[This transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

National Health Information Infrastructure (NHII) Workgroup

April 9, 2004

Hubert H. Humphrey Building
Room 725A
200 Independence Avenue, S.W.
Washington, DC 20201

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, 160
Fairfax, VA 22030
(703) 352-0091

TABLE OF CONTENTS

P R O C E E D I N G S

Agenda Item: Welcome, Introduction and Recap of NHII Workgroup Work Plans

DR. LUMPKIN: – raise their voice when they introduce themselves as we go
around the room. Let’s go around the room. We are going to do
introductions. I’ll talk a little bit about the agenda, what we are trying
to accomplish today, and then we’ll get going.

So let’s start off with Marjorie.

DR. GREENBERG: I”m Marjorie Greenberg from the National Center for
Health Statistics, CDC, and the Executive Secretary to the committee.

DR. HARDING: Richard Harding, member of the committee, and at the
University of South Carolina, School of Medicine.

DR. STEUERLE: I’m Gene Steuerle, member of the committee and from the
Urban Institute.

MR. HOGAN: I’m Bob Hogan, on loan from Kaiser Permanente, working with
NHII.

MS. FYFFE: Kathleen Fyffe. I work for the U.S. Department of Health and
Human Services, and I am staff to the NHII Workgroup of committee.

MS. BEBEE: Suzie B. Bebee, working on NHII.

MS. WITHIN: Olga Within(?), ASPI(?), working on NHII.

MR. YASNOFF: Will Yasnoff, NHII.

MR. BUTELL: Ted Butell(?), NIH, MCI.

DR. STEINDEL: Steve Steindel, CDC, staff to the workgroup and liaison to
the full committee.

DR. HUFF: Stan Huff with Intermountain Healthcare and the University of
Utah in Salt Lake City, and member of the committee and the subcommittee.

MS. DEERING: Mary Jo Deering, Office of Disease Prevention, Health
Promotion and lead staff to the workgroup.

DR. LUMPKIN: John Lumpkin, and I’m Chair of the committee and from the
Robert Wood Johnson Foundation.

Kelly Cronin just arrived from CAHIT.

MS. JACKSON: Debbie Jackson, NCVHS staff.

MS. BICKFORD: Carol Bickford, American Nurses Association.

(Several off-mike speakers identify themselves).

DR. LUMPKIN: Okay. We have three major things that we are going to cover
today.

The first, we are going to do some updates from the department on the
conference plans. We are going to – have four things actually – an update on
the Connecting for Health Initiative. Carol Diamond should be arriving some
time this morning to update on some of their recent activities. Kelly will do
an update on CAHIT, the Council for Application Health Information Technology.
Then, we are going to have some discussion following that.

What I would like to attempt between now and when we adjourn – and I am
going to be shooting for a two o’clock adjournment, because there is a
CAHIT meeting at two o’clock – and that is that there are two issues that
I think are going to be important for us to discuss to begin getting our work
done on our time line, other than those activities around the conference and
keeping up to date some important developments.

Those two issues are to try to define the new dimensions that we discussed
when we started mapping out our concept, and second is to look at the areas of
overlap that we would like to focus in on between the current dimensions and
any new dimensions that we may want to define, and that will then set some
tasks that we may want to then do in order to follow through on those areas of
work to flesh out those pieces of our new recommendations. That’s
agreeable?

Okay. Let’s start off with Bill.

Agenda Item: Update on NHII Conference
Plans

MR. YASNOFF: Thank you, and good morning.

Can the folks on the phone hear me?

MR. BLAIR: Yes, we – at least I can.

Simon?

DR. COHN: I’m fine. Is anybody else on the phone?

MR. BLAIR: Jorge, is, I think, also on the phone.

DR. LUMPKIN: And the rest of us, so to speak. (Laughter).

MR. YASNOFF: Okay. Well, I am going to go ahead. In keeping with your
plans, I’m going to try to be very brief.

Just as a reminder, we have our six-point strategic plan – inform,
collaborate, convene, standardize, demonstrate and evaluate – under which all
our activities fall.

Under inform, collaborate and convene, we are making presentations at
multiple places. We are doing ongoing educational seminars. We had a very
interesting one yesterday where we discovered a number of new local health
information infrastructure efforts that we were not aware of previously being
done in the private sector, so those are very helpful.

We had a meeting with stakeholders on March 29th to talk about
the requirements of NHII, and I’m sorry I don’t have a detailed
summary for you, but we promised the participants that we would let them review
the results of the meeting before we distributed it, but I think it was a
productive meeting, in terms of thinking about things that NHII must be able to
accomplish before we can say that it is completed.

Also, as I have mentioned here before, I think it is very important to have
a good set of requirements that everyone agrees on before we engage in detailed
discussions about architecture, because, clearly, the measure of any
architecture is whether it can meet those requirements. So at the next meeting,
assuming the next meeting is not – the next meeting of this group – assuming it
is not going to be in the next few days, we will have some preliminary
information on the requirements, and we’ll be asking the workgroup to
comment on those, add to them, et cetera, and we intend to circulate those
widely for comment.

We have been collaborating with a number of outside organizations,
including Connecting for Health – and I’ll let Carol Diamond talk about
that – and, of course, we are planning for the NHII 04(?) meeting, and
I’ll spend a few minutes on that.

We do have our website, which I can show you, which is ready, and this is –
this is not a live shot of the website, but it is a reproduction of what is
live.

The eight topic areas we are going to be considering at this year’s
meeting are personal health; governance; incentives; number four is standards
and architecture; five is confidentiality; six, measuring progress; seven,
population health; and eight, clinical research.

And, in addition, we are going to – as I believe I mentioned last time –
have a tutorial evening before the meeting, so that new attendees can get up to
speed on what NHII is.

In addition, we are going to have sessions for specific stakeholder groups.
We have defined 10 groups of stakeholders, and for those on the phone, those
are consumers, healthcare providers, healthcare organizations, employers,
public health, payers, system developers, researchers, long-term care and
health plans.

SPEAKER: These are in your handouts, too –

MR. YASNOFF: Yes, you have handouts of all this.

DR. LUMPKIN: Now, is this on the website?

MR. YASNOFF: This is all on the website. These are just copied right from
the website.

DR. LUMPKIN: Okay.

MR. YASNOFF: And I’m not going to go through this in detail, but I did
want to point to one thing that was changed, based on the feedback from the
workgroup from last time.

There was some concern expressed last time. As you recall, we are going to
have breakout groups by topic, but we also put in one breakout group by
stakeholder, and there was some concern expressed at the last meeting that one
breakout group by stakeholder was not sufficient, and what we did is – since
that breakout group with the stakeholders is adjacent to a lunch period, we
changed the lunch to a box lunch and basically extended the stakeholder
discussions to a longer period of time. So the stakeholders’ discussions
actually are almost three hours. We have almost three hours devoted to that. We
are not going to have any kind of a speaker at that lunch, and everyone will
stay in their breakout rooms.

As you can appreciate, one of the reasons we wanted to do it that way has
to do with the logistics of reconfiguring the space for the stakeholders versus
the topics, but we were trying to be sensitive to the feedback and have
reconfigured it in that way. So be interested in your comments on that.

Again, I won’t go through all of this, but I do want to highlight our
endorsers were having a great deal of success in getting endorsements from
various organizations, and I’ll just flip through them on the screen. I
believe we have over 40 endorsing organizations at the moment, and we are still
contacting people. So there’s a great deal of interest in this,
substantially more interest than last year, and so we are very excited about
that.

So I will – let me move on.

So in our other strategic area – standardize, demonstrate and evaluate – we
are working with HL7. As I suspect most of you know, there is a set of
functional standards for the electronic health record, which is currently in
ballot. That ballot closes in a few days, and we hope that it will be
successful. We expect that it will be, and we are in the process of tasking HL7
to develop an EHR interchange standard that will allow the easy transmission of
electronic health records in total from one place to another in standardized
form, essentially enabling the transaction, Send me Mary Jones’ entire
record.

In this work we are coordinating very closely with the VA. They are very
interested in working with us on this, and anticipate using this standard to
connect with local health information infrastructures all over the country, and
this is very helpful in their efforts to integrate their information, not only
within the VA, but information outside the VA about their patients who are
treated elsewhere.

Interestingly, according to their data, 40 percent of the folks who seek
treatment from VA facilities also are being treated elsewhere. So there is a
significant issue in terms of information from the VA being available to
outside providers, as well as the information from outside providers being
available when folks come to the VA for treatment.

On April 13th, the full details of a solicitation for state
demonstration projects of health information infrastructures will be announced
by AHRQ. This is public information already. There has been a preliminary
announcement made.

The intent is to receive applications from state governments or their
duly-appointed agents for the development of statewide infrastructures,
infrastructures within the state, perhaps – in the case of smaller states –
regional infrastructures that involve multiple states, and the details – in
terms of receipt dates for applications, evaluation and so on – will be
released on April 13th.

We are also working hard to try to do something in our backyard, so to
speak, in terms of bringing together the stakeholders in the National Capital
Area and trying to create a local health information infrastructure here, and
we are going to have our first large stakeholder meeting on April
26th – folks from Virginia and Baltimore and DC – to talk about how
we might organize such an effort.

We believe that, in addition to the obvious advantages of having a local
health information infrastructure of where we live, so that we are less likely
to be the victims of medical errors and so on ourselves, we also feel it is
important to be able to show to senior policymakers who are obviously in this
area how this type of improved information flow can impact the quality of care
that they and their families receive.

We are also working on evaluating financial and other potential incentives
for accelerating NHII. For those of you who were not at the Connecting for
Health meeting – and I hope I am not taking anything away from what Carol is
going to say – Mark McLellan(?) was at that meeting, and, as you know, he is
now the Administrator of CMS, and he made it clear that he wants to do
everything possible to – from his point of view – to accelerate the adoption of
electronic health records and promote the development of the NHII.

So I’ll stop there and we should have plenty of time for questions.

Thank you.

DR. LUMPKIN: Okay. Questions on the phone?

Okay. Steve.

DR. STEINDEL: I have a comment and a very quick business question.

I am very pleased to see the merging of the box lunch and the stakeholder
session. I didn’t understand that when I saw the agenda. I think that is a
very good move, very good idea. Thank you.

MR. YASNOFF: If you have any suggestions for how we could make that clearer
– indicate it more clearly on the agenda –

DR. STEINDEL: I think – I’ll think about that.

MR. YASNOFF: Thank you.

DR. STEINDEL: Thank you, Bill. I thought you were going to ask do I have
any suggestions what to serve for lunch. (Laughter).

MR. YASNOFF: Well, we would be happy to hear – (laughter) – but we will
take those under advisement.

DR. STEINDEL: Yes, my business question: Last year, the members and staff
to this workgroup attended the NHII meeting had no registration fee. Will that
continue this year?

MR. YASNOFF: That is not up to me.

DR. STEINDEL: Okay.

MR. YASNOFF: And, essentially, just to make the situation clear, the way
the financing for the meeting is working is basically the department is paying
the entire cost of the meeting, except for meals, and so the registration fee
basically covers meals. So whether the members of the committee are subsidized
–

DR. GREENBERG: We actually paid the registration fee for all the committee
members last year.

MR. YASNOFF: Yes, but those are from funds that are – those are committee
funds.

DR. GREENBERG: No, that’s what I mean. The NCVHS budget –

MR. YASNOFF: Right.

DR. GREENBERG: – paid for committee members, and I think government and
staff paid their own –

MR. YASNOFF: Right. I certainly would not object to that and would
recommend it, but those funds are not under my control.

DR. GREENBERG: I think when I inquired, I got the explanation that you did,
and then I think we have to actually deduct the per diem appropriately, because
of the meals, but we will pay for the – the NCVHS budget will cover the –

MR. YASNOFF: And it’s certainly –

DR. GREENBERG: – registration.

MR. YASNOFF: – would be completely appropriate to also pay for travel and
hotel and so on.

DR. GREENBERG: Well, we will do that as well.

DR. STEINDEL: Just one more comment, John. This is to the workgroup. We
announced – at the last meeting, there was some discussion on the HIMS(?) NHII
survey, that it was coming out. It is now out. It is on the HIMS website, and
if anybody is interested in participating in the survey, they can go to the
HIMS website and there is a link off the first page to do that.

As the coordinator for that, I encourage our participation, so we can help
skew the results. I mean, so we can get some good results. (Laughter).

MR. HOUSTON: Back to that last point you made about coverage of NCVHS,
there are two sessions at the end related to NCVHS. So I can’t imagine not
being able – I mean – support that, because, frankly –

MR. YASNOFF: Right. There is no tuition fee associated –

MR. HOUSTON: I understand that, but – travel – well, these two things –
workgroups or NHII workgroups –

DR. GREENBERG: Right. And those are completely open to the public. There is
no registration fee –

MR. HOUSTON: But the point in terms of the staff is is that if the staff is
going to get there to support that, so, in terms of travel, that would have to
be covered –

DR. GREENBERG: Be like any member meeting.

MR. YASNOFF: But the committee members would not have to register for the
meeting to attend those hearings, because those are – well, first of all, we
wouldn’t charge the committee members to attend their own hearing –
(laughter).

DR. GREENBERG: We appreciate that.

MR. YASNOFF: After long and hard consideration, we made that decision –
(laughter) – but –

SPEAKER: Charge us double.

MR. YASNOFF: – but those sessions are open to the public at no charge. So
what we are talking about is –

MR. HOUSTON: The registration.

MR. YASNOFF: – registering for the rest –

MR. HOUSTON: But I believe Steve had also talked about travel, also.
That’s the reason I just brought that up that it would seem
counterintuitive not to cover travel.

DR. GREENBERG: Who? Whose travel –

MR. HOUSTON: Committee members –

DR. GREENBERG: Of course.

MR. HOUSTON: – or staff members.

DR. GREENBERG: But we don’t cover the staff members’ travel.
Their own agencies cover that.

DR. LUMPKIN: Just one other thing on logistics, we probably should open up
that session to other members of the committee, and if they are going to be
there, we may want to think about the layout –

DR. GREENBERG: Oh, no. Don’t go there. (Laughter). Excuse me.

DR. LUMPKIN: Yes, ma’am. (Laughter).

DR. GREENBERG: Jackie has been working very closely with Bill’s staff
on the layout. It is fairly complicated.

DR. LUMPKIN: Okay. Okay. Never mind then.

DR. GREENBERG: So I’d rather not open that up.

SPEAKER: I didn’t hear a thing.

DR. STEUERLE: Can I just ask, do we have any formal role at all on
Wednesday or Thursday or we just – we go to what sessions we want to go to?

DR. GREENBERG: Exactly. Unless you are asked by Bill’s staff to serve
as an expert. I know last time some NCVHS members did.

DR. STEUERLE: I have something else major going on those days. I was just
curious what sessions I really need definitely to be there for.

DR. GREENBERG: I would say it is your call.

DR. STEUERLE: Okay. Okay.

MS. DEERING: But it does occur to me it would be good to ask people which
sessions they do plan to attend, if they do, because we know that our agenda,
as a workgroup, is fairly broad, and so it would be interesting to see if there
are any gaps in attendance at any of these sessions. So while we don’t
necessarily need to steer anybody toward them, it would be good to know if we
are covering all the sessions.

MS. RYPEN: When you register, please note which one, because you are going
to be grouped according to which one you put in, and that is important for us
when we do the breakouts.

MR. YASNOFF: And, again, as we did last year, assuming even distribution of
the attendees across the topic breakouts, there will be two simultaneous topic
breakouts for each topic. So, actually, there are 16 sessions, and so looking
at the number of workgroup members, it doesn’t seem possible to me that
every one of those 16 sessions could be covered by someone in a workgroup.

DR. LUMPKIN: Other general questions?

DR. STEUERLE(?): So, Jack, you’ll be –

DR. LUMPKIN: Yes, well, I think what we’ll do is – we are still
talking about a conference that is very short, for those who are doing the
planning work, but for those who are not day-to-day involved with the planning
work, still is a ways off. So I think what we’ll do is, closer to the
date, we’ll do a survey of where members and staff intend to go, and then
look and see if there’s any significant gaps.

Like you, I have a meeting of our board of directors which I kind of have
to be at, so I won’t be there for the last day.

MR. HOUSTON: Along those lines, I noticed you have a lot of TBAs for topic
experts and reporters, and, actually, topic leaders also. How are you making
the determination who is going to be a topic leader and a topic expert with
regards to these specific –

MR. YASNOFF: We, typically, are trying to – I mean, it’s within our
staff, and if you have recommendations, we would be happy to hear them.

The criteria are, in general, just as last year, we know who the experts
are. We are not engaging government folks for those roles. So the government
folks are not being asked to take on any of those roles.

When we find the topic leaders, we really are primarily asking them to
identify the other people for us, but we work with them on that.

Frankly, it also revolves around people’s willingness to spend the
time doing the work. So the people who – in some cases, the people who have the
most expertise also have the least time and so are really unable to make those
kinds of commitments.

So if you have any suggestions in that regard – specific suggestions about
people we ought to approach or process suggestions about how those people
should be identified, those would be welcome.

We are working as hard as we can to get all those people nailed down as
quickly as possible.

We do, however, this year – last year, we asked the folks who were in the
lead to actually do facilitation at the meeting. This year, we are not asking
that, and we really want the lead folks to essentially cull material for
background information for attendees, so that we don’t start the
discussions of the topics with a blank slate, because, obviously, all those
topics have been extensively discussed before.

MR. HOUSTON: And is it going to be a pickup – is a lot of that discussion
going to pick up from last year’s –

MR. YASNOFF: Yes.

MR. HOUSTON: So there is going to be sort of the background from the prior
year’s –

MR. YASNOFF: Yes, the recommendations from last year are the starting point
for all the discussion of this year. There will, of course, be some – since the
topic areas are not identical, there will be some judgments made as to which
recommendations apply to which topics.

MR. HOUSTON: And sort of a followup point to that, near and dear to my
heart are both privacy, confidentiality, as well as security, and I am
wondering where – is security an architectural issue at this point or is it to
fall under confidentiality at this point?

MR. YASNOFF: Security is primarily an architectural issue, and, in general,
I think my view of security is that it represents the mechanisms by which you
implement the privacy and confidentiality policies that you decide that you
want to have, and in the meetings that I have had previously where we have had
security as a topic, it has been concluded, on multiple occasions, that the
security needs – the actual computer security requirements for healthcare
information are – now, this is the security requirements – are no different
from those in any other area and can be satisfied by industry standard security
techniques.

The real issue seems to be in the area of privacy and confidentiality – in
other words, what policies need to be set. Once those policies are set, you
have to make sure that you have an architecture that allows for security
implementation and that you have a security regimen that provides the
appropriate level of protection that is consistent with your policies.

So I guess long and short of it is I don’t think a specific discussion
of security in the context of health is particularly productive, but if you are
volunteering to work on the confidentiality area, we would welcome additional
assistance.

MR. HOUSTON: I would be happy to – my benefit.

MR. YASNOFF: We will make a note of that.

MR. HOUSTON: And am I allowed to ask one other – I had one other question –

DR. LUMPKIN: Is this going to be a lawyer question or a regular question?
(Laughter).

MR. HOUSTON: Yes, it is. It’s an attorney question.

DR. GREENBERG: I gotta sit between the lawyer and the doctor here.

DR. LUMPKIN: Go ahead.

MR. HOUSTON: And that actually is a good lead in.

There were some regulatory issues that came out of the last year’s
session, and I do know that some of the guidance that just came out in the
Federal Register –

MR. YASNOFF: Yes.

MR. HOUSTON: – helps improve the climate with regards to developing –

MR. YASNOFF: Yes.

MR. HOUSTON: – NHII. Is that going to be consumed under a
confidentiality also or should – I want to make sure that – because that came
as a big recommendation a lot of groups that there were regulatory issues that
needed to be addressed –

MR. YASNOFF: Yes.

MR. HOUSTON: – and I am wondering how that is going to be handled in the
framework of this.

MR. YASNOFF: I think the issue there – that is a good question.

First of all, let me highlight what has been done, and I apologize for not
doing that in my presentation, because I do think this is a major positive
development.

There has been established now a safe harbor under the Stark Rules for
investment in information technology that is in general in the community, and
this issue has been brought up again and again, the problems that Stark creates
for these kinds of investments, which are – in our view, as long as there is no
quid quo pro and they are relatively disinterested, these are legitimate
investments that should be no reason to preclude those, and so that has now
been changed, and I think that is a major positive step.

So I’m very happy that we were able to get that –

MR. HOUSTON: Yes, I read the regs, and I’m very happy, too. I think –
frankly, I don’t know if it is in the purview of NHII to maybe – I know
there is a comment period here. Maybe it’s passed by the time we get to
this, but I think there’s a little – I wish it was even a little bit
better, personally, but maybe I am asking too much.

MR. YASNOFF: Well, it is certainly not for us to comment, but if other
people wish to comment, that would be wonderful.

There was a strong recommendation from last year’s meeting that the
regulatory barriers needed to be examined and removed, and, as this action
shows, we have taken that recommendation seriously and have been working hard
on it.

As you know, we cannot say anything about what we are doing with respect to
regulatory activities until they are announced. So I cannot brief you on what
we were doing, what we had been doing, before it was done, nor can I brief you
on what we are doing before it is done, but we did take that recommendation
very seriously. We are looking at those, and the sense for this meeting was
that that recommendation, essentially, has been made. We are acting on it, and
we don’t see the need to have another discussion and recommend it again,
and so we wanted to focus on those areas where additional discussions were
needed.

MR. HOUSTON: But there were some other discussions, I know, at least last
year, when I was in the confidentialities group, with regards to issues related
to state law, as I recall, and, obviously, that is a much more complex issue,
but I know in the State of Pennsylvania, where I am from, state law is going to
be a definite barrier to establishing local health information infrastructures,
and so I am just – I don’t want to loose sight of it, because I think it
is –

MR. YASNOFF: I agree.

MR. HOUSTON: – hugely important to try to make sure –

MR. YASNOFF: I think within the area of confidentiality, those ought to be
discussed, and, again, we are cognizant of those.

MR. HOUSTON: Great.

MR. YASNOFF: Let me tell you what my experience has been with these
regulatory barriers.

I consistently hear from people as I give talks across the country that
there are these regulatory barriers, and what I ask people to do is to send me
the legal opinion about those. No one has actually sent me such a legal opinion
at all. I have literally not been able to document, even in an email, a single
legal opinion related to this, but I believe that they exist, but other people
have been able to document these, and when they research them, they find that
the issue is not that the regulations prevent the proposed action, but that the
counsel involved misinterpreted the regulations and was being overly
conservative, which is also a problem which we recognize.

So we are – I just want to emphasize, we are aware of those problems. We
are doing what we can, but I can’t tell you what we are doing.

DR. LUMPKIN: So let me see if I understand it. This is a problem because of
lawyers.

MR. YASNOFF: I didn’t say that.

DR. LUMPKIN: (Laughter).

MR. YASNOFF: But it could be true.

DR. LUMPKIN: But it could be true. (Laughter).

MR. YASNOFF: And I just point out I am not under oath.

DR. LUMPKIN: (Laughter). I couldn’t pass that one up.

MS. DEERING: I have a little diplomatic point, and then three substantive
issues around the breakouts.

The diplomatic point is under your conference endorsers, and as we are
staff here, part of the Office of the Secretary, you have the Department of
Health and Human Services listed separately, and then you have AHRQ and CDC
listed as other organizations, and, with a smile on my face, I point out that
they are very much a part of the Department of Health and Human Services, and I
urge you, in your graphic layout, to make sure that they are grouped with the
Department of Health and Human Services.

We know that they are sovereign nations – (laughter) – and we have NIH, the
most sovereign of them all, speaks directly to God, as we say, but, anyway, we
like to remind them now and then –

DR. LUMPKIN(?): We have a Messiah going there. (Laughter).

MR. YASNOFF: I will refer –

MS. DEERING: I’m an evangelist –

MR. YASNOFF: I agree with your commend and I appreciate it and I will refer
it to the NHII diplomatic department for resolution. (Laughter).

MS. DEERING: Good. Good. And to the graphics people –

MR. YASNOFF: We have our liaison with the State Department. We’ll be
working on this.

MS. DEERING: Good. Good. Good. We can negotiate that.

Turning to the page that shows the breakout process on your conference
overview, I have some comments about the personal health bullet, the governance
bullet and the clinical research bullet.

As you would expect of me, in characterizing the personal health breakout
session as focusing on inviting consumers and patients to participate in
discussions, that is extraordinarily condescending and it doesn’t get at
the substance of what I know you really are trying to do and what David Lansky
is trying to do, so I suggest alternate language developing the role of
consumers and patients in the NHII and LHIIs –

MR. YASNOFF: If you could pass that to me in writing, that would be very
helpful.

MS. DEERING: Happy to.

And under governance – and I know that this came out at our last meeting,
you are still only talking about how to organize LHIIs, and I think that
language is a carryover from last time, and you have shifted your conference
goals, et cetera. So, based on my understand of your shift in orientation, I
would encourage you to expand that language as well, and getting into
diplomatic issues, perhaps it is the sovereign relationships between LHIIs and
their – you know, maybe it’s the federal structure of the NHII to continue
our – image here, but I think that it would help if that were expanded.

And then under clinical research, again, it seems to me that you have
framed it even more narrowly, in that it is purely about discovering health
risks, using these data streams, and, again, my understanding – I’ll ask
you there. Was that intentional and is that supposed to be the sole discussion
at this conference about clinical research within the NHII?

MR. YASNOFF: We would be happy to expand it.

MS. DEERING: I mean, it’s important, but I just didn’t know if it
was intended to be –

MR. YASNOFF: No, and I appreciate your comments on this. We have not
reviewed this since the last meeting.

MS. DEERING: Okay. Well, I can suggest some language on all of this.

MR. YASNOFF: That would be appreciated.

MS. CRONIN: I have another point about how you are describing the various
breakout sessions. I think that during the last NHII workgroup meeting we
talked about referencing quality or patient safety in the context of measuring
progress, given that that is one of the short- and long-term outcomes that we
would like to see. So if that could be incorporated in some meaningful way to
these areas, I think we would be consistent.

MR. YASNOFF: Actually, I can – we did address that issue, and let me speak
to that directly.

I think it is completely clear that one of the most important goals of NHII
is to, in fact, enhance the quality and safety of patient care, and, as you
recall, at last year’s meeting, there was a draft on quality and safety,
and, basically, it is so clear that you need a health information
infrastructure to improve quality and safety that we did not feel that any more
discussion of that was worthwhile. This is – again, we have recommendations in
that regard. It is well known.

Now, in terms of including quality and safety measures in terms of
measuring progress, I would not want to include that in the description of the
measuring progress section. That is up to the folks in the breakout group
whether they want to include that, and, in fact, if we were in such a breakout
group, I can see arguments on both sides, in terms of whether those kinds of
measures should be included.

I think, at this stage, the types of metrics that we need are not related
to quality and safety because it is going to be some time before we have enough
infrastructure to influence quality and safety in a measurable way. So I can
see that you might argue against that.

So I have no objection to it, but I think that if I include quality and
safety, then I think it would be necessary to include a whole laundry list of
potential metrics which I don’t really want to include.

MS. CRONIN: But I think it is also important to keep in mind that
improvements in quality and safety could end up helping with sustainability –

MR. YASNOFF: No argument.

MS. CRONIN: – and being a key factor in decision making to even initiate
LHIIs or, you know, within an institution.

I know, in the Connecting for Health meeting, a leadership sign that Carol
will talk about – there was some very clear expression or comments made that we
may not have the ultimate business case – to even start – these activities
around different regions. We are going to have to do it because it is the right
thing to do for quality of care. So –

MR. YASNOFF: It’s precisely because everyone agrees on that that it is
not here, because it does not need to be discussed. There are no decisions to
be made. It has all been discussed already.

MS. CRONIN: But I think that there are issues around evaluation and – that
have not really been decided upon.

MS. RYPEN: I think the great thing, though, is during the breakout group,
I’m sure that’ll be discussed, and I know that people that are doing
some of the work are including some of the discussions, but, again, it’s
up to them, because there are the topical experts with regards to what do they
believe are included in that – but just to let you know there is – there will
be. So –

MR. YASNOFF: If there is anything I have learned in this process, it is
that the topics that are suggested for discussion are only vaguely related to
the topics that actually are discussed, but I should mention specifically that
before excluding quality and safety from any of these discussions, I did have a
discussion about this with David Bates, who was – you know – the lead in
following safety, and he agreed that we have said this over and over. It’s
all agreed, and there really – to have another meeting where we discuss that we
need information infrastructure for quality safety just is not a productive use
of people’s time. If people want to talk about it – I mean, nothing that
is on any of these pieces of paper is going to preclude people from talking
about anything they want to at the meeting.

MR. BLAIR: Can you hear me?

MR. YASNOFF: Yes, Jeff.

MR. BLAIR: I would like to make a suggestion, and it is to try to avoid a
problem that we have encountered with the evolution of electronic health
records, and I am concerned that we encounter a similar problem with the
National Health Information Infrastructure and LHIIs.

We have gone through quite an evolution with electronic health records, but
we saw a period of time, beginning, I’d say, in the mid-1995, ‘96,
‘97, where some folks would have some functions that were part of an
electronic record, and they would either say that they had an EHR or other
people would perceive they had an EHR, and when they didn’t have all the
functions and capabilities that other folks wanted, they really became
disenchanted with the capability of EHR.

So we went through a period of disappointment, disenchanted expectations
that were not met, and my thought here is, I am a little bit concerned, as we
begin to have growing support on Capitol Hill, Congress, the Administration –
and the press, eventually – for NHIIs, that they would look at LHIIs – we
identify that there is an LHII here, an LHII there, people would look at those
and say, well, those are geographical subsets of where we want to go, and so I
am wondering if we could come up with some kind of a distinction, maybe
referring to the ones that exist today as emerging LHIIs versus a comprehensive
or complete LHII that would be closer to our ultimate vision of where we want
to go.

MR. YASNOFF: I certainly have no objection to that.

DR. LUMPKIN: How about LHII in situ? (Laughter).

MR. BLAIR: I couldn’t hear what he said.

MR. YASNOFF: It’s just as well. (Laughter). Unless you want to repeat
it, John.

MR. BLAIR: No, that’s okay.

DR. LUMPKIN: No, no. I think your suggestion is better, Jeff.

MR. YASNOFF: I think that is right, and I think that, again, the work we
have begun to do with requirements, hopefully, will lead to a consensus set of
functions that an LHII must have in order to declare itself complete, including
criteria for participation in a given community, which, obviously, would have
to be very, very high. So I agree with you. Is there a way you think that
should be reflected in the material for the conference?

MR. BLAIR: Thank you for asking that question, and I don’t have – I
haven’t thoroughly thought this through. I just reacted to it as I was
hearing the discussions.

The first thought that came to my mind was to refer to the existing
networks, existing LHIs as emerging LHIIs, but maybe we need to give that more
thought to see how we could make the distinction.

MR. YASNOFF: Okay. I’ll try that – I’ll try using that term and
see what kind of reactions I get, and I’ll let you know.

MR. BLAIR: Okay.

MR. YASNOFF: It would be interesting to see how emerging LHIIs – whether
they like being called that.

MR. BLAIR: (Laughter).

MS. DIAMOND: Yes, I was just going to make a suggestion, in response to
Kelly’s comment about quality and safety, and I do agree with Bill sort of
saying having another session on whether an HII is important for quality and
safety maybe isn’t the right angle, but I was going to suggest – and I
know you would agree with this from out last meeting, too – that one way to
look at this is also to say that we have a tendency to think linearly about
this sometimes, in that the infrastructure will have a lot of derivative
beneficiaries. I worry about the patient being the beneficiary. Somebody else
might worry about quality, safety. Somebody else might worry about research,
public health, what have you, and I agree those are all derivative
beneficiaries, but, in fact, the timetable is not coordinated, and so there are
lots of efforts and investments and projects going on that could be laying some
of the groundwork for the NHII and are well-funded and out there, and I think
sort of flipping it and asking whether or not there is an opportunity to think
about the IT investments being made in quality and safety projects as part of
building the NHII, rather than always thinking that the NHII is there first,
and those are built as derivative outputs.

And we talked a little bit about this in our meeting. I think the same
opportunity is there for public health, so that we start to have a conversation
that is more aligned than looking at these as separate silos or sovereign
nations or whatever the right term might be, and I would just make a suggestion
that it might be interesting if you took some of the investments that are
getting made either in the demonstration projects, the CMS, you know, all of
the other funding that Art does outside of the II’s and sort of pool that
into something that would look at IT investments or IT projects that that might
be an interesting angle, and it might be a way to sort of begin to tie those
pieces together.

DR. LUMPKIN: Steve.

DR. STEINDEL: Yes, thank you, John.

I would like to pick up a little bit kind of in a parallel a little bit
with what Carol just said and picking up on what Jeff and Kelly said with
regard to patient safety and emerging LHIIs.

I like Jeff’s phrase, emerging LHIIs, because I think it puts that in
a good context, because, as far as I know, none of the LHIIs can communicate
with each other, and that is an important aspect of the NHII. So using the word
emerging, in that case, in the context of the NHII is very important.

But what I – in regard to that, what we are hearing a lot today with the
electronic health record, which we are really trying to beat onto people – we
are saying this is very important. We are saying this will improve patient
safety. That is an important reason to have it. We need the decision supports
in there at your local place where you are delivering medicine at your point of
care.

Now, the difference between that – and we are driving that very hard and I
think – I don’t think anybody argues with that, and I think it is more or
less a given, but the extension of that to why do I need all these
point-of-care systems that are handling quality, why do I need them linked
together nationally, I think that message is not as clear, and I think that is
the message we should try to drive forward at the NHII conference, not
necessary quality NHII, yes, it’s axiomatic. I don’t think that is
axiomatic to a lot of the people. It’s axiomatic to everybody in this
room.

MR. YASNOFF: Well, actually, you could have a complete fully functioning
NHII and not improve quality and safety one bit.

DR. STEINDEL: Right.

MR. YASNOFF: Although, it would be difficult to not improve it at all, but,
you know, you certainly – let me put it another way. It certainly would be easy
to miss the bulk of the quality and safety benefits if you are not careful
about implementation.

For example, as you point out, the need for decision support at the point
of care. Without decision support at the point of care, you miss most of the
quality and safety and efficiency improvements of information technology, and
one of the points that we have been making over and over is that in order to
have that decision support at the point of care, you need to have standardized
and coded information that can be processed by decision support algorithms,
and, therefore, the widespread universal transmission of free text, in fact,
misses most of the benefits that we believe are important for NHII and the
reason that it is such a high priority. So I couldn’t agree more.

My question back is how do you – how can we emphasize those points within
the framework of the meeting or are there some changes that need to be made to
the framework?

DR. LUMPKIN: Can I maybe make a suggestion? Because I think we all tend to
agree with that concept, but we – as Bill raised, there are issues that really
need to be – a case for it we think it’s been made, and that, to my mind,
says plenary speaker.

MR. YASNOFF: Right. Which we have.

DR. LUMPKIN: To have a plenary speaker to make the case and to infuse,
therefore, in all of the discussions the importance of –

MR. YASNOFF: Right.

DR. LUMPKIN: – doing this with quality as being an underlying –

MR. YASNOFF: And, actually, one – I mean, we have very few plenary talks in
this meeting, as you well know, and we have – one of the very few plenary
sessions is devoted to NHII benefits which are, basically, quality, safety and
efficiency. So – and Carolyn Clancy is going to come and talk about the need
for NHII for quality and safety, and the case is very, very clear.

But I am not sure that that – you know, obviously I agree that we need to
do that. That was our suggestion to begin with, but I think that the idea that
we have to build the NHII in such a way that we do not miss these benefits, I
believe is very important and we, at a minimum, we can make sure that in the
materials that are prepared for the topic discussions that those kind of
overarching points are made to each group.

DR. STEUERLE: I think Kelly was – one thing Kelly was stressing what
perhaps we should include some metrics for measuring progress that involved
quality, and your comment back was, well, we all know that needs to be done. We
don’t know if that should be discussed – but we might want to think of
asking that group to discuss ways to see how the dissemination of better
healthcare is facilitated through the NHII. Like, for instance, the gentleman
who is sitting next to me from NIH, they are undergoing a massive project on
getting research information out into the clinical community faster, and the
NHII will help facilitate that greatly, and we might want to put in a metric on
that –

MR. YASNOFF: I agree, and I think the place for that is in the background
material for that session, but I don’t want to prejudge or influence in
advance what that metrics group talks about. I will be shocked if there are no
recommendations for metrics related to quality and safety that come out of that
group.

MS. DEERING: I have a – I don’t know if it is a comment or a question
to both Carl and Steve, and it would certainly effect Kelly then – and it gets
at Carol’s comment about the multiplicity of efforts that are already out
there, and it occurred to me that maybe there’s another type of metric
that might be of interest mostly to HHS within its realm, and maybe – for our
overview, and my question to Steve is I don’t see this in HIMS or any of
the other metrics discussion – maybe I’m wrong – which is the metrics
that I have seen are still mostly bean counting. You know, the discussions are
about which beans to count.

Is there any discussion or any effort to try and think out what kinds of
connections and links between projects and efforts could be valuable from a
policy point of view, not necessarily from a – from a policy point of view to
actually – is that an old issue or is that being looked at?

MR. YASNOFF: I think that is a very important point, and I can tell you
that I am very dissatisfied with the progress that we have been able to make in
terms of defining what the – even what the universe of metrics to choose from
should be, and I think the reason is that it is a difficult issue.

As you know, I brought that issue to this workgroup and got some feedback.
We are thinking about ways we can address that, and we believe that, at this
point, we are going to need to engage some contract assistants in order to
begin to define a universe of areas where you may wish to measure, but I think
that whole area of relationships is very, very important and speaks directly,
in fact, to the workgroups 2001 report where the NHII definition includes, if I
am not mistaken, the word relationships, and so it obviously makes sense that
we ought to, if possible, try to measure those relationships, because, clearly,
I can tell you, in communities, that you don’t get health information
infrastructure until you first build strong and numerous relationships among
all the stakeholders in the community. I’m not sure how we could measure
that, but it clearly needs to be done.

MS. DEERING: It may be, Ken, that you are doing some metrics within your
own sphere that would be pertinent in terms of not just measuring the quantity
of something that is happening out there, but since you are explicitly linking
such a wide variety of entities, but it does seem to me that it is almost a
challenge for HHS itself, if nothing else, only within its own range of funding
efforts.

What do we want to require them to do with each other? Do we even know? And
do we want to spend the time to say, okay, AHRQ, when you go out, this is what
you’ve gotta be able to do with whatever ASPI is funding. Okay. CMS, when
you go out, whatever you do, this is what you’ve got to link out to
HERSA(?) in its community health plans, and you’ve got – and we’ve
got to bring everybody within the larger circle, but defining what that is that
we are asking them to do together, I think is a little bit of an intellectual
challenge that people should be equal to, and it’s got huge policy
implications for us.

MS. CRONIN: Yes, I think we are just starting to get at that, and maybe we
can talk about it a little bit later. I think it’s really –

MS. DEERING: Are you coming up with anything, Ken, in that regard?

MR. BURTON: We are coming up with a diverse collection of measures, as you
might guess, in different contexts, because, in our repertory, we are, in many
ways, related to what the NHII is doing, but in other ways also orthogonal,
because we are taking a broad cut of biomedical research.

But, yes, actually, we are looking at metrics that look at – and it is hard
for me to do this without being too much in the weeds, because I haven’t
thought of it at the global level, but, you know, how we actually go about
sharing tools, how we go about sharing infrastructures, how we – so things that
are not the direct – you know – how many lives have we saved? How many – you
know – well, how many dollars have we saved, but, actually, what is the sharing
ratio of important biomedical research tools? How commonly does a wrapper that
we have for a particular infrastructure get deployed at multiple locations? How
commonly can a data set that is generated in one location be communicated and
utilized by another community?

So, I mean, so we actually have a whole collection of those that we are
going to be tracking as part of this, and I think, again, there is parallels,
clearly, to what NHII would want to do, and as well direct intersections,
because, obviously, in particular, in the area of clinical research,
there’s touch points for much of what we are doing – what the NHII is
trying to accomplish.

DR. LUMPKIN: Let me perhaps suggest, in the time that we have remaining,
that we may – I would like to maybe suggest that we look at some of the
breakout groups and have some discussion about the preparatory work,
particularly to the extent that there may be some ideas that we may have to
suggest on how those documents or issues the documents should address that
would help frame the discussion, suggestions we may have for authors or
approaches to developing those.

MR. YASNOFF: Or volunteers –

DR. LUMPKIN: Or volunteers.

Let’s start off with the personal health – and I don’t know what
your thoughts have been already moving forward on framing that, building off of
work that has happened before. We have, obviously, as a workgroup, have had a
lot of concern about that dimension being the slowest-developing dimension.

MS. RYPEN: (Off mike) – are actually taking – moving forward on it, and
they already have draft work. I mean, again, we are treating these as – you
know, the leads are the ones that are taking it – looking at what is being
done, what was done at NHI04 – 03 and moving it forward.

So, with regards to how best to provide input into these groups would be –
you know, we would like your suggestion. I’m just saying that they are –
many of them – already going on and moving forward.

Bill, I don’t know –

MR. YASNOFF: Yes, I mean, we’re happy to take suggestions into that
process. This is by no means finalized.

I will say that our intent is that these products will be finalized by
mid-June.

MS. RYPEN: Yes –

MR. YASNOFF: So we have approximately two months before they are finalized,
but they are all still relatively early. We are happy to take any comments or
suggestions into the process.

DR. LUMPKIN: I think that you have identified key players and I were to
make suggestions, I probably would make those suggestions.

The question that comes to my mind is to –

MS. DEERING: Actually, on that, the only thing that does occur to me that
may be one suggestion for them, and David would certainly know all these
players, but it could be very useful to get one of the providers or payers who
is fairly far ahead with patient-centered care and very comprehensive, not just
treatment – and we’ve got Blue Cross and Blue Shield in the room, and
they’ve got a good portal, and certainly Kaiser has excellent
patient-centered efforts, so it could be useful to make sure that from the get
go you are incorporating lessons learned for the provider domain.

MS. RYPEN: Yes, they have actually identified two people – but it would be
premature to announce –

DR. LUMPKIN: Okay. Governance.

DR. STEUERLE: Well, in governance, you know, one sentence says how to
organize LHIIs. I would like to see how to organize and link –

SPEAKER: I think Mary Jo has different language –

SPEAKER: Yes, we have that language.

DR. STEUERLE: But the point I want to make that – I don’t care what
the language is.

MR. YASNOFF: We definitely want to expand the area, but I guess what we are
looking for are there specific suggestions of issues to consider or things that
the workgroup would like to be sure are included in the thinking process in
preparing the background materials.

DR. LUMPKIN: I think –

MR. YASNOFF: This particular issue is a very, very difficult one.

DR. LUMPKIN: Yes, and I think the – where I would have a concern would be
to get the input from the United Health Care, Kaiser, those organizations that
sort of span multiple regions of the country to try to get some input, and the
vehicle I was thinking of – even with the personal health – is that if there is
an early draft, rather than trying to influence that, but maybe having a select
group of responders who may be willing to prepare a page or a page-and-a-half
that could be then sent or made available to the participants, so they would
not only see what the group leaders are thinking, but some initial response,
and that will help allow the discussion to not have to retread some of that
area, but actually be more of a thought thinking and taking forward. So that
would be my thought in the government’s area.

MR. BURTON: And I guess I would like to interject what I’m not sure is
a popular comment here as well, but leveraging a little bit what Mary Jo is
saying, it is – there are other national activities going on, even over and
above what is happening in the private sector, that is going to happen through
NIH and other activities. So figuring out how we coordinate or govern all of
those – to a common setup standards I think would be – standards and
operational units I think would be very important and actually help stitch
everything together. So, clearly, national things are happening in Blue Cross
and Kaiser Permanente, but the NIH is doing activities, CDC is doing national
activities. I mean there’s other activities that are crosscutting to those
that would be important in a governance structure.

DR. LUMPKIN: And why should an LHII care? Well, I mean, that is sort of a
rhetorical question, but there is some extent to which that is well and good,
but, you know, I’m in Springfield, Illinois. It doesn’t really
matter. I’m just trying to share information with the doc down the street.

MS. DEERING: But I think articulating – is important, because it does
matter, because you are also having to report probably through CDC – and you
probably have people in your region that are – maybe they are one of Ken’s
grantees, et cetera, and, certainly, you’ve got CMS, who is an active
player. So you do have to care –

MR. YASNOFF: Well, you have another issue that is even more direct, which
is you take any arbitrary area in the country, and that – if you say here is
where we are going to build an LHII, and adjacent to that area you have – you
know, living on the boundaries, you have people who are going to get their care
in the next LHII over in every direction. So you have to – at a minimum, in
order to, again, satisfy the requirement of being able to deliver complete
patient information at the point of care, you have to be able to communicate
with the patient information to the adjacent LHIIs, and, if we do that, with a
set of standards and a set of standard functions, the same standard functions
will then allow you to communicate with VA, DoD, CDC, NIH, other national
organizations.

So I think that, in Springfield, Illinois, what I would say is that
wherever you draw the line, you have to be able to communicate outside, and the
issue then becomes how do we define the set of functions that need to
communicate between LHIIs? Where do we define what those are and what the
standard should be? And that is a governance issue –

MR. BLAIR: This is Jack. Can you hear me?

DR. LUMPKIN: Yes, but I need to see your hand.

MR. BLAIR: Yes. (Laughter).

I would like to chime in on this, that we also have someone really focus on
this issue from a slightly different vantage point, and, again, I am going back
to the history of information systems development within our healthcare
industry where we saw certain vendors and certain healthcare institutions adopt
standards because they saw the benefits of interoperability, but we also have
vendors and systems that exist today that are very successful major vendors
that basically have wound up saying, I am going to put my priority on improving
patient care or selling my healthcare information systems and having it
functionally rich, and I am not going to get slowed down by waiting for the
standards to all be in place for me to be interoperable.

Both of those viewpoints exist. Both have been successful, but, as we
develop the national health information infrastructure, Bill, with what you
just said with the importance of being able to do the linking together, and,
Steve, you were also emphasizing this point, we don’t want to be in a
situation several years from now where there are two major groups of LHIIs,
those that are interoperable and those that have very high function and have
been able to develop quickly, because they ignored standards for
interoperability with others, and I think that we actually need to have an
individual or a couple of individuals really address the issue of how do we put
incentives in place. They might be financial incentives. They might be
regulatory incentives. They might be other types of incentives to tilt the
balance towards the adoption of standards for interoperability.

DR. STEUERLE: Jeff, if I may comment on that, when I was focusing on
governance, agree totally with you. I think there’s multiple areas within
the breakout groups that we will be addressing the distribution of standards
and using the same standard, but when I was looking at governance, I was
looking at more of the legal and the contractual issues about forming LHIIs,
and especially in the exchange of data between LHIIs that needs to be looked
at, and a good example was brought up when Bill mentioned what happens if you
have an LHII that borders on another LHII in a region, and we picked on
Springfield, Illinois, but I would rather pick on Chicago or Chattanooga –

SPEAKER: Careful there.

DR. STEUERLE: Well, basically –

SPEAKER: Now, you are getting close.

DR. STEUERLE: You know, because they are boundary cities between two states
–

MR. YASNOFF: DC.

DR. STEUERLE: DC is another area.

MR. YASNOFF: That is one of the reasons we are working on DC, because we
figure if we can figure that out here, that probably will – either we
won’t be around to – (laughter) – or we will be able to share some –
lessons learned.

DR. STEUERLE: Yes, that was the point I was making, Bill. Thank you. You
are sensitive to it.

DR. LUMPKIN: But I think that the – you know, we are kind of swinging the
pendulum.

What I want to be careful about in the governance is that we do think about
that whatever we do there is going to need to be a balance between the local
needs and desires and the regional, national needs and desires, and so just to
encourage us, we are moving the preparation, that we have a balance presented
to the breakout sessions, so that they can see the interplay in the issues.

MR. HOUSTON: That is as much of an architectural standards issue, I would
think as a governance issue.

DR. STEUERLE: You know, some of it is legal.

MR. YASNOFF: I think this issue of how the LHIIs relate to each other is
something that ought to be brought to the attention of all the different groups
to at least consider as part of their deliberations, because it clearly effects
governance. It clearly effects architecture. It essentially creates a set of
requirements for standards, one of which we are already addressing which is the
interoperability standard for a complete record, but that is not all that is
needed. There are other standards that are needed, I believe. Those need to be
addressed.

The measuring progress, obviously, if there is no measure of progress that
relates to how LHIIs link to each other in any way, we are not measuring the
right thing or we are missing a big piece.

Population health. How are we going to do anything about population health
if the LHIIs don’t talk to each other? That is going to be very difficult.

Clinical research. I don’t think we are going to restrict ourselves to
local area clinical trials, although I assume my NIH colleague will not
disagree.

MR. HOUSTON: Framing that to what stage is set, then, I guess maybe, then –
I guess maybe what Steve said was is we need to reserve governance to those
things that inhibit all the other pieces from coming together, so that LHIIs
flow up to it – an NHII concept, whether that be – whether it be legal issues
or – you know – an overarching framework that, frankly, has to be in place, I
guess maybe that’s it. So it’s sort of like, I guess, you know,
railroads in the 1800s where the track sizes and everything differed, based
upon where you were and what railroad you were on.

MR. YASNOFF: Right. But it’s worse than that, because even if we
define the track sizes, it is as if each state has certain specifications for
the size of the engines, and so when you get to the state boarder, you
basically have to change engines to get into the other state.

MR. HOUSTON: Exactly.

DR. LUMPKIN: But just to take the railroad analogy to its ultimate, there
are certain areas in the mountains of Virginia and other areas where a 4.8-foot
gauge doesn’t work and you actually need to have a narrow gauge in order
to be able to accommodate the curves. So one size doesn’t fit all, but it
should where it makes sense for it to do, and that really is the interaction
between the local and the national standards.

MR. YASNOFF: And, you know, I certainly would not at all minimize these
issues, particularly the communication issues, and I hark back to my experience
with the immunization registry in Oregon when I had a conversation with the
folks in California about exchanging information, and, basically, the
conversation went like this: They said, well, here in California, we have a
stricter confidentiality law than you do in Oregon, and, therefore, we can
never talk to you. Goodbye. (Laughter). So, obviously, that is an obstacle –
those kinds of obstacles, when it comes to healthcare information, have to be
overcome.

If you look at metropolitan areas in the United States, a huge percentage
of them actually go over state boundaries. So this is a huge issue.

MR. HOUSTON: Question. Attorneys aren’t supposed to ask questions they
don’t know the answer to already, but –

DR. LUMPKIN: (Laughter). You just gave away a secret. You’re not
supposed to do that.

DR. GREENBERG(?): This isn’t a court of law.

MR. HOUSTON: That’S right.

DR. GREENBERG(?): This is many things, but not a court of law.

MR. HOUSTON: Thank you, and I am not under oath.

Are there models – is there something that we can look to from the European
Union that – EU and what they are doing with regards to privacy and other
things that might help us in this regard or are we really charting such new
territory here that – and, again, I don’t know the – I mean, is there
another model out there that helps us at all?

MR. YASNOFF: I think there are lessons to be learned from what is going on
in other countries. Those lessons learned may be things we wish to avoid, and
in the case you mentioned, I think that may be the case.

There are increasing efforts to facilitate the discussion of those issues
between countries, and, in fact, there are some preliminary discussions of
having an actual conference to talk about the developing health information
infrastructures around the world and to facilitate sharing that information.
So, yes, there are some lessons to be learned.

On this particular issue, I think that from what I know of what the
European Union is doing, it does not particularly facilitate the sharing of
information. In fact, quite the contrary, makes it quite difficult.

So, to the best of my knowledge, there’s no solution out there
somewhere else that is easily importable, but I am anxious to find one.

DR. LUMPKIN: Okay. Let’s move on to the next area. I think we’ve
given you enough on governance, at least that is how I would govern –

Anyway, incentives. Here – no, please. What I was going to do to frame this
up is, as I have worked more and more with health economists, I have learned
that – how little I know about health economics – (laughter) – and so I was –

DR. GREENBERG: Fortunately, Gene is –

DR. LUMPKIN: Well, yes, I know, because I saw his hand and gave me a good
lead in, but maybe – I don’t know where your thought is going on that.

One of the thoughts I had is that CMS is currently actively involved in
looking – under the Medicare Reform Act – of looking at incentives for quality,
and there has been some work that has been done, I know both internally and
also with some consultants that they have been working with on looking at
models for incentives, and that might be a nice lead in to look at, because
there are similar obscure and contradictory incentives in the area of quality.
So I think that may be one area that I would suggest looking at. Gene. And
maybe – were you volunteering to help on this one?

DR. STEUERLE: Yes, I would be glad to.

When I look at this vast health structure we have built in this country –
the latest numbers I have calculated, we are spending something like over
$15,000 per household on healthcare. That is using CMS numbers and dividing
that into households.

MR. BLAIR: Did I hear you say $15,000?

DR. STEUERLE: That’s correct. Per household.

MR. BLAIR: On healthcare.

DR. STEUERLE: That’s right. That’s adding everything together.
That’s counting the research and the insurance companies and everything.
That is just the CMS numbers divided by the 110 million households, and I have
over half of it coming from government, because I add in the tax subsidy. So
government is chipping in maybe $8,000 per household.

I look at this system and I keep wondering why, with all this money,
haven’t we been able to create what I think the people in this room think
would be an obvious advance would be this type of – infrastructure, and I have
to conclude, as an economist, it must be we have in place some very bad or at
least wrong set of incentives, and what I would really like to see out of this
section is actually two things.

One is I would love for some of the people who come in the room to be
really encouraged to talk about what are the disincentives within their own
structure, and, as far as that is concerned, I wouldn’t mind having some
of the government people either, given that they’ve got half the money at
stake or that is being thrown around. I wouldn’t even mind knowing why NIH
– I wouldn’t mind somebody from NIH saying, you know, we don’t do
this because if you look internally to what our rewards in our structure are,
there is really no reward for us to do this, but there’s a lot of reward
for us having this clinical –

But, at the other end, I would also like to have some focus on what are
some possible incentives that might make things move – and, here, I almost have
the sense that this ball is sort of being pushed up the hill and we are almost
near the top, and we are talking about – you know – we’ve got this
obstacle in privacy and we’ve got this obstacle in terms of protocols –
I’m suspicious that pretty soon that ball is going to go to the other side
of the hill and what we are going to have is instead of people complaining
nothing is going on, they are going to be complaining that we are not quickly
enough – more quickly than we can probably do it, adopt the protocols, take
care of the privacy issues, and I think – you know – particularly about your
example about the Oregon-California sharing, what would happen – this is off
the top of my head, which may be no more advanced than off the bottom of my
head, but suppose that the Secretary of HHS were able, through regulation or by
some change of the law, to say in paying for shots for Medicare recipients, we
are going to pay $3 less for any shot that is given that is not backed up by a)
an electronic health record within the office of the doctor giving it, and b)
is not in a form that can be shared across states or something.

Well, my guess is that if he could do that that there would be a clamoring
at HHS for figuring out, well, how the heck can we do this? The California
people would be complaining about the privacy issues and how can they resolve
that so they can get the extra $3, and I am wondering if some people can’t
be thinking in this section – what are some incentives that might, in the small
– I mean, I see this in the small, but I think what happens if having to have
an electronic shot record meant all doctors decided, well, I’ve gotta set
up an electronic system. If we’re going to do it for shots, I’m going
to do it for some other things, and whether there aren’t incentives – even
small ones that could be put in place even for a few items that might start
create a snowball effect. Again, my notion about having this ball roll down the
hill.

So I would love to have this structured in a way that we really have people
think freely, even – have a lot of wild ideas than none at all in terms of, as
I say, what are some possible incentives, even the small, that might really,
really change the dynamic of the system, as well as my first notion about
having some people tell us what are the disincentives –

MR. YASNOFF: I couldn’t agree more. I think – and we will be sure to
include in the consideration of that group, the issue of what are the current
disincentives, because removing those, in some sense, could be equally or
perhaps even more important than putting in place good incentives.

And, in fact, the incentives now, as Don Berwick(?) has said many times,
every system is designed perfectly to produce the outputs that it produces, and
our healthcare system is designed to produce very expensive, very inefficient
care, which is of very inconsistent quality, and, in fact, one of the obvious
disincentives is that if you practice quality care, not only are you not paid
more, but you are likely to decrease your income if you do a better job, and,
clearly, that is not a good incentive.

I will say that, in addition to, obviously, the deliberations that are
going to occur at this meeting, there are already discussions going on in the
department about those very issues. We are also in our group sponsoring some
specific research looking at that exact issue of what kind of incentives and
what amount of incentive is required to move the adoption of electronic health
records and to facilitate the adoption of LHIIs.

And just – I would summarize the current state as follows: That we have the
benefit now of a substantial number of experiments in pay-for-performance for
physicians, and what we are finding – and I am overgeneralizing, but,
typically, the results of those pay-for-performance programs are disappointing,
and so, in essence, what we believe is the case, is that we are asking
physicians to perform, but we are not giving them the tools they need to
perform, and the analogy here that I like is if you take a group of ordinary
people and give them a financial incentive to travel at 25 miles an hour, and
you do not give them any tools, few of them, regardless of the size of the
incentive, will be able to accomplish that task, but if you give them bicycles,
a number of them will be able to perform, and if you give them automobiles,
probably all of them will be able to perform, and so the question, then, is
what is the equivalent in the information world? If we are talking about
financial incentives, what level of financial incentive is necessary? Is it
sufficient to remove the disincentive or what percentage of income is necessary
– increase is necessary to incentivize the adoption of the HR’s or is
there a specific dollar amount or does it vary by specialty? And so I think all
of these issues are of tremendous interest.

DR. LUMPKIN: Well, let me just throw one other piece into the pot, and that
is that most of what we look at incentives are tied into what I think of as
being a capital-intensive conversion to electronic health records, and that is
a model where you buy the equipment and you buy the software and then, every
now and then, you have to buy the upgrades.

There are also models in back-office electronic health systems where the
vendor sells, on a per-transaction basis, the utility that – the ability to use
their system, and those sort of models then may lend themselves to different
kinds of incentives or reimbursements, because there is no up-front capital
cost.

MR. YASNOFF: That’s right. I agree. I think that if we provide the
financial incentives, one of the results will be that the creativity and
entrepreneurship of the private sector will be very helpful in moving these
systems along.

As an example, in the hospital environment, where savings are, in many
cases, already documented, there are vendors that will essentially give you in
a hospital their information system under a contingency agreement where you
share the savings with them as a form of payment. If we had such incentives in
physicians offices, I suspect that similar vendor arrangements might be
possible, but we – clearly, those savings have to be clearly there, so that
there is something to share to pay for those capital costs or to pay for
ongoing use of non-capital systems.

MR. BLAIR: This is Jeff. Are you able to hear me?

DR. LUMPKIN: Yes, let me just make one comment and I’ll toss it back,
because I just want to remind the group that Bill showed us data at our last
meeting that the difference between the inpatient setting and outpatient
setting was that the benefits in the inpatient setting accrued to the
hospitals, but the benefits in outpatient settings did not accrue to the
providers in adopting electronic health –

SPEAKER: In general.

DR. LUMPKIN: Jeff.

In general. In aggregate.

Jeff.

MR. BLAIR: There’s been, I guess in Health Affairs Magazine and in
others, a fair amount of discussion of pay-for-performance, and I thought, from
the things that I had read, that that was very much on target, in the sense
that it wasn’t going to be paying for the hardware or the software,
because it is so easy to wind up implementing an electronic health record or
the software or the hardware or the network and not really improve quality or
safety or cost effectiveness, where if we look at changing the healthcare
reimbursement system, where our reimbursement system is focused on improved
quality and safety and efficiency, then, it requires that the transformation to
achieve that is that the information infrastructure be put in place.

So I thought that the sections in the most recent law passed in November –
the Medicare Prescription Drug Improvement and Modernization Act – that that
already set out a set of incentives which comes to the reimbursement system
which leads back to the funding for IOM to be able to have the indicators of
performance and the work being done by HL7 on the EHR functionality model to
make sure that the vendors are producing the functions that’ll support
those capabilities.

So, you know, given all of this, I was kind of puzzled by the conversation
here on incentives, because I thought that that was the model we were
converging on for incentives. What am I missing here?

DR. LUMPKIN: I think you’re right, but the issue is is it’s just
as it is with pay-for-performance and the models or the – really, the studies
that are encouraged under the act –

MR. BLAIR(?): Could you speak up a little bit, please?

DR. LUMPKIN: But I think the point is is that we don’t know quite how
to do pay-for-performance yet, and we are not sure which of those models for
pay-for-performance will work, and just as we need to look at that and sort of
get some experience and learn from those experiences, the economics – the
micro-economics in the office as well as the overall system economics, are
different for quality than they are for the use of electronic health record,
and we need to understand those differences – the similarities and the
differences.

DR. STEUERLE: I think there is an analogy between the debate in almost all
public systems or private systems as to whether you want to measure inputs,
outputs or outcomes.

In the ideal, you always want to subsidize the outcomes. The complication
has always been that we often don’t know how to measure them very well, so
you don’t stop for the fact you can’t measure the outcomes and still
– at certain points, you don’t want to pay for outputs or you don’t
want to, in fact, pay for inputs. You know, an educational system being a prime
example. We ideally want to pay for the outcomes of the students, but it still
doesn’t mean, at some point, we don’t decide we want to pay for good
teachers, even though that’s an input. So that is sort of the dilemma.

If you could measure all this perfectly well, you’re right, and that
is where the literature sort of gets very, very mixed is how well can you
measure a lot of these outcomes. Some you can. When you can do it, you really
can get quality improvements, but you can’t stop there.

MS. DEERING: Picking up on a couple of comments that John made, getting at
– the first was about the model where a vendor might provide a utility. The
second was picking up on your own report, Bill, about the benefits on an
outpatient basis not going to the providers themselves. I had two comments
about that same thing.

The first is that, clearly, then, you are looking at incentives for the
payers, because, under any scenario, they benefit. So incentives that
don’t just look to the individual provider at the point of care or his
office practice or the provider organization might be another issue to keep
clearly on the table.

The other is just – this is more a small point. I know that the phrase Hill
Burton(?) continues to crop up, and I have even seen it in, I think, the
presentation that you shared with us, and think those – and, Gene, maybe
you’ll remember this – but I haven’t been around the health policy
trenches as long as my grey hair would look, but I have been told by those who
fought those battles that you want to avoid that at all costs. Hill Burton was
responsible for some of the worst things that happened to the American
healthcare system and that the use of that as an analogy, even simply as a
rhetorical analogy, is something to be avoided at all costs, and so I would put
that on the table for those who may be more knowledgeable about the ugly, dark
side of the Hill Burton Act, and maybe, John, you know that, but –

DR. LUMPKIN: Yes, well, actually, what I was just going to toss in in your
comments about the incentives, the difficulty with the incentives – if we even
know what to measure and can measure it – is that, at some point, for the
payer, does the cost of the incentive initiative cost – in order to give out
enough incentive to change the behavior – is that still going to be cost
effective? And that is where it is a much more complex analysis, because if you
determine what the individual incentives are and then you roll those up for the
whole system, you may say that it is going to cost you more than doing nothing.

DR. STEINDEL: I think picking up on that a little bit, John, what we found
at CDC, and I think what Ken had mentioned in a – conference call we were at,
that they found at NIH – NCI – when they were rolling out systems, it is one
thing to provide incentives, which is what we do when we give grants. We say,
okay, here’s money. Do a standard, and we are going to pay for you to do a
standard, and we did that our first couple of years, and we found out that the
states were more than willing to take our money, and they were going to say, we
are going to do standards, and we didn’t get standards. The incentives
were there, but the tools weren’t there to do it.

And so, now, what we are starting to do is we are starting to say, okay, do
standards. Well, if you have some people that can actually prove that they can
do standards, we’ll give you money. If you don’t, we’ll provide
you direct assistance to put that money in – to put the standards in place.

So I think what you need is the tools out there to augment the incentives.
Just having the incentives out there themselves is not important.

The example that came out now, as Bill was pointing out, these vendors who
go into hospitals and say, here, take it. You know, we’ll take the money
back from what you save. That is really providing a tool and the incentive
coming back. It is a similar type of strategy to what we are doing, and I think
that is something that is important for this group to pick up on.

DR. LUMPKIN: And this is actually going to segue into the next item, which
is standards and architecture, because what overlaps on incentives is how do
you prove that they are actually doing it, and so as we think about
architecture and we think about incentive, then we need to think about
certification and other things of validating the fact that what they are doing
actually meets some sort of reasonable standard.

So any comments on standards and architecture? I tried to sort of bridge
into that to move the agenda.

MR. YASNOFF: Stan, I think that you have to admit that you are involved in
this –

DR. HUFF: I do?

MR. YASNOFF: Stan is our co-lead in that area –

DR. HUFF: Yes, maybe I could start that off. In this area, Bob Greeness(?)
–

DR. GREENBERG: You don’t have to recuse yourself. (Laughter).

DR. HUFF: No. Bob Greeness and I are the cochairs that have agreed to work
as the task leaders, topic leaders in this area, and the things –

MR. BLAIR: Closer to the microphone.

DR. HUFF: I’ll just speak louder. Can you hear me now?

MR. BLAIR: I can hear you now, Stan. Thank you.

DR. HUFF: Bob Greeness and I have had a conference call and are getting
organized in selecting the other experts, but maybe I can share the things that
we talked about and then get some additional ideas here.

One of the things we talked about is we needed to work on process; that is,
if you are adopting architecture, you are adopting standards, and, actually, in
implementing, how does that happen? I mean, it’s one thing to have an HL7
standard or some other thing. We know how, maybe, to do the standards, but, in
terms of architectures, we have – you know, in the two LHIIs that exist, you
have very different models about how the data is put into repositories and how
it is shared, and –

SPEAKER: You mean, the emerging –

DR. HUFF: Yes, the emerging – and so how do you put a process in place
where that can be examined and find out what the best way to do this is, and
talk to people about whether the incentives for a given architecture versus a
different architecture – So trying to set up a process about how you adopt
architectures.

But, then, the second thing is we could also work on what are the options
for architectures, and look at Santa Barbara and look at Indianapolis, look at
others that people have conjectured in terms of the kind of architectures.

A third topic was the special problems related to decision support and
sharing decision support and actually being able to execute decision support
within this framework. So sharing as well as execution and all of those issues.

Other ways that you can organize to implement the standards – I mean, there
have been the possibilities of open-source consortiums to share software and to
share implementations and applications. There could be tool kits. There could
be other business models that we haven’t thought of, in terms of how you
can share tools and architecture and those things.

So, I mean, those are some general things that we had talked about, and,
then, you know, from the discussion so far today, I think – I gleaned that
there are probably some important issues related to architecture at the
boundaries of LHIIs to the national NHII.

It occurred to me that there are issues related to your strategy of
exchanging. So we are creating a standard to exchange a whole EMR, and an
alternative strategy is one where you would request parts of the record that
you needed at the particular time that you are providing care, and there are
pluses and minuses to those things. I see some problem with exchanging whole
records in how you maintain that as new data comes in and all kinds of –

MR. YASNOFF: Actually, what we are contemplating is a standard for changing
the whole record or any defined part.

DR. HUFF: Yes.

MR. YASNOFF: So I neglected to mention that. So the idea is –

DR. HUFF: And those are key and important, and then the next question is,
though, as soon as new data comes in, what happens? And how do I know I am out
of date, and how do I get – you know. Anyway, there are lots of fun things that
–

Also, I think, in terms of architecture and other things that, again, it
occurs to me that we ought to at least look at what is going on in the UK and
the EU and other places about how they have architected their thing and whether
they are doing it right, doing it wrong, what lessons they might have learned
already about architecture, and then just the most recent comment, which was
ways about certifying or validating whether things are good or bad or meeting
the standards. So those are the issues that we have thought of so far.

MR. YASNOFF: Let me answer a question that hasn’t been asked, but,
undoubtedly, is burning in everyone’s mind, which is why are the
architecture and standards discussions combined into one group?

Sorry, Jeff, we dropped you.

And, again, it is an issue of – obviously, standards are crucially
important, but another long series o meetings resulting in recommendations that
we need standards didn’t seem to be very helpful. So by combining them, we
certainly don’t need to minimize the importance of standards, and,
actually, I think one of the things that I am hoping this group will produce
are some recommendations regarding gaps that they see in standards development,
and, in particular, for example, the need for a standard for computable
guideline exchange. So that is why that was done. So before someone says, gee,
this is a problem. I want the answer to that question.

MR. BLAIR: Bill, let me say that I very much support the idea of combining
standards and architecture. I think that is a very appropriate thing to do at
this time.

MR. YASNOFF: Thank you, Jeff.

DR. LUMPKIN: I think I would just want to add one term to that. It is the
concept of being incrementable, that when we think about it, just as Bill
discussed the standards for exchange of electronic health records, the standard
needs to support being able to exchange a subset of that or the entire record,
so that as the capability of the systems – the architecture, the new internet,
all this stuff happens – that we have a standard that can be incrementally put
in place, but, also, robust enough to support what we think ultimately we are
going to be able to do.

MR. HOUSTON: Is the intent, with regards to standards, though, to defer
like to NCVHS or somebody with regards to adoption of specific standards? Is
that what you are really saying is that we are not going to delve into
standards because we are already doing that?

MR. YASNOFF: No.

MR. HOUSTON: Okay.

MR. YASNOFF: No, the intent is to not have another long discussion that
leads to a recommendation that we need to have standards, because we know we
need to have standards. So the issue – the idea is to say, we know that
standards work is going on. There could be recommendations saying we support
that. We are concerned about it, but, in particular, the recommendations we are
looking for are here, the things we see that are not going on in standards that
we would like somebody to deal with.

MR. HOUSTON: I would think it would be of value – at least in order to
settle this particular issue entirely – is to defer – and, again, I know what
NCVHS is obviously doing with regards to providing official support for
specific standards in adopting of specific standards in all these different
recommendations that have come out of the standards subcommittee is maybe
making some type of explicit recommendation that NHII is going to defer
entirely to whoever in that regard.

MR. YASNOFF: Well, I don’t think it is a question of deferring, and,
in fact, the way the meeting is structured, as you know, all the
recommendations from the meeting are going to be presented to this group on the
final day of the meeting, presumably for consideration and further action, but
the activity of NCVHS is obviously very important and helpful in terms of
standards.

On the other hand, NCVHS does not develop standards. Those are developed
elsewhere, and while NCVHS is part of the process of identifying gaps, as we
are thinking about the development of NHII, it is becoming apparent that there
are additional gaps that have not previously been identified that need to be
called to people’s attention.

MR. HOUSTON: Well, maybe I’m not articulating it clearly. I mean,
NCVHS has made recommendations with regards to the adoption of specific
standards, and I’m just wondering whether that is the way you settle – you
avoid delving into the issue of why isn’t NHII recommending specific
standards is to defer that point –

DR. LUMPKIN: Well, but what actually here Bill is suggesting – and I agree
– is that when we adopted the 24 domains for CHI, a number of the domains said,
well, we have maybe one standard. There’s some gaps. There are additional
gaps, and that part of what we hope to come out of the conference will be
saying, this is where there needs to be standard development work, and so as we
put all these pieces together, the recommendations that come from here and
other places, we may continue to make recommendations to HHS as a product of
this workgroup and other – of the conference and other efforts, saying, you
know, HHS, there are these gaps. We see the ball getting near the top of the
hill, and it is going to start rolling down the hill, and if it is going to be
able to continue the momentum, we need to really invest in the standard
development process to make sure that there are standards available, when there
is a demand for them.

MR. HOUSTON: Is there a fear that NHII, though, as it is going through that
process ends up identifying or deciding it wants to adopt different standards
than –

DR. COHN: John.

DR. LUMPKIN: Yes.

DR. COHN: This is Simon. Can I make a comment to John Paul?

DR. LUMPKIN: Yes.

DR. COHN: I think, first of all, he needs to realize this is a meeting,
and, really, what we are talking about is an agenda for the meeting. So,
actually, you know, should remember we, at our last session, had actually
suggested a deemphasis on standards, because we thought that it had been sort
of – I don’t think that there is really any major concern about where Bill
is going with this one. I think it sounds like a very reasonable way of putting
together an agenda for a set of breakout sessions at a major plenary session, a
yearly meeting.

Can I ask Stan a question, though?

DR. HUFF: Sure.

DR. COHN: Okay. And I don’t mean to get off this particular issue, but
I guess this one I am a lot less concerned about than many others.

Stan, you actually mentioned a variety of issues, many of which sounded
like walking through marshmallow fields around architectures and standards and
everything else.

Are you going to sort of have business cases or priorities help focus the
discussion? I mean, of your discussions, the one that really seemed to stand
out and maybe would drive a lot of the issues has to do with the
decision-support piece and really would seem to me that, if, indeed, we
consider a decision support at the point of care to be a high priority issue,
begins to order a lot of the architectural discussions.

DR. HUFF: I think that is a good input, and, you know –

DR. COHN: I don’t mean to interrupt you, but – I think we are all
comfortable with a meeting where standards are not terribly emphasized.

MR. YASNOFF: Let me comment on that specifically. I think that if, at this
meeting, we get to the point where there’s a recommendation that there
needs to be work focused on developing a standard for a guideline exchange and
– that would be sufficient.

The intent of this meeting is not to figure out what that standard should
be, but, perhaps, there may be some recommendations for an ongoing process. We
have already identified this as an important gap, but it would be nice if the
stakeholders agree, and, of course, if the stakeholders say it is not an
important gap, we’ll stop working on it, and we have some ideas about
process as to how to pursue this, but I think this is an important area where I
am very anxious to hear the stakeholders weigh in, because this is – I perceive
this as a serious productivity impediment in the implementation of electronic
health record systems and in deriving the benefits we all want.

If you have to, at each site where you implement a system, in effect, take
written material from the literature, translate that into algorithms and
essentially carve it in stone and no one ever gets the benefit of the work you
have just done again, it seems to me we have imposed a work burden which is
intolerable.

DR. COHN: Bill, this is Simon.

I certainly agree with you, Bill. I don’t know whether a standard for
guideline exchange is necessarily the solution. I mean, there’s the issue
there about how we make good decision-support rules – but, obviously, what you
are describing is one particular solution of what might be many.

MR. YASNOFF: Well, this is why we want to ask the stakeholders.

DR. LUMPKIN: Right.

DR. COHN: Absolutely.

DR. LUMPKIN: Yes, I think we are getting into the conversation for the
workgroup, but I –

MS. DEERING: Can I make a 30,000-foot-level comment on this, which is that
unless I am mistaken and/or deaf, virtually the entire discussion in the data
standards world is around clinical data standards with a little bit around
public health – standards for public health data – a lot, actually, around the
public health exchange, and what I think would be interesting, because these
are questions that are more at the 30,000-foot level, is what are the
categories of needs to support the development of the personal health dimension
and to support other kinds of exchanges between the dimensions that are not
purely related to the precise field of clinical data exchange? I mean, I
don’t know what they are, but it is a broader and more preliminary
question that a lot of good minds might have some ideas about.

DR. STEINDEL: Mary Jo, picking up on that, as I think one of the primary
things that I see from this group is identifying the gaps in the standards, and
I think that is a gap in the standards, as well as like decision support.

I think a key thing is like at recent discussions, the last meeting, all
the work that the NCVHS has done through the years and everything, everybody
accepts the idea there should be a standardized way of exchanging information
in the form of a message. There should be standardized terminologies that
people are using. What we are hoping to move in this session is one step beyond
that.

DR. STEUERLE: I just hope that when you have the stakeholders on this
architectural standards that you can really get them to pinpoint where they are
liable to serve as obstacles. I mean, there is no standard, whether it’s
meters versus speed – standards are IRS trying to get electronic filing and
what they are going to do when there are not a lot of stakeholder things,
don’t do it that way, because you are going to hurt my business, and I
don’t think we are going to resolve that, but I would really like to have
that better identified for me, just – you know – at what points are we really
going to hit those conflicts?

DR. HUFF: Yes, I think that is one of the parts that I didn’t express
very well, when I thought the issue was when we were talking about
architectures and incentives, but I think that is one of the real questions is
if I am one of the commercial vendors – you know, Sir(?), McKesson(?), IVX, all
those guys – I think they have to be asking how do we play in this game? How do
we fit into this architecture? You know, is there a new business opportunity
for us in supplying these repositories or whatever the shared part of this is
or is there somebody else going to do that and we are just the gateway for
that?

I mean, I think those are all really – those are some of the really
important – I mean, as I look at Intermountain Healthcare and this, I mean, we
look at it and say, what is the business proposition that we would do? I mean,
is all the informatics now going to be done in some other institution? Do I
need to buff up my resume because IHC won’t be in the information business
anymore? It’ll be somewhere else. I think there are real issues – and the
vendors have to think about it in the same way.

DR. LUMPKIN: Let’s move on to confidentiality. Are there any items we
want to toss into the mix there? We don’t have to.

MR. YASNOFF: On confidentiality?

DR. LUMPKIN: Yes.

MR. YASNOFF: I think John Paul – we should just drop that –

DR. LUMPKIN: Yes. (Laughter).

Okay. I think we have already talked about measuring, measurement and
metrics.

Population health. Anything to toss in there?

MR. YASNOFF: We are in favor of it.

DR. LUMPKIN: Who is taking a lead on that? Or they have been identified?

DR. GREENBERG: Andrew Ballis(?).

MR. YASNOFF: Andy Ballis and –

SPEAKER: (Off mike).

MR. YASNOFF: No, we did. Andy Ballis and Scott Williams.

DR. GREENBERG: Who is the other one?

MR. YASNOFF: Andy Ballis is the Dean of the School of Public Health, St.
Louis. Scott Williams is the Director of the Utah Health Department.

DR. LUMPKIN: Good. Good mix. I was going to yell at you if you didn’t
have a state person. (Laughter).

Okay.

MR. YASNOFF: That’s why I told Scott Williams he had to do this,
because, otherwise, John Lumpkin is going to yell at me.

DR. LUMPKIN: (Laughter).

MR. YASNOFF: That convinced him.

DR. LUMPKIN: Clinical research?

MS. RYPEN: We have one, but we –

DR. LUMPKIN: Oh, Marjorie wants to go back to population health. Sorry.

DR. GREENBERG: I wasn’t quick enough here.

I was just thinking that – I mean, we obviously have a population health
subcommittee, though, I don’t know that there’s anyone here around
the table – any of the members of this workgroup who are on that.

SPEAKER: (Off mike).

DR. LUMPKIN: Yes, but he’s not here.

SPEAKER: But I’m saying –

DR. GREENBERG: Well, yes, it’s true, but he isn’t here.

But if there’s some way to engage that subcommittee, which is actually
a – the quality workgroup is part of that subcommittee. So it’s a natural
link also, then we would be happy to try to facilitate that, but –

MR. YASNOFF: Especially if we can get some volunteers to help. (Laughter).

MS. DEERING: I was going to suggest former NCVHSers, certainly Dan
Freedman(?) could be very helpful here or Barbara Starfield(?), and I know that
Dan probably would be delighted to play a continuing role in this field, which
he is in his new life.

DR. LUMPKIN: Okay. Back to clinical research.

I wanted to perhaps toss out a name that the Institute of Medicine has a
clinical research roundtable. Alex Omaya(?) is the person who heads that up
from IOM. That might be an important –

MR. BLAIR: Are you able to hear me?

DR. LUMPKIN: Yes.

MR. BLAIR: I always ask, because I can’t see the button to tell
whether my mute is on or not.

DR. LUMPKIN: Okay.

MR. BLAIR: One of the things that I would like to suggest – and I’ve
done this before, but I want to reiterate it, and some of it is a matter of how
we organize our lists, how we organize our topics, and it’s a sensitivity.

I think that we ought to have things related to consumer health and privacy
at the top of our lists, and that when we list breakout sessions and when we
list the topics, that those become at the top.

I have become increasingly sensitive to the intensity of the parts of the
public that feel threatened by the National Health Information Infrastructure.
Obviously, I don’t share that threat at all. I see it very differently,
but there’s so much good work that we are doing, I don’t want to see
it derailed by this idea that that is not a major priority, that that is not –
that we are not sensitive and supportive of privacy and the use of healthcare
information for consumer purposes.

MS. DEERING: As a sort of a followup to that, it occurred to me that I
think we also talked – Jeff, you might have raised it – about making sure that,
wherever appropriate, that we have consumers and patients represented in
breakout groups, other than just the personal health dimension.

It occurs to me that the clinical research area is really perhaps the next
in line. I wonder if we could turn to NIH to help us identify any one who could
help represent the patient perspective in clinical research within this
workgroup.

SPEAKER: We have any number of groups –

MS. DEERING: Absolutely. I think that could be really helpful.

SPEAKER: Right.

MS. DEERING: Again, it makes that statement that this is a value – we are
not just trying to improve research for the people who get more grant funds,
but, actually, the ultimate beneficiary is the patient.

MR. HOUSTON: How are we eliciting people to be involved in the personal
health workgroup?

MS. RYPEN: I think he said how are we –

MR. HOUSTON: How are we getting people to participate in the personal
health breakout –

MS. RYPEN: The co-leads identify and recommend who they think would be part
of their working activity.

MR. YASNOFF: Are you talking about the leads –

MR. HOUSTON: No, I’m talking about –

MR. YASNOFF: – getting people to the meeting?

MR. HOUSTON: Getting people to the meeting, and, obviously, you know, if
the title says consumers and patients, is there any type of outreach
that’s –

MS. RYPEN: Yes, yes, AARP. Yes, we have some, but any recommendations that
you have would be greatly –

MR. HOUSTON: Because I think that sort of applies to, I think, what Mary Jo
was saying which is how do you get consumer participation in everything from
research to confidentiality to some of these other –

MR. BLAIR: Well, I believe there are privacy advocacy groups in health
care, and I think we should reach out to make sure that they know they are
welcome.

MS. RYPEN: Yes, and we are trying to – we are aggressively doing that,
but we always are – sometimes miss opportunities. So if anyone has any ideas of
organizations or individuals, please – to us.

MR. YASNOFF: Particularly in the consumer area, you know, any suggestions
would be very, very welcome, because we would – we want to invite consumers to
come to this meeting, but we want to do it through some kind of organizational
channels.

MS. DEERING: Well, I think that you might, then, reach out to the executive
directors and presidents of all the major constituency groups – the Heart
Association, the Cancer Association, the Diabetes Association – especially
those for chronic diseases – the National Caregivers Alliance. In fact, come to
think of it, you haven’t mentioned the word caregivers here at all and I
am just going to add it to the personal health dimension right there – inviting
consumers, patients and caregivers – because this is a huge issue.

Within the past week, I think, the figures came out about the number of
Americans that are, in fact, giving care directly. I know the VA is looking at
caregivers as a specific population, and they are quite well organized, and
there’s funds out there that perhaps need to be brought into alignment
with NHII issues. So I suggest that, too.

DR. STEUERLE: Are you thinking of approaching groups like Consumers Union?
I mean, I’m not sure – just advocates for –

MS. RYPEN(?): Yes, we actually are.

MS. DEERING: Consumers Union? There’s something called Consumer Web
Watch, by the way –

DR. STEUERLE: I’m trying to think of groups that might at least
pretend to represent a broad swath of the population in our particular areas.

MR. YASNOFF: Yes – at our requirements meeting we did have a representative
of the Consumer Federation, and we have been regularly having representation
from AARP, so – but, you know, the more the better.

I think that the last thing we want is for some important group to feel
slighted because we haven’t reached out to them.

DR. STEUERLE: I’m just more worried about getting a balance and not
having just the people who have some complaint about something possibly going
wrong – people who actually have a stake in seeing –

MR. YASNOFF: Totally agree.

MS. DEERING: Do you have a representative from AARP?

MR. YASNOFF: Oh, yes. Yes, they endorse the meeting.

MR. HOUSTON: Back to Mary Jo’s point, you know, there’s always
conference endorsers that include – you know – you’re talking about
caregivers and otherwise that – why don’t we try to leverage them also,
because you have the American Association of College Nursing and –

MR. YASNOFF: All – have already agreed to –

MR. HOUSTON: Okay.

MR. YASNOFF: – distribute information about the meeting to their members.
So they’re – presumably, they are already doing that.

DR. GREENBERG: We have any consumer groups who are –

MR. YASNOFF: But we are looking for even more people.

MR. HOUSTON: Lean on them for some of these representations – when I heard
caregivers, you know, you’ve gotta – I think you can lean more heavily on
these endorsers than – you know – others to even push – you know – participate
more.

MR. YASNOFF: Absolutely.

DR. STEUERLE: If you get a weak sign-up for any of these sessions, are you
thinking of possibly merging them? Is that –

MR. YASNOFF: I’m sorry?

DR. STEUERLE: I’m sorry. If you get a very low level of sign-up for
any of these particular sessions are you thinking of possibly merging it or are
you just –

MR. YASNOFF: Yes, we did that last year. If it’s a small number of
people, instead of having two groups, we’ll have one, and if it is a large
number of people, we may – in theory, might have to split it into more groups,
although that will be logistically challenging.

DR. LUMPKIN: At this point, why don’t we take a five-minute break?

(Break: 10:50 a.m.)

(Resume: 11:00 a.m.)

Agenda Item: Update on Connecting for
Health Initiative

DR. LUMPKIN: I assume – but I’m not sure that everybody knows Carol
Diamond who is with the Markle Foundation, one of those foundations in New York
City.

MS. DIAMOND: One of those.

DR. LUMPKIN: One of those.

SPEAKER: Do they look down on New Jersey?

DR. LUMPKIN: You know –

MS. DIAMOND: Yes. (Laughter).

DR. LUMPKIN: Okay. Because we have a second, I just have to make this
comment about Hoboken and New York City – (laughter) – and this is something I
learned when I went to Tupelo, Mississippi. So this is like how I had to go to
Tupelo to learn this.

Everybody in New York City looks down on people who live in Hoboken, but
the response is is that when you live in Hoboken, you look out and you see
Manhattan, and when you live in Manhattan, you look out and see Hoboken.
(Laughter). So who’s so smart?

Anyway –

SPEAKER: Wasn’t – from Hoboken?

DR. LUMPKIN: Yes, he was.

DR. GREENBERG: Actually, Hoboken has gotten pretty good.

DR. LUMPKIN: It is. It’s getting to be quite a – because you can look
out your window and see Manhattan, without having to live there. (Laughter).

Anyway, Carol, as part of her activities at Markle, initiated the first
round of Connecting for Health, and is now actively engaged in the leadership
of the second round of Connecting for Health, which is moving to – trying to
move the agenda forward and develop as one of their activities a road map – a
short-term roadmap – that actually in many ways is complimentary to our
attempts on our workgroup that is developing a long-term roadmap.

So with that –

MS. DIAMOND: Well, thank you for having me here. I – Oh, louder. Okay. Oh,
boy. It’s hard for me.

DR. GREENBERG: A quiet New Yorker?

MS. DIAMOND: Imagine that.

I feel today I have a lot to say, but I have a little to say. A lot of what
I am going to present today is work in progress, but there is a lot of material
to go through, and I made the decision to present more work in progress than we
normally would, given where we are in the process, because, as I understand the
time line of the committee, this was a key opportunity when I laid our time
line over it. I think by the time there might be another opportunity would be
very far into our process.

So I may say some things or present some things today which are unpopular
with this committee. They may also be unpopular with my own committee, and I
want to make that clear, but I wanted to give you a sense of where the work is,
and we do things in Connecting for Health very much through workgroups, and we
sort of bubble it up and vet it within broader input and bring it to a
leadership group, and so we are in the process of that, and I just want to
emphasize that none of this is official recommendations of Connecting for
Health, but just to give you a taste of where the work is and where we think it
is headed. So I say that as a disclaimer.

Those of you who are familiar with the first phase of Connecting for Health
know our purpose, which is to motivate an interconnected health information
infrastructure, catalyze change.

The assumptions we have going into this, which aligns with the conversation
this morning, is our assumption is the network is worthwhile, that it provides
value and the future base is for high-quality care.

Our view is it can only be accomplished by what we have called dynamic
connectivity, which is a term we coined to talk about information moving when
it needs to move, where it needs to move in a private and secure manner.

And achieving this goal requires public and private-sector collaboration.
That is a premise of the initiative, and it is a premise of the participants.
So everything that we do, every committee we organize, every leadership group
we put together always involves some combination of public and private-sector
stakeholders.

DR. LUMPKIN: That sounds like Mark and Clay.

MR. OVERHAGE: Mark is here.

DR. LUMPKIN: Okay.

MS. DIAMOND: I just got started.

MR. OVERHAGE: Yes, thank you.

DR. LUMPKIN: Can you introduce yourself, Mark?

MR. OVERHAGE: Hello. My name is Mark Overhage. I am faculty at the Indiana
University School of Medicine and have been working on the Connecting for
Health Project since it’s first days.

DR. LUMPKIN: Great. Welcome.

MS. DIAMOND: Our most basic agenda is to improve the healthcare system for
patients and consumers through connectivity and information sharing. Those are
the two parallel goals.

And just to remind you of Phase One – I won’t spend a lot of time on
this here. We have presented to the committee in the past on consensus around
an initial set of data standards a year-and-a-half ago. We identified privacy
and security practices for electronic information exchange. We defined the
high-level characteristics or attributes of – the personal health record, and
there was a call to action from the Connecting for Health Steering Group
regarding moving toward an interoperable infrastructure.

We completed this phase in June, and many of the people in this room have
been involved in Connecting for Health, and many have participated in the
committee. So I won’t belabor this, but between June of last year and
January of this year, we were in sort of the development phase for this next
phase of work.

We have, essentially, two key components of the work this time. One key
component is what we are calling the incremental roadmap or the shared path.

This came about, I should say, from a lot of feedback that we were hearing
from the Steering Group, and for those of you who don’t know who is on the
Steering Group, it is on our website. I did not bring lists of people today.
It’s on the Connecting for Health Website.

But we were hearing a lot of feedback from the leadership within
healthcare, all stakeholders, that it feels like there is a lot of activity
going on in this area in IT and healthcare, but we are not sure where it is all
going, and, actually, I think it was John at our last meeting coined the term
Brownie in Motion. You know, somebody turned the Bunsen burner on and the
molecules are jumping around. We are not sure where it is leading, and people
are being pulled to many of the same meetings, the same initiatives, the same
conversations happening in multiple places.

So there was a lot of value placed on trying to identify – I really want to
shift from the conversation we had this morning – which was a long-term view –
to a short-term view, which is what we are about, I think, in this incremental
roadmap, but to identify, at least in the near term, are there some things,
even if it is a handful of things, that public and private stakeholders can get
together and agree needed to be done.

The second piece of the work bubbled up from the work we did in the first
time, which was, in addition to those issues, there were some issues that
people raised that still were big problems or barriers or impediments to the
information infrastructure and needed to be addressed. So we put together some
new workgroups.

The first is looking at the business and organizational aspects of health
information exchange. This workgroup is chaired by David Brailer(?), and,
again, all the members of these groups and their charge is on the website. I am
not going to go into much detail on this today.

The second is looking at policies of information sharing between doctors
and patients, and David Lansky is chairing this.

When we did our initial PHR work in the first phase, we learned that there
was a lot of both confusion and lack of clarity around what can you share with
patients? How do you share it? What are the policies that are sort of
implicated in that sharing? What are the privacy issues? The security issues?
You know, how do you sort through that? And that workgroup was wholly focused
on that.

The third is the technical and policy aspects of what we are calling
accurately linking health information.

And the fourth is some of the additional technical aspects of health
information exchange that go above and beyond the initial set of standards, but
were identified in earlier work as areas that needed to be addressed, and I am
going to go into more detail on that.

The roadmap process is essentially a five-step plan, and the bottom of the
slide gives you the time line which punctuates my earlier comments, which is
that we are very early in this process.

We really started in February to do what we call the first phase of input
and outreach, and that started with a series of interviews – informational
interviews that were designed to create a foundation for focus. The roadmap is
really something that the steering group will put together, and the first step
of trying to do that was asking them what they thought the near-term issues are
or areas of focus.

The second is to try to bring a broad set of leadership within healthcare
together to establish at least a shared view of those key opportunities. So
it’s a second step in this process, and that is the phase we are in now,
and I speak to you today in advance of our steering group meeting which is in
two weeks. So a lot of what I am going to describe is not necessarily yet the
shared view, and I feel the need to emphasize that.

But what you see here on this continuum is that we are going to move
quickly into trying to define some specific actions over the next couple of
months coming out of this early work, and then do outreach and do our usual
sort of – you know, trying to solicit individual commitments in Step 4, and
getting the steering group to really define what they think the actions are to
get these milestones accomplished.

The interview process was conducted by me, primarily. I spent at least an
hour with every member of the steering group, and I asked a series of 10
questions that were distributed ahead of time. I want to emphasize this was not
a scientific poll. It was done to organize the work and to figure out where
people thought the priorities were. So it was wandering and probing.

There were over 60 leaders interviewed. There were also interviews
conducted for the public sector by Kelly Cronin, which led up to the leadership
retreat that happened a couple of weeks ago that Bill referenced earlier, and
the assimilation of these interviews has formed the foundation, at least for
the beginning of this work.

The ten questions are in the next three slides. I won’t go through
them, but feel free to peruse them.

I want to emphasize that all these questions focus on what do you think the
near-term opportunities are? And so everything that I present bifurcates on,
yes, it is all important, but what do you think – if you had to think one to
three years, what are the most important areas for focus?

So the assimilation resulted in what I have called Forks in the Road, and
that is, I guess, a metaphor for saying that there is a divergence of views
about what near-term priorities are, at least within our steering group and
within our leadership group.

There were seven areas identified. I am not going to go into all of them
today, although I am sure that there would be interests in many of these.

In the seven areas – the first one stemmed from the question do you think
having the National Health Information Infrastructure – do you think creating
that is an incremental process? That was one of the – I think it was the second
question that I asked, and I was forced to ask that question. I actually
didn’t think it was necessary. I thought everybody would say, yes, of
course it is incremental, but, in fact, there is a divergence of views, and
I’ll elaborate on all of these.

The second area was funding. There wasn’t really anyone that I talked
to who didn’t talk about either the misalignment of incentives or the need
for up-front incentives to get this going.

The third was data standards.

The fourth is something I called incremental applications, which is the
difference between focusing on a full EHR and some incremental application or
some subset application that might be more readily doable in the near term.

The fifth was already mentioned here today, and I am not going to go into
it, the IT exemption for Stark.

The sixth was this problem of linking health information or the identifier
issue.

And the seventh was federal leadership.

The two items in grey, I am not going to talk at all about, but I’ll
elaborate on some of the other areas.

As I said, this incremental infrastructure emerged from asking people if
people believed the path was going to be incremental, and the bifurcation is a
yes/no bifurcation. The yes camp, in this group, bifurcates again. So, yes, it
is incremental and then there is a group that says and it is all going to
happen through local health information infrastructures. That is how it should
start. That is where we should focus. That is where we should invest our
energies.

There is another camp that thinks it is incremental that says – and, again,
I am speaking not for my own opinions, but just trying to give you a sense of
the feedback – another camp that thinks healthcare has a long history of doing
local demonstration projects. We have a long history of not connecting things
and we think they are going to connect. We have a long history of not having
sustainable models, and I just don’t think that that model, in and of
itself, is going to result in sort of the bigger or broader infrastructure that
exists. We need some national network. Some parameter that gets defined that
gets focused on the near term to make sure that those things happen in a way
that ultimately does work.

The no camp, interestingly, bifurcates, too, and so ones you might call
predictable bifurcation here is – the camp says it is not incremental, and
there is some big initiative or big event that could be funded if people really
wanted this to happen, if people were serious about getting this to happen,
there would be this big initiative that got funded. It is not an incremental
pathway. If we were really serious about this, this is what we would do.

The other side of the no – and, again, there are 1,000 points in between
here. Maybe 1,000 is an exaggeration, but this is a spectrum of views, and I
mean to give you the polls only.

The other side of this is a group of people who feel, you know, health care
is too vested in the status quo, too comfortable. The system is doing what the
system is designed to deliver, and it is not going to happen unless
there’s some consumer-based demand, some disruptive strategy that occurs,
and there’s lots of ideas about this from having new companies that
collect information for patients and, in effect, force the standard on the
system. You know, lots of different ideas here, but thought it was an important
point of view to highlight.

As I said, no one interviewed didn’t highlight the issue of funding in
some way, either the realignment of incentives or new incentives, and the
bifurcations do exist here, too.

While everybody who said incentives were important – you know, you could
say that is a consensus – there is a bifurcation about what to incent, and we
had this discussion earlier. Are you funding the tool or are you funding the
outcome? And all of the sort of – the continuum of issues in between those were
raised.

On the other side, in addition to sort of incentives, there is a camp that
focused on the need for up-front capital. At this stage of infrastructure
development, there is a need to provide some up-front capital, that incentives
aren’t enough, and this falls into loans and grants are group purchasing,
but, in effect, reducing the cost of entry.

Standards. Everyone identified the importance of standards for information
exchange, and I think it is important to say that a divergence arises when you
ask people what is the near-term focus? What needs to be focused on in the near
term?

So there is a yes camp here, and the yes camp says, yes, standards should
be focused on in the near term, but there is a bifurcation. There is one poll
that says we need to focus on this full-set issue. We have missing pieces. You
know, we talked about some of these this morning. We have some areas that need
to be developed. We should really finish all 20-some-odd areas, get all the
standards done, harmonize them and get that work prioritized.

There is another camp here that says, yes, focus on the standards, but
let’s focus on the ready set and get those implemented, because we are
still not satisfied with the rate of uptake implementation and the rate of
knowing that people are using the same standards the same way, even where we
have a standard.

And both of these groups raised the issue of compliance. Ed Hammond
corrects me every time I say compliance, and he says, no, it is conformance or
compliance or – the issue, I think, is a market-based one, at least from the
interviews that I did. The question is, if you are buying a system and the
system is supposed to be HL7- or LOINK(?)- or what have you compliant, what
does that mean and how do you know that it is really compliant?

The no camp here says, you know, standards are going to take a long time,
and I think someone alluded to the sentiment out there that I would say is
growing. Standards are going to take a long time. Progress has been slow. We
need to jump on the ability to move information, however the information moves,
quickly, and there is a camp here that focuses on things like let’s
standardize some documents and content and just get it out there and make sure
people are using it and at least information will be shared, and there is a
camp here that focuses only on the data. So don’t even worry about the
underlying standards, but let’s get some of these national lab data
sources moving, so that people can start to benefit from it, and, again, this
is a spectrum of views that are out there. We have all heard them, I know, from
all the meetings you have gone to, but I think it does reflect in the way
people are thinking about the near term, the different kinds of views that are
out there.

The applications are also – also entertain a divergence, and, here,
it’s – again – what to focus on in the near term.

There is a camp that says incremental applications are a near-term focus,
and that is where you should focus. The full EHR is not necessarily something
everybody is ready to entertain, and we’ve got some buses that have left
the station, like e-prescribing and some other sort of e-tools that are out
there that we should make sure we leverage as opportunities to lay the NHII
infrastructure.

There is another camp that says, no, incremental applications are not the
way to go, and we’ve got to focus on the full electronic health record.
That is a starting place. Don’t worry about connectivity or other issues
yet. Let’s get everybody using the tool.

In this no camp, there is another bifurcation which is there’s a group
that feels we should not only focus on the EHR completely in the near term, but
that if there was some public model available and distributed, people would use
it.

Linking information. This is an area, as I mentioned before, we have a
whole workgroup on, but there was feedback about the ID. There’s a yes
camp and a no camp, as you might imagine, and each of these views is
represented, I think, in a variety of stakeholders, and I’ll go into more
detail on this in a minute.

So I am going to give you, now, moving from forks in the road to a progress
report about where we think we are going to come out on a shared path on some
of these issues, and I am only going to focus on four of the issues that I have
mentioned.

I also want to emphasize that the whole intent of this exercise was to
start from the divergence, that we wanted to understand that divergence, and
that pretending that it is not there, that people don’t have different
views about what needs to be done in the near term is not acknowledging all the
Brownie in Motion that is out there, because there is a lot.

But we do want to get to a place of agreement and a place where people can
agree on the near-term steps. So one of the things we did was we held a
leadership retreat a couple of weeks ago, and there really was unprecedented
leadership from all stakeholder groups. As Bill mentioned earlier, Mark
McLellan was there, but so were many other public-sector leaders and private
sector leaders, and this was our first pass at trying to create some shared
path.

In addition to the leadership retreat – and I am going to go through some
of the very high-level recommendations, we did some workgroups leading up to
the leadership retreat where much more specific views and recommendations have
started to bubble up, and I am going to share those with you as well.

So, first, to the leadership retreat. On the infrastructure and
architecture, I think the key ah ha that came out of our retreat is that it is
not an either/or. It is not all LHII or all NHII, that it doesn’t all
happen locally and it doesn’t all happen nationally, and, in fact, people
felt neither approach can succeed without the other, and that there was a need
to develop – and I heard this a lot in the interviews that I did – some common
framework to support locally-built networks. A lot of the conversation this
morning resonates that, which is how do we ensure that the LHIIs ultimately do
end up talking to each other. That is really, I think, on everybody’s
mind.

Leading up to this, we did have a workgroup. We called it the Technical
Expert Panel. Mark Overhage was kind enough to be on the phone to help me go
through this section, and there were others involved in this meeting. We were
very fortunate to be able to lock these guys in a room for several days and try
to hammer through some issues, and what I’ll present today are high-level
summaries of things. They don’t represent, necessarily, full-blown
consensus and they don’t represent recommendations, but I do think they
are early breakthroughs that we want to at least pressure test more broadly.

Architecture. So, again, here, same output from this group. It is not an
either/or path, and there was a lot of consistent belief that there is a need
to have some common framework. This group actually went farther in defining it,
and I am going to share some of those early attributes with you.

First principles, again, are that it can support both local infrastructures
and connecting local infrastructures, that it also supports the needs of what
we term secondary users, like research, public health, quality improvement,
patient safety, so all the derivative users of the infrastructure, and that
there is a wealth of clinical traffic really waiting to traverse this highway,
that if this were available it would really enable a lot of pent-up demand to
be realized.

There were five technical specifications of the common framework. Mark, do
you want to go through these? Do you have your slides?

MR. OVERAGE: Sure.

MS. DIAMOND: Okay.

MR. OVERAGE: And these won’t be surprising to anybody, but one of the
points here was that everybody thought that there needed to be a common,
well-established infrastructure underlying framework for communications and
that that had to be ubiquitous, obviously built upon the internet for
communication, had to have agreed-to and consistent security standards that
addressed the usual issues of confidentiality, authentication, integrity and
non-repudiation, and then an authorization infrastructure to deal with who is
allowed to do what, and then the notion that participants in this framework,
things that connected this will have a minimum level of system functionality in
terms of response time, in terms of longevity or retention times of data and
things of that nature, and then, obviously, needs to be built upon messaging
standards, leveraging the existing standards with common connectivity
parameters in order to facilitate the communications.

No real surprises there, other than that one key step, if you will, is that
having this agreed-to secure communication authentication infrastructure
everybody thought was a huge leap forward in building these.

You want to pick up from there, Carol, or –

MS. DIAMOND: Sure.

The group talked – and just to backtrack a little bit. I think Mark is
right. I think the big common revelation for this group or its point of
agreement was that having a security layer was a very important attribute for
moving forward.

The policy attributes of the framework, people felt strongly, needed to be
voluntary, that it needed to be built on the premise of patient control and
authorization, and that it provided local data exchange for primary users and
time and efficiency improvements for secondary users, meaning if it created
additional burdens for secondary users, it wouldn’t serve all its needs.

Some of the architecture considerations that the group has put forth are:

That a decentralized federated architecture was desirable with permanent
data residing in local participants’ data stores.

That, fundamentally, the data exchange contain directories, permissions,
authorization tables, interface engines, but not persistent data stores,
although the group hasn’t defined persistent or non-persistent yet, and
that is one of the areas we’ve got to follow up on.

That interchanging with the exchange layer was done through SLAs that would
also guarantee, as Mark was alluding to before, the length of time the data
would be available and the response time for requests.

That data needed to reside with the provider who had the primary
relationship with the patient.

That it included a permissions and authority database from patients, and if
you look at some of the LHIIs, this is very much a part of the infrastructure.

And that transparency and audit are necessary functions of the layer.

Mark, is there anything you want to add to that?

MR. OVERAGE: No, I think you covered it, especially given the time.

MS. DIAMOND: Okay. Essentially, the beneficiaries of the infrastructure
include everyone who uses it. Primarily, here, the providers who are generating
and accessing data.

The group emphasized that it was important that the infrastructure support
a full continuum of functionality. So whether you had a full EHR with all the
bells and whistles or you could only access the infrastructure through a portal
to retrieve information, the system had to accommodate the full spectrum of
users.

That there were what the group called service providers who are,
essentially, mini-users. They generate the data. They are not necessarily
looking at it, but there were anonymized data consumers to meet sort of the
anonymized data needs.

Decision support systems would also be beneficiaries of this, and that for
patients, there was an opportunity to incorporate their view here through a
thin browser or longitudinal data store, but that this was clearly viewed as
part of one of the beneficiaries of the infrastructure.

There are lots of open issues, and, as I said, this is – we are very early
in the process, but we do want to drill down on some of these – and I said
pressure test them, because I think we need to do that.

The issue of SLAs is a big one and how would that work and how would – you
know, thinking about the different kinds of providers, the rural, the – all the
different issues to deal with.

Whether or not it includes administrative data, a strong feeling about
privacy policies that this infrastructure requires and would need to have some
view of privacy policies that needs to be articulated.

That policies need to be addressed that allow patients to both preclude the
collection and enable the transmission of information, and, again, there are no
answers for these, but these are questions.

The issue of persistence or is there any persistence or data storage, what
data? What is the appropriate data? How do you integrate fragile data? This was
alluded to earlier in terms of updates and disambiguation, especially if you
are thinking about things like full record or problem lists or medication
lists. You know, how do you deal with those kinds of things?

And then the issue of population data bases and how to address that and who
addresses it.

Moving to standards and incremental applications, the leadership retreat
and some other groups that we have convened are saying that there is a need to
have sort of a standards roadmap that includes time lines, prioritization,
deliberables and coordination, that people don’t have a full sense of how
this will all happen, and I think the work that we did with the technical group
also is sort of pushing us in that direction.

And I think the groups all feel that any incremental approach can’t be
a dead end, that if things are a dead end, we have missed a big opportunity,
even if it feels like we have done something in the near term.

So on applications, first principles are that we need to balance complexity
and speed, that both the full EMR and partial solutions are necessary. I mean,
there is a whole spectrum of users and systems and people out there. There is
no point in thinking this is a single solution, that all approaches work, as
long as we don’t create dead ends, and that the fastest incremental
application is a huge motivator, so where there is an incremental application
that is out ahead, that is the train we should be thinking about anyway for
standards and for the infrastructure.

Dead ends – and I have referenced this a couple of times. There are two
requirements that qualify something as not being a dead end, and it is a first
step to the EHR, if it has a pathway to added functionality. If it doesn’t
have a pathway to added functionality, then it is viewed as a dead end.

And the second is that it has connectivity to health information exchange
or complies with the common framework standards. In other words, it’s got
to have the messaging component as well.

Incremental applications, I think, were viewed by the group as exchange
transactions or use cases, and a whole myriad of near-term opportunities were
identified. I have had e-prescribing up here a couple of times, but there are a
whole myriad of applications that are out there, and I was trying to allude to
this in some of my earlier comments, that all of these – you know, where we
can, we should view these as helping to lay the groundwork for the
infrastructure.

I’ve said this already, but I think the incremental application with
the fastest implementation need to take into consideration both the content and
the exchange standards if it really is going to be a segue to some broader
infrastructure, and I think that is something where we will be able to get a
lot of consensus and generate some recommendations.

On standards, I think the group felt we need to harness the growing demand
for exchanging information, so leverage the existing standards and don’t
hold up those efforts as we sort of go through the LHII and other funding
initiatives.

Align new standards development efforts with use cases and user demand. In
other words, let’s prioritize around some of these quick incremental
applications, so that at least when they emerge and they are there, they
don’t happen without the standards, that the standards are there to
support theme where we know they are going to be out there.

And then there has to be a mechanism for standards conformance and
compliance testing that results in some form of certification, that without
that, saying something is standards compliant doesn’t really provide
people with value along this trajectory.

Clay, are you on the phone?

MR. SHERKEE: Yes.

MS. DIAMOND: Okay. We have a whole workgroup focused on this issue of
linking health information, and I thought it was important to give you a sense
of where they are. Clay Sherkee(?) is on the phone. Clay is the chair of the
workgroup. He is a professor at NYU, but also a very well-known speaker and
writer on peer-to-peer architectures and a myriad of other technical and social
issues.

There essentially has emerged an early set of issues that this group is
viewing as a starting point, just even from their first meeting, and, again, I
won’t go through all the people on this workgroup, but it is a fabulous,
unbelievable, actually, group of folks who come from not only healthcare, but
other industries, and that has really been our first experimentation of taking
healthcare folks and non-healthcare folks and mixing them together to try to
deal with some of these problems, and it has really been a very important
lesson for us, because I think it has stimulated new thinking and different
thinking, and I think Clay would be the first to admit that he is not a
healthcare person as chairing the group, and so it really has allowed us to
emphasize the learnings from other industries and other places where this issue
has come up.

Clay, do you have the slides in front of you or do you want me to go
through them?

MR. SHERKEE: Sure, or, I mean, however you want to do it.

MS. DIAMOND: Go ahead. Why don’t you go through them –

MR. SHERKEE Okay. Hang on a sec.

So I didn’t open them up because I thought you – why don’t you do
the bullet points and I’ll –

MS. DIAMOND: Okay. Sure. Sure.

MR. SHERKEE: Sorry about that.

MS. DIAMOND: The first principle is that any system that improves the
linking of information needs to be accurate, secure and responsive, and that
the system essentially has these four additional parameters, and, again, this
is early sort of group consensus, but we are very early in the process.

The group is feeling that it should be a decentralized system and that it
needs to be federated, some organizational structure that provides a shared
policy framework for safe and appropriate data sharing needs to be a part of
this.

MR. SHERKEE: And, in fact, Carol, I’ll even say that maybe a little
bit more strongly.

MS. DIAMOND: Sure.

MR. SHERKEE: Echoing some of the stuff you were talking about earlier, I
think that the push towards decentralization comes from a sense that since the
U.S. healthcare system has so many different players and is arranged in so many
different ways, it will, of necessity, be decentralized, that we are not going
to replace the current system with a single centralized system overnight, and
that, as a result of decentralization, we need some organizational structure
that looks like federation, so that participants in the system can do things
like sign contracts with one another that guarantee security of data at remote
sites, some of the things that Mark was talking about earlier. So, in a way,
the pressure towards federation comes form needing an organizational framework
to deal with the fact of decentralization.

MS. DIAMOND: Great.

The second point here is that it needs to be transparent to the user, so
that individuals should be able to see the contents of the system that relate
to them, that it should be backwards compatible. Again, we are focused on near
term, and I think the group consensus was that in the next foreseeable one to
three to five years, even going out five years, that we had to work with the
infrastructure that we had. You couldn’t take it down for a weekend and
bring it up with some new system, that backwards compatibility was essential to
uptake and that it should be minimally – it should disclose minimal data even
in a secure environment, and, Clay, you may want to elaborate on that.

MR. SHERKEE: Sure. There has been some work on the idea of a kind of secure
layer, basically the notion of – you know, the – infrastructures was originally
built on leased lines to make it secure, but there is, obviously, enormous
expenses there, as we have seen in EDI efforts generally.

There’s been talk of moving to a sort of virtual private network, a
VPN-based system, which has a data layer that has minimal standards of security
for moving health data around between institutions. That, we think, is a
necessary, but not sufficient characteristic for security, because, in
addition, as the number of players grows, you worry less about
man-in-the-middle attacks, as if were – people sniffing the data as it
goes by – and more about man-at-the-edge attacks. You worry about privacy
spills from participating institutions.

So in addition to the data being secure as it moves from Point A to Point
B, we are looking at ways to make the data secure even when it is at Point B.

As an example, instead of, say, sending Social Security numbers in the
clear, you send a hash of the Social Security number, essentially, a digital
signature, so that someone at the receiving end can essentially compare that
signature of the Social Security number and either say yes or no, we have this
on file without seeing the Social Security number itself. So it is a way of
comparing data to see if it is the same, before you actually commingle the
data. So that is a kind of security that is not accounted for in
transport-layer security, but we think still needs to be in the system.

MS. DIAMOND: Yes, and I should emphasize all of this work was motivated by
the understanding that unless we figure out how to better link patient
information, we are not going to be able to solve the quality gap, and we are
not going to be able to give patients their information from a fragmented
system, and so these are at least some early principles for trying to balance
the issues.

Clay’s group has articulated several second-order ramifications which
are that the – as I said, the ID will probably not be practical in any
five-year work effort, and the group actually felt the risks outweigh the
benefits. They went through a whole process to articulate this.

MS. DEERING: I’m sorry. It says do not outweigh, and you just said do
outweigh.

MS. DIAMOND: Oh, sorry.

MS. DEERING: Was that a typo in your slide?

MS. DIAMOND: Yes, it is. Thank you, Mary Jo. I’ll be sure and fix
those – fix your slides.

The second is that backwards compatibility means compatibility with
whatever people are using today, and there is a whole infrastructure set up
today intra-enterprise to try to deal with this problem, you know, hospitals
sending patients to multiple sites and what have you.

A federation requires some set of mutually-enforceable agreements that
include technical standards, privacy and governance, and that information has
to be both accurate and secure from privacy spills using some mix of
authentication and encryption to allow for remote matching in a secure fashion,
which is essentially, I think, the point that Clay was just trying to
articulate.

They are now working in two tracks, now that there is sort of a direction,
and they are coming out with a way to approach the problem. They are looking at
the technical, privacy and organizational standards of federation – what does
that mean and what should they be? – and also what are the requirements for –
security and responsiveness in this federation? In other words, what are the
two different attributes of going forward?

I wanted to take one minute and talk about the personal health record
working group. Again, here, David Lansky is chairing the workgroup in this
phase, as he did last time.

They have several key deliverables. One is a guide to implementing PHR, and
this is trying to look at recommended policies for integrating personal health
records and electronic health records. Simply said, what do you share? When do
you share it? What are the timing issues? What are the constraints? What are
the best practices as far as we know them? And where are there gaps?

We are conducting a series of site visits. There are nine installations of
PHRs across the country that the group is looking at. There’s a lot of
stakeholder outreach. We’ve got some collaborations going, one with the
AMA and one with AHRQ, one looking at policy, one looking at the issue of
ethics, medical ethics and professionalism, and we are doing some work in
messaging.

We learned last time that we don’t have a good way of talking about
this issue in a way that people understand what we are talking about, and we
have all talked about the need for consumers to understand this and to require
this, and we are going to do a little bit of working testing some messages
around connectivity and personal health records.

And then we are going to do another set of focus groups and telephone
surveys, again, testing some of the messages and then trying to test some
approaches that might get patients more interested in the infrastructure and in
the personal health records.

Finally, David Brailer’s group, which is looking at legal, financial
and organizational issues – I am not going to go into much detail here. They
are a little bit earlier than some of the other groups, but I did put this
information together to give you a sense of what they are working on.

Again, it is multi-pronged, and I guess the thing I would want to emphasize
in the financial side is they are looking to develop a qualitative analysis
around certain use cases. They have identified six use cases. All the working
group chairs got together and identified some key use cases, like, I’m a
patient moving between physicians. I’m a physician writing prescriptions.
Whatever they may be, and then looking to put some qualitative parameters
around the exchange of that information and the financial implications.

As I said, they are early in this process, but it will at least give, I
think, people a methodology to work with when they are looking at this. Even if
it is a plus-1 to plus-5 methodology and people’s numbers might be
different, it’ll at least give people a methodology for looking at some of
these as information exchange use cases.

And, finally, we are going to look at some of the legal and organizational
issues within the context of this group.

And that’s it.

Mark and Clay are available on the phone for questions, and I would love to
entertain them. I’m sure there are many.

DR. LUMPKIN: Great. What we were going to do is hear from Kelly, and then
we are going to have an open discussion.

MS. DIAMOND: Oh, okay. Great. Oh, okay.

MR. BLAIR: Jeff Blair, can you hear me?

DR. LUMPKIN: Yes, Jeff.

SPEAKER: I can hear you. I don’t think they can.

MR. BLAIR: (Laughter). All right. Let’s try it again. Can you all hear
me?

DR. LUMPKIN: Yes, we can.

MR. BLAIR: Yes, I would like to express how impressed I was with this
overall presentation. Many of the general topics have been considered by many
organizations for a number of years, but what impressed me was the balance and
the respect for the divergent views and your obvious attempt to reconcile those
divergent views with trying to build consensus, and that gave me a very high
level of confidence that your process and your approach will yield results that
we can have confidence in. I was very impressed. My compliments.

MS. DIAMOND: Thank you very much.

DR. COHN: Yes, you know, I actually was also going to chime in. I actually
really appreciated what I consider to be some sort of fresh thinking around
some of these areas. Nice to hear about people outside of healthcare being
brought in for some of these discussions.

SPEAKER: Amen.

MS. DIAMOND: Thank you.

I appreciate those comments, although I always need to defect them back to
the tremendous number of volunteers who work on this stuff with us who spend
whole days locked up in rooms hashing through some of these issues, and people
like Mark are few and far between, but we manage to find them to help us work
on these issues, and I do have to give the credit back to them.

DR. LUMPKIN: Well, while we are waiting for that to –

DR. COHN: Yes, actually, it sounds like we are waiting for something to
happen here.

DR. LUMPKIN: Yes, for the slides –

DR. COHN: Well, Carol, let me ask – this is Simon Cohn again, but is there
– we are on the phone, so I can’t tell – you may have brought along a
whole bunch of paper to share with everyone else. Are there paper versions of
any reports that are easily accessible for us to peruse at our leisure?

MS. DIAMOND: Yes, I guess what I was saying in the front end is I shared
more today than I think I could have, largely because I thought that the timing
for bringing things to this committee was not necessarily in concert with the
time line we had for our work. So these will all end up in reports.

I do want to say, you know, we did Phase One in nine months. We are doing
this phase in six. So by June, July, there will be papers to share, and, in the
meantime, I am going to try to do some interim postings on the website, to the
extent that the workgroups are comfortable and the steering group is
comfortable, as we get consensus.

I am thinking, actually, after our steering group meeting in April, we
might be able to provide a greater level of detail around what the roadmap
areas will be and where are the areas that we are going to – you know – sort of
drill down, that need more work. So it will happen over the next couple of
months, but all of this will end up in papers, and Clay is himself going to be
doing the paper on both the issue of linking health information and will
certainly help us in some of the technical aspects as well.

DR. COHN: Great.

MR. BLAIR: I would like to – this is Jeff. I would like to add one more
observation. I especially appreciated your discussion of whether – of the
different views as to whether an incremental approach was appropriate or a
long-term change, and I kind of feel like you are probably going to – your
workgroups will probably lead towards this anyway, but my thought is that not
only are both necessary, you need to have a strategic view of where we are all
heading –

MS. DIAMOND: Yes.

MR. BLAIR: – but you also need to recognize the reality of what
incrementally could be done, but then you added in the point that you
don’t want any of the incremental approaches to be dead ends, so that goes
back to the need for the long-term vision.

So I am kind of anticipating that, as your workgroup thrashes this out,
they’ll see that those two views are complimentary, not in opposition.

MS. DIAMOND: Yes, if I could just respond to that.

On the first point, what we did with the forks in the road, actually, is
more than just say they were forks in the road. We actually asked people to
talk about, in meetings, what they thought the key benefits and the key risks
of those polls are, and we found consensus or we found the shared path by
asking people to come up with solutions that accommodated the key benefits and
risks, because it is hard to say that there aren’t any benefits or any
risks for any of these positions, and I do think that that – has led us to not
necessarily middle of the road, but opportunities somewhere that accommodate
people’s divergent views and where people can see what is important to
them materialize in the proposed solution.

MR. OVERHAGE: This is Mark Overhage. Jeff, as usual, you hit a really
important issue on the head, and I think the other corollary to that is – I
think – and, again, this is not an official position, but it is my sense of the
groups – is that the long-term strategy and plan probably can’t be
absolutely crystalized yet, and while we need to lay it out and have a
direction, it may be a little bit fuzzy out there in the future, I think an
important thing is being able to accept that fuzziness for now, but know that
we are headed in the right direction, and then the fuzziness will get resolved
over some of this early time.

MR. BLAIR: I totally agree.

DR. LUMPKIN: Okay. We are going to sort of put a bookmark right there.
Kelly has now got – perhaps has her technology ready to go –

MS. CRONIN: It’s up on my screen –

DR. LUMPKIN: And now it’s up on our screen.

Agenda Item: Update on the HHS Council on
the Applications of Health Information Technology (CAHIT)

MS. CRONIN: Well, since some of you probably haven’t heard too much
about the Council on the Applications of Health Information Technology, I
thought I would just spend a couple of minutes just giving a little bit of
background information on it.

This is something that the Secretary created back in June of last year, the
cochairs are Carolyn Clancy, who is the Director of AHRQ and Bill Robb(?), who
is Acting Assistant Secretary for Public Health Emergency Preparedness.

I came in at the end of last year as the Executive Director from FDA, after
sitting on the council for the five-or-so months after it had been started.

Just to give you a brief overview of what we are focusing on, we have a
pretty broad charter, but our key activities right now are to promote a timely
exchange of information about different activities that are going on across the
agencies and also try to share information about opportunities that we know
about or are exploring.

We are also making recommendations to the Secretary regarding strategic
opportunities related to the adoption of HIT across the whole – system, and we
are serving as the primary forum for both identifying and evaluating activities
and investments that really are supposed to be complimenting what is going on
in the private sector, which is one of the reasons why we are so enthusiastic
in being involved and really staying involved with Connecting for Health
Initiative, particularly this year.

As everyone knows, it is very difficult to get any work done with councils,
so we have actually tried to establish several working groups to really focus
in on some of the key activities, one of them being data standards, as we have
all been talking about this morning.

We have had some immediate priorities that we have had to focus on over
recent months. Helga Rypen, who was here earlier today, is chairing this
workgroup, and she has led the group of people that we put together on this
workgroup to try to focus in on our activities around the HL7, electronic
health record functional model standard that has been developed over the last
six months or so. As some of you may know, it has been a rather complicated
process, and an awful lot of time and energy has been put into it, as Mary Jo
can testify to.

But we have successfully, I think, gotten everybody together on this, and
gotten input and consensus on not only our comments to earlier and the current
ballot of DSTU, but we are now in the process of supporting the ballot, and,
now, we really are going to be shifting our focus to coordinate on other
activities having to do with HL7 and likely other standards developing
activities that are high priority for HHS.

We also have an e-prescribing working group. This is largely stemming from
the need to coordinate the implementation of the e-prescribing provisions and
the new Medicare law. This is requiring very close collaboration with the
Office of HIPAA Standards at CMS. In fact, Karen Trudel and I are chairing this
workgroup to make sure that we are completely in synch with all our activities
since, really, the deliverable here is a regulation on standards over the next
several years that her office really will have to be responsible for.

And then we are also closely coordinating with NMA Council. They have
similar responsibilities. There is a team that is focusing on this general area
having to do with access to drugs that we are in synch with, and, then,
obviously, the large burden is placed on NCVHS at this point, the Standards and
Securities Subcommittee, to have a very aggressive hearing schedule over the
next year to hear from all the stakeholders who we have to get input from to
make sure that we are going to be putting together an adoption or a
recommendation in September of ‘05 that is going to be palatable to
everyone, and then move forward with a regulatory process.

But beyond NMA implementation – this is going to be a sort of a long-term
effort – we really think there’s a lot of short-term opportunities. As
Carol alluded to before, there’s that bifurcation incremental
applications, where, you know, one of the options is to go forward with
e-prescribing on a national basis. Perhaps all the standards aren’t there
yet, but there are some that are working. We know that there’s some very
good case studies out there. For example, in the State of Florida, there is a
very successful e-prescribing program with Medicaid providers, and since
there’s anecdotal data early on that suggests that that is very positive,
we are continuing to explore similar type of activities and see if Medicaid
would perhaps adopt that on a more widespread scale.

We also have a workgroup that Bill Yasnoff and Scott Young are chairing
focused on electronic health record acceleration. Again, this is a coordination
effort across all the agencies, and we have recently completed an inventory of
all the programs that are involved with the use or funding electronic health
records, but also those that really are going to, in any way, accelerate
adoption.

We are in the process of drafting a policy principles document to sort of
guide a lot of the HHS activities that we’re making sure we have sort of a
consistent approach to adoption that will also be in support of all the other
activities we have going on, namely, the emerging LHIIs and NHII.

We also are working very closely with the consolidated health informatics
effort. As we all move into Phase Two, we realize that there is an important
perspective that people who sit on K-HICK(?) can bring to the process if we can
be very mindful of our policy and program priorities and trying to do not only
a more careful gap analysis, but, really, sort of say, okay, out of these 24
domains and the gaps we have identified, what do we really need to focus on in
the next six months to a year?

But we also need to be thinking very creatively about an implementation
strategy, given that HHS does deliver some healthcare, but that’s – most
of what we do is very much outside of that, but we do fund – grant
administration contracts, cooperative agreements across all the agencies, and
we are thinking now sort of strategically how can we work together to make sure
we have a systematic reasonable policy that will encourage the adoption of
standards, particularly as it pertains to data exchange with the government.

We also, in our council meetings, which occur about every three weeks or
so, we have been reviewing a series of high-priority projects across agencies.
The first one we reviewed earlier last year was Biasense(?), which is involving
syndromic(?) surveillance and the use of data from various sources outside the
public health system.

FDA has a proposal that they would like to implement trying to integrate
their adverse-event reporting systems, which we have commented on and tried to
add some value to.

There is an initiative out of CMS, doctor’s office, probably IT
project that has recently been reviewed.

The National Electronic Clinical Trial Network from NIH has recently been
presented, as well as the National Children’s Study, which is a large
longitudinal study involving 100,000 children which will be followed every
time, which will be enabled by emerging LHIIs and HII and Nectar(?).

So we are trying to make sure a lot of these opportunities and activities
are coordinated, and, actually, this afternoon, we’ll be hearing more from
CDC on FIN(?), as well as their futures initiative, which they have been
working on for the past year.

So this is sort of a highlight of a lot of things we have been working on.
Much is in progress, and we are trying to sort of keep up with the pace, but
also think sort of strategically ahead about where we really need to be
focused.

DR. LUMPKIN: Thank you.

We’ve had two presentations that look at the strategic approach to –
both as a public/private partnership in Connecting for Health, and the CAHIT,
and so I have to – in the sense of full disclosure, I have to say that, as
chair of the NCVHS, I do sit on CAHIT, so I’m partial to that group, and I
also am one of the principles of Connecting for Health in that my organization
is a cofunder with the Markle Foundation, of Phase Two.

So questions? Comments?

DR. COHN: John, it doesn’t sound like you can say anything about
anything.

SPEAKER: He has to leave the room –

MR. JOHNSON: Well, it’s interests which are not fiduciary. So I
don’t think those conflict –

DR. GREENBERG: No, and I think you are going to be all right, too, Simon,
on the issue we discussed.

DR. COHN: (Laughter).

SPEAKER: And your affiliation with those two organizations that happened to
present today is totally coincidental.

DR. LUMPKIN: Totally coincidental.

SPEAKER: We can’t hear the person speaking.

DR. LUMPKIN: Oh, it was just another side comment at my expense.

MS. DEERING: Well, I just had an observation that I am glad that Carol did
come today and raise, however slightly prematurely you feel some of your
comments were, because it occurred to me in listening to Kelly make her
presentation that your contribution to HHS, in looking at the various
initiatives that Congress mandates us to do, and to help us discern what – how
to avoid the dead ends, is absolutely crucial, because we know that that
happens so often with federal funding, that it gets thrown out there well in
advance of our ability to really think it through, and while we are never going
to change that, why, the more we can perceive in advance what those dead ends –

MS. DIAMOND: I appreciate that, and I think we have a job to do – try to
draw down and define that for many of the incremental occupations that are on
the docket, if you will, because our members are also asking, for other
reasons, if they should be making investments in some of these or is this going
to be the standard? Are people going to use this, that or the other thing? And
I think trying to understand at least some broad parameters is a better
decision-making process than what we have.

MR. FERRER: Carol, this is Jorge Ferrer – I was wondering since you led a
considerable amount of private initiatives if –

MS. DIAMOND: Hey, Jorge, can you just speak up a little bit? I’m
having a little trouble hearing you?

MR. FERRER: Sure. Can you hear me now?

MS. DIAMOND: Yes.

MR. FERRER: Okay. I was wondering if you could comment – you know, you have
worked quite a bit with the federal government the last two, two-and-a-half
years on this. Has the federal government met the needs of the private sector
with regards to the communication that we established? And, if so, are there
any recommendations as to what you see have been some of the – between the
federal government, the private sector?

MS. DIAMOND: Did anybody hear the end of that?

MS. DEERING: Can you repeat your last –

SPEAKER: You faded a little bit on us.

MR. FERRER: I’m sorry. If you can maybe share with us a little bit
about what you felt were some of the barriers between the private sector and
federal government initiative and what you would consider to be some
recommendations for this continuation of private, federal, collaborative that
you’ve been heavily engaged for the last three years?

MS. DIAMOND: I see. You know, I’m probably the wrong person to ask
about the barriers, because we have enjoyed a level of participation and
dialogue that I think has been very valuable.

I actually think the only reason we still exist is because people found
value in having a place to have these conversations, which is not always
completely easy to do.

I do think that it is very important that we align strategically and
carefully as we sort of map out these things. I mean, as Mark was saying, there
is some fuzziness about long term and we’ve got to deal with that, but we
should be very well aligned.

I think, in addition to having the dialogue and the working groups and the
opportunity to flesh out some of these issues, there is a role for, I think,
both public and private sectors to play on dissemination and communication of
these things when they are agreed to, and I think that may be an area we fell
short on last time, and it is certainly something that I don’t have the
answer for, but we are thinking a lot about this time.

DR. LUMPKIN: And if I can sort of put this into context with the work of
the workgroup, there are really two parallel processes that are happening this
year, and it is very fortuitous, because that is when we also want to engage in
developing our next iteration of suggestions and recommendations on the
development of the NHI, and those two developments are really the work that we
had spent the morning – the first part of the morning talking about, which is
the conference, and then the work that Carol reported on, and that is that, in
a sense, the Connecting for Health is – for lack of a better term – an elite
process, because, really, it is going out towards all the leaders, and the
people are represented on the steering committee represent leaders in the
federal government, leaders in the vendor community, the provider community.

The NHII conference, as a conference of 1,000, represents, in many ways,
the breadth of those who are interested in that, and then our job, as a
committee, is to take that input from both processes and try to integrate that
into recommendations, to take the long-term perspective from the roadmap that
the Connecting for Health will pull together.

Now, to complete the picture, as we all know, this issue of health
informatics and its important role has gotten attention and focus from the
President and was part of the State of the Union Address, and so the work of
K-HIT(?) and other work within HHS is a key component of making sure that, as
we make recommendations, as recommendations come from the outside that the
department has a single approach, and what we have seen in the report from
Kelly is that, really, we haven’t seen that there has ever been a central
focus where these major initiatives by various operating divisions within the
department have gone to one location so that others know what is going on, that
there is some sort of common focus, and so there are a lot of pieces that are
coming together that enable us, as we are developing our vision, to suggest the
long-term approach.

MS. DIAMOND: If I can just add to that. I mean, we rely on your vision for
the work we are doing, and – of this committee – and we hope that, as the
long-term vision, both through the conference and the work of this committee
become more elaborated, it can also further our ability to try to provide some
clarity about the near term, but I very much feel that that is a necessary
ingredient for us also to be successful, that we can’t bring the public
and private sector together and focus on near-term actions if they are not in
concert with where the committee feels the long-term view is. So I hope we can
fulfill that balance.

DR. STEUERLE: This is probably discussed indirectly, but it certainly would
help me, as you proceed and you write up recommendations as things come out to
our committee or wherever, to the Secretary, whoever, public, if you can not
just identify what, but the extent that your members would do it is who. You
know, if Ken and Steve would not agree on the allocation of a health budget
between NIH and CDC, I would like to know who should decide it. If I am not
going to give it to one or the other of them, I might want to know who is going
to do it, and I sort of have the same questions, a lot of these things is – as
a recommendation, we’ve got this conflict, we have to get the groups to
recognize there’s a conflict. Who – not only who can decide how to break
the logjam, but, in some cases, is somebody actually even accountable,
especially if it’s the government. I think, government accountabilities is
very important to force decision making.

MS. DIAMOND: I couldn’t agree with you more, and I think there is a
lot to figure out there. As you saw, one of the 10 questions that I had
distributed in the interviews was who should do this and when, and I do have to
say that there is more unclarity about that. So even where people think they
can identify something near term, there isn’t often and so-and-so should
do it and here’s how long I think it will take.

I think for many of these recommendations we have a responsibility to try
to understand that, and without that, I think they will be less helpful. So I
completely agree with you. I just want to punctuate the fact that I think some
of these are tough questions to answer.

MS. DEERING: And this is to Carol. As you know, one of the things that I
most appreciate about your work is how you have really taken the lead in the
personal health dimension, and David’s work through you is just absolutely
wonderful, and you are the furthest along and you’re doing the most and
you’re doing all the right things.

I still have to note, as much for the record as anything else, a persistent
contradiction in this whole field, and even in your areas that is demonstrated
by two of your slides that your Slide Number 35, the Policy Attributes of the
Common Framework, Point Number 2 is built on the premise of patient control and
authorization, which I know that you believe in.

On the other hand, as you transfer over to Slide 38, the Open Issues, you
are just looking at policies that will allow patients to control their
information. So I’m just saying that it’s a fine line and it may seem
to be only language, but I think, deep down, it does permeate the issues that
we are struggling with.

MS. DIAMOND: Yes, actually, the Open Issues slide was three slides long and
I did cut it down, and there are a lot of other issues imbedded and
second-order issues.

Some of these have no answers, but I think the issue of the patient, in
particular, is one that I hope that – will begin to help us understand also,
because we have got to learn from the implementation that is out there. We
can’t just sort of sit around and make it up, and that is the whole reason
we are making the effort to actually go sit down and talk to people and
understand what they are doing on many of these fronts because it is the only
way forward, I think.

But point well taken. I appreciate it.

DR. HUFF: A comment and a question.

Again, I would just echo that you are doing some wonderful work, you know,
and the background that you provide – a lot of what you presented, to me,
focused right on architecture and standards and things that we are going to
discuss in the July meeting.

My comment is that there seems to be a building counterculture to
standards, which is interesting, and I can’t let that go without some
comment, and I guess I would characterize actually what is happening, and I
have heard this, now, I guess a couple of times from different people. I think
there is a misunderstanding, and by that I mean people talked about or I have
heard Dr. Brailer say, if we had done standards, we wouldn’t have been
able to achieve what we achieved, and I think it is really misstatement,
because, in fact, what they did is created their own simpler standard, and by
simpler, what they did is they had lower expectations, and because of that they
were able to do something simpler than using standardized coded terminologies
and using HL7 messaging and other things. In other words, their goal was only
to get information so that a physician, a human, a provider, anybody could read
it and understand it. Whereas, the goal – if you want to achieve most of the
financial benefits of this, in fact, it needs to be coded and structured and
represented in another way, and so I guess one message is that it is sort of a
pay-as-you-go. If you want more functionality, then you are going to have to
pay the price of the greater sophistication and complexity, but even at their
level, they created standards, essentially. What they did is created their own
standards to implement their system. They didn’t do it without standards.
They just created their own, and there is a great temptation to do that.
There’s this big feeling in the community that because XML exists and I
can send you an XML message and anybody can parse it, that somehow we have
created understanding, and so, anyway, that is just the comment –

MS. DIAMOND: Stan, I have to respond to this because I couldn’t agree
more with you, and, actually, one of the things that motivated me to do these
interviews was I was hearing that, too, which was some combination of
inpatients with do we really need it, and I think one of the opportunities we
have in Connecting for Health, both in defining what a dead end is and in
talking about near-term needs, is to articulate the risks and benefits of doing
them both ways, and it is okay for people to decide, but I think people need to
make informed decisions, and that is what we are going to do with the steering
group and with the committee.

But I do have to emphasize that we’ve got to find some middle ground
on this issue, because there is a growing tendency to look for some silver
bullet that – you know, there is so much pent up demand for IT and information
mobility and all this, that people will be quick to get behind something that
feels like, you know, tomorrow you are going to log on and you’re going to
have some information about a patient that you didn’t have yesterday, and
that’s better than nothing, and so let’s just do that, and I just
really do think we’ve got to balance those two issues seriously if we are
going to be appealing to those polls.

MR. YASNOFF: I agree with what has been said. I think what people are
searching for is an incremental path to get there, and so recognizing that if
you don’t show anything to physicians until you have completely
standardized and encoded information that that doesn’t give you an
opportunity to recruit the physicians in terms of getting them interested, and
part of the theory of this – and it is kind of an interaction between the
incremental approach to systems and dealing with the organizational issues
involved in getting people to use systems – part of the theory is that if you
can present free-text information to physicians that they can interpret – for
example, of lab results – that, then, physicians will – once they get used to
it – ask the question, well, can I have flow charts of that information, and,
of course, the answer is no, and they will ask why, and the answer is because
it is not standardized and fully encoded, and the hope is – by people who are
taking this approach – that then physicians will become part of the demand for
standards, because they see every day what it is preventing them to do, rather
than it being theoretical. So that is kind of the framework in which this
exists, but we do have to be careful that we don’t, essentially, miss all
the benefits, as Stan said, by, essentially, abandoning our efforts to have
standardized encoded information at the point of care that can be used for
decision support.

MR. BLAIR: Can you hear me?

DR. LUMPKIN: Yes, Jeff.

MR. BLAIR: Okay. I agreed with Stan’s comments and I agreed with
Bill’s comments, but we have been thinking in terms of two dimensions, and
I think we open opportunities to address this if we think of a third dimension,
and let me go back here.

We are talking within the idea of standards, and we are thinking of
incremental approach – that’s kind of one dimension – and then we are
thinking of where we want to go in the future – that’s long-term, whether
that’s architectural or standards, whatever – and we recognize the value
of both, but there’s a third dimension that could help us, and that is
that for those folks – for those folks – for those healthcare institutions and
providers that have a less than optimal local standard – and maybe that is not
the right term to describe – maybe that is not how they would describe their
own enabling capability as a local standard. Nevertheless, for those folks that
are looking to get function and value quickly – all right? – and that is going
to be with us. There’s always going to be some folks, whether it’s a
vendor or whether it’s a standards organization, whatever, that is going
to say, I could get benefits near term. Please don’t make me wait for the
optimal solution or please don’t make me conform to the incremental steps,
and we can accommodate that if we also think of the third dimension which is –
oh, boy. Did I lose the word here – convergence, where, ultimately, we need to
converge to our long-term strategy, but in the short term, we can accommodate
multiple different incremental – as long as they will converge to the long-term
goal, and that way, the value of that is that we are inclusive, and we broaden
the support for where we want to go.

So I would encourage those three thoughts – the incremental, the strategic
long term and the idea of convergence, which opens the door to multiple
implementations or incremental steps in the short term, and that broadens our
appeal and our support.

DR. HUFF: Just my last question – I see so much of what you’ve done as
being relevant to the discussion that we can have in July in the standards and
architecture part, and I just want to try and understand the process. I mean,
when is that going to come back together? I mean, does it come back to this
committee ultimately, so that we’ll have – you know, your further input as
your process goes on will have the input from the 1,000 folks at the – is there
a specific time when this is going to come back together and we try and
reconcile or correlate or something?

DR. LUMPKIN: Well, what thought I had is maybe at – we have a hearing on
Friday during the NHII conference, and the morning of that hearing we’ll
be getting the reports from the breakout sessions. We then have the – we
adjourn, have the closing sessions of the full meeting. There’s lunch.
Then we have an afternoon, and my thought would be is perhaps if we could get a
report from Connecting for Health and then spend the remaining amount of time
at our meeting of looking at areas that we may want to – in sort of setting a
work plan for the next couple of months, based upon hearing what we heard in
the morning, what we have heard from Connecting for Health.

MR. YASNOFF: Carol, when are those reports going to be ready? Because it
would be nice if – I mean, if we could have them available to people before –
at least a little bit before the meeting, so people could read them and they
could also be the subject of discussion and consideration in the breakouts.

MS. DIAMOND: Yes –

MR. YASNOFF: But it depends on your time line.

MS. DIAMOND: I think that would be ideal, because if we line these up as a
– ours is a longitudinal process that benefits from months of thinking and
bringing people together and what have you, and you are going to have a set of
breakout sessions that aren’t going to be as deep.

I think one way maybe to balance that is to try to get things distributed,
and I think it would be easy for us in each of the areas to put work in
progress out there.

On the time line that I showed before, actually, we had identified the
summer months for vetting, and I think it is a perfect opportunity to do it.

I do think that, on the technical side, getting that input over the summer
and at your conference would be ideal for us.

What we could do is potentially make a presentation, someone from the group
would make a presentation, Mark or someone else, and say this is work in
progress from this group. There’s actually –

MR. YASNOFF: Can we – I mean, is that written material? Could that be
available by mid-June, in which case, we could put it on the website and
distribute it at the meeting? Let’s talk after –

MS. DIAMOND: Yes –

DR. LUMPKIN: At our hearing on Friday, we may want just a very short
briefing, because it would already have been vetted –

MS. DIAMOND: I think we should put work in progress out there. Yes, I think
that could be available by June. Our full roadmap won’t be done until
after that.

MR. YASNOFF: Yes, and my concern about presentation is a) there’s no
slots in the conference, but the other thing is that in doing these things
before, it is the material that you give to people in advance, if they have
read before they come, that really influences them more than what you hand them
when they get there or even what they hear in the session.

MS. DIAMOND: I agree. Okay. I like it.

DR. LUMPKIN: Great. We have a plan.

MS. DIAMOND: Aye-yie-yie.

(Laughter).

DR. LUMPKIN: And a deadline and commitments.

MR. YASNOFF: Let me say that I appreciate the work of both CAHIT and
Connecting for Health, both very helpful, and, in particular, keeping up with
the pace of Connecting for Health has been very challenging, and so I –

MS. DIAMOND: You just made it more challenging.

MR. YASNOFF: Right. Well, I’m happy to return the favor by asking them
to speed their process up even more. (Laughter).

DR. LUMPKIN: Thank you.

And, at this point, I would like to thank our presenters.

We will be taking a break for lunch. We’ll be back at one
o’clock.

(Lunch 12:25 p.m.)

(Resume 1:12 p.m.)

Agenda Item: Workgroup
Discussion

DR. LUMPKIN: What I would like to suggest that we do is if we can identify
the new dimensions we want to talk about and which one of the overlaps we think
we may want to focus in on for the next one. It could be all three or if we
develop new dimensions, there could be more.

And then, between now and the next meeting, which we probably need to meet
some time late May early June –

DR. GREENBERG: The full committee is meeting, I think, the 15-16 or
16-17th.

DR. LUMPKIN: Do we have a slot?

DR. GREENBERG: We can give you a slot.

DR. LUMPKIN: Okay. So we’ll meet at the next –

SPEAKER: Can we get more than an hour-and-a-half, pretty please?

DR. LUMPKIN: Can we get like a real slot?

DR. GREENBERG: Oh, a real one.

DR. LUMPKIN: Instead of a workgroup slot?

SPEAKER: What do you mean a real slot?

DR. GREENBERG: What? Two hours?

DR. LUMPKIN: Yes.

DR. GREENBERG: More than two hours?

DR. LUMPKIN: Yes.

SPEAKER: Instead of an hour? Is that significantly different?

DR. LUMPKIN: Well, it’s different than like getting stuck on at the
end of – you know, like – like the real subcommittees get like a real slot, and
then everybody is supposed to go from that meeting all tired to our meeting.

DR. GREENBERG: I hear you.

DR. LUMPKIN: Yes. Okay. So anyway, we have put in our plea.

DR. GREENBERG: Um-hum.

Do you have any influence with the people organizing the meeting?

DR. LUMPKIN: (Laughter). Very, very little.

DR. GREENBERG: (Laughter).

MR. BLAIR: Could you slide the phone a little closer to John?

DR. LUMPKIN: I actually was going to the –

DR. GREENBERG: Blackboard, whiteboard.

DR. LUMPKIN: You know, there’s a whole generation of kids growing up
who have no idea what a blackboard is, but I am going to the wall-mounted
writing –

SPEAKER: Is that better, Jeff?

MR. BLAIR: Thank you so much.

SPEAKER: Yes.

SPEAKER: He’s standing right over it. Of course, it’s better.

SPEAKER: Well, it’s better. Of course, you can hear me, but, I mean,
can you John.

DR. LUMPKIN: What we are going to try to – attempt to do in the next 40
minutes or so is to identify the new domains that we want to address, the
interfaces we may want to address, and then to maybe get a little bit of
homework, if we can get some people who – volunteers who may be willing to sort
of put together an outline of what might be a descriptor of that domain or the
issues that need to be discussed within that domain, so we can go into the next
meeting and perhaps begin to flush that out. If that’s agreeable as a work
plan.

DR. GREENBERG: And who all is on the phone?

MR. BLAIR: Jeff, I’m here. I think – Simon, are you there?

DR. LUMPKIN: We haven’t heard from Simon for a while.

MR. BLAIR: Okay. How about Jorge, you were there. Are you still there?

SPEAKER: I think Simon heard the word homework –

SPEAKER: Homework.

(Laughter).

DR. GREENBERG: He heard the word homework and he dropped off?

DR. LUMPKIN: No, he’s really on, but he’s not admitting to it.

DR. GREENBERG: But Jorge is still on?

MR. BLAIR(?): I heard somebody say something about volunteers.

DR. LUMPKIN: Right.

SPEAKER: Yes, and you dropped off at that point, Jeff.

DR. LUMPKIN: Okay. As I remember from our current discussion, we have one,
I think, fairly solid candidate for a new dimension, which is –

DR. GREENBERG: Why don’t I write and you talk?

MR. BLAIR: Well, let me ask – is there something we can’t do or
represent because we lack another dimension?

DR. LUMPKIN: Well, I think the issue, though, is is there an audience that
we don’t speak to well, because we haven’t defined NHII to them in
their dimension? That was where we got to in talking about new dimensions,
because, really, the function of the dimensions were to say that if it works
for individuals, if it works for healthcare providers and if it works in the
population health field, then we will have achieved our goal of implementing a
functional NHII, and I think the further question is are there other groups who
we think are not as active participants in this process who we need to speak to
that we haven’t, and those would be reflected in a dimension.

And so the first one I put up was research.

MR. YASNOFF: I am certainly going to speak strongly in support of that,
since I have been now giving talks about this for months and months where I
show research/policy as a fourth dimension. So I think that that is a very,
very important area, and a very important use of the information, and it,
ultimately, may derive the greatest long-term value.

MR. BLAIR: Bill, when you say research/policy, my thought is you are
thinking of public health research, as opposed to clinical research.

MR. YASNOFF: No, no, not at all.

DR. LUMPKIN: Health services research?

MR. YASNOFF: I’m talking about clinical research and developing health
policy in a general sense.

In other words, health policy has always been informed, to some degree, by
health statistics and information about the health and the care of the
population, and, clearly, to the extent that we have all the information
available, those policy decisions can be informed by much more complete and
much more accurate data.

MR. BLAIR: Then I would just suggest that you add the words that you just
added, clinical research and public health policy research, because, otherwise,
I think people might misunderstand what you meant by research.

DR. STEINDEL: I totally concur with adding a research domain. I think – is
there a group that we are not really speaking to, and the research community I
think it is very clear we are not speaking to that community with the original
document.

SPEAKER: They left.

SPEAKER: They left. Take them off. (Laughter).

MR. BLAIR: – underneath it where you have both clinical and public health
as subsets of research.

DR. STEINDEL: Jeff, let me go on and address the policy part second. I
wanted to address the research part first.

It is an area that we didn’t address, and it is also an area that NIH
is now putting in the forefront that the clinical research needs to integrate
faster with the clinical practices. So they have identified themselves as
wanting to integrate more with this community. So I think it is very important
for us to start emphasizing them as another dimension.

Now, I want to comment on the policy part and forget about the word public
health or whatever we want to put in front of the policy part. You know, I
agree with Bill, totally, that if we have an NHII together that we will make
more and better-informed health policy decisions, but is there really a policy
group that is not addressed by the other areas of the NHII. It kind of comes
with administrative. You know, we had the discussion about an administrative
domain, and we realized that the administrative domain was really encompassed
within the other domains, and also within HIPAA itself, so we weren’t
going to enumerate it separately, and does policy fall in that same type of
area, where, if we did have an NHII together, we would be getting the
information that would better inform the policymakers or are they a separate
group?

MS. DIAMOND: I was just going to ask what is left in population if you
spike out research?

SPEAKER: Like all of public health.

MS. DIAMOND: So that’s my question. If it is only public health, then
you should call it public health, because my view is – (laughter).

SPEAKER: No.

SPEAKER: No.

MS. DIAMOND: But, well, here’s the thing, why isn’t research
population?

DR. LUMPKIN: Because clinical research is not really population –

SPEAKER: And biomedical research is not population research.

DR. STEINDEL: Well, when we say research, you know, we may not be
necessarily talking about humans. We may be talking about animal models of
cancer research. That’s the start. That will move up into the clinical
area more rapidly.

MR. YASNOFF: Clinical research, in general, is not population research. It
is typically research on specific diseases and their ideology and management
and so on, and so, actually, one of the criticisms of the medical research
community is there has been inadequate focus on population – population
research.

MS. DIAMOND: So does population-based research stay in population?

DR. LUMPKIN: Yes. Actually, what happened was the original –

MS. DIAMOND: And I recognize the distinction. I’m just trying to
understand why you put them in buckets.

DR. LUMPKIN: All the way up until probably the next-to-last iteration of
the document, what is now the population health dimension was called the
community health dimension, and it was thought that the word population
communicated that – I think Jeff was the one who made us change it.

MR. BLAIR: I probably did.

SPEAKER: We can go back to the minutes, Jeff.

MR. BLAIR: It seems to me that the research area that we have omitted is
the clinical research area, and that the population area includes public health
research and policy. So maybe –

DR. STEUERLE: Not necessarily policy.

MR. BLAIR: Okay.

DR. GREENBERG: Probably includes public health research and health services
research.

MR. BLAIR: Okay.

DR. LUMPKIN: Let me give you an example of what would not be included. Jack
Winberg(?) up at Dartmouth takes Medicare data and creates what is called the
Dartmouth Health Atlas, and he does a lot of research on variability and cost,
variability and quality. That is a – really, that is a health services research
entity, and we really haven’t addressed that.

DR. GREENBERG: Well, I think that should be under population.

MS. DIAMOND: That was my question –

MS. DEERING: Well, I would like to argue on John’s side of the table,
because we – in previous discussions of adding new dimensions, we did, in fact,
come to agreement that one of the guiding criteria would be not to not only
influence people who needed to be influenced, who were major players in the
field, but also to capture efforts and initiatives that were underway that
haven’t been captured, and so when we talked about research, it was,
indeed, biomedical as well as clinical, because of what Ken Muto(?) represents
and the huge effort that he has coming underway and the need to be sure that
that doesn’t stay outside the fold, and since everyone’s goal is
eventually to have a continuous stream of data exchange. So that was part of
our previous discussions around research.

And in terms of policy, we agreed that there is a whole universe of health
policy wonks out there who really aren’t going to look at any one of those
other budgets, and, actually, Gene and I, at lunch, were having a discussion
about different data needs that – for example, his way of looking at CMS data
and splitting it by households. There’s different kinds of health data
that may emerge from the NHII that aren’t really – aren’t necessarily
done automatically within any of the other buckets, and, yet, the people on
Capital Hill and the people who write policies and the people in academia who
think like health-policy people need to be influenced and need to understand
what it means to them and their decisions. So I think we took sort of an
audience-based approach as well as an opportunistic approach.

MR. FERRER: Mary Jo, this is Jorge speaking –

SPEAKER: Speak up, okay?

MR. FERRER: Can you hear me now?

SPEAKER: Not well.

SPEAKER: Only faintly.

SPEAKER: Shout.

MR. FERRER: Can you hear me now?

SPEAKER: Talk loud. Keep going.

DR. GREENBERG: Maybe we might need to adjust the phone.

MR. FERRER: I think regarding research and policy the crossroad of the
clinical and financial – oftentimes at CMS, one of the things that I have often
been concerned with that there are some huge policy decisions that are made on
very faint clinical evidence, and I haven’t heard a lot of discussions as
to – quote – the clinical ramifications of data collection that actually will
influence the financial policy, because so much of our healthcare system, we
like it or not, is driven by the policy decision makers that finance our
healthcare system. So I would like to see people at least have that on their
radar screen. I’ve been trying to do that for 30 years, but it is
something that is not going to go away, and as our health begins to consume
much more of the resources of CMS, you know, they are going to be really tied
up to try to make some decisions about allocation of finances to services that
might not have a lot of clinical evidence.

Dr. LUMPKIN: Do you see, then – are you saying that you would see policy as
a separate dimension from research or population or would you see that as being
an important component of research, to guide policy?

MR. FERRER: Well, I think it is critical. I mean, as you all have – you
know, walk through some of these policy decision making bodies, at least within
CMS, that are making decisions about the payment of clinical evidence, and some
of you guys might not want to be in the room when you realize how little
evidence there is at times, and you make these huge payment policies that
clinicians have to deal with for like the next 20 years.

DR. LUMPKIN: But I am going to try to pin you down. Would you make that a
separate dimension or would you say that those decisions that are being made
aren’t guided by adequate research?

MR. FERRER: I think those decisions are made by inadequate clinical
evidence.

SPEAKER: And that is different from research. Okay.

MR. FERRER: However you think you want to –

DR. LUMPKIN: Okay.

MR. YASNOFF: But I don’t think you can put it in the same – I
don’t think you have to create a separate dimension for policy –

DR. LUMPKIN(?): So we could call it the research policy.

SPEAKER: I do. I think – really different audiences.

MR. BLAIR: Can I ask a clarification?

DR. LUMPKIN: Yes.

MR. BLAIR: Clinical guidelines and protocols, where would they fit within
these dimensions if we add a clinical and biomedical research and policy?

DR. LUMPKIN: Well, let me remind you of our visual image, which are these
VIN diagrams of overlapping circles.

MR. BLAIR: Right.

DR. LUMPKIN: So where I would put clinical guidelines would be in the
overlap area between research and provider dimension.

MR. BLAIR: Oh, thank you so much. That is a good clarification.

DR. LUMPKIN: I may not be right, but that’s –

DR. STEINDEL: Yes, I mean, I would put it in the overlap of all the
dimensions, but I would put it in the overlap area.

DR. STEUERLE: When I think of policy research, and I may be thinking
narrowly, but when I think of the people I know in public policy schools or
economics departments or places like that, which, by the way, is a very small
community, so I am trying to think of how much we could add to these sessions
and in the context of an HII, which is even also a narrow component, it seems
to me what they often do, which is slightly different, which leads to your
VIN-diagram world, is they are often one way – Jeff, you got dropped again –
(laughter).

SPEAKER: Are you guys still there?

SPEAKER: Jeff, are you injured?

MR. BLAIR: I can’t hear anymore. (Laughter).

MS. DEERING(?): John is kicking you around.

DR. STEUERLE: When I think of what they often add is they are adding a bit
more of a – I don’t know, a double-entry bookkeeping system or a
cost-benefit analysis or they are adding the financing side. So they might make
use of clinical data in some cases, but then they want to compare that to the
cost of what you are buying to be able to make a policy decision over whether
this is the right allocation of resources.

It seems to me it often does sort of pull in the resource side,
cost-benefit analysis, something along those lines to try to make decisions,
that that’s often the types of things that goes on in policy. Obviously,
there are other things that go on, too.

And so then the narrow question is, within the context of NHII and the
sessions we are going to have, is which of these people could we pull in or
make participatory. You know, David Cutler has a book out now just recently,
Your Money or Your Life, if you haven’t seen it, and he’s got a whole
long discussion about whether we are getting our money’s worth out of the
advances in healthcare and whether we are measuring it right relative to cost.
You could question whether that research is right or not or somebody like Inuvi
Rhinehart(?) at Princeton or somebody like that.

I’m just trying to think of who we could pull in and how they would –
the policy researchers might narrowly focus on what we could get out of this,
and I’m not quite sure – I don’t think you could certainly get a full
session, you might pull them in somewhere else, regardless of where you fit
them in your VIN diagrams.

DR. LUMPKIN: Let me try this – Kelly, you’re shaking your head.

MS. CRONIN: I’m sorry – (laughter).

DR. LUMPKIN: Go ahead.

MS. CRONIN: I just argue that. I think it is much broader, because I think
that historically –

MR. BLAIR: A little louder, please, Kelly.

MS. CRONIN: Well, I just think that, historically, people have been so
critical of the fact that policy is made in this country without evidence, and
that this presents an enormous opportunity for research to generate the
evidence that can then truly inform policy in a more meaningful way. So I think
it relates to almost each one of the circles so far in the VIN diagram. It is
just a matter of how we want to present it.

DR. LUMPKIN: I have a solution. Let me ask this question: What if we were
to take these ideas and for the time being, ‘til our next meeting, play
with them as if they were going to be separate dimensions, look at how they
flesh out, and then revisit the discussion about whether or not we can refine
them into one, or if they seem to stand alone, whether there’s some
lopsidedness that maybe the policymaking is too narrow?

MS. DEERING: One way that might accomplish two things at the same time, and
it adds to the homework assignment, but it would be – I know that you are going
to then say, who is going to start flushing them out? And you are going to look
for volunteers, but it does seem to me that in order to foresee what these
kinds of questions will be, whoever does this homework should take a little
stab at not just flushing out, say, the research dimension or the policy
dimension, but even if it is in one or two bullets, should touch on the
interface areas and what are the policy implications of personal health
dimension? What are the policy overlays with the provider dimension, et cetera,
and the same for research as well.

Again, I don’t think we are going to do lengthy dissertations on any
of this, but just so that, up front, we have already thought about that, so
that we don’t have to do that work once we sit down again.

DR. LUMPKIN: Really thinking just sort of as an outline, what would be
examples of things in the interface? Like we talked about the interface of
research and the provider dimension being clinical guidelines.

MR. HOUSTON: The other way around. To me, it’s the same thing with a
different fashion is take all the different component pieces and decide where
they go in a VIN diagram before you decide the answer to Mary Jo’s
question. Just sort of what you just said. We gotta figure out what the
intersections are, what goes in those different intersections before you try to
answer how they can relate, because, in theory, they relate to all the
different – you know – they relate to research – policy and then – you have to
first determine that they do before you decide to answer what – you know – how
they relate –

DR. STEUERLE: I think all of us are sort of coming at this from our own
perspective in terms of defining what you mean or what other people mean by
policy and then whether it’s part of the big global scheme or something
separate.

I think I would find it helpful if there were some way to have a one-page
note that I could actually send. If you want to ask something about policy
research, I wouldn’t mind sending a one-page note to some policy
researchers, say, here’s what we are doing. Maybe it’s a longer note.
Here’s what we are doing at this session. What are we missing out on? As
opposed to us just perhaps repeating this conversation.

We are trying to define the global issue without knowing the particular
things that fit into it – that might fit into it. You could probably pass
something around RWJ and get 100 comments, right? Does that make sense?

MR. BLAIR: Is this a time when somebody could suggest another dimension or
do you want work on the ones we have?

DR. LUMPKIN: No, go ahead.

SPEAKER: Bill has a comment.

DR. LUMPKIN: Okay, Bill.

MR. BLAIR: The –

SPEAKER: Jeff, hang on one second.

DR. LUMPKIN: Hold on to that for one second.

MR. YASNOFF: Hang on one second.

No one asked me the question why I added research/policy as another
dimension. So since –

MR. BLAIR: Why did you do that?

MR. YASNOFF: Thank you.

So the reason I added research was because clinical research was missing,
and I needed to address that audience, and the reason I added policy is that I
am presenting this over and over to policymakers who are happy to see that, in
addition to improving quality and reducing costs and all these other things,
that it actually will help them to make policy with information, which, in many
cases, is a revolutionary concept. Because, often, the policy has to be made
for various reasons with no information, many policies have to be made without
research because the research that would be needed to make the policy is
unethical. So that’s why those were added.

Now, as to whether they should be separate dimensions or what, I think that
is up to the workgroup, but I think those areas need to somehow be recognized.

DR. STEINDEL: Just responding – Jeff, if I may respond quickly to Bill.

You know, one of the things when we put together the original VIN diagram
was we wanted a way to visualize what we were talking about, and Bill just
introduced another aspect of the visualization, and that is who are we
presenting this to?

Well, when we published the original – whatever it was –
information-for-health document, we were focusing that more in a narrow
community, and, now, it is obviously not a narrow community. It is a very broad
community, and the policymakers are very involved with it. So some way of
visualizing the policymakers in the diagram, I agree, is very important.

DR. LUMPKIN: Let’s go to Jeff for the next dimension.

SPEAKER: (Laughter). The fifth dimension.

MR. BLAIR: Okay. Payers. A payer dimension, and, initially, I had been
resistant to that, because I really wanted it to focus on patient care, but, as
time has evolved, and I am aware of the fact that payers provide incentives for
how patient care – what priorities will be executed in terms of patient care,
and so I think that they need to be represented.

And the additional idea that I have – and I am not sure we’re there
yet – we have a personal health dimension and a provider dimension if we have a
payer dimension, and I think if we have a research community health dimension
and a public health dimension, then all of our dimensions represent user
communities, and I wound up saying a research community and a public health
community in the sense that the word policy – policy could be done by many
different of these entities, and so I am not excluding policy, but I think
policy would be within one of the dimensions in terms of – if each dimension is
like a user group, let’s put it that way, then we are consistent in the
way we are representing the dimensions.

DR. LUMPKIN: Well, let me sort of run through a little logic chain to
explain why I think I may agree with you, although I think payers may be too
narrow.

If we were to have this discussion in the UK, we could all agree upon the
provider dimension. We could all agree upon the consumer – the personal
dimension and population dimension, if we were all speaking with those funny
accents that they have over in UK or maybe they think we have funny accents.

We certainly could all still identify with a policy research –
research/policy or a dimension of – those two dimensions.

With a single payer system, we would probably be less – all that stuff
would sort of be incorporated into.

SPEAKER: Part of policy.

DR. LUMPKIN: It would be part of policy, but we don’t have a single
payer system. We have multiple payer systems. We are different from the UK, and
this may be one of the ways that we are.

So I think I’m kind of leaning towards exploring that.

MR. HOUSTON: Take, again – one of Jeff’s ideas – take the whole policy
thing and sort of wrap it around the whole VIN diagram and say, everything we
do has some policy implication to it. I mean, don’t just say it’s a
component of each, but sort of make a big circle around the whole thing,
because, really, I mean, policy is, I think, probably what guides all of those
areas in its entirety, in all cases.

SPEAKER: I would suggest that it’s not only the recipient, but it
controls these dimensions you are looking at. Sometimes, what we do with these
dimensions isn’t the basis of previous policy. We silo healthcare data.
We’ve got things going on right now that are differentiating between
public health and battle terrorism. We collect data and change data because
policy dictates it, even though you would have to say from a clinical
standpoint, we shouldn’t change data. So I think you have to also be aware
of how policy impacts what you do in these exchanges. You can’t just say
the exchanges will result in new policy.

MS. DEERING: I have an idea, but I know it’s a bad one, but what I am
asking for is a reason why it’s bad – (laughter) – and that is these are
all – I go back to the comment that these are all user dimensions. What
about the enabler dimensions? I’m getting at industry. I’m getting at
industry, and according to one criteria, there is certainly a distinct target
audience for us, but, as I say, I’m sensing that it’s not right, and
yet they are so huge –

DR. LUMPKIN: Can you elaborate on what you mean by industry? Business?

MS. DEERING: I think I’m thinking the technology industry. I think
that’s what I’m thinking.

DR. LUMPKIN: Vendors.

MS. DEERING: I think I’m thinking vendors, but then I started to ask
myself should I use the term enablers, I mean, those who actually – the
suppliers. Maybe that is another way to look at it, you know, the suppliers. I
don’t know. Vendors comes closest to the classic characterization.

MR. HOUSTON: They react to each one of the dimensions. I mean – vendors –
react to the requirements that the dimension imposes on them, I mean, because
you are only going to do things that there’s something – a commercial
outlet for. So you are going to respond – you know, if there is a desire on the
provider side to have – AHR functionality, you’re going to respond to
that. So I think it is part of the dimension.

DR. STEINDEL: Mary Jo just – I think – keyed a thought pattern in my head
that I would like to throw out. You know, in the original document, in the
original VIN diagram, we were talking more about consumers and users of the
NHII. While we did make in our recommendation section some ideas on how to put
this into play, we never really talked about the enablers of the NHII, the
people that – and the reasons we are causing this to happen and the people that
would sustain it in happening, and the payer dimension might fit into an
enabler area. Technology fits into an enabler area. Vendors fit into that area.
You know, maybe we should think about changing some of the focus and adding not
another dimension, but another aspect.

MS. DEERING: Another plane of being. (Laughter).

DR. LUMPKIN: Maybe I could suggest that everything that we have raised are
pertinent areas that we need to address in our document and audiences that we
need to speak to. One could argue that the metaphor of the dimensions may not
necessarily fit.

MR. BLAIR: Well, maybe we have lost track of why we did that, and if I
recall, the reason we used the dimensions was because of a way to represent the
overlap. There was a certain amount of data that was commonly used by all of
these different constituencies, but they used it or looked at it from different
perspectives. I thought that was a very valuable thing to try to communicate.
So I would hate to lose it.

DR. LUMPKIN: Yes, but I think that we kind of morphed into it, because –

DR. STEUERLE: I was going to say we went through two years worth of
discussion.

DR. LUMPKIN: The first – one of the placeholder terms that we had for
dimensions was views.

MR. BLAIR: Right.

DR. LUMPKIN: Because what we wanted to do was stay away from it being a
program, a thing, but really talking about if it is going to work it needs to
work from this approach. In other words, are the people – is it going to meet
the needs of individual people?

I’m not sure – and looking at the time, maybe, Bill, you want to jump
in first – if we can tease all of this out, but the inability to decide whether
or not each of the candidates are a dimension really doesn’t need to
impede us in moving forward and –

DR. STEUERLE: Can I just ask – I hate to do this, but could you take me
back to the first question? For what – I mean, we all can come with our
crossing VIN diagrams and define things differently. Tell me what the basic –
what is it – you want to achieve by laying out these dimensions? You’re
not changing the structure of Bill’s eight categories anywhere, right?

MR. YASNOFF: Actually, what I want to say relates directly to that, and
that is I think that – and I wasn’t here when this report was written, but
I have read it quite a few times – the original report – and what I have
inferred from reading it is that the purpose of these dimensions was to help
communicate the concept, and so I think that, in revising the report, that a
key objective should be to further improve the communication of the concept,
and, in fact, today, this is now – let’s see – almost, well,
two-and-a-half years after the original report, and we know much more about
this and what needs to be done, what obstacles there are and so on, and I think
that the richness of that complexity should be reflected in the report, and so,
specifically, we have a number of stakeholders, and I’m not sure if it is
worth arguing about which stakeholders get their own dimensions, but we could
certainly make a list of stakeholders, and, then, in terms of issues that need
to be addressed, in terms of the long-term strategy, which is what we are
getting to in this next report, I would reference back to the recommendations
that – the categories of the recommendations that came out of last year’s
meeting, namely, how is this going to be managed? What are the enablers that
are needed? How is it going to be implemented? And maybe there are some other
things that need to be discussed, like how is it going to be paid for?

So I would suggest, rather than trying to take the prior framework, which
was very visionary, that helped to communicate the idea, that was very helpful,
has created a lot of momentum and try to tweak it that we take, now, all the
information that has been discovered and recognize and acknowledge the
additional complexity and try to communicate clearly that complexity in laying
out a long-term visions, rather than spending a lot of time trying to figure
out which stakeholders get their own dimensions and – you know –

I think we could make a list of stakeholders that’s pretty
comprehensive. I think we know what the enablers need to be. I think the
management issues have been made very clear, and I think what we need to think
about is what should be the plan for moving it forward, what are the
intermediate steps and so on, rather than these issues that really are already
well defined.

MS. DIAMOND: Yes, I actually was going to agree with much of what Bill said
– just add something to it.

I do think that it would be very useful to drill down on the NHII in a way
that is different from the initial report that creates, not necessarily an
architecture, but a functional model. What should it look like and what are the
key components of it, which is critical to answering how does it get done and
what do we need to do? And maybe that is a way to begin to create yet another
visual for it that incorporates all of the potential users of it and all the
potential enablers of it in some visual model.

I think the visual is powerful, but I do agree with you, I think we need
one that looks – that says, and this is what it looks like, because what you
want is the stakeholders to see themselves in the NHII, not necessarily as
waiting for the NHII or retrieving – or, you know, getting something from the
NHII, but as part of the model of what the NHII is, and as I think about
research – and I had a conversation with Ken before he left – it is a perfect
example of so much groundwork is getting laid, so much infrastructure is
getting built and that needs to be viewed as a piece of this, not necessarily
as a satellite.

MR. BLAIR: Kelly, this is Jeff.

MS. DIAMOND: That was Carol. Sorry.

MR. BLAIR: I’m sorry, Carol. Oh, then, Carol, I guess you were not
familiar with our NHII discussion in January –

MS. DIAMOND: No.

MR. BLAIR: – where we suggested that there be a series of models to define
the NHII in greater depth for what it would look like seven to ten years from
now, and we were trying to use the word models, because we want to go beyond
what the vision is –

MS. DIAMOND: Yes.

MR. BLAIR: – which – the original report articulated the vision, and we
didn’t want to go all the way to a detailed architecture, so we felt like
sort of the next step would be models, and we felt like some of it would be
like an information model, not a technical model, but an information model, a
legal model, a model of the users, a model of the values, you know, that we
would be going by, the principles and values that we would be going by, and
probably several other types of models. Is what I described what you were
trying to say?

MS. DIAMOND: Much more eloquently.

DR. LUMPKIN: So as we are –

MS. DIAMOND: Sorry I missed the January meeting. (Laughter).

MS. DEERING: Are you free in June?

DR. LUMPKIN: Where do we go from here?

I think that we have identified that there’s some key stakeholders
that we want to flesh out how this ought to speak to them. What is it that they
have to offer? What is it that they have to gain from this vision of
interconnectivity interchange of data?

SPEAKER: What are the rights?

DR. LUMPKIN: And what are their rights? What do they have to offer? What
are their benefits and what should their rights be?

DR. STEUERLE: Can I suggest that maybe the issue you are addressing is not
one document fits all? I mean, when I go to conferences on health, I put at the
top of my vita the latest thing I did on health. When I go to conferences on
tax, I put on the top of my vita the latest thing I did on tax. It’s the
same vita, but I reorient it a little bit differently.

Maybe the question isn’t that you get one document that is going to
sell to everybody, but that, at some level, there’s a question for this
committee about marketing what it does. So if you want to go to insurers, you
may not – you know – to try to figure out – you’ve got this exact document
that is going to sell to insurers what they want and everybody else may be not
the trick. It may be you need just a cover page which says, and insurers really
fit into this – this way, and maybe – I don’t know whether
everybody’s picking up one document and being sold on NHIIs.

DR. LUMPKIN: No, but I think what we want them to do is be able to look in
the document and find something that speaks to them.

DR. STEUERLE: Right. But I’m saying you’re asking a marketing
question and maybe it’s not a one-document question.

DR. LUMPKIN: Well, no, but I think, in your analogy, anyone who wants to
look in there and see your – knows that you have done stuff in economistics
areas. They can find that in your CV.

DR. STEUERLE: Right. And Bill suggested a way to handle that, at least –
you know – you have a – document to start with, but I think you’ve got a
bigger marketing issue than getting one document right.

DR. LUMPKIN: So how do we get there from here would be at our next meeting
is that we would spend time going down the stakeholders list and answering
those questions, because whether we do a marketing approach or whether we
include them all in the document, that is going to help us flesh out some of
the materials that we are going to be looking at, this document we are going to
start preparing at the end of the year, and it will also, hopefully, identify
the GATS(?) – thank you – that we may want to conduct hearings on, where if we
feel fairly comfortable in one arena, we may decide we don’t want to do
hearings. Others, we may want to invite purchasers or payers or vendors to say,
you know, what would you need to hear? Or researchers, particularly researchers
we know for sure we want to do, but what would speak to you?

MR. YASNOFF: I would argue that the place to start, in terms of defining
this long-term vision is to develop a comprehensive set of requirements, things
that we will – capabilities that we –

MR. BLAIR: Bill, you’re breaking up a little bit.

MR. YASNOFF: I would argue that the place to start is to develop a set of
requirements, a set of capabilities that we will have when NHII is completed
that we do not have now and that we could – for the stakeholders that we have
already heard extensively from, we can make a list of those requirements and
ask for comments, and from the stakeholders we haven’t heard from, we can
bring them in and say, well, what do you think are your requirements? What are
your expectations?

And, then, we have essentially said – we are starting our long-term vision
by saying this is where we are going. We are going to a place where we are
going to have these 48 capabilities that we do not have now, and, then, we can
begin to address the issues of how do we move in each of these key areas in
terms of management, enablers, implementation, whatever the areas are going to
be, how we move from where we are to get to these capabilities. What are the
intermediate steps? What has to happen first? What has to happen second, to
whatever level of detail we want.

MS. DEERING: Since I am sort of task oriented and yet also a lumper as well
as a splitter, it does seem to me that perhaps you could charge staff before
June, because there’ll be nothing lost, it seems to me, to do this ever so
succinct, bulleted exercise for at least research and maybe policy with a few
items to flush out what are the information components, what are the overlaps,
et cetera, in ways that if you look at – I think it’s page 16 in the
chart, it shows the example of – okay. Like where do the clinical guidelines
go? No more than one page each or a half-a-page each, perhaps. Just something,
because I think it could be valuable, and if we just pick, say, research and
policy for starters, I think staff, you know, can probably get that started.

The other thing is I know, Jeff, you have said for months now that you
would like to see us to move on to models, and I don’t know whether Jeff –
if there’s anyone who could take a stab at – I don’t know what you
mean by an informational – I have no idea what it is going to look like.

MR. BLAIR: Let me indicate that I agree with Bill that a prerequisite to
the development of the models would be the requirements. We have to define the
requirements first.

MS. DEERING: Okay. Jeff –

MR. BLAIR: I think that after we identify the requirements, then, some of
them, it will be helpful for us to make models, and some of them, we won’t
need models for. We could wind up saying, okay. What is the roadmap to get to
this group of requirements, but I do agree with Bill’s modification that
we need to identify the requirements first.

MS. DEERING: We’re coming deep out of the HL7, EHR functional model
and requirements statement. I just wanted to share sort of a conceptual
equivalent of what they went through and what they eventually came out with.
They have certain broad categories for functional capabilities. Within those
broad categories, they’ve got some subsets of capabilities, and they are
stated at a very high level. Is that the sort of thing that you’re
thinking of getting to?

MR. BLAIR: In a sense, I think that could be one of the models, because –
and that is a functionality model of an EHR.

DR. LUMPKIN: But let me suggest that what we did in our first report by
defining the dimensions is we actually started talking about some of the
requirements within three key stakeholder groups, and –

SPEAKER: Right. But at a very general level.

DR. LUMPKIN: Very general level, that –

DR. STEINDEL: When we first started doing it, we did not talk at a very
general level. We talked at very specific levels and worked up to general –

SPEAKER: Scenarios.

DR. LUMPKIN: Right.

So what I am suggesting, because we are running out of time – actually, run
out of time – but what I would like to suggest is that we follow through with
Mary Jo’s suggestion with the addition of the administrative
purchasers/payer arena, and start to – because we are really looking at what is
the work that we can do before the July meeting that we won’t have to
rework after the July meeting. Because I think we will have a lot more material
to work on after that meeting, and fleshing out these three areas, I think,
will give us a good start to then go back to this concept of building the
requirements from which we will construct the models.

DR. STEINDEL: Do you think we are going to be able to do that in a one- or
two-hour meeting in June?

DR. LUMPKIN: The question is can we do that in a one- to three-hour meeting
in June? Not necessarily, but we need to all et on the same page, and I think
we can get on the page by trying to do that, see if it works for us, and that
will better position us for the work that we will do in July and afterwards.

MR. YASNOFF: And so what is the output of that process that you are hoping
for in June?

DR. LUMPKIN: The output of the process in June is that we will try to drill
down on what we would – lead to the requirements in these three new areas that
we are looking at, and we may only be able to get to one of them, but I think
we need to kind of re-engage our minds in the process of how we are going to
get to what we started off with in developing the dimensions of requirements.
How should this – what is the functionality that we think this thing ought to
have for a patient in this new future? And we need to think about – in this
context, get back in that frame of mind.

MR. YASNOFF: So you want some suggested functions in the research and
policy – is that it?

DR. LUMPKIN: Um-hum.

DR. GREENBERG: Meanwhile, somebody – sounds like some staff might do some
work on this before that.

MS. DEERING: Well, I think what we can perhaps try to do is if anyone wants
to just send me ideas, that’s fine. I think one of the things that would
be most helpful is to try and think through what format you want this in. Do
you just want sort of a bulleted list for starters?

DR. LUMPKIN: Yes.

MS. DEERING: Okay. What maybe we can do is even start out with as few as a
handful of things, just to sort of prime the pump in each of these areas, and
start circulating, and you can either shoot everything down, you can build on
it, you can build off it. You can do whatever you want, but, at a minimum,
we’ll send out three pieces of paper that have some bullets on them and
headers that say, what are the requirements for users within this dimension?

DR. LUMPKIN: And let’s use email to kind of get a dialogue going on
between now and June.

DR. STEINDEL: And then probably we can work out the system on one of the
three at a June meeting.

MR. YASNOFF: And when I have the results of the requirements meeting that I
held, I will try to organize it by dimension somehow – I’m not sure how
that will work – and then I will distribute that, and that will be
substantially before June.

DR. LUMPKIN: Right. And it may not work, in which case we may need to –

MR. YASNOFF: Well, now, you know –

DR. LUMPKIN: If it doesn’t that is important to know, too.

MR. YASNOFF: Whatever those results are, you will have them.

MS. DEERING: But what I like about trying to hang the requirements or feed
them into the dimensions just for now is that, again, it is still – it
accomplishes the combination of the – dare I say – more technical need to get
to a requirements statement with the communication purpose of allowing the
users within certain sectors to see it and what it means for them.

DR. LUMPKIN: Um-hum.

MS. DEERING: So it is just a different framework for looping the
requirements.

MR. YASNOFF: I think it is important to have – to have hearings where we
let the people from these various stakeholder groups say, well, you know, we
don’t care about that requirement, but here are three others –

SPEAKER: Exactly.

SPEAKER: Absolutely.

MR. HOUSTON: Let me ask you a question – if we are doing this conference in
July, isn’t that sort of a surrogate for just that or am I – you
don’t think –

SPEAKER: No.

MR. YASNOFF: No, that conference is not a venue where you could get
requirements. I mean, it’s more of an action agenda. I mean, there
undoubtedly will be recommendations at the conference that say we should get
requirements, but you are not, in a meeting like that, going to get any. You
might by accident, but it just – with 1,000 people, it’s hopeless, and,
actually, the whole issue of generating requirements is very complicated and
requires a lot of time and small groups and a lot of recycling of information,
because it is easy – I mean, what typically happens in these processes is you
work with users and you work carefully, you spend a lot of time, you get the
requirements and then you build the system, and you say, one of our key
requirements is missing, because nobody thought of it.

So it’s, I think – but in a big meeting like that – I mean, if I
thought I could get requirements at that meeting, I’d be doing it.

DR. LUMPKIN: We are adjourned.

[Whereupon the meeting was adjourned at 2:06 p.m.]