American Health Information Community

Biosurveillance Workgroup Meeting #13

January 5, 2007

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*The views expressed in written conference materials or publications and
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by the U.S. Government.*

**[\>\> Judy Sparrow:]{.underline}**

Good afternoon, everybody. And welcome to the 13th meeting of the
Biosurveillance Workgroup and the first meeting in 2007 and Happy New
Year to all of you. Just briefly again, to remind you, this is a meeting
conducted under the Federal Advisory Committee Act regulations which
means it is public, it is being broadcast over the Internet and being
transcribed. Those transcriptions will be made available to you on the
Website.

Also, just another reminder that we conduct this workgroup and all of
the AHIC workgroups trying to build consensus toward our
recommendations. Just a few reminders that since it is being broadcast
over the Internet, and we\'re all sort of virtual here, please identify
yourself before you speak and speak clearly and distinctly. Also, at the
end of the meeting there will be an opportunity for the public to make
comments.

Mute your telephones if you are not speaking. We tend to gather a lot of
extraneous noise if you don\'t. With that I\'ll turn it over to Matt,
you can tell us who is on the call from your end and then we\'ll go
around the table here and identify who is present at the ONC office.

[**\>\> Matt McCoy:**]{.underline}

Okay. On the call today we have Lisa Rovin from the FDA. Art Davidson
from Denver Public Health. Steven Solomon from CDC. Laura Conn from ONC.
Leah Devlin from North Carolina Division of Public Health. Michael Barr
from the American College of Physicians. Scott Becker from the
Association of Public Health Laboratories. Marc Paladini from New York
City Department of Health. Edward Sondik from CDC. Brian Keaton from the
American College of Emergency Physicians. Paula Soper from NACCHO. Rick
Heffernan is also from New York City Department of Health. John Lumpkin
from the Robert Wood Johnson Foundation. Brian Carnes from the Indiana
State Department of Health. And I believe that does it. Do we have
anyone joining late also on the phone call? Workgroup members or
designees?

[**\>\>** **Tom Savel:**]{.underline}

This is Tom Savel on behalf of Bob Martin, for CDC.

[**\>\> Matt McCoy:**]{.underline}

Thank you. Any others?

[**\>\> Leah Devlin:**]{.underline}

Jean-Marie Maillard is here with me, in North Carolina.

[**\>\> Matt McCoy:**]{.underline}

Okay, thanks. Judy, that does it.

[**\>\> Judy Sparrow:**]{.underline}

Okay, and in here in the room we have Shawn, or excuse me, yes, Shawn
Fultz.

**[\>\> Shawn Fultz:]{.underline}**

The Veterans Health Administration.

**[\>\> Kathleen Nolan:]{.underline}**

Kathleen Nolan from the National Governors Association.

**[\>\> Chip Kahn:]{.underline}**

Chip Kahn with the Federation of American Hospitals.

**[\>\> Gretchen Woodworth:]{.underline}**

Gretchen Woodworth, (inaudible) Leadership Council.

**[\>\> Mark:]{.underline}**

Mark (inaudible) from ONC.

**[\>\> Betsy Ranslow:]{.underline}**

Betsy Ranslow from ONC.

**[\>\> John Loonsk:]{.underline}**

This is John Loonsk from the Office of the National Coordinator.

**[\>\> Jodi Daniel:]{.underline}**

Jodi Daniel, Office of the National Coordinator.

[**\>\> Judy Sparrow:**]{.underline}

Okay. And that\'s it. We can proceed with the opening remarks from the
co-chairs.

[**\>\> Chip Kahn:**]{.underline}

Great, and John is first.

[**\>\> John Lumpkin:**]{.underline}

Thank you. I just wanted to go \-- start off first by going over our
goals for the meeting and we\'re going to have three things that we want
to do today.

First is we\'re going to go over and review the expanded charge for the
Workgroup, review and approve that. We\'re going to talk a little about
the upcoming work of the Workgroup, particularly in relationship to
adverse event reporting and response management and how we\'re going to
conduct hearings on that. And then to review the changes to the time
line related to our recommendations on biosurveillance.

The first thing I just wanted to comment on is that we have reached some
agreement with the Office of the National Coordinator and the AHIC chair
on the name for our committee, which would be Population Health and
Clinical Care Connections.

So that will be our new Workgroup name, unless anyone has any objections
to that. And I\'ll read that again. Population Health and Clinical Care
Connections.

[**\>\>**]{.underline}

Sounds like everybody agrees.

**[\>\> John Lumpkin:]{.underline}**

Good. Chip?

**[\>\> Chip Kahn:]{.underline}**

Okay. On my side, you\'ll remember that in the last meeting we spent a
lot of time and got useful input on the draft letter recommendations
that were to be brought up for the January meeting of the AHIC. And that
now \-- or that process that we were bringing to a head, was as I said
supposed to be for the January meeting. But the decision has been made
there\'s going to be some discussion at the January meeting of AHIC on
overarching priorities which could have some effect on how we choose,
and what we choose to recommend. So that we will come back in March and
make our recommendations.

So the letter which is still in process considering all of the feedback
we got from those on the phone and others, we will put off until next
meeting to discuss when we\'ve been informed by the discussion of the
AHIC in a couple of weeks, so that makes this meeting a bit simpler,
because we\'ll come back to the letter later.

And I guess the time line for that would be the February meeting. And
then \-- I mean March meeting. And then hopefully we\'d move into the
March AHIC meeting with an approved letter that everyone is satisfied
with.

So that\'s my part. And I guess the next piece, going on to number 4,
would be the document, the meeting document, called meeting summary. And
I want to see whether we can get approval for that, that\'s been sent to
everybody.

[**\>\>**]{.underline}

Yeah, that was included.

**[\>\> Chip Kahn:]{.underline}**

In the packet. And not hearing anybody speak up, I assume that everybody
is happy that it describes what it\'s supposed to describe.

So then we\'ll move on to the next steps and as I was saying, we\'ve got
the 23rd AHIC meeting for priority setting, then we\'ll come back with a
revised recommendation letter updated by the staff that would be in
alignment and that they\'ll work on that from the 24th to 29th. And then
that letter should be sent to you by the end of January. We have a
Workgroup meeting on February 2nd when we\'ll consider that and then
hopefully we can get an updated letter done that comes to everybody\'s
satisfaction, get comments on that revised version, and by February 16th
come back with a final letter that everybody is satisfied with.

Also, we\'ve scheduled testimony for adverse events and response
management for February and March meetings of our group, the next
Workgroup meeting as I said is February 2nd. And that sort of covers
that part of it.

So next we\'ll go into Kathleen Nolan, and let me introduce her.
There\'s been interest in learning about their new initiative and how
they may contribute to the advancement of our priority setting. Kathleen
is director of health division at the National Governors Association
Center for Best Practices. She directs research policy analysis,
technical assistance, and project development for all health issues. Her
division works with states to share and implement best practices on
health care issues facing states, including health care quality, health
IT, cost containment, coverage initiatives, long-term care, public
health programs, regulatory and legal issues impacting health and health
care and I guess what you do not do?

And so you\'ve got her PowerPoint slides, which she is going to go over
now.

[**\>\> Kathleen Nolan:**]{.underline}

I don\'t do economic development or education. And just to be clear for
those of you who may not be familiar with NGA and its structure. The
center for best practices within that is the arm focused on state
policy. We\'re not part of the lobbying portion of the organization, and
do that separately. So I just wanted to mention that for those of you to
have a construct with it. The State Alliance for e-Health, the project
overview is pretty straightforward. We have \-- got a contract from the
Office of the National Coordinator that became effective at the end of
September of 2006. And we\'re working to essentially put together the
forum in which states can begin to discuss these issues as they are
state-relevant.

This process started, as I said, in September 2006, we have one year of
funding with a hope of ultimately three years of funding to end and
conclude the discussion in September 2009.

We\'re working with a number of other partner organizations on this. We
have already some agreements together with the National Conference of
State Legislatures, with the National Association of Attorneys General,
and also with the National Association of Insurance Commissioners.
There\'s a number of other folks who are contributing and we\'ll be
working with as issues emerge, including ASTHO, the Medicaid Directors,
and then potentially working with the group that puts together uniform
state laws, the commissioners for those at the state level. And those
are some work that we\'re continuing to do. So that is the overall
project overview.

Moving to the next slide. This is the structure for the State Alliance
for e-Health that we worked with ONC to envision. The State Alliance
itself will have 12 voting members, and will be supported by an advisory
committee of 8 non-voting members who will sit together as the primary
group and discussion, and discussion group here, with the
decision-making resting in that alliance. They\'ll be supported by three
task forces that we are working to assemble now. We\'ve got a number of
issue areas under each of these task forces that we think we\'ll be
addressing and I\'ll talk about those a little bit more. The idea being
that the task forces themselves will make some statements, put together
some reports and review issues, and then provide that to the State
Alliance for their consideration, as well as potentially also putting
out their own efforts. So we\'re still working on the design and flow
process between those groups.

The next slide, I talk about the structure of the State Alliance itself
in terms of its membership. We currently have the structure as laid out
there with current governors, two there, two former governors to give us
advice, four state legislators from different states, attorneys general,
and insurance commissioners would comprise the voting membership.

We\'ve worked really to identify different potential members from a lot
of different states. We are \-- as of right now have no two members from
the same state and we\'ll work very hard to make sure that that\'s true
so we can get the broadest perspective possible of different states and
their environments.

As I said, the non-voting members will include people from state
leadership on health issues, including technology, health policy, public
health, and other potential private sector advisors who will help them,
at the voting level, frame their discussions and think through issues in
terms of how they impact states.

We have announced, in the next slide, we have announced the two chairs
who will be governor Phil Bredesen of Tennessee and Governor Jim Douglas
of Vermont will co-chair in the first year of this alliance. And we are
putting together and hope to soon announce the membership for the State
Alliance itself. And there we\'ve identified, as we\'ve put together
with ONC what we really hope the Alliance will be discussing in terms of
looking at this from the state perspective, and attempting to build
consensus across states and across different sectors within the states
about a strategic direction forward for state-relevant issues for health
IE and heath IT adoption.

And so we\'ll be looking for expertise and input with a focus on those
state issues working to frame a dialogue and build consensus on those
issues. And that\'s a furthering on that.

Moving to the next slide, the structure of the task forces underneath
the State Alliance, we\'ve identified some early issues that we believe
that will be covered by these different task forces and I\'m just going
to walk through those here. The first one would be the Health
Information Protection Taskforce. Essentially this is a lot of issues
around privacy and security and other types of protection for health
information. And NGA has been working with RTI and ONC on the privacy
and security project with 33 states and one territory. And at least in
the first year will draw heavily from the experience there, what did we
learn about what states need to do within their borders and what we need
to talk about in terms of across states. So really drawing from that as
being a key lead-in point and where can the Alliance and task forces
best contribute to that discussion.

The Health Care Practice Taskforce will deal with those issues having to
do primarily with state-level environment actions and policies that
impact not specifically to the record but specifically to the practices
of health care. There are a number of issues around licensure, a number
of states have dealt with this in the telemedicine arena for a long time
and are moving into health information exchange arena, what is the
environment set up at the state level that either hinders or supports
health information exchange and how can we impact that. That would
include medical malpractice liability issues and the way we license
facilities, professionals, and other things like that, dealing with that
at the state level.

And then the third task force will \-- the health information
communication and data exchange task force will really attempt to look
at how are states contributing to health information exchanges and what
are the opportunities, in particular to focus around how to get public
programs more involved in health information exchange in an appropriate
way. Certainly that group will probably look at public sector funding
for these efforts. But really will focus a lot on public health and
Medicaid and other things like that and how they can play a strong role
in health information exchange in an appropriate way.

And I added the caveat at the end that this is how we\'ve set it up at
the first meeting. The first meeting of the Alliance has not taken
place. And we have left ourselves the ability to potentially in the
future add other task forces or to distribute issues among the existing
task forces as they emerge and so that\'s how we're going to be handling
that issue.

Next slide has a table of the kinds of people that we are \-- bless you
\-- that we are recruiting for this task force, for these different task
forces. We\'ve got a lot of different people who can meet different
aspects of this, or multiple aspects, and are really trying to get the
most relevant people to these issues at the table. These individuals
will also be focused on \-- from a state perspective. Sorry about the
siren.

(Siren blaring)

All right. I hope they don\'t stop in front of the building. So these
individuals will be looking at these issues from a state perspective. So
when we identify mental health or public health, what we\'re talking
about there is particular individuals and perspectives having to deal
with state-space public health. That\'s really the idea there, so
employers in the third task force, how do they relate with the states
and that\'s really the overall orientation for those task forces.

So moving to the next slide on timing and access. The first meeting of
the State Alliance will be on January 26th, in just a couple of weeks.
They will meet quarterly thereafter, at which the Alliance members will
gather in face-to-face discussions of these issues and talk about and
share state perspectives and attempt to build the consensus that I
discussed.

The individual task forces that will contribute to this will primarily
meet monthly, although there\'s a different schedule for one of them.
But the basic bottom line is that all of these meetings will be open to
the public (audio disruption) \-- casting all of the Alliance meetings
live and have those archived on our Website, and task force meetings
will all be transcribed, and those transcriptions would be available on
our Website as well.

We currently have a Webpage at NGA\'s Website that is dedicated to the
State Alliance. It will be an important place for tracking the effort
and we\'re really working to provide as many opportunities as we can for
input from states which is harder to do because of these locations and
being out in the states and making sure we can provide a forum for broad
state input. And then also doing outreach and trying to provide as much
of the richness of the dialogue that we expect to come from the Alliance
discussion back out to the states for them to absorb and consider.

The next slide is outcomes and what we\'ve identified here is really
more the kinds of things that we expect to see rather than specific as
yet, as I said, the Alliance has not yet met. But again, I emphasize
that this will be really looking at the opportunities to impact the
state environment in a contributory way. So that would be when I say
model laws and regulations on key issues as a potential product or
outcome, that would be state model laws or regulations in a particular
area.

Likewise there\'s a tremendous amount of interest among state leaders,
governors, legislators, on these issues. And so one of the things that
has been successful in these kinds of forums elsewhere has been an
opportunity to really drill down and help states prioritize their
actions and think about what are some early wins. What are some things
that make a lot of sense and that are ripe for working on and so that\'s
also the guidance as well as the recommendations is really looking at
what are some good steps to take and that are appropriate for the
environment, and high priority.

The thing that I would emphasize as well, is that our expectation is
that the outcomes and the work of the Alliance will be complementary to
and supportive of ongoing efforts. And I mean that to say both at the
local level, at the state level, and at the federal level. These
discussions are taking place and rightfully so, and so how do we make
them strategic across that? And that\'s really the intent of the
Alliance. And to that end we will work to actively seek input. And I
added "wisdom" this morning because I thought that was even more right
with what we had been talking about, which is that because of the
dialogue of this group, of AHIC, and of a number of others, those
discussions have generated tremendous amount of thinking and sort of
some collective wisdom that we would think would be drawn into the State
Alliance work, and we refocused to what is relevant at the state level
and what is an appropriate role and contributory role for states to
take.

And those are the outcomes that we\'re looking for. And then the last
slide is simply the Website to get to the State Alliance. We are
developing a listserv for folks who are interested to get the word out
as much as possible. And then the staff who are working on this, the
prime staff, so that you can contact them if you have any questions.

So that is my presentation. And I\'m happy to take questions if that\'s
appropriate.

[**\>\>**]{.underline}

Sure. Do we have any questions? Anyone on the phone?

[**\>\> Brian Keaton:**]{.underline}

This is Brian Keaton. I just had a question in an area that always bugs
me because we don\'t have good data on it. Do we \-- or do you have in
your plan some way of applying metrics to look at the impact, whether
it\'s return on investment, decreased state Medicaid spending, clinical
impact of some kind, in terms of improved population health, is there
some way to look and say, you know, we\'ve reached these consensus
ideas, we\'re telling states to do all this stuff, but does it really
make a difference?

**[\>\> Kathleen Nolan:]{.underline}**

Sounded like a governor. Yes. What \-- we have not built that into the
process, but it is something we have begun to try to figure out how to
do that. We get the other part of the question as well, which is what
are states already doing and what has been the impact? The best
practices side.

We\'re just starting to figure how we can begin to answer those
questions and be sure just because the State Alliance as a collective
consensus group considers it to be a high impact opportunity does it in
fact turn out to be so? Part of that will be addressed by public input
and the opportunity for states to come back to us and say that\'s a
great idea but here\'s what\'s not working for us in that arena.

But as more of an analytical approach, we\'re still struggling with how
we might be able to do that and we\'re looking into it but we\'re
hearing enough of those questions to seriously consider a way to do
that.

[**\>\> Brian Keaton:**]{.underline}

There\'s lots of people asking the question. I haven\'t found too many
that have answered it yet.

[**\>\> Kathleen Nolan:**]{.underline}

Sorry, we don\'t have it either, but we\'re really trying to figure out
how we can get it as well.

[**\>\> John Lumpkin:**]{.underline}

This is John, I have a question.

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

Go ahead.

[**\>\> John Lumpkin:**]{.underline}

Okay. Kathleen, it\'s good to talk to you. I think I may have met you
once before.

[**\>\> Kathleen Nolan:**]{.underline}

Yes, on the trip up there.

[**\>\> John Lumpkin:**]{.underline}

Yeah.

What I wanted to raise with you was the fact when I look through the
scope of what this project is working on, that there\'s one major area
that doesn\'t seem to be addressed. And that has to do with \-- well,
actually two, and they\'re interrelated. Which is one is a burden
that\'s placed on the private sector by government. And the second is
compliance with state law.

In the area of burden, there is \-- and the best example is when I was
state health director in Illinois. We used to interface with
laboratories who were required to report infectious diseases. They, by
and large when they did their reports, they would do a data run at the
end of the day, print it out, and then they would hire somebody who
would then write this down on the pieces of paper that they mailed in to
the state.

And the inability of state government to receive those reports in
electronic fashion; in other words, data exchange, created a burden upon
the private sector. So one of the aspects of data exchange would be how
\-- if you look at it in a holistic way, whether it be providers or labs
or whatever, to what extent can e-Health approaches, HIT, reduce the
burden of compliance with state mandates.

The second area, which is enhanced compliance, is that every state \--
almost every state, if not all \-- have on their books laws mandating
reporting. And we all know from various studies that the rate of
reporting is significantly low on \-- in a number of areas, from quality
measures all the way through reporting on infectious diseases. And I
don\'t see within these three task forces how that issue would be
addressed, one that we\'re very concerned about within this Workgroup.

[**\>\> Kathleen Nolan:**]{.underline}

Let me start with the one on burden, and I think that one clarification
and then one recognition of how we can deal with that issue.

The task forces, as I said, would have a state focus, but would include
individuals from the public and private sector. It is not only state
individuals on that. So we do hope to be able to identify in that arena
the task forces, exactly the issue of impact so that there is a
discussion and dialog between the public and private sectors and not
activities in a vacuum in the public sector arena that never get
discussed in terms of impact. And I think that that is certainly one of
the things that the task forces will at least begin to be able to
address. I would be lying if I think they would get all the way through
that. But I think that would be at least be a forum for that discussion.

The other thing that I think is critical and a place where this thing
will come up is the task force on data exchange. And looking at how the
public sector is or is not, in many cases, integrating with efforts at
health information exchange. And you\'re absolutely right that we\'ve
increasingly got private sector capacity and no public sector capacity
to even receive the information, much less to generate it in tandem with
public sector programs. And so that is something that we are certainly
\-- we certainly hope that conversation will be centered there in terms
of how can we change the dynamic in public health programs and Medicaid
and other places like that, so that it\'s a better integrated and more
strategic fit with health information exchange, as well as how it might
contribute to those actual exchanges where they exist.

In terms of the compliance issue, and in terms of how that integrates
with quality measurement of disease reporting, I think we\'ve got, in
some ways I\'d respond that that\'s centered in some of NGA\'s other
work around quality improvement, and integration with this effort. And
that there are a number of things going on in that arena. But I would
also say that there is the opportunity in terms of moving forward with
integrated efforts and in building some of that accountability and the
ability to receive the information in, as a better way of doing
compliance.

One of the issues of compliance is exactly because of the first thing
that you raised. Because of the difficulties and the burden on the
private sector. And so I think that\'s another place where we can begin
to integrate that. But I also think that one of the things that has been
a challenge is that the kind of population-based health measurement and
assessment. And I think we\'ll have a lot on our plates, particularly in
the first year, but certainly think that how public health programs and
population health management is integrated into this, NGA, I think, or
governors and other leaders have a tendency to talk about health care
only and not in terms of health care and public health. And I think that
that would be an overall direction, but might be too early to get to at
this point, but certainly one we recognize.

[**\>\> John Lumpkin:**]{.underline}

If I can make just one other followup comment. And that is that how you
\-- the composition of the workgroups will be very important in
relationship to that discussion. If you get insurance folks, you know,
insurance commissioners, and Medicaid, and providers into the room,
providers are going to be predominantly concerned about how they get
paid and when they get paid. And those delays. And frequently these kind
of issues never make it to the table because they\'re just not front
burner for providers.

But from the government side, these are often some of the early wins
that you can make. You know, budgetwise it\'s kind of hard to say we\'re
going to accelerate payments for Medicaid, but you can provide
alternative give-backs to the industry in terms of simplification that
might not get on the table if you don\'t have the right people in the
room.

**[\>\> Kathleen Nolan:]{.underline}**

And I think that\'s exactly the kind of thing we hope to be able to play
out in those discussions.

Are there other questions?

[**\>\> John Lumpkin:**]{.underline}

Other questions?

[**\>\> Michael Barr:**]{.underline}

This is Michael Barr from the American College of Physicians. Really
ambitious effort, it looks great. I had question about representation on
some of the task forces. Are you striving to get representation from
small practices, perhaps through the state chapters of some of the
professional societies?

[**\>\> Kathleen Nolan:**]{.underline}

Yes, and that\'s actually been something that we wanted to ensure we
have strong voices that are also representative. And so we have looked
to go to some of those individuals. We have also put out a broad call
for nominees and I would encourage you to do that still. It\'s not past
that if you know of people who are able to speak to some of these
issues. We\'ll also be rotating membership as well. I think that\'s a
point I didn\'t raise earlier. Potentially turning over a third or a
half of these groups on a regular basis so that we can ensure the
addition of broader perspectives and other perspectives.

It\'s been a struggle. We go as a default to some of those that are
bigger because they\'re easier to reach out to and we know they have
some capacity. But there\'s also certainly a desire and a need and
we\'ve been working to identify those who are more \-- in some ways more
relevant at the state level because of the fact that they are very much
sort of state-specific.

[**\>\> Michael Barr:**]{.underline}

Absolutely. I guess the question would be if we can facilitate anything
through the national society to get you to the state level. And I don\'t
recall seeing sort of a call for any kind of nomination, so if you could
circulate that, that would be great. And what states in particular
you\'re looking for representation from.

[**\>\> Kathleen Nolan:**]{.underline}

Absolutely, will do.

[**\>\> Michael Barr:**]{.underline}

Thank you.

[**\>\> Chip Kahn:**]{.underline}

Any other questions? If not, then we\'ll go on to the next, section 6,
and I\'ll pass it on to John.

[**\>\> John Lumpkin:**]{.underline}

Great. We have two things that we want to get through under this
section. The first is to talk about the charge, and the secondary then
is to talk about the scope. And we have two documents that are part of
the handout.

Let me turn your attention to the first one on the broad charge for the
workgroup. Let me first call your attention to what our previous charge
was. Which was to make recommendations to the community, to implement
the information tools and business operations to support realtime
nationwide public health event monitoring and rapid response management
across public health and health care delivery communities, and other
authorized government agencies.

If you look above that on that sheet, on the proposed charge, it\'s a
shorter charge but I think much broader in scope. Which is to make
recommendations to the community that facilitate the flow of reliable
health information between population health and clinical care necessary
to protect and improve the public\'s health.

[**\>\> Chip Kahn:**]{.underline}

John, could I break in just for a second?

[**\>\> John Lumpkin:**]{.underline}

Please.

[**\>\> Chip Kahn:**]{.underline}

Let me make it clear, what John is going through now we actually will
bring to the AHIC in January. As I said, whereas, the recommendations
will be pushed off until after their priority setting, this sort of
rescoping of our body, which John is going to lead the discussion on, is
really critically important because this is what we\'ve been thinking
about bubbling along and we really \-- it\'s going to be brought to
closure in January at the meeting of AHIC.

[**\>\> John Lumpkin:**]{.underline}

Great. Any comments on the expanded scope?

[**\>\> Steven Solomon:**]{.underline}

Yes, this is Steve Solomon at CDC. And I want to express our enthusiasm
here at CDC for the expanded scope, and how excited we are about this
decision on AHIC\'s part to expand the scope of the Biosurveillance
working group. This is very consistent clearly with CDC\'s strategic
direction for the future, and very, very pleased about that.

One point of clarification that I would ask, we certainly want to be
very proactive about promoting this internally, within the organization.
In the charge, when it talks about the linkage between population health
and clinical care, I want to be sure that we\'re understanding all of
the nuance, and the importance of calling population health an entity in
its own right and understanding how it enhances our understanding of the
broader public health system. Commonly we talk about the public health
system meaning the combination of both governmental public health
functions and non-governmental organizations involved in population
health improvement.

And my sense is that that is what we mean by population health. And I
just I want to get that confirmation from the group. When we\'re talking
about population health, we\'re talking about the broader public health
enterprise that explicitly includes all the aspects of governmental
public health plus all of the various non-governmental organizations and
entities that are included, that are involved in population health
improvement.

Do I have that understanding correct?

[**\>\> John Lumpkin:**]{.underline}

And in fact the attached document that we\'re going to walk through
again, which we previewed last meeting, puts that into five domains.
Public health surveillance and response. Health communication and
education. Population-based clinical care. Population-based research.
And health status and disease monitoring.

Does that answer \--

[**\>\> Steven Solomon:**]{.underline}

It does. And I\'ll wait until we get into the background document. But
that absolutely is coincident with what I think we would, you know, in
our current parlance talk about as being the broadest definition of the
public health system.

[**\>\> John Lumpkin:**]{.underline}

Great. Other comments on the expanded scope?

[**\>\> Brian Keaton:**]{.underline}

John, this is Brian Keaton. Almost along that same line. Will the \-- I
mean, the background document spells out what we believe. But it\'s not
referenced in the broad charge, which leaves a lot of questions in terms
of what the broad charge really does. Is there a way to link that
together so that it\'s clear as to what we intend with this?

[**\>\> John Lumpkin:**]{.underline}

If Judy is there, or someone who is more familiar with how these fit in
with our communication, I think our \-- obviously, when Chip and I
report to AHIC in \-- at the end of the month, we\'re going to explain
what population health is, within that context. But through the work of
AHIC, will this broader charge be explained on the website and so forth?

[**\>\>**]{.underline}

I\'m looking at Judy.

[**\>\> Judy Sparrow:**]{.underline}

We can certainly do that. I mean there's (inaudible) with the change \--
name change, some sort of a document, as you said, background document.
We can put that on the Website.

[**\>\>**]{.underline}

All that being said, I think that it\'s broad charge \-- (audio
disruption).

[**\>\>**]{.underline}

Yeah, I think John, having gone through a number of these discussions at
the AHIC level, it seems to me that the broad charge becomes a really
important thing. Ultimately, when you get back to checking back to see
what you were supposed to be doing. So I guess the question is, John,
are there a sentence or two that we could put in so it doesn\'t add a
lot but it adds the thought? We probably would be better off if we did
that. It would save time and trouble later.

[**\>\>**]{.underline}

I can remember about three meetings that we spent just trying to figure
out how to address the charge.

[**\>\>**]{.underline}

Yeah, I\'m \--

**[\>\> John Lumpkin:]{.underline}**

How about if we were to include a trailing sentence that would say, the
five domains for population health are \-- and then list them?

[**\>\>**]{.underline}

That sounds good to me. Other people buy that?

[**\>\> James Hadler:**]{.underline}

Yeah, this is Jim Hadler from Connecticut and CSTE. I think that would
be very helpful, because similarly to the other two questions, the
definition of population health left me a little bit confused, as you
sort of think a little bit more of who and not \-- I mean, public health
in a sense is more recognizable. We explain that we deal with population
health, but what population health means is always something that kind
of needs definition. So I think if that can be defined, then the term
population health could certainly \-- by using the domains, I think that
would go a long way toward addressing at least some of our questions.

[**\>\> Edward Sondik:**]{.underline}

This is Ed Sondik. I agree with all of this. I think it needs some
clarification. Because you can read this as meaning population health is
a source of information, and yet when you look at the five topics, areas
that we\'re going to be talking about, these include interventions of
various sorts, sources of information, a variety of things.

So I do think it requires clarification. But I\'m very enthusiastic
about this change.

**[\>\> John Loonsk:]{.underline}**

This is John Loonsk. I apologize for my voice. I would wonder about, in
some of the same context, whether the description of population health
as it currently exists "between population health and clinical care",
isn\'t a little bit suggestive of population health as a separate
entity, whereas to a too significant degree and whether that might be
refined as we move forward to be population health functions or
activities, as we advance that language, because obviously a lot of
population health occurs in clinical care. We\'re not trying to be
exclusive of those activities. And it\'s just, I think it\'s correct to
assert that most people don\'t have a concrete idea of an entity that is
population health. Like they do public health.

[**\>\>**]{.underline}

Perhaps including population health functions, entities could be linked
to the \-- those activities that were being described.

[**\>\>**]{.underline}

If we can just ask again that if you\'re not speaking, you put yourself
on mute because there\'s a lot of background noise today.

[**\>\>**]{.underline}

I like functions better than entities.

[**\>\>**]{.underline}

John, where do you think we are?

[**\>\> John Lumpkin:**]{.underline}

I thought I knew where I was until I just heard a comment about
functions. And who made that comment?

[**\>\>**]{.underline}

I was backing up \-- John, the other John, you should illustrate what
you think. Or give us an example of how you would say it.

[**\>\> John Loonsk:**]{.underline}

Well, specifically are we talking \-- the language that\'s here says
"between population health and clinical care". It\'s very suggestive of
these as distinct entities. It\'s suggestive of population health as an
entity. Whereas I think that the categories in the background document
and the realities of practice have population health being carried out
in many different places, including clinical care. And that it\'s not
\-- population health as a term is not evocative to most people of a
particular type of organization.

Public health, you know, for many means the public health department.
And so I\'m just suggesting that maybe we include public health
functions instead of alluding to public health as an entity. Population
health as an entity.

[**\>\> John Lumpkin:**]{.underline}

I was dealing with this earlier today on \-- from the standpoint of a
different sort of workgroup. But what we\'re basically talking, about, I
think, is \-- and I\'m not saying we should word it this way. But if I
understand it, is what can EHR, assuming that we have electronic health
records all over the place, how can they be used for looking at the
health of groups of people, either in terms of reacting to it,
responding to it, or knowing about it to do other things. To stop other
people from getting sick. Rather than individual clinical care for a
particular patient. But the clinical care for particular patients are in
the EHRs and we\'re talking about getting the information up in to a
level for a population that can then be used back for the health of that
population.

[**\>\> John Loonsk:**]{.underline}

Some of that may occur in the EHR proper as well. We\'ve talked about
some of those functions and I just think that \--

[**\>\> Art Davidson:**]{.underline}

This is Art in Denver. I want to hark back to the comments from the CDC.
I think it was Ed Sondik and Steve Solomon, using the term "systems".
Because I think this word population health doesn\'t really imply an
entity, and I was wondering if maybe it could be worded something along
the line, "between population and personal health care systems to
promote and improve the public\'s health."

I think we\'re kind of hung up on this word because \-- the way that
it\'s currently structured, because we don\'t see in it some entity
where data will flow to and from.

[**\>\> John Lumpkin:**]{.underline}

Well, part of the problem, that\'s what we\'re going to be dealing with.
Where the data should flow to and from, right?

[**\>\> Art Davidson**]{.underline}

But I think the earlier comments, there was another one, I think, from
Connecticut, about how we just don\'t see in this population health some
entity. That was described \-- the earlier comments around systems, that
maybe we need the word systems in there.

[**\>\> Steven Solomon:**]{.underline}

Yeah, this is Steve Solomon again. I want to support that comment, and I
think John Loonsk also articulated very well the idea that the charge as
stated does talk about movement of information in a sense from point A
to point B. And that if we were going to talk about the clinical care
piece, I think we would have a pretty good sense of who to go to to
engage in moving the clinical care activities. I\'m not sure it\'s as
clear who we would go to to engage in moving the information to or from
population health.

Actually, the comment that was made just very shortly ago about the use
of EHRs really speaks to the issue of how to maximize the availability
and the utility of that data broadly, both for individual care and for
population health, which is a \-- it seems to me a corollary and related
concept in addition to the idea of simply moving the information back
and forth.

[**\>\> John Lumpkin:**]{.underline}

Well, let me suggest one approach. Because the difficulty is, you know,
I think that there are a couple of purposes for a charge. One is to have
a brief statement in a list of charges that would tell people that
they\'ve come to the right Workgroup.

The second is something that will memorialize what we all agree we\'re
working on. So we don\'t have to bounce around from meeting to meeting.
And I just wonder if we\'re trying to get this one sentence to do two
things, when maybe we ought to have a sentence and then a descriptive
paragraph.

[**\>\> Chip Kahn:**]{.underline}

And I think there\'s a third function, John, and that is \-- this is
Chip. That is to, when we go back with recommendations to the AHIC, that
they can say, oh, yeah, that fit within the scope of what we assigned to
you, as well as the first two points you made.

[**\>\> John Lumpkin:**]{.underline}

Right.

[**\>\> Chip Kahn:**]{.underline}

And don\'t have them coming back and saying now, tell us again why
you\'re doing that because that doesn\'t seem to fit into what we
thought the scope was.

[**\>\> John Lumpkin:**]{.underline}

Right. So I could see that if we use something like this sentence, and
then had a paragraph to say that the domains of population health
include the following five areas, the providers of population health
services includes federal, state and local health departments,
community, you know, health resources, and so on. And sort of a list.
And they would be interfacing with direct providers of care who collect
information in electronic health records and also from personal health
records. And that there would be an exchange that\'s bidirectional. I\'m
not doing a very good job with this paragraph. But I think getting the
nuances that we want to have in in a paragraph would be easier than
trying to do that in a very short description.

[**\>\> John Loonsk:**]{.underline}

Yeah, I mean I just \-- this is John Loonsk. I\'m not sure we want to
get to the level of a specific list, because we will invariably leave
some people off. And what we\'re really talking about is among and
between population health needs and care provision, you know, provision
of care activities. And maybe we could just finesse some of the
language. I don\'t think it\'s far off at all. I think this is something
that could be refined offline and easily advancable in the January time
frame.

**[\>\> James Hadler:]{.underline}**

It might even simply be enhanced by just adding the word systems after
clinical care, between population health and clinical care systems. I
mean, because again they\'re sort of entities without saying who they
are.

But I think we can all identify that we\'re part of a system, one or the
other, or perhaps both. But \-- there\'s just that need for a word like
\-- for an entity. Like systems. And certainly what was proposed
earlier, population, and personal health care systems is a possibility,
too but if you wanted to leave the same wording put system after
clinical care system, I think that would apply to both population health
and clinical care, and that would potentially \-- and then you could
still potentially define domains of population health.

[**\>\> John Loonsk:**]{.underline}

I find the domains of population health and perhaps say reliable
information among population health and clinical care systems.

[**\>\> John Lumpkin:**]{.underline}

Ah. That\'s it.

[**\>\> James Hadler:**]{.underline}

Say that again.

[**\>\> John Lumpkin:**]{.underline}

Okay, let me read it as I think I hear it. Make recommendations to the
Community that facilitate the flow of reliable health information among
population health and clinical care systems necessary to protect and
improve the public\'s health.

[**\>\>**]{.underline}

I think that captures anything we could possibly want to do.

[**\>\>**]{.underline}

Other than the nuance that John Loonsk brought up before, maybe it\'s
not just a nuance, but that in a way it\'s sort of a Venn diagram and
you don\'t know what is contained in what. I mean, the clinical side is
contained in the population health and sort of vice versa, but I like
what you read. I think that\'s okay for now.

**[\>\> Rick Heffernan:]{.underline}**

This is Rick Heffernan in New York. I support the reading that \-- that
latest reading. I thought that was very good.

[**\>\> Scott Becker:**]{.underline}

This is Scott Becker. I, too, agree with that.

[**\>\> Brian Keaton:**]{.underline}

This is Brian. I think it gives us the latitude to do what we want to
do. And it also gives a pretty good idea to the AHIC as to what we\'re
trying to accomplish, especially if they read it with the background
documentation and presentation you planned.

[**\>\> John Lumpkin:**]{.underline}

Great. Sound like a wrap.

[**\>\>**]{.underline}

Sounds good.

[**\>\>**]{.underline}

Good.

**[\>\>]{.underline}**

Great, John, that\'s good.

[**\>\> John Lumpkin:**]{.underline}

Okay, let\'s move on to the document with the greens and the blues and
all those other colors for those of you who printed it off in color.
Different shades, if you didn\'t.

The five domains as we talked about. Let\'s walk through those five
domains, starting off with the public health surveillance and response
domain.

And I\'m not going to read that. We have gone through that before. Do we
\-- one of the questions that came up last time was how do we
differentiate between public health surveillance and response versus
health status and disease monitoring. Are we comfortable now with that
division, with the descriptions between the two?

[**\>\> Lisa Rovin:**]{.underline}

This is Lisa Rovin at FDA. I did have one question, very small one, we
can do it offline if you want. The food monitoring in the health status
piece, rather than the public health surveillance piece, I\'m not sure
what was intended there. It may be what CDC does, and so that may be
fine. From an FDA perspective, our food safety surveillance is all
product-related, so it may belong up in the first category. We don\'t do
general environmental scans outside of the \-- our statutory mandates
for product regulation.

[**\>\> Steven Solomon:**]{.underline}

This is Steve Solomon. I think it\'s a very reasonable distinction. The
lines can\'t be hard and fast, because they\'re obviously is a continuum
among any kind of disease assessment or health status assessment.
What\'s on paper is perfectly reasonable as a construct.

[**\>\> John Lumpkin:**]{.underline}

How about if we put it in both places?

[**\>\> Lisa Rovin:**]{.underline}

I don\'t really care where it goes. I just wanted to make it clear to
the group in case there was any question that our statutory \-- the
statutory constraints around our public health surveillance on food
relates to our regulated product and isn't the kind of broad
environmental monitoring that I see elsewhere in this category. I was
just making a clarification.

[**\>\>**]{.underline}

Right.

[**\>\> Lisa Rovin:**]{.underline}

But conceptually, yeah, I don\'t care which category it goes in.

[**\>\> John Lumpkin:**]{.underline}

Okay. So we\'re going to leave it the way it is, then? Recognizing that
that \-- yeah, it could go either way or both. So we'll just leave it
there.

[**\>\> Lisa Rovin:**]{.underline}

We don\'t do, you know, random, periodic \-- not random. We don\'t do
periodic assessments of community and all the other stuff that\'s up
there, but anyway, just it\'s just a point of \-- just so you guys know
what we can and can\'t do.

[**\>\> John Lumpkin:**]{.underline}

Right, understood.

And of course it\'s interconnected because much of the food safety
monitoring related to infectious diseases comes in under public health
surveillance.

[**\>\> Lisa Rovin;**]{.underline}

Right.

**[\>\> John Lumpkin:]{.underline}**

And then turns into a food investigation.

**[\>\> Lisa Rovin:]{.underline}**

Of course. And then there\'s all the stuff that CDC does that\'s much
broader than what we do but relates to food.

[**\>\> John Lumpkin:**]{.underline}

Right. Okay, so any other comments on those two and the division between
those two?

Okay. Let\'s walk \-- look at public health surveillance separately. Are
there any additional comments on that domain?

Okay, let\'s move on to health status disease monitoring. Any specific
comments on that domain?

Moving on to population-based clinical care.

[**\>\> Lisa Rovin:**]{.underline}

I did \-- this is Lisa at FDA again. I just had a question. How does
observation of adverse events in this category differ from the active
surveillance and reporting on adverse events in the first category? I\'m
not clear on the intent.

[**\>\> John Lumpkin:**]{.underline}

I suspect that, if I can get into our minds when we wrote this a while
back. If you have someone who is \-- let\'s suppose you're doing what
they\'re doing in New York City and monitoring diabetics and hemoglobin
A1c, or so forth. And you\'re going to be monitoring sentinel events
like admission to the hospital with diabetic ketoacidosis. That would be
kind of a sentinel kind of event that would not be the same as would be
in the first category.

[**\>\> Lisa Rovin:**]{.underline}

So here \-- here you don\'t mean adverse events related to a product.

[**\>\> John Lumpkin:**]{.underline}

That\'s correct.

[**\>\> Lisa Rovin:**]{.underline}

Okay. Got it. I understand now.

[**\>\> John Lumpkin:**]{.underline}

This would be more related to a chronic illness.

[**\>\> Lisa Rovin:**]{.underline}

Got it, thank you.

[**\>\> James Hadler:**]{.underline}

This is Jim. I kind of read that to kind of be sort of thinking of
immunizations or adverse events to any product is ultimately \-- or at
least initially, the initial observations are made by clinicians, and
then they\'re reported through reporting systems, be it to public
health, be it to FDA, and then gradually immunologic studies may be done
if it\'s merited. But I think the actual observation of adverse events
is kind of a clinical care contribution to population-based health.
Because those individuals detect something, some of which may be
coincidental and some of which may be the sentinel event for what turns
out to be a problem, like intussusception with rotavirus or whatever.

[**\>\> John Lumpkin:**]{.underline}

I think the intent of this, though is not how does clinical care
contribute to population-based care as opposed to how population-based
care enhances clinical care.

[**\>\> James Hadler:**]{.underline}

Okay. Right, in which case the ketoacidosis example is, as you said,
relevant for that.

[**\>\> John Lumpkin:**]{.underline}

Right, but it may be that for instance in that instance looking at
vaccine-preventable diseases you wouldn\'t be looking for an adverse
event related to the vaccine but you may be looking for a population
that is beginning to break through the vaccine, which would result in a
change in the recommendation for the vaccine schedule.

That would be how the impact of population health based surveillance
would then result in changes in clinical schedules. Does that make
sense?

[**\>\> James Hadler:**]{.underline}

Partial, although I would also see that as possibly being a public
health kind of function, as we monitor and see \--

[**\>\> John Lumpkin:**]{.underline}

That\'s why the circles overlap.

[**\>\> James Hadler:**]{.underline}

Right.

[**\>\> John Lumpkin:**]{.underline}

Any other comments on population-based clinical care?

[**\>\> Brian Keaton:**]{.underline}

John, this is Brian. Brian Keaton.

[**\>\> John Lumpkin:**]{.underline}

Yes?

[**\>\> Brian Keaton:**]{.underline}

Two areas that I think are implied but they\'re not spelled out and I
just want to make sure I\'m understanding this properly. Under
evidence-based clinical care, we have measuring the quality of care, we
have delivering evidence to the point of care, and development of
measures. No place do we have development of evidence-based clinical
care guidelines. Which I think is one of the key things that we wanted
in there. And the other part of it is nowhere do we have measurement and
development of best practices for system management. In terms of the
systems that deliver the care.

[**\>\> John Lumpkin:**]{.underline}

Good point. Let\'s add them. Unless there\'s some objection.

[**\>\> John Loonsk:**]{.underline}

This is John Loonsk. I don\'t think there\'s an objection to that
inclusion. I do think that it\'s important to recognize that not all of
the areas that are referenced in this document are the domain of this
working group, per se. I mean, and there\'s a fine line there between
defining these domains and talking about them as being included in the
scope. And I just \-- clearly we have a working group on quality and we
have \-- and there is a, you know, a limit to the scope of what any of
the working groups are doing relative to some development of metrics, et
cetera.

[**\>\>**]{.underline}

And I really think \-- I\'m not intimately familiar, but just with a
little exposure I\'ve had with the measurement group, there\'s a real
interconnection between this group \-- I mean on population health side,
and the measurement group, because it\'s hard to differentiate between
collecting information for measurement and some of the things we\'re
going to end up talking about.

[**\>\> John Loonsk:**]{.underline}

I wasn\'t trying to suggest that we wouldn\'t talk about some of these
areas and make sure that we know the lines. It\'s just I do think it\'s
important that we have a conceptualization, just because we have
something listed in here does not mean it\'s exclusively the scope \--

[**\>\> John Lumpkin:**]{.underline}

And John and the rest of the folks from ONC, I think it might be useful
if we were to, before our presentation, to make that point. Put
asterisks on those items where we believe that there\'s another
Workgroup that\'s looking at aspects of that item.

[**\>\> Brian Keaton:**]{.underline}

I think what we\'re looking \-- this is Brian again. I think what we\'re
looking at is providing a framework or a structure where these
activities can take place, and I think we\'re creating the shopping list
of things that become possible or become more likely to be done if
indeed we create this atmosphere for those things to happen in.

[**\>\> Lisa Rovin:**]{.underline}

Yeah, I think \-- this is Lisa at FDA. That would definitely be worth
stating clearly what John said. Because when I first saw this, I thought
it was outlining the scope of this group\'s marching orders.

[**\>\>**]{.underline}

Uh-huh.

[**\>\> Laura Conn:**]{.underline}

And this is Laura. We had talked about doing that or trying to identify
the activities that would potentially cross multiple workgroups.

**[\>\> Lisa Rovin:]{.underline}**

Or even just a statement on top saying this is a conceptual framework,
blah blah blah, however you do it. But I was confused. So that would be
really useful, for some kind of clarification.

[**\>\> Brian Keaton:**]{.underline}

I mean, a good example \-- this is Brian again. From a standpoint of me
representing a specialty society, I wouldn\'t expect ONC or anybody else
to develop clinical care guidelines for my specialty. But it would be
enormously useful to me to be able to have access to that data, in a
de-identified manner, to base my guidelines on evidence rather than
consensus.

[**\>\> John Lumpkin:**]{.underline}

Right. Okay. Any other questions? So we will either by asterisk specific
items or an intro comment, denote the fact that there are other
workgroups of AHIC that will be looking at aspects of \-- within some of
these domains.

Any other comments on population-based clinical care? Okay.
Population-based research?

[**\>\> Lisa Rovin:**]{.underline}

Lisa at FDA again. I have just some questions about the clinical trial
entry here. To whom is that directed? This is one of the few that
actually mentions A, a specific condition, and B, specific entities. So
I\'m having a hard time understanding it in the context of this
document.

[**\>\> Laura Conn:**]{.underline}

This is Laura. They were just examples that we had taken from different
documents that we were using. So if it\'s too specific for the type of
research that we want to talk here, in population-based, we can either
modify it or take it out.

[**\>\> Lisa Rovin:**]{.underline}

I\'m just starting to want to understand it. I mean, clearly there was
something specific in mind. Who should conduct the trials and clearly
drug-resistant infections are an important population health problem,
but so are infections generally and we don\'t have good antibiotics even
for other kinds of infections. So my initial question is just probing
why these \-- who you had in mind to conduct the trials and why this
particular public health problem was singled out.

[**\>\> John Lumpkin:**]{.underline}

Can I sort of tease out your comments there, then. Let\'s start off with
\-- let\'s suppose we were to lose everything after \-- if we were to
reword this and just say facilitate the conduction of \-- that\'s a bad
word, but anyway \-- of clinical trials? Would that be a better generic
statement?

[**\>\> Lisa Rovin:**]{.underline}

How would it read? Conduct clinical trials ideally in collaboration with
the industry to determine the efficacy and safety of new medical
products?

[**\>\> John Lumpkin:**]{.underline}

Let\'s start off with that part.

[**\>\> Lisa Rovin:**]{.underline}

And then again to whom is it directed? Who should be conducting these
trials?

[**\>\> John Lumpkin:**]{.underline}

That\'s the reason why I said to facilitate the implementation of
clinical trials. Well, that changes the structure.

[**\>\> Lisa Rovin:**]{.underline}

And what\'s the action item? Who should be doing something here?

[**\>\> John Lumpkin:**]{.underline}

Okay. Population-based research includes field-based efforts to foster
improvements in public health practice, and other population health
management activities.

So it would be the research that would be doing that. So \--

[**\>\> Lisa Rovin:**]{.underline}

Is what you\'re getting at, are you trying to make the philosophical
statement that regardless of who is doing it, whether it\'s government
or industry or some combination, when you are addressing issues such as
the efficacy of infectious disease counteragents, that\'s part of public
health research.

[**\>\> John Lumpkin:**]{.underline}

Population-based research.

[**\>\> Lisa Rovin:**]{.underline}

Right. Is that the statement that you\'re trying to make?

[**\>\> John Lumpkin:**]{.underline}

I can \-- I believe that is correct.

[**\>\> Lisa Rovin:**]{.underline}

I can definitely help you wordsmith it then. We don\'t have to waste
people\'s time. I think that\'s a really excellent point to be made. And
I can certainly help you make that.

[**\>\> John Lumpkin:**]{.underline}

Okay. Everybody else comfortable with that approach?

[**\>\> Lisa Rovin:**]{.underline}

Because what you\'re saying is some of the stuff gets done in the
private sector, some of it gets done in the public sector, it doesn\'t
matter. We\'re looking at how new agents can be developed and tested
that will improve population health.

[**\>\> John Lumpkin:**]{.underline}

Right.

[**\>\> Lisa Rovin:**]{.underline}

Okay.

[**\>\> John Lumpkin:**]{.underline}

And through the access to information, do that in a much broader fashion
through, you know, not only, the early, the preintroduction, but also
the phase 4 stuff.

[**\>\> Lisa Rovin:**]{.underline}

Got it, right. And it\'s all about population health.

[**\>\> John Lumpkin:**]{.underline}

Right.

[**\>\> Lisa Rovin:**]{.underline}

Absolutely.

[**\>\> John Lumpkin:**]{.underline}

Okay.

[**\>\> Lisa Rovin;**]{.underline}

I just didn\'t understand it when I read it. I thought we were trying to
make a point about infectious diseases. Now I see where you\'re going.

[**\>\> John Lumpkin:**]{.underline}

Okay. Everybody okay that we\'ll wordsmith that for \-- within the
context of that brief conversation?

Anything else under research?

[**\>\> James Hadler:**]{.underline}

This is Jim. I don\'t think I\'m going to suggest any changes. But when
I took a look at the bullet to develop, evaluate and monitor effective
vaccination programs, and especially the monitoring side, I would sort
of \-- I might call that kind of public health surveillance more than
public health research. And the only reason I make that semantic point
is having sat in on numerous human investigations committee
deliberations over whether something is research or surveillance and
therefore can be done with or without consent, is, of individuals whose
records might become, might be examined as part of the project.

Just want to be sure that as you \-- the examples that are used for
research are ones that aren\'t, clearly aren\'t surveillance, because
obviously when we\'re doing surveillance, we don\'t know necessarily
what we\'re going to find in the course of doing it. And then ultimately
you have to try to explain the results, especially if they\'re ones that
are different than we expected. So disease incidence goes up or we see a
lot of break-through chicken pox and that leads to thinking about
needing a second dose of chicken pox or various things like that. Some
people might call research but actually it\'s all surveillance and the
results can lead to changes in policy and practices. And especially
around the vaccination programs, the monitoring side. Clearly developing
and evaluating is one part but the monitoring may be more of a
surveillance function.

[**\>\> John Lumpkin:**]{.underline}

So what I hear you saying is that it would read, it might be better for
it to read the following way: Develop, evaluate effective vaccination
programs for new vaccines and those involving new populations of people
to be vaccinated.

[**\>\> James Hadler:**]{.underline}

Yeah. Maybe that actually would make that statement of a slightly less
\-- or make it of less concern than I had. Although I mean, I wasn\'t
necessarily going to propose a change, but that actually would be a
change that would be, I think, potentially good.

[**\>\> John Lumpkin:**]{.underline}

Okay.

I\'ve had the same experience of IRBs myself, so I agree with that.

Okay, anything else under population-based research?

[**\>\> Paula Soper:**]{.underline}

This is Paula from NACCHO. I\'m not exactly sure where this would go,
and let me preface this by saying I\'m not an expert in this. But
NACCHO, through funding with the California HealthCare Foundation has
been working with community, local health departments in Connecticut to
develop indicators to get at the root causes of health disparities and
health inequities and I know that this work has been ongoing for a
couple of years now. And I think this issue fits into three, maybe four
of these different categories. But I\'ve been talking with our program
manager at NACCHO who has been working on this project and discussing
kind of when is the right time to integrate what they\'re working on
with these root causes indicators in with some of the work that ONC and
AHIC are doing.

And I\'m thinking that this might be the right time. Again, I\'m not the
expert on this. But I\'m just wondering if this group would entertain
the notion of getting more information on what this group has been
working on in terms of indicators that have been developing and if we
should be looking at them now to include in this paradigm or if perhaps
they aren\'t ready for prime time, but at least start looking at what
some of the root causes are, why health disparities are occurring, and
not just identifying the factors that create \-- you know, that identify
the disparities.

[**\>\> John Lumpkin:**]{.underline}

Would that not \-- there are two things that sort of pop into my mind
with your comment. One is that the issue of disparities seem to fit
under health status and disease monitoring.

[**\>\> Paula Soper:**]{.underline}

Probably it may come under a little bit under the clinical care, and
surveillance and research as well. But probably the most reasonable home
would be under the status and monitoring.

[**\>\> John Lumpkin;**]{.underline}

Right. But when you talk about indicators and talk about NACCHO, it
seems to me that there\'s \-- we haven\'t discussed in any of these
domains how we monitor the performance of the public health system.

[**\>\> Paula Soper:**]{.underline}

Sure.

[**\>\> John Lumpkin:**]{.underline}

And that ought to be somewhere.

[**\>\> Paula Soper:**]{.underline}

That\'s a good point.

[**\>\> John Lumpkin:**]{.underline}

You know, which would be down the road from the accreditation process?

[**\>\> Paula Soper:**]{.underline}

Right, absolutely.

[**\>\>**]{.underline}

Would that come under public health surveillance and response in the
first bullet?

[**\>\> John Lumpkin:**]{.underline}

Yeah \-- well, it can if we want it to.

[**\>\> Leah Devlin:**]{.underline}

This is Leah, Leah Devlin, and I was just wondering also along a
parallel track, how do we monitor how much of the research gets
translated into practice?

[**\>\>**]{.underline}

Yeah.

[**\>\> Leah Devlin:**]{.underline}

If we\'re going to monitor things. That\'s the thing that always stumps
me, is all the good ideas that we aren\'t able to, you know, put across
\-- put in place across the system.

[**\>\> John Lumpkin:**]{.underline}

I hate to say this, but that almost sounds like another domain. It has a
significant overlap with the quality work. Except to the extent that it
looks at the performance of the population health system minus the
quality. The clinical care system.

[**\>\> Leah Devlin:**]{.underline}

You mean it goes in a different workgroup, John?

[**\>\> John Lumpkin:**]{.underline}

No, no, same Workgroup, but I'm just saying it's sort of a new \-- it\'s
another aspect. Because it seems to me that, from what you\'re saying,
and the other comments, there are two components of system performance
of the population health system. Performance. One aspect is how are the
public health Service providers doing, how well are they performing? And
then as an overall system measurement, how well is the population health
system taking what \-- and maybe that will be under research. But how
well are the things from research moving into practice?

[**\>\> Leah Devlin:**]{.underline}

Right, and also I guess best practices that come up within the
community, in the practice community, get translated across the system,
too. So there\'s great things that come out of research that never get
out of the university. But there are also good things that come from
different practices, communities that never get across. It\'s sort of a
systematic review of best practices from wherever.

[**\>\> John Lumpkin:**]{.underline}

How about this. How about if we include an introductory paragraph that
talks about some of the overarching \-- you know, and we\'ve just talked
about two kind of overarching issues. That the overarching issues, how
well is the system performing and how well are the discoveries in all of
these five domains, getting into practice. Or practice itself within
population and clinical health.

Is that \--

[**\>\> Art Davidson:**]{.underline}

I think \-- this is Art. I think the key word Leah mentioned is this
translational research. Kind of moving it from the discovery phase to
actual implementation.

[**\>\> Edward Sondik:**]{.underline}

This is Ed Sondik. I think that\'s one aspect of it but I think the
point just before this, the monitoring of the public health system and
the health care system in general, as to their functioning, I think is
another dimension to this, other than the five here, and I think should
be a part of it or in an intro. I think that\'s important.

[**\>\> James Hadler:**]{.underline}

This is Jim \-- a question, though I agree that\'s important. Does that
fit \-- is that really within the charge of what we\'re \-- the broad
charge for what this group is about? Does it have to do with the flow of
reliable health information between population health and clinical care
systems? Because obviously it\'s an important issue. But how does that
relate to what you know, our expanded but still finite focus is?

[**\>\> Leah Devlin:**]{.underline}

If you talk about research it sort of broadens it for me, from the broad
charge you just talked about. It does broaden it. And for me, any time
you talk about research, the point of that is to get it implemented. The
best practices. That\'s why I threw it in there. The domain in here of
research broadens our charge, I think. I\'m okay with it. But if we\'re
going to talk about research, we\'ve got to talk about getting it
disseminated. That\'s all I\'m saying.

[**\>\>**]{.underline}

I guess I saw this as how this aspect of evaluating the systems, if you
will, as how the information would be used. It can be used at the
individual level, at the practitioner level, at the vaccine monitoring
level. But it can also be used at a higher level to say how well the
system is functioning. The systems are functioning in particular areas
or for a particular population group. And it strikes me that this is
something that could go into an introductory paragraph as to how all of
this would be used.

[**\>\> John Lumpkin:**]{.underline}

Right \-- if I can sort of pull what I\'m hearing together. It seems to
me that probably measuring the performance of the public health system
is out of our scope, but bears some comment. Both that and the
translational aspect. That if this works \-- in other words, if these
five domains are working, then you also have the resources to make those
assessments. Does that work?

[**\>\>**]{.underline}

Yeah. That seems reasonable to me.

[**\>\>**]{.underline}

Okay. Anything else under population-based research?

How about health communication, health education?

Okay, it sounds like we\'ve got a statement of \--

**[\>\> Edward Sondik:]{.underline}**

John, could \--

**[\>\> John Lumpkin:]{.underline}**

Yes?

[**\>\> Edward Sondik:**]{.underline}

This is Ed Sondik. Could I go back to public health surveillance and
response?

[**\>\> John Lumpkin:**]{.underline}

Sure.

[**\>\> Edward Sondik:**]{.underline}

Within the first paragraph, or perhaps under event detection, I\'d
suggest putting in on the first bullet at the end of the first line,
where it says "analysis and interpretation of public health data", add
the phrase "and vital events". The reason for that is that I think the
\-- it\'s important to include in this the vital statistics system.
Which isn\'t otherwise, it seems to me, included specifically. And I
think it\'s really a foundation for information on the public health
side, and apparently what we\'re doing, it relates to that.

[**\>\> John Lumpkin:**]{.underline}

I resonate to what you say, but I would think that would go under more
health status, disease monitoring, rather than a surveillance system.
Just because the turnaround time on vital events is so \-- it\'s a
monitor, more so than a surveillance system.

[**\>\> Edward Sondik:**]{.underline}

I\'d be happy to see it in either place, but I think it\'s lacking \--
we\'re lacking without it.

[**\>\> John Lumpkin:**]{.underline}

Okay.

[**\>\> James Hadler:**]{.underline}

Actually, in the second bullet of health status/disease monitoring, it
does say attention to the vital statistics health status and functional
status indicators.

[**\>\> Edward Sondik:**]{.underline}

Yeah, I know, but I\'m not really sure what "attention to" means. The
thing that I \-- when I read that, see, the emphasis there is on
specific groups that are at higher risk.

[**\>\> John Lumpkin:**]{.underline}

Right.

[**\>\> Edward Sondik:**]{.underline}

And I see the vital statistics as really fundamental. And not solely for
groups that are at higher risk.

[**\>\> John Lumpkin:**]{.underline}

How about at that point "on the collection and assessment of vital
statistics"? Or something like that? Can you give us a dot point, Ed?

[**\>\> Edward Sondik:**]{.underline}

I\'d be happy to.

[**\>\> John Lumpkin:**]{.underline}

Okay. That's agreeable?

[**\>\> James Hadler:**]{.underline}

Yeah, from my perspective it could be focused on either the surveillance
or the health status disease monitoring sections. I know in Connecticut,
even though it's not, I mean, I oversee the infectious disease side of
things, but the unit in which the vital statistics is located does have
a "surveillance" in its title.

[**\>\> John Lumpkin:**]{.underline}

Okay, great. Anything else? Because I think we're done with this
section. We have a scope \-- expanded scope document, we have a broad
charge.

[**\>\>**]{.underline}

Great, John.

[**\>\> John Lumpkin:**]{.underline}

Okay. That takes us on to item 7 on our agenda, then. The next activity
is to begin to flesh out the two areas that we\'ve already identified as
being priorities in our work, timeline. And that is adverse events and
response management. And what we \-- so the way that we can go about
that is through the process of conducting hearings, in which we would
invite key experts to come in and help us formulate what it is that we
would want to recommend to the Community, consistent with our charge.

Now, just as \-- just to give you a little background, what we said
adverse event reporting was, which is reporting encompasses this \--
encompasses the electronic submission of a report of many different
types of adverse events, including nosocomial infections, medication
errors, adverse drug events, adverse events related to medical device,
biologic, or other type of medical error.

The thought \-- the suggestion would be that we would do adverse events
in February, and response management in March. That we would encourage
as many members as possible to attend in person when we did have these
hearings. So that we can get all the nuances. It also gives us an
opportunity to take the pulse of those who have stakes in these two
particular issues.

So let\'s focus first on adverse events reporting on who we think it
would be important to hear from. And I would think, doesn\'t the FDA
have something to talk about?

[**\>\> Lisa Rovin:**]{.underline}

Yeah, I think so. I was talking with Laura about this earlier. Let me
ask the group a couple questions. One is, do you guys just need a
baseline? Would it be useful for me to have some people come in and just
tell you what kind of reporting is mandatory, what kind of reporting is
voluntary, what we actually get on paper and what we get electronically.
And this does not address all the categories of adverse events that were
just mentioned, this, of course, only relates to our medical products.
Not, you know, nosocomial infections and all these other categories. But
would setting that baseline be useful for the group?

[**\>\> John Lumpkin:**]{.underline}

I think so. Anybody \--

[**\>\> Chip Kahn:**]{.underline}

This is Chip. Really, here we have sort of a set of \-- I mean, some
federal but some state, too, so we\'ve got really a broad base \-- I
mean our baseline really needs to collect, sort of cover, both, doesn\'t
it?

[**\>\>**]{.underline}

Yeah.

[**\>\> Lisa Rovin:**]{.underline}

Right, I think we can only cover the baseline for our regulated
products.

[**\>\> Steven Solomon:**]{.underline}

Yeah, this is Steve Solomon from CDC, obviously CDC has a very
long-standing and very active program across all of those domains, and
we\'re happy to provide whatever information or whatever input you think
would be most helpful to the group.

[**\>\> John Lumpkin:**]{.underline}

And CSTE? Someone on the call from CSTE?

[**\>\> James Hadler:**]{.underline}

Yeah. In terms of CSTE, and adverse events reporting, I think it might
be \-- I mean, even though states are sort of one focus for making sure
adverse events around \-- some adverse events get to CDC, I\'m thinking
of vaccines or to the VAERS system or \-- actually I should say the
state epidemiologist's role in adverse event reporting has been
relatively minor but on the other hand to the extent that there\'s the
whole, now, issue of reporting of hospital-acquired infections,
something that\'s increasingly seeming to be becoming a state function,
it might be worthwhile having somebody talk from the perspective of
people who are trying to collect that data.

We\'re not doing that in Connecticut directly. I could try to find out
who would be, you know, a reasonable person to testify there. But I
think that there would be value in having somebody talk from that
perspective.

[**\>\> John Lumpkin:**]{.underline}

What about having someone from \-- there are a number of states who now
have mandatory adverse event reporting systems that are more related to
medical errors. Do we know if the Quality committee is looking at that
issue, or is that something that we should include in this?

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

The Quality committee is just looking at \-- well, they\'re going to
look primarily at the hospital and HQA, and AQA, sort of reporting
measures. I don\'t think they\'re going to \-- I don\'t know whether
they\'ll verge into that or not. I just don\'t know the answer but I
don\'t sense they will.

[**\>\> John Lumpkin:**]{.underline}

So I think it would be \-- probably would be useful to have one of the
states that are engaged in the medical error reporting system.

[**\>\>**]{.underline}

Yeah, whoever I think has the most stringent legislation probably ought
to be involved. Which I don\'t know offhand.

**[\>\> John Lumpkin:]{.underline}**

And I don\'t either. And ideally \-- Leah? Doesn\'t North Carolina have
something like that?

[**\>\> Leah Devlin:**]{.underline}

We have the hospital association working on the 100,000 lives campaign
but we do not have adverse reporting to the public health system or
nosocomial infections yet.

[**\>\> John Lumpkin:**]{.underline}

Okay.

[**\>\> Steven Solomon:**]{.underline}

We have a lot of folks at CDC very involved in that. If you want to give
me a contact name on- or offline, I\'ll put them in contact with the
people at CDC who handle that.

[**\>\> John Lumpkin:**]{.underline}

Now, that\'s \-- they handle the nosocomial \--

**[\>\> Steven Solomon:]{.underline}**

No, I mean \-- They have a broad-based charge on adverse event
activities, and I was just responding to your query about which states
\--

[**\>\> John Lumpkin:**]{.underline}

Okay, good.

[**\>\> Steven Solomon:**]{.underline}

And we can \-- we can supply all that information to you on who has
legislation, the extent of their legislation, we have a very broad-based
program in that and can supply you with any information that you need.

[**\>\> John Lumpkin:**]{.underline}

Good. So then we can get, we can identify a state which we consider to
be the most \-- not being pejorative, but the most aggressive in
collecting this data. Through regulatory structure.

Any other aspects of this we want to look at? Anybody have a feel for
whether an organization like NAHDO, state health data \-- you know,
hospital discharge data systems, have they been used to any extent? I
know they weren\'t in Illinois, so \-- Did I hear someone start to
speak?

[**\>\>**]{.underline}

I was going to suggest the provider side.

[**\>\> John Lumpkin:**]{.underline}

Uh-huh.

[**\>\>**]{.underline}

So whether it\'s \-- I mean, the usual suspects of AHA, and AMA, I think
we ought to have the people that would be on the other end.

[**\>\> Steven Solomon:**]{.underline}

And the other groups that have very active programs are the Joint
Commission, the National Community on Quality Assurance, I mean,
there\'s a long list of players. It really depends on how you want to
put this together.

[**\>\> John Lumpkin:**]{.underline}

I think that\'s a great suggestion. We need some of those. The Joint
Commission, is the one I know best but there may be others that are
better. I\'m not judging one versus the other.

Okay, so the only other component is whether or not we want to get
somebody from the regulatory side. Whether that would be CMS, and
whatever the successor is to certification.

[**\>\>**]{.underline}

Just, it\'s not connected directly to our point here, but CMS starting
this October or next October, I can\'t remember which date it is now,
and I should have it memorized. They\'re going to start penalizing
hospitals for specific DRGs if there\'s an iatrogenic infection, if an
infection is caused by the hospital. And so CMS has got to be spending
time thinking about something along these lines right now.

[**\>\> John Lumpkin:**]{.underline}

Okay, so it sounds to me, if I can sort of group these, we have three
federal agencies, CDC, FDA, and CMS. We want to look at also having
some, a state group, so maybe a panel would be federal agencies, another
panel in this would be what state government may be doing. We could make
state and local include, you know, if there\'s a city that\'s doing this
collection. And then the third panel would be the provider perspective.
And I think that would be enough for a full day.

[**\>\> Lisa Rovin:**]{.underline}

This is Lisa. Are we just talking now about the baseline and what is
happening today? Are we also talking about what we would like to see
happen over time and into the future?

[**\>\> John Lumpkin:**]{.underline}

I would think about two-thirds of the baseline and one-third of the
future.

[**\>\> Shawn Fultz:**]{.underline}

This is Shawn Fultz of the VA. The VA is also working to implement an
active surveillance system for hospital-acquired infections, based on
the electronic medical record that's already in place. My understanding
is that the system is still in development and I\'m not sure when it\'s
expected to be rolled out but we may be able to give some information on
sort of the design of the system and what it\'s expected to do.

[**\>\> John Lumpkin:**]{.underline}

I hope you don\'t mind but I think that I would put the VA then in the
provider panel. As an example.

[**\>\> Shawn Fultz:**]{.underline}

Either way. However you feel it fits better, I think.

[**\>\> John Lumpkin:**]{.underline}

Others can please comment on that. Anybody have a preference?

[**\>\>**]{.underline}

Sounds good. I mean, they deliver care.

[**\>\> Shawn Fultz:**]{.underline}

I think compared to the other federal agencies, our motivation for it is
slightly different. So it probably fits better in the provider group.

[**\>\> John Lumpkin:**]{.underline}

Okay. Do the three panels sound good? Are there others? I mean, are we
excluding anyone?

[**\>\> Art Davidson:**]{.underline}

John, this is Art in Denver. From my own hospital, we have a voluntary
system of reporting errors that\'s part of just the general culture of
care. And it\'s not something that\'s in an electronic health record,
it\'s an ancillary system that tracks events and I just wonder if
you\'re going to be capturing similar sorts of health systems that do
this not necessarily through an electronic health record but do have
electronic means of capturing these data.

[**\>\> John Lumpkin:**]{.underline}

Well, if we \-- if people agree with my off the cuff two-thirds and
one-third. So two-thirds of the existing systems, then we can
specifically ask the Hospital Association to comment on that as part of
their description of what currently exists.

[**\>\> John Loonsk:**]{.underline}

I think \-- this is John Loonsk. Art brings up an important point that
we should get clear in the charge definition. Because the initial charge
of the Biosurveillance Workgroup was to use clinical care data almost
\-- I mean the stamped clinical care data to support biosurveillance
purposes and I have been interpreting the expansion in charge as being
broader than that and could include places where there may need to be
additional data accumulated or managed in association with existing
clinical care data to support those purposes. In other words, having,
you know, forums or adjunct systems that are \-- have overlap, as well
as the important middle ground between them, where I think a lot of the
meat lies, where you may get some data from the existing health record,
but also may need some complimentary data as well. So I just wanted to
put that out because I think it\'s an important point and my
interpretation of the broadened charge is that that broadened scope is
part of what we\'re talking about.

[**\>\> John Lumpkin:**]{.underline}

Right. Again, back to the description of adverse event reporting, which
includes electronic submission of reports, related to \-- including
nosocomial infections, medication errors, drug events, medical device,
biologic, or other type of medical error.

[**\>\> John Loonsk:**]{.underline}

But I\'m speaking, John, in terms of the overall working group and that
\-- because \-- and some of this was inherent before you came on. But
the initial specific charge was very focused on extant clinical care
data.

[**\>\> John Lumpkin:**]{.underline}

Right.

[**\>\> John Loonsk:**]{.underline}

I just want to make clear that I think, and correct me if I\'m wrong,
that the broadened charge, we\'re talking about that but we\'re also
talking about adjunct systems and adjunct data that complement that as
well.

[**\>\> John Lumpkin:**]{.underline}

Yeah.

[**\>\> Lisa Rovin:**]{.underline}

Along those lines. This is Lisa Rovin at FDA. I don\'t know, is there
anyone from NIH on line? They are doing some work to create a, what
they\'re calling the basal adverse reporting form, which would be
something that could be used federalwide. All the federal agencies have
been participating in the creation of that. I don\'t know if the group
would like to hear about that or not.

[**\>\> John Lumpkin:**]{.underline}

Speak up if you would not like to hear about it.

Seeing no one with their hand in the air.

[**\>\> Lisa Rovin:**]{.underline}

I can give you the contact people at NIH offline if you like.

[**\>\> John Lumpkin:**]{.underline}

Okay. So I think we would add them to the federal panel, so we now have
four. We\'ll have to look at the time. Given the involvement, I think we
would perhaps kick off with the FDA, and then CDC and CMS, and then NIH.
But we may want to give a little bit of extra time to FDA because of the
extent of the currently existing network. That's agreeable?

Yeah, I think we \-- it sounds to me like we have a fairly reasonable
outline that we can work off of. Laura, everybody comfortable with that?

[**\>\>**]{.underline}

Yeah, I\'m good. I just want to emphasize that the need to hear about
the need. So that the two-thirds, one-third is fine, but it\'s really
that our recommendations would be growing out of the needs and how we
can have health information technology help facilitate some of the that.

[**\>\> John Lumpkin:**]{.underline}

Right. We need to be fairly clear to the presenters what it is that
we\'re looking to get out of this.

[**\>\>**]{.underline}

In terms of a timing question, we have this meeting on February 2nd in
which \-- when we have to spend a little \-- some time talking about our
recommendations letter. But obviously we would spend most of the time
with testimony. But Judy expressed some concern about the nearness of
the day to now, but you think we could carry it off?

[**\>\> Judy Sparrow:**]{.underline}

I\'m not really concerned. Just to keep in mind that do have to submit
the testimony questions in the Federal Register, which needs to go out
15 calendar days ahead of time. So you need to be fairly well organized
by that point. You know, with your questions that you\'re going to ask
and your testifiers.

[**\>\>**]{.underline}

Say that again, Judy. Fifteen days prior to the testimony?

[**\>\> Judy Sparrow:**]{.underline}

Yeah, to the 2nd.

[**\>\>**]{.underline}

Okay. Thank you.

[**\>\> Judy Sparrow:**]{.underline}

So we\'re okay on that. And for my part, I need to find a room, make
sure we can get a room that will accommodate it. It\'s a little bit
different than the room we\'re sitting in here because you\'ll need to
have a table set up for the people to actually testify before you. And I
think we need a longer time, we were talking about 9:00 to 2:00.

[**\>\> Chip Kahn:**]{.underline}

Oh yeah, when we talked to Shu the other day, I think both John and I
left our calendars open so as long as you think \--

[**\>\> Judy Sparrow:**]{.underline}

So I\'ll deal with Shu and we\'ll get the room and the time and all that
sort of organized.

[**\>\>**]{.underline}

I think you need to \--

[**\>\>**]{.underline}

I think \-- I mean, that\'s what we were going to potentially propose to
the workgroup members today, if that was doable. Making the 2nd meeting
not a three-hour call in the afternoon, but an all-day, potentially
in-person, if possible.

**[\>\> Chip Kahn:]{.underline}**

I think it\'s important, to stress, and though I assume we'll do it at
the beginning, because I think we should, having then been informed by
the AHIC meeting, in January, we need to go over and try to come to
closure in our letter, I think.

[**\>\>**]{.underline}

Correct.

[**\>\>**]{.underline}

Absolutely.

[**\>\>**]{.underline}

Right.

[**\>\>**]{.underline}

Yeah.

[**\>\> Brian Keaton:**]{.underline}

This is Brian. Just from a logistics standpoint, a 10:00 am start makes
all the difference in the world compared to a 9:00, in terms of being
able to come in and leave the same day.

[**\>\>**]{.underline}

Fine. Those were just suggestions.

[**\>\>**]{.underline}

Let me clarify in the list, someone had mentioned NAHDO as a potential,
and I don\'t think anybody responded to it. We can check with them and
see if they have got anything going on. Should that be in or out at this
point, do we know?

[**\>\> John Lumpkin:**]{.underline}

Well, I think we were looking at a state level panel that would include
CSTE, a state that is significantly engaged in doing medical error
reporting. And I think we need to just talk to NAHDO and see what states
are doing to decide whether or not there would be any value.

[**\>\>**]{.underline}

Okay, thank you.

[**\>\> John Lumpkin:**]{.underline}

Okay. So on the 2nd, then, we\'re looking for pretty much a full day,
in-person meeting. Starting at 10:00 AM. With \-- the first portion
would be finishing up the biosurveillance letter, based upon what
happens at the AHIC meeting later this month. Followed by a panel \--
three panels related to adverse event reporting.

Federal panel, state panel, and then provider panel. Provider panel
including the Veterans Affairs, AHA, and AMA.

[**\>\>**]{.underline}

Sounds good.

[**\>\> John Lumpkin:**]{.underline}

Okay. Response management. This one just to remind us all, response
management area includes multiple aspects of response from outbreak
investigation, to knowledge of \-- collecting and monitoring knowledge
of bed and resource availability, as well as helping to inform clinical
decision-making. As well as managing countermeasures. That may include
use of registries for responses, such as specific immunization
registries, registries of emergency response personnel, or registries of
people given countermeasures and then requiring longer-term followup.

Some of the areas for testimony that have been discussed included three
perspectives on \-- I\'m sorry \-- basically looking at five aspects of
that. Countermeasure delivery and apportionment. Stockpile distribution
and management. Contact tracing and outbreak management. Isolation and
quarantine systems. And event registries.

So thoughts on who, and structure?

[**\>\> Steven Solomon:**]{.underline}

Obviously \-- this is Steve Solomon again. CDC has a very broad and
actually growing portfolio in all those areas. So we\'ll just \--
whatever information the committee would like, we\'ll work with you on
how to structure that and provide you with any resources or information
you think would be helpful.

[**\>\> John Lumpkin:**]{.underline}

So does CDC want to take the lead on putting this together?

[**\>\> Steven Solomon:**]{.underline}

We\'d be very happy to do that if you\'d like us to do that.

[**\>\> Chip Kahn:**]{.underline}

Let me ask a technical question. That would \-- I mean, obviously that
would be for our March meeting.

[**\>\> John Lumpkin:**]{.underline}

That\'s correct.

[**\>\> Chip Kahn:**]{.underline}

I wonder whether we should put it on the table today and ask people to
\-- on the phone \-- to sort of send e-mails in with suggestions. And
then John, maybe the staff, ONC staff and you and I can sort of whittle
\-- sort of go through it and come back and maybe we can go through an
e-mail process to sort of settle it. Does that make sense to people?
Because we have time.

[**\>\> John Lumpkin:**]{.underline}

Right.

[**\>\> Steven Solomon:**]{.underline}

So you\'d prefer for us at CDC, to wait and hear from you on what kind
of input you think would be best for us to provide?

[**\>\> Chip Kahn:**]{.underline}

I think we have, John described, it though, didn\'t you?

[**\>\> John Lumpkin:**]{.underline}

Yeah, I think that \-- you know, I think as part of the e-mail process,
having CDC give input on how they would envision it would be very
helpful.

[**\>\> Steven Solomon:**]{.underline}

Oh, okay. Happy, happy to do it.

[**\>\>**]{.underline}

So then we would ask each of the \-- each of the groups involved (audio
disruption).

The only other thought is that if the ONC staff could touch base with
the emergency response at the Secretary\'s level, I forget what that
group is called. And who heads that up.

[**\>\>**]{.underline}

We\'ll do that.

[**\>\> John Lumpkin:**]{.underline}

Okay. And then we probably \-- and this is something that we can do when
we are putting this together. I think, if we don\'t have somebody from
DHS there, we'd be making a mistake. Homeland Security. In my
experience, frequently, I find those of us in health and public health
have a whole lot of plans which DHS may be completely unaware of, and
dismissive of. If we don\'t talk ahead of time.

[**\>\>**]{.underline}

John, that may be a good place to invite somebody like John Kramer who
is the new deputy chief medical officer with Runge.

[**\>\>**]{.underline}

Yeah.

[**\>\>**]{.underline}

Are there any programs in FEMA related to things that we need to know
about?

**[\>\> John Lumpkin:]{.underline}**

I think that \-- within the, FEMA within the umbrella of DHS.

[**\>\>**]{.underline}

Okay.

[**\>\> John Lumpkin:**]{.underline}

So we\'re going to ask everybody to send in your suggestions, and we\'ll
try to shape this up through e-mail. Okay, I think that we\'ve made a
lot of progress on this item and it sounds like we have a very
interesting session for our next meeting.

[**\>\> Steven Solomon:**]{.underline}

I\'m sorry, Steve Solomon again. Is the date of the March meeting set
yet?

[**\>\> John Lumpkin:**]{.underline}

It is. While we move on to the next point and while I wait for my
computer to get off the screen saver I will tell you what it is unless
somebody else has it.

[**\>\>**]{.underline}

It\'s March 2nd.

**[\>\> Chip Kahn:]{.underline}**

And let me suggest that March 2nd we sort of do the same schedule. If
we\'re going to do \-- yeah, live. And let me ask the question on the
people from out of town that would plan to come. If 10:00 is a time on
the one side, what is the other side? Is 3:00 or 3:30 okay?

[**\>\>**]{.underline}

Works for me. I\'ve got a 5:00 flight that I can get back on.

[**\>\> Chip Kahn:**]{.underline}

Okay.

[**\>\> John Lumpkin:**]{.underline}

Good.

Okay, next step?

**[\>\> Chip Kahn:]{.underline}**

Well, the next step is \-- in my notes, I already did early in the
meeting. When I was sort of hurriedly \-- which is our timeline, which
I\'ll go through again just to sort of review with people. Is that on
the 23rd at the AHIC meeting there\'s going to be priority setting. Then
we\'ll go through a process leading up to the 2nd to get to everyone on
the phone a revised recommendation letter that both accounts for all the
input that\'s already been \-- already been placed with staff post-the
last meeting, as well as informing the draft of the letter with whatever
we learn from the AHIC meeting. And then we\'ll review that letter on
February 2nd, as I said, and then go through a process after that of
making final revisions and hopefully getting approval, consensus, and
getting it out by the middle of February. And then we talked about the
hearings, I think, as much as we need to, and the timing, and John, I
think, at least in terms of my notes, that that would cover everything
other than the \-- what was done today would be taken \-- or decisions
made today would be taken to the AHIC on the 23rd regarding the charge
and the title and everything.

So that\'s everything I have. Do you have anything else?

[**\>\> John Lumpkin:**]{.underline}

No, I think we\'re ready for public comment.

[**\>\> Chip Kahn:**]{.underline}

Okay, so now we go to public comment.

[**\>\> Judy Sparrow:**]{.underline}

Great, Matt, can you bring up --

[**\>\> Matt McCoy:**]{.underline}

Sure. Excuse me. If there are members of the public who are listening to
the Webcast right now, you'll see that there\'s now a slide on the
screen with a phone number to call. When you are connected you have to
press star-1. If you called in to join the call previously and you are
on listen-only mode, press star-1 to get in the queue for a question.
We\'ll wait about a minute through, and if nobody calls in by then,
we\'ll be done with public comments.

[**\>\> John Lumpkin:**]{.underline}

Do we have an idea, on these calls, how long do we wait?

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

One minute.

[**\>\>**]{.underline}

Yeah.

[**\>\>**]{.underline}

And \--

[**\>\>**]{.underline}

Another few seconds.

**[\>\> John Lumpkin:]{.underline}**

While we\'re waiting, just a detail, Chip. I think we\'ll need to get
together probably in a week or so to finalize the questions.

[**\>\> Chip Kahn:**]{.underline}

Yes, I think so. Judy, I guess \-- will set it up?

[**\>\> Judy Sparrow:**]{.underline}

Yes.

[**\>\> Matt McCoy:**]{.underline}

No public comments today.

[**\>\> Chip Kahn:**]{.underline}

Okay, well, thanks everybody.

[**\>\> John Lumpkin:**]{.underline}

Just one thing before we go. If you would like to have input on the
questions that are formally sent to the people who will participate in
the meeting on the 2nd, please send those in.

Okay.

[**\>\>**]{.underline}

Great. Well, thank you, John.

[**\>\>**]{.underline}

Thank you.

[**\>\>**]{.underline}

Thank you.

[**\>\>**]{.underline}

Thank you.

[**\>\>**]{.underline}

Bye.

[**\>\>**]{.underline}

Bye-bye.

[**\>\>**]{.underline}

Bye.