American Health Information Community

Biosurveillance Workgroup

May 4, 2006

1:00 p.m. EDT

**Disclaimer**

*The views expressed in written conference materials or publications and
by speakers and moderators at DHHS-sponsored conferences do not
necessarily reflect the official policies of the DHHS; nor does mention
of trade names, commercial practices, or organizations imply endorsement
by the U.S. Government.*

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

Let\'s do a roll call, and let me also say that as the last meeting,
we\'ll have for the members an open phone so people can comment. It
worked fine last time, so we\'ll do that again. Let\'s start the roll
call.

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

Okay, sure. Joining us on the phone today for the AHIC Biosurveillance
Workgroup meeting we have Jeff Wells, who is calling in on behalf of
Mitch Roob; Brian Keaton, from the College of American Physicians;
Thomas Frieden from New York City; Scott Becker from the Association of
Public Health Laboratories; Leah Devlin from North Carolina; Dr. David
Brailer at ONC; I believe Lieutenant Colonel David Parramore is there;
Chip Kahn, our Co-chair, is at ONC. And I believe there\'s a few more in
the room.

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

Yes, John Loonsk, I\'m here.

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

Laura Conn from the CDC, sitting in for Dr. Gerberding who will be
joining us late.

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

Is there anybody we missed?

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

Sounds good. Well, welcome, everyone, again. And let me go through all
the agenda, and then I will pass the baton off to David for a few
comments. Let me say to all the members that I sent out an e-mail
yesterday to alert you that I believe with the letter that we\'re going
to discuss, and after I finish my letter discussion now, today\'s
comments, we\'ll get into a review of those draft recommendations, and
then talk about the next steps. Hopefully, if we have a consensus, to
proceeding to the Community meeting.

I believe that we had a great discussion last meeting that we got really
out the major concerns, and that what the staff has produced to
recommend to us is a set of recommendations that on the one hand, in a
sense set up a process, a process that I think will respond to a lot of
the issues, in terms of expert designation of what the \"it\" is in
terms of what might be collected, and then direction towards a
memorandum of understanding that would be drafted and negotiated between
the public health entities here. A subject I think that the
recommendations are such that we can go forward.

And as I said in my e-mail yesterday, I know how anxious the Secretary
is that we proceed. And so depending obviously on our discussion in a
few moments, I think it is important for us to make a hard try at coming
to closure on this so that we could go to the AHIC at its next meeting
in May, rather than waiting until June, which is what I suggested to the
Workgroup at the last meeting.

I just think we made a lot of progress, and that in a sense everything
here is in the details of the process that will come after the AHIC has
acted. And I think there is a will to go forward with this project, and
I personally think, from the standpoint of my constituency, but just
generally as someone who does health policy, that if we look at the
threat that we\'re under, that the Secretary \--obviously protected
information, but the Secretary needs to be put in a position where he
has the best information available. And well have an opportunity here to
help provide him that information, to meet the threats, albeit with all
of the responsibility of local jurisdictions and State jurisdictions of
carrying out investigations and the enforcement that they must in terms
of implementing their responsibilities in a public health emergency.

But the Secretary needs to have information, and this I think provides
the basis for that.

So with those remarks, let me pass the baton on to David, and then when
David is finished we can go sort of step-by-step through the letter, and
have a full discussion, and see where the group is after we go through
that.

David?

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

Okay, thanks, Chip I appreciate it very much. Let me start by thanking
the members of the Workgroup for what has been an enormous investment of
time and energy. I know by participating in part of the meetings,
getting debriefings on all the meetings, and talking with a number of
you outside of the context that this has been a big investment in
something that you\'re all very passionate about.

To that end, I know that we\'re now coming to the end of a very long and
fast-moving march towards getting some results that we can bring to the
American Health Information Community that marks our work. And May 16
obviously is that date, and you know that well.

During that meeting we\'re going to be having presentations from all
four workgroups, yours included. And the presentations will be divided
into three categories.

First and foremost, and of most importance to this group, is our
recommendations that will come forward in the form of a draft letter
that you have before you, followed by a PowerPoint that encapsulates the
key pieces as well, that is asking the American Health Information
Community to accept by consensus these recommendations, to make them
their own, and to pass them on to the respective parties, in many cases
the Federal Government.

We\'re asking the AHIC to also pass recommendations on to other parties,
private-sector groups, State and local groups. Where in law it doesn\'t
have the jurisdiction or authority to do that, it certainly can do that
on behalf of its role as a public and private convener that we tried to
vest with the leadership role.

The AHIC could choose to send back these recommendations for further
work, it could choose to turn them down. It\'s an unpredictable thing,
it\'s a group of commissioners that have again their own collective
views. But I think your workgroup\'s role is to defend the
recommendations.

The second category is things that are issues that require guidance.
Large issues. We\'ve had these in many groups, about whether data should
be patient centric or transaction specific, is one that\'s come up in
another group, and it\'s actually been resolved in the Workgroup. But if
you have issues that you believe you simply can\'t resolve in the
Workgroup, and you need very large-scale guidance about big fractures,
big divides, issues that require this group to come together and give
you some guidance, perhaps, to allow your work to be more accelerated,
those are issues we would ask to you bring forward. Those are not
written in letter form, those come in the form of a presentation and
oral discussion.

And finally, an illumination of things to come, we called these evolving
recommendations in the past. What it is you\'re going to be talking
about as you begin to look further into the future.

May 16 represents a turning point in another way, which is we will move
from this rapid short-term focus of a very narrow-term set of
recommendations to a broader set of recommendations that are for the
broader charge. Things that will take place over the longer term. We\'re
going to decelerate a little bit, we\'re going to step back, make sure
we have time for those broader-scale things to play out. But there\'s no
substitute for coming forward with recommendations that you can help
focus on the short-term goal.

Now, I know particularly for this Workgroup, looking at your letter, you
have many fewer specific recommendations than other workgroups at this
point. And I think that\'s because of the nature of the different
constituencies that are participating in this, and the very big issues
that you\'ve had to wrestle with. So it\'s our hope that you will
actually do something different than the other workgroups, which is on
May 16 present some of these core recommendations that are ensconced in
your draft letter, and on the June 13 meeting, less than a month away,
you\'ll come forward with more specific recommendations, still relevant
to the short-term charge, and that you don\'t really turn your attention
to the broader charge issues until that work is dispensed.

Largely speaking, if we don\'t have recommendations coming into the
Federal Government by June it would not be possible for us to have
actions taken in 2006 that could allow these 1-year goals we\'ve laid
out for the specific charges to be realized.

So we\'re down to the last week, here, for the May 16 meeting, and the
last 5 weeks for the June 13 meeting. So from that perspective, I think
the discussion you\'re about to have, about this fundamental issue of
simultaneity of data, and conditions that have to be present to allow
that to happen. I\'m certainly hoping as a gateway and enabler of many
other specific recommendations to come, and certainly the broader charge
in the future.

With that, let me just thank you all for your hard work, and I\'ll pass
it back to Chip.

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

Thanks, David. Let me make the recommendation that if we look at the
letter, obviously, the first number of pages are sort of background. And
my recommendation to the group would be that we turn pages to see
whether anybody has any objections or suggestions for modifications, but
that we then focus on each of the numbered recommendations specifically.

So let\'s sort of rapidly sort of turn pages, and let somebody have
specific thing they want to change, and then let\'s sort of focus on
1.0, and then obviously each of the numbered, 2, and 3, and 4, which is
sort of the key areas.

Are there any \-- in terms of the basic introduction to the Secretary
and the background as outlined here, sort of a summary of where we are,
our purpose, and the study that we\'ve done, are there any concerns,
thoughts, ideas for revision before we proceed beyond that?

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

Just one very minor one, this is Tom Frieden in New York. On page 3,
just before Recommendation 1, that paragraph I think is unnecessary, and
raises a whole lot of issues that I think are complex and about which
there may not be consensus. So it just \-- I don\'t think it adds
anything, it\'s just easier to just delete it.

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

That\'s the finding?

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

I\'m sorry, under preliminary recommendations, data strategy, the
paragraph just before Recommendation 1.0 that begins, \"In determining
the value.\"

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

Oh, okay. Then let\'s \-- looking around the table here.

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

Tom, this is Kelly Cronin. I think we tried to reflect what had been
discussed from the first Workgroup meeting. We don\'t want to have
anything that\'s inflammatory, but I think we tried to capture sort of
the public deliberations, here. Is there something you think is
factually incorrect?

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

It\'s just the subjective, objective types of data is a little
confusing, and it just raises a whole host of issues. Maybe there\'s a
way to say it. I\'m not sure even exactly what point is being made,
here.

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

So it\'s in determining the value of the data needed? Then I think a lot
of this discussion was more from the clinical perspective. I think
Brian, if you\'re on the line, you may want to speak to your opinions,
here. Because I think that you had raised this issue a couple meetings
ago.

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

This is Brian. I agree with Tom, in that in this particular context
it\'s probably not necessary verbiage. It\'s something that\'s going to
need to be considered once we put together the Data Workgroup, and I
think it gets hashed out at that level. I\'m not sure that it
necessarily adds anything to the recommendation or the discussion and
just maybe causes some confusion at this point.

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

Okay, so let\'s excise that, and let\'s go on to substance in
Recommendation 1.

And I guess what this part does, is by putting HHS in collaboration with
the public health representatives at both levels, we set up the group
that\'s actually going to make the recommendations on what information
would be sought. I think that\'s a fair characterization. So \-- and we
discussed at the last meeting, I think there were concerns expressed at
the last meeting about exactly, you know, what the data points were
going to be. And in a sense, here, we set up a process to get the right
people together to make those determinations, meeting all the different
criteria for that, that we have discussed.

How do people feel about that as an approach? Does it respond to what we
had in the last meeting, and are there any suggestions for
modifications?

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

This is Leah in North Carolina. The comments that Dr. Brailer made about
the time frame, and getting things together in some specificity by June
18 or so, does that have implications for the dates in all these
different recommendations, or are we in synch with what he was saying?

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

I\'m looking at Kelly to make sure I understand that because I\'m
not \--

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

Yeah, I think \-- I think it does, in spirit. If we feel that this
independent group of experts needs to get set up immediately, so that we
can have some progress realized this year, that we probably would not
want to wait until the June 13 meeting, which is probably an issue that
requires some immediate action and organization. But yet if, you know,
we have further discussion today where we feel that we need to make more
recommendations that would specify perhaps the mid- or longer-term scope
of this group, we should have ample opportunity to do that for the June
13 meeting.

So we have another opportunity to get more specific, but I think, if
this group is going to be established and take on this responsibility,
then the early work to get that done needs to be done immediately. If in
fact this (indiscernible) recognized by the Community.

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

In some ways this is the keystone of everything else. Before you even
get started you\'ve got to decide what you\'re seeking.

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

Right.

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

And it seems to me what we\'ve got here \-- I don\'t want to sound like
a broken record, but tries to respect the discussion with that, and if
we can agree to this, then clearly we want to do this, and if we \-- and
once it gets started, this group should have the right kind of people on
it to take care of itself.

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

I just had two small or \-- issues, and one larger one about 1.0. First,
I would recommend that CSTE be specifically named in addition to ASTHO
and NACCHO. And second, I think the time frame to expect them to
actually have the technical specifications for data elements and
filtering by September 30 is probably not realistic.

My more general comment has to do with the four different types of
information that we\'ve been speaking about in the other calls that
we\'ve had, and I think in the interests of moving it further along, I
thought we had some consensus on those issues. And so specifying them
might help define and facilitate the process, those four things being
hospital, bed, and intensive care unit utilization; second being
electronic laboratory reporting of specific notifiable diseases; the
third being the biosense kind of deep application and the importance of
getting data, analyzing, and seeing what\'s of utility; and the fourth
was looking at existing large data systems that might be available in
States and localities or easily become available, which could be
aggregated to give real-time, helpful information on a nationwide basis.

So I thought it might be worth mentioning those four things. I\'m not
sure exactly where that fits, whether in this recommendation or a
subrecommendation or separate recommendation, but those are just two
small, and one more general comments. No real disagreements, just a \--

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

If we could take it from the top, I think in terms of ASTHO \-- I mean
in terms of CSTE, my question I guess is is that sort of up to ASTHO to
decide that?

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

These are independent organizations.

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

Hi, this is Scott Becker, and I\'m with \-- obviously, with ATHL and we
are an ASTHO affiliate. I think I would echo Tom\'s interest in having
CSE and ASTHO, because I think of course we do work with and through
ASTHO, but we would bring a little bit different input to it.

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

This is Leah Devlin. I guess I\'m kind of representing ASTHO as well,
and I would agree with that. I think they\'ve been pretty vocal about
the specific issues that they need to see addressed, so I think we can
be explicit.

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

This is Brian, I would echo those comments when it comes to ASIP, they
were likely the major source of the data in process \--

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

I\'m confused by that last comment.

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

If we\'re going to be naming the people that participate in this group I
want to be sure the emergency physicians are represented in that \-- if
we trust the group is going to be made up of the appropriate people, and
leave that as a general term, and trust that all of the interested and
appropriate individuals are included, and that\'s fine, too. But my only
point is if we\'re going to name participants that we be added to that
list.

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

This is John Loonsk. I think we\'ve sort of encapsulated some of the
issues here, that when you start to get into much more specific
detailing the group starts to get pretty big pretty fast with a lot of
interested parties, and just that was I think one of the reasons for
thinking about ASTHO, NACCHO, and HHS, that that\'s a balance that has
been accomplished in previous circumstances in public health issues. But
it does become pretty big pretty fast, if you start to name specifics.

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

Well the specific is you\'re asking my vendors and members \-- this is
Brian again \-- to do the work, and I think we need to be involved in
the discussion of the work involved in getting that data.

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

Well, let me \-- I guess part of the question is who is mentioned here,
and who is going to be on the commission, this doesn\'t limit it. But
then the question would be if you\'re not going to limit it, why are you
limiting it here and not assuring people \-- I guess there are two ways
we can go. One way would be to blow it up, I mean in terms of putting
more groups in. Which I\'m sort of hesitant to do. Let me look at the
people around the table here. We could just say in collaboration with
State and local public health \-- representatives of State and local
public health officers, and not mention organizations, and then we would
know after as we go back to them.

Is that something we could do? I\'m going the other direction, but
leaving it \--

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

I\'m assuming that the membership will be something that is exposed to
this working group \-- this working group, and if there are groups that
aren\'t represented when it gets that detailed, there will be an
opportunity for that discussion.

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

But I think in terms of \-- obviously, with all these kinds of issues,
you\'re going to get the usual suspects. So rather than expand, why
don\'t we just change the language that of course HHS would do this in
collaboration with \-- public health partners, actually that\'s good.
Because that will obviously allow us to have the physicians. Okay.

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

This is Brian. I would say public health partners and appropriate care
providers. Because again, the hospital association is not maybe on this
call, but they\'re going to have a vested interest as well.

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

Thank you for watching for my vested interest. Thank you. Thank you.

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

Forgot all about you, Chip.

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

You\'re the one that reminded me. So okay, we\'ll take care of that.

Now, Tom, I\'m sorry, I was making notes, what was your date issue
again, the second one?

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

9/30/06 seems unrealistically ambitious. I\'m always thinking things
should be done tomorrow, but it\'s a huge amount of work, and to expect
it will be done in a 2- or 3-month period just doesn\'t seem very
realistic. Maybe a preliminary report by then, but to get the details
down is actually a huge amount of work here, it includes the filtering
data, it just \-- just realistically seems like it\'s going to be
difficult to meet that deadline.

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

This is John. There are some contract deliverables that are dependent on
having at least at a high level some specifics in this area. And, you
know, I don\'t know the exquisite detail of exact codes for filtering
will have to be determined, but the Health Information Technology
Standards Panel, for example, has contract deliverables and turnaround
standards that are based on having some specificity here.

So I would encourage trying to keep on track with this time frame, and
I \-- you know, certainly would be within the purview of the group, I
suppose, to stage those deliverables to some extent.

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

So maybe get the first set of deliverables by 9/30, but not have the
entire suite?

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

When you say should identify the technical specifications with these
requirements \--

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

HITSP is being expected to not determine which data, but determine how
the data that has been named are standardized. So what the terminology
would be, for example, to express a particular data field.

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

So I guess the question then is can we have any data decided on by then,
that you then provide the specs for? Is that really \--

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

Yeah, and in general, they\'ve started to focus on the broad set, and
that that focus on the broad set, determine what the appropriate
standards are for that broad set could be something that is then honed
by the deliberation of this committee. Instead of having for the HITSP
to start afresh when the committee comes to some sort of conclusion.

But to do that, and to have September deliverables, HITSP still needs
some level of determination in the time frame identified.

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

It seems to me if you\'re going to do it in traunches, then whatever
this initial traunch is, is going to have to carry you for awhile.
Because it\'s a lot \-- your cycle in other things is going to be at
least annual or something, isn\'t it? Am I missing something?

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

Well, there could be subannual refinement as well, but generally,
you\'re correct.

You know, one of the efforts that this working group has been pursuing,
is looking at the systems that are out there. So I don\'t think this is
green field. I mean, this is an area that has been worked to a
significant degree. So I would be optimistic that at a high level, the
data needed could be identified in this time period.

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

What about the phrase the necessary filtering, is that necessary? Seems
to me it\'s kind of vague. Because it\'s really getting into issues, it
seems to me, related to sort of what the uses, specific uses are going
to be, exclusions, and so forth. And that might be \-- you know, might
be better to let the group address that, and it might vary.

But filtering, I don\'t think of this as filtering, per se. I think of
it very \-- actually, in part related to what HITSP needs to do.

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

The context for the filtering here, is if indeed you\'re talking about a
set of data that are going to the purposes of say ICD-coded diagnosis
coming from an emergency room, for example, that there are probably,
there are, diagnoses that do not need to be forwarded in this context
that are of a sensitive nature, and are not contributing to the overall
need.

And so because of the concerns about privacy and confidentiality, that
having a reasonable set of those codes that would be forwarded in the
context of this activity, I think is helpful to many to understand that
its focused on the areas of need.

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

Also, when we finish filtering does that means in terms of records
taking stuff off of it?

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

Taking records off, you don\'t necessarily for these purposes need, for
example, every single lab result that is being done in a clinical
setting, or every diagnosis. There are intermediate diagnoses, you have
to address issues of are you getting a single diagnosis for that visit,
are you getting a diagnosis every certain number of hours. But the \--
in thinking about the number of these codes that travel inside of the
clinical setting, it is a subset of those that are needed to advance to
support this need. And not, as was specified before, the zillion results
that travel across the \-- inside the hospital network.

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

I don\'t want to argue, but it seems to me that the committee could deal
with that. That should be on the table.

But, you know, I view this as kind of a feedback process. You know, we
start with a dataset, it\'s not inviolate. Down the line it could very
well change. And what\'s necessary filtering now could well be
determined to be unnecessary or it\'s important that it not be filtered,
and in fact we want to come back and change it.

I think if we give the right charge to the committee, we can handle it.
It makes it sound inviolate.

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

Let me ask this question, though. It seems to me that the filtering, in
a sense, to have it here as explicit as it is, so it meets some of the
discussion we had and concerns in the discussion, previous, at least the
one I was involved in, and I wonder on the phone if anybody else has any
comments, because I think it does \-- I understand the point, but I
think we were in a sense trying to meet concerns, here. It could be at
this level, or it could be at the level of the charge to the committee,
but I think \-- is that the case?

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

I do think \-- this is Tom Frieden. I do think it\'s important to at
least get the principles of, again agree with \-- don\'t expect the
committee to get all the LOINC codes down, but the principles of what
kind of information gets filtered out at different levels, and doesn\'t
get filtered out. You know, for example, there are locally and
State-notifiable diseases where you get all the information and you want
to be clear that some of the personal identifiers wouldn\'t go further.
There might in some applications be recodings that would go, but not raw
data that would go out.

So I think the concept and the principle that filtering is a key
component of building biosurveillance systems, that seems to me to be
important.

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

Is it the term "necessary"? Would "needed" be \--

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

I was thinking "appropriate." I was thinking "appropriate," actually.

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

Okay.

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

Tom, is that okay with you?

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

Absolutely.

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

I guess I\'m wondering, just to get this date settled, it seems to me
that if we\'re going to have the traunch concept that this sentence here
really refers back to this group is going to get together and identify
data elements and appropriate filtering of the data ,so on and so on.
HITSP should identify the technical associations for these data
requirements by \--

It seems to me if we\'re going to be talking about an initial set, that
concept needs to be up here, don\'t you think?

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

We could say HITSP should identify the initial technical specifications
for these notifiers.

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

I would say for the initial dataset, whatever. Implicit in an initial
dataset, is that there may be other datasets, and it doesn\'t mean it
has to be this dataset, it\'s just the one you come up with first, but
we want to come up with something by 9/30/06.

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

If we don\'t, we won\'t implement anything in this program. Because you
really have to have the technical specifications to take the next step.

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

Right. The problem we have is that the reality of these things, you
know, Tom is actually talking about the reality things, so the best you
can probably do is couple with a limited number of items that you
consider really essential at this time, and then get those on track. And
that\'s going to be hard within that period, I would imagine.

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

Because this is going to continue the cycle, you know, later this is
not \-- it\'s not going to stay like this forever, as you said, it will
come back, and this can be expanded appropriately.

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

Tom, does that work for you?

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

Yeah, that\'s fine.

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

Okay. Now, let me make sure I\'ve got the other items. You were
suggesting someplace in the document, but we might as well discuss it
here, I\'m not exactly sure, with the hospital bed unit use,
utilization \-- I have my notes \-- and then the deep applications and
existing large dataset. What\'s the feeling about that?

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

I felt that we had had discussion about the separation of some of the
utilization data at some conceptual level, but I think there were still
some issues here that weren\'t discussed that make it unattractive to
get to those trunks, if you will, and part of it relates to common
infrastructure, and the needs to not be making multiple requests in
different planes, and trying to identify common streams where possible
for doing that.

And some of it relates to just the fact that some of these lines, these
traditional lines of the way data are chunked, fall apart when you start
looking at clinical data. You know, we\'re not going to be getting
full-fledged case reports. Lab results don\'t \-- are going to need to
come from the same clinical care sites at times that are producing some
of the other clinical data. And we don\'t want to be expressing the fact
that we are thinking of these as necessarily separate \-- based on
totally separate infrastructure and totally separate systems, and I
think we run that risk if we start to prejudge that conversation and
start to (indiscernible).

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

Given that, I think we have all four of these types of data sources in
Recommendation 1.0 and 1.1. So 1.0 talks to \-- utilization is not in
there, and it should be.

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

Yeah, I don\'t want to spend a lot of time on the call, you could just
add into 1.1 kind of a comment about limited dataset, with demonstrated
value, and then add kind of an e.g., hospital and intensive care
utilization, electronic laboratory reporting, which is usually not from
clinical care sites, it\'s usually from laboratories.

And then clinical data from different sources, and we\'ve been talking
some about two different approaches to that.

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

I\'m sorry, I just \-- I think the opportunity here for lab results is
that the vast majority of them in fact do occur inside of clinical care
sites, and that that opportunity will be lost if we separate them out. I
mean, I know that the activity you are largely referring to, Tom, is
getting the national labs to make their results available, but I think,
I hope, that the scope of it is broader than that.

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

Right. And the national lab as a data source target would fall under the
1.1. So a broader geographic coverage, but narrower essentially dataset.
So I think your fourth item there is really 1.1.

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

Let me ask a question, I understand this. So if we \-- the difficulty
with an e.g., for me, is not what\'s in there, but what\'s not. And even
though an e.g. is not an i.e., it still presents issues in something
like this, because if you put it in there, you meant it, and if you
didn\'t put something else in there, why didn\'t you when you had the
opportunity.

So I come back and say utilization is not embedded in 1.0, 1.1 right
now, and it should be. Rather than specific, conceptually, other than
utilization, what is not imbedded in 1.0, 1.1, let me throw that out as
a way to approach it.

Tom, could we live with putting in utilization, and at least avoid the
e.g. at this point, and knowing that this expert panel is going to come
around on all these items, and there will be another chance to get it
into the \-- I mean, actually there will be a chance to get into what
the \"it\" is? Is that something or \--

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

That\'s okay. I\'m going to have to leave the call at 2:00, so I\'m
particularly agreeable to any changes you want.

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

You know the two rules, Tom. One is you should never negotiate yourself,
and the other is you should never tell the Chairman when you\'re going
to leave the meeting. We won\'t abuse either one.

Okay, so let\'s move on to 2, and this is for purposes of
biosurveillance breakthrough initiatives, CDC should establish
memorandum of understanding. I mean, in a sense \--

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

Can I raise something, just go back \-- but \--

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

Sure.

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

There\'s \-- in terms \--

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

Recommendation 1.1 says a more limited data across a broader geographic
area. But 1.0 doesn\'t reference a geographic area, and references only
a limited number of clinical data providers.

I\'m just pointing that out, and you know, I don\'t think it\'s
necessarily an issue, but, you know, for the truly anal compulsive, this
will raise the question as to what is the attachment area for
Recommendation 1.0, okay? Since it\'s going to be broadened in 1.1.

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

Yeah, I think in previous conversations we reached agreement that it
wouldn\'t be realistic to have a very broad-scale implementation of 1.0,
because the data is not going to be readily available across \-- maybe a
very large number of local and State jurisdictions.

So the 1.1 is intentionally meant to be more narrow in geographic scope.
Because of the limitations with either, you know, the capacity on the
public health side, or the ability for the local providers.

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

I get that. I understand that, it\'s just that 1.0 \-- I\'m just saying
that makes \-- it drops back to 1.0, and then how narrow is that, you
know. So is it \-- you know, several city blocks, is it \-- you know,
half a county, whatever. But I think, you know, I think the data
committee is going to have to address that. And it will.

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

Now, I think in a sense that, you know, the things that hold up the
stool, here, is obviously the data committee. And then second it\'s the
understanding that would be arrived at between the public health entity
to allow for this \-- and I guess a simultaneous data flow, actual \--
you know, or real time, hopefully, or relatively real time, which makes
this meaningful.

This is the other piece. So I don\'t need to read it, it\'s in front of
everyone. What\'s your \-- what\'s your take on this? How should this be
worded if other than we\'ve got it down already?

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

This is Jeff Wells, I just have a question. Is it anticipated then that
the data steering committee would be the group responsible for coming up
with a list of that initial scope of providers, in that first
recommendation, and they would make those recommendations, along with
the data?

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

No, Jeff, I think \-- this is Kelly \-- I think we were intending just
to have their scope to be really more focused on the data itself, and
then it would be up to \-- you know, the partnership that we try to
establish more on an operational level, you know, between local, State,
and Federal public health, and the clinical partners. So that\'s going
to be probably more of an implementation issue. We need to figure out
realistically what can get done in the next 12 months or so.

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

I don\'t think the \-- obviously you\'re going to be looking at, you
know, what are the threats or the information that we want the Secretary
to have that he could act on, if he needed to. I assume that\'s one of
the criteria. And you sort of go through that. Obviously, the committee
is going to be knowledgeable about where you get the information from.
So I mean, it sort of goes hand in hand, but at the end of the day it\'s
the memorandum and the relationships between the entities and the actual
providers that will have to \-- if I\'m catching it, that will determine
that.

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

I think also it\'s going to be sort of natural that the local
jurisdictions are going to have the relationships with the clinical
providers, and that\'s where the work will \-- you know, be spinning
from, and we\'ll be building off of those relationships and, you know,
probably the larger hospital systems as well, that really have the more
sophisticated technology and data.

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

It seems to me the first group wants some data point that obviously has
to come from doctors' offices. It ain\'t going to happen, it just ain\'t
going to happen. So there\'s going to be some discussion around \--

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

From a practical standpoint a lot of this has to be opportunistic, it\'s
a matching of what\'s available, and who is ready to provide it, against
the need. So I think it\'s not something you can specify sort of out
from the start, you need to work with the different communities, and the
different involved parties, to pull that out.

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

I mean I think at some point when whoever is chairing the expert panel,
when they provide some mandate to the panel, obviously this is something
the panel is going to have to think about. I mean, how realistic it is
to collect. Whatever the X is. But I think it\'s the memorandum under
which \-- assuming that made decisions that are realistic, you have to
talk about how the information is going to flow.

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

And what sites can contribute.

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

And what sites can contribute, and I guess that you could argue that
seems like a little bit of a chicken and egg, but I think all this is
going to proceed simultaneously in terms of the expert panel, if we\'re
going to make our schedule, and the public health entities working with
HHS to come up with this memorandum.

Does that satisfy people? Or do we need to make any other changes to
what we\'ve got, here?

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

Now, this is Leah Devlin. Are you all talking about #2?

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

Yes.

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

Okay, I have some comments about that.

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

Okay, Leah.

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

Specifically I think that where you say the Workgroup recognizes that
public health investigations are led by local, you need to say and State
jurisdictions. That\'s the reality of it out here in my State, and I
think when people say local, a lot of times they mean State and local,
but we need to be specific about it. Because I think what we\'re really
trying to articulate is almost more the Federal Government\'s role here,
than State and local.

So that\'s my recommendation. And then the next sentence would also say
local and State, might ask. And then it would just be CDC to
participate, when necessary, and when asked to come into your State. Or
CDC becomes involved when there\'s something across State or national
jurisdictions, that\'s what I would suggest.

And then there\'s one place in the recommendation itself where it needs
to say local and State jurisdictions.

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

Okay, I\'m sorry, Leah, you went back to the preamble, and then
obviously in the recommendation, where it\'s just local, and you\'re
suggesting it should be \--

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

Local and State, uh-huh.

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

The local and State additions I think are very helpful here. I think if
we go down the road of too much specificity about roles and
responsibilities outside of the MOU we\'ll get on a slippery slope
because they\'re out there on a public health emergency criteria that
needs to be considered. So I think to some extent that\'s the kind of
detailed work that needs to be done in the MOU versus in the
recommendation.

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

I mean, I\'ll throw it out, I\'m not suggesting it, I just wonder as
long as they\'re preserving traditional roles, that in a sense responds
to your point. But I think if people feel more comfortable with having
investigation there, it\'s fine with me. Okay, so \--

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

I have another suggestion, this is important. And I don\'t mean to be
working with you, but the sentence about typically States become
involved in investigations across local jurisdictional boundaries is not
accurate.

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

I\'m sorry \--

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

That\'s backing up.

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

I\'m still up in the preamble. That sentence is not accurate, that
States becomes involved in investigations that cross local
jurisdictional boundaries. We\'re in the counties when it\'s an even
individual county outbreak a lot. It doesn\'t have to cross county
boundaries for the State to be involved in a leadership role.

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

Yeah, I think on those you suggestions, which are excellent, will you
send the staff your wordsmithing suggestion? Because obviously we have
to take care of those, and they will do that for you.

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

Okay I\'m happy to.

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

So I\'m going to proceed beyond 2, if I hear no objection. And also I
want to give Tom the opportunity to comment, because I know you\'re
going to be leaving.

And let\'s proceed \-- obviously there\'s a preamble to 3. And 3 then
gets into this issue of confidentiality, and HHS should develop sample
data, use agreements to facilitate the sharing of data from health care
providers to State, local and Federal public health authorities.

And then under 3.1, is the guidance. And then 3.2, you know, is sort of
the collaboration over communications regarding these things.

Where are we with \-- and I\'ll sort of \-- I think the three \-- the
three is sort of a package together. So are there comments, where do we
want to go with that? On the preamble to that, if there\'s any
wordsmithing we could probably dispense with that and just have the
staff work on it. But are there substantive issues?

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

This is Tom Frieden, we\'ll send minor wordsmithing things. But I guess
the bigger issue on the third point for me is just as in the data, the
recommendations are to establish separate body to look at that, I think
that\'s probably even more important in the privacy issues, where the
public is going to want to know that it\'s someone beyond the government
that\'s safeguarding this, and setting the standards for it.

I think that\'s important in terms of credibility issues. Obviously, as
with the other, the government would have a key role in informing and
guiding that. But I think it is important, and I\'m not sure with the
other workgroups whether that would be an AHIC-wide privacy steering
committee, or something specific for \-- to biosurveillance. Because as
I understand, the issue is coming up in a lot of the workgroups.

And really, the need for strong participating, open discussion, is very
important, building on existing standards and policy. And I think that
the key concept for me is minimum data necessary. And that\'s something
that helps to sell it to the public and to providers.

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

Let me make this suggestion. Minimum data necessary is \-- I would
prefer we proceed \-- I think that there is a material difference
between the discussions, at least that I was involved in in the EHR
Workgroup, and here, in terms of this issue of identifiers, and the
protections. Because whereas in the other workgroups \-- and I can\'t
speak for all of them, but my sense is we\'re talking about
individualized \"its.\" Here, we\'re talking about something that is
quite different, we\'re talking about \-- you know, we\'re talking about
datasets that really are not designed for any personal identification.
Albeit there are situations where, you know, if you\'ve got a certain
town and certain demographics you probably could track it back. But
so \-- but let me make this suggestion, that we \-- that we \-- because
I think that if we set up a whole new expert panel to oversee that
specific issue in this context, we will get totally bogged down, and I
think that that will not serve the public well. Despite public concerns.
And my suggestion would be the following, is that we develop \-- and
there is language, but we somehow figure out how to address this notion
of minimum data necessary, with a big exclamation point.

And you look to #4, and maybe we strengthen in #4 \-- and here, I\'m
referring to 4.1. In 4.1, in the feedback loop, we have the protection
of patient confidentiality. And I know that looking at something after
the fact may be really problematic and, you know, for publicity and a
credibility standpoint, you know, you\'re almost \-- you know, if
you\'re right, Tom, and we\'re really exposed here, which I\'m not sure
I agree we are, but it\'s dangerous, but I would almost suggest that why
don\'t we embed your concept of minimum data necessary, and
strengthen \-- figure out some way to strengthen the 4.1, so that we\'ve
got people watching the process rather than establishing the process.

Because I think if we have it on the establishment side it ain\'t going
to get anywhere, and it really is a different issue than the other
groups.

I don\'t know how people feel about that.

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

So I guess I would reiterate, I think there are two separate issues
here. One is the "minimum data necessary" concept, and having that in
Item 4 is fine.

The second is the process. And I guess I am concerned that we have a
process in place that very clearly addresses the concerns, really, in
all of the health IT initiatives. Clinical care, consumer empowerment,
across the board. The Achilles heel of these projects is privacy
concerns. And unless we address them very well, it\'s likely to cause
serious problems in the future.

So I guess my feeling is that it should be a separate process for this
not to slow things down, or throw a wrench in it, but to make sure that
it doesn\'t get derailed in the future, when it\'s already starting to
move.

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

I guess my problem is I \-- having it as a watch \-- I guess I\'m not
responding \-- I\'m not responding to your need on the watchdog notion.
I think, though, if we go beyond the watchdog notion, this is just so
fundamentally \-- not that there aren\'t dangers here, and not that here
you aren\'t dealing with the government, which is \-- which some would
look upon with real suspicion, but this is really \-- I mean, this is at
the community level, this is not at the individual level, it is
fundamentally different than the rest of what we\'re working on at the
AHIC.

But all that being said, the possibility of misuse is always there, and
I\'m trying to find a middle ground here. Because I just think if we \--
if we go the whole route you\'re suggesting, we\'re not going to make
any progress, here. I mean, I think this is going to get bogged down.

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

Maybe the issue and the compromise is rather than specification, is to
think about policy guidance, or principles in this area. And we had some
comments at the last call, I think that individual is not on the call
here, but I think there are some real issues here. And I again emphasize
I raise these not to try to slow it down or derail or stop it, but
because I see it as a potential of undermining the process in the
future, if we don\'t address it well up front.

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

You know, and I\'m open. I guess my one concern is \-- and if we set up
a process, and then the next thing \-- because we\'ve had this at the
last discussion \-- the necessary things one would say is, well, we need
to have all the stakeholders there. And as soon as we have all the
stakeholders there, we have people that look at this from an
individualized level rather than a community level.

And at the end of the day, this is a community, not \-- I mean, it\'s a
community issue, and not an individualized issue. And I guess \-- so
I\'m a little bit \-- you know, if you get the experts around the table
to define what the principles are to meet a mandate that nothing
individual be revealed, that\'s one thing. But as soon as you get people
with the \-- who as stakeholders are protecting the individual, you get
in a circle and you can\'t get out of that circle. Am I missing
something?

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

Isn\'t it \-- it seems to me it\'s a practical consideration of this
that whatever Recommendation 3.0 or 3.1, these are going to have to be
shared. This to me says that development is going to take principally
from HHS, that there\'s going to be some \-- you know, some feedback
along the way, and we\'re just being less specific about it at this
point, to move the process along. I certainly \-- I think everybody
shares the concern about this topic, and it\'s only going to get hotter
than it has, because we\'ve got these potential regs in other areas
coming down. New Hampshire today, for example, they\'re marching on the
State house to support New Hampshire not being part of the real ID
initiative. And it\'s just going to get hotter. So it just behooves us,
we have to be sure we\'re talking to experts in this area.

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

Now, let me say that \-- and I know everyone received the e-mail from
Mark Rothstein, so I think this would be the appropriate time to bring
up his recommendation. Obviously, he felt strongly \-- you know, of the
minimum necessary data. But his #2, I think the recommendations should
include a statement that health care providers, covered entities under
HIPAA, should mention the biosurveillance network in their notice of
privacy practices distributed to patients. Current notices list
disclosures for which no additional authorization is required, including
for public health. Nevertheless, a new system characterized by real-time
electronic transmissions of partially identified health information is a
departure from public health reporting that should be exposed to
patients. The failure to do so will turn the biosurveillance issue into
an operation issue that will lose public support.

One alternative we could do is ask for such a notice. I mean, obviously
in HIPAA compliance all this stuff is out there now, and I suppose the
Secretary could ask that this be included, and then you\'re noticing
people. And you\'re saying that it\'s a public health information, but
you\'re noticing them.

Maybe that\'s the best way to go, because I\'m just concerned that if we
try to adjudicate this, in the way that we might end up doing it, that
we\'re going to get on some kind of circle that we never get off of.

I\'m not necessarily suggesting on that, but that\'s a possibility,
then, going to your public with it, then you could say it was disclosed.
I don\'t know. How do people think about that?

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

I think it\'s a reasonable approach to consider it. One of the things
that \-- you know, the HIPAA experts might have some concern with it.
HIPAA already explicitly allows for the sharing of data for public
health purposes. Is just all of a sudden treating it differently, does
it make it somehow inconsistent with the current law, if you are going
to explicitly require \--

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

Well, it depends on what you\'re requiring. I think if you \-- here we
get back to, e.g. \-- and I don\'t have my HIPAA language memorized, but
presumably, you know, there are HIPAA forms for everything, and I guess
the question is, in whatever public health information sentences there
are, in the basic forms, if there was something that says \-- I mean,
you know, \-- there\'s a new X, and just let you know. But it\'s no
different, we already have the \--

Understand I\'m not arguing for this wording, I\'m just wondering is
there some wording that could be found \--

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

It will set the precedent for every kind of new message for collecting
existing health care data for public health purposes, then we have to
inform them that we\'re going to use it for \-- 

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

Let me put it this way, first, the language could be extremely broad.
And second, I suppose that would be an issue, and then other people in
the future would have to think about it.

But I mean, we want to get this biosurveillance thing going. I think the
issue that Tom has raised and that obviously Mark has raised is a real
one. For me, to for me to come back and \-- for me to come back and just
say we\'re going to do another evaluation is not going to meet the \--
is not going to meet the objection.

Let me ask this, because this is really a substantive thing. What if we
did the following. If we accepted the language that\'s in here now, for
the purposes of May, and maybe even put in here a sentence that the
Workgroup is going to do a little further work on the issue of
confidentiality, and we then ask for wordsmithing on this \-- on Mark\'s
recommendation, because I think there have been concerns raised about
the specific wording, and came back to the group between \-- you know,
after the May meeting, but in time for June, and have this as a \--
notice the AHIC that we might come back, and then spend some time
working on this language and this issue, and come back for the June
meeting.

Nothing, I don\'t think, will happening, obviously whatever is done in
May. Everybody else could get done, because \-- and we\'re not going to
lose any time by spending a little bit more time on this.

Would that be acceptable to the group?

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

Sounds good. Someone said at the outset that what\'s going to happen in
May is a presentation along with an outline of some issues \-- I think
David Brailer said, outline of some issues that AHIC may want to comment
specifically on. So you might broaden the suggestion to include some
input from AHIC, because I know a decision issue that\'s a common theme
across the initiative.

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

Leah: This is Leah. I\'m not in agreement with the language that\'s
here, and I\'m not sure that I\'m \-- I mean, I\'m not going to
obviously drag this out too much longer, but I believe that when we try
to treat this data sharing system, which is here for the public
protection, age of bioterrorism, national security, all that stuff \--
to try to fit that into the other models of patient privacy, clinical
care, and all that other individual kinds of stuff, that we\'re making a
big mistake, and we\'re shooting ourselves in the foot, and we\'re
raising unnecessary concern that is going to get in our way.

That \-- I really have a whole different view of this than some of us
have. And so I\'ll just say that. I just have a very \-- I think
there\'s a lot more interest in people sharing data that they think is
going to protect them and their families, than the other issues.

Now I do \-- and I think public health has a very strong traditional of
protecting confidentiality, and I don\'t want to do anything in this
process of overassuring to the point that we undermine our traditional
role. We are very good at this.

Now, the third thing I want to say is to say \-- those are just
overarching comments. I feel that to have three recommendations on the
privacy issues, 3.0, 1, and 2, is too much. And I would suggest that
Recommendation 3.0 and 3.1 be collapsed. That we have data use
agreements and implementation guidance for the data providers and
sharers, and then you can have a second one that\'s on the public.

I think to have three for privacy and two or one for everything else, is
overkill. In line with my first two overarching comments.

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

Let me ask two questions. First, so \-- I think Leah makes a good
suggestion in terms of the three, so I\'m going to work backwards on her
comments. Would that be acceptable to everyone, to just collapse those
two? It seems to me that makes sense.

Now, in terms of your other comment, I guess on the one hand I
completely agree with you, and that\'s one of the reasons I am concerned
about any kind of new big mechanism that will definitely get us bogged
down.

On the other, it seems to me that \-- let me ask you if you would
withhold your final judgment, because I think that we ought to play \--
we ought to have staff play with this language, and you could word the
language in such a way that it is both a warning \-- actually, I
shouldn\'t say warning \-- it is both a notice, because there\'s already
some notice there in the confidential language, I mean in the
confidentially \-- confidentiality forms people have to deal with
already, and you could word it in a positive way. That, you know, to
help protect you, public health information is being \-- whatever,
whatever. I don\'t want to wordsmith it here, because I think these are
the kinds of things where words really do matter.

But i would make that suggestion, then ask you to sort of wait until we
have \-- to see whether something like that might work for you?

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

Sure, that\'s fine. I\'m trying to bring some balance to this, because
I\'m on other end of this whole spectrum. But I\'ll be glad to look at
it later.

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

If we do that, in a sense it could be a sale language as well as notice
language, because if we only go as far as this, which is as far as I
think we should go, but I think others think we should go further, this
is partly CYA. Because we really do need to have on the evaluation side
some people really paying a lot of attention to this, because if we
screw up, that\'s going to be real bad.

I think that\'s your point, Tom.

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

Exactly.  I have to sign off, but thank you all very much. And Rick
Heffernan from the health department will be on the call.

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

Leah, do you have something else to say?

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

No, I say I like it being part of the evaluation. I like that initial
recommendation you had.

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

Let\'s do this, unless there are any more comments on 4 \-- are there
any more comments on 3? Let\'s go to 4. And obviously, this is the other
piece. Which is we\'re starting all this new stuff, and it\'s going to
have to be overseen to make sure, one, that it works; and two, that this
is a ramp up over time to some things, we\'re going to have to sort of
have a feedback loop to determine whether we should keep asking whatever
we\'re asking, or whether we should ask for other things or whether \--
you know, obviously that\'s what the evaluation would do.

Are there suggestions for any changes in the evaluation language, do we
want \-- I guess I wonder, let me make one thought, do we want to
separate out the protection \-- the patient \-- protection of patient
confidentiality? I\'m not sure how to word it, but almost make it
another sentence? Because in some ways, it\'s a little bit different.

I mean, it\'s a protection issue. Whereas the issues with respect to
value of data exchange and the need of modification in the program,
those are really \-- I mean, those are programmatic, whereas we just
want to make sure we\'re not doing anything wrong, would that be okay?
So we have, in a separate sentence \--

Not a separate recommendation, because there it\'s more highlighted. And
actually, it may be different people.

Here, yeah, under Evaluation.

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

Looking at that, I think the people in 1.0 are not necessarily the same
people that we would want in 4.0. I could see some overlap. But I think
a lot of people in 1.0 are just not going to have this outlook.

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

So we\'re getting to a second committee, then.

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

I wonder if we could have an overarching group, and have experts that
serves for more data purposes, versus experts that are going to have the
evaluation experience. But I think in essence, if we are wanting to have
the evaluation component recommend, you know \-- or take action to
specifically change the scope of data, or the type of data being
collected, they need that expertise. So there\'s a lot of overlapping
expertise, and perhaps we just need to figure out the comprehensive
composition to make sure we have the right \-- all the right disciplines
represented that can take on these different functions.

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

This is Brian. One comment, the same comments I made on 1.0 and 1.1, you
need to include the clinical care providers. You may find that CDC and
public health are thrilled with the way the system is working, but it\'s
killing the care providers and the hospitals that are having to collect
the data.

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

I endorse that. I endorse that.

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

I agree that might change throughout. \--

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

To protect \-- \--

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

And me.

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

All right, it seems like on 4, do we need to go on 4 anymore, or are we
sort of \-- obviously, from all our discussions, there were a lot of \--
not a lot, there are many areas where we needed some wordsmithing. Let
me look at the staff and say how long do you think it will to do the
next draft?

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

We\'ll try to get something done at the latest tomorrow morning, but
it\'s possible we\'d like to get something out tonight.

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

So we would then sort of move to e-mail in a sense that you would send
it out.

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

Yes.

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

And then if people have comments, they would feed them back to you, and
obviously \-- I\'ll be reading the comments, and if in the extra after
that, if there were any concerns, I\'d be happy to try to help work it
through.

That\'s the letter. Is there any other comments generally about the
letter, or can we move on?

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

Just one more minor process comment. We will actually get it out tonight
to everybody. Try to get back with comments by the end of tomorrow, it
will allow us to stay on time with all other workgroups in getting
materials out on Monday.

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

Okay, and in terms of next steps for finalizing the recommendations, we
discussed those, I think, right? Is there anything else that we need to
discuss regarding finalization?

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

Well, I guess the other thing I\'ll just mention is that we are going to
try to put PowerPoint presentation (indiscernible) select the final
language. So we\'ll have one slide per recommendation, and some
background for each area that we cover. But since we do have this open
issue regarding privacy, security or confidentiality, we\'ll also
include that in the presentation, and tee that up for input from the
committee so we can get their guidance on how we might move forward. In
any way that would be different from our proposed recommendation. And
we\'ll try to \-- we\'ll work with Dr. Gerberding, Chip and Mr. Kahn,
and Mr. Roob, excuse me, to make sure we finalize that in time for the
Community.

The only other process point I\'d bring up is if we are going to have
more deliberation around the issue related to the HIPAA privacy
notification, and there are probably going to be some other areas that
we might like to fine tune or have more discussion on before the June
meeting I think we\'re going to have the need to have one more Workgroup
meeting later in May and we\'ll also follow up with you to find out what
date might work best with everyone.

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

I think we\'ve finished our substantive agenda before we get to the
public input, right? Okay, if there are no other comments, we\'ll
proceed to public input. And the number is up. And I guess we\'ll give
you a few minutes.

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

Yeah, we\'ll give people about two or three minutes, is what we usually
do, Chip, to let people get through the operators, and if nobody calls
in by then I\'ll let you know.

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

We\'re ready. Oh, we have someone in person who would like to comment.
I\'m sorry, you are \--

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

Laura Tillinsky, one comment with regards to the data steering
committee. Given the fact that this is a new committee, probably, that
will be established, how will the public be able to give input, and may
I make the suggestion that that committee actually fall under the AHRQ
that allows other Federal agencies and the public and other public
health officers or partners to input into that, for the minimum dataset.

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

Thanks, that\'s a good question. We hadn\'t thought exactly about an
administrative home for this. It will really be unique in that it\'s
going to represent a local, State, Federal jurisdiction partnership, and
I don\'t know if we\'re thinking about it as a sort of federally housed.

So I think that\'s really going to \-- input, it will help us to
consider what would be the appropriate home, because that would be
transparent and allow for \-- the diverse input that it might need to
make some final or \-- (indiscernible) final.

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

Right. And the other thing that might be also is a possibility of the
metric part of the house, that there\'s a possible study being done at
the Federal level to look into the value contribution of doing
biosurveillance out there in the public sector. To share information,
both from a preventive health and wellness issue but also from a public
surveillance perspective, like for avian flu and other issues.

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

Thank you. Do we have anyone on the line?

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

No, we don\'t. Maybe another 30 seconds, and if nobody has gotten in by
then, we\'ll call it.

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

Okay. Appropriate for me to make a comment in regards to that comment?

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

Sure.

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

The National Committee on Vital Health Statistics, which advises the
Secretary, actually has quite a long history of looking at minimum
datasets for public health purposes. So I think it\'s something that we
ought to consider, maybe that could be a home for this. Or AHRQ, or
wherever it may be. But they have specifically focused on
(indiscernible) there.

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

Yeah, I think when we\'ve looked into this issue and at least gotten
some guidance internally from a legal perspective, that we need to
probably be careful not to have it a FACA process per se, because this
is an entity that will have direct \-- would have direct implication
over biosurveillance activities in local jurisdictions. So it\'s not
necessarily advising just the Secretary, I guess FACA committee does
what we\'re all involved with, and if it\'s going to be acting more like
a data, safety monitoring board which overseas clinical trials, which is
what we talked about last time, then it would have a different shape or
different administrative structure.

But I understand the critique and history, and suggest that perhaps we
can at least learn from them, from what they\'ve done in the past.

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

Doesn\'t look like we have any \--

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

Okay, that being the case we will \-- obviously staff will work on this
issue of how this group will be impaneled. And we\'ll proceed to get our
materials ready for the full AHIC meeting in a few days, and then we
will reconvene post that to consider the input from AHIC, and to work on
both the confidentiality issues, and other issues that may arise out of
the discussions, and further development of the effort. Thanks,
everybody.

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

Excuse me, who was it that we\'re to give the edits?

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

Yes, Laura, if you could e-mail them to me, that would be great.

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

And you\'re Kelly, right?

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

Yes.

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

Thank you.

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

She\'s on that list. Thanks, everybody.

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

Bye.

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

Bye.

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

This concludes today\'s conference, thank you for your participation.