve that, in any case. That's really a critical thing to do. The
connectivity between physician offices and personal health records has
to be solved, and pharmacies, if we're going to take the next steps in
making this function for the patient. And that has to do with
interoperability, certainly. It also probably has to do with
portability, having the patient be able to carry that information with
them as they move to a new system. And then issues of state laws, and
being able to do things in different places.

There also is the additional issue of consumer-entered data, and how you
assure that that data is identified. Patients would like to have access
so that they can, sometimes, correct diagnoses; and we want to be
certain that those corrections are done appropriately.

So tremendous advances here, a potential for increasing the engagement
of the consumer and a use case that would have great benefit, we think,
to the community. Thank you.

SECRETARY LEAVITT: Rose Marie, thank you.

DR. LOONSK: As Rose Marie points out, each of these three choices in the
consumer facing area have some commonality, and as we sent out these
materials to you, we listed those enabling technologies on the right
side, and it is our hope, that regardless of the choice in this
category, that we will be able to attend to those enabling technologies
in the next step use case from the consumer domain.

I should point out that those enabling technologies very closely relate
to the types of activities that the NHIN contractors have been working
on throughout the course of the year, and we need to take next steps in
that activity.

So with that, I'd like to turn to Blackford, who will talk about the
choices in the provider perspective.

DR. MIDDLETON: Thanks very much, John. And good morning to the
Community, and Mr. Secretary, it's a pleasure to be here. Thank you for
the opportunity to discuss and present. And it's my honor and privilege
to represent the Workgroup, whose recommendations we'll bring forward.

I'd like to take the opportunity, though, just to provide a few
introductory comments to some of the challenges I think that are before
us on the table. We know, as it's already been alluded to, that the
adoption of EMR in this country, at best, is probably on the order of 24
percent in primary care. And that varies dramatically between small
office environments and large office environments. It also varies
between specialty care and subspecialty care.

In our own environment at Partners HealthCare, where I am the Corporate
Director for Clinical Informatics R & D, we find the primary care
practitioner is adopting EMR about twice as fast as their subspecialist
colleagues.

We know, though, that we are in the middle of an information explosion
in healthcare. Physicians who have been studied for their information
needs, on average, have a question \-- two questions for every three
patient care visits that go unanswered. We know that a great \-- very
often, information needed for decision making, at the time of the
clinical encounter, is not available for the decision making to proceed
efficiently.

It's also been discussed, and I'll highlight it briefly, that there are
significant market barriers or market asymmetries. I think we have to
consider, as we look at use cases, and as we look at the business
models, that might support their adoption. It's been alluded to already
that the physicians are, oftentimes, asked to be the purchasers, the
buyers, if you will, for healthcare information technology; but one
study we did in analyzing the value of laboratory CPOE, at the Center
for IT Leadership, we found that the benefits arising, accruing from
using that HIT in ambulatory care practice environments, 89 percent of
the benefit went to the payer, public or private. So the questions
asked, I think, often by physicians, why should we buy this when someone
else is benefiting? So there is significant market asymmetry there.

We know \-- in the analysis we did, we found \-- and this kind of work
has been correlated by other studies, coming out of Rand, for example;
if we had EHR adoption, and in particular, the EHR advanced computerized
provider order entry capabilities, we could save the country on the
order of 44 billion.

If all those EMRs \-- in the second study, we asked the question, if all
those EMRs could communicate, one to the other, we found that the value
of that healthcare information exchange was on the order of 78 billion.
So when you add these figures up, we're talking about some real dollars,
even in Washington. Five, six percent of perhaps our net expenditure on
healthcare.

We've done another study, which will be coming out shortly, on the value
of IT for chronic disease management. That's been submitted for
publication. Interestingly there, it seems that IT has differential
effects, when it's in the hand of the payer versus the hands of the
provider. We are now also embarking on an eval of PHR study to try to
get at this fundamental question, what's the value of a PHR? How does a
PHR fit into the context of a world of EMR gradual adoption? And what
role might it play, and provide the most value in doing?

I think the question before us, though, is what of our use cases might
\-- most stimulate the EHR adoption? We have already got the labs use
case in flight. We have the emergency responder use case in flight. When
we looked at the many use cases available for consideration, in this
second wave, these two, medications management, and the referrals and
transfer of care information exchange, emerged as the two leading
contenders.

These are useful use cases, in the sense that they build on enabling
technology. As John Loonsk has already alluded to, these take advantage
of some of the other features that are crossing all of the use cases, by
way of enabling technology, very, very readily. So the meds healthcare
information exchange, if you will, builds on enabling technology. We
know that physicians, in primary care practice, may be unaware of as
many as 25 percent of their patients' prescriptions, due to the fact
that patients get medical care from a wide variety of different
providers on a regular basis. Medicare beneficiaries, for example, see,
on average, approximately 6.7 or seven providers per year.

The feature in medications management that is most valuable, of course,
is this decision support capability. What's the right drug, for the
right patient, at the right time, at the right dose, in the right place,
et cetera. These systems for decision support in medications are mature,
and robust. They have been in most of the commercial and academic
systems now, for many years. They have been very well studied. They do
lead to cost savings. They do lead to reductions in ADEs, adverse drug
events, and they do lead to reductions in hospitalization and clinic
visits, or other utilization expenditure.

The referral use case, this is the one that focuses on how to improve
the transfer of care to have the data follow the patients, as they go
from one side of care to another. This is also a significant problem in
US healthcare. Oftentimes, consultants don't receive reports from the
primary care physicians as to what the consultation is all about.
Oftentimes, the primary care physician doesn't receive a report back
from the consultant as to the insights gained from that consultation or
recommendations made.

This would help allay some of the duplicative costs and expenditures in
repeat labs, tests, and procedures; would allay certain risks in having
a unified information base for the consultant, having the consultation
reports back to the primary care provider. And we leave it to you to
choose the finalist, although I wish we could do both.

DR. LOONSK: Thank you, Blackford. And as Blackford suggested, there is a
different traunch of enabling technologies for the provider perspective
as there is one for the \-- for the consumer perspective. The \-- from a
population perspective, we actually have choices in use cases that span
different Working Groups, and we thought it would be most appropriate if
we had representatives of the Working Group, formerly known as
Biosurveillance, and the Quality Working Group, to both speak to their
\-- some of their priorities in the options here.

So we're going to begin with Carolyn Clancy, I think, who will speak to
the Quality use case option.

DR. CLANCY: Thank you, John. And good morning everyone. John, I really
want to commend you and your colleagues for the amazing amount of
clustering and sort of distilling of information and issues to inform
this discussion. And I'm very much looking forward to the opportunity,
this afternoon, to talk to you about where the Quality Workgroup has
been.

But just to remind you, you created this Workgroup in August of 2006,
and you may recall, we had a very enthusiastic discussion that went way,
way over schedule, which I think was a very strong reflection of
people's excitement. And I do have to thank Chip Kahn, again, for his
persistence here in persuading folks that this was a good focus to have.

Now, as I'm listening to the presentations of my colleagues, beyond
being very proud of the fact that we've made a good investment from AHRQ
that is in Blackford's work, I do want to say that it's hard not to
listen to the first two presentations, and realize that a lot of what
Rose Marie and Blackford have presented is very much about quality of
care. But the focus of our Workgroup is very strongly aligned with the
Secretary's focus on value-driven healthcare, one that pervades the
public and private sectors.

How can we take advantage of applications of health IT, to make
reporting on quality of care transparent to consumers, and at the same
time, helping providers get a view not only of how they're doing, but
actually give them information in something close to real-time. So the
quality reporting is not just about driving \-- looking \-- using the
rearview mirror only, but actually helps you do the right thing in
something like real-time.

So I mention this just because what it says to me is that quality, as a
potential use case here, shares an interesting interface with both the
provider and the consumer Workgroup focus that you just heard about.

A little bit about the context, to build on Blackford's point about
relatively low adoption rates. He's talking about physicians in
practice. In hospitals, it's actually much lower, so a big focus of our
Workgroup is going to be to try to identify the very specific steps
needed, so that certified electronic health records will actually
include the functionality for quality reporting, which they don't right
now. But we all know that that is essential.

I'm thinking of Secretary Leavitt's description, which I think you might
have gotten from Lillee Gelinas, about seeing a nurse in front of a pile
of charts. That is pretty illustrative of the current quality enterprise
right now. It's largely paper based and so forth.

So that means that our Workgroup has two sort of parallel tracks, which
we hope will converge. One track focuses on how do we make sure that
that functionality can be built or hard-wired, if you will, into
certified electronic health records? The other track actually focuses on
the hybrid world that the majority of providers are likely to live in,
for the foreseeable future. I'm going to say five years, but we could
debate whether my crystal ball is too cloudy.

What I mean by that is that any efficient quality reporting is going to
have to take advantage of electronic billing data, hopefully enhanced
and supplemented, by clinical IT elements; most likely in the near
future, lab and pharmacy.

Now, we know from a study, that a couple of my colleagues worked on and
published in early January, in the Journal of the American Medical
Association, that adding a couple of elements to claims data can make a
huge difference in reporting on hospital quality.

The two elements here are whether a diagnosis was present on admission,
an issue that CMS is working on right now, and also lab results. Because
no billing stream can tell you what the results are. They can tell you
if you ordered the right test for a diabetic or patient with another
condition. It can't tell you about the results, which are really
critical. So I see in almost any way, we're going to benefit by any of
the use cases you've just heard about in the provider and consumer \--
particularly if there is a focus on lab results, as well as medication
use.

The policy issues, as you've heard, are quite common to our Workgroup as
well, and that is the issues of secondary data use, and the issues of
privacy and security. The last thing I will say is that to the extent
that a use case can begin to take on, which I think is much more likely
to be applicable in this highbred world, it's going to be a slightly
different use case in application of what the NHIN contractors have been
up to. But I think it's one that may be well worth exploring.

By that I mean the study that we published took advantage of the fact
that in the state of Pennsylvania, there was a mandated collection of
clinical data, in addition to the usual hospital discharge abstracts.
That doesn't answer the question, how do you get lab results into those
discharge abstracts or into that billing stream, the present on
admission diagnosis, and so forth.

Let me just finish by saying as well, I have been very moved by Craig
Barrett's comments, in particular, this morning. And my only comment is
that I think a lot of the adopters tend to be younger, and a lot of the
people who are sick, and end up incurring a lot of expense, tend to be
older, which I think is one challenge. So they'll need to be hooked up
with the younger people, to take advantage of the applications that
we're talking about.

But we do hear repeatedly, the consumers are very, very, interested in
information about quality of providers, whether that's physicians,
whether that's hospitals, nursing homes, and so forth. And any time I
doubt that premise, I simply look at my e-mails, over the weekend, which
is when I tend to get lots of messages about, "I have a friend moving to
the area, can you remember a doctor."

So let me just close there, and I'll turn it to John.

DR. LOONSK: Thank you, Carolyn. And the final two choices in the
population perspective will be described by John Lumpkin.

DR. LUMPKIN: I have the unenviable task to tell you which of my two
children I think that you should pick \[laughter\], seeing as I spend a
lot of time in my life working on quality, and have had fairly extensive
experience in public health.

But let me tell you about the public health part, and perhaps tell you
two events that occurred to me \-- occurred while I was State Health
Director in Illinois, within a 12-month period of time.

The first event was related to three laboratory tests that showed up
from three different parts of the state. All of them were for the same
organism, Salmonella Agona, which is a rare type of salmonella.
Fortunately, there was a technician in the laboratory who said, \"You
know, we only see about five of these a year. Maybe something is going
on.\" And they tipped us off, and we called up the CDC and said, "Is
anything going on?" They hadn't heard anything, and so they passed the
word amongst the states, and what we ended up finding out was that there
was a major problem. It was associated with a food substance,
particularly oat cereal, and it involved 11 states, and over 150 people
ended up becoming ill.

So this is what public health case reporting is all about, is trying to
detect these sort of events. And it could be due to an outbreak of
infectious disease, or it could be a cluster of cancer. How do we get
the information out of the electronic medical record? Right now we try
to do it on a paper record. And it makes some sense in a way that can
have an impact upon the care of individual patients.

And this is what the public health case reporting, use case is really
all about. It talks about how we can take \-- keep elements out of the
electronic health record. And then how do we get lab reporting? And just
to give you an idea of the challenges, when I was State Health Director,
we had a meeting with some of the laboratory folks about how we could
get information. Well, most labs now run electronically. And what they
do is they \-- at the end of the day, they do a data run, and they print
it out on hard copy, and then they hire somebody to write down in state
health reports. They mail it in to the state health department and then
they have to hire somebody to key it into the computer system.

Well, as we know, that's obviously not the most efficient way to do
that. But what also has the capability in our future that really isn't
that far off, is once we identify that there is an outbreak, how do we
let clinicians know? How do we help them decide in that, you know,
decision support, that maybe if \-- you know, if you're seeing somebody
who has bloody diarrhea, it may be related. Maybe you should ask them
what they ate. Maybe if they ate this specific product, we could begin
to identify these outbreaks much quicker, and, thus, respond to them in
a quicker fashion.

The components of this use case really gets a very broad range of
issues, and I think one that make it very attractive. It talks about
interoperability in both a horizontal and a vertical fashion. By
horizontal \-- by vertical, I mean from the clinician, through the local
health department, to the state health department, to the national
health department, in a process that's ongoing and can be very time
consuming. And through exploring this use case, we can look at ways to
speed that up.

But it also looks at horizontal interoperability, sharing of information
between clinicians, between health departments, between states, is
something that becomes a challenge. And the longer it takes, the more
difficult it is.

Finally, what also is attractive about this use case is that it's an
area of moving information from the electronic health record, a similar
process, a very similar process, to what's done in moving information to
quality measurement, what's being done in moving information for
research or other mechanisms. But the advantage of this particular use
case is that there is a legal basis for moving this data.

Public health has been collecting health information for as long as
we've had a country. State and federal laws are in place to not only
move that data, but also to protect that data; and it gives an
environment in which we can have important components of how we would
implement this use case in place, which aren't in place in other kinds
of case reporting.

Finally, the advantage of this use case is it enables providers to do
something that they're legally mandated to do, and by and large most of
them don't do it, which is to do these state and federally mandated
reports.

The second event that happened to me, in that same year, occurred when
the attack happened on September 11th. I'm an emergency physician, and
so when I became State Health Director, we did a fair bit of emergency
planning. And I can tell you that we did a very good job in Illinois.
Within two hours, we knew the \-- how many beds were available, how many
ICU beds were available, how many ventilators were available. That's the
good news.

The bad news is it took us two hours. And the reason why it took so
long, or it went so quickly, is because we had set up a phone tree. And
we were able to collect the data, by telephone, not by inventory, not by
electronically managing the resources of the state. That information
should have been available immediately. If that had been a hurricane, or
I'm sorry, a tornado, that frequently goes through Illinois, or a flood
along the Mississippi, two hours would be a long time to wait to decide
where to send patients.

And so the response management use case begins to address how the public
health system, in connection with the health treatment system, can begin
to address the issue of allocating resources, of tracking immunizations.
How do we provide the immunizations? Do we have the right immunizations
at the right place? How do we use the national strategic stockpile when
it comes in? And even more importantly, how do we manage the
immunizations, use of antibiotics for the emergency responders? All of
these would be managed within this kind of response management, getting
information out to providers.

And then also, what if we have to do quarantine? How are we going to be
sure that people are going to be quarantined in their houses, are going
to get the right foods, and other things that they may need in order to
keep them there, so that they don't feel like they're obligated to
wander out.

So there are, I think, two very interesting use cases. Between the two,
I think the one that provides us the most opportunity to explore in
advance key issues, related to our future health information technology,
is the public health case reporting use case.

DR. LOONSK: Thank you to the panelists for some compelling
presentations. I don't know about you, but I want to do all of them. We
did query the AHIC members about their views on prior \-- on ranking of
these, and in front of you now is the way that the results have come
back, so we have structured this in the context of three decisions.

And in the consumer perspective, the top ranked item was consumer access
to clinical information, entrusting relationship to their previous
discussions, followed by remote consultation and remote monitoring. In
the provider perspective, medication management over referrals and
transfer of care. And in population, quality followed by public health
case reporting, followed by response management.

So this is an opportunity to express what the next steps are going to
be. Our panelists are here to answer questions, as you have them, about
the specifics of some of these use cases; but maybe we could start by
talking about the consumer perspective.

SECRETARY LEAVITT: Could we have a brief conversation about what
constrains us to one in each choice?

DR. LOONSK: There is a bandwidth and throughput issue here, certainly at
the standards harmonization level, but also as we have been using the
use cases to work into the NHIN architecture, and policy considerations,
et cetera. This is \-- simply having three more, because we have the
emergency responder EHR, is aggressive. And the number, as you can see
them, of priorities that we have associated with each one of these, is
fairly large.

Now, some of these are extensions of existing use cases, where we can
build on what's already been done, and some are completely new. And this
is not a science, this is an art. But what we've tried to do is to
titrate in appropriate amounts of priorities, as associated with what
can be done in an extension, what can be done in an entirely new use
case, and with the target of coming out with four, in total, for the
next round.

We would hope that this is \--

SECRETARY LEAVITT: Four within the three?

DR. LOONSK: Well, we have emergency responder EHR, so what we're ideally
coming up with is \-- are three more. And that \-- so that with ER, EHR,
we would have four for this coming round.

SECRETARY LEAVITT: Good. We're ready for a conversation, then, first
upon the consumer perspective. Doug, is your flag up?

DR. HENLEY: Well, thank you, Mr. Secretary. I would first make the
comment that I think all \-- while we've divided these into three
different categories, in the end, they are all about patients, and
therefore, all about consumers.

But let me take the first group. I'm not going to quibble over rankings
here, because I appreciate your question about why do we have a limit
here. Actually, I wrote \-- or ranked remote monitoring first, and let
me tell you why. Because I thought of it in a much more broader context
that I've kind of developed over the last year, year-and-a-half, in
consultation with a colleague of mine, Mike McGee.

This country, over the last 20 or 25 years, has evolved from a three
generational structure of families to four and five generations, because
of advancing life span and things of that nature. And it's that third
generation, the middle generation that is doing \-- predominantly
populated or controlled by women in their 40s \-- mid 40s to mid 50s,
where not only are they caring for their children, but they are caring
for their parents. They have other jobs to do, by the way, and they
aren't getting paid for any of that. And they are the caregiver for the
family unit.

They are not accounted for in any of these scenarios. All of these use
cases talk about the care provider \-- the care provider physician and
other clinician hospital, whatever, and the patient. But there is an
important link \-- there is a triangle there, not just a two-way
communication. And remote monitoring, and the continual project that
Intel and others are involved in, and so forth, and so forth, is meant
to link using technology to link the physician or clinician with the
caregiver, most often a family member, not a home health agency.
Sometimes a friend or colleague or a paid care worker that lives in the
home, but usually a family member.

So I think we need to look forward to that, and I think for the consumer
perspective, that remote monitoring becomes critical, because the
caregiver, often the family member, cannot be in the home, most of the
time. The \-- especially in the Medicare population, the patient wants
to be independent and remain in the home, to the extent possible, and
not in an institution. In fact, it's unsafe if they're in an institution
versus the home, by and large.

And there needs to be that free flow of information among that triangle,
to alert the caregiver that something's wrong with mother or father at
home. They didn't get up that morning, and take their medication, or
whatever the case may be. Communication to the clinician that that has
occurred, et cetera, et cetera.

So I'm trying to think bigger here. That remote monitoring also means
\-- also includes remote consultation, also includes the transfer of
clinical information among that triangle, not just between two points
but three points. And if we don't anticipate that, we're going to wear
that middle generation out, that \-- we're wearing them out now. And if
\-- bless their hearts, if they didn't exist, as dysfunctional as the
system is now, it would totally collapse without them.

And so I vote for remote monitoring, but in a much broader context.

SECRETARY LEAVITT: Thank you. Here is the way I'd like to organize this
conversation. We have too little time, but we've all had a chance to
express our views, both quantitatively, and we've had this conversation.
I'd like, in each category, to ask one person, who would be prepared to
advocate for a choice other than the one that received the most support
in the quantitative, to talk about it. And then I'm going to ask each
\-- and I'm going to ask the AHIC, if anyone feels compelled, who voted
for a second ranking, to be moved to a first. And if not, I'm going to
ask for your support of the quantitative expression of priorities.

And Rose Marie, did you have a comment you'd like to follow with \--

DR. ROBERTSON: I was just going to say that in thinking about consumer
access, indeed, access, it did include providing that access to others,
perhaps, you know, mom in Kansas, when the patient is somewhere else or
the daughter is somewhere else. So it was inclusive of the technology to
do that, was inclusive of that. The broader increasing technology of,
you know, having mom's blood pressure be an icon on the screen that you
can monitor, you know, has a little ways to go yet in some
circumstances, but providing access didn't just mean the patients,
themselves.

SECRETARY LEAVITT: We have \-- it's interesting that remote consultation
was a robust second choice for nearly everyone, but no one ranked it as
their top choice. I'd like to ask if there is anyone here who, on
reflection, would like to advocate it be our first choice as opposed to
our second.

Hearing none of those expressions, and having heard the remote
monitoring, I'm going to ask if there is anyone on the panel, or on
AHIC, would who like to change their ranking from either remote
monitoring \-- rather, change their ranking to be different than it was.
Then I'd like to declare a consensus around the consumer access as our
first priority. All right.

Let's go, then, to the provider \-- the next provider perspective. And I
would assume we would \-- we should, first of all, hear from those who
would \-- who advocated \-- anyone who'd like to speak, let's say,
regarding referrals and transfer of care, as our highest priority.

Doug?

DR. HENLEY: \[low audio\] \...again, Mr. Secretary, the way I approached
this, in my thinking, was reduction of medical errors. And yes, better
medication management reduces medical error. But I think abundant
research also shows that what produces the most medical errors is
hand-off of patients from A to B to C. And frankly, that includes
handing off of medication lists and so forth. So, again, I think
referrals and transfer of care in that context, to me, was why I ranked
it much higher than the first one, simply because it's that hand-off.
Again, the more people that touch the patient, the greater number of
errors you get and the lesser the degree of quality. So it's that
hand-off that's critical, whether it's from the ER to the ICU, the
operating room to the ICU, the hospital to the doctor's office, whatever
the \-- doctor-to-doctor, whatever the situation may be. It's that
hand-off that's critical, and I think that's why transfer of care, to
me, is far more important. Not to the clinician, although that's
important, but to the patient.

SECRETARY LEAVITT: Doug, you're quite persuasive on all of these points.
Are there those who would choose to change rankings that they have
expressed prior?

Then I would declare a consensus on provider perspective, and I would
now move to population perspective. And I would ask if there were \--
are those \-- someone on response management from AHIC who would like to
advocate \-- John gave a, I thought, quite thoughtful analysis of why
this is important. If there \-- are there others who would like to speak
on that, or, for that matter, on the public health case management
reporting?

Seeing no other comment, then, I'd like to declare a consensus on
population perspective. I would like to, having established those three
areas \-- I've made my thoughts known about this over and over, about
turning the crank three times. I think what we have accomplished here is
that we've teed up an on-deck circle. I think I'm mixing golf and
baseball there, but \-- \[laughter\] \-- anyway \-- that's quite
remarkable, actually. \[laughter\] We have created \-- tee ball, thank
you. \[laughter\]

We have created an on-deck circle, and I would like to ask the Office of
National Coordinator to begin leaning forward to the next priorities
expressed. That isn't to say we take them on, but I think the third
crank will be the most difficult to get within the timeframe.

And we're also going to be \-- if we follow our inclinations of earlier
today, we're going to go through a transition. We're contemplating a
transition to a successor group, and there will be some need for us to
be especially well prepared for that third crank. So I think there is
\-- this has been particularly useful, in that I think it has created an
agenda for \-- at least a tentative agenda for us on an ongoing basis.

Kevin, do you wish to speak?

MR. HUTCHINSON: This goes actually toward the consumer access to
clinical information and the medications management. One missing item, I
saw, in the write up of the detail of it, was around authentication
identification of the end users; that I think we need to make sure that
we include. We're not talking about \-- I assume we're not speaking of
actual manually entered information here on medications management, as
well as clinical consumer access to information. And the identification
\-- the original identification of that user is who they say they are,
and then the authentication of each time they log in is critical, if
we're going to be delivering information from live EHR systems, or
pharmacies, or payer databases.

SECRETARY LEAVITT: Which, I assume, is in some ways reflected in our
Privacy Workgroup, and overarches all of this.

MR. HUTCHINSON: Right.

DR. LOONSK: There will actually be some recommendations later this
afternoon that go to \-- start down that road of identifying from an
identity proving standpoint.

SECRETARY LEAVITT: Secretary Nicholson is going to join us soon, if not
immediately. I would like to just reflect on the fact that in our
morning, I think we've accomplished three very important things.

The first is that we created, I think, an assumption for conclusion on
AHIC and its transition, and its need to connect with state counterparts
in a way that has continuity, coordination and communication, and also a
reflection of the financing broad principle, not necessarily a strategy.
It's an important conclusion to be reached, hopefully, at our next
meeting.

The second is that we have made ourselves a lot better prepared for
what, I think, will be important decisions on NHIN. And I think we all,
I suspect, came away with the conclusion that that remains complicated,
but that there is a light at the end of the tunnel. There are
sustainable business models, and that we're pursuing a course that will
bear fruit.

And last, we've established priorities for the near term, and
potentially for the medium term, on use cases. Very fruitful morning,
and may I say to our colleagues at the Office of National Coordinators,
it's been an extraordinarily well orchestrated meeting, and we have more
this afternoon, but we're about ready to break for lunch.

And our host, Secretary Nicholson, is going to join us shortly, and then
we'll have lunch. I see heads turned to the door. \[laughter\] No. Well,
I think what we'll do is \-- are there other matters? Rob's gone, too.
Anybody have anything they want to say while we're all here?
\[laughter\]

DR. LOONSK: I could put a plug in for the Nationwide Health Information
Network Conference, and talk a little bit about what's going to happen
there.

SECRETARY LEAVITT: That would be helpful.

DR. LOONSK: So on Thursday, all day, and Friday \-- and we're going to
get a preview of some of this this afternoon, and I know Mr. Secretary,
you won't be able as to join us for that, but a preview of the
applications that represent verifying of the architectures that have
been worked over for the course of this year, what have been developed,
how PHRs fit with EHRs, how that can connect in a network environment.

And although the applications, the systems, themselves, aren't the
network, it's probably the clearest image you'll get over the kind of
activities we have all been talking about in the course of the Community
meetings, and in the course of the year, and the rest of the agenda. And
I think it's going to be a very tangible way to see some of this. It's
\-- each of the four consortia will put on a live demonstration. They're
going to do that this afternoon as well. So it will have an element of
excitement to it also. \[laughter\] But it's going to be at the Grand
Hyatt, here in Washington, Thursday and Friday. And you can come up and
register at the door, so there will be opportunity for those of you who
haven't yet registered, to come and participate as well.

SECRETARY LEAVITT: I would express to those in the various Workgroups
who have created those, our appreciation, and my disappointment at not
being able to see them, firsthand. I'm going to be traveling in a way
that won't allow me to do that. Secretary, good to have you here.

In conclusion, I would like to just give you all one brief report. We
talked earlier about the throw weight, if you will, behind AHIC, is the
commitment on the part of large payers and providers to work together to
implement this.

On the payer side, I would like to report to you that in addition to
those that \-- public payers that have come behind this effort in the
executive order through the Federal Government, we have now received
firm written commitments from nearly 50 of the largest payers in the
country, in addition \-- of the top 200.

Yesterday, I was in attendance, when a large union joined that number,
and another pledged their support to sign the document. We expect that
by the end of \-- by the spring, as RFPs start going out on the 2008
contract year, that we will exceed the 60 percent goal that \-- or at
least get to the 60 percent goal that we've established. So that 60
percent of the healthcare paying \-- payer's system will be in a place
that they are moving toward the four cornerstones, among them being
health IT, and quality, and the \-- and a method of measuring cost, and
then incentives.

So Mr. Secretary, you are \-- you have been gracious to have us here.
We've enjoyed this rather unique design of a conference. \[laughter\]
This is a tribute to innovation, as well as ingenuity.

SECRETARY NICHOLSON: Tribute to shoehorns. \[laughter\]

SECRETARY LEAVITT: And I mentioned earlier how much we appreciate Rob
Kolodner's continued service with this group, and what he has \-- what
we're learning from your great experience here at the VA. So thank you
for joining us.

SECRETARY NICHOLSON: Well, thanks for having me, and thank you,
Secretary Leavitt, for your hard work, and your sharing your
extraordinary ability and talent, leadership, of this important task.
And my thanks also to the members of the Committee for your commitment
to harnessing the technologies of the 21st century that are available to
benefit healthcare in general, in our country, and healthcare for our
military and veterans, in particular.

And Mike mentioned this unusual conference room. This is the biggest
assembly room we have at this, the second largest agency in the U.S.
government, so you can see we can only get a representative group of our
235,000 into this room, but we do use technology pretty well, and we
televise a lot of things out of here, throughout the building, and to
the field.

Last night in here, interestingly, we had a wonderful gathering, and we
had Ken Burns in here previewing with us, for 45 minutes of video and
about 40 minutes of colloquy, the new documentary that he has finished
now, which is called, "The War", and will be coming out in September.
And I think it's 16 hours worth of television.

Interesting, it's World War II, and it's seen through the eyes of
participants and their families, not the hierarchy of the military or
the government, but these four individuals from four parts of our
country, and their families and their communities. So I recommend that
when the time comes, that you take a look at that.

And again, my welcome to you all. I don't want to take up very much of
your valuable time, and I know I'm probably the last thing between you
and lunch, also. But I do \-- and I'm very excited to join you, and to
make an announcement here. And it's one that the Department of Defense
and we know will come as welcome news, probably to all who watch IT
things, and particularly, we think, to the active and reserve military
and the veterans' communities.

To begin with, you know, let me affirm the President's goal of assuring
electronic health records, for most Americans, within ten years, and
affirm the support of the VA, and our belief that that is achievable.
And the American Health Information Community's mission to advance that
goal, under the leadership of Secretary Leavitt, is greatly enhanced
toward that probability. And again, my thanks to all of you for that.

You know, last year, Mike said \-- I don't remember if you remember
saying this or not, but I'm going to quote, you did, you said, "There is
a growing imperative for action, and it has already triggered the forces
required to reshape the healthcare system in our country." And I think
you were exactly right. And this morning, I want to build on the
President's and Secretary Leavitt's imperative for action, and announce
a joint VA DOD program that will also reshape healthcare for America.

As you all know, to be a veteran in our country, you first must wear the
uniform, and then when you take it off, you become a veteran. So the
flow is into the military, Department of Defense, and then out, and into
the veteran world.

As you also know, the Department of Defense and the Department of
Veterans Affairs have worked together for many years to arrive at a
common medical record protocol. Ideally, such a protocol would capture
all of the information needed to care for active duty troops, and then
move that information seamlessly over to us at the VA, so that those
same soldiers, sailors, marines, airmen, would have their records
available immediately to the professionals here at the VA as they, then,
come to us for their care.

So this is not a new issue, of course, by any means, but \-- and even
before computers came into being, the VA and the Defense Department
wrestled with this problem of sharing and flowing medical information.
And I don't know which was probably more challenging, finding a way to
deal cooperatively with overflowing sheaves of paper documents, encased
in bulging files, for a 30 year career military person, you can imagine
the thickness, the weathering, the yellowing of the paper, the
illegibility, and the challenges that ensued from that.

So I don't know whether that was a bigger challenge, or trying to share
a burgeoning abundance of electronic information encased in dissimilar
computer platforms.

Nevertheless, we are proud of the significant accomplishments that we
have achieved thus far, to address this challenge. For example, we're
now able to exchange selected medical data bidirectionally between our
departments. But we recognize that we still have a considerable amount
of work to do. But we now have an opportunity to accomplish this, and
build a common cyber-solution with a real expectation for a lasting
union.

So I'm very pleased to announce that our departments have agreed that
we're going to make this happen, to make a joint inpatient electronic
health record, a reality. And that \-- if you've been involved in this,
you know that that is a groundbreaking event, and one that will have
benefits that will, of course, reach well beyond the military and the
veteran community. It can be an agreement that can change the future of
electronic healthcare records nationwide, maybe worldwide.

The joint VA DOD inpatient electronic health record will result in
significant savings for our taxpayers. It will make inpatient medical
records instantly accessible to doctors and other clinicians, in both
departments. It will help the VA and DOD share medical data more
seamlessly, and most important of all, it will help us provide better
care to our patients.

The first step toward achieving this jointness will be an examination of
the clinical and business processes of both departments, and a
determination of the means and methods to achieve cost effectiveness, in
the efficiencies that we seek.

Once we've laid that necessary groundwork for the development of this
joint inpatient record, the doors of opportunity for other healthcare
systems, both public and private, will begin to swing open. We will, in
effect, I believe, become the model for other large providers, in our
country, to emulate.

The potential that this joint effort holds for the nation's healthcare
community is probably immeasurable. Successful, vibrant, and dynamic VA
DOD model can be synthesized and reproduced in healthcare systems, both
large and small.

Secretary Gates and his staff, and we at the VA, are committed to
finding every opportunity to work together, to provide top notch care to
our patients. Our patients, the veterans, the active duty service
members who have all sacrificed so much for our country.

Today, we are taking an important step toward honoring our patriots by
relieving them of a burden that they have shouldered too long. And in so
doing, we're moving closer to realizing the President's call for better
healthcare technologies for all Americans by improving it for our
military and our veterans.

With that, I would like, as I spoke of Secretary Gates and his great
staff, to introduce one to you, probably well known to all of you, you
probably heard from him today already, but it's a pleasure for me to
introduce and ask Dr. Bill Winkenwerder if he would now say some
comments from the perspective of DOD.

Dr. Winkenwerder is a great public servant. He epitomizes public
service. He has both an MD and an MBA. He's been serving as the
Assistant Secretary of Defense since October of '01, and he is the
principle adviser to the Secretary for all DOD health policies, all
their programs, activities, and the oversight over all of their
resources. And his responsibility is self-evident to all.

We know we have to have a healthy fighting force, supported by
combat-ready healthcare system. They provide medical care to 9.1 million
beneficiaries through a \$33 billion dollar system; consists of 76
military hospitals, over 500 clinics, and extensive private care
partnering that goes on as well.

And I think, you know, one of the manifestations of the competence of
Bill Winkenwerder and the Department is the absolutely extraordinary
method of both protecting, and then evacuating those combatants in our
combat theatres today, when injured. I have been over there. I've
witnessed this firsthand, both the courage, the competency, and the
anticipation and the innovation that there is.

The ratio of wounded to mortal incidence in this combat is something
like ten to one. In our most recent, heavy engagement, Vietnam, it was
three to one. It is one mortality out of every four incidents. Here it's
one out of 11. And the DOD, and the work that they do in evacuating
those young people, and bringing them through their system is absolutely
laudable, and Bill is responsible for that.

He's a graduate of Davidson College, and the North Carolina School of
Medicine. He's board certified in internal medicine, and as I said, has
an MBA from Wharton. So with that, I'd like to call on Bill
Winkenwerder. Bill?

DR. WINKENWERDER, JR: Thank you, Mr. Secretary. Secretary Nicholson.
Thank you, again, Secretary Leavitt for your leadership. This is a great
day for the DOD and for VA. And this is a surprise. We intended it to be
a surprise.

As Yogi Berra once said, we're all fond of quoting Yogi Berra, "When you
come to a fork in the road, take it." \[laughter\] And DOD and VA have
come to a fork in the road, and by golly, we're taking it. After years
in this realm of holding hands and serious dating, we're deciding to get
married. And we're not going to go to the church. We're going to go to
\-- we're going to go to the hospital, because that's the place that we
have become increasingly intimate and familiar with each other.

But let me just say, we are very excited about this. This has happened
fairly quickly. We're very excited about the prospect of developing a
common, mutually beneficial solution to our inpatient needs. And let me
just say a word about how this developed.

I think people know here, certainly around this table, but for the
larger audience, and for those that see this on video or audio
recording: we have Alta, our outpatient record system, and it has been a
great success. It's at 140 locations around the world, today. Nearly 40
million patient visits have been recorded. Huge central data repository.
Some of the AHIC group saw it yesterday, a demonstration. It's really
working very well.

On the inpatient side, on the other hand, we had some nascent efforts.
We do have some inpatient electronic medical record capability working
with certain private entities. We also had considered, in our long-range
plan, developing the inpatient module, ourselves. The VA already,
obviously, has proven it's able to do this, and do it very, very well.

On the other hand, the VA was looking at an upgrade of a platform of
Vista. And so we were really \-- this is sort of a natural confluence of
events. It made a lot of sense for us to do this together, the upgrade
to the platform, and our adoption jointly, of whatever we develop.

So as the technical people within the DOD and the VA talked about this,
they brought it to our attention, and it didn't take us very long to
just say, "Absolutely, amen. Let's go do this." And so we're delighted.
This will provide, as Secretary Nicholson said, I think our vision is
end to end inpatient, particularly for the seriously wounded capability,
so that the theatre version, if you will, of AltaVista, will be the same
system that will carry that information back along through our hospitals
and onto the VA.

And we will be looking at a feasibility study here, over the next few
weeks, to look at the requirements to \-- we do have requirements that
are slightly different, but more alike than different. And so as we go
through that process and complete that process, we hope to have another
announcement in the not too distant future about how we exactly intend
to proceed.

But let me just say thank you, to all our respective staffs, for the
great work they've done to bring us to this point. We're excited about
\-- we're delighted to contribute to the broader effort, and candidly, I
would say, Mr. Secretary Leavitt, I'm not sure this would have happened
without AHIC. It might have. But you have certainly brought us together,
and it's caused all of us to work together, and think about how we can
do things more collaboratively, and in a more shared and coordinated
way. So here we are. Thank you.

SECRETARY LEAVITT: I would like to express congratulations to both the
Department of Veterans Affairs and the Department of Defense. I believe
this is a monumental event, and the integration of these two remarkable
and renowned systems, both committed to migrate toward AHIC standards,
constitutes an important step forward; not just for your systems, but
for the vision we have of a healthcare system based on value, healthcare
system that can put the patient at the center. And I'm most
enthusiastic.

Well, I'm so enthusiastic, I'd like to have lunch. \[laughter\] And I
understand \-- can someone give instruction on where we go? Because I'm
not sure.

MALE SPEAKER: I can. Go to the tenth floor, right? Okay. So we have
elevators out here, and just make your way up to the tenth floor, and
we'll guide you in.

\[break for lunch\]

DR. KOLODNER: We're going to convene the meeting for this afternoon, and
\-- not on yet? Okay. Turn on the mic.

Good afternoon. Welcome back, and we're going to get started for this
afternoon's session for the 11th meeting of the American Health
Information Community.

And this afternoon we have two segments. The first is recommendations
and updates from a number of the Workgroups, and then we will be going
into the \-- seeing the prototype architecture demonstrations for the
National Health Information Network from the four different vendors.

So we're going to start this afternoon, first, with the panel of two
from the Confidentiality, Privacy and Security Workgroup, and Jodi
Daniel and Paul Feldman will be presenting some of the recommendations
from the Workgroup. So Jodi and Paul.

MS. DANIEL: Thank you, Rob, and thank you Community members. I will \--
Paul is going to go through most of the recommendations; I'm just going
to provide some input at the beginning and the end. Kirk Nahra, the
other co-chair of this Workgroup, was unable to be available today, so
he asked if I would sit in for him and represent the Workgroup in
presenting these recommendations.

So just to give you, again, the list of the members that are on our
Workgroup, we've got a great group of folks representing privacy
interests as well as representing the other \-- three of the other
Workgroups, the other AHIC Workgroups, in order to make sure that we
have the benefit of the information and discussions that occur at those
Workgroups as well.

Again, just as to refresh your memory on our broad and specific charge:
our group was formed in response to requests from the Consumer
Empowerment Workgroup, the Chronic Care Workgroup, and the Electronic
Health Record Workgroup, who are all talking about privacy and security
issues, independently. And each of them thought that it would be better
to have a specific Workgroup focused on confidentiality, privacy, and
security issues so all of those issues could be discussed in one forum,
and that there could be the appropriate privacy and security expertise
brought to bear on those issues.

So this Workgroup was formed this summer, based on the May
recommendations from those three Workgroups, and we have been working
diligently since then. We are \-- our first set of issues that we took
on, and that we had hearings on, were identity proofing and user
authentication.

Today's recommendations are about patient identity proofing. We have
come to consensus on some issues regarding patient identity proofing,
which Paul will get into more detail on. And then we also wanted to talk
a little bit about some of the next steps that have been contemplated by
the Workgroup. We've started to think about, and have some preliminary
discussions about topics for future discussion, focusing a little bit
more on some of the privacy specific areas, rather than the security
specific areas. So we will talk a little bit about that, and we look
forward to your input on those, as well.

What we plan to do is just walk through all of the recommendations, and
then open it for discussion, unless \-- if the Workgroup \-- I mean if
the Community would like to jump in at any point in time, that's fine.
Otherwise, we'll just continue on with the recommendations and take
comments and questions afterward.

MR. FELDMAN: Thank you. Is this on?

DR. KOLODNER: Just start talking, I'll turn it on.

MR. FELDMAN: Okay. Excellent. Good afternoon, Dr. Kolodner, members of
the Community. I appreciate the opportunity to present these
recommendations. Our Workgroup has formed quickly, and you will see
before you what we've gotten done so far. And I'm happy about it, in
fact. I think we're working together well. We have a group with a broad
representation, and it's going very well, if I say so myself.

So I'd like to start with a few general statements about the
recommendations to sort of place them. And the first is \-- the first
bullet there is about sort of defining patient identity proofing. And
just so that we all have kind of a shared understanding here, patient
identity proofing is one step in what, generally, I guess, is referred
to as credentialing.

Identity proofing answers the question, who am I? Identifiers are used
to answer the question, how is that I.D. represented. And that is a
one-time thing, or if it's not one time, it's refreshed, not very
frequently. Frequently, at each encounter, the individual authenticates
to the system, and that's how can I prove who I am. All very
existential.

And then the issue is \-- the reason I bring this up is, is first of
all, to make the distinction between one time identity proofing and
encounter authentication, which will occur very frequently, many times a
day, in a lot of situations. For a patient, maybe not many times a day.
And then the related topic is authorization, which is what can I do now
that I've proven who I am?

We are making \-- just wanted to call that out, because these are not
about authorization. That's a related but separate topic. And it kind of
helps \-- as these recommendations are relatively detailed. So there is
that.

We've already \-- Jodi already mentioned that these recommendations are
scoped to respond to the breakthroughs in consumer empowerment, chronic
care, and EHR, and we talked a great deal about this, and we make the
statement that all data, included in secure messaging, EHRs and PHRs.
And we mean specifically by that, the scope of the breakthroughs should
be considered sensitive. And we believe that appropriate policies and
supporting security measures must be in place to mitigate the risks of
unauthorized or unintended data discloser.

MS. DANIEL: One other point that was in the recommendation letter; it's
not represented on the slides, but the Workgroup suggests that the
recommendations, which are going to \-- Paul is going to present right
after this \-- would be used for adoption as HHS policy regarding
current and future activity. So activities related to the breakthroughs,
if there are any funding of particular breakthrough activities or the
like, that these \-- that these recommendations would be incorporated
into those activities.

However, the Workgroup also said that they hoped that these
recommendations would apply more broadly, and that the public and
private sector organizations would parallel HHS in following these
recommendations. So I just wanted to call that out as well.

MR. FELDMAN: Thanks. So we'll move on to the first recommendation, which
is \-- I'll just try and read this. "The entities that offer healthcare,
consumers or their authorized proxies, electronic access to data and
services through secure messaging PHRs or EHRs, should perform or rely
upon identity proofing, performed by the entity, or an accountable
trusted third party, that meets or exceeds one of the following three
options."

We set this up to make a couple points. First, and probably foremost,
these are recommendations about identity proofing. They are not
recommendations about whether an individual has access to healthcare. We
make \-- in fact, we specifically call out that the failure for an
individual to be identity proofed should not impede her access to
receive healthcare.

And then the other sort of major topic on this slide is the concept of a
trusted third party. As you'll see, as we go through the three pieces of
this recommendation, that in some instances, implementation of the
recommendation would be made \-- would be made far easier, would the
entity have access to a trusted third party. We all understand that this
is something that is \-- that is of interest to many people, and
currently in the conversations. So\...

So there are three options and for \-- to identity proofing, and we'll
walk through each of them.

The first one is the easiest, I guess, to sort of \-- to grasp. And when
you think about it, it's the one that comes to mind, which is to do it
in person. When it is practical and feasible for the consumer, or her
authorized proxy, to present in person, that's what \-- that's what
should be performed by the healthcare entity. Identity proofing can be
achieved by using, at a minimum, a valid government issued picture I.D.
to verify identity. And we list some examples of what that might be, so
that's option one.

Option two. When the healthcare consumer or the proxy has an established
and durable, and we mean that to be longstanding and trusted, with the
entity, this relationship could be used to confirm the identity on the
basis of that relationship, so that the identity proofing encounter
could occur by a synchronous, but not in-person, telephone dialogue. We
specifically call out that it's synchronous and not asynchronous. So a
voicemail left would not satisfy this.

And when we go to the next slide, here's the relatively more complicated
one. We work very hard to make this as readable as possible, but the
detail is \-- it was important, so our apologies for that.

When the consumer is unable to meet, to be able to go in person, or does
not have a longstanding trusted relationship with the entity, and the
\-- a relationship still does exist between the consumer and the entity
\-- therefore, one that is not longstanding, but that does exist \--
identity proofing should consist of a method that verifies a person's
identity based on information they know, and can produce about
themselves when asked.

And we call that out by saying that the entity or the trusted third
party should one, request some basic identity data, and we name a few
choices, name, address, date of birth, those sorts of things; and
require the individual to provide some personal information specific to
that relationship. What was your last prescription, what kind of medical
device are you using, what hospital were you last seen at, such. So that
is Recommendation One.

And we will go on to number two. Number two is \-- I wanted to kind of
set this up a little bit. This came specifically as a recommendation as
a result of some of the testimony that we heard around identity theft,
medical identity theft. And it's quite specific in response to that.

So essentially, it says that should you, you \-- should an entity
collect identity documents or information about the identity of a
consumer, for that purpose alone \-- for the purpose of identity
proofing, not for clinical purposes, but for identity proofing \-- that
information, the image of a driver's license, for example, or the data
points, themselves, should be maintained separately from the consumer's
clinical data.

MS. DANIEL: I just wanted to note a couple of points that came up in the
discussion on this topic. There was some discussion about what's
currently going on in the paper world, and this recommendation could be
different from the way healthcare providers currently do this. So we
just wanted to note that this is \-- that when a provider shifts to
electronic health records, that this could be a shift in their workflow,
to make sure that that information is maintained separately.

Also to note that since we did talk about third party identity proofing,
using a trusted third party, that if, in fact, a trusted third party
were used, then inherently that information would be kept separate from
the clinical record. So that is an appropriate way of dealing with that
as well.

MR. FELDMAN: Thanks. So Recommendation number three. And this is
specific to the EHR breakthrough. Converting from a paper-based system
to one that uses EHRs does not require identity proofing for patients,
just by creating the electronic system. Where the conversion provides
patients with access to data within the EHR, then we recommend that the
identity proofing scheme, described in Recommendation One, be executed.

I guess this is a good place to also do another reminder, that the scope
of these recommendations is with respect to patient consumer identity
proofing, and not that for providers or representatives of the entity.

Number four, and this is the companion for the other two breakthroughs,
given that PHRs and secure messaging, by definition, include working
with the consumer or patient that, in fact, the recommendations in
number one should be followed.

And in the final recommendation, we ask that the Certification
Commission for Healthcare Information Technology, the CCHIT, should
develop criteria for the systems and networks they certify to support
these practices, as they do their work.

MS. DANIEL: Okay. Onto the discussion of the next topic candidates that
were \-- that we've had some preliminary discussion on, although they
haven't been finalized at this point. We don't have Workgroup consensus
on the next step, at this point. Just wanted to bring these up and get
some input.

The first issue that was on the table, and was discussed at the last
Workgroup meeting, was sort of furthering the discussion about identity
proofing. If you noticed in the first recommendation, and particularly
in 1.3, we said where a relationship exists, but where in-person
identity proofing isn't possible, here is how you can handle that.

The question came up, what if there is no relationship? So what if it's
a new PHR vendor who is trying to establish a relationship with a
consumer, and has no prior relationship, and \-- how does that get
handled? In the recommendation letter, we did note that in-person
identity proofing would be considered acceptable by the Workgroup, and
that could be either directly or with a trusted third party.

But there was some concern that that might not be a practical approach
in all circumstances. So we noted that there may need to be some
continued discussion about this, and the Workgroup was interested in
continuing that discussion, and trying to think through if there are
other options that the Workgroup was comfortable putting forth as a
recommendation, in order to identity proof an individual, based on
information alone and not in an in-person situation.

So that's one of the topics that was up for further discussion that's
related to our current recommendations. So there was that one hole that
we may want to plug, and have further discussion on in the future, and
would be interested in any input on that.

Then we were looking at the next topics that we may want to take on. The
Workgroup looked at three criteria that \-- in trying to think through
the next topics.

The first was sort of the tactical or impact, considering what else is
going on in the environment, what might be timely, where there might be
an opportunity for the recommendations to be more quickly adopted versus
something that may be a couple years down the road, and that sort of
thing. So looking at where we might have the most impact, what topics
might have the most impact, and where recommendations could be the most
helpful.

The second was looking at the quantity of work in process, and trying to
avoid duplication. So one thing that came up, there was some discussion
that the National Committee on Vital and Health Statistics is looking at
secondary uses of data. And we wanted to make sure we weren't
duplicating efforts with another advisory committee, or with another
group out there. So we are having some conversations with NCVHS to make
sure that we can either act in a complementary fashion, or wait until
\-- to see what they come up with before we act. So that's another issue
that was being considered in looking at next topics.

And finally, looking at recommendations to the CPS Workgroup from other
Workgroups. You'll hear, in the next presentation, that the Consumer
Empowerment Workgroup had made specific recommendations to work with CPS
on a particular issue, and that, again, was another criteria that we
were considering in trying to prioritize topic areas.

MR. FELDMAN: Thank you. So like Jodi said, we have looked at a number of
issues and we have \-- it was very helpful to have these criteria to
kind of winnow some stuff down. And there are, evidently, some broader
policy issues that we want to be able to consider, and we call a few
things out here. And we've had some conversation, and are quite
interested in hearing from the Community as well.

The first is identification and analysis of changes in the health IT
environment since HIPAA, in order to look at the activities of
noncovered entities with respect to EHRs, PHRs, and health information
exchanges. We are mindful of the enormous changes and rapid changes
coming into the landscape, I think particularly with respect to PHRs and
their status, with respect to covered entities in HIPAA.

We are not looking at so-called opening up HIPAA. We are looking at sort
of the universe of protection and the universe of the various types of
products and services that will be available.

We are \-- the other two we're looking at, with the Consumer Empowerment
Workgroup, as Jodi said \-- and we'll hear more about that presently.
And the last bullet is quite important. An analysis of the effects,
consumer choice, and control could have on the benefits of health \--
electronic health information exchange. We all know this to be the case,
and we want to give you some more information that will help drive
adoption of these services. Thank you.

DR. KOLODNER: Well thank you very, very much for the presentation of the
recommendations, and I can see that the way our agenda is shaping up
with the various recommendations and updates, that it's going to be a
tight afternoon.

So what I'd like to do right now, for this particular group, is to \--
topic, is to start with the recommendations. The discussion that looks
like would be a very useful one to have, I think we might want to pick
up at the next \-- at the next AHIC meeting so that we can give it the
attention that it needs, and the feedback to you.

So let's start, then, with the first set of recommendations, which are
Recommendation 1 through 1.1, 1.2, 1.3. And is there discussion from any
of the members about those before we vote? If not, why don't we go to
the voting there, and are there \-- is there a motion to accept? Nancy?
Okay. And a second? Okay. Any further discussion? Is there any dissent
to accepting or can we accept by \-- accept unanimously? Anyone have a
reservation about that? Okay. Then I declare a consensus, and that one
is accepted. They are set.

The next is Recommendation Number Two, and again, this has to do with
the \-- keeping the information separate that is used for that identity
proofing.

MS. DAVENPORT-ENNIS: Can I ask a question about this one? The word
"separate," can it be interpreted to be physical, or by some firewall,
not that you have to have two separate \-- okay. I just wanted to make
sure.

MS. DANIEL: Yeah. That was actually discussed and people were saying,
"Can we have it in a separate file, even if it is an electronic file,"
or that sort of thing, and there was an intent not to specify separate,
meaning a separate system or a separate file.

MS. DAVENPORT-ENNIS: Thank you. Thanks. Very good.

DR. KOLODNER: Okay. Any other comments or questions? And is there any
one who would not want to accept it? We can go through this more
quickly, if we need to. Any concerns? Any reservations? If not, declare
a consensus, and that also is accepted.

Number three. This has to do with the time of converting from
paper-based to electronic. Any questions or comments? And again, any
concerns or any reservations about accepting this? If not, again,
declare a consensus on Recommendation Three.

And actually, why don't we go to Recommendation Four. Comments? Okay.
Again, any objection to accepting this? And again, a consensus to accept
it.

And finally, Recommendation Five, in terms of recommendation regarding
CCHIT. Kevin?

MR. HUTCHINSON: On Recommendation Five, it talks about the process for
CCHIT to develop certification criteria for the systems, but I'm curious
if we focused on the data requirements of the process. For instance, I
mean I know we can use last prescription and other things like that, but
are we looking at other even more readily available information like \--
I'm not suggesting \-- like credit reports are used in the financial
industry. Last transactions, or other means of their \-- have we looked
at federated IDs, where there may not be an existing relationship with a
health system, but maybe an existing relationship with a financial
institution or a bank?

MR. FELDMAN: I think that's exactly the intention, is to, understanding
that there are a variety of potential data sources that would be useful
here, and to let CCHIT dig into that.

MS. DANIEL: And I think this also gets to the conversation we had about
allowing \-- in-person identity proofing could be either directly or
through a third party. And so it could be that there is a trusted third
party that would use another mechanism for \-- where there is a
relationship for identity proofing.

And then again, where there isn't a relationship, that's where we said
\-- the Workgroup said that they wanted to talk about that more, and to
think through what, for instance, the financial industry is doing, or
what other industries are doing, and whether or not, with respect to
health information, those processes are sufficient, or if there is a
sufficient set of information that the Workgroup was comfortable putting
forth for proofing, where there is no relationship using a trusted third
party.

DR. KOLODNER: Okay. Yes, Dan?

MR. GREEN: I have a question about \-- I'm missing something, I guess,
on the recommendation. How do you build into a certification process a
mechanism that says, okay, this product or this system is good because
somebody has checked somebody's ID; or yeah, I know Joe, he's okay,
that's really Joe, so we can go ahead. How do you build that into a
system? Am I missing something? Isn't there a step in between these two
things?

MS. DANIEL: Absolutely. If you noticed, the first two words in this
recommendation "where applicable," so if it is based on an existing
relationship, where the provider just has had a longstanding ten year
relationship with a particular patient, and is willing to verify the
identity based on that longstanding relationship, the system would have
no criteria in it for identity proofing.

However, where, for instance, there is the recommendation to keep the
information separate, there could be a review of the system to make sure
that there is a way of keeping that information separate, in order to
meet that requirement.

So I think your point is absolutely correct. There are certain pieces of
these recommendations would not be applicable for certification
criteria. Other parts may be, and so we just wanted to put forth the
recommendation that where it is applicable, that CCHIT considers these
recommendations in coming up with criteria for systems.

MR. GREEN: I still am a little bit concerned because it seems to me
there needs to be a \-- or would CCHIT develop the standards or the \--
I guess I misunderstand what their role is. I thought there was a
standards setting process first, rather than taking, you know, broad
recommendations like this.

MR. FELDMAN: The intention is to have \-- there are a suite of processes
in Recommendation One, for example, to accomplish identity proofing, and
just as CCHIT validates various functionality or interoperability
capabilities, it would be to evaluate whether this capability exists.
Can this identity proofing scheme be accomplished, using this product, I
think is the intention.

DR. KOLODNER: Justine?

MS. HANDELMAN: Just following up in what Dan just discussed, and I know
in the Consumer Empowerment Workgroup, we had some very lengthy
discussions over certification. And I think on some of the questions Dan
asked, there probably does need to be some policies that are developed,
based upon these, and some standards to support it, and is certification
at this time premature? Do we need to do some of the additional work
before looking down that road?

And I guess the other point of clarification, those need to be developed
and then looked at. Is CCHIT the right entity to be doing some of this?
I just am worried some of this might be premature, and we're putting,
perhaps, a new role on CCHIT, when there might be some other policy
development or standards development that's needed, before it can even
go there. So I'd just like to raise those issues.

DR. KOLODNER: Kevin?

MR. HUTCHINSON: I was going to echo a little bit of that. I think we
ought to give CCHIT a chance to evaluate, based upon the work that they
are doing, where this fits in that work, because \-- I can see, though,
if you are going to do identity proofing, you may want, in the systems,
to be documented, what method was used to identity proof, and who, in
fact, was the provider that gained access. Was a driver's license used,
and you check the box, and the initials go in, or the user goes in that
actually granted access to the information. Maybe that is a function of
the EHRs or the PHRs that they're giving access. But I think that, you
know, we could sit around and debate and brainstorm all kinds of ideas,
but I think we should give CCHIT an opportunity to have the discussion,
before we put the requirement on them to do that. So I was hedging on
the first two words, the "where applicable," quite a bit, on the
recommendation. So I'm assuming that this "where applicable" would go
over to CCHIT, and they would get to decide.

MS. DANIEL: I think that was intent, was that \-- it wasn't clear that
\-- there was some things that could potentially be certification
criteria. We didn't specify this specific recommendation should be a
certification criteria, and also should be certified against it. We
wanted, basically, to put this on CCHIT's radar screen, make sure that
there are \-- and if they are putting forth criteria, they're consistent
with these recommendations, and where they feel they can support these
recommendations through systems criteria, to do so. Is that a fair
statement?

So I think your points are well taken. We just wanted to make sure that
one, that CCHIT wasn't doing something inconsistent with these
recommendations, and wanted to put forth that as a priority, and two,
where there might be an opportunity in order to help support these, to
do so. And that was sort of the intent of this. And that's why we put
the "where applicable," because it's not going to always be \-- all of
these recommendations won't be a perfect fit with certification
criteria.

MR. GREEN: I suggest that the recommendation be revised a little bit to
include some of those ideas. When you have words like "CCHIT should
develop certification criteria for systems," it sort of is, you know,
like a foregone conclusion before you've had that dialogue. You know,
should be \-- CCHIT should be \-- we should request that CCHIT review
the processes and \--

MR. FELDMAN: See where they may add them.

MR. GREEN: Yeah.

DR. KOLODNER: Given that we probably aren't going to be able to get that
acceptable rewording today, would there be any objection to tabling this
for now, and having the Workgroup bring that back to us with some
alternative wording? Any objection to tabling? Hearing no objection,
declare a consensus, and this recommendation is tabled.

And with that, thank you very much, Jodi and Paul, for moving us through
and getting \-- certainly the confidentiality, privacy and security area
is a key area, as we saw. That's why the Workgroup was set up in
response to the numerous requests from the other Workgroups. So thank
you for bringing forth the first set of recommendations. So we can move
that forward. Appreciate it.

And with that, we will change to the next Workgroup that will be
presenting recommendations, and as they move to the front, Nancy
Davenport-Ennis and Rose Marie Robertson will be talking to us about the
recommendations from the Consumer Empowerment Workgroup.

And now \-- what I noticed from this group is that you've got quite a
number of slides and recommendations, so we'll do our best to move
through this expeditiously, and also very exciting to see these
recommendations coming forth. So please proceed.

MS. DAVENPORT-ENNIS: We would like to thank you for the opportunity to
address the AHIC group this afternoon, and I think, indeed, we do have a
number of slides, and that does reflect the intense work that our
Working Group has actually been engaged in since the last time that we
were here.

I owe a debt of gratitude to Kelly Cronin, as well as to Jodi Daniel,
for the work that you have done with our Working Group since the last
meeting that we had. It has really helped us in what we are here to
proffer to you today.

Our broad charge is reflected for you, and I'm not certain who's
advancing slides. Not me. Okay, there you go, Jodi. Thank you.

If we look at what our broad charge is, it is to make recommendations to
the Community to gain widespread adoption of a personal health record
that is easy to use, portable, longitudinal, affordable, and
consumer-centered. I would also like to add to that broad charge that
our group remains to be very focused on the issues of privacy and
security; and with regard to that matter, I would like to share, with
the full AHIC committee, that we have convened a meeting with the
privacy and security representatives, since the last time that we were
all together, and we are beginning to develop with them what are the
next steps that we will be taking with them in the area of privacy and
security.

Our broad charge issues to be addressed, today, include essentially
four. Ideally, personal health data can be exchanged among PHRs and
sources of personal health electronic medical records payer or pharmacy
systems, under the control of the patient while preserving the meaning
of the data. And I think for our group, it is very important that as
those transfers are happening, that the patients understand what we are
trying to say, and that the information is transferred in a language
that patients are, indeed, going to understand from the medical
community.

Number two, privacy protection and security safeguards are paramount,
and timely access for all consumers to their personal health information
needs to be ensured. And I think the issue of timely access is
particularly important, and has been discussed by this group in depth.

Appropriate incentives to encourage consumer and provider adoption of
PHRs should be identified and promoted, and we will be dealing with a
specific recommendation to the group this afternoon on that matter.

Number four, research on effective messaging for consumers and providers
should guide broad educational efforts to engage them, because as the
Secretary has said, on numerous occasions; indeed, we do feel that the
adoption of electronic health records and personal health records will
be driven by the consumers.

As we move into our specific recommendations, Rose Marie will be
addressing those with you, but I'd like to call to your attention the
letter that is also included in your book, and you're going to see that
in this letter, we have, under our recommendation section, under section
one, two recommendations. And you're going to notice very quickly,
today, that we are presenting to you only one of those two
recommendations.

Recommendation 1.2, our Working Group determined, after having
additional meetings this past month, that we would delay, for later
discussion with you, after having an opportunity to have speakers
address the Consumer Empowerment Working Group, to understand a bit more
around the issue of certification. So we will come back to that
recommendation with you next month with better information, we think,
than we could have been ready for today. So Rose Marie, thank you.

DR. ROBERTSON: Thanks very much, Nancy. The recommendations that we'll
talk about fall under those broad issues that Nancy just addressed, and
the \-- we started out with a relatively simple and straight forward
one, we think, that \-- having to do with interoperability and
portability, and that is that HHS should promote consumer access to
their personal health information, in the trial implementations of the
national health information network.

We've seen many different kinds of demonstrations, different kinds of
personal health records: stand-alone, employer based from large
employers to small meat packing plants. And in addition, are aware of
large-scale planning and implementation efforts, such as that by CMS and
AHIC, Blue Cross/Blue Shield. Within \-- and those have various
different approaches to consumer access. We think it's important that in
the trial implementations of the network, that consumer access is
promoted.

Then under privacy and security, we have actually four recommendations.
First, we think that it's very important \-- and we will work with the
Privacy and Security Workgroup \-- that principles be developed, and
best practices for privacy policies for consumers' PHR data, and that
those policies be interoperable and/or portable.

The definition here is important. The concept is that we think that it's
very important that if the consumer identifies data, and says that it
should \-- it should be handled in a particular way, that that should
hold forth as that data moves into a different personal health record,
or as the data is shared within a personal health record and other data
sources. And that those recommendations \-- that recommendation should
apply to both covered and non-covered entities.

Second, we would suggest that the Office for Civil Rights should provide
guidance to clarify the protections provided under HIPAA, regarding the
rights of consumers and their proxies. Remember, proxies may also have
access to \-- have timely access to the electronic personal health
information when they request it from a covered entity.

As you know, there are guidances for that in terms of getting your
information, if it has to be Xeroxed on paper, and although we recognize
that it is \-- that there is still work to be done, in taking
information from an electronic health record and transferring it to a
personal health record, for example, or giving it to the patient, that
may still take time. We think it should probably take a little less
time, and we'd like some guidance on that.

Recommendation 2.3, we would suggest here - you'll notice that we're
making a lot of recommendations for other groups, and \-- \[laughter\]
\-- we have vetted these recommendations with those other groups, where
they have been participants in the discussion. We didn't just decide to
foist all this work off on others. And we did keep some for ourselves.

Here we'd recommend that CMS, in collaboration with the Office for Civil
Rights and other appropriate agencies, should develop policies and
guidelines for HIPAA-covered entities, and their business associates,
for authorizing data released to and from PHRs. We think it's important
that those guidelines and policies be in place before these next steps
can be taken, and we would hope that that could be done over this next
year with the development of appropriate authorization language.

2.4, and this will finish up the privacy and security ones, that \-- we
have been concerned, and we'll talk further with the state alliance for
e-health about the background information here, that there are some
state privacy laws that may, in fact, make it difficult for the \-- for
the widespread adoption and development of PHRs, and data sharing. And
while we don't think that there necessarily needs to be a broad \-- a
broad ranging assessment of all state privacy laws, we do think that
issues related to those laws should be explored, and we should be
certain that they are not barriers.

The next recommendations have to do with incentives for adoption, and
again, these are largely done through other agencies. First, that at HHS
through ARQ, and in collaboration with the Indian Health Service CMS,
Department of Veteran Affairs, and the Office of Personnel Management,
should \-- not should evaluate, but should develop an evaluation
framework that can help assess PHR offerings to federal employees, and
their beneficiaries. Indeed, the Federal Government covers many people,
and is a \-- would be a great place to gather this information.

3.2 refers to the fact, and we will have several under this, that HHS
through ARQ, when it's appropriate, should conduct evaluations that will
provide information needed to develop that evaluation framework. So the
framework needs to be built. We need information to build it. And the
specific study topics are listed there, and I won't read them. But
basically, they're to assess impact and value.

3.2.1, we think that HHS needs to assess how the sharing of personal
health information with consumers, through PHRs, impacts the quality of
care and patient satisfaction, because we think that will have an
important impact on the adoption of these personal health records.

3.2.2. HHS, through ARQ here, we're suggesting should conduct a study to
assess the comparative value of, and challenges related to using
different sorts of data. Here we \-- this would be data related to
diagnoses and medication \-- medications, and those can be derived from
many different places. There can be claims data, administrative data,
clinical laboratory, pharmacy data, and consumer based data. And we
think that there needs to be more information developed about how both
patients and physicians feel about the data, and feel about medical
decisions, based on that data.

We would think that this should start where the data is most available,
and then move to \-- move to other sources, as those are available. And
we would hope that we would have some kind of an interim report on this,
the Community could have an interim report by the end of this next year.

We think that architectural models, in the next recommendation, also
need to be assessed; and would hope that HHS, through ARQ, could fund
evaluations of the impact on quality and patient satisfaction. Those
issues, we said previously, were important on the various architectural
models. So there are a number of kinds of models, and there are a number
of kinds of delivery systems, as you all know very well; stand-alone
PHRs, those that are integrated with other systems, those that are
networked.

And then there are also delivery methods. We think about the web based
systems, but in fact, data can be given to patients in other ways, on
flash drives, CDs, et cetera. And we think that it would be worth
looking at what the impact is of those systems. Some may be more
applicable to different populations that we would want to target than
others, and all would need to be recommended. And you'll see that we
have those grouped, the incentives, as one \-- as one set of things to
evaluate.

And then the last of the recommendations under incentives, work actually
for the Consumer Empowerment Workgroup, we will plan this next \-- we
would hope to plan this next year, to identify a range of incentives
that might increase the adoption of PHRs, whether those are \-- we could
have Recommendation 3.5 up \-- whether those are \-- thank you \--
\[laughter\] \-- whether those are financial benefits for providers or
other offerers, financial benefits potentially for consumers, or other
kinds of economic or even other benefits that might encourage this. We
would plan to report back on any evidence that we can find about the
effectiveness of those kinds of incentives, and how they could be best
deployed.

And then last, we believe that it's important for us to study activities
that are already beginning to increase consumer awareness of personal
health records. There is data suggesting that 60 percent of consumers
believe that something, like a personal health record, should be
available, that their information should be available.

And we think that that needs to be done with attention to social
marketing. We think it needs to be done with attention to consumer
engagement, and how one can best move that forward in a way that will
encourage people to utilize the potentially great benefit of having
their personal health information available. And we would plan to report
on that to the Community. Thank you.

DR. KOLODNER: Okay. Thank you very much. A full spectrum of
recommendations there, and let's see if we can move through, and discuss
them, and make a decision on these various recommendations.

So starting with Recommendation 1.1, is there any discussion by any of
the Community members about 1.1?

And do I \-- is there any objection to moving this forward and accepting
\-- Mitch?

MR. ROOB: How?

DR. ROBERTSON: You know, in depending on how those trial implementations
are set forward, so if there \-- if there are implementations that are
funded, that that \-- that it be encouraged in the description of
projects. If there are \-- in whatever ways that those trial
implementations can be encouraged to include that.

There will certainly be a number of trial implementations where that
won't be necessarily feasible, but the area's expanding rapidly enough
that we would think that encouraging it, if \-- not mandating it, but
encouraging it, would have a great impact on the field and would help
the spread to happen more quickly.

So we didn't prescribe specific mechanisms for that, but left that to
the innovativeness of the implementations that would come forward. We
could be more specific. Nancy?

MS. DAVENPORT-ENNIS: I think, Rose Marie, your points are completely
correct, and let me answer by saying this further. I think that the
Consumer Empowerment Working Group felt that we needed to put a
placeholder out to say that as we are implementing these various trials,
that we need, within that process, to be sensitive to creating processes
so that consumers can, indeed, have access to their information.

And I think in some of our later recommendations today, when we're
actually asking for us to look very specifically at what are the
different methods that consumers could use to get this information, that
we will also find information from that location. Candidly, I do not
think our group answered the question of how.

DR. KOLODNER: Just to clarify, by trial implementations, you're talking
about at the next round of NHIN contracts \--

MS. DAVENPORT-ENNIS: That is correct. Any of the contracts that are
going out.

DR. KOLODNER: And so the idea for there is that there will be a spectrum
of things that will be encouraged, not required. There will be a set of
requirements for all of the applicants, but then in terms of the
spectrum of what might be done in any particular trial implementation,
what I'm hearing you say, is at least encourage that some of them will
include access by the consumer.

MALE SPEAKER: This won't come as a surprise to you, because I say it all
the time, which is if you want to encourage adoption of these, if you
put it inside \-- if you have Medicaid fund it, at the 90/10 rate, you
will encourage states to do it, particularly in the disabled
populations, which is a terrific trial opportunity. And so since no one
asked me how I would it, that's how I would do it. \[Laughter\]

DR. KOLODNER: I think that's the broader impact, as opposed to this one
being focused just on the trial implementations for the NHIN. But you're
welcome to talk to CMS about that. \[Laughter\]

\[inaudible\]

Okay, so regarding Recommendation 1.1, which is about the NHIN trial of
limitations \-- Kevin?

MR. HUTCHINSON: To answer Mitch's question, and kind of share with the
group why this is such an important recommendation, and I know that \--
I don't know if we're going to go through each one of these one by one,
but I think overall, what the Consumer Empowerment Workgroup is saying
is there is \-- a lot of work needs to be done on PHRs with \-- around
privacy, security, adoption.

But getting directly to Mitch's question, one of the things that already
has been trialed, as part of the original NHIN deployment, just
recently, just in the last 30, 45 days, in fact, has been the sharing of
information between the personal health record, which is, in this case,
the CapMed solution as part of the IBM contract, with respect to the
National Health Information Network and pharmacy information.

And so in this particular case, in North Carolina, the pharmacy played
the authenticator, if you will, of passing out the IDs and passwords to
patients coming into the pharmacy. Once they get the ID and password,
they can actually pull their medication history out of the pharmacy
databases and view it in the personal health record.

It was a very short, confined, fenced-off pilot. What was learned from
that \-- and I don't want to steal thunder from those who are going to
present this afternoon \-- but there is a lot of additional
understanding. For example, immediately the patients were saying, "How
can I request a refill to my pharmacy using this personal health?"

Now you're getting into kind of two-way interaction, not just pulling
information, but doing two-way things. Those are things, from a trial
implementation, that need to be followed on contracts as part of the
NHIN, follow on implementations and trial implementations. But very
successful, very confined, due to budgets. Goes back to the monies that
need to go on for additional trial implementations of this.

DR. ROBERTSON: And I think in circumstances where people have used these
\-- have used these and found them useful, they have sometimes found
them really transformative; the data, you know, being able to see your
data graphed out in terms of laboratory values can have a tremendous
impact. So we would like to foster that.

DR. KOLODNER: So again, getting to Recommendation 1.1, and we will get
through all of these. Any further discussion? Okay. Any objection to
accepting this recommendation? Hearing none, I declare a consensus, and
we can move forward.

If we can bring up the next recommendation. What I'd like to do is to
see about clustering the group of recommendations, this being under the
several that are under privacy and security. The one thing about the \--
this 2.1 is that it talks about the CPS Workgroup and CE Workgroup, and
it really doesn't need to go to the Secretary, in order for it to
happen. So I'm wondering if the \-- if this seems like a good idea,
whether the Community wants to just recommend, to the Workgroups, that
they go ahead and pursue that, and \-- so we don't need to actually make
a recommendation to the Secretary about it. Any comments, objection \--
okay. I see heads nodding, and again, hearing no objection, just go do
it.

On 2.2, 2.3, and 2.4, which have to do with various recommendations
about either providing guidance, OCR; or 2.4, the state alliance,
consider exploring issues relating to privacy laws, can we take those as
a set? Are there any items within that that members would like to
discussion? Tony?

MR. TRENKLE: Yeah, just one. On 2.3, actually, it should be \-- it
should read the opposite. It should be the Office of Civil Rights,
because CMS is not responsible for HIPAA privacy. It's the Office of
Civil Rights has the lead, government-wide, so this \-- CMS can't
develop the policies without the Office \-- the Office of Civil Rights
would be the ones who would have the overall responsibility for that. So
I'm not sure why it says CMS.

MS. DANIEL: I'm probably not the best person to answer this, so feel
free to jump in, but my understanding was that there were some \-- there
was some interest, on the part of some CMS folks that were participating
in the Consumer Empowerment Workgroup, to sort of set up some model
authorization language for CMS that could set the stage for others, that
they would work with OCR on that, rather than OCR setting a policy.

MR. TRENKLE: They work for me and that wasn't the \-- \[laughter\]. It
wasn't the \-- they had told me, so, no, I mean \--

DR. ROBERTSON: It should be reversed, okay.

MR. TRENKLE: It should be reversed.

MS. DAVENPORT-ENNIS: And so what we would, perhaps, like to do is to try
to make the language reversal, with the understanding that the CMS
representatives, that have been working with us on this particular
matter, are certainly invited to have further discussions with us.

MR. TRENKLE: Right, I think that's fine, but not driving it.

MS. DAVENPORT-ENNIS: Thank you. I understand.

FEMALE SPEAKER: As HIPAA applies to covered entities, and at this time,
to my knowledge, patients aren't themselves, a covered entity. And maybe
it's a philosophical question, because in the case of VA, for example,
My Healthy Vet is owned by \-- once the information is in My Healthy
Vet, it belongs to the patient. So I'm just grappling with, are you
asking for them to have language that applies to the patient?

DR. ROBERTSON: No. I think we're asking them to have language that
applies to data release to PHRs \--

FEMALE SPEAKER: From the source systems, okay.

DR. ROBERTSON: From the covered entities. Now, that data may come back
to a covered \-- from a PHR to a covered entity, and then be sent
elsewhere, and then it would, again, come under the covered entity
issue.

FEMALE SPEAKER: Okay I would just maybe ask you, that in your
recommendation, you make that more clear.

MS. DANIEL: ...in terms of the discussions between CMS, and OCR, and the
Workgroup; which is how we got to this point, I think \-- the thinking
was that CMS, as a covered entity, and offering the services \-- so if
you're through the beneficiary portal, there is information that's going
to be shared with the PHR, that you would be working collaboratively
with the Office of Civil Rights, who \-- since they have the expertise
and the authority, when it comes to privacy policy, in crafting that
data authorization release form with you. But as a covered entity, you
would actually be offering that data.

So it was intended to be collaborative, and I think they \-- in spirit,
they wanted to be working with you in developing that.

\[inaudible\]

\[laughter\]

\[inaudible\]

DR. KOLODNER: With that one change to 2.3, and looking at
Recommendations 2.2 to 2.4, are there any other discussions? Are there
any objections to accepting those three as a group? Hearing no
objection, again, declare a consensus, and those are accepted.

Now moving on to the next group, which are the incentives for adoption.
We have, again, a set of these. And why don't we look at that group
together?

Again, if we go to Recommendation 3.5, for just a moment; again, this
talks about what the CE Workgroup wants to do, and again, it's something
that doesn't need to go to the Secretary, so unless I \-- hearing no
objection from Community members, go do it.

So taking the rest of those recommendations in 3.1 through 3.4, are
there elements that any of the \-- that anyone wants to discuss,
including some of the entities that may be so named? Lillee?

MS. GELINAS: Just the \-- thinking of why December 28th is the magic
date to have reports back, because every time we hear the Secretary,
there is a sense of urgency of getting things done. My Healthy Vet has
been out there, and it would seem to me that VA personnel could do an
evaluation and have a report back to us. It doesn't take a year. So I'm
just curious what the timeframes were.

FEMALE SPEAKER: I would like to clarify that we just released the
patients \-- outside of the pilot group, the patients' direct access to
the clinical data. While the portal's been up, and there has been a
contingent of about 1,500 of them that have had access, actually the
release for the broad Community just happened at the end of December. So
while we could confer about moving the date up, it isn't data we have
readily available today.

MS. GELINAS: Even on the 1500? You know, you had a \--

FEMALE SPEAKER: I mean we have some data on those. We'd really have to
look at \-- I guess, from my perspective too, you're getting just varied
information from each of the individuals that has a PHR, how you want to
compile that, too, as opposed to more structured \-- what questions
would you like us all to answer about a PHR, I think might be more
beneficial information for you, than random information from VA and from
the varied entities.

DR. ROBERTSON: I think what we were looking for there had to do with
data that would suggest that there was value that could, then, be used
in encouraging the adoption of these. So that could be used as a case
for adoption. So it could be \-- it could be quality of care data, it
could be patient satisfaction data, and it could be other issues of
impact and value.

So we could discuss the \-- we would hope to discuss the specifics of
that, and we did pick that date as a date that seemed feasible, given
that we knew that this release was happening. We could discuss it
further.

MS. DAVENPORT-ENNIS: I think that we would also be accurate in saying
that if any of this were going to be accelerated, when it is initiated,
certainly it can be delivered prior to December the 28th, but we wanted
to make certain that by December the 28th, it was completed.

MS. GELINAS: I just know that in seeing the demonstrations at the VA
Medical Center, and talking to the veteran that was actually doing the
demo, you just heard directly, empowerment, taking control of his own
health. The minute he did the remote monitoring, he knew his weight went
up and his blood pressure went up, and, you know, the quality of care
and patient satisfaction issues should really come roaring out at us, so
\--

FEMALE SPEAKER: And actually we presented to many, many of the subgroups
on the data that we do have today, and I guess really what we're asking,
and we can work with you offline on this is, is what we have sufficient?
Would you like more specific information? We have lots of testimonials.
So we just want to be sure we give you something that's reusable in the
goals that you have.

DR. KOLODNER: You had mentioned that you had vetted these with various
representatives from ARQ and from CMS, although ARQ is not at the table,
I see Tony does have \--

MR. TRENKLE: Yeah, I just had one \-- and maybe this belongs more with
4.1, but I'm looking at a lot of these evaluations that are occurring,
and then 4.1 talks about convening an expert panel to report on findings
of a, you know, informational consumer engagement. It seems to me like a
lot of this information you get out of these evaluations should feed
right into 4.1. And it seems to me they should be linked more closely
together than they are now, because it almost sounds like separate
activities, but one should feed the other.

DR. ROBERTSON: We separated them, really, because of the importance of
using these for education and outreach, not because of how they would
come into the Workgroup. But yeah, you're right.

DR. KOLODNER: And regarding Recommendation 3.4, any problem with that,
Tony?

MR. TRENKLE: No. My only concern with that one is it says, "We shall
develop plans," and I guess I'm not clear as to what it means beyond
plans. It just sounds fairly nebulous. In fact, Lorraine Doo, who is on
that group, I talked to her about that as well. I said, "You know, what
is a plan without some activity beyond that?" It just seems like it's
\-- well, it's a plan. It doesn't say anything beyond that. And it seems
like \-- I don't know what a plan without any activity beyond it means.

And, of course, there is funding and resource issues that relate to
that, so I'm very interested in what it means to have a plan.

DR. ROBERTSON: \[inaudible\] \... we could say you must do this. You
know, both because of funding and because it was, you know, obviously it
was not \-- not our place to do that. We were hoping to encourage the
plan, and then see what came from that.

MS. DAVENPORT-ENNIS: And I think it's probably a fair assessment that
perhaps within the plan, there could be a section that would address
adoption, or promotion, or integration within a system, that would,
then, allow us to have a talking point to move forward and address
things like, what is the funding going to be, and what will the
implementation schedule be.

MR. TRENKLE: Right, because it's very important, because we're in a
funding situation now that's very tight, and I think if the Community
could send a signal that's a little stronger than says "develop any
plan," I think it would certainly help us in terms of getting additional
funding for activities related to PHRs. So \--

DR. ROBERTSON: We would have been happy to have a stronger
recommendation. \[laughter\] Perhaps we should come back with a stronger
recommendation.

MS. DAVENPORT-ENNIS: We certainly could make it a more robust
recommendation.

DR. KOLODNER: So based on this discussion, do we want to table 3.4?

MS. DAVENPORT-ENNIS: Let's table \-- bring you back a better
recommendation.

DR. KOLODNER: Okay. So we still have left 3.1 through 3.3. Any further
discussions on that? Any objection to accepting that set of
recommendations as stated? Hearing none, declare consensus, and we have
those moving forward.

And finally, Recommendation 4.1. Again, like a couple of the others, it
looks like CE wants to do something, and unless anyone objects, we can
tell them to go do it, don't need to move that up to the Secretary. You
can move faster on that.

MS. DAVENPORT-ENNIS: We would like to thank the AHIC for your questions,
for your comments, and for the opportunity to improve the work of the
Working Group. Thank you.

DR. KOLODNER: Well, thank you for a robust set of recommendations coming
in from Consumer Empowerment, and advancing the activities within PHRs.
And I look forward to your coming back with a reworded recommendation
regarding Recommendation 3.4.

MS. DAVENPORT-ENNIS: Thank you.

DR. KOLODNER: Thank you so much. As you can tell from the time, we're
slightly out of sync with the agenda, but we're going to proceed. And we
will have two more sets. In this case they're not recommendations, but
they are, in fact, updates from important Workgroups that we have.

Starting with the Quality Workgroup, and Carolyn Clancy will be making
that presentation of the update to the Community. Thank you, Carolyn.

DR. CLANCY: Well, good afternoon, everyone. And Rob, I did get your
sense of urgency about the agenda here, so I've ditched all my jokes.

DR. KOLODNER: When the Secretary talks about urgency, it's a different
set of urgency, but \--

MS. CLANCY: That's right. I wanted to actually start with a question of
all of you, and to ask all of you, as consumers, on behalf of yourselves
or a family member: Have you looked on the Web for quality information
about a provider hospital, whatever? So keep your hands up if the
information you found was flawless and answered all your questions.
\[Laughter\]. Okay.

That is the challenge that the Quality Workgroup is intended to address.
So this is our member list, and you don't need to read the details. Let
me just tell you, though, I'm really excited. My co-chair, who couldn't
be here today, Rick Stephens, is from Boeing. And I'll just tell you,
he's a high voltage guy when it comes to promoting value in healthcare.
And I don't think we ever have a conversation that he doesn't remind me
what it's costing his company, and how very much he wants to do
everything he can. And he's also kind of organizing the aerospace
industry to help out to promote value in healthcare. He is onboard in a
big way.

We also have leadership from those leading efforts in quality at a
national level from the Hospital Association, from the AMA, from leading
clinicians health plans, and so forth, as well as from Charlene
Underwood, someone from the National Committee on Quality Assurance, and
so forth; and Jerry Shea from the AFL-CIO, as sort of a consumer
representative.

And if there is one point where I would ask for all of you, if you have
comments, if you could send them to us, we would really appreciate it on
the visioning side. It's the consumer response part. In every meeting I
go to about quality, there is always a consumer representing the vast
American public, and we forget how important that perspective is. I
think Craig Intel is doing \-- Craig Barrett rather, excuse me, was
doing a great job reminding us of that this morning.

So what we're trying to accomplish is to get recommendations to this
Community, so that health IT can help us accelerate what we're doing
now; and ultimately, refine and transform how we're assessing quality of
care, how we're using the information to improve care, and how we're
reporting that information back to the public so they can make good
choices. And also to clinicians, so that they can improve that care in
real-time. Finding out that you provided poor quality last year is
useful, on some level. It's not very helpful to what you're doing today.
The Holy Grail here is to get the information, and do it right, before
you get a bad report card.

So where are we today? I won't belabor the points here. I think you've
all gotten the point that to a large extent, this is pretty much a
paper-based enterprise.

The good news is that there has been a lot of effort, over the past
several years, and Chip Kahn has really been at the helm on the hospital
side, and it's happening on the physician side. Indeed, even the
surgeons were gathered together earlier this week to discuss the fact
that they need a consistent set of measures to report on for quality of
care that has buy-in from a broad set of stakeholders. So there is a
great deal of work going on about \-- around alignment of measures.

What we don't have yet is a unified agenda about goals for the
enterprise. What do we, as a nation, want, from the healthcare system?
Which sounds a little bit surprising, but if you think about the
challenges in healthcare that inevitably come up in discussions here,
and you reflect on that a bit, you realize it does sound a little bit
like many blind people and an elephant.

Many of the measures that do exist lack detailed data specifications,
and let me tell how this comes about. A lot of them come out of clinical
professional organizations who, believe it or not \-- at least in this
room it may sound surprising \-- do not think about where the data are
going to come from. They think about what's the evidence, what's the
right thing to do, what should we be measuring, what comes from good
science, and so forth, which is great to do.

They don't take it that next step, and I'm going to say yet, to say,
okay, I know what I should see happen, how would I get that information?
And ultimately, that's what we need to see. We need to move way upstream
in the quality supply chain, if you will.

And, of course, most of the data that we need for many of these measures
are housed within specific silos of healthcare delivery, so hospitals
have their data, offices have their data, nursing homes, and so forth,
which is all fine, except that patients often have episodes of care and
need to transcend those silos.

Clinical decision support. Now, this is the piece about providing
feedback in something like real-time to providers. I think it's fair to
say, has limited penetration and is not \-- I wouldn't say closely \--
it's not remotely aligned with quality reporting, right at this moment.
It could be, and I think that it will be, and that's going to be one of
our clear goals. And the reporting that is done, which is why I asked
you the question at the outset, is not terribly consumer friendly at the
moment.

Now, Chip made a very strong point, this morning, about pay for
performance really being some rocket fuel for this whole enterprise, and
I would agree. In some of those efforts in the private sector, there is
a great deal of innovation going on right now; have, in fact, come up
with some pretty creative IT solutions to make that easier for
physicians to participate. The problem is, most of those are not
scalable. They're customized, not quite homegrown solutions, but highly
localized. And the trick, and really the reason for the existence of
this Workgroup, is to figure out how to scale that more broadly.

And you've heard a lot about privacy and security gaps. Let me just say
that we, too, come under the umbrella and are so thrilled that Jodi
Daniel is at the helm here.

So we did some visioning, and in your packet of materials, you'll see
both an executive summary, as well as a longer version. We went through
the same exercise that all the Workgroups did, which was to try to
figure out \-- where we are now was pretty easy. Where we wanted to be
in the future was also pretty easy. Putting specific times on that
turned out to be a little more challenging, consistent with what I heard
a futurist say once, that everyone can predict the future. What they
disagree about is when that will actually happen.

So we thought it would actually be very helpful to have a summary, so
that's why that's in your materials.

The Vision Group was really terrific, and we got a lot of fabulous
input, and people redid and reworked and so forth. Again, the one area
where I think that we could use additional input \-- so if anything
strikes you as missing, we're all ears \-- and that is on the consumer
part of it. Because that is not a strong portion of our Workgroup; and
actually, I think, remains a rate-limiting step of the enterprise right
now.

But ultimately, quality needs to be part of the fabric of healthcare,
not something we measure after the fact. Now, I say that, and I think
many of you, certainly, who are connected to clinical care, in some
fashion, recognize that if you go through medical training, you are
hardwired to see one patient at a time. You do the very best you can,
and you move on to the next patient.

The idea that it's part of your job to step back, and look at how I'm
doing for all my diabetics, is not part of what you're taught in medical
school, yet. I think a few schools are beginning to step into this
territory, but fairly daintily, right at the moment. I see Mark Overhage
nodding here, so I'm making him responsible for Indiana's School of
Medicine, since that would be a great place to start.

Ultimately, the information has got to be timely and comprehensive, and
it has to be meaningful for consumers. And it has to actually help
providers do a better job. So that is really what we're talking about.
It's an aligned set of goals, an aligned set of metrics that help us get
there, and aligned with the capabilities of health IT, so that we can
get there in the kind of timeframe we want to.

Clearly, when we get there, this will be part of the common expectations
of healthcare. And not only that, there will be a greatly reduced
administrative burden. We've heard pieces of this today, in how much
health information exchange can potentially help in that regard. We
heard about it with respect to e-prescribing. If I don't have to call
back about refills, or because somebody can't read my handwriting, that
makes a huge difference.

In addition to that, there are obviously a lot of applications. And I
should have said, at the outset, that the one other limitation to our
visioning, I think, is the constraints of our own imagination. It can be
a little bit hard to imagine the transformative capabilities of some of
these applications which are, right now, in their infancy. But we did
the best that we could that way.

Ultimately, we would hope that consumers would use this information to
make decisions about their own healthcare, or at least a significant
enough fraction of the public would exert the kind of demand that you
all were discussing this morning, that it would begin to create a
significant toll on healthcare. All of this clearly needs to be done
within the context of a national framework, where secondary uses of data
from multiple purposes are very clearly defined.

The National Quality Forum, which for those of you not familiar with
this enterprise, is an entity \-- it's a public/private entity. It's
actually a private sector organization that has a unique legal
structure. It is a voluntary consensus setting organization, and what
that means is that the Feds can purchase standards from this
organization, in lieu of the regulatory process.

Now, if you think about the fact that science is constantly being
updated and refined, that has some significant advantages, because the
trick in quality is not simply to create measures or metrics, but to
make sure that they're constantly updated. Otherwise, there will be no
clinical creditability with people providing care. Doing that through a
regulatory process is potentially very unwieldy, so the Quality Forum
has got a unique opportunity and responsibility, and their President and
CEO is on our Workgroup.

They are, right now, literally today, launching the exercise of trying
to bring many people together to set some national goals for this entire
enterprise.

It's very clear that in the next few years, we need to define, very
carefully, the roles and responsibilities of what we're calling a data
steward. This is a multistakeholder entity, that establishes uniform
operating rules and standards, for sharing and aggregating public and
private sector data on quality and efficiency.

Notice how those words just rolled off my tongue. Right now, there are
six pilots that were launched a number of months ago, including one led
by Mark Overhage, who you'll hear from very shortly, in Indiana, that
are in the business of reporting on physician performance, and they will
be merging Medicare data with multiple private sector data sources. It's
really messy business, because they all have their own unique coding
rules, which would be okay if they were written down somewhere, which,
by and large, they're not always.

But that is the direction that we're headed. And ultimately, of course,
we want to see that health IT, and its applications, are aligned with
the need for reporting on what's most important about care, to give
people good information about what's happening in quality, and also how
to improve it.

Sorry, I was going to slide behind. There is clearly a lot of work to be
done to standardize methodologies for clinical decision support. This is
not just about content, but it's also a lot about human factors. I think
one good mental image of clinical decision support might be Amazon, for
those of you who buy books, or other things, from Amazon.com, where they
know what you have bought before, and pop up with little suggestions.
Most clinical decision support and reminders for providers are not
nearly as friendly or helpful. I'll just leave it at that. But there is
a fair amount of work to be done.

It's very clear that we have a lot of work to do in terms of inspiring,
and reinforcing, and encouraging the demand from consumers for this kind
of information. I think we heard a lot of speculation, and I thought
very optimistic predictions, about what consumers would demand if they
had a sense that they could, in this morning's discussions. But right
now, we know that actually a whole lot of consumers don't even ask their
doctors questions. So the idea that they're out there demanding
information anywhere else, I think certainly makes me humble.

To make all this go, I think as Chip said, very, very, clearly this
morning, reporting and producing quality of care has to be aligned with
how we pay for care, and right now it's not. Our payment system right
now says, if you do a great job, which often requires often heroic
behavior, that's great. And if you don't, that's great, too, because we
pay you about the same. And, in fact, sometimes we pay more for harmful
care, and that's all I'm going to say about that.

Some of the other enablers I just want to call your attention to \-- I
talked about the uniformity of measures, and there is a great deal of
work proceeding there. Ultimately, the next phase of that work needs to
get at measures that span care delivery. There needs to be a very clear
hand-off, to make this very concrete. Right now, the majority of the
nation's hospitals, and I'm sure that Lillee is involved in this, are
focused on something called medication reconciliation.

So an individual is admitted to the hospital, who takes, say, five
medications, and for the purposes of that admission, some of those
medications may be changed, and they are discharged home on a different
set. And sometimes the patient leaves without the clear understanding
that the old bottles they have in the medicine chest are not what
they're supposed to be taking anymore. That's medication reconciliation.
It leads to a readmit \-- a failure to do this well leads to a
readmission, either to the hospital, emergency room, about 14 percent of
the time. That's the kind of harmonization and sort of span and care
delivery that needs to happen.

We talked a lot this morning about, I think, the need for much stronger
alignment between those who are working on the nationwide health
information network prototypes, and health information exchange
activities, and those who are developing quality measures. And I think
anything that we can do to reinforce those linkages is going to be
incredibly important.

One of the other issues, and I think huge opportunities, for reaching
this mid state, would be the creation of a knowledge management
repository in the public domain. HHS funds a huge amount of research,
and findings are distributed through publications and a variety of other
sources.

Making that knowledge, and representing it in a way that it could be
imported into clinical decision support, is something that Blackford
Middleton would be happy to talk to you at great length about any time,
since he always talks to me about it, but I think is a really, really
important opportunity.

And again, I think consumers want this information more and more, so
we're looking to you, Nancy, to keep helping that demand. There will be
a demand for that, and that looks much, much different than simply
knowing what publication came out, or what a newspaper story says. It
draws, really, on a synthesis of information. And I think we're only
beginning to learn how to do that.

We're clearly going to need to clarify the role and responsibilities of
a national health data steward for the quality enterprise, and to figure
out, as Secretary Leavitt articulated very clearly this morning, is that
all one entity, with all of the constellation of functions that surround
the Office of the National Coordinator and this body. Are they separate,
and in some ways aligned and mutually accountable, I guess might be one
way to think about it. Again, I don't think that there is a clear answer
to that question, but I think it's one that's going to bubble up over
the next year or two.

I think the six pilot projects that I mentioned, that are a key part of
the Secretary's focus on value driven healthcare are a very, very
important opportunity here, not only to learn how to aggregate claims
data, but how to add to that claims data, clinical IT data elements. So
we're going to be looking to Indiana a lot, and we're going to be
looking for other communities, as we expand this network, to build on
that work in progress.

So some of the near term needs that we'll be addressing: We're going to
be focusing on these harmonized measures that I have been talking to you
about, that are coming about from these quality alliances. So AQA
focuses on doctors, HQA focuses on physician performance. And our goal
is that in the near future, I'm going to say 2008, although I still have
to learn a little bit how that fits with the certification commission's
schedule, and it may be a little bit slower than that for hospitals.

If you buy a certified electronic health record, you will know that the
functionality for reporting on quality is built in. You can't do that,
today. So right now, that means the four cornerstones of the executive
order, on value driven healthcare, don't quite fit together; or as I
tried to tell someone in the department \-- he didn't get this at all
\-- IT and quality are a different tents here. You know, quality is
moving, and has some momentum, even though it's inefficient. IT is not
quite aligned there.

At the same time, we want to make sure that those records have the
capability to give providers feedback about how they're doing, because
that's really the value added for them. We're going to continue to work
on enabling data aggregation, because as I noted this morning, most of
the provider world is still going to be living in a hybrid world, using
some financial claims, some paper reporting. The more we can automate
that, I think the better we are. Ultimately, moving upstream in the
quality supply chain so that when people are developing measures,
they're also saying, okay, where would I get the data, and maybe even
modifying their idea of the perfect measure a little bit, because it
would be easier \-- they can get 80 percent of what they want, given the
data that's available.

So with that I'm going to stop, and thank you for your attention, and I
hope I'm helping us get back on schedule.

DR. KOLODNER: Very good. Thank you very, very much. A very rich
presentation. What I'd like to do is to see \-- to make time, if members
have a comment or two that they'd like to make about this presentation.
If not, I'm sure that that will serve as a basis for lots of rich
discussion in the future. Thank you very much, Carolyn. Look forward to
you coming back. Maybe next month you'll be bringing back some
recommendations from the Workgroup \--

MS. CLANCY: Yes.

DR. KOLODNER: \-- and that will give us a chance to have further
discussion. Thank you.

And the next presentation, the final one, before we get on to the
demonstrations of the Nationwide Health Information Network prototypes,
is from the Biosurveillance Workgroup. And we'll be getting an update
here in just a moment from our two presenters, one being Chip Kahn, and
the other being John Lumpkin. And appreciate having you both here, if
you can find your identities. There we go.

\[Laughter\]

Little entertainment to get started. Make sure everybody's awake. Very
good. Well, look forward to hearing your presentation now about the
Biosurveillance Workgroup.

MR. KAHN: Let me start off by \-- \[inaudible\]. First, this gives a bit
of background on the Workgroup, and let me say that this Workgroup began
with a \-- the job to try to help the Secretary, as best we can, bring
information to him, the right information, as quickly as possible,
regarding the biosurveillance area. That's why our original name was
biosurveillance. We had \-- we set up a technical group. They advised
HHS, and in a sense, that job is done.

But as we \-- as we talked about what to do next \-- next slide \-- we,
then, saw ourselves as the \-- in a sense, public health aspect of the
AHIC's activities. And with the discussion that took place at the last
few meetings regarding population health, we seemed, I think, the
natural home, considering the expertise of our members; and because this
is the one area where we were looking broadly, rather than more at the
\-- how the HIT could serve the individual patient, we were looking
broadly at how populations would be affected, so it was a natural
transition.

And in a sense, our task, that we'll discuss in a few moments, and the
new charge that we will ask the AHIC to approve, and the Secretary to
approve, really is interdisciplinary, as you can see. All different
kinds of activities of public health overlap here in the various
possibilities of electronic health records, the National Health
Information Network.

So in a sense, we see ourselves as the center for the populations. Now,
let me say that that means, and if you look at the materials in the
background document, that there will be overlap. And I think one of the
things we need to be careful about is overlapping, in terms of how data
that we would want to see used in the public health arena, which is the
areas in green, how that data is asked for in a way, and produced in a
way, that does not overburden providers.

In my particular area, the hospital area, there is the potential for
this. We have the Quality Workgroup that's going to be looking at how
best to facilitate, through better records, better electronic records,
the collection of information that can then be turned into measures that
can be reported, studied, and used for various purposes, both for
consumers, and for providers and physicians, to improve their services,
and for regulators and payers.

Here, the information that will be \-- that we will be seeking, from the
improvement of HIT, really is information that needs to be used
generally real-time, in the kind of example that John talked about
earlier, where right now, there are many sources of information for
public health agencies whether they be local, state, or federal. But
with the advancing of the health information possibilities, the ability
of public health to react, quickly, to illnesses or symptoms in
populations, will be heightened.

At the end of the day, though, we have to be very careful, that as
Carolyn's group comes up with new criteria, new standards that need to
underlie the record, that we're not asking for something similar, but
\-- I mean something different, but really on its face, similar; or that
we'll be asking for information through the standards that we propose,
asking for processes that will duplicate what's done on the measurement
side. So we've got to spend a lot of time, I think, with the other
Workgroup, working through the implications of our recommendations.

All that being said, at the end of the day, I think the measurement
Workgroup is primarily focusing on improvement of quality of care,
whether it's in the patient safety area, or other institutional areas.
In a sense the population health is a comparable issue, but we're
looking at it from a different angle. And I think that will be
illuminated in the next part of our presentation, when John will talk
about the very specific areas that we see ourselves working in.

DR. LUMPKIN: As we looked at the charge to \-- the new expanded charge
to the Workgroup, looking at what population health is, we recognize
that you can't just sort of draw one circle around it. And you'll notice
that our diagram has a number of interlapping, intersecting circles; and
that's to represent that we're really describing a population health
space, and then sort of describing regions within those spaces.

So the first region is the public health surveillance and response. And
that's the one I talked about \-- a fair bit about earlier, today.
That's infectious disease reporting, it may be a cancer registry. It's
the moving of data out of the clinical system.

A good friend of mine, Chris Gabby \[spelled phonetically\], for those
of you who may know her said, at a meeting ten years ago, that public
health and clinical medicine look at the same data \-- use the same
data, they just look at it differently. And so the components of this
aspect is to pull the data out of the clinical system and use that to
address population health, to improve the health of the public.

The second area is health status and disease monitoring. This may
include not only looking at health status, so how many people in the
population are healthy, what are the ongoing diseases, but involve vital
records, which are an ongoing system of collection that currently comes
out of the healthcare system, in one aspect or another, from birth to
death, and many other events in between, as well as national health
surveys, in looking at the way that the new future that we're describing
and working towards, will enable us to collect the kind of data that we
do at the National Health Survey, so we can monitor the population and
determine the important health trends.

And then the fourth \-- third area, it's a new area. We're kind of
calling it population based clinical care. One of the aspects of this
would be looking at the impact of disparities in healthcare delivery,
and the differences between different populations giving input into
that, and measuring adverse health events; and then feeding that back
into the clinical care system, looking at those approaches to clinical
care that are \-- really derived their interventions. Which population
is it most important to reach out, if you're going to have an impact
upon diabetics, or those who may be most susceptible to hantavirus. You
know, people in the southwest, in the four-corner region: Arizona,
Colorado, and so forth.

The fourth area is population based research, and this is a \-- has a
number of components to it, and again, we'll have some overlap with the
other Workgroups. But this includes: How do you develop the right tools
for the public health system? How do you test those tools? How do you
reach out and determine whether or not a drug, which has been in
circulation now, is perhaps appropriate to go into phase four, it's now
been out, how do you monitor that? What kind of research are we going to
do? Secondary uses of data within that domain.

And then the last domain is health communications, health education. And
this is, again, a relatively new domain for us to be talking about,
although everyone knows that this is something that we need to do. How
do we inform, educate, and empower providers? How do we get the
information that they need to make those kind of decisions?

Let me just give a real example of what may happen, in this future, for
a provider, who's treating patients with asthma. And in the population
health dimension, we may be monitoring air quality. So you have a bad
day, you get an inversion. This aspect of communications may reach out
to the provider, saying, you know, "You asthmatics probably ought to
stay indoors." And then their system would be able to reach out to those
asthmatics, to the personal health record and say, "Hey, you know, the
weather is not all that great. You may want to consider staying
indoors." Similarly, there could be a direct communication, health
education, to reach out and give those kind of alerts to the population
through their personal health records.

Other aspects are to reach out, again, to key populations that may be at
risk because of where they live, may be to provide the information, the
personal health records to encourage people to exercise and to \-- and
how they manage their diet.

So this sort of looks at it within the context of how we bring
information in, and most importantly, how that information is analyzed.
And support for decisions can be, then, passed out to providers, and to
the individual consumers, as well as the overarching public health
functions that we talked about, a fair bit about earlier, today. Chip?

MR. KAHN: So that leads to our proposal that we change the name of our
Workgroup to Population Health and Clinical Care Connections, the PHCCC
\-- \[laughter\] \-- which, I think, captures this notion of the public
health function that was described by John, and the connections through
improvements in electronic health records and other means to clinical
care.

And then, with the name change, would be a change in the broad charge,
and I'll read it. "Make recommendations to the Community that facilitate
the flow of reliable health information, among population health and
clinical care systems, necessary to protect and improve the public's
health." And I think that charge is described in detail by the review of
the main topic areas that John just reviewed.

And with that, go to the last slide. So maybe this \-- if the AHIC
decides, today, to go with our new title, this will be the last time
that Biosurveillance Workgroup member list is up. We will turn it into
the PHCCC Workgroup member list.

But I think you can see that we have a great collection of both public
health experts at all levels, as well as broad representation from the
various arms of the Federal Government that deal with various aspects of
the areas that John described.

With that, I guess we are finished, and we're happy to answer any
questions, and hope that the AHIC will consider our recommendations for
the change in name, charge, and the basic areas that'll be covered by
the Workgroup.

DR. KOLODNER: Thank you very much, and we're now open for discussion.
Lillee?

MS. GELINAS: You did a great job, by the way, but as you know, to get
work done, you have to have focus. And there was great intent on why the
Workgroup was called Biosurveillance in the beginning, to focus on a
very critical area. And this seems like a much broader agenda. How will
you maintain focus? Will you come back to us with what the agenda of
work is going to be?

I remember our very first meeting, when we talked about biosurveillance,
it was around bird flu. We were talking about how do we get our arms
around this, reporting is not great, et cetera, et cetera. So just a
couple comments about that.

MR. KAHN: The simple answer is yes. And in tandem with this, we also
were working on a letter with a set of recommendations as to the areas
we should specifically address that was comparable to the earlier
Workgroups, but our feeling was that one, we wanted to present this
proposition to you first, and two, that we wanted to go through the
priority setting process to sort of see how that played out before we
came back to you with specific recommendations and use cases. But we
will be ready to do that at the March meeting, which I now think is
March 6th \--

DR. KOLODNER: 13th.

MR. KAHN: Moved to March 13th.

DR. KOLODNER: I know that part of the name change was in response to a
prior meeting where we said, consider the name change. I think the other
context is that at times, I hear some members talking about are the
Workgroups task forces that should be formed and then disbanded, or
whether they are \-- you know, that they should have a longer life
because there are some broad areas that need to be moved forward, and
you can't do that in a piecemeal fashion. So I didn't know whether
anyone wanted to address that area as part of this, as we look to the
name change. And obviously, now, moving to the next phase from what was
the original focus, the biosurveillance group.

MR. KAHN: Let me say that one of the things that we went through, in
sort of our historical development was beyond the sort of immediate
biosurveillance function, or target that we had, we also sort of did a
review of all the areas in public health that might be affected by
changing electronic possibilities. And so even prior to the discussions
about population health at the AHIC level, we were exploring the various
functions of public health that needed to be covered, in some way, by
the AHIC.

So at least I'm confident that, from our discussions, we are talking
about a functional area that albeit having overlap, some overlap with
the measurement Workgroup and other Workgroups, it is a very distinct
set of functions, and ones that can't be ignored. I don't know if John
has anything to add to it.

DR. LUMPKIN: And I think that we will, you know \-- we, at the last
meeting, presented a series of priority areas, many of which are
reflected in the use cases that you discussed today. And so we will
continue to flesh those out, and begin to move those forward as we do
our work.

But it begins to set a longer term agenda, and I think what Rob was
pointing out is that this now not becomes a Workgroup that's going to
look at a task that can be completed within six to nine months, but
obviously a much longer agenda of things that will need to be done.

DR. KOLODNER: Kevin, and then Nancy.

MR. HUTCHINSON: Design of the Workgroups, obviously, we designed in a
little overlap between them. There is some collaborative opportunities
between the various different Workgroups. This seems to also scream for
the need of cooperation with the EHR Workgroup, to some degree. And so
with CCHIT, if there is going to be need for additional capabilities
inside of electronic health records, to support population health, as an
example, I'm just curious if you gave any thought with those two areas.

DR. LUMPKIN: You read our recommendations. \[Laughter\] Wait until the
next meeting. No. Obviously, we're very \-- you know, I think one of the
key things about this; the overarching concern that I have is that in
order to communicate with the public health, within the population
dimension, that people who are designing electronic health records need
to think about that function. Because while those pieces won't be there,
the fact that things will need to be sent into the public health system,
things that are currently required to be reported ought to be things
that people who design electronic health records are thinking about.

The process by which we begin to move to that would be CCHIT. And the
harmonization, which we're all committed to, would be through HITSP.

DR. KOLODNER: Nancy?

MS. DAVENPORT-ENNIS: I think also, as you're looking at the next step
that you're going to be taking, that this is another opportunity to
engage the private sector or healthcare providers, and to integrate them
within the system, and to encourage their adoption into the EHR and the
PHR world, because by collecting that additional data from those
sources, again, you have more opportunities to track and to see trends
that are happening in the country that have direct relationship to
public health. So I would look forward to seeing recommendations in that
area.

DR. KOLODNER: Now, given that we still have the demonstrations that
we'll be seeing shortly, and not having heard any objection to the name
change itself \-- let me see whether there is anyone who has any
objection to having the group go forward with the name change, and have
the longest set of initials of any of the Workgroups. \[laughter\]
Hearing no objection, by consensus, we will go forward and have you have
the new name. Congratulations. Look forward to you coming back with your
recommendations next time.

And with that, we now move to the final portion of the meeting. As we
have been alluding to, this is the culmination of the work that we've
been doing in the Nationwide Health Information Networks over the past
year, and now we get to see the fruits of that work, from a number of
the contractors that have been working with us. And we have some
distinguished individuals who will be joining us here, and soon you will
know who they are with the name tags that are placed out.

And so John Loonsk will be leading the esteemed group, and having them
step through the general discussion of the prototype architectures, and
then on to the demonstrations.

So John, if you're ready.

DR. LOONSK: Yes. Thank you, Rob. It's been a long day, but now it's
really time for something completely different, and I would suggest that
any of you who are on the edges, either on the top or the bottom, may
want to move a little bit toward the center. We are going to be using
two screens, and there are some spaces in the middle, I'm told,
upstairs, so that you can see both of them.

As Rob suggested, we're going to be demonstrating some aspects of the
Nationwide Health Information Network, and with me, today, I have
representatives of the four consortia.

From Accenture, Brian Kelly; Mark Overhage, representing Computer
Sciences Corporation; Ginny Wagner from IBM; and Robert Cothren from
Northrop Grumman.

This does represent a tremendous amount of work that's been done over
the last year, and what we're going to demonstrate is really a taste of
that work. A couple things in that regard.

First of all, we asked each of the NHIN consortia to work on the same
breakthroughs that the AHIC advanced last year, so specifically what
we're going to talk about today is the parts of those breakthroughs, and
the parts of the NHIN work that relate to consumer empowerment and
electronic health records. And I think this will put a face on some of
the activities that we have been talking about for some time.

It's going to offer great specificity in that regard. And a warning in
that regard is that not all the specifics up here necessarily represent
definitive implementations or necessarily policy decisions about how
things will be implemented. These are prototype architectures, and more
specifically, these are software implementations of those prototype
architectures.

The Nationwide Health Information Network is intended to be a network of
networks. These are the applications, a presentation of the way the
applications would connect to it. So you're really looking at the most
tangible and visible part of it; the software systems, the PHRs and the
EHRs that attend to it, but you can't necessarily see the network that's
behind it. And that's an important caveat. So these are limited
demonstrations.

We're not going to show Biosurveillance, because we have limited time
and because, frankly, there have been references to the fact that
watching data move on a network, from one place to the other, does
relate nicely to watching grass grow. So it's not because it's not
important, but it's very hard to demonstrate. And we're going to
demonstrate some of the more \-- the tangible aspects of PHRs and EHRs,
and how they can connect up.

The full demonstrations that each of these prototype architectures, a
discussion of their architectures and a discussion of the full software
implementations that they've talked about, will be on display at the
Grand Hyatt on January 25th and 26th, as I referenced earlier.

What we've asked the consortia to do, for today, is to do a live
demonstration. And for anyone who's experienced a demonstration before,
there is one rule of a demonstration, is that something will go wrong.
We are doing four live demonstrations today, so you can pretty much bet
on it. But it's not an indication of anything that's fundamentally wrong
with the architectures. There are just a lot of connections, and
hundreds of people that have literally participated. You're seeing some
of the faces over on the right here.

I would like to thank the Veteran's Health Administration for their
support on the technical aspects, as well as the NIH and all the others,
from the different consortia, in putting this together.

We're going to use two video screens. And on one of those video screens,
we will be showing you this slide, and variants thereof. But this is
intended to show \-- this is the map of where you are at a given time.
So you will be at a given place on this screen.

And on it, metaphorically, are PHRs and consumers, EHRs and clinicians.
The yellow cloud \-- and, you know, it is metaphorical. When there are
clouds on the slide, you know you're speaking in broad brushed terms.

The yellow slide is intended to be the health information exchange or
network that is most proximal to those consumers and clinicians, and as
the NHIN is a network of networks, the other clouds represent other
health information exchanges and other networks. Also, on that slide, is
represented specialty systems or networks, e.g. prescribing, or
medications, labs; it could be a number of different types of networks
that would be represented there.

So we'll be tracking this on one screen, at the same time that we're
talking about a scenario, as implemented through the applications that
they have been working on to demonstrate the validity of their
architectures. So three things: scenario, context, and the applications
themselves.

And the applications are intended to prove that the architecture worked,
and mind you, the architecture work, we told them, should represent
about 80 percent of their efforts. So this software is about 20 percent
of the effort, over the past year, that we've expected from them.

We have expected them to do functional requirements, security models,
business models. You heard some of that earlier today. And a variety of
other deliverables for which they will think of me frequently in the
coming years.

In the next year, we are, as I think you already all know, are moving to
trial of limitations. We're going to directly engage state and regional
health exchanges, and bring together this technical expertise that is
demonstrated to you here today, and at the NHIN forum, with the kind of
business and governance issues of those exchanges, to try to move
forward with this network of networks, that is, the NHIN.

But for today, there is a scenario. That scenario was e-mailed out to
you all, and I'm not going to go through it in great detail. We are
constrained on time. It is also printed out, and you should have it next
to your seat. But it's about an 89-year old female, with diabetes, who
recently had total knee replacement surgery. She's now moved in with her
daughter in a different state, hence the different geographic locale, to
get help with her rehab. She has a new primary care physician. She'll be
visiting a specialist, and she has a personal health record. The
consumer empowerment use case/breakthrough, that was advanced last year,
included a number of different things that will be demonstrated now.

One of them will be the consumer viewing and updating registration and
medication history information. Another will be the consumer
establishing provider permissions to view their PHR data. And still
another will be the provider retrieving registration and medical history
data from that PHR. So hopefully, this rings true in terms of things
that you all had expressed in the past, as part of this breakthrough,
and as part of this opportunity.

I'd like to point out some key issues for you to consider here as well.
We have asked each of the consortia to also show something that's
special about their particular architecture, so we've asked them to
cover some of the aspects of the breakthrough in the use case, but also
to point out some interesting things that they have been able to do, in
the course of the work, that they think distinguishes them in terms of
what they're doing.

Some of the key issues in consumer empowerment to look for: we have
examples of both a commercial, a connected commercial, and a tethered
PHR, where the PHR is a face on a network service. So we have examples
of both. We have opportunities for consumer management of the PHR data.
I said that before. But there are also considerations here for how a
consumer could also influence the way in which data could be exchanged
on the NHIN. So in other words, the issue of how the consumer may
control their personal health record data, but also some technical
possibilities for how they could also influence the flow of data on the
NHIN, as it moves from place to place.

And then also pay attention, please, to the many needs for associating
providers with patients. It's one of the complexities that we all face.
There are a number of other complexities that will come forward as this
goes forward \-- through.

What we're going to do is we're going to start with IBM, who will go
partway through the consumer empowerment demonstration. We will then
switch to Northrop, who will go over some of the same material, so there
is going to be a little bit of redundancy, but we wanted to give each of
the consortia an opportunity to exercise some of what they have been
doing. And then we'll extend it a little further as well.

We will then pause, and we will then have an opportunity for some
questions related to the consumer empowerment portion, if you have them,
and then we will do the same with the electronic health record lab
result reporting breakthrough and use case.

So with that, as an introduction, I'd like to introduce Ginny Wagner,
who will talk about the IBM work. And Ginny, why don't you just wait
until we get \-- were you going to get a screen \--

MS. WAGNER: Okay. We're there. Thank you. It's been my privilege to be
the project executive for IBM for our NHIN-prototype architecture
project over the past year. We've worked with an outstanding team, both
from ONC and from the IBM extended team. What a phenomenal effort this
has been.

Assisting me, today, is Beth Hurter. She's the director of product
development for CapMed. That is our personal health record vendor that
has worked with us this past year.

As John said, our architecture will be demonstrated this afternoon,
although hopefully, it will be totally transparent to you. Mic up? Okay.
Sorry. Can you hear me now? Okay.

Our architecture is open standards based, and it does adhere to the
standards that have been recommended by HITSP. It is IHE, XES, and we
work with HL7 data. We are a hybrid model, and that is one of the things
that differentiates us a little bit from some of the others. Our
functionality is driven totally by the needs of the healthcare
community. We can fully accommodate either a full-federated model, or a
centralized architecture, or a combination. We utilize a registry, but
we do not store data centrally. We do, however, store metadata at the
community hub level, so that we can register the location of the data
that is stored within the local communities. And that's something that's
important for you to know.

We utilize that metadata, then, to provide additional insight into the
data, such as the document type, the service date, the source
information, and in the future, document types. That will allow us to
tag the data. That will be critical if we want to aggregate the data,
and use the data in a secondary manner in the future.

Okay. So in this segment, we're going to cover several things. We're
going to cover the patient authentication and registration process, how
the patient can pull information through the NHIN, or the network, into
their personal health record so they don't have to enter it all. We'll
cover the registration information. We will request, review, and modify
information. And then we'll do similar functions for the medication
summary. Again, request, review, and modify, and that information will
be obtained through the NHIN.

We are demonstrating partner products today, but it's also important for
you to know that we are a hardware and software agnostic, both for
personal health records and electronic medical records, products that
might attach to our architecture, and also for architectural components.

So to speed the demonstration, and to make it a little bit more
interesting for you, some of this could get to be, like you said,
watching grass grow. We've already completed the registrations and a
download, and that's where our registration will start.

So we've pre-registered Patricia Walker to the CapMed PHR, to the online
version, to the NHIN, and to SureScripts. And we've invited the
physician, Dr. Douglas and Lois Parker, his office manager, to access
Patricia's PHR online. So those things are already done. We've uploaded
a registration summary to the NHIN for consumption by an EMR product.

Okay. And with that, we will start. What you see in front of you is the
CapMed PHR log-on screen. She logs onto her desktop version of the PHR.
This vendor does have both online versions and a desktop version, but
we're using a desktop version today, because that's what the patient
would do. We want you to see this as realistically as possible.

So following login, you see a dashboard that's kind of a springboard to
the features of the PHR. This product allows personalized education
links that display \-- that are pertinent to Patricia's medical
conditions and also to her allergies.

So at this point, she goes into her PHR to manage her information. Here
we see a picture of Patricia, which will help with identification of the
patient. The screen displays her emergency health information, and
includes basic demographic information, and a list of her current
medications.

Okay. So Patricia has moved to North Carolina to be with her daughter.
As she's looking at the PHR, she notices she needs to update her
address. So she's going to do that. You'll notice this is a family
health record. It's actually being maintained by Patricia's daughter, as
you might expect, since Patricia is 89 years old. Therefore, Mary
selects her mother, Patricia, as the appropriate family member. And the
address change is made, and then will be reflected in the general
information display. That will take just a minute to do that.

Okay, updated. And there it is in the general information display. So
now we're going to move on, and rather than entering all this
information by hand, Patricia would like to pull this information
through the NHIN, through the Nationwide Health Information Network. So
we're going to demonstrate limited functionality today, but in the
future, we anticipate that you can download any type of information that
would be provided by any type of provider through the network.

The CapMed product already allows download into the PHR through the
NHIN. It allows us to set download by individual level, by group level,
or by institution level, preferences; and that's pretty much dependant
on who is sponsoring the PHR. If it's an individual, the individual
would set it.

So here we see the discharge summary from Kingston Hospital that's made
available through the NHIN by her orthopedist, Dr. Cooper. Beth is
already way ahead of me. Patricia has selected the discharge summary,
and she has chosen to preview the document prior to download. She's
pulling in conditions, allergies, a list of her medications, and that's
all made available through the discharge summary. And she will now
select import. And that will be imported into her PHR.

A second step now, is that she wants to import a current list of
medications into her PHR. You've already seen her discharge summary from
Kingston Hospital. That contains some of her medications, but she also
gets medications at her local pharmacy. So she wants to capture those.

Now, we use a network, provider of network pharmacy service, in this
case SureScripts, to do that, and she will need to request that
information from her medication history service. We see that SureScripts
medication history is available for download. We download it. We could
choose to preview that document, but you've already seen that function,
so we're just simply downloading. We're downloading the remaining
medications. And in the future, if Patricia should go back in to update
those medications, only the new ones at her pharmacy will be available
for download.

So we'll now review the imported medications to ensure that those
medications are all correct. Well, Patricia takes a look at this, and
she realizes she's got a composite view of her entire medical history
here. It's color-coded for easy recognition. The black text indicates
information that's been entered by the patient. Blue text indicates
information that's been imported through the NHIN, through emergency \--
EMR, through pharmacy information, or even from home monitoring devices,
which Patricia does use, to record her blood glucose readings.

So from the functions that we just completed, we see in blue text, the
data. It was imported both from the discharge summary and from the
medication history, and it reflects new medication allergies and new
medical conditions. Okay.

So the import is complete, but she notices that her medication dosage is
higher than she takes. She wants to annotate that drug so she's going to
pull that up. She will add a comment, because it's really critical that
we keep the original order intact. Her comment will contain a date for
point of reference in the future, and she'll type in a comment that says
that instead of two tabs, she's taking one. Okay.

So Patricia will complete that information and she will choose to upload
that information through the NHIN, and send it to her new doctor
directly. Okay. And that moves us through scenario one.

Now we're into scenario two, where the consumer establishes provider
permissions to view the data. And this is a little bit different view.
In this segment, we're going to demonstrate how the patient can control
several of the functions, how she can add a provider, establish
permissions for the provider, and integrate the registration information
into the physician's EMR at the data element level.

And again, that is something else that differentiates us, we feel, that
we're pretty proud of. As Patricia prepares to see Dr. Douglas, for the
first time, she wants to send him a complete medical summary prior to
her visit. The first step is to add Dr. Douglas to her PHR, as her new
primary care physician. And she needs to be in the online version of her
CapMed PHR to invite Dr. Douglas to view her information. The system
invokes a wizard to invite the doctor, and that makes it much easier for
the patient to complete that.

It also will allow Patricia to choose the extent of the access that Dr.
Douglas will have. So if she wants to restrict certain conditions from
his view, certain medications or whatever, she can do that. In this
case, Patricia will grant Dr. Douglas full access to her PHR. And after
she has completed that function, she can review the level of access that
she has given to him.

Okay? So we've seen the patient's view, but what about the physician's
perspective? What can they see? Dr. Douglas can also log into the online
PHR. He'll be notified by e-mail that he has received permission to get
into her online PHR, and he'll get a cumulative list of all of his
patients who have given him access to their PHRs.

While we're currently demonstrating an invitation to a physician, this
could equally apply to anyone that she's giving access to, another type
of clinician, but also family member. So that's how the access works.

Dr. Douglas can now see a listing of Patricia's medical conditions, with
her medical history, her medical treatments, and any medical devices
that are used. So one of the points to make here is that the physician
can get patient information certainly through an electronic medical
record in a hospital or his office as well, but the PHR allows Dr.
Douglas to get complete medical information, a complete medical summary
on his patients before they're seen in the office, or in the hospital,
and he can get information from home monitoring devices such as those
that Patricia is using. Okay?

Now, from an office manager's perspective, Lois, the officer manager,
logs on to the PHR, and she also sees a cumulative list of patient
invitations. However, Patricia only wished the office staff to be able
to see demographic and third party payer information, very limited
information. And that's what Lois will see. All else will be denied to
her.

So in summary, the PHR, the import of the data, the access to it, is
controlled by the patient, but the physician and office staff also have
the appropriate level of access, as designated by the patient. Okay.

Now, there is one final thing that we can demonstrate, and we'll do it
very quickly. And that is we can demonstrate that Lois, the office
manager, can integrate the continuity of care document into an EMR. In
this case, we're using the open EMR product that Dr. Douglas uses in his
office. So we will go out and search for Patricia. Search, first, the
current community, and she will not be found in the community, because
after all, she lived in New York, right? She's coming from there. So a
second search will be done, and we will search all communities for
Patricia Walker, and that \-- she will be found. Now, this document will
take a few seconds to retrieve, as you're going out across the NHIN to
do that. See if we have it here. I might point out that the slide on the
\--

DR. LOONSK: Those pauses are very exciting, aren't they? \[laughter\]

MS. WAGNER: Yes, aren't they, though? Okay. And there you see it, and we
are assigning authority, and what is happening now is a new open EMR
record for Patricia is created, and we now can view the updated patient
information as a record in the open EMR system.

So we've demonstrated interoperability across a couple of products
there, and the NHIN capability in our architecture. And with that, I
want to thank our healthcare community partners, and our vendor
partners. They have worked very, very hard this past year alongside the
IBM team. It's been a fabulous team. They have worked untold numbers of
hours, provided people, resources and so forth. We look forward to the
next phase of the NHIN. Thank you.

DR. LOONSK: At this point what we'd like to do, with a couple of
caveats, is we'd like to switch over to Northrop and to Rim Cothren.
What you may notice is that the locales may change, and that is not to
protect the innocent, necessarily, although we are doing that, too. But
because each of the consortia had been working in different markets, so
it may add a little bit to the confusion, but the scenario is the same.
Some of the emphasis may be slightly different, and then Rim will also
take it through to some \-- the third part of this scenario, after he
has gone over some of the same material. So Rim.

DR. COTHREN: Thank you, John. Dr. Kolodner, members of the Community,
I'm really pleased to be here and give you a glimpse of some of the
prototype work we've done during the past several months. I'm also
joined by Dr. Wendell Ocasio, who's over in the shadows there someplace,
and will be driving for me today.

While you're mostly going to see end user applications, today, one of
the things that I'm going to try to do is concentrate some of what I say
about what happens in the network behind the scenes, so that you
understand the flow of information here.

We'll begin with Patricia who's already logged in to her PHR. The PHR
you see here is a simple model of a web-based application that Patricia
can use to manage an online store of personal health information, and
access NHIN services. It could be provided by any PHR provider and is
just a model.

As Patricia scrolls down, we see that her PHR already includes her
updated information, her address, previous provider of care, et cetera,
and one medication, Avandia, which is her Type II diabetes medication
she was taking before her knee replacement surgery.

What we'll do today, is we'll demonstrate sections two and three, the
scenario will begin by updating her medications and providing access to
them, and then add Dr. Douglas to her access list. First, we'll update
her medication history in her PHR using NHIN services. So Patricia
scrolls back to the top of her record, chooses to import electronic
records, and chooses to import medication history. Now, she could have
chosen to import other information as well, but her other information is
already being updated, so the task at hand here is really just to update
her medications, and so that's all that we're going to end up doing.

If we turn to the context slide, the PHR is now performing a query to
retrieve medication history for Patricia Walker. In our architecture,
this is an abstracted service for medication history. And a number of
different sources could respond to this query. That could include our
RxHub or SureScripts, it could also include other EHR systems, or even
other PHR systems, et cetera. For the purposes of today's demonstration,
it's just RxHub that is responding to this query.

But what's important to the user, Patricia, is that she doesn't need to
know who is responding to this, or even that RxHub is capable of
responding. She merely asks for medication history.

We turn back to Patricia's PHR, we see that RxHub has returned four
medications, the Avandia that she was already taking and three new ones,
oxycodone, coumadin and amoxicillin; all that were prescribed following
her knee replacement surgery. She selects to import all of these
medications into her PHR, which stores them in her online repository.

Now, you may have noticed, as she scrolls down here, the number of the
different \-- all of the different fields include a check box to share
this information electronically. By default, the medications we just
imported weren't included to be shared electronically, and she chooses
to share all medications electronically so that they are shared on the
NHIN. But in reviewing her medications, she notices that amoxicillin is
included there, but she no longer takes that medication. Now, there are
lots of ways that she could deal with that fact. Today, we're just going
to demonstrate how she could restrict access to certain information by
selecting that that not be shared with NHIN.

Okay. Now, all of these last settings, about sharing medications and
other information, were things that happened within her PHR. And they
indicate what information her PHR would share with NHIN. In order to get
Dr. Douglas access to this information, she needs to take one more step.

Our architecture supports controls for the exchange of health
information, through a mechanism in NHIN, that we call the permissions
registry. The permissions registry is implemented as an NHIN service,
and allows or restricts exchange of health information. And that health
information could be coming from her PHR, or other sources of
information as well, and could restrict it based on the name of the
requester, the entity that's requesting the source of the information,
the type of data to be shared, or all the way down to the data level.
What Patricia will do today is add Dr. Douglas to her permissions
registry so that he can retrieve information on her, including
information from her PHR.

So what Patricia does is she scrolls back to the top, and selects "set
nationwide permissions." As we scroll down the list here, you see that
her previous provider, Elizabeth Norton, has access to her health
information. She could choose to eliminate Dr. Norton's access, but
we'll leave it the way it is for now, and search for Donald Douglas.

Now, what's happening here, is as we perform this search, is that her
PHR is reaching out to NHIN, and using an NHIN service to look to a
directory of providers for Dr. Douglas. It finds it. Patricia selects
Dr. Douglas to be able to share information by adding him to the
permissions registry, and this caused the PHR to interact with NHIN yet
again, and update the permissions registry to allow Dr. Douglas to
access information.

So now Dr. Douglas has access to Patricia's health information,
including the information in her PHR, in the online store that it
manages, save for the amoxicillin that she chose not to share from her
PHR controls.

What we'd like to stress here, is that what you've seen is an
application that gives access to NHIN services, not a number of controls
that happened within the PHR, themselves. Now, Patricia has finished
with her work, and with her PHR, and now we'll turn to Dr. Douglas'
office.

We begin with the login screen for University Hospitals in Cleveland.
And this is the First Gateway's product, that University Hospitals
currently uses as their EHR system. We're going to be using a test
system here, and some test accounts in it, in order to demonstrate
what's going on.

First, we'll register Patricia as a new patient for Dr. Douglas. One of
the key goals of NHIN services we're going to demonstrate is the ability
for Dr. Douglas to get information on Patricia, without having to access
her PHR. Instead, he's going to use his EHR system and NHIN services to
do that. So Lois Blonder has logged on, his office assistant has logged
on to his EHR system. And Lois checks Patricia into the office by
searching for records in the local EHR system. And as you would expect,
that search fails to find Patricia, and that's because this is
Patricia's first visit to the office, and she hasn't been registered
before.

In order to register, using information from the online store in her
PHR, Lois selects to search NHIN, add some additional demographic
information to support that search, and click search again.

While that's happening, if we turn to the context slide, what's
happening here is that Dr. Douglas' EHR system has reached out to NHIN
and performed a query for information on Patricia Walker. And what we
see is that it did find that Patricia Walker does have records on NHIN.

We move back to the EHR. Lois selects Patricia from the search screen,
and the EHR makes a more specific query to NHIN, on Dr. Douglas' behalf,
for her demographic information and medication history, from her PHR. In
our architecture, this is another abstracted service, to provide
registration information.

These services request that information of the PHR, but they could also
come from other sources of information and be combined and provided back
to Dr. Douglas.

What happens here is the PHR responds to that request, respecting the
controls that Patricia put on to only share certainly pieces of
information. That information, then, passed through the permissions
registry, and NHIN services ensure that Dr. Douglas is allowed to
receive all of the information in that response. When Patricia added Dr.
Douglas, she didn't put any restrictions on that information, and so no
information is removed.

Then what NHIN services do is take that information that was returned,
formats it, and translates it into the form that's expected by Dr.
Douglas' EHR system. In this case, it's a CDA document, and returns that
document. Now, while I have been talking, Wendell has been scrolling
through that document, so that you can see how quick an operation that
actually can be.

So now what Lois is doing is she's taking a look at that information,
she's reviewing it with Patricia to make sure that it's accurate, and
then can incorporate it into the EHR system by clicking on import at the
bottom of this screen.

And this is the pause that we wait for. While that import, I'm sure, is
being successful. \[Laughter\] There we go. So now Lois has registered
Patricia within the local EHR system, and Lois' job here is done. So
Lois logs out, and we'll turn to Patricia actually seeing her physician,
Dr. Douglas, and while Dr. Douglas is logging into the EHR system.

Now, again, what we're trying to show here is that Dr. Douglas is using
the EHR system to access Patricia's information. So the final step is
for Dr. Douglas to review medications. Dr. Douglas logs in and searches
for Patricia Walker within the local EHR system. Last time when Lois did
this, she didn't find a record. Now Dr. Douglas does, and that's because
Lois has gone through the registration process, and incorporated
information on Patricia Walker within the EHR. He opens up the record
and reviews the information that's located there.

In particular, if you take a look at the medications here, you find,
again, that there were three medications that were included. Those are
the three that were shared by Lois' PHR, and again, amoxicillin is
missing from that list.

In our implementation of today's demonstration, Dr. Douglas did not need
to perform any additional steps in order to review Patricia's
medications, outside of what he would normally do with his EHR. He did
not need to access her PHR, he did not need to access NHIN services, and
as the final slide \-- final context slide indicates, he is only
interacting with his EHR system itself.

What is important there, is that Dr. Douglas didn't have to learn
anything new or perform anything new, and that \-- it demonstrates how
NHIN can keep from getting in the way of the normal work flow of a
physician.

I'd like to thank the team that put this all together for us. As is
normally the case in these situations, I get to take the stage here
while all the people that did the real work are sweating behind the
scenes, hoping that everything works here. I knew that it would. And I
appreciate the opportunity to give you a small glimpse into the work
that they've done. Thank you, John.

DR. LOONSK: Thank you. They can relax now. We're going to pause now, and
recap a little bit of what we've just been through from the standpoint
of the consumer empowerment scenario. And I will note, if you think of
questions you'd like to ask, I will note that both Accenture and CSC,
Connecting for Health, have implemented the same consumer empowerment
use case in the context of the work that they've been doing as well. So
if you have a question, you may want to ask it of any of them.

We've just flashed a number of screens in front of you, perhaps a
dizzying array, but essentially what was accomplished was a consumer
viewing and updating the registration and medication history. The
consumer establishing provider permissions. And you'll see the
connections between the needs \-- or the patients to identify providers,
and the providers to identify patients. And the provider retrieving
registration and medication history data, and you saw that through in
EHR. The use case also asks for it through a PHR, as well.

So are there any questions or comments people would like to make on the
consumer empowerment, as it was displayed? Yes?

MALE SPEAKER: On the last screen, when you looked at the new physician,
you didn't have \-- you didn't have a procedure on that. Was there a
reason why the procedure wouldn't have been loaded?

DR. COTHREN: There is no good reason for that. Patricia's PHR system
didn't happen to include procedures, as part of the data that it
manages. It could have easily included that data as well, and it could
have been imported, but that's simply something that wasn't included in
Patricia's PHR, in the example of the PHR that we presented here.

DR. KOLODNER: Lillee?

MS. GELINAS: It's heartening to see you come this far, when in October
2005, I don't think we were anywhere near. In nursing, we're having just
a real challenge with implementing electronic health records with baby
boomer nurses, and the fonts are so small. We're getting enormous
complaints from medical and nursing staff, as we have spent millions on
computers, and they can't see the fonts. And it is really creating quite
a workplace issue, either by lighting or by font. And it struck me \--
Brian and I had the same exact reaction the minute that first screen
went up. When we're thinking of 84-year olds, or 89-year olds, and the
size of the font, maybe our Department of Defense and Veterans
Administration colleagues can comment on that, because you're certainly
dealing with an elderly population, in many respects, for some of your
patient population. But did you consider that aspect when you were
designing the screens and the fields that consumers would actually have
to utilize?

DR. LOONSK: I'll turn this to the group to talk about, and we clearly
saw this as a huge challenge here, today, because usually when you're in
a presentation setting, you're using large fonts, a la these fonts. And
putting up screens that are intended to be directly in front of your
face, in terms of a computer, it is a challenge. But your issue is well
taken. And does anyone want to respond?

DR. COTHREN: I will very quickly. First of all, as I said, what's really
easy to do is to focus on the end applications here rather than the flow
of information, and it's really the flow of information that we were
asked to concentrate on during the course of the last year.

Now, that all said, the PHR industry is very new. It's very young, it's
very immature, and I think there is going to be a lot that still needs
to be developed in PHRs to really address some of those issues, and
strike the balance between the type of information that could be
provided to the consumer versus their ability to deal with that level of
information.

MS. WAGNER: I think the real message needs to be communicated to all the
end applications, and the screens that we demonstrated here today, while
I think that's an excellent product, I have no problem with that, but
that's a message we certainly can communicate back. That is something
that the CCHIT maybe wants to communicate back to the vendors they're
working with.

DR. KOLODNER: Okay. One other thing. In terms of being on the network
and finding information, Ginny, you mentioned that there is, I think, a
record of where some information is located. So if a patient, or a
psychiatric patient and had a psychiatric condition, is there a storage
of that information, that they were seen at a particular institution, in
sort of a locator, or is the architecture such that it goes out and can
poll entities so that there isn't that revelation?

MS. WAGNER: Right. In our \-- I feel like I don't have a microphone
here. In our architecture, that is controlled by the local community of
what will be published, and at what level it will be published out
there. And then it goes out to a registry, and it only publishes the URL
from where the data is located, and you must have the appropriate level
of access to get access back, controlled by the local community.

DR. COTHREN: If I can add one thing to that. I think that you bring up
an important question in where information is stored. You actually saw
two different versions of how that might be handled here in these two
examples, and there are other examples the other contactors are going
through. In our architecture, there is no registry, and no publishing of
information, so it's handled strictly through a query.

And, for instance, NHIN services don't know what \-- what types of data
may even be stored at certain facilities. Plus the permissions registry
allows you \-- allows the consumer the ability to block that information
so that it isn't carried on NHIN as well. So there are different answers
to those questions that all have pluses and minuses to them.

MALE SPEAKER: I think, Rob, when you look at our approach, it's very
similar to some of the methods that have been previously described. The
key is that the local community can set the parameters for what type of
data gets shared, under what circumstances; and that can be also
impacted by how the patient feels about that particular data.

DR. LOONSK: Now we will move on to the second part of the demonstration,
which is part of the electronic health record lab retrieval use case,
and the specifics of this scenario include first, that an ordering
physician receives the lab test results. Second, the physician
retrieving \-- retrieves historical results. And third, a non-ordering
clinician receives lab test results or notification thereof. So three
different models around getting lab information, both current and
historical, to providers of care. And we're going to start with Marc
Overhage from \-- I think you actually got \-- of \-- from CSC
Connecting for Health. Marc.

DR. OVERHAGE: Thank you very much, John. Thank you for the opportunity
to be here with the Community and the rest of the audience, today. I'm
very proud to be able to represent the work that the CSC Connecting for
Health team has done over the last year.

As was described, we envisioned \-- and can we have the context slide,
please? As was said, we envision the Nationwide Health Information
Network to be a network of networks, and we referred to those component
networks as Sub Network Organizations or SNOs. And it's not just
nomenclature. It's an important conceptual view, as you'll see in a bit.
These SNOs, or Sub Network Organizations, can be national in scope, like
SureScripts, RxHub, or the VA; or regional in scope such as the
Mendocino RHE, or the Indiana Health Information Exchange. But in either
case, they consist of a collection of care delivery organizations that
have specific trust relationships, and may represent a wide diversity of
how they move information within their community. And as was just
described in the comments, may have different approaches to what
information is shared and exactly how that is controlled.

These Sub Network Organizations, in our model, can implement two
important pieces of technology that are illustrated on the diagram here;
the ISB or InterSNO Bridge, and the RLS or Record Locator Service. The
ISB, or InterSNO Bridge, is really the SNO's window to a Nationwide
Health Information Network. It is the adapter that accommodates the
diversity that we see in our existing healthcare environment. By
implementing common network messaging and clinical data standards, it
allows informations to be moved between these Sub Network Organizations
that may be quite different inside.

The record locater service, or RLS, is a critical component within the
SNOs, because it is how a request for information can be directed to the
appropriate care delivery organizations, where the patient has received
care in the past. This record locator service contains only demographic
information, no clinical information or data about the clinical
information, sometimes referred to as metadata, but only the demographic
data.

And this separation of clinical data and demographic data is a critical
issue for our architectural design that helps ensure that the patient's
privacy is always being protected under the agreements that the local
environment may have.

So our prototype of a Nationwide Health Information Network is really
the sum of the parts. There are no central structures, there are no
central services; just these two key pieces of technology that have to
be implemented within a particular network, or Sub Network Organization,
that InterSNO Bridge and Record Locater Service, that enable these
diverse Sub Network Organizations, whether they're regional or national
in scope, to share clinical data.

Next, I'd like to take you, if we could flip to the applications screen,
as well as the next context slide, through two of the examples \-- I'm
sorry. I took you one too far. On the context slides, please. No, you're
okay, I'm sorry. You're right. Sorry about that. I'm too slow reading.

Through two of the examples that were outlined earlier. The first is a
physician orders a laboratory test and receives it back. This is
something that happens thousands of times throughout the day. The
patient, Patricia Walker, in the scenario that we were given, is seen by
Dr. John Watson in Mendocino County, California. Now laboratory results
take a while to process, so we've captured earlier in the day the
interaction that Dr. Watson would have had with the laboratory ordering
application, in this case, Care 360. And here on the screen he has
authenticated himself to the system and entered Patricia Walker's
demographic data, since she's a new patient to his practice, having just
moved to California from Indianapolis.

He chooses to order a glycosylated hemoglobin, in order to assess her
glycemic control, since she's had this hip surgery, is having some
symptoms, maybe a little less active than she used to be. So he would
like to understand where she is in that process.

So Dr. Watson, in the normal course of his day, sets some time aside to
review laboratory results that have returned from his patients. We're
going to switch to his electronic medical record application, in this
case, i2i MediTracks. And I should emphasize that these are actual
applications that are being used in these healthcare markets that I'm
describing today. i2i MediTracks is being used in the practices in
Mendocino, and as well as some of these other applications. So these are
actually live applications that are being used by providers in these
markets today.

So he reviews the laboratory results that have returned. He finds the
result for Ms. Walker, ensures that this is the correct patient, and
imports it into her electronic medical record. So he's been notified
that this result is available, and incorporated it after confirming the
proper identity, into the patient's record, where it's available for him
as he sees the patient subsequently, to review and take advantage of in
his interactions with the patient.

Now, this may seem like a trivial scenario, but you have to realize that
some of the research shows that 14 percent of laboratory results either
don't get to the outpatient physician, or get there later than would
have been optimal for patient care. Fourteen percent. And so this is an
example of how we can make sure that that data is delivered and
available to the clinician, when he sees the patient, or even in between
times, when he sees the patient.

So this result is now available to Dr. Watson in his EMR, the i2i
system. And under laboratory results, and Quest, which happened to be
the laboratory where it came from. And so that result is now available.
Well, that's a wonderful thing. So this information can flow, it can be
notified, be aware of it, and help address this 14 percent problem.

In the second scenario, the physician is going to go \-- if we can flip
the scenario slides. Now we're ready. To retrieve historical results,
obviously any result \-- or any patient that we deal with in practice,
you need the clinical context. You need to know how to interpret that
glycosylated hemoglobin that just came back. Is it better, or worse, or
indifferent, unchanged, from previous?

Now, this is a new patient to Dr. Watson's practice and so he has to go
elsewhere to find that information. In this case, he authenticates
himself to the open HRE, which is a browser-based application that
enables him to access the Mendocino health record exchange. He enters
Ms. Walker's demographic data. In the interest of time, we'll cheat here
by clicking a magic button. And based on the patient's history, selects
to retrieve data from California and Indiana. He clicks the look up
patient button which initiates the query.

If you'll now focus your attention on the left-hand screen for a moment,
what has happened is Dr. Watson, on the upper \-- can't get oriented
here \-- upper right of your slide \-- it's the same \-- has initiated
this request, which is sent to the Mendocino HRE through the InterSNO
Bridge. It is, then distributed to, again, a health information exchange
in Indianapolis, Indiana; and in both of those markets, the record
locater service is consulted to find out where the patient has received
care previously.

A second level query is then sent to that care delivery organization,
that's that separation I talked about before, to retrieve the data. The
data are formatted in a standardized, consistent format, returned to the
Mendocino HRE, after being aggregated in Indianapolis. That data from
Indianapolis then aggregated with the data from Mendocino, and returned
back to the provider in \-- this is a particular example of an
application as illustrated here. So you can begin to see the context,
but importantly, because the data are structured and consistently
standardized, the physician can choose data, or \-- and this is just an
example of how to use it, look at that data as a graphical function, for
example, by clicking the run charts button in the Mendocino HRE
application.

And you can see the trend, probably resulted from Patricia's hip surgery
and her inactivity, and so her diabetic control is much worse than it
was now. Well, Dr. Watson, after looking at that says, "Boy, this is
really important information for me to have, as I take care of this
patient in the future," selects her glycosylated hemoglobins, and
exports them for use at a later time, in his electronic health record,
the i2i application which you've already seen.

Now, just to highlight for a moment how important this ability to move
the data in a standardized fashion is, I'm going to ask Greg to switch
us to a completely different application; this one developed in
Indianapolis that's used to access the patient's data. Again, this is an
actual running application today, where again, you can choose the
patient, and use a little cheat button to enter her demographics; click
the submit query button. And in the process of doing that, this will
actually go out and query Mendocino, Boston, Indianapolis, and return
her laboratory results, again, structured format, reusable for many
different applications. And if you'd just scroll down on that, please,
Greg. It can be used for a variety of different purposes in the
patient's care.

So if we return back to Mendocino, that data is now available in Dr.
Watson's electronic health record, as he goes on to take care of Ms.
Watson in the future. And we've emphasized the importance of this
standardized structure data, because this is what really enables, with
the patient's permission, multiple uses, diverse uses of the data, and
stimulates, we think, innovation and the creation of new value.

As other speakers have said today \-- and there is the data in the i2i
tracks, electronic health record. As the other speakers have emphasized,
what you've seen today on the screen are healthcare applications,
software that uses the ability to move data throughout a Nationwide
Health Information Network. But the Nationwide Health Information
Network is not a healthcare application, rather, it's a set of
capabilities for data transfer in a structured standardized format built
on policies, and ultimately, the trust that has to underlie that, as
well as the process. It's not really about the technology.

So we think this thin NHIN, or very thin set of functionalities
approach, accommodates the diversity that we see in our current
healthcare environment in these different Sub Network Organizations,
with different infrastructures for exchanging data, and that this really
will enable us to create a healthcare system that will become much more
efficient, and deliver a higher quality and safer care for our citizens.

And lastly, I'd like to thank, as everybody else has, the hundreds of
folks, but also the other contractors who worked on this project, who
we've learned a lot from, who've made this all possible. And there is a
slide that lists many of those in your deck. Thank you very much for
your time.

DR. LOONSK: Thank you, Marc. It has been a remarkable collaboration
among these different \-- four different consortia. And I did not expect
it to go that way when we started out, but it really has turned out that
they have gained a lot from each other.

So some of the key issues here in EHR, routing of lab data to the
appropriate EHR, not necessarily a trivial task. We do see some models
for both portal and EHR-based retrieval of historical lab results, so
one of the issues is if the clinician does not have an EHR, how do they
get the historical results, or how do they get results? And that's one
of the things that's been modeled in some of the implementations as
well.

Different ways of doing notifications when lab data are available. Part
of the use case was routing to non-ordering providers of care, and then
something that Marc pointed to, that I think is also going to be a theme
in Brian's presentation, which is the importance of data to get
comparability across different sites. And with that, I'll turn to Brian
Kelly, who we have dragged in out of his sick bed to make this
presentation.

DR. KELLY: Much better today, thank you. Thanks. Thank you, John. Good
afternoon. My name is Brian Kelly. I'm from Accenture, and I have the
pleasure today to represent Accenture's NHIN prototype. Assisting me is
Dr. Scott Cullen, one of our clinical architects working in the dark, in
the back.

Over the past year, hundreds of people from Accenture, and our
technology partners, as well as from the distinct healthcare markets and
provider organizations in our distinct healthcare markets, have worked
very hard to make this prototype a reality.

I'd like to start by talking about a few of the underlying principles of
our architecture that I think are worth highlighting. As you're going to
see, and as you can see from the slide on your left, one of the
fundamental premises that our architecture really emphasizes is the fact
that normalizing data, as you extract it from provider organizations and
you bring it up to the NHIN to facilitate sharing, we believe is a
critical enabler, and a critical blocking and tackling piece that really
has to be addressed to achieve true healthcare interoperability. So what
you'll see in our prototype, and what I hope you'll see more if you can
come on Thursday, is just the amount of work and effort that we
undertake in this regard.

We are \-- our architecture is based on a very flexible hybrid model,
that allows local communities to determine where healthcare data is
stored. It uses a service oriented architecture approach consistent with
best application designed methodologies. Our architect \-- we do use a
repository at our distinct healthcare or RHIO level, but that is by
local choice.

Next, our architecture is designed to sit alongside and leverage the
very large investments in local provider EMR, and laboratory, and
medication systems. We recognize that these systems \-- that these
hospital organizations have made millions of dollars of investment in
these systems, and their average life cycle is 10 to 25 years, so any
functional architecture needs to leverage those and take full advantage
of that.

In our model, we aggregate data at the distinct healthcare level so that
a more complete view of a patient is available to caregivers and
patients alike. As you will see, as we take you through our prototype,
we can supplement this data, with information from remote healthcare
settings using the NHIN. Our philosophy and approach is based on the
premise that most healthcare is a local phenomena, and that providing a
critical core dataset at the regional level, that can be supplemented by
additional data from remote locations, will be of great value to
patients and providers alike.

Our three distinct healthcare markets did not have preexisting regional
information exchanges. Therefore, our prototype not only demonstrates
that you can quickly build a NHIN, but that you can also, in less than
12 months, stand up three \-- the infrastructure for three regional
healthcare organizations.

Lastly, we believe to truly support interoperability, and realize the
benefits of secondary use, such as biosurveillance and pharmaco
vigilance, it is critical to deal with the difficult problem of
normalizing data to federal health architecture standards. Therefore,
our prototype extract data from local systems, maps all of that data
extracted to local FHA national standards. This allows us to trend data,
as we are now able to compare apples to apples when looking at lab
tests, medication results, and other demographic data.

In less than a year, our prototype successfully interfaced with 31
different provider systems at these 15 provider organizations, to
extract demographic data, lab, and medication data, and convert it to
FHA standards.

We'd like to begin our scenario logging in through one of our regional
exchanges, the one, obviously, down in Kentucky. So as we had mentioned
before, Dr. Watson, yesterday, saw Patricia Walker and had ordered a
hemoglobin A1c.

So we're going to log in to our site, and this is actually \-- we had
already preset the permission so that Dr. Watson does have access to
Patricia's electronic record. And we're logging in, and we're going to
search for a new patient, and we're going to search for Patricia Walker.
So we log in, and Scott is going to click on Patricia Walker.

We're then going to be taken to Patricia Walker's home page. Now,
because most of our distinct healthcare markets, none of them, had
preexisting regional exchanges, and we believe this is the status for
most of the United States. We believe that aggregating a core set of
clinical data, that reflects fairly well what's in the HL7 continuity of
care record, is very important.

So what you see brought back to you is a compilation of demographic
data, medication data, allergy data, and social history data. This data
can be populated through messages from the local provider organizations,
it can be populated from data entered by the provider, if they choose
to, or it can be populated by data entered into the patient's personal
health record.

We see that there is a lab test there under the chemistry panel, and Dr.
Watson will click on that and we'll be able to view the hemoglobin A1c
level for Patricia Walker. What was retrieved now is basically the lab
result, and Dr. Watson notes that the hemoglobin A1c is abnormal.

His first inclination is to wonder, is there additional datasets
available on Patricia? So he queries the NHIN, in our view, going out to
the globe. And what our software does in the background is it launches a
query, and it pulls back information from other data sources.

Now, what you see is that additional information that now has been
imported from other distinct healthcare markets, such as other
conditions, past medical history, other medications, now have been
automatically populated onto the portal screen. Additionally, you see
that there is other hemoglobin A1c tests, so we'll choose one of those.
And again, we'll retrieve that lab result.

Now, because there is additional \-- there are multiple lab tests here,
what we can do is ask for a cumulative view of those healthcare data,
and we basically demonstrate that here. So we'll click on cumulative,
and we'll go out and we'll search for all of the other lab results.

Again, you can see that there are \-- many doctors do like to look at
things on chart form, so similar to what Dr. Overhage presented, we
basically can click on it, and pull back a chart, and have the ability
to trend information. Additionally, if we want to show extra detail, we
can actually show what all of the norms are.

Now, what's particularly important to point out in our architecture, is
that every one of these hemoglobin A1c tests have been mapped to a
single long standard. What that allows us to do is we have now shown
that every medication, lab test, and set of demographic data, that we
pull from all of our 15 provider organizations, now have been mapped to
federal health architecture standards. That allows powerful capabilities
for biosurveillance and for the aggregation of data sets.

What we're now going to do \-- okay. Now, later that evening \-- we're
going to now log out as Dr. Watson, and we're going to log in as
Patricia's primary care physician, Dr. Thomas Douglas. Dr. Douglas is
logging into his portal to check on his patient views. So Dr. Douglas
logs in, and what Dr. Douglas receives is he receives an alert that
there is a new lab test on Patricia Walker, because Patricia Walker is
part of his panel. Again, he can click on that, and we could either take
him directly to the lab test, or what we have in our model, we actually
take him to Patricia's home page where he can then pull all of the lab
tests. He can basically access that data, and as we previously
demonstrated, if he chose to, he could go through the steps of pulling
up the lab test, pulling up the history of lab tests, and then charting
it also.

Finally, we're going to log out as Dr. Douglas, and we're going to log
in as Jane Smith. Jane is one of \-- like Dr. Douglas, Jane is part of
his primary care team, and has already been granted access to Patricia
Walker's information. Jane logs in and sees that there is also a new lab
result in her box, just like Dr. Douglas. Jane can click on that, and
will be taken to Patricia's view of the data, and can click on the lab
test and see that result.

In this scenario, we had previously set all the permissions for Dr.
Watson, Dr. Douglas, and Jane; and established relationships between
them and Patricia Walker. One of the features of our system is that it
requires providers to verify that they have a relationship with the
patient before accessing their information.

I would like to conclude by thanking the hundreds of people from
Accenture and our technology partners, as well as the providers, the
administrators, and the patients in our distinct healthcare markets.
They have worked tirelessly over the last year to make this a success.
And if you notice, five or six people that look like they haven't seen
sun in six months, you'll recognize our messaging team at the NHIN forum
on Thursday. So thank you so much for the time. It's been a real honor
to be a part of this group.

DR. LOONSK: Thank you, Brian. A number of important themes in this EHR
use case and implementation of a generalized infrastructure for an NHIN.
Clearly, the emphasis on standardized data. And one of the issues here
is the threshold effect, too, is when you're working to standardize
data, if the people who you're going to give it to can't accept that
standardized data, you have to, then, work to get the data out of
standard form to give it to them in the form that they need. This is a
really difficult problem and a really difficult task to get through.

Another important point here is the reference to summary record. And a
summary record has been referenced several times, today. It was
referenced in the context of the HITSP interoperability specifications
as important, and we are all looking forward, I think, in terms of
advancing the next steps of the NHIN, to have a harmonized summary
record that can be used to advance these efforts, and that the clinical
care \-- the CCD is the target for that, and we look forward to that
fostering these efforts as well.

Are there any questions about the electronic health records display? All
of the consortia did implement this, all of the consortia implemented
biosurveillance in one level or another, and will be displaying them on
Thursday at the forum.

DR. KOLODNER: Questions or comments by members of AHIC? Nancy.

MS. DAVENPORT-ENNIS: I just would like to compliment the entire
consortia on the work that you have done, and seeing you demonstrate
particularly the ability to pull the test, and to exchange medical
information, provider to provider. There is, indeed, a great opportunity
to reduce medical errors and to ensure that consumers are going to have
a more comprehensive, timely set of medical decision making tools in the
hands of the doctors that are working with them today. So kudos to all
of you on the panel, a very \-- a job very well done. Thank you.

DR. KOLODNER: Kevin?

MR. HUTCHINSON: I'd just like to comment that I think it also highlights
another important topic around the sharing of information, while
respecting patients' rights to share information and not share
information. It also could introduce significant issues with respect to
the quality of care that can be delivered, if physicians feel that they
are looking at a complete record of information when, in fact, certain
levels of information have been hidden at the patient's request.

We ran into the same issues with Katrinahealth.org, when sharing that
information, making sure that there are alerts, letting the physician
know that not a complete record is being shown. We have to find that
balance in making sure that patients know when you are taking
information away from the eyes of the physician, of your care provider,
that you are increasing the risk of the quality of care that could be
delivered.

MS. DAVENPORT-ENNIS: Kevin, I would also like to add to that that not
only do we have to identify there is missing information, but I would
encourage that we have to identify at least the type, the universal type
of information. It's different if there is one field of one prescription
missing as opposed to an entire diagnosis that is missing. That becomes
very relevant, so certainly we support the position you've just noted.

DR. KOLODNER: And I think that it will be interesting to see \-- I think
the Workgroups will be mulling this over, and bringing some things back.
Because on the other hand, right now the consumer, in a non-electronic
world, has the right to keep that information away and not have it
revealed, that there is information being held back. And so the question
is, do they lose that right, just because it's electronic.

But what is that correct balance? Because there certainly is increased
risk when information is missing. We happen, right now, to deliver care
in a world where there is always missing information, but we kind of
know that, whereas if we move into the electronic world, there is often
the assumption that it's now a complete set. So finding that balance and
\-- whether that's \-- you know, how we do that is, I think, going to be
something that is a very important discussion, and will be probably an
ongoing one for the Community for a period of time. Lillee?

MS. GELINAS: I want to really commend you, too, and I'm sure there will
be a final report, and I'm sorry I won't be at the next meeting. But you
know what would really help our Workgroups? I'm sure that there were
some enablers that helped you get the job done, and you identified some
barriers along the way. And having those visible to us, in our
Workgroups, could really help us, because, you know, at the end of the
day we're all about trying to adopt technology. And it would be just so
helpful to \-- thousands of man hours on each of your teams had to have
gone into this process. And if we were able to distill out, you know,
the enabling top ten, the barriers top ten, and then those of us that
are on Workgroups, that are working to eliminate some of those barriers,
but also use some of those enablers to speed adoption, it would really
inform our work a great deal.

But I don't want to burden you with that, knowing what went into it so
far. But you're just sitting on a wealth of knowledge that we don't
have.

\[low audio\]

\[laughter\]

DR. LOONSK: Thank you for those comments. In closing, I would like to
just show you the numbers of people that have participated in this, and
this will go into the presentation that is posted to the web, but not
just the three markets represented, but all the vendors and technical
contributors for IBM, for Northrop, for CSC Connecting for Health, and
for Accenture. It gives you a real sense for the numbers of people that
have been participating and working on this work, and congratulations
everyone. You did it flawlessly. Thank you.

\[applause\]

DR. KOLODNER: That's certainly a terrific, terrific ending to the
meeting. Thank you so much. This is a culmination, certainly, of an
incredible amount of work, and I think shows that when we work together
to \-- on an aggressive time schedule to show some of the new
capabilities in the things that we need to have, that industry can
certainly join with the Community to come through, and to be able to
deliver that capability in this case, the prototypes.

At this point, we move into the final phase of the meeting, and that is
the public input. What I'd ask is if there is any public upstairs on the
second floor, on the third floor here, who want to have public input,
that they please come down to the second floor. We have microphones down
here, and you'll be able to have that comment heard by the Community.
And because of the logistics of that, I want to pause just a moment and
give people time to make it downstairs, and have somebody monitoring
upstairs and downstairs, to see if we have anybody making their way
here.

While we're waiting to give them a chance \-- do we have someone for
public comment? Yes.

MS. SERKS: Thank you. It was hard to hear in this room without the
speakers. I'm Catherine Serks \[spelled phonetically\]; representing the
Association of American Physicians and Surgeons, the largest
professional association of physicians in the practice of private
medicine since 1943. So most of our guys are solo practitioners or small
group practitioners.

And as a note, I'd like to also tell you that I also sit on the Health
Information Technology Subcommittee of the Health and Human Services
Task Force of the American Legislative Exchange Council, which is the
nonpartisan association of state legislators. So we are working in that
group, as well, to develop a set of principles for state \-- and model
principles, guidelines, for state legislators to take back to their
legislative bodies.

But I am speaking on behalf of AAPS today. I wanted just to make two
brief comments today, and the first is on the subject on incentives on
adoption of EHR, HIT, and then the PHR, by extension. And that is, I
want to commend the Workgroups, because all of the recommendations that
I've seen, and the discussions that I've heard, in sitting in the
Workgroup discussions, have been to take an incentive approach, the
carrot rather than the stick. And I've seen this consistently.

And just to mention that in previous meetings, the Secretary has alluded
to Congressional action that would actually take a little bit more of
the stick approach. So I want to commend the Workgroups for that
approach, and that as an extension of that, we would also like to make
sure that the incentives are incentives on top of, rather than instead
of. For example, rather than having a decreased reimbursement rate, for
example, if you don't adopt, that it would be an additional
reimbursement rate if you do adapt, on behalf of providers. That's a
true incentive, in our view.

And also to that end, AAPS has unanimously passed a resolution
supporting the voluntary adoption of HIT, and that further adoption of
\-- and further in that resolution, that adoption of HIT, or an EHR, not
be a requirement for participation in a government program for either
the provider or the patient.

I can also report that ALEC, as I mentioned, is working on a set of
principles for HIT adoption, and that the draft versions take that
approach as well, preferring the incentive. And for the state
participation to be on an incentive base rather than a \-- a voluntary
and incentive based.

Now, my second comment is on issues regarding the HIPAA noncovered
entities, the issue that has come up with the consumer empowerment
recommendations. And as the Committee already recognized, in your
discussion earlier today, the language regarding the extension of the
best practices, et cetera, to noncovered entities poses some tricky
problems in that the federal rules, of course, only apply to covered
entities. AAPS believes that it would be valuable to suggest best
practices for noncovered entities, but we would oppose any efforts to
extend HIPAA regulations to noncovered entities. So that's simple
concept.

We have many members \-- and let me give you a brief background on that.
We have many members who have chosen to remain noncovered entities. But,
that is not the only reason that we have a concern. It's on behalf of
our patients and their ability to give informed consent. And as all of
you know, HIPAA does not require patient consent for disclosure of
records, but merely the advisement of how the records may be used, and,
of course, there is the provision for the nonbinding request for
specific restrictions.

So some of the patients who chose to utilize noncovered entities as
providers do so to protect their ability to consent to disclosure. The
privacy issue is one of the reasons that patients do go to noncovered
entities. And this would be lost.

So in summary, AAPS believes that patients should be empowered as
consumers, as the Workgroup says, consumer empowerment, but \-- and that
consumer empowerment means greater and better choices. But we also
believe that one of those choices should be the choice of refusal. That
we believe that patients should be able to refuse treatments. We also
believe that patients should be able to refuse to participate in an HIT
or NHIN system.

So it's very promising to see the demonstrations today include multiple
opt-out points for patients, in the granularity that we have discussed
in the past. So I want to thank you for your work, and I would be happy
to submit to the committee, or the Community, for the record, a copy of
our resolution, if you would like that. Thank you very much.

DR. KOLODNER: Thank you very much for your comment. Are there any other
individuals who have comment for the Community?

Not seeing any, we will draw this 11th meeting of the Community to a
close. As you have seen, it's been a very full meeting with a wide
diversity of topics, and most importantly, we've seen the culmination of
a number of the activities that we started over a year ago, and see that
we're making great progress and now have the priorities set, at least
for the standards activities. We can turn that crank, again, and get the
next set while we move on to the next phase of the NHIN.

So thank you all for attending, and for staying through the long, full
day. And we will see you next at the March 13th meeting of the
Community. Thank you all. With that, we'll draw the meeting to a close.

[\[Whereupon, the meeting was adjourned at 4:30 pm\]]{.underline}