**AMERICAN HEALTH INFORMATION**

####### COMMUNITY MEETING

**JUNE 12, 2007**

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## Hubert H. Humphrey Building

## 200 Independence Avenue, SW, Room 800

## Washington, DC 20201

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### 

### List of Participants:

### 

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

-   Secretary Michael O. Leavitt, Chair

-   Robert Kolodner, M.D., Acting Vice-Chair

-   Craig Barrett (also represented by Colin Evans)

-   S. Ward Casscells (also represented by Robert Foster, Stephen Jones
    and Ron Pace)

-   Robert Cresanti (also represented by Bettijoyce Lide)

-   Nancy Davenport-Ennis

-   Julie Gerberding, M.D. (also represented by Steven Solomon)

-   Gail Graham

-   Douglas Henley, M.D. (represented by Rosi Sweeney)

-   Kevin Hutchinson (also represented by Paul Uhrig)

-   Charles Kahn, III (also represented by Howard Isenstein)

-   John Menzer (represented by Linda Dillman)

-   Leslie Norwalk (also represented by Tony Trenkle)

-   E. Mitch Roob

-   Scott Serota (also represented by Justine Handelman)

-   Linda Springer (represented by Daniel Green and Michael Garth)

-   Lillee Smith Gelinas, R.N.

-   Phillip Swagel (represented by Adele Morris)

# Presenters:

-   Robert Hutchens

-   Shannah Koss

-   Sheera Rosenfeld

-   Sharon Benjamin

-   Lisa Kimball

-   John Loonsk

-   John Halamka

-   Kirk Nahra

#### 

#### TABLE OF CONTENTS

-   Call to Order: Secretary Leavitt

-   Introductory Comments: Secretary Leavitt

-   Comments: Robert Kolodner

-   AHIC Standing Committee of the Whole: Secretary Leavitt and Robert
    Kolodner

    -   Presentations from three Contractors

        -   Bob Hutchens, Shannah Koss, Sheera Rosenfeld, Sharon
            Benjamin, and Lisa Kimball

-   Standards Roadmap and Healthcare Technology Standards Panel (HITSP)
    Update

    -   John Loonsk and John Halamka

-   Chronic Care Workgroup Recommendations

    -   Craig Barrett and Tony Trenkle

-   Electronic Health Records Workgroup Recommendations

##### Lillee Gelinas

-   Confidentiality, Privacy, and Security Workgroup Recommendations

    -   Kirk Nahra

-   Privacy and Security Framework Discussion: Robert Kolodner

-   AHIC Recommendation Implementation Status Report: Robert Kolodner

-   Public Input

PROCEEDINGS (8:30 am EST)

SECRETARY LEAVITT: Good morning everyone. Thank you all for the
continued effort you make. It's our 14^th^ meeting of the AHIC. I'm sure
that many of you have heard that Dr. David Brailer has stepped down from
his position as vice-chairman of AHIC. Most of you will be aware that
David has started a private equity fund that will focus on issues
related \-- or on companies that are engaged in this kind of business,
and it's clear that the nature of that would provide him some challenges
in his continued service, and he \-- so I will just say all of us
recognize what a great loss that will be to AHIC, but also what a great
contribution he has made. We'll all miss him, but I want to publicly
thank him, as I have privately, for the years of outstanding service
that he has provided, and obviously wish him well as he goes along
changing the world continually in his own way.

I want to just acknowledge the fact that this is our 14^th^ meeting, and
I think we're making significant progress. It's never fast enough for
me. If I were in the market, I could buy an ambulatory EHR product from
a vendor that has been certified by common standards. I can know that
the product will work, and I can connect to others in the healthcare
community, rather than having it isolate me. This is \-- this was not
the case 20 months ago, in an industry where problems of
interoperability have been studied and debated for decades. The
significance of being able to move forward is a high one.

A little bit later today, John Loonsk is going to use a graphic, and
I'll point out at that time, that essentially takes our case studies in
'06, '07, likely the ones in '08, and then lays out what still has to be
done in '09 and beyond. And it's clear to me that if this job of
interoperability was this big, we're still only about here. But the fact
is we're started, and we're making progress. And while I suspect for all
of us, it doesn't move as fast as we would like, I would like to suggest
we all keep this in perspective and just keep working.

Some of you have heard me talk about the \-- how work at a construction
site is somewhat analogous to the work we are doing both in health IT
and what we're doing in value- driven healthcare. I have been fond of
telling the story about a building that's down at the end of the street
where I live. I watched it for months as they went down \-- they just
kept digging, and digging, and digging, and digging, and digging, and
they had this sizeable hole, and every day there would be people, and
tools, and equipment that would disappear into the hole, and it was just
hard to see what was going on, if they were making any evidence of
progress.

And then one day the framers showed up, and they started adding about a
floor a week, and it just popped out of the ground. We're all putting a
lot of effort in what's going on in the hole right now and it's not
evident to everybody that we're making progress, but before we can get
the framers in and see those systems pop up, we've obviously got to
finish what's going on. So I would just say let's just keep working.

Today we're going to be discussing a topic that is, I think, a true
testament to our progress, and that's planning for the long-term
sustainability of AHIC. At our last meeting, I mentioned that I will not
feel as though my job has been done, as Secretary of Health and Human
Services, if I leave and AHIC is not in a \-- and its work is not
sustainable and secure.

That means the work can't depend on the direction of political whims,
and it can't depend solely, though hopefully some, on appropriations
from Congress. So for that reason, we contracted here at HHS with three
companies to develop potential business models for AHIC on a going
forward basis with a private sector model. Now we'll hear from those
contractors in a few minutes.

I'd like to keep in mind, as we listen to them, that there will be a lot
of questions. We have only had these proposals now for about a week and
we're still sorting through them. We'd like you to do the same thing.
Some of the answers will be things we work out as we go forward over the
next several months.

Today, however, does mark an important beginning to the phased
implementation of a successor organization. And yet it's just the
beginning. We need to work collectively to \-- on exactly how we'll hand
the torch off to another organization, and perpetuate this work and
accelerate this work. As I look at that chart that you'll see a little
bit later, it's clear to me that we've got to not just perpetuate but
accelerate. I know that Rob will have more to say in his comments on
this, and so Rob, why don't I just turn it to you now and thanks for
your ongoing good work.

DR. KOLODNER: Thank you very much, Mr. Secretary. Let's start with the
one order of business, and that is the approval of the minutes for April
24^th^, for the 13^th^ meeting. Are there any additions or corrections?
If not, we'll accept by consensus.

One other bit of business, before we get into the first item on the
agenda, is I wanted to recognize someone who has really been
contributing to this effort in terms of ONC's activities, and that is
Vic Eilenfield, who spent a year here, part on detail from DOD and part
after he retired from DoD, in an interim position, and helped in a
tremendous way in the transition that I had coming onboard, and was
serving as the acting deputy during the time that he was with me. And I
wanted to have him come up so that I could recognize him in front of all
of you. Vic?

\[applause\]

DR. KOLODNER: Vic, thank you for all that you did to help move things
along in this rapidly changing environment, and good luck to you in your
next activities.

Previously I had mentioned that we would be talking about a strategic
plan. We're still working on that, and I will be bringing that to you at
the next meeting. But since we had a full enough agenda today,
especially with what I think many of us feel is one of the most
important next items, that is the establishment of the next entity after
AHIC, the AHIC successor, or the partnership for healthcare, or whatever
we end up calling it, I'd like to get on to that item on the agenda. And
if I could have the slides, please?

What we're going to do is we will be hearing from each of the three
contractors. What I'd like to do is to start first by stepping through a
set of principles as well as a \-- the timeline that we'll be doing. And
Kelly, if you'll come up to the table, and I'd like to have us discuss
for a little bit, to make sure that we have agreement on the kind of
principles and kind of evaluation criteria we should be using for these
next things. So I'll be stepping through this, and we'll be talking for
about a half an hour before we have the presentations of each of the
contractors.

On this first slide, Kelly, if you'll step us through the timeline that
we have here.

MS. CRONIN: Sure. I think you all heard in our previous meeting that we
had awarded these three contracts to three different firms to initially
explore how best to design a governance structure, and develop a
business model for the successor entity, and so the people you see here
today will be presenting that work. It's been a very intense six weeks,
and they've done a really good job, which you'll hear about very
shortly.

So we did just receive deliverables on Friday. We apologize for the
short turnaround time for you all to review these, but I think after
today's discussion, we'll have a good handle on the breadth of work that
was done. So today, obviously, we will agree on the evaluation criteria
and principles. We'll be going through a public input process in June or
July. We've now extended that process to include three weeks. We realize
that there is enough complexity involved with these proposals that we
wanted to have a good three week public comment period.

We also plan to present a prototype organization to you all on July
31^st^, based upon an internal review period in June, and then the
public posting of that prototype. And this really will be based on the
best ideas that we all are going to hear about today, and then a lot of
discussion among experts in our community and at the staff level.

We will then be working over the summer to refine this prototype, based
on your input on July 31^st^, and will likely be discussing this with
you throughout the summer, given some of the complexities involved, and
then we hope to have a final prototype available for your review, and
then hopefully have that in the form of recommendations to the Secretary
on September 18^th^.

And then following that, the last quarter of this year, we intend to, in
whatever way we are able to, from an authority perspective, to support
the formation of this entity, and look for funding sources for that
entity, and then begin the transition of responsibilities from this
Federal Advisory Committee to that new entity, as it becomes formed, and
operational, and it's able to take on some of the responsibilities that
we'll be discussing this morning and then, again, as we develop the
prototype.

So this is a high level timeline. We obviously have an awful lot to work
on in the next even three weeks to really flesh out some of the details
we'll hear about today. But we feel that we will be seeking a lot of
input, not only from people who have been working on this intensely over
the last four years and have really seen what the formation of HITSP and
CCHIT has taken, but we're really going to draw on the expertise of the
whole healthcare community, not only through working closely with you,
but trying to get a lot of public input, in general, on how best to
organize this, given the importance to the overall agenda.

So with that, I'll pass it back to Rob.

DR. KOLODNER: Thank you very much. There are a total of six principles
that we're advancing, and then what I'm going to do after that is to
step through each of those and give you an example of the kind of
questions, the evaluation criteria that we could then use. So the six
principles are as follows.

First of all, that the entity should exist for the purpose of individual
or consumer benefit. And we had some discussion that I think will come
up about what's the right term to use for the individual, or the term
consumer didn't capture it, and we want to make sure we get across the
intention.

The entity should establish and enhance trust among stakeholders. The
entity should have broad participation across the healthcare industry
stakeholders. The governing bodies of the entity should have the
necessary authority to make decisions, but only the authority that is
necessary to do this. The entity should be feasible to establish and
operate, and sustainable into the future. And the entity should be
adaptable over time and across future circumstances.

So starting with that first principle about the individual benefit, the
kind of questions we would be asking, as we look at the deliverables
that you'll be hearing about in the proposals, are things like: is the
purpose of the proposed entity to advance the health and well being of
all residents of the United States. Or are there provisions in the
governing documents structuring operations of the proposed entity that
ensure the privacy of consumer and provider data?

For the next principle on trust, we will be looking at questions that
have to do with ensuring that decisions are made in an informed, fair,
and equitable manner; and that the rights and obligations of the members
are common across the various sectors and equitable between them. And
finally, that decisions incorporate the views of all the sectors and
cannot be dominated or controlled by any.

On the principle of the broad participation, we're looking to see, does
the proposed entity allow membership by individuals and organizations
from all sectors of the health community? And that participation is
voluntary with simple entry and exit, at a minimum impact on the
organization, as those entry and exits occur.

We also want to be sure that existing federal, state and private sector
health information technology initiatives are able to participate in a
smooth way, and in a way that enhances their capacity and progress. And
that the proposed entity has clearly delineated powers to set fees, if
any, but with sufficient restrictions on that power to prevent inequity
or abuse.

On the principle of the necessary authority, we're going to be looking
at things such as whether the proposed entity has a clear delineation
between the rights and responsibilities of the members, and those of its
governing bodies, and that those governing bodies are elected by and
fairly represent the members of the entity. Also, that the governing
body has sufficient authority to create the necessary rules and
procedures to guide its operations, and determine conformity and
compliance, but with sufficient restraint on that authority to prevent
abuse; and also, that the decisions, actions, and regulations of the
proposed entity are limited to the things that are essential for
collaboration and operation. And that all the other decisions, and
actions and regulations are reserved to the independent actions of its
members.

On the next to last principle on feasibility, we're going to be looking
at whether the proposed entity is consistent with applicable laws and
regulations, and will not place members in violations of those laws and
regulations, and whether there is a clear, practical plan to bring the
entity into being and to begin its operations by December of this year.
That may slip until early first quarter, as you saw from the timeline
that Kelly Cronin showed.

Whether there is a practical plan of action for the first three years of
that operation, and for financial sustainability after that time. Also
whether there is a practical plan for attracting a sufficient mass of
members at the beginning from key industry sectors. And that the
proposed entity can attract and reward outstanding leadership and staff.

And on the sixth and final principle on adaptability, we're looking to
see whether the entity can be durable over time with respect to purpose
and principles, but malleable in its form and function so that it can
revolve in response to a variety of changes in technology,
communications and the environment, without harming those objectives.
Also that all members can self-organize at any time, for any reason,
consistent with the charter, purpose, and principles of the entity, and
that those new organizations can have the same rights of membership
without taking them away from their constituencies.

And then another area to look at is to ensure that there is a continuous
delineation between the decisions, actions, and rules necessary for the
collaboration, and those necessary to preserve freedom of action and
competition among members. And that the powers for effective functioning
of the entity are vested in the successor organization, but \-- and \--
that all other powers are vested in the members.

As we have been talking about, there are three contractors that you'll
be hearing from that will describe the potential business models. They
have a variety of aspects to those presentations, the appropriate role
of government, the short, mid, and long-term goals of the entity,
mechanisms to ensure diverse and voluntary membership representing all
stakeholders and healthcare, a transition plan, and a path to
sustainability.

In addition to the three contractors, we have been very fortunate that
we have been able

to obtain the services of an expert advisor. That's Dee Hock, who was
the founder and first CEO of Visa International who will be serving as
an advisor to ONC on these potential business models.

We will be informed by case studies, which also have been presented by
the contractors, and as we have mentioned all along, this process of
developing a business model is evolutionary, and we will be starting
with this point, but we expect it to change, and grow and become
enhanced as we go through this process, and even once it gets
established, for it to continue to grow, if we've set it up properly.

And I'd ask Kelly to take us, again, to the role that AHIC has in
planning this successor.

MS. CRONIN: We've touched on this briefly before, but certainly today we
hope to spend at least an hour talking about what you hear over the next
45 minutes, about what is the appropriate governance structure, what are
the revenue sources for this entity, what is the appropriate role for
government, how does this entity interface with governance organizations
that oversee quality measurements or data aggregation for the purposes
of quality measurement and public reporting, since we know that there is
a lot of interdependencies between the quality improvement world and
what we are trying to do in order to reach value-based healthcare.

We also recognize the importance of getting public comment, which I
mentioned before, and we have extended our initial planned public
comment period from two weeks to three weeks, so we'll be spending a
good part of July trying to get \-- and process that public input, and
then to the extent possible, we'll be reporting back to you on July
31^st^ with the summary of some of the key themes that we heard from the
public input. We're also widely communicating the fact that we are
seeking input to really try to get the word out so people can respond in
that timeframe.

So we also expect to hear, this morning, and will be working intensely
over the next few weeks, to figure out the transition plan, how over the
next 18 months do we expect to take on certain \-- or have certain
responsibilities that you currently serve, transition to this other
organization, and how from an evolutionary perspective can they assume
certain operational roles and become more operational over time, as
funding increases and membership increases.

We expect to refine the prototype that we proposed publicly on July
2^nd^, over the months of July, August, and early September, and then
have a final proposal to you back on September 18^th^. And then
following that, as I mentioned before, we'll be looking to support, in
any way we can, the formation of this entity, and getting its initial
membership, and potentially a transitional board or whatever is the
proposed model to move forward, getting that established.

DR. KOLODNER: Okay. What I'd like to do, I'll go ahead and put the six
principles up, but I'd like to have us have a little discussion about
these principles, and make sure that we have a consensus on that, or
make any additions or changes that would reflect the guidance of the
AHIC. Kevin?

MR. HUTCHINSON: The one comment I would have is \-- maybe it fits under
adaptability. I'm not sure which point it might actually fit under, but
we hear it all the time when we're talking about whether it's CCHIT, EHR
use to establish the standards, what HITSP is doing and other things, to
make sure that what we're doing is not somehow hindering innovation, but
instead find that balance. And I think it's to ensure there is a
balanced purpose where we're establishing, as Mr. Secretary pointed out,
a foundation, you know, for the sharing of health information but we're
not necessarily, nor would the, I would think, the successor to AHIC
would want to somehow hinder innovation in the sharing of healthcare
information, the development of technology to be able to do that,
because that obviously is not the purpose of this organization, nor
would it be the purpose of its successor.

But maybe it fits under adaptability, where we're making sure that this
entity is there to ensure a balance between innovation, and at the same
time establish a foundation for the sharing of that information, and
it's not there to hinder the development or innovation of technology.

DR. KOLODNER: I think that's an excellent point, and I think there are a
few places where we tried to capture that. For example, under the
necessary authority, there is the restriction where there is enough
power to accomplish the organization, but only that much power, and that
all the rest of the actions are left to the members or to others. But it
is not meant to restrict that. And I think we'll capture that and make
sure that we have that explicit, about the innovation.

SECRETARY LEAVITT: Let me make this comment. One thing I don't see is
that we've got \-- there's a clearly focused mission. That this is about
achieving standards for interoperability. It's not \-- there is a
million other things it could find its way into, but this organization
needs to be about standards to achieve interoperability. And I think in
some ways, one of the things we'll have to decide is whether its
relationship is with CCHIT and HITSP and potentially others. But its
purpose and mission needs to be clearly focused and defined, and I don't
see that in the principles. I suspect that will be somewhere in the
mission, but we ought to \-- we ought to focus on the mission as well as
the principles.

DR. KOLODNER: Okay, and I think that will come up in the later
discussion, including the issues of the relationships or potential
relationships with HITSP, and CCHIT and the NHIN.

Other comments? Nancy?

MS. DAVENPORT-ENNIS: From the perspective of the consumer, certainly if
we look at the first principle, we would also want to pay attention to
the trust section, where we talk about data. I think consumers are going
to be very interested to see how the new entity is going to deal with
secondary use of data, and what protections are in place for the
consumer moving forward. And I think also, as we look at the initiation
of these principles, that for the consumers to lead this movement, as
the Secretary has often said is the only way it's going to happen, there
has to be a sensitivity to how do we incent the consumer. And if part of
these principles can address the issue of incented use, and certainly
that doesn't happen without interoperability, consumers will be
incented, and the direct proportion to which they think they will have
use and value from this, so those are just major points I would call out
as we look at each of those.

DR. KOLODNER: Excellent, thank you. Adele?

MS. MORRIS: Thank you. This is a basic question of what is the structure
of this new successor organization? Are we assuming it will not be an
organization under the Federal Advisory Committee Act? It matters a lot
to the process and governance of the organization. So if we've decided
that it's not going to be a FACA, then that kind of leads us down one
path. If it might be a FACA, then there are a host of other questions
that arise.

SECRETARY LEAVITT: I have been giving this a fair amount of thought, so
let me comment on it. I started off with the assumption that we wanted
to get this out of government so it wasn't dependent upon the future
Secretary or the \-- some other person in government taking it
seriously, as I hope this administration has, that it can become \-- it
can gather energy from the industry itself, and from the healthcare
family itself, and be self-perpetuating.

Having said that, I would appreciate some conversation on this point. I
don't think we ought to just pass it with that assumption being
accepted. If we're not able to gain enough credibility in the
organization, if it isn't clearly going to be, as we said early in this
conversation, the northbound train; if there is going to emerge
competing standards or organizations that, in fact, could tear asunder
its value, then we will have not have succeeded.

So if it takes government to do it, then we ought to decide what
government's role and what its relationship is, but I still believe that
our default position ought to be getting it out of government so that
it's able to function more as a direct functionary of the larger medical
family and consumers.

DR. KOLODNER: And Adele, one of the things is that the charter of the
AHIC did require or does require that we explore the formation of AHIC's
successor in the private sector, so the intent was to do that, and to
look at what functions still need to remain, because obviously, we do
have FACA functions that can't be passed to private sector. So what
needs to remain, how do we accomplish that, how might we be able to have
the government still adopt the Secretary, accept and recognize standards
so that we have the full force of the government behind it, but without
the AHIC necessarily having itself to be a back organization.

Bob, then Chip.

MR. CRESANTI: Let me add one quick point, that Rob and I had a
conversation on this morning. We have issues, sort of international
issues as well with regard to interoperability, and the way we share
information across border data flows, and privacy issues and so forth.
And I think we have to keep an eye on that. That's just one of the
little things that I would tick off in a list of things that would \-- I
think the default position, Mr. Secretary, is exactly right \-- but I
think that's one of the things we have to account for in this process.

In addition, the federal government has such an enormously large role in
healthcare that actually the sort of \-- when we started this
conversation, the first thing I thought of was an agency called the
PCAOB, on the financial services side, which is accounted for in one of
the presentations today as sort of having low ties to the model that is
proposed. But I think it's \-- it's sort of a similar circumstance.

I think there are some tangents that could be explored there. I just
wanted to bring that up as a conversation point. I see, having dealt a
tremendous amount internationally with regards to the issues of US
standards, there is a \-- there is a consistent malfunction or \-- you
know, when foreign governments expect the United States to step forward
and say this is the US government policy on this particular standard,
and we're going to come to the table with it. Not that we should change
our system at all. I'm not an advocate for that, but I think that it
puts us at a disadvantage when we're going across border with
information.

DR. KOLODNER: Chip?

MR. KAHN: A couple of things. I agree, theoretically and conceptually,
with Secretary Leavitt's notion of it being private, and I think it
ought to be private. But at the end of the day, I think authority and
responsibility, ultimately so much falls back to the government, and
because I believe that we need at least partial broad-based financing,
if not total broad-based financing. The government is going to play a
very important role here.

So I would suggest \-- and I guess the dilemma with what I'm going to
suggest is it may not be relevant, because it might require legislation
or would require legislation. But there are models, and this may sound
like off the wall, but the Medigap model, actually, is one that could be
very relevant to this, where the National Association of Insurance
Commissioners recommends to the Secretary model legislation for Medigap,
and then the Secretary promulgates a regulation. It's a private \-- it's
a nonfederal government entity, and I just was \-- I'm just wondering
whether some kind of model like that, where at the end of the day, the
Secretary would have authority to overrule it, but at the same time, we
know from that experience and possibly other experiences we could
identify, that basically, the Secretary is involved in the process and
signs off on it, and there is a regulation promulgated.

So at the end of the day, the recommendations of the entity, the
policies that the entity proposes, in a sense have the power of law. And
I think that kind of connection could add the power of not depending on
HHS for the process, for the entity, but having a role for the Secretary
that ultimately puts the ultimate imprimatur on the policy that this new
form of AHIC would approve, I think could be very powerful \--

Unfortunately, I presume, I haven't thought it all through, that that
would require legislation, that Congress would have to say that this
entity would work that way. But I think that would really add something
to this. And it would be possible to launch the private endeavor that
we're all talking about with the presumption that once that's done, or
when that's being done, that some kind of relationship like this could
be promoted in Congress to try to get that sort of together, so that we
could match up your concept with, I think \-- I think at the end of the
day, you're correct. A future Secretary may not have your inclination
and priorities, but on the other hand, this is always going to be such a
national priority, at least in \-- to the foreseeable future, that I
think any Secretary would have to take very seriously what was
recommended to him, from such a body, and it really enhances the
authority of that body, everyone knowing that at the end of the day, the
Secretary is going to have to take their recommendations and do a
regulation one way or the other on them.

DR. KOLODNER: Thank you, Chip. I think a couple of things. First of all,
I can see the energy that is here ready to jump into talking about the
kinds of things that will be stimulated by the presentations.

I think it's important for us to hear what you want to achieve rather
than how you want to achieve it. It turns out there actually are
structures and ways that private organizations can have a unique
relationship with government that are already in statute, so we can
explore that.

And the key thing is that as we get into it \-- and what I'd like to do
is to see if there are any other comments on the principles before we
then go to actually hear about the models, and then we can continue this
conversation. But, you know, the focus will be what do you want it to
do, how do you want it \-- how do you want it to function rather than
how it has to be structured, and that's what we'll be taking back as we
look at these structures. Scott?

MR. SEROTA: My only comment with regard to the principles of governance
is somewhere in those principles should be a bias toward action. I think
the biggest problem we run into is a debating society, and I think \--
so I think the principles should be very clear that there is a bias of
this group to act.

DR. KOLODNER: Excellent, thank you. Lillee?

MS. GELINAS: I just have four key points here, and I'm really glad you
brought this up, Mr. Secretary, because when I read all the materials
for the meeting, and yes, some of us didn't sleep last night with the
amount of material to read. \[Laughter\] But it just \-- it struck me
that we weren't talking about a government entity at all, that all of
this was around these models that were in the private sector. And to
that point, this is a case where the private sector is lagging behind
the government sector in terms of health IT. Clearly. Clearly. So it
scares me a little bit to put a model solidly in the court of a private
sector when the private sector is lagging so much behind the federal
healthcare system's interoperability and health IT capability. That's
the first important comment.

The second, it really strikes me that I don't see two words up there at
all, and I hope maybe at the end of the discussion we will. One is
quality and one is cost. At the end of the day, all the words, I don't
want us to forget that, that at the end of the day, what we really need
to accomplish is higher quality healthcare at a much lower cost.

And third, I was really glad to hear the international piece here
because I wrote the word swift down, Scott, as a part of my notes here.
All this process and all these models, I just thought oh, my gosh. Are
we going to get caught up in process again and not get the job done?
Since our last AHIC meeting, the landscape in nursing changes very, very
quickly, very swiftly. But we're beginning to watch the egress of nurses
out of the United States to international hospitals, because the
environment of work is so much better there. And just having had a
conversation with some nurses who have gone, and they talk about walking
into hospitals in certain parts of the world where there is so much
money to throw out that the health IT capability is incredible, and they
feel that it's a safer system in which for them to practice.

So those notions around quality cost, private sector lagging behind the
government sector and the international component, as well as swiftness
are all part of "what" conversation, I hope, in the next couple of
hours. Thank you.

DR. KOLODNER: Okay. Thank you Lillee. Any other comments on principles
before we go on to the contractors? Yes, Mitch?

MR. ROOB: This is a difficult question, what the role of government \--
what the right role of government here is, and I really think there are
two, and they are intertwined. To the degree you can tease them apart
sometimes it's helpful. The first is to provide some kind of regulatory
authority to \-- so privacy is established, et cetera. And then there is
a market weight that HHS brings to bear. But there are two separate
issues. It's not the same thing, all right.

And I do think as we reflect on this, having been involved in healthcare
now for some number of years and watched a number of, Mr. Secretary,
your predecessors who have not chosen, frankly, to use the marketplace
weight of your agency to move quality and cost forward, you've chosen to
do that. That makes an enormous difference. Your leadership in that
respect makes an enormous difference. And to say that this is not going
to be a \-- that you're going to divorce government as the purchaser of
50 percent of the healthcare in America from this process, I think is a
mistake, because we lose that throw weight that the federal government
brings to those choices. You, de facto, set the standard when you're 50
percent of the marketplace, and no one else has more than one percent of
the market.

DR. KOLODNER: I think, Mitch, one of the phrases we've used, and again
you'll hear it as we get into the models and proposals, is it's not a
private sector entity, it's a public-private entity in the private
sector. So the intention is, in fact, in some of the challenges, is to
see how we structure a public-private entity so that the government
representatives and government agencies can, in fact, participate as one
of those sectors, so that as you say, the full weight of the purchasing
power is there.

But also it brings some of the revenue, so there is a sharing in terms
of however this entity will be self-sustaining. There is just the cost
of operations. It isn't that the government is going to support it. It's
going to pay its fair share of the cost. And \-- Mr. Secretary?

SECRETARY LEAVITT: I didn't mean to interrupt you.

DR. KOLODNER: I think that's the key. It isn't intended to divorce it.
It really is a public-private entity.

SECRETARY LEAVITT: I think Mitch's point is this. Government doesn't \--
isn't so much a question of what is government's role, it's how does
government play a role? We can play a role as a regulator, and by the
force and power of regulation and law, given the right construct, we can
create finality with law.

The other role we can play is to add substantial weight to a private
organization with our purchasing power. As Mitch points out, we have, in
previous months attempted to bring the purchasing power of the federal
government behind this effort by committing that we will follow these
\-- the pattern of interoperability. I will tell you that I've learned a
lot about the federal purchasing power in the process. It's not like you
flip a switch. Medicare requires a long time to create a rule that can
\-- and there is a lot of places where you start upsetting other carts
that you hadn't intend to once you start promulgating rules with
Medicare.

Medicaid is not a program, it's 50 separate programs, and you have to,
then, unify 50 separate states or use some kind of regulatory power to
sort of stampede people into a place where they can do it. It probably
won't surprise people to find out that the Defense Department and the VA
don't always see things exactly the same way. Then you have the Office
of Personnel Management. So \-- and they have their own processes. So it
is \-- trying to unify this 40 percent of the market that we call the
federal government isn't as easy as it might seem or as exact.

On the other hand, if you have to \-- if you try to use the regulatory
power of the government, that is \-- every year we put out a rule on
pricing changes in Medicare. We work on it all year long. And it has \--
then you put it out, and there is 90 days for people to comment, and
then you come back and there is another 180 days for people to comment
on that. And then it just goes on and on and on, and that is an almost
impossible environment for standards of technology to operate.

And that's the reason I've come to the conclusion that we don't want to
be using regulation, government regulation as a means of being able to
set the course on what has to be a highly nimble, fast market efficient
process of adapting. On the other hand, we have to reach enough finality
that it is, in fact, the northbound train.

So I think this is a very healthy discussion, but let me just boil it
down. I think we have got to decide not if government plays a role, but
what its role is, and which of its tools do we use or some combination
thereof to reach market adaptability, and nimble quickness, at the same
time the level of finality required to make this a standard.

DR. KOLODNER: Could I have suggest we have two more comments from Chip
and from Leslie, and since so much of the discussion is now away from
the principles and into the organization, that we, then, transition
after those questions to hearing from the contractors. Chip?

MR. KAHN: I'd like to say something about the principles. I guess I'm
the one that probably drove the way number three is actually worded with
the entity should have broad participation across healthcare industry
stakeholders, in terms of my comments about the original draft. Those
lines really don't quite capture what I had in mind. I just want to make
a suggestion.

I think what I was concerned about was that this entity, I agree, should
exist in principle for the benefit of the individual who is actually
having the record used for them. But what I was concerned about \-- and
this is what I think principles really are important, because ultimately
things will happen and people will look back to them as sort of the
constitution of the reason we're here. And it's not a question of broad
participation or how many votes health industry people get one way or
the other.

The notion that I was looking for was something that recognized, and
actually I'd probably make it number two after the consumer, individual
consumer, is that the doctors, and hospitals and other healthcare
providers, are actually going to have to use \-- I mean purchase, use
and be responsible for this record that we're going to be \-- that the
future AHIC is going to provide policy for. And that's a little bit
different role than everyone else's, because ultimately, they have
obligations, they have actually workflow needs that I think need to be
recognized as we \-- as policy is set or recommended.

And that in some ways, that's as important as the benefit to the
individual, because the benefit to the individual ain't going to work
unless those who actually deliver care and are responsible for the
record, ultimately they will be responsible for the record, are sort of
in mind when we're developing policy.

And that's the notion I was looking for. It wasn't something in the
sense that had anything to do with governance, as much as \-- because
this is really a governance statement, broad participation across the
healthcare industry. I was looking for something that just recognized
that the role of the entities and people providing the care, in a sense,
is as much as something that needs to be benefited by this process as
the individual consumer, because without those people, the individual
consumer won't get the benefit. That was the point I was looking for.

DR. KOLODNER: And Chip, before we go to Leslie, I think the point is a
good one. It also reflects the way healthcare is today, and the way
things are delivered. So if we look at some of the evolution and changes
that are occurring, and the prevention and the individual taking a
stronger role in their health, so that earlier and earlier, there are
actions that may not necessarily be healthcare encounter based, but that
have a strong impact on the outcomes of health, that somehow in that
adaptability and durability, as the health system evolves over the next
10, 20, 30 years, and that genomics plays a role, what we need to do is
make sure that this interoperability, and this system that is being
advanced, is able to adapt to not only take care of today, and the way
that we have healthcare delivered today, but to be able to also respond
to all of those evolutions in the future.

MR. KAHN: If I could just respond, I agree with that. However, whether
it's the conventional providers and physicians that we have today, or
whether it's other kinds of intermediators, it ain't \-- the individual
is still only going to be part of it. I mean I have \-- if you look at
the diffusion of computers, all of us around this table have computers.
We still depend on suppliers, and experts and other people to make it
all work. And at the end of the day, we can do a lot, but we can't do it
all, unless we're expert in it.

So I just \-- I think that needs to be recognized in a way here, because
it's those people, whoever they are, in the current world or the new
world, that are really going to be as important as the individual,
because the individual is going to depend on it.

DR. KOLODNER: Leslie?

MS. NORWALK: I'm sorry, Chip. Going back to your original comment, and
then the Secretary's comment and Mitch's comment, I think CMS plays a
couple of different roles. Certainly as the largest purchaser, we play a
huge role in what happens because of the regulations that the Secretary
mentioned.

But we have another set of regulations that I think are \-- would be an
interesting thing to determine. How does CMS and the successor
organization play with the HIPAA transaction and code sets regulations?
How do the DSMOs or the Designated Standards Maintenance Organizations
interact with this successor body, and how is it that we can put it all
together so that CMS, as a regulator of transactions and code sets for
the entire industry, separate and apart from the Medicare payment
regulations or what we do on the Medicaid side of the house, how do
those all come together?

And how can we \-- because that process, in addition to our payment
regulations, the transaction and code set process has also been
cumbersome and slow. And so how can a successor organization help CMS
and the department do a better job to more quickly implement
transactions and code sets on a go forward basis so that it's more than
just something like the CCHIT, which has been much more nimble, I think,
than the CMS process. But how can we interact \-- how are those \-- how
are those combined, what do we see the future of the CMS role under
HIPAA, the transaction code sets.

DR. KOLODNER: Thank you. And at this point, let me turn the mic over to
Kelly Cronin, who will introduce the three contractors and we'll hear
about the deliverables. I'm not sure yet whether we have these posted on
the web, but if we don't, we will have them up shortly, so why don't we
proceed? Kelly?

MS. CRONIN: Thank you. I should also note that you received both the
presentations that you'll see this morning on Friday, and over the
weekend, and then there is a much longer power point presentation that
represents the entire amount of work that was done over the last six
weeks for all these organizations. So probably not all of us spent all
of our evenings reading all these deliverables over the last three
nights, but clearly, there is a lot to absorb that you will hear about
shortly.

I just wanted to briefly introduce the presenters. Bob Hutchens will be
presenting from Booz Allen Hamilton, who is the vice-president in the
group health practice group. Shannah Koss is a vice-president and head
of the health IT practice group at Avalere. Sheera Rosenfeld is a
director in that practice group at Avalere, and Sharon Benjamin is from
Alchemy. Lisa Kimball represents Group Jazz, and both of them convened a
network of healthcare executives over the last six weeks and worked with
them to address the tasks that were in this group of work that we gave
them.

So each will present for 15 minutes, and then we'll have the rest of the
time for additional discussion.

MR. HUTCHENS: Kelly, thank you. I have the unenviable task of distilling
100 pages into 15 minutes, so bear with me as we go through this. We're
going to do four quick things as we walk through our presentation this
morning.

First of all, to distill some of the discussions we had around what we
heard, as we talked to many of the members of the AHIC board, around
what the missions and goals of the successor organization would be.
We'll then spend the most of the next 15 minutes talking about the
governance structure that we are actually proposing. We then did a very
quick look at what the business model would be, to ensure that what we
were proposing was financially viable and had sustainability. And then,
finally, a very preliminary transition plan on how we go from here to
there.

We've put together a set of mission \-- a mission statement at the
request of the group, and just even listening to this discussion, I
think there's changes that we would make to this, just having heard this
discussion, things around achieving standards and more end state kinds
of objectives, would be things that we would be put into this.

I won't belabor this particular set of mission statement. I think it's
fair to say that this would be a topic for this board or the future
board to spend a fair amount of time on to get agreement around the
mission of the successor organization, and exactly what the scope of the
activities will be.

We had a lengthy discussion just now around the governance principles
that you have proposed. We also heard a number of things, and actually
thought about several things as we put together the governance structure
for \-- our proposed governance structure, and rather than walk through
these five bullets, let me make two comments.

There were two things that we heard loud and clear, as we went through
our discussions, again with many of you and with some outside experts
around this. One, the government cannot walk away from this. The success
that has been achieved to date has been largely because the government
is leading this. And whether that's because the government is 50 percent
of the market and there just isn't anybody else who can take the
leadership role on this, or whether it's just the credibility of having
the government has been in there, we heard both as reasons for that. And
that that has really been one of the leading key causes of success to
date around this.

We also heard that there was a desire for broader participation and
broader representation in this group, that the private sector did want
to play a bigger role, and wants to be more involved, and we want to
ensure that we have a balance across sectors and across interested
participants. And if you just look down at that, you see open, you see
the word balanced, you see the word equitable balance, and that is
really the themes that came out of those discussions. And as we look at
the governance structure that we put together, that's what you'll see.

One final set-up page around how we thought about the governing
structure we came up with. We listed six success factors, and we \-- I
should preface this page by saying we did think of this as a
public-private partnership, and the ultimate form the legal entity takes
is subject to be determined. We are not lawyers. We are a firm of
management consultants, so we did not render a view on that, but we
viewed this as a public-private partnership.

We've done a number of these over the years as a firm, and helped set
these up, and we listed six success factors that we believe any time
we've gone in and helped set these kinds of things up, that we saw. And
we've had the governance design requirements that we saw that came out
of those, and again, that's what this page does.

This is really the meat of the presentation, and it really does
highlight what we're proposing. And there are five elements that we've
suggested that the governance model have.

We begin with member organizations. The entity will be made up of groups
of organizations that are part of this. From those organizations,
members will be elected to a board similar to this one, and we'll talk
about the mechanics of how we suggest that that be done, but this board
would have the ultimate authority over this.

The board could periodically set up advisory groups with very specific
targeted audiences where we need some very specific input. For example,
we might have a group focused around nurses. We could have a focus
around independent private providers. We could have a focus group of
pharmaceutical companies who wanted access to this data, potentially.
There is a whole raft of those advisory groups, and those would be set
up on an ad hoc basis. And again, we'll talk about that more in a
minute.

We've got our Workgroups. They are similar to the Workgroups that we
have today. We would continue with those, and have suggested that those
have been successful. We have one minor change that we will talk about
when we get into them in terms of how they operate. And then probably
the most significant change that we've proposed here is around the \--
the actual entity, the actual organization that would do this. And
that's the creation of a not for profit organization that would consist
of a number of services but would, in effect, replace the role that the
department is playing in terms of providing secretariat kinds of
functions, supporting Workgroups, supporting standard harmonization. And
we've suggested that this be a stand-alone independent entity that does
that. And again, we'll go into more detail around that in a second.

We'll begin with the member organizations. We have recommended that this
group be open to absolutely anyone who has an interest in this. And in
fact, if we think about what this is, this arguably, as it should be and
could be of interest to any, it could be of interest to consumer groups,
it could be of interest to any employer group, it could be of interest
to large employers, small employers. What we have suggested is, again,
open membership and that government would be a member, and that their
membership would be subjected to the same bylaws as private industry.
They would, in fact, be one of the members.

When members join, we have suggested that members, in effect,
self-select a category. And the categories will obviously, in our view,
evolve over time. But here is what we're thinking about right now. You
could envision a group of government being one of the groups. You could
envision the payers, the private payers being a group. You could
envision private providers being a group. You could envision employers
being a group. You might envision other interested parties being a
group. Conceivably, technology companies might be a group.

And again, we can \-- we would \-- this is one of the things we need to
flesh out. But there would be a set of member categories that would get
created. And the key reason for that, those individual groups would
elect board members. And what we have suggested here is up to 20 board
members. So if we had five categories of members, each group we're
suggesting would elect four board members who would be part of this, so
there would be equal representation. Government would have four board
members, the private sector, private payers would have four board
members, employers would have four board members, et cetera.

The other thing that we have suggested is that in order to get the
private sector to take a more significant role, that the bylaws of this
would stipulate that the chair and the vice chair roles could not be
members of the government segment, that they would need to be private
sector people. And again, we can \-- that's one of the discussions we
can have, but that's really the first step, in our view, of, in effect,
shifting the emphasis to the private sector.

From a decision making model, in a perfect world, we would like there to
be consensus around the decisions that the board makes. We are also
realists, and we recognize that from time to time there may need to be
votes, and that the majority may win, and there will be agreement and
dissenting opinions will be noted, and there will be agreement in effect
to disagree.

The next entity that we want to talk about is the advisor groups, and I
said that these are really formed by the board and will be done at the
request of the board. We would envision five to eight members on each of
these, and they would be, in effect, particular stakeholder
perspectives, audience based groups that we want. We want to ensure that
board members have access to opinions that may be very specific, so if
I\'m the employer representative, I might want to create multiple
advisory groups, depending upon the size of employers, or regions of the
country employers, or we can envision a number of things. But it would
be what\'s going to be beneficial to the board to get advice and garner
opinions from their membership and from their constituencies to ensure
that they\'re representing them.

Advisory groups do not make decisions. They provide counsel. They strive
\-- we are again striving for consensus. When we don\'t have consensus,
we will make note of that, and that will be part of the deliberation at
the board. But again, what these groups are doing is there to provide
input to the board.

The Workgroups operate similar to what we have today. The big change
that we have suggested is, and you\'ll recall that the next organization
we will talk about is the permanent organization that we\'re suggesting
we stand up. We believe employees of the not for profit organization
should be members of these Workgroups, in effect be \-- so you have
full-time people who can carry on the work of these in between meetings,
and you don\'t create volunteer overload and exhaustion on the part of
your volunteers and, in effect, burn them out. That the heavy lifting,
if you will, and the ongoing work can be \-- the responsibility can be
part of the \-- can be actually part of the organization.

The other thing we have suggested is we want to make sure that the
charter of the Workgroups is really focused around beginning to end,
visioning, blueprinting, design, and ultimately responsible for the
implementation of the suggestions that they have, so they inevitably
have a fairly long life. But we don\'t want these to just be let\'s
create a plan and let\'s walk away from it. We really do believe that
these need to be focused very much around long-term implementation.

The management organization, the actual operating entity that we've
talked about has a number of elements to it. We start listing these
here. We believe that there should be an external liaison to coordinate
across the multiple stakeholders that exist around this. We believe that
there will need to be a member services function. We\'ve envisioned
three to 500 members ultimately around this, and we believe that there
will need to be some administration tasks associated with that.

We talked about Workgroup drivers or members of Workgroups who would be
full-time employees of this organization. That would be the third group.
We would envision a secretariat for this that would actually support the
board\'s activities. We would envision a standards harmonization group
to drive harmonization, and again, some of this will need to be sorted
through.

Longer term, we could envision health information exchange products and
services being a group. And again, we recognize that there is a number
of discussions that we\'ll need to have around what\'s actually in the
scope of this, but we could certainly envision this group playing a
role.

And then the overall management. We have suggested that there be a CEO
that also sits on the AHIC board, and we've also recommended that a
chief operating officer be established to oversee the day to day
activities of this.

Shifting now to the business model: we have done a very rough estimate
of the cost of this, and as we\'ve come through the numbers and added up
the various functions and added up the various pieces, our estimate is
that \-- and again, we\'re probably talking in the \-- let me say 24 to
36 month timeframe out, because there is going to obviously be a
transition as we stand this organization up; that the cost of this will
be roughly \$10 million per year.

On the revenue side, and we\'ll go into a little more detail on the
revenue side. We anticipate revenue probably beginning \-- starting out
at around five million a year. We do believe that we can get to the ten
million dollar a year revenue model in a relatively short period of
time, so that this \-- the entity itself becomes self-sustaining. And
that\'s really the test that we applied to these \-- with these numbers.

Just looking at the revenue in a little bit more detail, and the
assumptions are actually detailed in the full report in more detail, we
have assumed membership at three to 500 members. Annual cost of one to
\$25,000. Again, we would encourage private providers to join this. They
would be at the low end of this. Large companies would actually be at
the high end of this. This \-- there are many organizations that
actually price on the size of number of employees or size of revenues.

We would also envision annual conferences, one or more conferences. Not
only would this be a great source of fundraising, we also believe it
would enhance the public credibility of this organization by actually
convening large groups of people around this topic, and being seen as
the leading thinking \-- as the leading thought organization around the
questions.

Training and publications are much smaller, but will have an important
role, again. Frankly, we would use in the private sector, the term brand
building, creating awareness in the public of the work that we\'re
doing. Practically more importantly than the revenue that they drive.

Longer term around the health information network, we could envision a
number of products and services coming out. We could envision consulting
services coming out. We could envision potentially certification
services. Again, we are stating this to be a much longer term, probably
at least three years out before we are ready to do this.

We did do some very preliminary numbers that would indicate that this
would be a revenue neutral set of activities. Basically whatever it
costs is what you would do, so it wouldn\'t be a source of profit. It
would frankly be a \-- one more activity that the group would do.

In terms of how we get from there to here, we\'re suggesting between now
and the fourth quarter of 2007, we\'ll be going through the design,
beginning the standup in early 2008, and then by the end of 2008, moving
into the first operating phase; shifting at the end of 2010 into what we
call operating phase two. The big difference between operating phase one
and phase two is the role of the government. The government will have a
bigger role, both in terms, frankly, of leadership potentially, and
certainly around funding, because if you go back to my \-- the funding
page we showed, we do believe that in the first couple of years, that
this thing will actually be \-- have an operating loss, and would
actually need government funding to sustain itself in the first couple
of years.

We would recommend at the end of the operating phase one, that there be
a very detailed performance assessment to ensure that we\'re on the
right track, that we\'ve got the model right, that if we need to refine
the business model at all, if we\'re too big, too small, if we\'ve got
\-- need to do something on the revenue side, we can, and then we would
move into the second operating phase which was \-- essentially would be
what we discussed, what we believe at that point, it would be a revenue
neutral, self-sustaining organization. And we would see that in 2011.

Just some more detailed transition activities. Again, you can see the
current AHIC model around the design phase. During 2008 beginning to
transition to an interim board, and then in January of \'09, primarily
government funded, but the private sector would actually, at that point,
lead the AHIC, and lead the AHIC board. And then by January of '11, we
would be talking about a self-funding private sector led AHIC. That\'s
sort of the transition, how you get from here to there.

I\'ll stop there, and just ask if there are any clarifying questions
around any of this.

DR. KOLODNER: Scott?

MR. SEROTA: Bob, do you see the principle mission of this organization
as an organization that\'s intended to standard setting,
interoperability standard setting, or is it to become a stand-alone
business entity, in and of itself? I got a little concerned, as you went
into some of the details, that the organization may evolve into one
which is more interested in selling product because it needs to sell
product to fund its operations, than the principle mission which we
articulated it.

MR. HUTCHENS: Well, if you go back and look at the actual revenue
numbers, the vast majority of revenues are coming from memberships and
conferences, so those will be the two primary sources \--

MR. SEROTA: But even those are products.

MR. HUTCHENS: A fair comment. I mean fair comment. It would be our \--
we walked into this and still believe that ultimately, this is about
standard setting and coordinating the activities that are already out
there.

DR. KOLODNER: Adele?

MS. MORRIS: Thank you. I strongly believe the form should follow the
function, so the discussion of exactly what the mission of the
organization is I think is critical. And if you look at the deliverables
of the AHIC so far, when you look at the whole list of recommendations
that have come from this group, the overwhelming majority of the
decisions taken by this group are in the form of recommendations,
specifically to HHS, one of its component organizations such as CDC, or
AHRQ, or federal agencies that have a healthcare line of business, or to
HITSP. I mean \-- or recommendations to the AHIC itself.

So if the successor organization is going to have a mission that
parallels what this organization has done so far, then it\'s good to be
clear that this is an organization that\'s going to make policy
recommendations to the federal government and perhaps state and local
healthcare agencies.

So if it\'s a policy advisory organization, then we should really be
thinking about what kind of structure is the best structure to provide
the best possible advice to the government. If it\'s not that, and it\'s
something about bringing people together and foster some kind of
clearinghouse or coordinating something, I\'m not quite sure what, then
I think we need a lot more clarity about what those functions are going
to be, because that\'s not what we've been doing.

DR. KOLODNER: Adele and others, what I\'d like to suggest, because these
are very important discussions, and they are ones that we will want to
have after we hear all of them, so if we can use this time in between
and hold that, because we need to come back to that. It\'s a very
important one. But if we can use this time just for clarifying questions
about the proposal, then we can get into the broader one after we\'ve
heard all three. I think it sounds like we\'re going to have a robust
discussion. I saw some other hands. Are they clarifying? Yes? Bob?

MR. CRESANTI: I had a question, Rob, because it struck me as we were
going through this how much it looked like other organizations that are
out there, and I just wondered, did you consider in this process, is
there \-- under this set, because it\'s so similar, just finding a deep
channel to swim in? Why not align yourself with another trade
association or ANSI or I want you to have somebody else that you \--
because it looks so much \-- is there benefit to that, if you were going
to pursue this business model?

MR. HUTCHENS: You could \-- again, what we felt is that the \-- this has
been relatively unique, in terms of what this group has done, and what
we didn\'t want to lose was the momentum that this group has achieved.
And if we come back to the principle that we said in the beginning, a
lot of that success has been because of the role of the government to
date, and that was really \-- let\'s not completely walk away from what
we\'ve done. Let\'s build on what we\'ve done, and again, a slow
transition out of that.

DR. KOLODNER: Kevin.

KEVIN HUTCHINSON: A couple of comments, and I would echo Robert\'s
comment. Look at organizations like the eHealth Initiative, or other
organizations that have a very similar structure, nonprofit, down below,
paid staff, a board, above it, Workgroups, advisory, membership
organizations that kind of fit that role and that model, and there is
others like that that exist out there. But did you also consider or \--
I didn\'t see it anywhere in the slides, the role that ONC would play in
this process as well, where does that fit in your thinking?

MR. HUTCHENS: Frankly, they would only support the government delegation
in effect to this. It would be limited to that. We are actually
ultimately pulling out all of those functions that support the AHIC
board into the separate organization.

MR. KAHN: I have a question about the makeup of the board. Why did you
give member category equal weight? There are other splits that could
happen; economic size, some value judgment about impact on the system.

MR. HUTCHENS: We had a lot of internal debate, even within the Booz
Allen team, about that. At the end of the day, the principle we tried to
adhere to was again come back to that one slide that I put out that
talked about the need for balance participation, and the need for
balance, and that every group got heard.

And again, if you\'re going to do that, admittedly we\'ve got to get the
groups defined right so we don\'t have \-- at the risk of offending my
colleagues from the pharmaceutical industry, ten pharmaceutical
companies having four seats on the board. You wouldn\'t want to do that.
We need to make sure we got that defined right.

DR. KOLODNER: Okay. Kelly? Go to the next.

MS. KOSS: Good morning, and I want to thank the Community for having
Avalere participate in what has been a very interesting and challenging
process. I also want to acknowledge my colleague, Sheera, and our team,
Greg Fuller, Malen Koenig \[spelled phonetically\] and Sharon Sailer
\[spelled phonetically\] who have worked pretty extensively over the
past six weeks to pull together what I was concerned might be sort of
just another flavor of vanilla, but I think you\'ve gotten some very
distinct kinds of proposals in front of you, which I think was one of
the goals of the three-contractor exercise.

So first, we start out thinking about the vision and then the mission,
and the vision really being an interconnected health system that enables
real time, secure, authorized access to health information by each
relevant stakeholder. So clearly, the consumer, but also the very broad
set of stakeholders that the current Community represents and the entire
healthcare industry includes.

We\'ve used the name that was coined in the President\'s budget, the
Partnership for Health and Care Improvement, and I\'m going to call it
the Partnership, because the acronym has the same challenges as the
Community. But three core components to the mission, which is really to
prioritize the expanded information needs of the health system, and in
our conversations with some of the existing commissioners, the message
was loud and clear that one of the concerns about the activities of the
Community, to date, has been perhaps that it has \-- has had such a
broad set of goals that maybe some of the progress that might be made
with a more targeted, you know, or, you know, perhaps picking a few to
complete, and then moving on to the rest, might have helped succeed in a
way \-- even greater than it has to date.

Enabling the generation, transmission and use of information \-- and
I\'ve heard consistently this morning the notion that this is really
about interoperability standards, but based on our conversations with
ONC, and again talking to some of the commissioners, it\'s not the \--
the term standards we\'re thinking of quite broadly, and so it speaks to
what information are we missing in the emerging infrastructure as well
as how will it get developed, generated, shared, and used throughout the
system.

And then lastly, but not unimportant is given, and again, I think some
of the dialogue this morning has emphasized this, the many stakeholders
and players that are already supporting some of the key components of
how we stand up and support this interconnected system to really help
synchronize, coordinate, and collaborate across what are many
interdependent activities that are happening both in the public and the
private sector.

And one of the things that we\'ve emphasized in how we thought about not
only what the structure of this partnership would be, but also how you
stand it up, is to ensure that this public-private partnership would, in
fact, embrace and maintain the momentum that the Community has already
started. And part of that is dependent on not only maintaining, but in
many ways expanding the value proposition that the Community has had to
date.

And again, we\'ve heard that this morning, but I think the consistent
message from the membership is not only is it the federal leadership,
but Secretary Leavitt, it is really your sustained commitment and
participation in this activity that has made everybody really be
committed to sit at the table, stay at the table, and work what has
been, I think, some pretty extensive nonpaid hours, if you will, on
something that we\'re all committed to, but how much of that commitment
people are really willing to stick with is a challenge.

So this graphic was really intended to look at how we can not only
sustain that, but also expand the value proposition, and what kind of
entity, how would you structure this entity to expand the value
proposition to areas of not only policy influence, but maintain
visibility and market improvement, and who are the players and the
stakeholders, and what kinds of activities or what structure would
support that broadened and sustained value proposition.

So moving on to what is our first phase is to really stand up
purposefully a transition board that will create some of the necessary
buy-in and value proposition for the entire healthcare stakeholder
community, and then define, arguably, its own mission consistent with
what the Community has already done, but arguably with something of a
fresh start with a recognition of an open, transparent, trusted, and
equitable structure that would have all voices at the table, and bring
along whatever parts, perhaps, of the industry that haven\'t felt quite
as represented as they might have liked.

The next four slides after this is going to go into some of the detail
of that top layer. Given the 15-minute constraint, we didn\'t go heavily
into the Workgroup structure, but I want to pause for a minute and touch
on it. Right now, it should look very familiar, since all of the
italicized names are the current Workgroups under the Community, but the
idea being one of the first tasks of a newly nominated transition board
would be to revisit what are the prioritized focus areas for health
system improvement, and therefore, what Workgroups need to be stood up
right away to ensure a smooth transition from where the Community and
the Workgroups are working today, and where we want to see them continue
to work, arguably without too much of a bump in the road.

We differentiated these health system improvement Workgroups from what
we see as infrastructure enabling Workgroups, and clearly today\'s
confidentiality, privacy and security group represents that; but these
are groups that think about what are the infrastructure needs that
support across all of the focus, improvement areas or health information
improvement areas that have interdependencies and need to be coordinated
and collaborated, and even in what the Workgroup\'s doing, let alone how
the industry operates.

So I\'m going to now go into what is perhaps one of our more unique or
different concepts here. For one thing, our design of the successor is
not a membership organization in the sense that was just discussed. It
is \-- it will leverage some very critical membership organizations, and
I think I heard this in part of the discussion previously, but the
notion is to help foster and facilitate, and this is really on the
ground running, starting in the fourth quarter of this year.

How do we establish health industry sector councils modeled after the
critical infrastructure partnership advisory council, which if you\'re
not familiar with, is a FACA group that advises the Department of
Homeland Security, and has each industry represented, and perhaps some
of you sit on that council. And I know it has its challenges, but this
is to create similar types of councils across key constituencies
throughout the stakeholder community of healthcare.

Now, these aren\'t necessarily the right ten buckets, and is it ten or
is it 12, don\'t know, but this is what we came up with. And it is with
a standing relationship to both the transition board, and ultimately the
formal partnership as it gets stood up. And this is where initial
nominations for the transition board would come, and they would each
nominate two to three representatives, and the Secretary for purposes of
the transition board would then select from those nominations.

So this is a key component of how we maintain and support ongoing input
from all stakeholders in the healthcare industry. In our bylaws, we
actually talk about how they have to be open and inclusive, and if
someone says they can\'t find a place to sit, there will be a process by
which any organization or individual can be represented through these
organizations. And I\'ll talk more about that in a little bit as we talk
about how we transition to the board.

Next are what we are categorizing as affiliates, and these are all the
organizations that clearly have existing activities that are focused on
a core component of what the partnership is trying to advance. So we\'ve
identified some likely affiliates, but clearly, these will be \-- you
know, these will be identified over time. One of the early activities of
the board will be to identify affiliates and establish memorandums of
understanding with those affiliates. And the notion here is really to
facilitate the coordination process, but also to ensure that the
partnership isn\'t recreating any wheels.

So to the extent that CCHIT is going to continue to thrive and operate
as it does, how will the new partnership leverage what CCHIT is doing,
how will they use them for technical advisory panels, or to advance what
are needed incentives and promotion of key standards in existing HIT
applications, for instance. We\'ll talk a little bit more about the
quality of affiliates, because we\'ve got an example of how the quality
Workgroup might work across both affiliates and other organizations.

I think that\'s probably enough for now, with respect to the affiliates.
This next slide, and if you recall or glance back at the model, speaks
to the federal entities. And we did approach this not as a FACA, and not
as \-- in part, with guidance from ONC, and as not requiring any federal
legislation, that that would be the quickest way to move to a private
partnership.

But consistent with what we\'ve heard this morning, and what I said at
the outset, which is it\'s critical, and to Ms. Morris\'s comment about
how this is predominantly recommending policy. Now I think it\'s
recommending policy both to the private and the public sector, but the
government has some critical roles and ongoing roles. First and
foremost, both the current Community and ONC would be the underpinnings
for how you stand up the councils and how you foster the creation of the
transition board.

Second, once this new entity is put in place, I\'m sorry to say that the
current structure of the Community really needs to shift. So what we\'re
suggesting is that there be an executive order that shifts the
activities of the current \-- the federal activities of the current AHIC
to what would be an interagency council for healthcare improvement, and
arguably being the touch point and the lever for all recommendations
coming out of the partnership. So it\'s almost a counterpart to this
partnership, and critical for maintaining what is the obvious weight and
support of federal agencies, all the federal agencies, and how they can
include both in their regulatory roles, in their oversight roles, in
their purchasing roles, sustained support for what comes out of the
partnership.

We highlight the executive order on transparency as something that is
also a lever, if you will, with the federal agencies, and we highlight
both the Office of the National Coordinator and NCVHS, which is a
standing FACA committee that has some key roles and responsibilities to
advance similar goals, not unlike the private sector affiliates. This is
almost like a government affiliate that could be used to, again, forward
recommendations coming out of the partnership.

Just touching on Administrator Norwalk\'s comment on the CMS HIPAA
transactions, clearly all of the regulatory capabilities would come into
play once a recommendation is forwarded into these various points within
the federal government.

The next slide highlights one of the questions we were asked, is how
will we ensure that this partnership is well coordinated with the state,
since the states have as much of a stake, if you will, in an
interconnected health system almost as much as the federal government.
And there are three ways we have in mind.

There would be a state and local council that would be one ongoing
avenue for input and interactions. There would be a state affiliate,
perhaps the current state alliance for e-health, if it is sustained,
that would have an ongoing role, and would be looked to for what is
needed on behalf of the states. And then lastly, we think because it\'s
such an important aspect of how we will move towards the long term goal,
we recommend twice a week forum where there really is a dialogue between
this new partnership, and state and local representatives.

This next slide highlights a fairly aggressive timeline and some key
tasks in the transition, starting with phase one, which doesn\'t yet
have a board, but stands up the councils and gets the nominations for
the board. And then I will touch on the remainder of these tasks in the
next several slides. I will highlight, though, that this purposeful
phasing was, in large part, to stand up a transition board that would
look very carefully at what its priorities are and how it will
ultimately want to be structured to meet the goals and the mission of
this entity, and then using a very FACA-like or administrative
procedures-like process to ensure that there is a public comment on what
the three year agenda is, and how they\'re going to structure these
activities, and how organizations throughout the industry will be
involved.

So the next slide highlights some of the key steps in creating these
councils, and I don\'t want anybody to think that we think this is a
simple activity, by any stretch. We know that all of the associations
that we mention can play well together at times, and are often at
opposite ends of spectrum of certain policies, but we do feel that
health information exchange and technology has proven to be something of
a both bipartisan and industry-wide supported activity, and that maybe
we can move beyond this.

But clearly, there is a lot to do, including working with existing
associations to stand up this type of council. But it is not without
value and benefit to those organizations, and to have this ongoing role
in working with the partnership. I\'m sure there will be questions about
how we do this, but we do see this first phase as a critical catalyst
for fostering public and private engagement and ensuring the broad
representation of healthcare stakeholders.

Once those nominations come in, we are envisioning an 18-member
commission, ten of which would come from these councils. Obviously if
the council numbers expand or contract, that would vary. We also think,
to Secretary Leavitt\'s point about bipartisanship, that there will be
four Congressional appointees, along with four federal representatives;
and we suggest that the four federal representatives be recommended by
the nonfederal participants of today\'s Community, that you have been
working with your public sector counterparts for many months now and
might have some good insights into what the critical participants would
be. And that\'s not to say, remember the earlier slide, that the federal
government and all of its leadership wouldn\'t have ongoing
participation going forward.

I will highlight that there is, in the details \-- we have a first 90
days where once the board is identified, they set initial priorities and
stand up priority Workgroups. They stand up an executive committee,
which has two co-chairmen, and our executive committee does have federal
representation and three vice-presidents, operations, finance, and
membership, external affairs which will be critical relative to the
council as well as the affiliates.

We have an initial staff of an executive director, deputy director,
general counsel, and an estimated three to six staff, but we rely
heavily, heavily, heavily on existing staffing and support from the
federal government, certainly in these first two transition phases.

And I didn\'t mention our estimated cost for that phase one, just
standing up the councils is one to two million. This second phase is
five to six million on an annual basis, and is estimated to try to come
to closure in early \'09. And I\'m not going to skip over the next
slide, but \-- I will come back to it. I just want to touch on the final
phase where it is \-- once a three year plan has been vetted and gone
through a public process along with a restructuring of the board, once
it gets into a mature phase, we\'re anticipating 15 to 16 million annual
budget.

I will come back to this last slide, but I wanted to touch on, again,
another task for the contractors was, in part, thinking about quality as
an example of a focus priority area and tremendous activity throughout
the public and private sectors, how do you coordinate and leverage
what\'s already happening, as well as achieve the prioritization and
collaboration and synchronization, if you will.

So one thing I didn\'t mention, the board has the authority to create
technical advisory panels, and we are suggesting in the more detailed
part of the model that there is a standing community health information
exchange panel. Given that that, you know, is where the rubber hits the
road, and that is where if the feds and this new partnership are going
to stand up what is the overall framework in which we\'re going to be
interconnected, the folks in the community that are trying to make that
happen locally need to have a consistent way to inform these activities.

Throughout the \[unintelligible\] a number of maybe every single one of
those stakeholder groups would have input into what\'s happening in the
quality and then, of course, there are many affiliates that we have
already highlighted, but the notion being once this \-- if this was a
targeted priority Workgroup, the very first thing they would do would be
identify and put those memorandums of understanding in place, with the
affiliates, some of which are suggested here, determine what technical
advisory panels would be useful, and see to what extent they could be
stood up within existing organizations or would need to be stood up
separately, work with AHRQ and the various value exchanges that are
emerging to look at how they can inform what would ultimately be the
role of both the quality Workgroup and then advising the board on how to
move forward with respect to quality.

Coming towards the end, and I know I\'m getting close on time, I
mentioned the final phase is once the three year agenda with explicit
goals, milestones, and tasks, and a revised structure, insofar as the
transition board think it\'s necessary, has been vetted through
administration procedures-like process and revised \-- and part of that
process would also be the transition board saying what timeframe they
thought they need to sunset. You would, then, have a new nomination of
the formal board going forward, based on that vetted process, and that
would be the standing of the mature \-- the mature organization.

What I didn\'t mention in the funding of the second phase and on \-- and
I\'m going to look for raised eyebrows \-- the way we anticipate getting
private sector funding is a very, very, very small percentage on \-- of
association dues would come the way of the board and would also help
support the councils. So \-- and obviously that\'s scalable to the size
of the association. But we think if you really get broad participation,
I won\'t use the T word, but a very small amount of membership dues that
all of these associations have coming in to help support both the board
and in the councils would actually be a sizeable amount of money, and
could support a sustained portion of this. Along with \-- we have
recommended a minimum of five year, 50 percent funding from federal
sources, and we go into more details of that in other areas.

This next slide highlights the ongoing and breadth of roles in the
different phases. I think I\'ve spoken to most of these, so I won\'t go
into them in any detail, but if there are questions, I would be happy to
entertain them.

This slide highlights the various types of funding mechanisms that we
thought about. And as I mentioned before, the phase is one to two
million. Phase two is five to six million, annually. Phase three, or the
mature partnership, is 15 to 16 million, estimated at 15 to 16 million.
The first two phases are more heavily funded from the \-- by the
government. Phase three is funded more heavily \-- more evenly, I should
say, but still sees an ongoing role for federal funding.

I skipped by this operational function slide, so I\'m going to come back
for a second. We do anticipate some services that this entity would
provide and would have to staff up to provide in the mature state, and
two focused areas we highlighted, but the conversation about
international standards might also sit in this component, if there is
\-- if there is an operation.

But this is really where there would be self-funded activities, and the
two areas are one, to certify trusted local networks to join onto the
Nationwide Health Information Network. This is not to replace what CCHIT
is doing, which is really certifying the system, if you will, but it
goes to the policy and the nature of how these local networks are being
supported more from both a policy and organizational standpoint, and
having that public-private blessing, if you will, to say that, yes, they
have covered all that\'s necessary to ensure that theirs is a trusted
network and it can be viewed as a trusted network as a part of the
national network.

And then also related to the national network, but something that
doesn\'t exist and wouldn\'t clearly fall anywhere else, is once this is
up and running, we\'re all looking forward to the day that we can get
secondary data from a national level secondary data, and who is going to
authorize and certify the individuals that want to come through the
national network and pull that data, as opposed to are they still going
to have to go to the individual entities. And a process and approval and
certification for that could be a funded activity that this partnership
could take on in a subfunction.

And just lastly and quickly, I will mention, we do have a set of bylaws
that go into the details in each of these areas, and on how the board
functions, and some important operational aspects. And finally, the
formal and mature partnership would look similar at the top end, to a
degree, but would evolve based on the vetted process that I\'ve talked
about, that again, we think is critical to bring along all the
stakeholders in the industry and to maintain the value proposition.

DR. KOLODNER: Okay, thank you, Shannah. And the third we\'ll hear from
Sharon Benjamin \-- oh, excuse me. Yes. Clarifying questions for
Shannah? Let\'s proceed.

MS. BENJAMIN: Thank you. Good morning. I\'m Sharon Benjamin, and can you
all hear me? Great. There is a third person who is in the room, but not
at this table, that I\'d like to take just a moment to introduce,
because who we are as a consulting group influenced greatly the
recommendations that we come to you today with, so Curt Lindberg is the
executive director of the Plexus Institute.

Plexus is a nonprofit organization that helps foster the health of
individuals, organizations, and communities by applying the principles
of complexity science to intractable problems. So for those of you who
don\'t know Curt, Curt, would you stand, please? Great. So there is our
third partner.

We come to you today with some considerable enthusiasm for the design
build process that you have undertaken. It was a wonderful experience to
be in a consulting process in which we knew we could depend on our
colleagues at Booz Allen and Avalere to do some things extremely well,
to allow us to focus on what we think are some key dynamics that you
face and the decisions that you make over the coming days. So I believe
that the consulting recommendations that you have in front of you are
substantially different in both form and perhaps content.

So let\'s move into those. We started with some profound assumptions
about this work. And those assumptions drove the recommendations that we
ultimately came to you with today. The first is that this process, this
consideration before you really is all about the network. You are
embedded in a very complex network of stakeholders and activities, and
if that seems obvious to you, to us it drove our process and structural
recommendations, so it\'s all about the network.

And because it is all about the network, one of the first questions we
said to ourselves was, why are we talking about creating a successor
organization to AHIC? What if there were multiple entities created
coming out of this body of work? To that end, we recommend three verbs.

We recommend that AHIC broker connections, catalyze innovation, and
facilitate communications; and those come with three very different
structures. You want different structures to undertake each of those
kinds of actives. In addition, there are legitimate roles for government
to continue to play as the guardian of American\'s interests in this
area. So four entities resulting from our assumptions that it really is
all about the network.

The second assumption that we made \-- I keep going backward, I\'m so
left-handed \-- is, and perhaps this seems obvious, but I\'d like to
spend just a moment talking about why we thought it wasn\'t, perhaps, as
obvious. We recommend that AHIC accept an unforeseeable future. One of
the things that we noticed in our conversations, both with members of
this Community and conversations outside this Community of knowledgeable
observers, is that many of \-- many of the recommendations and
considerations about structure are predicated on our ability to know the
future.

And, in fact, we believe that the future is not knowable. The change in
the technical arena particularly is nonlinear. And because it is
nonlinear, you are facing a complex adaptive problem. Because you\'re
facing a complex adaptive problem, that\'s an appropriate application
for some of the principles of complexity science. So we think that you
are actually facing an unknowable future and that change will be
nonlinear and unpredictable. And to talk about how we operationalize
those assumptions, I\'m going to turn it over to my partner, Lisa
Kimball.

MS. KIMBALL: So someone already said form follows function, and we
totally believe that, and as we\'ve thought of what the key functions
were to create a system of standards that would create an interoperable
health IT system, we really looked at three different kinds of things
that we thought needed to happen.

One of the other key things that we thought is there is a little three
letter word in the AHIC mission about use, and that as we thought about
what needs to happen, we were very influenced by thinking about it\'s
not just creating some standards, it\'s not just creating a mechanism to
tell everybody they have to use these standards, but the mechanisms that
are required to actually make it possible for people to use them are a
little bit different dynamic. So we looked at three mechanisms.

One is a mechanism that is the most like AHIC as it currently exists and
as some of the other proposals, which is the mechanism to bring in the
voices of all the stakeholders to figure out how to synthesize and
prioritize ideas so that recommendations can be made, not only to HHS,
but to the other possible players who might take in a recommendation and
act on them. So there is that kind of mechanism.

A second mechanism, though, is what it\'s really going to take to
catalyze the creative development of technical and other innovation
that\'s required to really make this work. And that\'s a different kind
of a mechanism. One of the things that stakeholder representative
mechanisms are not widely known for is swiftness, I believe a word that
Scott used, and so a mechanism that is going to create the kind of fast
moving technological innovation that\'s needed is not going to be
achieved, we don\'t believe, through a system of stakeholder
representative councils of meeting, so we have an idea for something
that would ignite that kind of change.

And the third thing is really looking at the use, that the ability for
people to actually take in and use new technical developments is not
about telling them what they are. And we\'ve had some experience,
particularly in the health field, with looking at some of the ideas for
helping people deal with transmission of hospital acquired infections,
and it\'s not that everybody doesn\'t already know what you need to do
to prevent that. It\'s not that they don\'t have the technology needed,
such as the hand washing dispenser. But it\'s really that there are
thousands of local and individual adaptations and problem solving
strategies that need to be developed and deployed; and so a mechanism to
really help use at the end of the process is required as well, so we
have some ideas about that.

One of the things that we recommend, then, is that we actually think
about three different mechanisms that may not be in the same structure,
and one which we\'re calling a roundtable is similar to the idea of the
partnership, or it could be the health information community, just using
that name so we don\'t get confused with what is.

A second is what we\'re calling an innovation fund which is a mechanism
to really catalyze all that kind of skunk works and targeted development
that we think is needed. And the third is this notion of a diffusion
network.

One of the reasons that we\'re \-- we think it\'s so important to look
at those is if you look at this famous adoption curve, Everett Rogers,
who was one of the Plexus initial founders, created this innovation
adoption curve. This is Jeffrey Moore\'s version of it. Which makes the
point that there is a big chasm between what it takes to get people who
are in the early adopter end of the curve, to take in, and use, and
deploy any new innovation, particularly technology; and what it takes
for the mainstream to do that.

And so even if you brilliantly get exactly the right standards to find,
you get exactly the right standards developed, the technology to support
them is there, there is still that big chasm between that and what it\'s
going to take to really make this system work widely. And we think it\'s
very important for the next phase of post AHIC to address that issue and
not just the defining of what they are.

MS. BENJAMIN: We\'ll talk about some short term activities and goals. I
won\'t read to you the slide, you can read it yourselves; however, what
I will say is that we think that there are different initiatives needed
in the short term, as opposed to the mid and longer term. And we thought
that the folks at Avalere did a particularly nice job on that transition
piece.

We\'re talking about a couple of activities in the short term that are
perhaps somewhat outside the current comfort zone of both AHIC and ONC,
and as part of the transition, learning to undertake those activities
and monitor them will actually be a wonderful process of education for
this community.

One of those is to create roadmaps that are actually owned by the
communities, and that likes look like a vernacular phrase; in fact, we
mean something quite specific and disciplined with that phrase, and
you\'ll see that in the full report that you have. I\'m not going to go
through that now.

We\'re also talking about the need to nurture key relationships. One of
the things that we found in our conversations with you, and with
knowledgeable observers of this Community, and you call yourselves a
Community, is that there is some variance of opinion about how much
relationship nurturing and building has, one, been done, and what that
has either fueled or slowed down in the Community. So I would just
highlight that we think relationships across this Community are
extremely important to find ways to nurture and create.

Moving on, we\'re talking about the creation of a health information
roundtable. We chose that phrase specifically because for a thousand
years, the word roundtable has had a specific valence in our culture. It
is a meeting place for wise folk to come to advise the kingdom on
policies and programs future opportunities and threats, and we
envisioned that as the function of one of the successors to this \-- to
this entity; so that there would, in fact, be a roundtable created.

We are suggesting that there are some models for that creation in other
places in this culture. ICANN, which is the governance body for part of
the Internet is one model we suggest you take a look at and consider
carefully. And I won\'t go through all the reasons for that. You\'ll
find those in the full task report from us.

Finally, our assumptions about the health information roundtable are
based on two assumptions. We recommend that the roundtable be created
with one distributed control, that is the control for that institution
and that Community be distributed across the community, that it not be
owned by a single entity. And you\'ve heard some good opportunities for
how to do that already this morning, so I won\'t talk any more about
structural ways of doing that, but as a principle, we think that
distributed control will actually accelerate the use and relevance of
the health information roundtable.

And finally, finally, and perhaps more importantly, we recommend a
fairly high tolerance for the coexistence of order and disorder or
chaos. There are many folk in the complexity science field, including
Ralph Stacy\'s \[spelled phonetically\] work, who speak to the need for
organizations to move back and forth from stability, to growth
innovation and change, and then back to stability. And we recommend that
this institution have a particular high tolerance in its early days,
especially for moving back and forth fairly rapidly from stability to
what may feel chaotic, and then back to stability. Other industries call
that stabilizing. There are other phrases for it, but moving back and
forth across that divide actually will accelerate the work of the health
information roundtable. Thank you, Lisa. Here is a picture of what we
thought the health information roundtable ecosystem might look like. It
is, as you see, a network. And I\'m going to let Lisa walk you through
the basic assumptions underneath that.

MS. KIMBALL: In order to do that, I\'m going to move ahead to \-- we are
very interested in the notion of how a network that\'s really functional
develops, and this slide shows a number of stages. We think the current
AHIC is around at a stage two kind of hub and spoke mechanism at the
moment.

In order for interoperability across an HIT system to really work, there
needs to be a network that looks more like that stage four network,
where things are much more intertwined. And yet, you have different
players, you have apples and oranges together, you have things that are
different sizes, and it\'s necessary to really create a mechanism to
move through that, and that\'s really what we see the roundtable doing.

But I want to move and talk a little bit about the notion of what needs
to happen to really catalyze the sort of innovation that\'s required.
One of the things that we know about, making sure that new things
happen, is there has got to be a lot of messiness, a lot of activity at
the front end, and actually this process, this design process that
we\'re going through now is a good example of taking that kind of
approach.

That needs to keep going throughout this system, so it\'s our
recommendation that there not be the hope that there will be a linear
systemic process that\'s going to spend a long time, establish a set of
standards. That set of standards is now fixed, and then we worry about
deploying it; because that\'s not how good technology gets developed,
and we don\'t expect that\'s what\'s going to happen in this case.

So what we want to talk about is how might this body influence the
system that\'s already happening in terms of development, and also
target, and tend the system towards the things in which there is the
greatest public interest. Because there is going to be a lot of
development, but there might not be enough development fast enough to
deal with some of the issues of privacy that are highly in the public
interest, or the issue of perhaps the last mile to rural health
providers, those kind of things.

So that those might be choices that get prioritized for some kind of
innovation fund. In our full report there is more information about how
that might get set up. But I\'m reminded of another very good management
thinker, Carl Wyke \[spelled phonetically\] who talks about the fact
that leadership isn\'t really about solving problems, but leaders kind
of reach into the system, and the problems form around their attention.
So it\'s not just about resources, it\'s about attention. And we see an
innovation fund kind of strategy as a way that this successor entity
could focus attention on the key developments that need to get made.

And the third mechanism that we talked about is to foster a diffusion
network because we see the problem not as use, but in development. And
not in development, but in the use. Because what we\'ve discovered is
that that kind of technical assistance is really what\'s going to be
required to make this work.

One model that we noticed might be worth exploring is the department of
education has a methodology for providing technical assistance to follow
the No Child Left Behind initiatives and regulations. So it isn\'t just
about saying everybody has got to take the tests, and everybody has to
have these certain standards. It\'s really about, okay, how are you
actually going to do that? And so we\'re recommending creating a network
of regional and local technical assistance providers that can be a
combination of something funded by government or by a public-private
sector entity, and a way of linking up many of the mechanisms that are
already out there independent of this new entity.

This is really because our theory of action is that knowledge, or
announcing, or even regulating standards is not going to change
behavior. Sometimes we say if that were true, nobody would smoke and
everybody would floss.

So instead, what we really need to do is figure out what we\'re going to
do to facilitate a system in which these new behaviors, these new ways
of doing things are going to be made possible, and the people who are
doing them, say, in a small service provider, in a rural area, are able
to share how they manage to do that with another small service provider
in a rural area. Because that, going back to the diffusion of innovation
curve, is going to be the only way there is going to be uptake. So
we\'re recommending a methodology for doing that kind of diffusion
rather than doing the regulatory and announcement only type of
diffusion.

When we think about the diffusion of innovation, one of the things that
we know is that best practices don\'t work very well. They\'re hard to
manage. They\'re expensive. And the reason they don\'t work very well is
because best practices must be locally adopted and adapted. So when we
talk about knowledge doesn\'t change behavior, simply telling people,
here is a best practice in health IT or EHR does not help solve the
problem of the local physician office that simply has to find a way to
adapt and adopt this technology.

So what we\'re recommending is that the network begin to teach itself
that. And we found models for that in other activities that we conduct
in hospital systems currently around methicillin resistance, staph
aureus infections that are hospital acquired but across other
disciplines and literally across many other cultures and countries.

We\'re talking so much about the diffusion network because that\'s where
peers learn from each other. And the gap between what we know needs to
happen around electronic health records, and the actual use of them,
seem to us to be the important and critical gap that needed to be
closed. The technology gap seemed, perhaps, somewhat less pressing over
the long term. In the short term, that\'s probably where there is a
great deal of pain, but over the longer term, it is the diffusion
problem that seemed to us to be of critical importance.

What you see on this slide, and I\'d like to take just a minute to
describe what you\'re looking at, is a network map. When we talk about
networks, we are not talking about the vernacular use of networking in
which you go to a cocktail party and hand out your business card. We\'re
talking about the discipline of mapping, creating, nurturing, building
and weaving networks. And there are, in fact, principles behind that
which you\'ll find in our full report.

What I\'d like to tell you about this slide is that on the left, you see
the early stage network of a Plexus initiative on hospital acquired
infections. It was a small group of people who thought this was an
important problem. We thought we had an approach that might make a
difference in hospital systems, and to help protect the lives of people
who both work in hospitals but are also being cared for in them.

What you see on the right is the developing network, and that\'s about a
two-year network map. The total elapsed time in that network is about
two years. And what you see is a color-coded map of regional networks
that have emerged, but also interregional networks. So as you think
about how the successor to AHIC is going to begin to work with states
and localities and regions, because we know there are places like
Pittsburgh where it\'s not just a state level problem, you\'ve also got
regional issues around, okay, what happens if somebody comes from \--
all of those issues.

That is a map of how a network was deliberately woven in a very smart
fashion to create much more significant impact. So diffusion networks
actually make a difference and fuel much faster uptake of innovation.

Our major recommendation to this body, today, is that you power the
transition that you are in with multiple simultaneous actions across
four particular frames. The first is in the creation of a health
information roundtable. The second is in the creation of an innovation
fund. The third is in the recognition that what you have is a diffusion
network that must be a smart network. It needs to operate in some
particular ways. And finally, that HHS continue to play the guardian
roles that it plays so very, very well currently, while it divests
itself of some of the things that it is not particularly suited for.

So power this transition with multiple simultaneous actions, and don\'t
think about it as creating a single entity as a successor to AHIC.

And finally, I will close with \-- I was with Henry Kendall the morning
he won the Nobel Prize in physics, and so I have a soft spot in my heart
for Nobel Prize physicists, and this is a quote from Abdul Salaam.
"Nature is not economical of structures, only of principles." And what
we\'ve tried to do, in our full report, is outline the both the
principles and dynamics which we think you\'re grappling, and provide
you with a structure that is complicated enough to actually address
those dynamics.

Thank you for your attention, and if \-- many of the recommendations
that we have about specifics related to each of these entities are
included in the notes with the slides, so if \-- take a look at those.
We won\'t take your time this morning on those.

DR. KOLODNER: Thank you very much. We have about 20 minutes for
discussion on this, so I see a number of interested parties. Why don\'t
I alternate sides, start with Robert.

MR. FOSTER: Can I ask a clarifying question, because I\'m interested in
your innovation fund concept, but \-- and the government has a number of
different funds that sort of act like this. What would make this
different from \-- I tend to have a personal bias towards favoring the
market driven approach. What is the \-- in your vision of this fund,
what is the market failure that this fund could address that wouldn\'t
be existent in, say, you know, in a Dr. Brailer\'s \-- new endeavor.

MS. BENJAMIN: That\'s a really good question. One \-- the thing that we
thought was that there might be some market lags, if not failures, in
some of the things in which there is a keen public interest. For
example, underserved categories or particular aspects of privacy and
those kinds of things.

With the mechanism that we suggested, which you can see in the full
report, is there are increasing numbers of philanthropic venture funds
being formed to deal with issues in education, for example, and some
other issues in health in which there is a combination of public sector
money and private sector money creating a pool.

The incentive for the private sector money is that everybody gets to
play in setting priorities and, in some cases, private sector funders
may feel that they would like to develop something they anticipate will
be required, such as a privacy module, but they themselves don\'t want
to have to pay for the whole thing. But if they pool in an innovation
fund this becomes possible.

DR. KOLODNER: Craig?

MR. BARRETT: Are we in general comments?

DR. KOLODNER: We\'re in general comment.

MR. BARRETT: Good. First of all, I find all three of the presentations
very interesting. And if you look at the back of most of them, they
compare structures with existing structures. Being a corporate member
and an individual member of a lot of these existing structures, I wanted
to just present one observation; which is the larger the constituency
that the structure represents, that is, the more members it has, the
slower it always moves, by definition. And you can look around and you
see this time after time after time; because the larger the number of
constituencies, the more the number of parochial positions, therefore,
the less agreement, therefore, the slower it moves.

I\'m very concerned about setting up any structure which represents a
two trillion dollar industry in the United States, and in principle,
impacts every citizen in the United States. So there are 300 million
people who are going to be interested in the output as well.

Absent any market pressure, the thing that makes systems move is market
pressure. And several earlier comments were made about the importance of
HHS as purchasing power in this whole system. I think absent a very
active role of HHS with its purchasing power, this system, the system
suggested, will probably set back any progress by, I\'d be conservative,
five or ten years, because you\'ll go back to ground zero, and you\'ll
try to get agreement between two trillion dollars worth of parochial
revenue, and you won\'t get agreement.

I\'ll give you one classic example related to my industry, which is the
American Electronics Association, which represents every electronic
industry in the United States, big and small. It is impossible to get
that organization to take a position on any topic because there is no
consensus, big and small, different industries on any topic.

So I would just like to caution the group in terms of moving forward to
a super structure arrangement representing every segment equally into a
board. I think you guarantee yourself gridlock.

DR. KOLODNER: Chip?

MR. KAHN: Yeah, I\'d like to \-- since these three groups thought about
this process, and I know they may have had \-- answered my question in
their presentations, but I\'d like to ask it again just so I can \--
just to clarify.

Would each group respond to this question? If you were going to set up
the organizations or the processes that you\'re envisioning, if you
think \-- 24 months from now, assuming that we got them set up, what are
the two things that you would want to look back and see that that group
accomplished?

I\'m extremely concerned about the issues that Craig is bringing up, and
so I guess I\'d like to know, if we\'re going to take on this endeavor
from your work, what \-- if the board was looking at the CEO of this
organization, and evaluating whether or not he or she should get their
bonus, what are the things that that CEO should have overseen that
organization accomplishing over a 24 month period that\'s the most
important that could make the biggest contribution to what AHIC is
trying to do, and not get in the way of a market that we want to have
innovation in, and we want to have proliferation in, without sort of the
wrong hand of regulation? Keep it really simple, like just a few
sentences.

MS. KOSS: The really simple is the first thing the transition board does
is identify the priority areas where it wants to stand up, Workgroups
that are arguably counterparts to the current Workgroups of the
Community. So it may not be the current six, but whatever that priority,
based on input from the industry and affiliates, that\'s intended to
happen, you know, really within the first year. That\'s sort of the
first order of business.

And those Workgroups would, then, sit with the current \-- and we talk
about the transition and the broader report from existing Workgroups
that have similar or comparable activities, and how that would
transition, and how they would say, what can you complete, if you will,
in the current environment. And what do we think needs to be, you know,
continued to evolve or taken over in this broader structure. So that
would be one.

And the other in the 24-hour period is to formalize the go forward
strategy. You know, we\'d all like to say this could happen, and no time
would lag, and no change would happen; but again, in order for there to
be sufficient buy-in and ownership of this new entity, you need to give
them some time to sort of step back, reevaluate and say, this is the go
forward three year plan on what we intend to accomplish, with very
explicit milestones and goals, and to be held to that, and report on
that on a six month basis.

MS. BENJAMIN: Okay. Three things. First, HHS should issue a tech
manifesto about its position on technical development of interoperable
software so that the community writ large knows where we stand as a
payer. That paves the way for two things, that then the successor
organizations in our case would then do. The first thing that I think we
would look for are, have actual innovation funds been granted. So that
would be number one, have innovation funds been granted, in areas of
particular promise. And the phrase that I would use around that is we
would be looking for small technical changes that could amplify into
very large effects across the system, so that we\'re looking for some
very particular kinds of technical innovation grants.

And the second thing for the successor entities is has the diffusion
network begun to meet and can you map that change. There are technical
ways to map whether a network is actually being built, and created and
sustaining itself, and that\'s what we would \-- that\'s what we would
be looking for. Thank you.

MR. HUTCHENS: I will be brief, and I do only have two things. There is a
lot that gets folded into this. But have we maintained the momentum?
That\'s number one. Number two, and I will be very candid. The first
time \-- I am a private sector consultant. The first time I saw the
membership of this group, I was very surprised about the lack, or the
very small private sector representation on this. I acknowledge the
government\'s half the market but there is another \-- there is another
half to that.

So for me, the other piece of this is whatever mechanism we use, do we
have a broader base of representation on the committee, or in the group,
whatever the successor is, to do this.

I\'m dying to make a comment and I\'m going to do it, because it\'s one
I\'ve made before in a public forum. Every time I look at this question,
I\'m reminded of EDI in the consumer products industry, and I can\'t
figure out if the person from Wal-Mart is here.

The issue in health is we don\'t have Wal-Mart. The consumer products
industry drove standards because there was an 800-pound gorilla in that
market. I\'ve done work with the consumer products industry, and I know
we don\'t have that here. The only thing we\'ve got, the closest thing
we have is the US Federal Government. And so at the end of the day, if
we\'re going to drive standards, there is going to have to be a role for
the government, just as there was when we looked at \-- when the
consumer products industry standardized around a set of standards that a
handful \-- and it was Wal-Mart and a handful of other major retailers
that imposed that discipline upon its very broad based supplier
community. And I think there is a real parallel that we can see here as
we think about this. Just some food for thought. I may be totally wrong,
but it\'s sort of my pet theory around this.

DR. KOLODNER: Okay. I see four individuals who would like to be seen.
I\'ll take them in the order that they indicated it, so Lillee Gelinas,
first.

MS. GELINAS: Thank you. And you are right, Craig. With 1,401 acute care
hospitals, let me assure you, the bigger you get the harder it is. But
it\'s not impossible. I would be curious to know, and this is again for
the staff. I know I asked the staff at the last meeting to understand
personalized healthcare in the Veterans Administration and the
Department of Defense, because we don\'t have My Health E-Vet in the
private sector, for instance.

And it strikes me when I listen to the network discussion, I would
really like to know how health information technology spread so rapidly
in the Veterans Administration and DoD. Was it mandated? How did it get
done? I don\'t understand those systems as well, but I know that we have
been trying to spread, in the private sector, health IT for some time.

Lisa, I really appreciated your comment about adoption. We don\'t have a
failure of evidence; we have a failure of execution. We talked about
that on the phone, Sharon. I remember us talking about that.

It strikes me that Florence Nightingale wrote about hand washing, and
hospital infection in notes on nursing in 1859, and we have not come
very far when we think about it. And it\'s only in the creation of these
networks that we\'re seeing some real big change. When I saw your big
picture, I saw VHA Pennsylvania, and we\'ve moved the needle on hospital
acquired infections in six months because of that network that came
together rapidly with a lot of really smart people that really want to
do a great job, but lack that interconnectivity to get it done.

I\'m struck with \-- I did read the entire slide deck. You all did
phenomenal work. In the network presentation on slide 29, for anyone
following this, there is a comparison between the traditional framework
that was presented versus this complexity framework. And the liberating
structure, that is, the \-- your suggestion versus the prescriptive
structures which are, I think what I\'ve heard some of the other
suggestions are.

The most valuable slide to me, however, was slide 75 and that was
lessons from current AHIC. And I know Bob and Shannah, I\'m sure you did
the same thing, but I would love just \-- you know, the lessons from
current AHIC, and the fact that the win, win, win solutions approach
we\'re taking is limiting our velocity and our progress. Again, this is
slide 75.

Do you have any other, you know, this is like speed dating fast, you
know. One sound bite. But I\'d like to hear from each of you the lessons
from the current AHIC and how to avoid speed bumps going forward.

MS. BENJAMIN: One of them \-- and I think the others echoed this as
well. It was probably the most prominent one that we heard was around
scope creep, to use the vernacular, and the notion that a lot faster,
more exciting progress can sometimes be made, the more narrow you focus.
And that tracks with what we know from complexity that sometimes, you
know, small changes have big effects; that rather than thinking it\'s a
big problem so you need a big program or a big organization, maybe you
don\'t. Maybe it\'s very small targeted acupuncture-like focused
attacks.

MS. KOSS: I just echo that, and then the notion that, you know, I think
the Community is perceived as trying to work with the various
organizations that are also undertaking activities, but not necessarily
always heeding or hearing what is sort of the on the ground experience.
And consequently, some of the recommendations aren\'t viewed as really
being implementable or necessarily going to be embraced, even though
there has been some consensus within the Workgroup \--

MS. GELINAS: Not listening to the frontline?

MR. HUTCHENS: Yeah. The one follow-up comment I would make on that is
it\'s the frontline, it's ensuring that we\'re hearing from all
interested parties, and again, recognizing we can\'t \-- you don\'t want
to turn this into analysis paralysis, but we need to make sure we've got
balanced representation.

MS. GELINAS: Thank you.

DR. KOLODNER: Okay. Next on the list is Ward Casscells.

DR. CASSCELLS: Thanks, Dr. Kolodner, and thanks, Lillee, for asking
about the VA, DoD issues. I\'ll answer that and ask one question, if I
may. I share your very high regard for the VA system, and my six weeks
at DoD, having been a doctor and a patient in the civilian sector and
DoD healthcare, and even in the VA sometime back, I\'ve seen it evolve.

The VA has done a splendid job, starting with a modest budget, and
without the lion authority that we have in the military where they
focused on processes, standards, metrics, and they \-- the management
rewarded people for using these systems. And they weren\'t in general
cash rewards as much as you might think.

And so rather than focusing on technologies and networks, they focused
on the hospital. This hospital here, this hospital here, we\'re going to
improve things, by golly, we\'re going to do it. It\'s worked. And VA
has got very high care at no increase in cost.

We\'re learning from them in DoD. We have a decentralized network of
networks. We\'re struggling with these issues that Mr. Barrett referred
to. We have mobile networks, and we\'ve tried to approach it from a high
technology network centric viewpoint, and it has been very challenging.
We have spent billions, and have relatively little to show for it,
building it from a technology perspective. We have to move a hundred
thousand people in a few days with all their equipment and families and
whatnot. This is a challenge. And we have special security issues. So
we\'re struggling with this, and that\'s why coming to a meeting like
this is so helpful for us.

But my question, in approaching this challenge at DoD, I\'m trying to
invert it a little bit. Because we have been very top down. And I do
think that we need to \-- I think Craig Barrett said in the minutes,
we\'ve got to get the customer more in this. And \-- or maybe it was
Chip who said it.

I want to ask you all one question each, and that is, what would you do
to give the consumer, whether it\'s \-- I mean the patient, the well
patient, the sick patient, the patient, more choices, more control,
which will lead to ownership and accountability? This is not trivial in
DoD, and I need your help with it, but we are trying to drive it in that
direction to get more ownership, and I think that\'s a very important
issue. I\'d like to have your thoughts. How would you increase choices
and control by the patient?

MS. BENJAMIN: We do not know the answer to that, and we know we don\'t
know the answer to that. But one of the things that we do suggest is
that perhaps a way to find the answer to that question is to begin a
demonstration project on a particularly difficult chronic disease,
because people who suffer from chronic diseases have very difficult
health records, and so if you\'re in a \-- some kinds of places, in
hospitals you will see people, patients or their advocates, carrying
roller bags full of health records with them, because they simply have
to have all that information.

And so one of the \-- we do not know the answer to that, but we thought
that one of the ways to begin to focus on finding answers to that
question is by picking a particular chronic disease and beginning some
demonstration projects in that area to find the answer.

MS. KOSS: I actually had a stint before Avalere with a health and
productivity firm. And there are certainly some private sector
self-insured employers that are incenting and providing a set of tools
that are helping and encouraging consumers to get more engaged and take
control.

Now, obviously, the whole population, the whole US population doesn\'t
have that advantage, and it is the larger self-insured employers that
can offer choices. So we\'re not, you know \-- it\'s not for everybody
in that model. But it is certainly showing us some evidence that with
incentives to engage, people will engage. But they have to be meaningful
incentives, and, you know, in today\'s environment, it\'s sort of a
third of a third of a third. A third of people will do it on their own.
Another third will do it with encouragement from their provider, and
another third, they are the smokers and the not-flossers. We won\'t put
them in the same category. \[laughter\]

MR. HUTCHENS: Yeah, I think \-- we certainly think you can have
incentives. You can envision staggered co-pays. If you're already using
a physician who is using electronic health records, there is a lower
co-pay. Something as simple as that. That could actually begin to pull
and ask patients, are you on an electric health record, because I have a
lower co-pay if I do that. And again, it sounds like a theoretical kind
of thing, but you could certainly envision creating incentives even at
that level.

DR. CASSCELLS: So if the patient \-- Bob, let me ask you, so if the
patient comes in with their personalized health record all filled out on
their home computer, or even on a scannable document, you could waive
the co-pay and they could say, I want to go to a participating provider
who waives the co-pay if I have filled out the electronic record.

MR. HUTCHENS: Or the co-pay is \$10 instead of \$50 or whatever. Yes.
Yes.

DR. CASSCELLS: Okay. That, I think, is \-- that\'s where my \-- I\'m
headed in my \--

MR. HUTCHENS: You force the consumer to do the shopping, right?

DR. CASSCELLS: Now, in a system where we have no co-pays like for most
of my soldiers \[laughter\] \--

MS. BENJAMIN: Can I just mention one other thing that I think would be a
huge driver in this area, and that is that in order for lots of
individuals, there needs to be lots of individual customization. And in
order for the kinds of mechanisms, there need to be for me to connect to
my electronic health record in different ways and for different
providers to do that, we really feel pretty strongly that some kind of
open source based, open API kind of technical system, that\'s what I
would put in the manifesto, were I to be writing it, that is going to
enable the vast amounts of development that need to happen that make one
that I want, make the Ipod the way I want it, and the way my physician
wants it, to allow that kind of development to happen, rather than
trying to sell me the one particular way that you thought would be good.

FEMALE SPEAKER: A comment to add to the aspect of consumer control, I
think one of the concepts that was presented at least by two of the
proposals you heard had to do with an accreditation or certification
process with the NHIN. So if there is a community or regional or state
based health information exchange activities so there is a governing
body over those activities that are developing data sharing policies.
There will be \-- a very important piece of those policies will be to
establish the role of the consumer, and how they will access and control
their data. So to the extent that there will be some, perhaps, phase
two, phrase three responsibility with the successor entity that would be
crediting or certifying other organizations that are data stewards, they
can ensure that there is clearly policies at that organizational level
that really enable consumer control.

DR. KOLODNER: I think we\'re going to just take the last few comments,
and want to remind people to speak into the microphone. Apparently the
people who are listening at a distance are having a little trouble. So
make sure you\'re close to the mic. We\'ll next take Kevin Hutchinson.

MR. HUTCHINSON: This is a follow on to the existing conversation that
we\'re having around this. I still am a firm believer that it is the
purchasers who's going to drive this change. If we are going to leave
this to the consumers, and find incentives for the consumers, that\'s a
good thing, but that\'s typically going to come through the purchasers.
I put the purchasers, HHS, the large organizations and employers, the
payers, Blue Cross Blue Shields of the world, and those organizations
that are really going to drive the necessary incentives to drive this
change.

The technology is not going to drive the change. The implementation of
that technology can support the change, but we\'re going to have to
drive those reimbursements. I still get concerned that we don\'t have a
clear understanding of how we keep the momentum going forward of the
purchasers' involvement in this process. And again, HHS, being one of
the largest purchasers \-- the largest purchaser in the United States of
healthcare services, but you have a number of other large purchasers.
How do we continue through the great I want to say pains, but maybe
it\'s strides that the Secretary has taken on for this public-private
partnership, and has gone nationwide, and signed up a number of large
employers to support these efforts, to implement these standards, to
support these incentive changes. And I\'d like to hear from the group,
specifically, what you think the role of the purchaser, broadening that
to be not just the government, but all purchasers, in this process, to
really drive this change.

MR. HUTCHENS: Yeah, I think ultimately it\'s going to be everybody
involved. I do believe \-- we do believe that incentives, consumer
directed healthcare, is going to be something that not only causes this
change, but may actually help us control overall medical costs, so yes,
absolutely will play a key role going forward.

MR. HUTCHINSON: Relative to the process that you\'re recommending, each
individual recommendation that you\'re making, where do you see that
influence playing a role? Was \-- the Secretary has laid out the
difficulties in regulatory, and the timeline for regulation changes and
the difficulties of that.

MR. HUTCHENS: So in the particular model we have proposed, we could
envision the private sector payer community, the Blue Cross Blue Shields
of the world, being one of the groups represented on the board. We could
also envision consumer advocacy groups playing a major role in this as
well.

MS. KOSS: We have a couple different ways in the councils, at least as
we\'ve initially suggested. There's three different councils that
represent key payers, so there is payers, you know, considered insurers
more. There's employers as a separate group. And we have a state and
local government, which is also one of the remaining largest players,
from a payer standpoint, and then, of course, as we highlighted, the
variety of federal ongoing roles, you know, I think behind Secretary
Leavitt, I think the involvement of CMS was highlighted by many of the
current commissioners as a critical sustained component of who needs to
be involved in this partnership.

And then in the Workgroup design of having health system improvement
group works, and then separately infrastructure Workgroups, we did
identify incentive and financial as an infrastructure component, and one
could envision not a technical advisory panel get stood up to look at
when there is an incentive or financing recommendation, how do you work
through that would be sort of the different levers that we would
envision to engage that broader set of payer stakeholders.

MS. BENJAMIN: One of the things that we recommend is a consideration of
the model offered by the Department of Commerce and the creation of
ICANN, and we recommend that for a couple of reasons. First, there is a
divestiture of control from the Department of Commerce to ICANN, and
that is a model that we are recommending in this case. So the first
thing is to say let\'s get clear about where the boundary is, and keep
that register fairly tidy, that is, not blurry.

And secondly, given the incredible influence of the large payers,
including HHS in this field, it would be a pretty dumb organization that
didn\'t understand that it needed to stay in very close sync in
relationship with HHS. So there is a piece of this that we\'re
recommending that HHS actually divests itself of in the notion that we
believe that those relationships are strong and resilient enough, and
that people understand where the natural affinities are. There are
incentives here.

DR. KOLODNER: Next, Nancy Davenport?

SECRETARY LEAVITT: Can I suggest, we\'ve got to drive onto the agenda. I
would like to see if we could summarize the next three in a couple
minutes each, and then I\'ve got a comment, and then I would like to
move to the next discussion.

MS. DAVENPORT-ENNIS: I\'ll make mine very brief. I\'d like to thank all
of you for your presentations, and I\'d like to go back to the draft
principles for a successful governance that Dr. Kolodner started with
this morning, which states that the entity should exist for the purpose
of individual consumer benefit. And I\'d like to just suggest a
challenge to each of the groups who presented today. And consider that
when we define consumer, or individual, that we also include, in our
language and dynamics, special populations; whether that is seniors,
whether that\'s pediatrics, whether it is special ethnicities, whether
it is at risk populations, financially underserved populations,
geographically disadvantaged populations.

And I know that we don\'t have time for you to answer it on the record
today, but one of the things I would like to invite you to do, is to
simply provide to us a simple descriptor of how you feel your
presentation, indeed, will bring benefits to the consumers for whom we
are trying to develop this translational entity. Thank you.

DR. KOLODNER: Briefly.

FEMALE SPEAKER: It\'s one of the reasons that we suggested that the
innovation fund be both a public and private partnership, partly to
serve those special populations that may not meet market criteria for
innovation, but whose needs absolutely need to be protected, and
interests need to be advanced. But we\'ll happily expand on that.

MS. KOSS: Our council design was also informed by some of the activities
in the local community HIEs, and we just finished a project with the
State of Maryland where they had intersector groups, one of which was a
consumer group, and we took it, knowing that it was the most challenging
sector of healthcare, but were very pleased to see the combination of
advocacy groups, consumer groups, and then organizations that serve
those special populations.

We use that combination of organizations to come together and inform
what the consumer perspective was. And we think that is a model for
enabling sort of that broad representation for those who can readily
represent themselves and those who really have, you know, advocates that
speak on their behalf. So we think that is a model.

MR. HUTCHENS: Yeah, and again, we believe our model is broad enough that
it could represent any number of stakeholder constituencies.

DR. KOLODNER: Okay. Chip?

MR. KAHN: I hope this \-- I mean this respectfully, and I don\'t want to
be glib. I\'m going to be very brief. But I was not happy with the
answers in terms of the two. I didn\'t think, as a board member if I was
looking at a CEO, I would have flunked two tests.

The first test is the bumper sticker test. You really didn\'t give me
something I could put on a bumper sticker.

And the second is the mother-in-law test, which is, when you\'re trying
to explain to your mother-in-law what you do, if her eyes glaze over,
you know you\'re in trouble. And I really think we need to be make sure
that as we push this boat forward, that the one or two things we\'re
going to do, we want this thing to do \-- everybody understands it, and
it passed the mother-in-law test. Otherwise we\'re going to flunk the
\-- Craig\'s challenge, which is we\'re going to end up screwing things
up. Because we\'re going to set up a lot of process, and then they\'re
going to get into a lot of different things, and we\'re going to have
trouble. That\'s my remark.

DR. KOLODNER: Craig?

MR. BARRETT: \[unintelligible\] was formed \-- there have been a number
of what I would call independent operations or entities to try to do
some of the things we\'re talking about here. For example, there is a
group of, I think, about 150 companies under the flagship Continua,
which is setting standards for home health devices and monitoring
devices. Nothing to do with AHIC. Industry is doing it by itself.

Another example is about ten companies, a couple of which are
represented here, have banded together to try to create an EHR with open
API so anybody can write an application on it, and you can put any third
party wellness program or financial management program, et cetera, on
top of that. What I\'m wondering is how do you perceive those
independent entities and operations would play into this global
monitoring system that you\'re suggesting? This overall direction
program?

MS. KOSS: Not an overall monitoring process, but I see those
organizations as likely affiliates. We also distinguished, to a degree,
between the Workgroups, that the focus of what technology gets stood up,
or even the specific standards aren\'t the ownership of this \-- either
the Community arguably today, or this partnership in the future. It is
establishing the functional requirements and the capabilities that the
industry is needing for the organizations that are established to be
responding to. So I would see nothing in the design that wouldn\'t
acknowledge what Continua is doing, and look at what it does, does or
doesn\'t sync up with what is being asked for in terms of the
organization.

So I don\'t see it as a replacement or a takeover, but there needs to be
a mechanism by which there is an open dialogue, and an understanding,
and if either group is doing something that\'s about to, you know, set
up a conflict or create barriers in the marketplace, that there be a
mechanism to address how you manage that.

MR. HUTCENS: I would just comment it would be our hope that \-- and
frankly, I think any one of the organizational models that have been
proposed here could do this, would just help you leverage that even
beyond the ten companies in one case, 150 in the other that are doing
this. It should be simpler to do as we bring more people into the fold.

MS. BENJAMIN: Just building on that, in our longer presentation we spent
quite a lot of time talking about staying out of the way, which I think
is in keeping with some of that spirit, and how instead, to be more like
a trim tab in the sense of guiding and providing some directional
mechanism so that those things that are truly in the public interest are
served while the market is taking place, taking care a lot of the other
aspects.

SECRETARY LEAVITT: I\'d like to answer your question, Craig. I think if
150 companies come up with a predominant standard for chronic disease
monitoring, we ought to adopt it, and we ought to use it as a piece of
this larger puzzle. And I\'d like to summarize my views on this
conversation by saying that our original \-- our task here is to create
a mechanism to reach conclusions on technical standards, and to organize
that into a thoughtful system that the marketplace can then operate
within.

As I\'ve said many times, there are three ways you get standards. You
can have a government prescribe them, and almost always we'll do the
wrong standard, when we do it on our own; or you can do the last vendor
standing, and that\'s not likely to happen in this case because there is
a lot of different ways to go about this; or you can use collaboration.
And when you do, it\'s hard. And what we\'re experiencing right now is
how hard it is to collaborate.

But we ought to acknowledge the fact that in many other industries and
settings, this has been done very successfully. The IEEE is an example
in your industry, Craig, where standards have been established. I don\'t
know how hard the collaboration was, but there are standards on 13 or
1400 different things that they have begun to coordinate.

Rob mentioned Visa. You got 90,000 members who somehow come up with a
means by which they\'re able to create standards that drive, and allow
an entire financial community, not just in the United States, but across
the world, to do this.

I would \-- so I think it\'s important that we realize that what we\'re
creating here isn\'t \-- we\'re not working to create an overall system.
We\'re trying \-- let me restate that. We\'re not working in a way as to
prescribe everything. We\'re trying to come up with technical standards,
and I think we\'re really \-- we've got to ask the question, what can
drive this?

Fundamentally, I think if you follow the money, that\'s what will drive
it. When a majority of the market ultimately lines up behind a standard,
that\'s why HHS is a player here. But we can\'t be alone in this.

Now, mention was made of the fact that I\'ve spent a lot of time in the
last six months running around asking large payers to agree that if AHIC
comes up with a standard, that they will not only adopt it for their own
use, but insist that their vendors do it. That\'s the only thing that
will ultimately drive this. If people begin to see that the market\'s
moving that direction, the only way they can be in the flow of the
market is to be adopting these systems.

So whatever \-- this has been a very helpful conversation, and I don\'t
think Sharon and Lisa, you have to worry about chaos. We\'re going to
get there quick. But there are \-- I mean we have made some progress. We
have made some progress because we have, at least for now, come up with
a means by which we can reach conclusions. And this is about reaching
conclusions, and then getting enough people behind those conclusions
that the market will begin to drive it.

And whatever the successor organization is, and I think we\'re having
the right conversation, what role does the government need to play? The
government, in my judgment, needs to play an organizing role, and we
also need to play a role as a participant and a vendor, and we need to
put our market force behind this. We need to put our dollars behind it
and we need to invite others.

If Blue Cross and its 90 million members decides that they\'re going to
be part of this standard, if the Department of Defense, as they have,
says they\'re going to be part of this standard, if the VA says they\'re
going to be part of this standard, if Medicare, if 50 Medicaid programs
decide they will be part of it, this is going to be the standard. If 150
companies come up with a chronic care management standard, AHIC doesn\'t
need to \-- doesn\'t need to redo that. We ought to just say hooray, and
let\'s put it into what we\'re developing. If the lab \-- if \-- because
as I see it, we\'re not inventing any standard. We\'re simply adopting,
we\'re deciding or coming to conclusions on what will be part of this
larger framework.

So let\'s not make this too complex. We can do this. Lots of others
have. And what \-- but our goal isn\'t to be the overall orchestrator of
all healthcare. A couple of you brought up quality. I mean one of the
things we have to achieve is when we have technical standards, how are
we going to line that up with the quality measurement.

Someone brought up the NHIN that\'s been part of our conversation. But
that\'s got to be part of the conversation, too. Three major components.
The technical standards on the system, value, and how we \-- or the
quality and how we measure it, and then lastly, how we create a system
to send the information back and forth. Very helpful conversation. I
think we can get there. We just need now to take this information.
We\'ll have more conversation. I think this has been the beginning of a
very helpful dialogue. Rob?

DR. KOLODNER: Thank you very much, Mr. Secretary, and thank all of the
contractors, all of you, for making your presentations today. We
appreciate all that you\'ve done and look forward to continuing to work
with the materials you provided. Thank you.

SECRETARY LEAVITT: We\'ve got to take a break.

DR. KOLODNER: We\'re scheduled to take a break afterwards, but if we
need a brief break now, we can certainly take a brief break now. Okay.
Let\'s take a ten minute break, and be back here ten minutes from now.
Thank you.

\[break\]

DR. KOLODNER: Could everybody please take their seats, and we will get
started?

We\'re going to make an adjustment in our agenda, and we\'re going to
start with this next panel which we will ask John Loonsk and John
Halamka to do in about 30 minutes. And then we\'re going to go ahead and
continue with a few of the Workgroup presentations, starting with the
Chronic Care and Electronic Health Record. We\'ll see where we are and
whether we take a break before or after the final Workgroup
presentation, where we can take a break, get some food, and then come
back for the final presentations.

And with that, let\'s start now. This is on the standards road map, and
HITSP update, and I\'ll turn the microphone over to John Loonsk.

DR. LOONSK: Thank you Rob. Good morning Mr. Secretary and members of the
AHIC. This morning we\'re going to talk to you, and show you a roadmap,
very relevant to the discussions earlier this morning, a roadmap of
where the AHIC work is on priorities and standards, and where \-- and
what comes next from the standpoints of priorities and process.

Then John is going to talk about the progress that\'s been made on the
first round of the health information technology standards panel,
standards and interoperability specifications which are now coming
available in version two form, and the path for the anticipated
secretarial recognition of those standards and interoperability
specifications moving forward.

So to begin with, this I chart is a representation of some of the work
that has been accomplished and some of that which is still yet to be
done. If you look at the left most column, you\'ll see the first three
break-through areas which were advanced and that John is going to report
on the status of. So we have consumer empowerment, EHR, and
biosurveillance.

In the next column, we have the four priority areas or use cases that
were clustered from a variety of different priorities and issues that
the AHIC and the AHIC working groups have advanced. So we have the
consumer access to clinical information, emergency responder EHR,
medication, management and quality. These use cases are about a week or
two away from completion and will feed into the next steps of the
process.

The third column represented by the tan headers are the possible use
cases that you asked us to begin to work up in the context of having
them available by the end of this year for a December deliverable to
represent the next step of priorities to be advanced. We would like to
bring those back to you at the next AHIC meeting to confirm that these
are the priorities to move forward with, and also to think about some of
the many \-- and these are the illegible priorities and issues that are
represented on the right side, which are still not touched upon in the
work that\'s been done, but hopefully, we can start to organize, as we
have done before, to move forward, and whether that\'s advanced through
the AHIC or in the AHIC successor organization, we would hope to convey
these as a kind of roadmap moving forward in terms of priority areas.

These priorities of attention and issues are fed into a process, and if
you\'ll focus on the top line of this next graphic, you\'ll see the
first three use cases that are represented in the upper left corner, and
then the two stages of the Health Information Technology Standards Panel
(HITSP) process represented by the yellow blocks coming to the
identification of standards, and then developing implementation level
guidance and culminating, if you will, in the \-- and this would be
where the \"you are here\" sign would go, which is right here at the end
of this second yellow block. That\'s where we are right now in the
process. Version two, these standards are being presented today.

Also on this graphic are the criteria development process of CCHIT, that
the intent is to be able to take up these standards, to be able to
include them in the development of criteria, and then the CCHIT testing
process, so the actual certification to those specific standards as well
as \-- of the specific criteria as well as standards.

On the top here, we have identified \-- by the diamond, the time of
acceptance. This is the act that Secretary Leavitt has performed on
these HITSP standards to date. They were accepted in December of 2006,
with the intent of recognizing them in December of 2007, and the gap
between those is the year of time that systems developers, and
implementers have, so that they can implement these standards in their
systems.

That clear block on top represents implementation in new systems and in
upgrades as well as contracts in the federal sector. So this is one of
the lever arms that was much discussed this morning in terms of
implementation in the federal sector. And below, at the bottom, the blue
bar represents inclusion in the NHIN trial implementations. The request
for proposals which is now out on the streets, and where the health
information exchanges will be implementing these standards in the
context of moving them forward.

So laid out in front of you, in this top line, are the steps and the
relationship between the various aspects of this. You could describe
this as the turn of the crank, as the Secretary has referred. And then
there are two other turns moving down from there. And I\'m not going to
go in great detail into these next.

You\'ll see the next round is a little more complicated because we have
an accelerated path for the emergency responder EHR, priority area and
use case. We then have three other use cases, as I\'ve referenced
before, that will move forward through this path, and then the plan on
the bottom line is for six use cases and priority areas to be moved
forward in the next round.

So I will note for you that on this graphic, we have expanded from three
to four to six anticipated in the next round; that there is represented
in this process six different comment periods for different aspects of
this. So the public comments on the progression of these activities,
through this cycle, include six public comment periods for which a month
is the target for \-- that the industry has identified as what they
desire, as well as a year\'s worth of wait time in terms of the delay
between having standards and implementation guidance identified, and
when they could be expected to be implemented in the system.

So overall, it\'s a process that is pretty packed with activities. As
you well know, there are literally thousands of hours of volunteer
effort that are going into this process now, whether that is at the
working groups, at the health information technology standards panel, at
CCHIT and the other participants that are progressing with this
activity.

And with that, I will turn this over to John, who will talk about the
specific deliverable that is here today at the end of this second yellow
box for version two of the interoperability specifications.

DR. HALAMKA: Well, thanks very much. And good morning Mr. Secretary and
the Community. So I want to present to you Version 2.0 of the work of
HITSP. This represents over 20,000 hours of work by 302 organizations
and more than 300 technical experts. Specifically, we followed what
Secretary Leavitt called the collaboration process. This was not top
down, this was not driven by a last vendor standing, this was built by
vendors, standards development organizations, consumers, payers,
providers, in fact a very open organization that anyone can join, and
just to reflect on what we did. In March of 2006, we were given the
three initial use cases that John has described of consumer empowerment,
biosurveillance and laboratory electronic health record
interoperability.

We turned those use cases into very detailed requirements documents. We
then looked at over 700 standards that would meet those requirements and
assessed their readiness and appropriateness. From those 700, we named
30. And those 30, then, required very detailed implementation guidance,
and that guidance was presented to you as Version 1.2 in October.

We recognize that these very specific guides had to be tested. We needed
extensive public comment and input from all the stakeholders. So between
October and May, we went through over 300 comments and resolved them
all. We, then, presented to the entire HITSP panel, all 300
organizations, the resulting work product. And by consensus, we achieved
unanimity, collaboration. The work product we bring you today is a
completed set of 30 standards of which there are two that are still
being balloted by standards development organizations in July. So I
bring you 28 out of 30 complete, and the last two to be completed next
month.

So let\'s go through just some detail. Consumer empowerment we know was
the eliminate the clipboard standard, the idea that you would have
demographics, medications, allergies and specific patient care
preferences like advanced directives in an interoperable electronic
document that could be stored in a personal health record and be
transportable.

This required really, I think, a historical collaboration between the
ASTM standards organization, HL7, NCPDP, federal medication
terminologies, IHE, X12 and SNOMED. Because we wanted to get content and
terminology, and we wanted to incorporate all the best of all these
organizations together.

So that was achieved in what I call parsimonious set of standards that
now can be used for consumer empowerment. And it required one of the
very first great acts of harmonization within HITSP. We know that ASTM
has the continuity of care record, and this is very much a clinician
driven XML construct that describes, in a very straightforward way, data
about a patient that goes between caregivers or is used within the
context of a personal health record.

We also have HL7s clinical document architecture, very detailed
terminology based, with good controlled vocabulary way of describing a
document, very commonly used in hospitals today. We wanted to leverage
the strength of both of these standards, the continuity of care record
and the clinical document architecture, HL7 and ASTM, work together
collaboratively to create the continuity of care document, truly
leveraging the best of both of these together.

In fact, many individuals from your organizations worked on that to
achieve our harmonious result. This continuity of care document will be
implemented in several vendor systems over the course of the next year,
and it really does represent a step forward in harmonization. It meets
the test of using a clinician driven set of data but also controlled
vocabularies and is therefore useable by all stakeholders.

So the consumer empowerment specification I bring you today is complete.
It includes all the implementation guidance necessary to implement and
the final balloted work products of all the standards development
organizations involved.

Biosurveillance. This was a particularly challenging and complex
specification. This is population level, not just individual patient
level. It requires that we anonymize data, that you may very well want
to report on the number of individuals that present to an emergency
department or the number of individuals that have a given diagnosis
disease or lab result. It similarly requires that we align multiple
standards organizations to provide such things as demographics and
counts and lab results radiology results.

So this also required many different types of architectures. It would,
in fact, get EHRs, or data that might come out of hospital information
systems or laboratories, all to be reportable to state, regional or
federal biosurveillance or public health entities.

We had to align this with existing public health initiatives, so we very
much involve stakeholders from the CDC and public health departments
throughout the country. This standard, and set of implementation
guidance I bring to you in a complete fashion with one small to do item
that will be balloted next month.

As you know, there are sometimes overlaps, as we described in the CCR,
CDA, harmonization, but there are also sometimes gaps, and there was not
a standard in this country for describing hospital bed availability and
utilization. If there is a mass casualty incident, and we need to know
how many beds are available at a given hospital, other than sending a
spreadsheet, there has not been a standard that was interoperable
developed by an SDO.

The Oasis International, one of the ANSI recognized SDOs, has in ballot
in July, what is the HAVE standard, H-A-V-E, which stands for Hospital
Availability Exchange. And therefore, we believe this will meet that
final last element of the use case for reporting on hospital utilization
and availability. Therefore, I bring you all the standards, all the
guidance, and the July ballot of that last small piece.

Electronic health and lab result reporting. This is, again, very complex
set of standards. We have to take into account two basic kinds of data
transmission. You might have machine level transmission between a
laboratory and electronic health record, but also human readable
transmission or documents that may go with a patient and a PHR, or may
be an electronic health record or a regional health information
organization. We had to support both kinds of standards.

We also have to recognize that the laboratories of this country have had
a very significant investment in HL7 2.2 and 2.3. There are thousands of
implementations of legacy standards, and we had to think about a roadmap
for modernization to a common set of standards. We wanted not only the
content of lab results, but controlled terminology which would describe
units of measure, reasons for ordering the test, very specific names of
tests. So we had to include, again, many standards development
organizations coming together to bring you this set of interoperability
specifications.

One aspect of what I presented in the last time we\'d met, version 1.2
had a lot of constructs in it that produced by standards development
organizations and implementation guide writers. And AHIC said we really
like the work you\'ve done with standards development organizations, and
we want you, as I think we said this morning, don\'t invent standards.
HITSP should not be a writer of standards. Point to standards that are
coming out of standards development organization processes.

HL7 has been working very hard on creating a single uniform laboratory
message result standard, and that is being balloted next month. This
represents hundreds of individuals coming together. It\'s called the HL7
2.51 implementation guide, meeting the tests of the laboratories,
various institutions and payers and providers coming together in a
single implementation guide. It is HITSP\'s desire to simply point to
that HL7 work product and say this meets the AHIC use case, and it\'s
coming out of the standards development world.

Also in interest of completeness, HL7 is working with ELINCS and the
California Healthcare Foundation. ELINCS was an HL7 2.4 construct that
came out of a laboratory harmonization activity historically. An initial
ballot of ELINCS was done by HL7 in May, and that had a lot of public
comment. So that public comment is currently being worked through and an
ELINCS HL7 implementation guide will come out likely in the September
timeframe.

Now, that September timeframe does not really impact what we have
described today as the July ballot of the HL7 AHIC use case 2.51 guide,
which HITSP will point to. But it does give us future work to do.
Because we recognize, although the HL7 work product coming in July is
very general, it does adhere to the use cases of biosurveillance,
electronic health record and consumer empowerment activities. The
laboratories of this country do want more constraints, less optionality,
and so as this work product comes out from HL7 in September, it will be
the job of HITSP to now take these HL7 work products that leverage the
ELINCS great work to date, and ensure that they generate some profiles,
some further constraints to the HL7 2.51 implementation guide. I really
do believe this is going to be an ongoing and iterative process. We\'ll
start with the AHIC use case and its generalness, but will continue to
provide specificity profiles and less optionality going forward, and HL7
and HITSP will work very closely on that effort.

So again, I bring to you today now a set of finished implementation
guides, but the messaging standard for laboratories, HL7 2.51 will be
balloted in July. I expect comments to come in August, and the final
implementation guidance to be incorporated into the HITSP specifications
by September.

So those are your first three use cases. Next steps, you, of course,
should review, and we are very happy to receive any input on the work
that we are presenting to you today. We do recognize that in July, HL7
and Oasis will produce their final balloted standards that we will point
to. We will continue to work with CCHIT.

Now, this is very important, because we recognize, I think to the
subject that was discussed by the consultants earlier, change in vendor
products is not immediate. We will develop standards, but there needs to
be a logical timeline by which the vendor products, the laboratories,
the pharmacies, the doctors of this country change their systems to use
these standards. HITSP and CCHIT have developed a roadmap together.

So, for example, on the laboratory standard, we recognize it\'s very
significant work to move today from the heterogeneous standards of HL7
2.2 and 2.3 to 2.51. So we said, that\'s work of 2008. We also recognize
it\'s a lot of work to use very controlled terminologies. LOINK codes
and SNOMED vocabularies. That\'s the work of 2009.

And finally, using standard units of measure in every laboratory of this
country is a particularly changing body of work and, therefore, we\'ve
said that\'s 2010. And this jointly developed CCHIT certification
roadmap gives the laboratories, for example, of this country the
latitude they need to change all their systems in a logical and
affordable way. We will continue to work with CCHIT and implementation
guidance for all standards and use cases with AHIC.

Our next level of effort, very important level of effort, is to finalize
privacy and security standards by October of this year. And we have nine
different classes of privacy and security standards. Now, of course,
it\'s not the role of HITSP to make privacy policy. That is really the
role of HISPC activity and the AHIC Working Group on security privacy,
and other organizations.

But we can come up with security standards that help enforce all the
variation of privacy policy. Common mechanisms to audit lookups. Common
means of authentication and roll-based action control. Even something as
simple as a common measurement of time. If, in fact, it\'s so important
to know when a record was accessed, you better have a standard for
measuring time across all systems.

So by October, we will be back to AHIC with nine different kinds of
security constructs that will work across all the use cases that I have
presented to you today, but also all future use cases; the four in 2007,
the six in \-- excuse me, in \'08, or however many is decided upon for
us to do.

Now, often it is asked, well, if you were getting these security
constructs for us by October, well, what do we do before then? Well, we
recognize that all the laboratories, for example, in this country are
already using good security transmission methods, such things as leased
networks, or virtual private networks, or security encryption using the
web. So those constructs would continue to be in place, and what happens
in October is we get even more specific about them.

The way I like to describe it is if you wanted to mail a letter today,
we have standardized the stamp and the eight and a half by 11 sheet of
paper, but we\'re still allowing different sized envelopes. Well, come
October, we will have a single standard for the envelope. But the mail
should still flow between now and then. So that\'s the work to date.
That\'s the work ahead. Certainly look forward for your comments and
your questions. Thanks.

DR. LOONSK: We\'re presenting this information to you in the context of
what, Mr. Secretary, you have already identified in terms of your
process and the suggestion that you would recognize this work in
December of this year. We \-- I\'m not sure that there is further action
necessary by the AHIC in this regard. It is our suggestion that the two
standards that have been delayed, that John mentioned had been delayed
because of the balloting of the standards development organizations
looks about three months, that we would suggest that those be delayed in
their recognition by a comparable amount of time. But otherwise, that
the plan as described is viable to move forward.

SECRETARY LEAVITT: You have essentially laid out the process on our 2006
work cases. We have delivered the 2007, and you\'re beginning to work on
those now. Not what have you done for me lately, but what do you
anticipate that those will \-- first of all, I congratulate you and
thank you for that, but anticipating \--

DR. HALAMKA: Great, and a very fair question. So as you\'ve seen, these
turns of the crank typically begin in March and end in October. So
although, as John has described, there are comment periods and
recognition and acceptance timelines, HITSP has very aggressive
timeframes between March and October to do this work.

We have received our use cases, as you\'ve described for privacy and
security, for emergency first responder, for quality, medication
management, et cetera. And we\'ve broken those use cases into what I\'ll
call the low hanging fruit. Standards already exist. There is relatively
mature implementation guidance that we can incorporate, and we\'ll bring
those back to you in October. We will follow the March through October
guidelines.

But we also recognize that because the timeframes are so tight, that
there is going to be additional work post October on some of the gaps,
and some of the areas that aren\'t yet quite mature. So I think you can
expect, as this describes, sort of the two phased approach, and there is
no question we will be back in October with privacy and security, and
emergency first responder, and some low hanging fruit, phase one
materials on the other three use cases.

DR. LOONSK: So just to add to what John has said, that HITSP is
essentially getting the use cases six months later than they would have
liked to, and the commitment represented in its timeline is one that
they probably should be given some flexibility with the next step of
deliverables, whether that be to February of this coming year or not \--
or of next year. And \-- but then if we do prioritize the next round,
the six next round, we can have those for them in December of this year,
and that from henceforth, they can have a regularly expected deliverable
in December that can feed their process and get onto a much more regular
cycle, which is important for not just HITSP, and the amount of time
they need to do their work, but also for all the dependencies of the
other processes that cascade from that as well.

SECRETARY LEAVITT: So we\'re beginning to develop a battle rhythm of
sorts, and it may not have been exacting, and likely won\'t be in the
future, but it\'s generally the March through October, with some
straggling items at the end that might come in in December, or January
or February, or whenever you\'re finished with it, is that \--

MR. HALAMKA: Right, correct, and we also need to align our work with
CCHIT, because as you can see, there is a clear dependency, and if CCHIT
has a June to June cycle, the timing is quite delicate to make sure that
this is incorporated and, therefore, certification can occur in a timely
way.

SECRETARY LEAVITT: As John will attest, I really enjoyed seeing this
chart. That\'s the one previous, the I chart. Because it \-- it gave me
a sense, at least, that this is the agenda for AHIC and/or its
successor. The blue and the beige represent \-- or the 2006, \'07 and
\'08, represent the initial flow of our work on the right, these are
items that \-- this is the menu of items from which AHIC will have to
choose to prioritize, and I personally believe there are two primary
objectives for AHIC, or two primary tasks.

The first is to decide what comes off that chart on the right, and in
what order, and then to be the process by which we create a conclusion
on those things that have gone through the HITSP and CCHIT process. Is
that a fair way to describe the division of labor here?

DR. HALAMKA: I see the Community as the board of directors, and I get to
serve as your CEO or COO, and together we will deliver what you
prioritize.

SECRETARY LEAVITT: I thought that Craig Barrett posed a very interesting
proposition, and that is that I\'m assuming that there are things
happening over this right side that are being driven by the market. And
he raised the point of chronic care management. There are organizations
that are beginning to create standards, and he references the fact that
there are many companies that are beginning to develop in chronic care
management. It\'s likely that we\'ll tee that up in 2008, to integrate
those standards into our larger picture.

Could you talk us through how, using this as a case, how the work
that\'s being done by that group of companies, or other similar
configurations that would be operating on \-- in these tasks, how
ultimately do we integrate them into the flow of this work?

DR. HALAMKA: Sure. And certainly we very much appreciate the work that
Continue was doing, recognizing that any consensus-based process that
meets the test of usability and applicability, is something that HITSP
is going to leverage. Specifically, we have what would be called a
Harmonization Readiness Committee that looks at what the industry has
done, or standards development organizations have done, and asks, is it
applicable for the purpose of a use case? Does it have an open,
transparent process that was used to develop it? Is it going to be
maintained going forward?

And if it passes through that sieve, we say, this is great. This is
something that now we incorporate into an interoperability
specification. Because we do not want to write standards nor maintain
implementation guides ourselves. We would much rather point to the work
of an SDO, or a group that has decided to create implementation guidance
that\'s going to help us.

So I would see, as we get the use case, harmonization readiness will go
and review all this work, assess its readiness and incorporate it into
our implementation guidance as part of our meeting the use case
requirements.

SECRETARY LEAVITT: Are you aware of other similar organizations on this
right side, on tasks that are on this right side of the chart that could
accelerate the pace of our work, as John pointed out? We started with
three, we went up to four, now we\'re looking at six. Are we going to be
able to see an acceleration of this process over time?

DR. LOONSK: One of the things to add to what John has said is that we
are guiding the Working Groups of the AHIC to look to where \-- to this
\-- where standards may exist or may not exist. The work that John is
talking about, about standards harmonization, only can occur when the
standard does exist. So in fact, we\'re trying to work upstream of the
process where \-- for example, in the personalized health domain, to
look to the standards development organizations to assure that
everything is being done to develop the standards, so that they can, as
they come through this process, be identified. So not only are we trying
to encourage looking for those groups, as this process moves forward,
but we\'re also trying to encourage the Working Groups to guide the
development, to fill gaps as early as possible, so that they can be
harmonized, or advanced in this context moving forward.

DR. HALAMKA: An example for you is all of the stakeholders involved in
clinical trials and research have come together and created C Disk, an
organization that is trying to do some harmony just across all of those
existing stakeholders. So clearly, if we were given a clinical trials
and research use case, we would leverage what work the industry had done
before HITSP had come into really reviewing that particular area.

SECRETARY LEAVITT: Again, to reflect back on the conversation we had
about AHIC going forward, I think this is a very helpful discussion
because it, again, focuses on AHIC\'s primary purpose. It is to reach
conclusions, to be the process by which things are ultimately concluded,
and second is to prioritize what comes next. And so we ought not to
allow our view of AHIC to become too complex. The complex work happens
at HITSP and CCHIT. Our job is to find a way to bring conclusions and to
prioritize what happens next.

DR. KOLODNER: Okay. Discussion? Questions? Kevin?

MR. HUTCHINSON: John, I want to congratulate both John and John. It\'s
great work, and you\'re now moving into some interesting areas. This is
not just technical standards. You\'re moving more into some medical
vocabulary standards. And something, John, you and I have chatted about
is this: as you get into lab result standard in the reporting, this
unified code of units of measure, this UCUN, is getting into some
standardization and medical terminology that the concern is a patient
safety concern. How do we transition, for example, milligrams? In
medicine it\'s MG, as an abbreviation. In the UCUN standard it\'s G-3.

So how do we get into a transition to where a position is not
interpreting the information incorrectly because of unknown new
vocabulary terms. And also the payer community is not confused by what
was submitting, as what was ordered, or what was delivered.

MR. HALAMKA: And this is why we set with CCHIT, a three year roadmap for
working through these issues, because you might imagine, the machine to
machine communication takes place with that G minus three, but the human
readable communication may very well have a visual mapping, which is
more consistent with what a doctor is used to seeing. The word
milligrams, for example.

So that is work that still would need to be done in the future. We\'re
simply saying we need to standardize units of measure so that every
machine in the world spits out the same information so a computer can
interpret it, and the roadmap to begin that process starts in 2007, with
2010 as a likely implementation date where we\'ve addressed some of
these issues as you\'ve raised.

DR. KOLODNER: Lillee?

MS. GELINAS: And I, too, want to congratulate you. It\'s a whole lot of
fun to be mirrored in this work and see the progress that you\'ve made.
And so congratulations on that.

The 2008 possible use cases, the one that just really stands out is
under remote consultation, structured e-mail reminders and online
consultation. I think we\'re moving from fog to concrete. But that is
going to beg the whole reimbursement issue, that as we get that
finalized, the ugly issue of paying for E-visits, electronic
communication with patients, that type of thing, it really strikes me as
an important component to tackle with the reimbursement aspect.

I recently had a meeting with our chief nursing officers and they talked
about ED overcrowding, how bad it is. When you look at ED overcrowding,
and the chronic care uninsured population that are bogging down
emergency departments, that if there were compensation for online
consultation, E-visits with physicians, we could potentially siphon off
some of that problem that we\'re now experiencing in our emergency
departments. Very simple things.

And at the end of the day, what you hear is we\'ll hide behind, well, we
don\'t have the standards yet, we don\'t have the certification yet,
we\'re hiding beyond that. But you\'re going to bring clarity, it seems,
to that conversation very soon, so that reimbursement piece is really
going to come screaming back at us, I think. Would you agree with that?

DR. HALAMKA: Well, certainly. And in our region in Massachusetts where
I\'m from, Blue Cross has taken an early lead in pilot programs to
reimburse E-visits, and so there is some learning, I think both in
California and in Massachusetts on this. So I hope the lessons learned
will be there by the time the standards are implemented.

MS. GELINAS: All right. Thanks.

MR. BARRETT: Let the record show I did not ask Lillee to ask that
question.

\[laughter\]

DR. KOLODNER: And I have a feeling we\'re going to hear shortly, in the
next Workgroup \-- other comments and questions? If not \-- yes.

MALE SPEAKER: What can you say about semantic web to a non-computer
literate person like me? What is the opportunity for semantic web
technologies in translating milligrams to G-3 ? My computer doesn\'t
care if the font is New York Times, or Chicago Bold or, you know, serif
something or other. Why can\'t we do that, using semantic web in
healthcare \-- what are the hurdles, what are the milestones?

DR. HALAMKA: Many of the standards I presented to you today are semantic
web based, so the CCD standard is, in fact, an XML construct. The notion
of transporting that securely, via the web, in an encrypted way,
certainly is a common mechanism of sending that from place to place. So
I think with this particular UCUN example, it\'s not so much a
technology challenge, it\'s just making sure there is an unambiguous
mapping between what the computer is using as a unit of measure, and
what the person sees. And implementing it, using a transform such as a
semantic web may be a very logical way to do that.

DR. KOLODNER: Okay. Any other questions or comments? If not, thank you
very much, John Loonsk and John Halamka, appreciate your presentation
and getting us up-to-date, and at this point we will continue and go to
the next presentation, which is the Chronic Care Workgroup.

So as people are taking their place, we will continue through this
group, and depending on the time, I believe the Electronic Health Record
Workgroup is also intended to be a fairly quick presentation, so we\'ll
take that before we take our break.

Presenting to us we have one of our AHIC members, the co-chair of the
Chronic care Workgroup, Craig Barrett.

MR. BARRETT: You have in your notebooks, three handouts which I think
are of significance to this presentation. One will be just the current
list of recommendations, one is a letter to Secretary Leavitt,
describing the recommendations in some detail, and the third is a
nonstandard eight and a half by 14 piece of paper that will fit in any
envelope, if you fold it sufficiently, showing the progress on the
recommendations that were made approximately one year ago by the Chronic
Care Workgroup.

And I might just briefly summarize the progress to date. There were
several categories of recommendations made. Three of the categories were
really to look at compiling and assessing various reimbursement
methodologies for secure messaging between clinician and patient,
looking for evidence, and continuing to contribute to the information
database on that topic.

Those three items, the first three items on the big piece of paper are
labeled with some progress in terms of statement of works have been
written in the contracting cycle to move forward on those topics. So
let\'s assume that we\'re making progress in those three areas.

The next topic was really one of having HHS work with the states to
discuss a topic of cross-state licensure such that you could have
telemedicine, if you happened to live in northern Wyoming, with a doctor
in southern Montana, for example. And the NGA has picked up that topic.
It\'s labeled with green here, so we\'re making progress there.

Pursuant to the discussion we just had, the Chronic Care Workgroup made
recommendations to HITSP to define standards for secure patient
clinician messaging transactions, and also look at remote monitoring.
Those were not prioritized to current use cases. You saw, in the
previous presentation, that they are possible 2008 use case topics. So
the statement made in the progress to date is minimal progress to date.
I\'d assume it\'s less than minimal progress, because we have made no
progress. They are just on the waiting list for possible 2008 actions. I
mention this because it will be the first recommendation that we will
make in this presentation as well, to urge Secretary Leavitt to put this
high on his priority list.

The topic for AHRQ to look at studies of information technology in the
elderly, ill and underserved populations, analysis of barriers and
drivers. That has been identified in their scope of work and moving
forward.

And there was an issue on broadband access, and as a necessary
infrastructural item to move forward for remote monitoring and remote
diagnostics, remote consultation, broadband access is being worked by a
number of groups, and the anticipation is over the next several years
the great majority of the US will have broadband access available to
them.

So having briefly summarized last year\'s recommendations, progress to
date, we come to this year\'s recommendations. And the first
recommendation is the one that I just mentioned. This is the Workgroup
member list. All who have attended meetings worked hard and deserve
recognition.

The recommendations that I just went through were primarily listed under
the specific charge of making progress in a short period of time, in
terms of having communication between clinicians and patients about care
delivery. We rather turned our attention to the broader charge in how to
make progress in terms of secure technology solutions for remote
monitoring, assessment of patients for communication between clinicians
and patients.

The first recommendation we have in that category is really a rehash of
where we were before, which was given that interoperability standards
and certification of secure messaging is important. We really need to
raise this up in the use case category, and hope that the Secretary will
make the case for us, that interoperability is important, secure
messaging is important, and we need a use case designation for this in
2008, at the latest. I'd settle for July of 2007, but I understand
that\'s out of the category.

My presumption on this is that there are enough experiments going on
around the US that we\'ll be able to take advantage of that technology
by the time we get to this. But this is absolutely going to be a
critical aspect, and adding a bit more commercial here, if in fact
chronic illness is the number one cost to the healthcare system in the
United States, not having remote monitoring and secure messaging, secure
communication diagnostics between clinician and caregiver. That will be
an absolute requirement, if we\'re going to make any impact on that
number one cost to the system.

If we go forward, it occurred to our group that the biggest limitation
in the use of remote diagnostics, remote consultation, remote monitoring
is, in fact, the whole issue that Lillee mentioned just a moment ago,
which is reimbursement. And I am not an historical expert in the rules
and regulations governing healthcare, but in the letter to the Secretary
we mentioned a summary of these topics, which, in fact, go through the
Social Security Act, the Balanced Budget Act, the Medicare/Medicaid, S
Chip Benefits Improvement and Protection Act, Medicare Modernization
Act, etc., etc.

If you look through all of those documents, you get to the interesting
point that telehealth, telemedicine, remote monitoring, remote
consultation, etc., whatever you choose to call it, has a series of
substantial limitations, limitations in terms of non-metropolitan
geographic areas, the care must be provided by clinician of some sort,
the patient must be in a specific facility of some sort to receive that
remote care, etc., etc. And then the reimbursements topics are severely
limited.

What we would propose, as a recommendation, is to change that by trying
to change the definition of the clinical setting. And let me use the
following example. If you want to carry out a financial transaction, and
you had a requirement that to carry out a financial transaction with
your bank, you had to be in the proximity of your bank, face to face
with your banker, as opposed to the way we carry out financial
transactions today \-- and I\'m sure you all carry out financial
transactions the same way I do. I have auto deposit. I have a checking
account. I can transfer funds at any time. I have an ATM card. I carry
out all sorts of transactions in moving accounts around, without ever
going to my bank. In fact, I would suggest that most of you haven\'t
been to your bank recently. Have you? But most of you carry out
financial transactions.

So the proposal is to change the requirement that the patient be in a
specific clinical setting, change the definition of clinical setting to
the information collected diagnostic services provided and treatment
rendered. In the same way that all of the financial transactions I just
mentioned are, in fact, transactions that take place outside of the
physical setting. Redefining the clinical setting by the services
rendered we think can be an important movement forward in this area.

And Mr. Secretary, we think you have, at your disposal, the ability to
do that. And we heartily recommend you move forward in that direction.
Of course, taking into account the standard issues of fraud, abuse,
etc., etc., truth in advertising, against my guidance, that last
sentence was included here. I think that\'s a boilerplate guidance that
we tend to hide behind many times, because fraud abuse can appear in any
situation. But the committee felt that that should be included.

Following up on that recommendation is a secondary recommendation that
the conducting demonstration projects to determine the value of
telehealth. Again telehealth, again, is a broad generic term to include
all of these services we\'re talking about, but in clinical settings
beyond those listed in the federal statute. Clinical settings basically
defined here in terms of services rendered, as opposed to physical
location. We think that the redefinition of clinical setting is the most
important aspect of this recommendation.

If you move forward with this line of thought, and you look at Medicare
regulations that revolve around the whole issue of store and forward of
information, that is, for example, reimbursement of remote examination
of X-rays or remote radiography, the whole issue of store and forward of
technology can be translated back to remote diagnostics as well, and I
think we can all think of hundreds of examples of this.

My favorite one happens to be, in fact, if you\'re monitoring someone
for the onset of Parkinson\'s disease, there are very simple devices to,
in fact, monitor manual dexterity on an individual at home, record those
results on a routine basis, store those, and then forward them in blast
mode to a doctor for analysis.

The advantage of this are obvious. The individual doesn\'t have to go to
the doctor\'s office to be tested. He doesn\'t have to incur the
emotional strain of going to the doctor\'s office to be tested to impact
the test that you\'re running. You can do this on a routine basis, on a
daily basis, bi-daily basis, weekly, monthly, whatever. Collect that
information to monitor the onset of a disease.

That sort of store and forward technology can be used for many hundreds
of different examples. That sort of store and forward technology is not
reimbursable, with a few exceptions. Alaska and Hawaii are, I believe, a
few exceptions. And we think that we should, in fact, move forward to
see how that technology has been employed in the two places where it is
currently employed, Alaska and Hawaii, because of their remoteness; and
determine if these services should be expanded beyond those two states.
Also taking into account, obviously, the great expansion of technology
capability for remote monitoring from a store and forward basis.

So I think there is a huge opportunity in this space for the chronically
ill to, in fact, monitor chronic illness, collect information, store
that information, forward that information and then have remote
diagnostics carried out about that capability.

The last recommendation we have is also, we think, under the purview of
HHS at this point in time. The Medicare Advantage Plans cover about 19
percent of all Medicare employees, enrollees, and there is the
opportunity, under the Capitated Service Program of this, to, in fact,
reimburse for specific programs that are otherwise not reimbursable by
federal mandate.

And we think there is the opportunity here, to conduct demonstration
programs, through the special needs plans and the Medicare advantage
plan, that specifically evaluate the use of home based remote care
monitoring for the management of specific chronic illnesses. We think
that this can be done without any legislative change. It\'s already
covered by the rules and regulations of the system, and it offers an
excellent opportunity to promote remote monitoring of chronic illnesses,
thereby, keeping people out of hospitals, lowering costs, giving better
care.

Our group was fairly unanimous in their forwarding of these
recommendations. We hope that they are treated accordingly. Thank you.

DR. KOLODNER: Thanks, Craig. Mr. Secretary, did you want to make a few
comments?

SECRETARY LEAVITT: Thank you for the work, and may I say that I concur
with the conclusions that you have reached. I do think it will be
valuable to talk a little bit about what a recommendation means from
AHIC to the Secretary, and how we deal with these. Today AHIC will need
to decide whether we accept them, reject them or table them. From my own
view, all of these are AHIC acceptable. But it\'s important that I
acknowledge that when AHIC forwards those to the Secretary, that in many
cases, I\'ll be able to deploy, and not just have them accepted, but act
on them. In other cases, I will have to act on them by modifying them in
some way. In other situations, they won\'t be practical for reasons that
may not be entirely seen or even, for that matter, agreed with by
members of AHIC. But nevertheless, factors for me as Secretary.

I think on your first recommendation, for example, that\'s one that we
have a path forward on, 2008. It\'s clear that the chronic care industry
is making a lot of progress, progress that will speed our ability to act
on those, once they have been concluded, or once we get to that point in
our work plan.

With respect to changing the way we pay to acknowledge electronic
monitoring, and to focus on the delivery of the service as opposed to
the proximity, that makes a lot of sense to me. It would have a profound
impact on the business model of HHS. And I suspect everyone at this
table believes that it would, in the long run, maybe even the short run,
produce a net gain for HHS.

It is likely the way we\'ll have to approach is that is to say let\'s
find some demonstration projects to make certain what the impacts are. I
will point out that HHS is not the only payer. There are many others who
could and should begin to weigh in in trying to figure out why this
works, and one could ask the question why they haven\'t up to this
point. They\'re not constrained in any way by the regulatory
difficulties that HHS has to go through in order to set our standards of
pricing.

I do have the need to maintain budget neutrality, and consequently
because it \-- in government, we don\'t do with they refer to as dynamic
scoring, which is to say I know if I make certain changes, that I\'ll
save a lot of money down the line. They require that we have some clear
evidence, and consequently, we have to start off with demonstration
projects.

If I receive this recommendation, as I suspect I should, and will, I\'ll
act on it. But it will likely be by modifying it to find ways to
actually demonstrate it. And then I will be reaching out to those in the
\-- in the private sector and asking them to do the same thing. We have
to figure out a way to compensate physicians who interact with their
patients on email. There is just no alternative to that. We have to
figure this out, and it\'s not just HHS. It\'s the rest of the industry
as well.

MR. BARRETT: I would just point out, the Committee, in interviewing tons
of people, and seeing examples, we\'re relatively all convinced of the
possibilities in this area for improved care delivery and also higher
quality care delivery at lower cost.

The group did find it rather amusing when we came to realize that if you
are an average citizen in the United States, you fall into a
substantially different category than if you happen to be a member of
the armed services, an American Indian, a convict, or an astronaut.
Those four categories of people all have opportunities and capability
for remote diagnostics, remote consultation. If you\'re an average
American citizen, you do not.

DR. KOLODNER: I think Chip, first, and then Dr. Casscells.

MR. KAHN: I am sympathetic with the Recommendation 2.0. I guess I \--
and I don\'t know the process here. I guess I wonder, when you say
accept, table, or reject, is it the language that\'s written, or can we
make suggestions? Because it seems to me that the \-- well, let me ask
that question first.

DR. KOLODNER: Okay. The Workgroup acts on behalf of the AHIC and brings
the product forward. The AHIC can do whatever it wants and change the
wording in whatever way it wants, and that\'s what can go forward.

MR. KAHN: Okay. The wording that "the Secretary should develop legal
guidance that defines," I mean I think that the Secretary just sort of
outlined the question of demonstration, and I think even before you get
to demonstration, there needs to be sort of exploration here of the
possibilities of payment policy. Because the trouble is, particularly if
you\'re thinking in a budget neutral, with a budget neutral principle
underlying it, that you\'ve already got a stressed system and budget
neutrality isn\'t necessarily helpful, although I understand it\'s
mandatory.

So it seems to me that \-- and Adele and I were just talking about this.
Any kind of fee for service here, unless it\'s a hundred percent
co-payment, which maybe it ought to be, is not going to work. And if
it\'s one hundred percent co-payment, then does the government come in
and set a fee schedule? You don\'t want the government to set a fee
schedule because that\'s not market oriented.

I guess I\'m wondering, you know, you\'ve got have to some kind of
capitation model or something that you\'re going to experiment with, and
whether we should \-- it seems to me that you\'ve got to have more than
legal guidance. You\'ve got to have some policy development that has to
be done here. I would suggest that we expand this to say that there be,
you know, some kind of policy development because the legal \-- because
the legal guidance would be that you probably can\'t do it without
legislation, whereas if there is policy development, that could lead to
demonstrations which could lead to either legislative action eventually
or action if the Secretary did have any authority.

SECRETARY LEAVITT: I think that\'s right, but I want to emphasis what I
said before, and that is, it would be very helpful to us, for example,
if private insurers, who have less arduous standards, in terms of
changing their business model, if they were leading in being able to say
let\'s figure out ways that this \-- to demonstrate that this works, it
would be very helpful to HHS in designing our demonstrations and hence
our rule making \--

MR. KAHN: Well, we could throw in language saying working with private
sector. I just think there has got to be thinking done about it, and
it\'s not going to be \-- it can\'t be fee for service. It\'s just not
going to work. It\'s got to be something else.

SECRETARY LEAVITT: Well, the thinking does need to preceed the model,
but generally when we do a demonstration, there is a concept put on the
table. Some research that goes behind it, and then a period where the
action is taken and an evaluation. Now, it \-- so there is policy
development in that process. I welcome your additional language, and I
would like to say, I think this is a place where government could be
substantially assisted by private payers and providers. If you have ways
of doing this, show us the way. We will move \-- we\'ll have a big
impact when we move, but we\'ll move faster if we can be shown that, in
fact, this works and that the \--

MR. BARRETT: We did review a number of examples where the results are
positive, with net cost savings, which is really what drove the
recommendation. And the rationale for these two, 2.0 and 2.1, one is \--
2.0 is specifically targeted at a definitional change which broadens the
scope and broadens the availability of service.

SECRETARY LEAVITT: I understand, and it also broadens the avenues for
people to \-- for payment.

MR. BARRETT: Correct.

SECRETARY LEAVITT: And there will be a lot of \-- it would certainly
open a new revenue avenue for physicians if they could pay for e-mail,
and I\'d like to be able to get a hold of my physician on e-mail. We\'ve
got to find a way in which \-- what we\'re doing is actually improving
\-- not only improving care, but at the same time, determining how we
can do this in a way that\'s fair to both taxpayers, and doctors and
patients.

MR. KAHN: If I could just say one more thing. It\'s got to be \-- to add
to that, Mr. Secretary. When you look at policies, you can\'t ignore
Congressional Budget Office and OMB. They don\'t think at things like
normal people do. \[laughter\] So when you develop this, the trouble is,
we\'ll come up with something, and I have never seen anything like this
not cost money. I mean it just does. Because of the woodwork effect,
they will come up with all kinds of other economic \--

SECRETARY LEAVITT: That\'s stated \--

MR. KAHN: So we\'ve got to think about that.

SECRETARY LEAVITT: That\'s stated more clearly than I did. As a matter
of practice, this makes sense. And common sense tells you that if
you\'re doing this remote monitoring, that there are some potential
efficiencies, but we \-- before we change our business model in a way
that costs the treasury billions of dollars, we need to know what those
impacts are, because as has been suggested, it doesn\'t always save
money.

MR. BARRETT: And again, that\'s why we combine 2.0 with 2.1. 2.0 was to
define the change, 2.1 was, in fact, to carry out the pilot projects, to
see, in fact, what makes sense as you move forward.

DR. KOLODNER: In order to keep the conversation together, especially
with the challenge that the Secretary made, Justine, if you would like
to \--

MS. HANDELMAN: I just want to, Mr. Secretary, agree with what you have
said, and say from the Blue\'s point of view, we will certainly help to
put information on the table to evaluate what is going on, what is
working, and what the barriers are.

A year ago, BCBSA, together with AHIP \[America's Health Insurance
Plans\], did a survey of all of our members to find out what was going
on in the area of secure messaging, and reported that information back
to the Workgroup. And we certainly can follow up with more detail. There
are several more pilot projects among our plans going on right now. Some
of them very successful, some of them not as successful. Many of them
are paying, I think, a key barrier that we found with our plans that are
doing this, is how do you fit it into the provider workflow, and how do
you ensure that the patient, as well as the consumer, is comfortable
with this?

We've had a few plans on our end that have done this and actually had to
turn off the pilot program because they couldn\'t get a critical mass of
providers to actually want to do this, even though we were reimbursing.
So we do have continuous challenges. But at the same time, we have some
plans that have found some real benefit, and found some critical mass
where they\'re making progress.

But certainly I can commit to us going back to our plans, surveying \--
a year has passed since we did the last survey. It was more of a high
level, and getting some more detailed information, and certainly we have
pilots that are ongoing, and we can reach out to our plans and see what
more we can do.

DR. KOLODNER: And Justine, just to clarify, because we\'ve had two
different kind of conversations weaved together, one about the secure
messaging, but the other about telehealth. Do you have pilots going on
in both areas?

MS. HANDELMAN: We do in both. The survey last year was more focused on
secure messaging. We can broaden that. I can give you a good example. I
know in the Medicare Advantage Program, we have one of our plans that is
allowing the use of remote monitoring for congestive heart failure. And,
in fact, they've shown, I believe it\'s a 20 percent reduction in both
ER visits as well as inpatient hospital admissions through this. This is
a comprehensive disease management program which has one aspect being
some remote monitoring.

So we do have some information as well, and we have some pilot programs
going on, not only in the private sector but through Medicare advantage
because of the ability that they have to do some things in disease
management.

DR. KOLODNER: And then Tony, I didn\'t know if you had any comments to
make from CMS or I just want to make sure, given \--

MR. TRENKLE: Just a couple comments. One, I totally agree with Mr.
Secretary, some of the comments you made. Certainly we are restrained by
regulation and statute. In general, when we do change payment policies,
it\'s done through a process whereby we look at what\'s going on in the
private sector. We have certain processes in place. Then we do
demonstration projects, and as you said, it needs to be budget neutral.

Also want to point out with the Medicare advantage, we don\'t have the
restrictions, but it\'s also up to the plans to offer \-- to conduct
something like this in a demonstration area. So I do agree with your
conclusion about the role of the private plans as well. And also in the
Medicare population, of course, it\'s not as technology savvy as a lot
of the major other population groups. And I think that also needs to be
taken into consideration.

But that being said, I think there is a lot in the Workgroup's
recommendations that we need to take a closer look at, and see how we
can begin to move in that direction towards \-- within our processes
that we have.

DR. KOLODNER: We have five members who have indicated they want to make
a comment, and if they would do so, and we get this conversation tight
so we can get on to, what I think we really want to do, is the decisions
about the recommendations. And move forward to that. Dr. Casscells.

DR. CASSCELLS: \[unintelligible\] concurs, thank you.

\[laughter\]

DR. KOLODNER: Okay. Next, Gail Graham?

MS. GRAHAM: As I\'m sure Dr. Agerwal brought up in your Workgroups, VA
has a fair amount of experience here, and documented avoidance of
hospitalization; but a greater benefit to frequently keeping people in
their home that otherwise would have been placed either in intermediate
care or skilled nursing facilities. So I wonder if there is an
intermediate step here for \-- I think for those of us that are running
closed systems, whether it\'s a Medicare advantage or DoD or VA, we can
see the return may be more readily, and our population probably is
pretty comparable to the Medicare populations in age, and computer
literacy. And the devices, I know, have been made pretty simple, really,
so that they\'re broadly used, and that hasn\'t been one of our major
obstacles.

But I wonder if there is an intermediate step here to really compile the
lessons learned. I know one of the challenges we had early on was trying
to call ANA and others to try to get codes to depict this, so that we
could follow what it was, whether if somebody paid us or not, and I
understand that we\'re unique in that we want to track things, whether
anybody pays us. But just getting at that point of having a common
ability to track, and compiling all these lessons learned, both in
breakdown of avoidance of hospitalization, but what is \-- are there age
limiting factors in this, are there \-- is it more helpful in some
diseases than others. We would certainly be willing to participate.

MR. BARRETT: Thank you for bringing up the \-- obviously the major issue
here, which is the target of all of this is, in fact, to keep
hospitalizations down, catch chronic illnesses as they\'re deteriorating
early, and treat them as opposed to waiting until the hospitalization
occurs. So it\'s kind of the shift left mentality, shifting out of the
hospital into the pre hospital remote monitoring, catch it early and
treat it.

I know that\'s you can pay me now or you can pay me later argument, but
that\'s precisely what it is. The remote monitoring is relatively
inexpensive compared to a single night in a hospital for anyone with
chronic illness. And that\'s where the savings comes.

DR. KOLODNER: Adele Morris?

MS. MORRIS: I want to thank Craig and the Workgroup for these very
sensible recommendations, and I just want to add to our thinking about
the potential net benefits from some of these recommendations.

We haven\'t talked about the time that family members must take to take
their loved ones to see healthcare providers, and that\'s an economic
cost that doesn\'t appear on any budget, but it can be extraordinary,
both for those who miss work and for their employers. So my point is
that as the AHIC sets its priorities going forward, to have a very broad
view of what the benefits of society might be from these things, and not
to worry too much just about the particular budget implications of any
one particular initiative.

\[low audio\]

\[laughter\]

MR. BARRETT: Again, these are very rational, rational pragmatic
statements. I totally agree with it. We do recognize the budgetary
issues that you do \--

MS. MORRIS: And I work for the treasury, so I \-- \[laughter\]

DR. KOLODNER: So you\'ll pay for it. Kevin Hutchinson.

MR. HUTCHINSON: As one of those persons who have not stepped in to my
bank since establishing the accounts seven years ago, and since moving
down to the Virginia area from New York four and a half years ago, there
are no branches of my bank, in even the Virginia area. I wholeheartedly
support this concept of electronic communications, especially in
healthcare.

The one thing that I would ask us to expand our thinking on, and in the
recommendation 2.0, and actually Craig just touched on it, so it may not
even be expanding the thinking, is making sure we\'re all on the same
page with it, is this concept of advanced electronic technologies, and
the use through those advanced electronic technologies. We\'re not just
simply talking about traditional services. We\'re not talking about an
office visit that\'s handled just electronically, but you can really
take advantage of preventive services, and education and maintenance
services of those chronic illnesses, versus simply just the traditional
services that we think about from a reimbursement standpoint.

So from a demonstration project, things like making sure patients are
taking their medications, staying on their medications, or taking the
preventive test to ensure that they\'re catching things early on, I
think are more critically important as part of the demonstration
project, to prove the cost benefit you\'re looking for, versus simply
the \-- I can have an online visit with my physician as part of this.

DR. KOLODNER: Thank you. And Linda Dillman.

MS. DILLMAN: I promise I\'ll be quick. Secretary Leavitt, I would tell
you as a self-insured employer, I know we\'re small, we only cover a
million lives compared to what you have. We are all over this. And it is
part of our wellness program, Kevin, so we\'re not viewing it as
traditional healthcare plan.

Contrary to rumors, we also have to be budget neutral in our
environment; there's that bottom line focus. But we believe it will
actually be a positive impact, when you look at the total well being of
the associate. We can look beyond just the healthcare environment, and
look at things like how well are you, what is productivity, what does it
do to sick days? But everything we learn, we will share. Very happy to.

DR. KOLODNER: At this point, why don\'t we bring up, as I think we have,
Recommendation 1.0, and the \-- is there any further discussion about
the wording or any other aspects to this recommendation that the members
would like to make? If not, those in favor of accepting the
recommendation \--

MR. BARRETT: I\'m one step ahead of you. I assumed they accepted it. No
comments.

\[laughter\]

DR. KOLODNER: You want to drive this?

SECRETARY LEAVITT: Is there any disagreement with this? Then I think by
consensus we\'ll assume it\'s been adopted, and I appreciate the
Workgroups. My comments earlier, and I think it applies to not only this
one, but future Workgroups. When your recommendation comes to HHS to the
Secretary, and we don\'t \-- and I don\'t run right out and draw a
regulation redefining the nature of work, I don\'t want you to believe
or think that your recommendation wasn\'t taken seriously. This is a
serious recommendation, and I agree with it. It\'s \-- but we aren\'t
\-- we\'re not in a position to run out and make a decision like that,
unilaterally, without going through the process of testing and
understanding what it\'s impact will be.

And I\'m using this one because it\'s \-- it\'s illustrative. There is a
reason that the Blues and Aetna and United and Wellpoint and all of the
other major insurers haven\'t just changed their regulation and allowed
doctors to start using remote monitoring, because they don\'t understand
yet what the full impact will be. And that there must be, in this, some
\-- as much logic as there is here, that there would be \-- it would
keep people out of the hospital. There must be other factors that
complicate this, and we just need to understand them. And we will move
aggressively on this recommendation. But you likely won\'t see a full
change in the regulation between now and our next meeting. That\'s the
only point I wanted to make.

DR. KOLODNER: And actually, as we step through, the Recommendation 1 was
for use case, which is actually a recommendation more to the AHIC than
it is to the Secretary, because the AHIC prioritizes those, but we will
remind you of that when we put the next ones through. We have actually
the Recommendations 2.0, 2.1, 3.0 and 4.0. And the question is whether
you want to step through those or \--

SECRETARY LEAVITT: I had assumed you were going to send all of them to
the Secretary as recommended by the Workgroup.

MR. BARRETT: I\'m done.

\[laughter\]

DR. KOLODNER: Craig is not waiting for a no.

MS. DAVENPORT-ENNIS: Secretary Leavitt, I would like to make one
comment. I think as we are shifting responsibilities to consumers and
engaging them more directly in the therapy, that as we look at the
Recommendation 2.0 that we have just passed by acclamation and full
consensus of the AHIC, that there is the opportunity to amend the last
sentence, to add one phrase. It would simply read, as well as benefits
to consumers with cost sharing identified within the pilot.

I think to the point made earlier, that consumers understand the
financial advantage to families if e-health could, indeed, be available,
and that cost sharing for consumers would probably be supported in that
particular area and would be helpful in that budget neutrality.

DR. KOLODNER: Now, would you be talking about both 2.1 and 4.0 for this,
the \--

MS. DAVENPORT-ENNIS: And 2.0.

DR. KOLODNER: So 2.0, 2.1 \--

MS. DAVENPORT-ENNIS: Yes.

DR. KOLODNER: And 4.0?

MS. DAVENPORT-ENNIS: Yes. I think consumers are understanding more that
they do have a responsibility within the area of cost, and that this is
a savings to families when they can actually stay at home and have the
benefit of e-health technology.

MR. BARRETT: I would just presume that there is ultimate flexibility in
terms of any reimbursement program, in terms of co-pays, cost sharing,
what have you; and that that would logically come out of the
deliberations and the pilot programs you would run.

MS. DAVENPORT-ENNIS: And I think the only amendment, Craig, to your
comment would be that on behalf of the patients that we represent, we
would strongly urge that it not be at a 100 percent co-payment for these
services. Thank you.

DR. KOLODNER: So just so I\'m clear in terms of the recommendations for
moving forward, we can either have it with your comments reflecting and
informing the recommendations, or are you suggesting we still need to
modify the recommendations?

MS. DAVENPORT-ENNIS: I think my recommendation can stand, and Craig\'s
recommendation that it be with the full flexibility possible, and my
further amendment that hopefully we will not be at one hundred percent.

DR. KOLODNER: Okay. We\'ll next move to the next Workgroup
recommendations, and that\'s the Electronic Health Record Workgroup.
Lillee, you will be presenting to us.

MS. GELINAS: Thank you, Dr. Kolodner and Mr. Secretary. Hopefully, this
will be a bit briefer, but Craig, you did a great job. Jonathan Perlin
sends his regrets that he was unable to be here, but he wanted to make
sure that I let you all know that he\'s fully in support of what it is
that we\'re trying to bring before you today.

The materials are under tab six in your notebook for this segment of the
presentation. I do I want to commend the ONC staff, though, because I
think being able to have the preparation work, the AHIC recommendations
across our Workgroup, you\'ll notice under your tab six, there are the
slides, the additional letter that John and I are sending to the
Secretary, the April 24^th^ original letter that was in your notebook
from the last meeting, so you didn\'t have to go dig for it. Thank you
very much.

And then the recommendations. This is extremely well done. If you look
at the EHR recommendations on what we have been able to accomplish so
far, there were eight recommendations; five are done, one is on target,
two have some progress. I\'m not a mathematician, but I think five out
of eight is a pretty good percentage.

To get centered on this work with the Electronic Health Record Workgroup
and what we\'re trying to do, I want to just call your attention to the
major accomplishments document that several of us got, I believe at an
AHIC meeting, several meetings ago, perhaps in December, but there is a
quote on the back of this document, and for those watching over the web
or in the audience, this is very easily downloaded from HHS.gov.

But the Annals of Internal Medicine citation has been cited many times
in the private sector. A study found that 80 percent of medical errors
began with miscommunication, missing or incorrect information about
patients, or lack of access to patient records. Lack of access to
patient records. So I want to get us centered on this work, referring to
that outstanding piece.

As you know, we presented at the April 24^th^ AHIC meeting, remembering
that all the Workgroups are functioning under five major areas that
we\'re trying to make recommendations around. Just as a reminder, those
are business case alignment, workflow and cultural concerns, medical
legal issues, privacy and security, and state of the technology. Let\'s
not forget that our conversation here is around EHR adoption and
physician practices. We are moving now into hospital settings. But
whether you\'re talking about the physician practice or the hospital,
the adoption rate is very low.

It was intriguing to us to hear testimony that in the ambulatory
physician practice area, only nine percent of physician practices have
adopted EHRs, and in the inpatient setting in hospitals, only ten to 20
percent. Now, I want just to get your attention with the fact that if we
look at the prevalence of electronic claim systems, physicians offices
are at 80 percent, pharmacies are at 93 percent, and payers are at 94
percent. So I guess we could say that we can get the bill right, but
harm the patient or worse, and not know it.

So, we are back before you with the recommendations that were sent back
to us. I\'d like to remind you and thank you that you did accept
Recommendation 2.0, which was the workflow and cultural concern
recommendation and Recommendations 3.0 and 3.1, which dealt with medical
legal issues. So thank you that those three were accepted at the
meeting.

But you did ask us to go back and reconsider 1.0, 1.1 and 4.0. After
spirited discussion, and Mr. Secretary, I think you may have missed some
of that spirited discussion, but it was very healthy discussion, and our
Workgroup spent the majority of its May 22^nd^ meeting trying to clarify
and bring the detail that AHIC was requiring. And just to give you an
idea, this is the transcript from our May 22^nd^ meeting, and I just
want to represent to you the outstanding work our Workgroup did. They
were fully onboard, and really appreciate the hard work we considered.
By the way, that was our 16^th^ Workgroup meeting, and I really want to
commend the robust participation we continue to have.

So we are now pleased to present to you our updated versions of 1.0 and
1.1, and we have given you an additional recommendation, 1.2, that\'s in
support of pay per use program evaluation. I want to also make it clear
I\'m not dealing with 4.0 today. We continue to deliberate and are
moving forward with a process for public input, and we plan to bring the
final recommendations to you later around that particular
recommendation.

I\'d also like to point out, as we consider our business case alignment
recommendation that Dr. Brailer summarized the Electronic Health Records
Workgroup discussions in our last AHIC in our transcript, and he said,
am I hearing that there is not opposition of EHR in pay for performance,
it\'s that it should be written more broadly. And I think as an AHIC, we
agreed that it was going back to be written more broadly and for
clarification.

We also, as a Workgroup, received information from AHRQ, around the
number of patients that are currently covered, operating in a pay for
performance environment. In 2005, there are about 50 million Americans
whose healthcare coverage was operating in a pay for performance
environment, and by 2008, there will be 80 million Americans, at least,
operating in a pay for performance environment.

So given that, we brought 1.0 back to you, to read, "As the federal
government develops languages and its contracts with health plans and
insurers to support the wide spread adoption of HITSP interoperability
standards, this language should foster, to the maximum extent possible
within existing authority, the use of financial incentives or pay for
use programs to incent the adoption and effective utilization of
CCHIT-certified EHRs. Structural measures should be included in these
programs, which may be limited to a specific timeframe with the ultimate
goal of using process and outcome measures to assess performance."

Now, your particular version says not mandate. If you\'ll notice, your
version says, "This language should foster and not mandate." We had
suggested that we make that language positive wording, not negative
wording. Not mandating had some negative connotation to it. So the
recommendation was that we say, "To the maximum extent possible within
existing authority, given that government entity certainly have legal
restrictions." We were trying to put as much emphasis there to reflect
what the Workgroup wanted, around fostering. And foster seemed like a
weak word. So the language we put in front of you is around the use of
financial incentives, but maximum extent possible with existing
authorities.

1.0 coming back to you deals with vetting national quality forum
structural measures when they become available. So this language has
been changed to say these pay for use programs should use reliable,
standardized, and validated tools which are currently available to
assess structural measures. For example, the NCQA\'s physicians practice
connections, or CMS\'s publicly available office system survey. When the
NQF endorses a set of structural measures, these should be employed by
these programs.

So we took MedPAC out of there and added NQF. And then this is the new
one for you, 1.2, HHS should evaluate pay for use programs with respect
to quality, cost and adoption, and we look forward to seeing that
evaluation. I think it will greatly inform our work. So Dr. Kolodner,
back to you. Those are our three recommendations; I hope they are
satisfactory, and given the broad input of the Workgroup are meeting the
needs of AHIC around these regulations.

DR. KOLODNER: Thank you, Lillee, and we\'re now open for comments and
questions.

MS. GELINAS: Did we hit the mark?

SECRETARY LEAVITT: Let me make a comment.

MS. GELINAS: Please.

SECRETARY LEAVITT: The issue of how we pay for this is obviously one
that the industry has struggled with for some time. And there is no
question that at least in the early stages, there is a disconnect
between those asked to make the investment. And I think what you said
was correct about when there are incentives, people respond. If there is
one area higher than claims processing, where we have employed
automation, it is in the software that optimizes Medicare payment.
\[laughter\] I think if I\'m not mistaken, we may have achieved 95, 98
percent of the physicians who have a system that will help them optimize
their billings to Medicare. So we know incentives work.

We\'re going to have to see the macroeconomics of this change over time,
and the question is, who bears the burden of it? And how do we go about
it? I will tell you that we\'re engaged \-- I\'ve had conversations
with, I think, eight of the largest insurers in the last little while to
say to them, we need to form some demonstrations where we can provide
incentives that will begin with some kind of pay for use.

But quickly, my grade from pay for use to pay for reporting, and then
pay for performance. We can\'t expect to always just go from nothing to
pay for performance. There are lots of steps in between.

So I\'d like to say to the Workgroup, thank you for your recommendation.
I think it is clearly addressing the right problem. It\'s unlikely that
we\'ll see any system go from where we are today to pay for use. But I
think it is quite likely that you\'ll see, in fact, that we have now in
the market just starting in four metropolitan areas where HHS is going,
essentially, pay for use, using AHIC systems that are CCHIT certified.
That\'s in four markets.

We\'ll likely deploy one very soon that will deploy that into many other
markets. I have invited the major insurers to do things on their own
that would mirror that. If we end up with a dozen markets where we are
starting with pay for performance \-- pay for use, migrating to pay for
reporting and then going to pay for performance, we\'re likely to see
that change.

So as you advance these to the Secretary, may I say, I think they\'re
the right recommendations. I\'d like you to know that our response to it
will likely be to deal with demonstrations and we\'re going to invite
the rest of the payer community to join with us.

MS. GELINAS: That\'s great counsel as well, but the gnarly discussion
around pay for use in the Workgroup is what is use. Does it mean you\'re
on a computer? Does it mean that you really used to it improve
healthcare? There is that range of \-- it\'s the semantics, it\'s the
terminology, and we greatly respect that.

SECRETARY LEAVITT: When I was governor, we were going through this with
a number of state functions, trying to allow people to \-- one in
particular that I remember, we did 106 different functions that people
could access online, and each one of them involved a lot of
collaborative efforts and changes in business model.

The one I remember, it was licensing of automobiles, registering
automobiles. And I went into register my own, and discovered that we
were charging \$4.50 to do it online. I asked the question, doesn\'t
this save us money? Why are we charging the customer \$4.50 in order to
save us money? Shouldn\'t we charge them \$4.50 less if they\'ll do it
online? Well it turned out there was a rather peculiar problem with
credit cards, and that the state law would not allow \-- we had not
budgeted for credit card charges and consequently, we had to charge
extra for it. We got the law changed and we were able to remedy that
problem.

But the principle here is that once we discover a way in which
interacting with providers, or hospitals and doctors, in particular,
save us money, we ought to be, then, willing to share that. And \-- but
we\'ll initially go in this gradual process, I think, until we can get
critical mass. Chip.

MR. KAHN: I really appreciate what you just said, Mr. Secretary, because
I think at the end of the day, all of the benefits from where the EHR
will lead will go back to the patients, and to the premium payers, and
that\'s where they ought to go. But at the same time, that\'s one of the
problems with federal policy, where everything has been to be budget
neutral, is that at the end of the day, you\'re going to take money away
from the hospitals, because hopefully there will be less
hospitalizations, and you\'re going to take money possibly away from
physicians, because hopefully there will need to be less encounters,
which is a good thing. But on the other hand, there are going to be
expectations about the hospitals and the physicians and the providers
having all the technology, which has capital expense.

So there has got to be a balancing found in this, because at the end of
the day, one man\'s loss in revenue may be great, but \-- I mean to
achieve, but at the same time there has got to be that sharing part that
you bring up in terms of the premium payers and the taxpayers, with
those that you\'re asking to do something, that\'s going to cost them
money and lose them revenue, if it all works, not save them money.

SECRETARY LEAVITT: We\'re going to have to go through an evolution to
change the macroeconomic equation. I just don\'t think we\'ve figured
out quite how to do it. I think if we had gone back 15 years ago and
said, look, the Internet is the thing. And everybody needs to have
Internet. And if you\'re going to do business in the future you've got
to have it, and, therefore, Congress ought to pay for everyone to have
it. We would still be in 1995. 1985. But what occurred was the
macroeconomics began to change, and people found way to save money, and
the market rewarded them, and consequently, here we are in 2007, and you
can\'t do business without the Internet. And the government doesn\'t pay
for it. The economics of what has occurred in that process.

All of us have to believe that there are huge savings here, or we
wouldn\'t be here. And it\'s a function of how we transition the
macroeconomics to the point that you can\'t do business without having
health IT. We\'re not there yet. There are many people who challenge
that you can do business with health IT in a smaller practice and make
it work.

So this is about finding that process of changing the macroeconomics of
the system and I agree, Chip, it\'s going to require a little bit of
risk and reward being balanced, and over time, we\'ll make it.

MS. GELINAS: And not just cost. It\'s the quality piece. Is there one
more comment? Kevin?

MR. HUTCHINSON: I was just going to add to take one healthcare process
where this has already been deployed in a private industry mode, which
is around prescribing. And we\'ve seen a number of payers in the last
six months begin to deploy, not just simply giving away devices, but
encouraging and putting incentives in place for use of those devices.

And not only the uptake in the number of physicians that are beginning
to adopt those technologies for electronic prescribing, but also the
number of prescriptions that are written electronically versus by paper,
by an individual physician, because it is focused on use. We\'ve seen a
dramatic improvement, even in physicians that have been using the
technologies for some time now. They are now part of programs. They\'re
focused on incentives for use. So by deploying this in other
environments, because prescribing is just one process. It\'s done in
electronic health records, it\'s done in standalone e-prescribing
applications. I really do believe that all three of these
recommendations are something that we, as an organization, should adopt.

SECRETARY LEAVITT: It will be happily received by the Secretary.

DR. KOLODNER: Are there any objections to the three recommendations that
have been advanced? If not, they are accepted by consensus.

MS. GELINAS: Thank you.

DR. KOLODNER: Thank you, Lillee. At this point, I\'d suggest that we\'re
close enough to the end that we push on and have the last of the
Workgroup presentations. If you look at the agenda, we\'ve even had a
review by the co-chairs of the \-- of two of the three recommendation
reports that we were going to do as well. So unless there is any
objection, we will move on forward and go to what should be an early
conclusion.

And joining us now for the presentation of the recommendation from the
Confidentiality Privacy and Security Workgroup is Kirk Nahra. Welcome,
Kirk.

MR. NAHRA: Thank you very much everybody. I will also try to be brief
today. We\'ve had one new member on our Workgroup. You can see from \--
I guess towards the bottom of that, from the Hawaii Department of Health
bringing to us a genetics focus. So that\'s been a nice addition.

Let me move on to the focus of what we wanted to talk about today, which
is two related recommendations, which we think will move us pretty
significantly forward on some of the bigger picture issues that we have
been trying to address. We got started as a Workgroup. We had tried to
focus on some smaller issues so that we could get ourselves going, and
we quickly found we were getting so many inquiries on so many issues
that were bigger picture, we wanted to try to move forward in that
direction.

So let me just read quickly the current recommendation. "All persons and
entities, excluding consumers, that participate directly in or comprise
an electronic health exchange network, through which individually
identifiable health information is stored, compiled, transmitted,
modified, or accessed, should be required to meet enforceable privacy
and security criteria, at least equivalent to any relevant HIPAA
requirements."

Well, we have taken to calling this the essential level playing field
idea for participating in these networks. We found, through our
research, and our testimony, that there obviously are a large number of
entities who participate in these networks, who were not, in our mind,
appropriately covered by the HIPAA rules. We had certain, for example,
providers who, just by nature of how the HIPAA rules were defined, were
not actually covered entities. We found certain entities such as the
networks, themselves, who might be technically be business associates,
but they sort of turned the business associate model on their head,
because they were really in charge more than proceeding a service. We
also had certain kinds of entities. Some of the PHR vendors, for
example, who had no particular connection to the HIPAA environment.

So our proposal here is that essentially anyone who is directly touching
these networks should be required to meet a level playing field baseline
standard that is at least equivalent to the HIPAA rules. So that\'s
essentially our core recommendation that sets out the baseline.

Now, a couple of things that I want to say what we\'re not doing. This
is not a criticism, one way or the other, of the HIPAA rules. We are not
trying to make any recommendations about HIPAA. Overall, we\'ve tried to
focus, obviously, on this particular environment, so I think that\'s
important.

Now, let me also move to the second part of our recommendation. And it
really is a second part of it, which is \-- and I won\'t read this one
necessarily, but the idea here is that again, under the HIPAA model,
there are obviously people who are considered business associates to
covered entities, whose obligation is to meet a contractual standard.
Our sense, and the recommendation of our group, is that if people are
participating directly in the network, in a role as a business
associate, we want them to have the same level playing field standards
as the people who are covered directly by these rules; so that we
suggested for this environment \-- again, this is not a criticism of the
existing HIPAA business associate structure, but we thought that in this
environment, to have a level playing field, we wanted to make sure that
all of the participants, again, who were directly touching the network,
would have to meet the same kinds of standards.

Now, just to be clear, we had a lot of discussion in our Workgroup. This
does not mean that everybody who might, in fact, be a business associate
would have to follow these rules. For example, traditional business
associates \-- I\'m a lawyer with a law firm. If I\'m a lawyer working
for a hospital or health insurer, and I happen to get information, some
of which might have come originally from one of these networks, I\'m not
covered by that kind of a rule, because I\'m not directly touching the
network. I\'m not going in and out and gathering information from the
network. So this was not an effort to make all business associates, who
receive any kind of information, covered by this, but the people who are
directly participating in the networks would be covered by that level
playing field baseline standard. So that\'s essentially our
recommendation at this point.

What we\'re going to be doing next, which I think is also important, is
to look at two key sort of offshoots from these recommendations. First
of all, we have recognized that not everyone who participates in these
networks are identical for all purposes, under the HIPAA baseline
standard.

For example, under HIPAA today, there are some rules that are not
applicable, for example, to clearinghouses. There is no point in a
clearinghouse giving a privacy notice to everyone whose information
flows through the clearinghouse, because the clearinghouse has no
relationship with individual patients. They don\'t \-- no individual
patient knows that their information is going through a clearinghouse,
so they\'re largely exempted from the privacy notice rules.

We\'re going to look at the different categories of entities that
participate in these kinds of networks to see whether there are any
particular part of that baseline that are not relevant to particular
kinds of entities. And that\'s going to be one of the categories of
testimony that we\'re going to be seeing in our next hearing, which is
later this month.

The next step, which frankly we expect to be the most controversial
piece that we will be looking at, if you go back to our original
recommendation, we said the baseline standard should be at least the
HIPAA standard. Our next step, which we\'re going to start taking
testimony on in our hearing in June is whether the baseline should be
something more than HIPAA. Now, again, this is not intended to be a
question about is HIPAA good enough for what it serves. What we\'re
going to be focusing our attention on is, is there something different
about this environment. Is there new rules, new participants, something
significant enough such that the baseline standard, that everyone will
need to meet to keep the level playing field, we\'re going to look at
whether that should be higher than the HIPAA baseline.

We don\'t have a view on that at this point. I think it\'s fair to say
that there are some people on our Workgroup that think the answer is
easily yes, there are some people who think the answer is no. So we\'re
going to be trying to build testimony to see whether there are
sufficient kinds of differences in this current environment, from what
HIPAA covers, to recommend that the baseline standard be higher than
that.

So that is essentially what we\'re going to be covering. That is our
recommendation, and gives you a sense of what our next steps are, and
I\'d be happy to answer any questions related to that.

DR. KOLODNER: Okay, we\'re looking for comments and questions. And first
Tony, then Craig.

MR. TRENKLE: I was wondering what you meant by enforceable privacy and
security criteria, since obviously HHS would have no statutory authority
to do anything beyond covered entities.

MR. NAHRA: That\'s a fair question, and it\'s a question that we
explicitly left open, which is, we did not view our recommendation as
something that could be just adopted and implemented, per se. There
would need to be some kind of change in the future. We did not recommend
whether that was a statutory change, whether it\'s development of HHS;
could, for example, come up with a rule related to participation in
these networks. We don\'t know what that step is going to be.

There clearly is going to need to be some kind of step. I agree that
it\'s not something that you can wave a wand at today and say, aha,
HIPAA is now different. That\'s \-- and that was clearly part of our
process, was recognizing that there are what we saw as gaps in HIPAA in
this context that came up for reasons unrelated to this. For example,
the idea of some healthcare providers, if they don\'t happen to bill
electronically, not being covered by HIPAA at all. You know, you
wouldn\'t start from scratch with this system and build a rule that way.

So we do recognize that there is going to need to be some kind of
implementation step, and we did not make a recommendation on what that
would be. But we think it\'s a rule or a statute, not simply policies,
not simply best practices. And for business associates, it\'s not simply
contracts to be enforced.

MR. TRENKLE: It couldn\'t be best practices, because we don\'t have any
legal authority to do it.

MR. NAHRA: Correct.

DR. KOLODNER: Craig?

MR. BARRETT: Can you remind me the formal definition of a health
information exchange network?

MR. NAHRA: Fair question. We \-- well, we struggled with how to define
sort of what our mandate was. We didn\'t want to say it\'s \-- for
example, we didn\'t want to limit it just to PHRs. We didn\'t want to
limit it just to EHRs. So we tried to \-- we tried to use that phrase as
essentially a proxy for what\'s often called the NHIN, but we\'re
recognizing that there's also state versions, regional versions, so
it\'s the type of entity that is the NHIN.

MR. BARRETT: So I want to see if I understand this. If I\'m a doctor in
Darby, Montana, which is a small community of about 400 people, 75 miles
south of Missoula, and I participated with an emergency room hospital in
Hamilton, Montana, who may participate and communicate with somebody
else, is that part of an electronic health network? And if so \--

MR. NAHRA: Well, I\'m not sure I understand the example.

MR. BARRETT: I\'m really intrigued by the comments here, which stored,
compiled, transmitted, modified or accessed, and what I\'m trying to do
is to get you to a remote location where information is being
communicated from that remote location to someplace else, and ask you if
every local telephone company, etc., etc., is HIPAA compliant.

MR. NAHRA: Well, that\'s certainly not our intention to go that far.

MR. BARRETT: But, okay. I read, "through which individually identifiable
health information is stored, compiled, transmitted, modified or
accessed," and by golly, if I do any of that over the Internet, I go
through, as you well know, a zillion possible routes to get from A to Z.

DR. KOLODNER: Craig, I think that it\'s not network in the sense of the
technical network. There is an organizational \-- the idea is that there
are, in communities around the country now \--

MR. BARRETT: You may be answering my question. It\'s got nothing to do
with the network?

MR. NAHRA: Computer network, yeah. It\'s not the computer network. The
idea \-- we had, in some of our earlier drafts, we used the NHIN name.
People said, well A, that doesn\'t really exist yet. B, there are lots
of other state and local variations on that. But it\'s essentially like
the NHIN. It\'s the \-- or you can use a RHIO as a model. The RHIO
organization would be a network that would fit this.

MR. BARRETT: Okay, I just want to register a concern that if, in fact, I
read this literally, my doctor in Darby, Montana is going to access this
network from a very remote location, it\'s going to go through all sorts
of entities to transmit that information that you don\'t want to be
HIPAA compliant.

MR. NAHRA: Well, let me be clear about that example. I mean if that
doctor is getting into a network, I don\'t \-- our view is, we don\'t
care where he\'s getting into the network from. Today it is possible
that that doctor, if he or she does not bill electronically, does not
have to follow the HIPAA privacy rule. That\'s \-- again, that\'s a
remnant of how the HIPAA privacy rule developed from HIPAA
administrative simplification.

Our recommendation is that in this environment, that distinction
doesn\'t make sense, and that that doctor, accessing the network, this
regional health information network or the NHIN, is no different than a
doctor in any other place. The other doctors, if they happen to bill
electronically, already would have to meet these standards. We want to
make sure that there is not someone who doesn\'t have to meet those
standards, simply because of the accident of how they bill for their
patient treatment.

DR. KOLODNER: I think you\'re using \-- and this is the issue of the
terms. What we can do is to see maybe what sort of clarification we can
get in passing it forward. It\'s not the communication and
telecommunications network. It is a network of individuals, and
companies, and others working together to exchange information.

MR. BARRETT: I understand you want the doctor to be HIPAA compliant. Do
you want the local telephone company to be HIPAA compliant.

MR. NAHRA: Okay.

MR. BARRETT: Okay. As worded, you are requiring that.

MR. NAHRA: Well, we\'re not intending to cover that. I appreciate the
questions, and we can try to come up with a better definition. Part of
our difficulty was that we had originally used that NHIN phrase which
isn\'t, necessarily, at this point any better defined. So the idea,
which is spelled out a little more in the letter that accompanied the
recommendation, is again, whether we call it NHIN, we call it the RHIO,
it\'s that model. It\'s that exchange that we\'re trying to cover. And
again, the idea is level playing field.

DR. KOLODNER: Next we have Kevin, and then Nancy.

MR. HUTCHINSON: We\'re one of these networks, I assume, that would fall
under this criteria, because we\'ve got over 95 percent of the
pharmacies in the United States on the network, exchanging medication
information, PHI information, so it may be helpful, because I agree with
Craig\'s comment. The way it is worded is you could take it all the way
down to the telephone switch packet type level. Because that is how the
information is ultimately getting there.

But maybe it is for an entity for the purpose of routing, like a
SureScripts type entity, that actually our purpose is to do business for
the routing of this information. I actually may surprise you, but I
would support both of these in the sense that we do view ourselves, even
though we don\'t fall under the official guidelines of HIPAA, that\'s
how we operate, as if we do. And in fact, every software company, and we
have hundreds of software companies contracted into the network, are
required to do business associate type of agreement to pass that
through.

The one concern that I do have, and you\'ve touched on it, that is a
follow up item is to understand the relevant HIPAA requirements, and the
definition of relevant, because as you know, not being a care provider,
there is many aspects of HIPAA that would not pertain to an entity
that\'s not actually providing care. So we just would need to be very
careful in the follow up. And again, I would support both of these
recommendations and put our company underneath that requirement. But the
definition of relevant is very, very important.

MR. NAHRA: And let me address a couple of these things. We heard
testimony from a number of companies, SureScripts included, frankly.
There was a witness from SureScripts. And all of \--

MR. HUTCHINGSON: Can you give me the name of that individual?

\[laughter\]

MR. NAHRA: It was brilliant testimony. It was by far the best testimony
we heard. \[laughter\] We were concerned that some of the companies
would come in and say, we can\'t do this, this is going to be a major
problem. All of the companies that testified, in fact, said they were
already holding themselves out as meeting those standards. So we didn\'t
view this \-- I mean that was a good thing. I\'m not sure if they had
come in and said we don\'t want to meet them, that that necessarily
would have changed our recommendation, but it made much easier, when
everyone was already saying that they both were meeting it, and they
felt that they had to meet it for competitive purposes, and to be in
this marketplace.

The idea of relevant is very much \-- that\'s clearly a next step. Now,
our assumption is that it\'s going to be essentially meet all standards,
unless there are particular ones that don\'t make sense. So it\'s going
to be sort of an opt out kind of thing. We\'re not going to be starting
at ground zero and say, all right, you got to do this one and this one.
It\'s going to be, you follow everything unless we decide there are a
handful of things that you don\'t meet.

Privacy notices being, I think, the most obvious one, which is, as I
understand your model, for example, it wouldn\'t really make sense to
give an individual patient a privacy notice just because some of their
information happened to flow through your business. There may be other
pieces as well. That\'s clearly \-- we have not made any recommendations
on that, other than we know that that\'s going to be one of our next
steps. As I said, we\'re starting taking testimony June 22^nd^ with two
of the panels will be addressing that specific topic.

MR. HUTCHINSON: You said the end user provides that privacy notice, the
pharmacy and the physician in that particular case?

MR. NAHRA: They would do that today, correct. That\'s right.

DR. KOLODNER: Nancy?

MS. DAVENPORT-ENNIS: I just had a couple of questions. As the first
sentence reads, "All persons and entities excluding consumers that
participate directly in or comprise," well, indeed, the consumer is
going to participate directly in. And if they\'re participating with
someone currently not defined as a business partner within the HIPAA law
and constraints, that consumer, indeed, may not enjoy enforceable
privacy and security. And so I wonder if, in the earlier discussion,
when we were talking about the fact that what this recommendation is
trying to get to is really a network, that you want \-- that would be
governed by these privacy and security criteria, as identified, if
perhaps it would be better to omit the word excluding consumers, and
just cast the language again, so that it more clearly defines your
addressing participants within a network.

MR. NAHRA: Well, I guess our group had exactly the opposite concern,
which was, we want \-- if we took out excluding consumers, there was a
sense that an individual patient now is obligated to follow enforceable
privacy and security standards, and that the individual patient could be
prosecuted. We wanted to say, no, we\'re not talking about the level
playing field and all of these rules being applied to individual
patients. So that was the goal of taking in that \-- including that
language, was to make sure that our recommendation was not read as
saying just because I, you know, I use the network to get to my PHR,
that I now, as an individual patient, have to follow these rules.

MS. DAVENPORT-ENNIS: I think historically, within the Consumer
Empowerment Working Group, since the first meeting that we had, we have
been on record as extremely engaged on what the language needs to be
that assures that consumers, using this process and these programs, do
have privacy and security protections; and that for those of us, and
many in this room, know HIPAA far better than I, but we are aware that
currently, there are areas where patients can be vulnerable, that
they\'re not, indeed, dealing with a business partner. So I think what I
will look forward to is the recommendation that may be coming from you
after you have future hearings on the matter, that will identify, more
specifically, what protections and safeguards will be for consumers.

MR, NAHRA: And again, I guess maybe I wasn\'t clear earlier. I mean your
concern was exactly what drove some of this recommendation. For example,
we were very concerned about consumers who would, without going through
a hospital or a health insurer, build a PHR, and that that PHR would be
linked up to the networks. Absolutely. Today, that PHR vendor is not
required to follow anything related to HIPAA. This recommendation would
say, yes, that PHR vendor does, in fact, have to follow HIPAA. It would
give you exactly the kinds of protections that are not there today.
That\'s a core purpose of this recommendation.

And our next step is going to be to say all right, we've now brought the
PHR vendor, for example, up to the same level that a hospital, who has
an EHR would have to follow. Is everyone going to get lifted up again?
But we\'ve lifted that PHR vendor from zero to a HIPAA baseline, to give
the patients exactly the protections you\'re talking about.

MS. DAVENPORT-ENNIS: I think you\'ve done a good job with that. I
certainly understand what you\'re saying. And I guess because we\'re
very patient focused and consumer driven, we would enjoy recommendations
that do characterize very succinctly, the advantage to the consumer. I
do appreciate how the recommendation is written, and can certainly
support it as written. But would like to see, in the future, further
clarification for the consumer.

DR. KOLODNER: Any other comments or questions?

MR. HUTCHINSON: One question.

DR. KOLODNER: Yes, Kevin.

MR. HUTCHINSON: So what\'s the enforceable mechanism that\'s going to be
used for these two recommendations?

MR. NAHRA: Well, that was what Tony\'s question was. We did not make a
recommendation on what that should be. We clearly recognized there needs
to be another step. Our group \-- neither our group nor the AHIC nor \--
well, I mean HHS may have some options, but we can\'t just wave a wand
and make this happen. Now, the easiest \-- I mean the most
straightforward way, I don\'t know if it\'s easy because of politics,
but \-- would be a new law. A law that\'s relevant to this situation. I
don\'t know if that\'s viable, we haven\'t made a recommendation on that
one way or the other.

There may be a possibility, again, depending on how the AHIC\'s overall
activities evolve, to have a rule that defines the NHIN, for example,
and defines participating in it, and says, we\'re going to apply these
rule to everyone. That\'s another option, but we did not go down that
road, at this point, as to what that standard should be, other than to
say we don\'t think general industry best practices, voluntary \--
that\'s not enforceable, from our perspective.

DR. KOLODNER: Any other comments or questions? Any objection to the
recommendations?

MR. BARRETT: I think you ought to get some Internet clarification into
that. That\'s all. I fully support the concept. It\'s just the way it\'s
written.

DR. KOLODNER: Let\'s see if we can get the wording \-- I think we have
an idea of what the intent is and what should be excluded and we need to
just make that clear, okay? With that, one caveat. Do I hear any other
concerns, objections? If not, I will accept that by consensus. Thank you
very much, Kirk.

Okay. We\'ve got two more items, one of which the second is pretty
quick. This one \-- the next one is \-- I\'ll take a few more minutes,
but let me run through this quickly. And this is about developing a
privacy and security framework. As you know, for most of the agenda
items, for the AHIC, we try and make sure that they\'re decision
focused. This particular presentation won\'t yet be at the decision
point, but it\'s setting the stage, and we want to make sure that you
understand and give feedback about the process, to make sure that we\'re
on target in how we\'re approaching this, and then we\'ll be able to
bring a product for consideration, actually, to Workgroups, as well as
to the AHIC, in a process that we\'re still evolving.

So if we go to the responsibilities that the national coordinator is
charged, it includes privacy and security issues. And I\'m going to be
addressing a process that we used to develop this privacy and security
framework. We need to be comfortable with that process in order to
develop the trust and support for this initiative. And once developed,
we\'ll build consensus around the framework. And that\'s why it\'s
important for you to both understand and give us any feedback about the
process that you might want to.

Nearly 25 years ago, the Fair Information Practices of 1973 were
developed by HHS\'s predecessor, HEW. And these foundational principles
have served not only as a framework for the development of privacy and
security laws, most notably the Privacy Act of 1974 and HIPAA, but also
as a springboard for developing principles by a variety of organizations
that tailor their fair information practices concepts to specific
audiences or applications, some of which are health related, some of
which are not.

HIPAA, as we have been talking about, serves as a legal floor, not a
ceiling, but a floor for privacy and security in the healthcare sector.
And what \[unintelligible\] are engaged in here is the further
refinement of harmonization of the developing principles as they relate
to the advancement of health IT now and into the future. And the privacy
and security principles that we hope to agree on, with input from the
public and private sectors and from the public at large, will serve as a
guide to the development of business practices and requirements for the
health IT agenda that we hope will instill the public trust necessary
for its adoption. So as we\'ve said in multiple occasions, the privacy,
security, confidentiality of the ongoing system is fundamental for us to
achieve success in the adoption.

The issues that we\'re dealing with obviously are complex, and the
objective is to build consensus around this set of principles that will
guide us. And although we have been working on privacy and security
since the inception of the office, we\'re just beginning this process of
developing and building consensus around a framework that incorporates
existing end developing concepts.

Let me explain, then, what we\'re going to do, and how we\'re going to
be getting as much input as possible. You see on this slide, a list of
some of the recognized privacy and security instruments. You may be
familiar with some and not with others. The OECD, which is an
international document, is a widely recognized set of principles, and
their application is broader than healthcare. And we kept that in mind,
as we looked at that. FTC has principles designed for the Internet,
which are also relevant to health information exchange.

Markel Foundation has put forth a set of principles that have been
articulated elsewhere. There has been a coalition of consumer
organizations. That\'s not their name, but it\'s descriptive of them. It
includes 20 organizations, including the National Partnership for Women
and Families, American Federation of Teachers, March of Dimes, AARP and
others. And they also have put forth a set of principles.

And then the last one is an international group that analyzed 12 \--
excuse me, 11 instruments around the world, including the OECD at FTC.
And they actually did a cross instrument mapping and accommodated the
many variations, and came up with a set of principles. And they also
included the Privacy Act of 1974, HIPAA, the European Union Data
Protection Directive, and the Canadian Standards Association Model
Codes. So they looked internationally.

And what we did, then, is we took this broad set of instruments, and as
we were looking through them, we found multiple examples of similarities
in the names of the principles. So all of them articulate principles,
and then concepts within the principles. And you see here some examples
where very similar words, very similar ideas were used, but with
slightly different wording between the different groups. And sometimes
they paired their concepts differently under a principle.

What we did, then, is we looked within each of the principles, across
all of these instruments, and were able to begin to identify various
themes that were there. And so you see on this slide a listing of
various themes, accountability and oversight, collection limitation,
individual participation or control, or access or correction. Security
safeguards and controls.

And the content within each instrument\'s principles didn\'t always fit
nicely within any one theme. So what we ended up doing was developed a
process to look at each concept at a more granular level than just
staying within each of the principles, because some had 11 principles,
some had nine, some had seven. What we really wanted to do is get to the
concepts.

So the methodology that we did \-- and I had some terrific staff who
were able to get into the level of detail that is really needed, but
certainly I\'m glad that there are people who can dig at that level of
detail and sort through things. And so they actually went down to the
wording or concept level within each of the principles, and then
determined whether or not to include or exclude these various wording
and concepts across the principles. And there were actually very few
exclusions. So on this next slide, you see an example of kind of a map
that they put together. So for a given principle, in this case we\'ll
call it principle A and it\'s a fictional mockup here. They had various
concepts. There were nine concepts that were part of this principle that
we reconstructed from all of the ones we looked at. And then we actually
marked for each of the instruments, whether or not it contained that
concept. And you see a little check mark if it was present in some form
or another, or a slash symbol if it was not present.

We also had a third category, and that was implied. So an example of
implied is that several principles indicated that data should be kept up
to date. But the FTC document was silent on that wording. But it did
indicate that data should be accurate. So we, then, assessed that word
accurate in the FTC, implied that it should be up to date. So we
indicated that it was implied. That\'s a soft area, but the idea is it
really wasn\'t all in or all out. Certainly the intent was there.

\[low audio\]

So first we did this analysis and then secondly, and you see in that
first column, made decisions whether or not to include or not include
concepts within that principle. And the rule of thumb was to be as
inclusive as possible, so as a result, very few concepts were excluded.
The most common reason for excluding a comment was because it appeared
either in another principle or didn\'t warrant duplication.

And an example of another reason for not including a concept was that
the wording either wasn\'t applicable to healthcare, and that would be
true for some of these instruments that applied to areas broader than
health, or that the wording was illustrative of the organization\'s
principle, in contrast to being part of the general principles.

So we\'re going through this process, putting together the kind of
tearing apart and then putting together a model principle to move
forward. And we\'re currently building this harmonized set of
principles, and will advance that forward, along with this map across
the principles, and actually, it\'s \-- you\'ll see, you\'ll actually be
able to click on the table and see the wording that\'s associated with
and highlighted in that associated principle. So it\'s a very
transparent type of process, if there is a question that\'s there.

And we\'re vigilant about consulting each of the primary sources to be
sure our tables \-- as we study our tables and develop a harmonized set
of principles, to ensure that we represent the important concepts. And
we\'re also making a point to keep the principles at a high level. By
keeping it at a high level, we can then incorporate later, as
appropriate, existing work in the area of privacy and security, as
implementation tools, as well as looking at the principles for guidance
in developing additional tools.

So for example, we did discuss very recently, whether or not to include
the NIST FISMA Privacy Act framework. Says it\'s a framework. Says it\'s
privacy. As we talked with NIST staff, and as we looked at the
documents, we realized that was really at a more operational level
rather than a high level. So it would actually \-- we need to make sure
we\'re consistent with that, but what we\'re looking for are the
principles that actually are at higher level than those lower level
documents would be able \-- to be examples of implementation.

So we\'ll have a set of draft principles in the very near future, and at
that point, we will be seeking comment from public and private sectors,
the public at large. We\'re planning on posting it for comment. As I say
we\'ll be bringing it to the various Workgroups and through the
Workgroups to the AHIC. And also engaging a broad variety of entities
and individuals in the private sector.

And I\'ll provide you with periodic updates as we move forward, but we
felt that this was an important enough area, this area of privacy and
security, and that we really need to move forward in developing the
dialogue, and in moving it forward, and moving towards consensus, that I
wanted to spend a few minutes with you today. Look forward to your
comments and questions about that right now. Mitch?

MR. ROOB: I was not really kidding about the use of the word "implied."
I think that if it doesn\'t say it explicitly, I would \-- I think
you\'re probably going to have enough that are explicit, not to use
implied. Implied, I think, will hurt your case more than will help it.
And I just think explicit is important in that respect. It looks from
just glancing at this, you\'ve got plenty of explicitly present pieces.

DR. KOLODNER: I thank you, and I think that in terms of the decision
point, we don\'t need the implied. I think it was meaning to give credit
that we weren\'t saying that it was being excluded by some of those
others. And as I say, you\'ll be able to actually click on that and see
what it is.

MR. ROOB: \[inaudible\] the word implied, which is used in other
contexts. It has not been \-- remains a very controversial issue in
abortion, for instance.

DR. KOLODNER: Okay. So maybe what we can do is we\'ll have the \-- that
it\'s explicit or absent, and then we may just have an asterisk or
something that \-- without using any particular verb, but at least
showing where there might be a similar word. Okay. Thank you.

Other comments or questions? If not, we\'ll move to the final item on
the agenda, which actually will be very abbreviated, because you\'ve
already heard two of the \-- we can switch the slides here. And what
I\'m going to do, actually, is be very brief as we go through.

Since Lillee did present the electronic health records report, and this
is really the summary that you see of the colors across the various
recommendations. These are the ones, May through August, that we\'re
beginning to work through.

I\'ll be glad to spend the time on discussing any of those, but I\'m not
sure that that\'s something that \-- that is the desire or the intent of
the group. But as I say, we\'ll be glad to go back to those. What we do
want to do is we\'re taking these first to the co-chairs, discussing
those, making sure that we have the right wording, and that the rating
is one that seems reasonable, based on the reporting of what\'s there.
And then taking it on to the Workgroup.

We did it in an expedited fashion. This first time we\'ll be doing it a
little bit at the pace that I prefer to do it with the rest of the
groups. Then we can bring that back to you and update it. I notice that
we\'re through the \-- this is just through August, so we\'ll need to
extend that as well.

Any questions on the EHR report? If not, I\'ll skip rapidly through here
to the Chronic Care Workgroup, which again, Craig Barrett outlined. You
can see that this is a little more colorful score.

MR. BARRETT: You know, you\'re suffering from the black olive syndrome.
Have you ever seen a small black olive? I mean they start at large, and
then they go to super large, and then colossal, and then super colossal.
It always helps to have a zero, one-half, one type of scoring index to
call it really what it is. If you\'re not making any progress, minimum
progress to date is a very polite way of saying, we ain\'t done nothing
in this space. I mean you got minimum progress, some progress, progress,
lots of progress, and done.

\[laughter\]

DR. KOLODNER: Craig, would you like to suggest better wording? We got
the one for the red. We understand that one now.

MR. BARRETT: You know, zero, one-half and one is a really good scoring
index. It requires you to put them in kind of categories of either
you\'ve really done something or you haven\'t. I love the technicolor
image, but \--

DR. KOLODNER: Lillee?

MS. GELINAS: The only comment I\'d make, you know, as we\'re going
forward is similar to Craig\'s. I don\'t know what some progress versus
minimum progress means, you know. Progress on target. As a suggestion,
because in healthcare in the United States we\'re moving rapidly to
report cards and transparency, and in support of the Secretary\'s value
driven healthcare initiative around report cards. If you\'ve seen the
document, you can download from the HHS website, there is a proposed
report card there.

There are colors that resonate across the industry where red means zero,
you know, whatever. Yellow means progress, and green means go, go, go,
done, very good. And so my only recommendation would be if we can have
some alignment with how the healthcare industry\'s report carding color
process is beginning to evolve. I see that happening very, very rapidly
across the industry, and I think that would be helpful. I don\'t know if
we can split the colors any further, but I\'m fine with red, yellow,
green, just as a way to be succinct.

DR. KOLODNER: I think the only reason that we used \-- and we can
certainly stay with green for all the done. The blue were ones that were
completed, whereas green is moving along. They\'re where they should be.
As what we also have \-- obviously the colors simplify a little bit. Too
much at times. We actually put what the status is, so when we say some
progress, you can see, for example, on this one, that there are things
that are done. We may have missed the timeframe that was there, and that
was the intention, that it wasn\'t as if it was where it should be at
this point in time.

MS. GELINAS: Probably match the HHS flag so \--

DR. KOLODNER: If you like it we can certainly keep it as green and say
done. The last is the population health and clinical care, and again,
you see here, using those words that aren\'t zero to one yet, but can be
that way. And this is the \-- this was the only one that was not
discussed and stepped through by one of the co-chairs. And you have the
material in front of you. I\'ll be glad to go through it, if you want,
or just leave that for your perusal after the meeting.

Hearing no great demand for further detail \[laughter\], we\'ll move to
the final agenda item, and that is the public input. So at this point,
we do have microphones that are in the aisle there, and we\'ll stop for
a moment and see what comments members of the public might have, and we
ask that you remember to introduce yourself, and please keep your
remarks brief and to the point, and no product endorsements, please.
Thank you. First person.

MS. BICKFORD: Carol Bickford, American Nurses Association. I have two
questions. One is in relation to the encounter discussion of being
\[unintelligible\] health. That Workgroup that was looking at expanding
that to being services provided and diagnostic activities. Is there
consideration of the implications of that change to that definition; for
those of us in the interstate licensure discussions that the state
governors are attending to for across state practice sort of things,
that has major implications, if we do move to that definition. So a
question for that Workgroup.

And the second question is in relation to the privacy confidentiality
discussion that just occurred. Are that standards bodies participating
in this initiative; you looked at very specific groups, but there has
been work done, I know in ASTM, in relation to some of the principles
and implementation for security, privacy, and confidentially. So are
those entities part of that conversation?

DR. KOLODNER: Thank you. We\'ll \-- what we can do is to pass those
along to the Workgroups, and in their discussions, they can certainly
take those questions into account and provide some answers. Next?

DR. SANDERS: Yes, good afternoon. My name is Jay Sanders. I am a member
of the Chronic Care Workgroup, so you can\'t assume anything I\'m about
to say is objective at all. But I would like to applaud AHIC for their
receptivity to the recommendations brought to you by our chair, Craig
Barrett, number one.

Number two, with respect to the issue of further demonstration projects
related to this, I would just like to suggest that there have been
thousands of projects already done reported in the peer reviewed
literature that might be looked at to help develop policy rather than
going through another cycle of demonstration projects.

And third comment, very briefly, as a physician, one thing which was not
mentioned that I would just like to underlie to someone who has been
using this for more than ten years, and that relates to the issue of
quality. Not simply compliance, but quality of evaluation. Taking a
patient\'s blood pleasure at home is a much better determination of what
their true blood pressure is than taking it in my office. Taking a
child\'s pulmonary function test with asthma, taking those pulmonary
function tests at home is a much better reflection of what their true
pulmonary function tests are than in the totally different environment
of my office. So this is not simply an issue of cost. It\'s not simply
an issue of convenience. It is an issue of quality. Thank you.

DR. KOLODNER: Thank you for your comments. And is there any other
individuals in the room who\'d like to give comments? If not, then thank
you all for your participation and we\'ll declare this 14^th^ meeting of
the AHIC to be adjourned. Thank you.

[\[Whereupon, the meeting was adjourned at 2:05 pm EST\]]{.underline}