American Health Information Community

Biosurveillance Workgroup

April 26, 2006

1:00 p.m. EDT

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by speakers and moderators at DHHS-sponsored conferences do not
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by the U.S. Government.*

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

We will begin at this time.

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

We have open lines today.

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

That\'s right, Kelly, and the public is listening now, if you want to
begin with introductory comments.

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

Okay, great. This is Kelly Cronin, welcome everyone to our
Biosurveillance Workgroup. We have an ambitious schedule today. I also
want to introduce Chip Kahn to everyone, he\'s the President of the
Federation of American Hospitals, he\'s also a member of the American
Health Information Community. He\'s been participating over the last few
months on the EHR Working Group, but since we\'ve been recognizing the
increasing importance of provider involvement in this particular
breakthrough project, we wanted to make sure that we had representation
from the community in a leadership role for this particular Workgroup.

We also recognize that we have several HHS agency heads who are
currently acting as Co-chairs, and while we greatly value their
participation, they\'re not always readily available to chair these
meetings. So we\'re thankful that Chip can join us as a Co-chair and
take a leadership role and trying to guide the Workgroup and
particularly bringing a provider perspective to this break group.

With that, I\'ll turn it over to Chip.

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

Thanks, Kelly. Welcome everyone, and I\'m happy to take over today to
help lead this meeting and lead us through a discussion. Apologize for
being a latecomer to the items, maybe in a sense that gives me a fresh
perspective. Because I think looking at the issues that we\'re going to
talk about in a next few minutes that we\'re actually fairly close.

And I\'d also like to say as a member of the community and having gone
through the discussions that the Secretary had with us, on the
community, regarding these various four areas that we had used as sort
of leaps to move forward, rapidly on, that in some ways, considering the
general health environment, this may be the most important group of all,
the one that can be most directly helpful to the work that HHS and the
Secretary have to do to help protect America\'s health. And I can\'t
overstate the need for us to bring our recommendations back to the
Community, and to really lay the groundwork for a program that will move
forward rapidly. Because the Secretary has set this as a goal that I
think we all really have to live up to.

Let me say to start off that it\'s my understanding that in terms of
this group reporting back into the Community, that we do have a luxury
that I hope you will not take \-- we\'ll take advantage of in the sense
we have a little bit more time, but that we\'ll try to come as much
closure today as we can. But we will be reporting at the June meeting
rather than the May meeting, in terms of our reporting back with our
recommendations.

All that being said, let me run through just the overall agenda, and
then we\'ll start. I guess the first thing that \-- should we do roll
call?

So before I run through the agenda, why don\'t we do a roll call, and
we\'ll start there. So would people start speaking up, identifying
themselves, and their organization. If they\'re here from the Workgroup.

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

I\'ll just do a quick rundown of people on the phone, it\'s probably
easier that way, then we can have members in the room introduce
themselves. Joining us over the phone we have Scott Becker from the
Association of Public Health Labs, Laura Conn from CDC, Leah Devlin from
North Carolina, Thomas Frieden from New York City Department of Health,
Adele Morris from Department of Treasury, Gavin O\'Brien from NIST,
Lieutenant Colonel David Parramore from the Department of Defense, Mark
Rothstein from University of Louisville, Larry Biggio from Wyoming, and
Jeff Wells and Mitch Roob will be joining us from Indiana. Is there any
worker members on the phone whose names I didn\'t read off?

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

Just a quick note, this is Jeff Wells, I actually am on the phone, I\'m
just not at Mitch\'s office today.

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

This is John Loonsk from the Office of the National Coordinator, I\'m in
the room here too.

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

Is there anybody else in the room at ONC who needs to be introduced?

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

This is Katy Barr with the Office of National Coordinator, recently
joined the team over here to be the Executive Director of AHIC.

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

Roll call is done. Then just to review the agenda very quickly we\'ll
start off with presentations by ASTHO and NACCHO on results from surveys
that they have done of the State and local health departments, and I
think the findings from those surveys in terms of what public health
departments collect and what their capacity is will be very telling for
our later discussion.

Then we\'ll review the outcomes from the subgroup discussions, those
discussions, and Kelly will focus on the conclusion to those
discussions. I know many of you or many of your organizations took part
in those discussions, and I think at least we have the framework there
for agreement on a number of different items.

Then we\'ll review a list of major issues that need to be resolved for
us to meet our charge of a biosurveillance reporting program. We\'ll
then go to review the outline for recommendation, and then finally
conclude, before we go to public, with next steps, agreement on a
timeline, and assignments for developing the final recommendations that
now will be reported at the June meeting, which is \--

\>\> June 6, I think. Yeah.

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

We\'ll check and see what the date of it is.

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

June 13.

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

I said that, I will restate that we do have a reprieve that we\'re now
in June rather than May, but I also hope that we\'ll not take too much
advantage of that. We\'ll try to come to closure. Because obviously, as
I said, I\'m fresh to these issues, but I also have the sense, in
looking at the particularly the summary of the issues that are
outstanding, that I think if we have the will to settle them, we can
settle them, or we could talk about them until \-- until far into the
future. And we really \-- we have a mandate from the community and from
the Secretary to try to come to closure. If we can\'t, we can\'t. But at
least, today I would like to come to closure on it as much as we can,
through this process.

I hope I\'ll bring, as we get into our discussion, a little bit
different perspective in terms of representing the hospital community,
which I do on the community. So without further a do, why don\'t we go
to the presentation, and begin with Angela Fix, then we\'ll have Paula
Soper doing the other presentation.

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

Thank you, Charles. This is Angela Fix, I\'m the Director of Public
Health Informatics for ASTHO, and Paula and I were asked by this
Workgroup to put together a survey of our members, and with ASTHO, that
would be the State health officials from the 50 States, the six
Territories and also the District of Columbia. And we did this survey,
and we received 29 States, three Territories and the District of
Columbia, results from them. And you can see in the handout \-- I hope
everyone has a handout \-- that the major findings that we found were
that majority of those responded did say that they have the capacity and
the need to participate in the biosurveillance effort, and that this \--
really emphasizes the need and the want for public health to be actively
involved in these kinds of activities.

Basically, we found that, you know, 82 percent of our respondents said
that they are receiving or planning to receive within six months
electronic data from clinical care settings for either \-- you know, for
any of the four biosurveillance capabilities that were asked about,
which include initial event detection, situational awareness, outbreak
management and response management support. And you can see those
findings are in \-- under Question 2 on page 2 in the table.

Then we found that 89 percent of our respondents reported that they do
have the active relationship with some of their clinical partners in
order to develop that capacity, if they don\'t already have it or if
they even do have it, they could develop it further. So for receiving,
processing and using electronic data for either notify (indiscernible)
reporting or a biosurveillance effort. And that\'s on page 13, Questions
13 and 14 were combined.

If you look on page 18, I apologize now for the amount of data shoved
into one table, but this is a very long question.

You see that this was \-- Question 18 was \-- on ours was asking about
basically what \-- I\'m sorry, Question 17 is what obstacles existed for
whether or not you would participate in a biosurveillance project. And
just to back up a little, the previous question was indicate your level
of interest, and 91 percent said they had some interest, ranging on
scale of one to 5, 5 being very interested, 91 percent said they were
interested, only 2 percent respondents said they were not interested at
this time.

And they did not have a chance to list why they were not interested,
other than the following question about obstacles that were in the way.
I\'m sure were some of the reasons why.

And you can see that some of the big ones there, 82 percent of the
respondents all claim that funding was one of the biggest obstacles.
Which I\'m sure we all could have figured that one out on our own,
without the survey. Seventy percent claimed it was for lack of trained
personnel in either IT or in FE or statistician or anything like that.
So those are the big ones that \-- you know, the funding, and what we
hear all the time from any project when we ask them.

If you look at the summaries of the results from Question 17 on page 17
you can see choose the technology infrastructures, big one at 64
percent, and there were concerns about either the national data analysis
plan, or the capacity to respond to a first alert, or just concerns in
general were some of the other large ones that were cited by the States.

And we also at that point of the survey asked a couple more questions
that weren\'t originally in the questions we had received from HHS,
things such as are you currently participating in a health information
exchange or regional health information organization, and half and half
of them responded, or a little more 55 percent said no, but 42 percent
said yes. Which was good news for us, at least, we thought it would be
less than that. And we also found out about whether or not of those that
said yes, they are, it looks like the majority of them are planning to
use that relationship and that participation to gather information for
biosurveillance efforts. Only four of them responded that they weren\'t.

And also we asked them about funding for their involvement in these
types of activities, and a lot of those people obviously chose Federal
grants as a large source of funding. There were a few States that said
they were using their own State funding for this, and also foundational
grants were being used.

The survey (indiscernible) going over every single question, for
everything, but some of the other things that I thought would be
interesting to find out were Question 3 on page 3 asked about, you know,
receiving \-- the capacity to receive the following types of electronic
data, which is something that I know that this group has really been
working on, to try to narrow that down on the minimum dataset. And you
can see that over half of them say that they are actually receiving or
will be receiving utilization data. That was really something we had a
long discussion about multiple times.

And as well as diagnostic data, of course. The majority of them said 56
percent said they are already receiving lab results, and I would imagine
it wouldn\'t be that much more difficult for them to add in lab orders.
But again, not knowing their specific plans or their specific programs,
I wouldn\'t want to say that. Don\'t quote me on that, in other words.

But it looks like the one that really hadn\'t been chosen that often
were vital signs, only 24 percent said they were actually collecting or
planning to collect information on vital signs. Chief complaint was also
there at 67 percent. Without, you know, making the survey even longer,
we unfortunately were not able to find out specifically what utilization
data or chief complaint data would be. Unfortunate, but we didn\'t want
to lose participants by making it any longer than it was.

And some other things that we thought it would be good for the Workgroup
to think about, Question 6 was we asked them about what extent does the
State health agency coordinate with the local health agencies to
perform, participate in biosurveillance efforts. And the majority of
them stated that it is a shared responsibility with information flowing
freely between the two. However they want to define what that means,
freely.

After that it was kind of a mix where there were the larger public
health agencies, local public health agencies and (indiscernible) are
going to be able to do it on their own, and have the majority of the
responsibility, and then there are other areas of the State where the
providers will actually report directly to the State. And that was the
one that we thought would be the majority of the respondents, but it
wasn\'t.

But between the sharing responsibility and the mixed, the vast
majority of our responses were that. Very few were \-- very few States,
which I\'m not surprised, said that it was the local public health
responsibility alone.  The column I had for it \-- (Laughter) .

Just to note with D.C., D.C. is obviously considered a State and local
public health agency all rolled into one, bless their heart. And
Territories, we had three Territories that responded, Puerto Rico,
Virgin Islands and North Mariana Islands.  They are a little different,
too. For most part it looks like a share effort. That is, if the State
actually has a local health department. Not every State does.

Other than that, the rest of the data is pretty self-explanatory.
There\'s a lot of effort going on around the States and also in the
health department, and obviously there is a very \-- they\'re very
interested in participating, is the general attitude I\'ve gotten. With
some caveats of, you know, we need to make sure that it\'s the right
thing to do, we can\'t \-- you know, rush into it, and all that. The
normal caveats that everyone always has.

And I don\'t know if you want to let Paula go ahead and we can take
questions at the end?

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

I think why don\'t we do that. Except I guess I have one \-- I just
noticed, why don\'t I say this. If people have technical questions on
this survey, why don\'t we get through those, and then we\'ll go to the
next survey. Other than technical \-- substantive points. I was just
curious, because I know in Puerto Rico the Reforma has a \-- which is
run by the \-- (indiscernible) but the health department, they have
electronic medical record in the western half of the State and could
easily provide this \-- and they collect all the information now
(indiscernible).

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

It depends on who actually answers the survey. If they don\'t \-- and I
did notice that sometimes where there was \-- when I was going over the
survey forms some respond that no, we\'re not participating in
a regional health organization and I would go oh, really. That\'s very
interesting, I know you are. You know. So \-- you know, the unfortunate
nature of the survey when it\'s \-- it wasn\'t necessarily the State
health official that always filled it out, it was obviously delegated to
the person (indiscernible) experience in the area at the health
department.

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

Any other questions? Then we\'ll go.

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

Yes, this is Scott Becker from APHL. Hi, Angela, this is great work. I
wanted to \-- and maybe this is something we can do offline, I was
actually pretty surprised about the 76 percent of the respondents saying
they can or they\'re able to in the next six months receive lab results.
And I\'m wondering if that was interpreted or internally. In other
words, from their own State lab, LIM system, into the FE department,
versus what I think has been a longstanding challenge for all of us is
from the commercial sector, or the hospital sector, into the agency or
the laboratory. So there may be some more to look at, there.

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

Right. That definitely could be the case that\'s something that we could
go over together and look at on a State-by-State basis.

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

That\'s great, thanks.

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

This is Kelly. I think we also heard from some of the reference labs
that they\'re currently doing electronic reporting to 19 States, or
something around that. And yeah, but they\'re obviously providing data
to 3,000 public health departments in general, but there\'s only so many
that have standard State transactions.

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

Exactly.

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

My name is Paula Soper, I\'m Public Manager for Public Health
Preparedness at NACCHO, National Association of County and City Health
Officials. We have approximately 3,000 members. We chose not to send the
surveys to the vast majority of those members because the average local
health department has approximately between 13,000 and
15,000 (indiscernible) complete, don\'t have the capability and never
need or want to have the capability of running biosurveillance systems
in their local jurisdiction.

What we did was chose a population \-- local health departments with a
population of 200,000 or greater. Of course the greatest, the largest
number, population number in there I think was 8 million, so at least
who responded, so there still is a significant amount of variation
within the respondents. And quite frankly, there simply was not enough
time to get into the data and look to see if there were differences
among the different sized health departments, but we still do plan to do
that.

We did have \-- receive 93 responses back within a week. It\'s only a 27
percent response rate, however, we feel that is a relatively decent
response rate given the time constraints and holiday weekend in there.
So we are quite pleased. And many of the members, jurisdictions that we
were hoping would participate, did.

Just a quick overview of some of the information that we found. The
majority of local health \-- and I am working off of \-- for those of
you who have the packet, I\'m working off of the PowerPoint presentation
rather than the research brief.

The majority of local health departments do have the capacity for
initial event detection, situational awareness and outbreak management.
Approximately half of those that responded have some capacity for
management support capabilities, so it seems like that is the area where
there is the most amount of work that still needs to be done.

Virtually all respondents have some type of relationship with their
local providers for preparedness planning, and most have an ongoing
relationship with providers for routine disease surveillance.

Seventy-two percent indicated receiving syndromic surveillance data from
clinical care setting in any format. That can be a piece of paper or
e-mail attachment. 56 percent indicated having the current capacity or
within the next 6 months to receive initial event detection data in
standard electronic formats, or plan to have that capacity.

We found that the interest in participation in a national initiative was
really quite strong. Forty-one percent indicated they were very
interested, 26 percent interested, and 24 percent somewhat interested.
So we found that very encouraging.

The next slide basically just gives a breakdown of the respondent type,
and that was basically to be expected given our type of membership that
we have.

As I mentioned, the greatest capacity exists with the initial event
detection, situational awareness and outbreak management. And certainly
you can see with the initial event detection a lot of work has been done
around syndromic surveillance, and I think that\'s \-- at 68 percent
that was not really a surprise for us

We did go through \-- and I won\'t go into details here, we asked what
type of applications were being used, and whether it was developed in
house. And I can give you much more detailed information on exactly the
applications that were indicated were in use. Certainly I think there
were no surprises at those rods, first rods, kind of your typical ones,
and what EOC for some of the outbreak management response management
support, as well.

In terms of the types of virus surveillance data being collected, very
similar numbers to what Angela reported for the States. Utilization, 60
percent indicated that they are collecting or will have the ability to
collect in the next 6 months, electronic data on utilization.

77 percent chief complaint data.

Similar to the States and actually even lower, only 11 percent can
provide \-- can collect vital sign data or to be collect that.
Forty-seven percent are collecting diagnostic data. And I thought it was
interesting, 73 percent claimed they are getting electronic lab test
results, and only 22 percent for lab test orders.

And again, I think it behooves probably all of ASTHO and NACCHO to try
to get into that a little more deeply to try to figure out exactly
what\'s going on there.

In terms of who is sharing the responsibility for managing
biosurveillance systems, next two slides go into that. Some very similar
to what Angela found, is that there is a significant amount of sharing
going on, and shared responsibility. I think there\'s slightly larger
proportion of health departments saying it\'s only their local health
department basically doing it, and I think that speaks to the large \--
the larger health departments, and certainly you wouldn\'t get the same
response \-- response ratio if we asked all of our membership that.

In terms of staffing, 47 percent indicated that they have sufficient
staff to fully implement their short-term biosurveillance plan.

In terms of funding, only 37 percent indicated that they have sufficient
funding to fund their short-term biosurveillance plans, which \-- the
question \-- you know, if the plans will be changing.

In terms of how they\'re being funded, there is the breakdown there. No
surprises, mostly Federal pass through dollars.

I\'ll skip Table 13. As I mentioned, Table 14, virtually all local
health department surveyed are working with their private provider
community on preparedness planning.

In terms of having an active relationship with some of the partners to
receive any kind of disease reporting or syndrome surveillance
reporting, very large number are doing work around this, may not be
receiving it electronically.

Provider participation, I am \-- I put these in here, however, I am
not \-- I don\'t have a lot of confidence in these numbers. As Angela
mentioned, I think that these were probably \-- this survey was probably
farmed out to technical staff, who did not have information about
exactly who the partners were, and we had very low response rate on
these two questions. Unfortunately. But there is obviously some work
going on, and I think, you know, looking at the next table, 19, whether
they will have the capacity in the next six months to accept, process
and use data in standard electronic message formats from clinical care,
it really it conflicts with what was being said earlier on about the
ability to collect biosurveillance data, whether they can collect it.

I\'m not sure if there was a misunderstanding about the word
"biosurveillance," if in fact we were only asking the previous questions
about whether they could expect it and not process and use the data, and
if they\'re feeling they don\'t have the capacity to do that. I really
would like to get inside these numbers some more, do a bit more probing.

In terms of additional information being collected, by and large all of
the poison control, pre-hospital admission, there really is not much
going on in the larger local health departments that aren\'t collecting
this information, and I think some of those are concerning in light of a
potential pandemic load.

I already mentioned the level of interest, so on Table 22, this is where
we asked obstacles to participation. My list (indiscernible) and
Angela\'s list varied some based on feedback that we both received from
membership about what some of the additional questions they would like
to add to this. Certainly, funding. No surprise. (Indiscernible) funding
to participate in a national breakthrough. Forty-one percent indicated
trained technology personnel. And 33 percent said trained, basically, no
secret, actually do something with the data.

Forty-six percent indicated that they thought providers were unable to
provide data. Which \-- again, given the folks who may have been
responding to the survey, I\'m not sure if they know whether or not
that \-- you know \--

**\>\> **What was the wording of that question?

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

It was obstacles to local health departments.

**\>\>** \-- in the question when you say \--

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

No, it wasn\'t.

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

It was the following obstacles exist for, whether State or local, to be
able to participate in a biosurveillance project.

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

Right, it was providers unable to provide data. And 46 percent thought
they thought providers would be unable to provide data. Now, they also
\-- the respondents could have not just been thinking of hospitals but
also ambulatory care clinics, and community health centers as well.

**\>\>** I just wonder \-- able doesn\'t mean willing.

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

Oh, unwilling was 31 percent, unable was 46 percent. Right. Yeah. So
it\'s definitely two different things.

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

And whether that\'s physically unwilling or politically unwilling, we
don\'t specify that.

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

Right. Right. And then we too did ask about participation in RHIOs, and
only 19 percent indicated that they are participating in a RHIO.
Which \-- (indiscernible).

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

And we did ask about source of funding for RHIO, and by and large it\'s
coming from Federal grants and local funding.

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

Just as a conclusion, certainly there\'s a desire to participate, and
capacity of large local health departments is strong. I think many
barriers can be overcome by a solid, transparent plan with appropriate
safeguards for privacy and security.

Funding and technical infrastructure and workforce continue to be a
struggle for local health departments. This is unfortunately nothing
new. However, the effectiveness of any program is dependent upon a
strong infrastructure in place on the ground.

I think that between the ASTHO and NACCHO data we would indicate
there\'s a lot of low hanging fruit in an opportunity to demonstrate the
different options that have been identified for this data
stream (indiscernible) opportunity here to figure out how this will
actually work in the field.

**\>\> **So (indiscernible) I guess we could have a glass half empty,
glass half full. But clearly if one was doing a voluntary program there,
there are people to connect with. In the health departments.

**\>\>** Absolutely.

**\>\>** Many health departments.

**\>\>** Yes.

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

Are there other questions from the audience? Members?

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

Hi, this is Tom Frieden in New York. I just wanted to ask whether either
group had asked respondents about demonstrated utility of the systems in
use, and just say parenthetically that there was an informal conference
call of 16 of the larger cities, it occurs every quarter, about a
different topic, and did discuss biosurveillance. And in that group,
that question was raised, and early recognition as well as
characterization of influenza was really the main thing that was found
by that group to be of demonstrated utility.

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

Tom, no, we did not ask any type of question like that. But we did ask
about \-- yeah, we did say insufficient evidence of efficacy of
biosurveillance. Thirty-seven percent of respondents did say that that
would be a barrier. But any more detailed question than that, or the
value, demonstrated value of systems in place, we didn\'t get into.

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

And the same for the States, there was 58 percent of the respondents had
noted that there was insufficient evidence, and we did allow for
additional comments at the end of our survey, and those were some of the
comments we did receive, were questions about the \-- how useful is the
type of system, and where is the scientific evidence behind it, and the
kind of things we heard before, so \--

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

Yeah, most of our comments were around that. And that we have this
information, I don\'t have \-- we have the data, I don\'t have enough
people to actually analyze it and tell me anything.

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

Other questions? Hearing none, why don\'t we proceed with this as sort
of the baseline work, and move to our discussions that have already
taken place at the subgroup level. I\'ll let Kelly outline those and
we\'ll discuss \-- we want to approach it.

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

Okay. In the last month we had two separate subgroup meetings of people
that volunteered to participate from the Workgroup, but also we tried to
bring in additional local public health, in some cases informatic
experts to get more perspective from the local health departments.
Angela and Paula were involved, the surveys were relevant to our
discussion. And we also brought in some reference labs, representatives
from the reference labs, given that we realized we hadn\'t had much of a
public discussion to date about their involvement and some of the issues
and barriers around getting data from reference labs.

So over two separate calls, we tried to focus on some of the most
pressing issues that we\'ve been grappling with over the last few
months, one of which was around the approach that we\'ve agreed to in
previous Workgroup meetings, around the use of a minimum dataset that
we\'ve described at a high level for the purposes of initial event
detection and situational awareness, outbreak management and response
management. And we recognize that there\'s been a lot of Workgroup
members and also the emergency room physicians that have been
participating that have different perspectives about what is really
feasible for us to implement in the short term, and should we be
considering a shallow approach that would maybe require not the minimum
dataset for all four public health functions but we just take a
realistic approach and even collect a subset of the minimum dataset that
would be reasonable and feasible and still meaningful to public health
for the purpose of biosurveillance.

So what we\'ve agreed to at a subgroup level is a two-prong strategy,
where we would proceed as we originally talked about to try to get the
minimum dataset to meet the four different kinds of public health
functions, in local and State jurisdictions that have the capacity to
receive the data, have the willingness to participate, and we also have
the data that\'s available from health care providers and other sources.

So that we would proceed where it is feasible on a voluntary basis.

But then we also agreed on a second prong or which would involve an
approach to get more opportunistic data or perhaps chief complaints or
labs or other types of data that would still be meaningful to public
health, perhaps for situational awareness but would not meet the needs
of outbreak management and response management, or perhaps even event
detection.

We had a fair amount of discussion around that, we started to talk about
what the opportunistic data is that\'s available like claims clearing
houses, and data from the reference labs. We even started to talk about
other data sources that others have used like retail, over the counter
drug sales data. But we have not gotten to a point where we sort of did
agree on what that dataset is for the broader strategy for Prong 2. So
that still requires a lot of discussion.

But the general approach to having both proceed in parallel seems to
be \-- you know, acceptable to the subgroup. We did also talk about what
would be the appropriate steps to further define what this dataset is,
and even figure out the specifications for the minimum dataset we
originally agreed to, since we only agreed to the higher category or
data element level. And I think we recognize that the Health IT
Standards Panel will be appropriate for naming standards related to
data, and technical standards, but that we still need to have public
health experts really sit down and consider what is going to be most
valuable, and needed, to meet some public health needs for this broader
strategy. So we may not be \-- you know, we don\'t have the time or the
process in place for this call, or in the very short term to carefully
define what data would be necessary for that second prong, but we would
like to discuss at a high level what we could be considering in terms of
opportunistic data and data sources.

But we need to \-- and as we think about recommendations, we\'ll need to
be thinking in terms of what process can we put in place to really
fine-tune the data elements, and support HITSP and their work to do the
technical standards, to enable the breakthrough.

So at a high level, that\'s really what we came to. We did have a lot of
other discussions, we touched on the privacy issues, recognizing that
there\'s still a concern, we still need to have more discussion around
it. We have some materials today where we hope to continue that
discussion, and figure out how we might be able to make recommendations
to address the concerns.

But we \-- for those calls we really tried to focus on the issues around
the data, and the approach to trying to get \-- you know, those data in
local jurisdictions following \-- and State jurisdictions following the
known dataset meeting the broader set of public health functions and get
a much broader strategy across a broader geographic area.

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

Are there questions? Of the subgroup?

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

This may not be a question as much as a further detailing, this is John
Loonsk. One discussion about work that needed to be done was to sort of
break out the difference between data elements and the codes that would
be reported inside of those data elements. And I think that was useful
for people to think about. So let\'s just take an example. If you\'re
reporting ICD codes from a clinical care site, and using them for
biosurveillance purposes, it\'s probably appropriate to filter at the
clinical care site, and not report all ICD codes to support these
purposes.

And so there was a desire by the subgroup to name this as a separate
activity, to recognize there\'s a need to have ongoing discussions as to
how \-- who can proceed with that, and sort of name those. And one of
the things that was discussed was some of the work that\'s gone on in
this area, but that that\'s an ongoing need as well.

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

Hi, this is Adele. Can I ask \-- at the Treasury. Can I ask a little bit
more about how the filtering works? Is it that the health care provider
who has the information, has a system that automatically checks for the
reportable codes, and then that\'s the data that sends? Or how would it
work?

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

In furthering this discussion, I think it\'s important to differentiate
between case definition reporting, which is the classic disease case
reporting that public health has done for many years, which is usually
still somewhat paper-based, and sometimes not entirely timely, and has a
relatively low catchment, in terms of the actual number of cases that
are reported. But where there\'s a case definition, say around
tuberculosis case, and wherein certain criteria have to be in effect,
and then the clinician usually initiates a report, there\'s that manual
stuff of reporting, and this other biosurveillance activity which is
descriptive of using the existing clinical care data such as diagnoses
from \-- just to take an example, the preliminary diagnoses or diagnoses
in an emergency room setting, they wouldn\'t quite meet those case
definitions because they\'re not at the level of filling out all those
criteria.

So in that second category, which is what we\'re talking about here, the
filtering could either be done with a prospective list of codes that
could be matched to be submitted, or at times it could be done with a
list of codes that shouldn\'t be submitted, in the context of sensitive
data that wouldn\'t be generally supportive of these needs, and would be
better off not being reported for these purposes.

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

So you\'re going to have to have a set of protocols so those decisions
are uniform across providers.

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

And there\'s a maintenance issue there, too. And so initial efforts in
this area have looked at, for example, ICD codes that relate to certain
presentations of illness, and then said these are the broad codes that
are of interest. That list will change over time. In clinical
environments, new codes come online, new \-- and some, there are some
mapping activities that may be involved there. And so one of the reasons
to name this activity is to say that it would be helpful and
facilitative if there was a standard set that could be used, so that
everyone didn\'t have to reinvent that every time.

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

I guess part of my question deals with optimizing the practical utility
of the data. There\'s some data that\'s useful for public health
purposes, and perhaps some that\'s not so useful, and I have in mind \--
and this is where I want to you educate me if I\'m wrong. Let\'s say
we\'re talking about laboratory data. Are we thinking that our program
is going to collect all the results of cholesterol tests and pregnancy
tests and, you know, all the jillion different kinds of tests that may
not really be related to like some of the urgent kinds of things that at
least I normally think about being the main focus of this effort?

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

I don\'t think that there are a jillion, I think it\'s only a billion or
so. But I \--

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

I\'m glad we\'ve narrowed it down (Laughter).

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

That\'s exactly the area that we\'re discussing here. So the concept of
not all results are necessary for biosurveillance, biosurveillance
activity, and that having a list is helpful for people so that they
don\'t have to create it every time, and that some of these other
results can be avoided.

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

In terms of the subgroup discussions, I guess there are two issues that
I\'d want to raise or ask for clarification.

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

I\'m sorry, this is Chip Kahn, I don\'t know everybody\'s voice.

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

Sorry, this is Tom Frieden in New York City again. There are two issues
I would just like to raise to get clarification on or maybe a brief
discussion on.

The first is, as I\'ve said a few times, I think really there are
different types of information with different types of utility, and
it\'s important to parse them out so that we\'re getting maximum
utility. One type is utilization data. And if we want to know, you know,
if we have an epidemic whether our hospitals are full, whether we have
intensive care unit beds, that type of information is one area.

A second type of information is definitive laboratory diagnoses of
information, which I think everyone agrees is extremely important, but I
think those of us who have been doing it are finding that it\'s a lot
harder than we anticipated it would be.

And the third is the more broad based \-- either volume based, or
electronic \-- whatever you want to call it, large amounts of
information, either deep or narrow or shallow and broad, which might
allow initial event detection, situational awareness, and might assist
with outbreak and response management.

That\'s one kind of question, or issue, or topic. And the second just
has to do with understanding a little bit better what the Prong 2
you\'ve referred to relates to, because it\'s a little unclear, and you
raised it as something for further discussion, if I understood
correctly.

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

I have something to say to the first item. Could you respond to the
prong?

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

The second prong? Yes, Tom, I think it still needs some definition, but
at a conceptual level what we were trying to get at is to really focus
on opportunistic data sources that would be readily available across \--
you know, a broader number of geographic areas, that would still be
meaningful to State and local jurisdictions.

A lot of people at the previous call talked about chief complaint data.
But there were a variety of other opportunistic data sources we had
talked about, but had yet to really sort of settle on. So we really
still need some definition, but we wanted to try to be responsive to
some of the feedback we were getting about the need for a fever monitor
or the need for looking at just chief complaints and trying to get some
consensus around what we really want to get out of this Prong 2 and what
kind of data elements or data sources would be necessary to make it
meaningful.

**\>\>** Some of the discussion around that was the desire to have some
objective measure. And I think that one of the things that was brought
up was that, you know, sometimes chief complaints can even include
things like that my wife made me come to the hospital kind of thing. And
there was also brought up that in an actual event, at times it
influences what people report, by virtue of that. So some of the
subgroup discussion was \-- and that\'s part of how it got to the
discussion of, for example, a fever indicator was the objective of
looking at objective measures potentially because of some of these
issues, as well.

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

And the other advantage of objective measures is that they\'re more
likely to be electronic, if we\'re talking about limited to electronic
systems.

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

I guess I would comment because we\'ve been looking in New York City,
that we\'ve been looking at different ways of detecting large and small
events, and flu and other conditions, and have documented pretty clearly
that having the richness of data in a chief complaint actually makes it
much more useful. Than other systems.

So I think it\'s misleading to say kind of subjective-objective, what
we\'ve looked for are systems that provide us with useful information,
and we\'ve found free text chief complaint to be quite useful.

Now the algorithms that then break that into syndromes are things that I
think should ideally be standardized nationally so that, you know, maybe
what gets transmitted isn\'t the actual free text, what gets transmitted
is the breakdown of that free text into a syndrome.

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

Let me \-- that\'s a good point. Let me sort of go back to the first
part of your question, Tom, though, because it seems to me that from the
discussion that I was a party to, and my understanding of the mandate,
we probably need to think about your free components, in sort of matrix
form. Because at least our mandate has to do with settings. I mean,
labs, and ER, and ambulatory. And the issue of utilization data, I guess
the laboratory diagnosis and the event sort of cross each of those
settings in some way. And maybe if we \-- we\'ll get to the discussion
of these other issues in a moment, but maybe that\'s one way of looking
at this.

But I think to the extent we can, and obviously any immediate
recommendations are going to be relatively limited because of the nature
of this, I think we want to try to meet our mandate, and I think we
could probably do both if we think about it in those terms.

Let me ask Kelly, unless \-- are there other comments immediately? Let
me ask Kelly to sort of \-- does that sort of cross over now into the
specific issues, and then these sort of issues that we talked about,
come back to at the end, where we are with recommendations, does that
make sense? Because I think we\'re getting into those.

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

Yeah, I guess so.

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

Does everybody sort of agree to that?

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

And Tom, I would appreciate it if you could \-- you know, just weigh in
on any description that we get into about what the summary of the major
issues are that we need to resolve before we feel like we can all agree
on recommendations. I think as the Workgroup probably know, Tom Frieden
expressed some concerns that New York City Health Department has with
our charge, and some of our deliberations to date, and we tried to
address those concerns, and recently came to sort of describing what we
thought were probably the four major issues that we need to address as a
Workgroup, but also, consider sort of the caveat or the conditions that
we have to meet to be able to adequately address these concerns, and
moving forward.

The first one has to do with privacy, and I think we have been touching
on this issue from the start, recognizing that HIPAA does allow for the
sharing of identifiable data for public health purposes. Yet there is
general public concern, particularly with privacy advocates, that if you
are sharing \-- maybe it\'s not name data, but it is data that has some
data that could be considered identifiable as defined by HIPAA. For
example, demographic data or zip code-level data.

But we recognize that there might be some sensitivities among \-- you
know, certain privacy advocates where the general population is a large
amount of data is being shared with public health.

So we thought it would be necessary to make sure as we move forward that
there\'s appropriate safeguards in place for both privacy and security
of data, and that, you know, we really do have specific recommendations
that address the necessary filtering of sensitive information.

We also had tried to, in previous meetings, talk about an issue that I
think has been more carefully described by ASTHO in an issue brief which
is background material that there may be some ambiguity under current
law with respect to sharing data with local, State, and public health
authorities for the purpose of biosurveillance, while HIPAA clearly
allows it, there are some jurisdictions that feel they may need specific
authorizing statute to enable the transfer of that data. So we would
like to \-- you know, formally address that issue in our
recommendations, and we can talk about perhaps ways we can do that
later.

And then in general, I think there\'s the need to try to address, you
know, the public concerns given that we may not know exactly what they
are, but we know that this is a general issue with \-- you know,
establishing an inter \-- \-- or health care system, and timely concerns
could apply to public health.

So this is a sort of larger issue, and that may be difficult to figure
out explicitly how we\'re going to address that in the short term, but
we can recognize it.

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

Is it better \-- are you going to go through all of them, or do you want
to take it piece work?

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

I think sort of \-- ask for feedback on each one.

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

Because I\'m not sure \-- this one is succinct, I think, isn\'t it,
Kelly?

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

Yeah.

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

Why don\'t we handle this one, and I guess the key here is \-- and I
sort of speak here as a community member \-- and let me say two things
about it. One is we can obviously make recommendations for legislation.
Two, on one of the first, maybe it was the second meeting, I remember
Secretary Leavitt was extremely explicit that well, you know, at the end
of the day, regarding \-- I like to think of it as protection of
confidentiality, because I think that if we\'re really going to be
purists about privacy there\'s not going to be electronic records. Some
people can decide to play, and maybe it could get to the point that some
people are just going to decide not to play.

I think the point here is if there are State laws that would present an
issue here, even with HIPAA understanding of public health, there are
(indiscernible). And I think we really may want to fall into a situation
where we recommend doing it, and if there\'s a State that stands in the
way, then we recommend some kind of Federal legislation or other
legislation.

I think the key thing here, in my reading of this, in looking at your
comments, Tom, on the privacy, is that we really can\'t let this be a
show stopper, and we\'ve got to have \-- maybe we need to find some
middle ground, and if there\'s a problem with the identification, as
it\'s set here \-- I\'m just going to throw this out \-- from the
perspective that I sort of see it, is does that set us into a situation
where it\'s really the information, and is there some kind of language
that maybe doesn\'t fall into a specific term of art that would describe
what we want to do, that clearly would be allowed under HIPAA, and that
would avoid some of the pitfalls here. Which is the ability at the
Federal level to identify the individual. I mean, that\'s the issue, is
if we\'re going to have some kind of simultaneous reporting of
information, we don\'t want the Federal Government to be able to locate
Aunt Minnie. We only want to have information about Aunt Minnie if
it\'s \-- you know, in whatever setting. 

It seems to me we need to know two things at a Federal level. One, we
need to know at least essential demographics about Aunt Minnie, that
won\'t get us to Aunt Minnie but at least we sort of know about Aunt
Minnie a little bit, whether it\'s age, sex or whatever. And two, we
need to know a zip code. And if you don\'t have that information, then
whatever we\'re talking about on the side of what the data we\'re
getting is really sort of meaningless, because you\'ve got to know some
of those basic things.

Is there any language \-- and I guess I sort of throw it back at the
group, that we could come up with, that would \-- you know, if somehow
this notion of anonymity, that is really a HIPAA notion, too, is there
something between anonymity and the identification that we could find
that maybe is descriptive that would allow us to move forward, and at
least in the short run cover these concerns?

Because if we don\'t get information that on the one hand has was I
would term essential demographics and doesn\'t have some kind of zip
code, you know, we\'re just no place. We might as well not have it. So I
throw it out to the group, with that sort of mandate, is there
something \-- what\'s the middle ground, here?

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

This is Mark Rothstein, if I may speak. I apologize to the other members
of the working group for my lack of participation in the last couple
months, I\'ve been on medical leave and I\'m now just getting back. And
as the person who is in theory at least supposed to raise the privacy
issues in this working group, I\'d like to go through some of my
concerns with where we are, and some recommendations to go forward.

A couple months ago, as soon as this working group was formed, I did
speak to senior leadership at ONC, with a very strong recommendation
that the name of the working group be changed. I don\'t know if this has
been brought to the members at all. I strongly recommend that we propose
that it be changed to something like public health monitoring and
response, or \-- I understand that surveillance and even perhaps
biosurveillance are terms of art to public health people, but
surveillance doesn\'t ring too positively with the public right now, and
to the extent that we can get that word out of the working group, I
think we would be better received in terms of our recommendations.

I also think \-- and I want to support what Dr. Frieden has said and
written, that we need to make a compelling case to the public that there
is great utility in what we\'re proposing, that there will be a
substantial improvement over current surveillance methods. And that as a
result of this initiative, public health will be improved. And I think
we can\'t really consider anything until we can make that case.

I do support the working group\'s move to a minimum dataset, and I think
we constantly need to be working on what is the minimum amount of
information that we need.

On the issue of anonymity versus the identification, I think we
shouldn\'t strive to make the data so devoid of fields that it has no
relevance. The way I would approach that is to limit what information
we\'re getting, and make sure that we have extensive public and
professional education and understanding that this is a limited
undertaking, and it\'s done for public health purposes. And explain
exactly in what form the information will be sent out.

Clearly, using zip code and other kinds of demographic information would
not satisfy HIPAA standards as they apply to other forms of information,
but under the exception for public health and the privacy rule it could,
depending on State law.

In addition to public and professional education, I think we need to do
a better job of involving all stakeholders, especially the public. I
think AHIC is not a substitute for extensive public input into this
process. We also need to I think recommend an ongoing program of
oversight, assessment and research to ensure that the system, if it\'s
set up, meets its objectives, and doesn\'t result in any unintended
consequences.

And finally, I just wanted to say that some people view privacy as being
somehow in conflict with public health. And the way I look at it is that
public health depends on the notion of privacy. No one in public health
would want to put in place any sort of mechanism that drives underground
undocumented aliens, people who are having scrapes with child support
agencies or law enforcement or anything of that sort. If we drive
millions of people underground who have communicable diseases we\'ll
have a public health nightmare on our hands, and it will be of our own
making.

So it seems to me that privacy is not an add-on, it\'s not a luxury,
it\'s not in conflict with public health. It\'s an integral part of
public health. And I\'m not sure that we\'ve yet achieved the degree of
recognition of that. And I hope we can in the future, before we
recommend it to the community. Thank you.

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

Thank you, Mark. Let me say a couple things. One is I think in terms of
the information coming out, we can work on plain language. The
biosurveillance itself is a title, we can obviously recommend another
title. However, in some ways, having been a party to the community
discussion about them, in some ways it does limit us in a way. And I
think you were actually advocating being limited. Because, you know,
we\'re basically here talking about the issues of the day, flu,
bioterrorism, really not the full swath of things that happen in the
health care system, but very narrow things. I\'m a little wedded to the
word.

Let me also say something else, I just want to tell a story. I\'m with
you 100 percent in terms of process, and leaving it \-- and I\'m sort of
a purist, leaving a lot of this to a commission, which AHIC is, but
remember AHIC really only advises the Secretary, so ultimately they will
have to be a \-- other than the recommendations they make to the
legislation and things, it will just go into the environment, anything
specific that AHIC would recommend the Secretary to do, he\'s got to go
through the regulatory process. So we would have to have on most of I
believe at least some kind of regulatory process. So there will be that
opportunity.

Let me say I think HIPAA is great in terms of the protections it has in
it, but if it actually had been left to a completely open public
process, it wouldn\'t have happened. And I was there actually \-- it was
a day, anyway, I guess staff people shouldn\'t say this kind of thing,
but I was the staff person that somebody turned to at some point and
said do we really need to leave those lines in. And I said well sure, I
said Congress will come back, you know, they\'re never going to let the
executive branch just set this privacy policy. You know, we\'re going to
have a congressional process.

And you know what happened? Congress couldn\'t digest it because it was
too controversial, and we ended up getting the regulation, which is all
the HIPAA protection we have today.

So I understand what you\'re saying, but the end of the day sometime the
executive branch and HHS has the ability to actually get things done,
and that\'s what we\'re trying to do here, is \-- and it will end up
being modest, really \-- actually get something done here, rather than
continue to talk about it.

So that\'s sort of my problem with worrying about, you know, three or
four more processes behind what we\'re doing right now.

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

If I could just say very briefly, I raised the privacy issue not to try
to throw a wrench in things. Just the opposite. My concern is that if we
don\'t address it, it\'s going to come back to bite us. And this is from
the perspective of local public health where we collect identified
information extensively on people with AIDS, on people with syphilis, on
people with TB, and we do followup directly, and we rely on the public
recognizing that we do have a responsibility to collect that kind of
non-anonymous information and use it.

However, when we get into these large datasets, the reality is it\'s
pretty easy to re-identify people if you have things like dates of
birth, or in some areas of the country, or even some areas of heavily
populated New York City, the zip code and age, race and sex. I\'m just
saying we need to address it effectively so that it doesn\'t haunt us in
the future, that was my point.

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

I just \-- I have a little trouble with that leap. Because I mean, I
think, as you\'re suggesting, Tom, that the history of public health in
dealing with sensitive data is extremely strong. And that as you
indicated, public health deals with name data in many circumstances. So
the suggestion that these same public health people that are dealing
with named data, in some circumstances, in sensitive diseases are going
to begin to attempt to re-identify people for some untoward purpose in
this context, is not a logical outgrowth of that kind of history.

And so I think it absolutely has to be addressed, but I would follow up
on the previous comments, and say that, you know, that there is
absolutely an education need, here. And that building on that public
health history, but ensuring that data that are advanced and used in
these contexts, and people know what the concern is, that they\'re
educated, that the public health \-- and the public are educated to the
needs and the requirements for working with these data, and that even
that might go further than education. I think there are certain efforts
in this field that I know of where those users, those public health
users that use it basically commit to a data use policy that says that
they will not, and that they \-- you know, and maybe that\'s more
education than regulatory teeth, but that these are to be used only for
public health purposes, and that no effort will be made to re-identify
except in the circumstances of appropriately authorized public health
investigation.

**\>\>** Let\'s go back.

**[\>\> LEAH DEVLIN:]{.underline}**

I\'d like to just jump in here just for a minute, if I would, this has
been a really good conversation and, I agree with most everything
that\'s been said, but I do think that when we \-- we could have these
debates, you know, at these conference calls, and that\'s what we\'re
here to do, but I think when we get out there and the recommendations, I
do think words are really important, and I like the notion of this is
really about protecting confidentiality. Which is what the time-honored
public health traditional is, as we\'ve said, it really is about
protecting confidentialities more than the privacy issue

Another principle of course as we all tried to do, is keeping this as
simple as we can. Our experience has been don\'t tangle with HIPAA,
let\'s just start and get this thing rolled off the ground as a
HIPAA-compliant system. Then when you\'re asked that question, you can
simply say everything we are doing is HIPAA compliant, we\'ve already
addressed that. I know we would like other information, but we\'re
trying to get started

I guess the third thing is we in our State is we can say here\'s the
public health benefit. There is a radar system out here while you were
eating, sleeping, playing, praying, whatever is \-- you know, on guard,
and we have this information, that public health experts are looking at
all the time. And we know that in this age of heightened concern about
terrorism and the emerging infections that for public health providers
we work with, hospitals in particular, 113 of them, they are much more
interested and concerned about protecting their patients\' health, and
the public health role they play, far more than privacy issues. They
know that these are issues, they know they\'re liable, but that their
liability is not doing everything they can to protect health. And they
want to play in this system that\'s being developed.

I do think the further you get from home with these systems, the greater
the concerns are. And I think that really means we\'ve got to be very,
very clear in this regard about the roles, which is one of the other
issues, the local, the State, the Federal. And it\'s got to be guided by
need to know, who needs to know what. I think also we need to keep the
issues of surveillance separate from the public health investigation.
When we even have our dialogues. Because what we\'re looking at here,
when you talk about surveillance, what we try to do is put it into lingo
for the public that makes it easily clear, which is this is an early
detection rapid response system. And that sounds bite right there, along
with the public health radar, which doesn\'t \-- that seems to help a
lot of people\'s fears go away.

So I do understand we have to address this issue, I think that we need
to thoroughly debate it internally. But if we get out there in the
broader community with a lot of concerns about this, and using language
that raise these fears, then we will have done ourselves a disservice.
I\'d like to see us frame this as early detection, rapid response, and
protecting confidentiality.

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

So Leah, are you suggesting then that we have language in this piece
that simply says we\'re going to be HIPAA compliant and protect
confidentiality. And then we could say, and for \-- put it on the table
here, make sure I\'m \-- and for the Federal aspect of this, or Federal
portion of this, we talk about the information that would only
include \-- albeit the other points made a few minutes ago \-- essential
demographics, and \-- you know, essential demographics and location
information. Meaning zip codes.

It seems to me we\'ve got to have some \-- we\'ve got to offer some
criteria, so we know, so that somebody can understand what we\'re
talking about.

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

Well, we have a 22-data element set that\'s fully HIPAA compliant that
does include the patient \-- the ID, it includes birth, sex, city,
county, zip code, and then the other elements. But it doesn\'t include
race.

We only have the five digit zip, we were not able with our legislature
to go beyond that. But yeah, it\'s got \-- it\'s 22-dataset \-- data
element set.

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

You said you have the identifier on there, which we don\'t, we wouldn\'t
want on this.

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

We have the patient identifier number. We would need that \-- you don\'t
need that at the Federal level.

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

Right, and we\'re not asking for it.

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

That\'s why I\'m saying about the roles, get clear about who\'s got
what. We have that at the State level, we control that, we would give
that to the local level on a need to know basis only. If the county has
something going on, then we would give that information to that county.

But only on a need to know basis. So we\'re controlling this very
tightly at the State. And that\'s \-- and our hospitals understand this.

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

Okay, well, I think \-- let me make this suggestion, because I think we
might \-- although there\'s silence from others on this \-- I think we
might have something close to here, and then I\'m feeling \-- and you
brought up some language that\'s going to help us with #2, I think. So
why don\'t we come back to this, having had our discussion bit, and then
go to the other three, and let Kelly sort of run us through the issues
under the other three. Then we\'ll take those, then we\'ll try to come
back and resolve everything. I have a feeling, and I really like your
notion of surveillance versus investigation, which is going to help us
in #2 with the language. That we sort of proceed and then we\'ll come
back, how about that?

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

Okay. So the second major issue has to do with trying to preserve the
appropriate roles for local, State, and Federal public health agencies
and officials. It\'s in investigation, and I think the conversation and
consensus we reached earlier around simultaneous data flow brought this
issue to light, because the intent clearly is not to disrupt any of the
current traditional roles. And that we really want to make data
available so that each public health authority can better do their job
according to their traditional roles.

So we can clearly specify that\'s our intent in our recommendations, and
also indicate that CDC is really not the first responder, or will never
really be the lead for investigation, public health investigations, that
that role is clearly with the local jurisdictions.

So we can again craft our recommendation around that, that will provide
some clarity, there.

And then Tom, I think that you had wanted to add sort of a third
condition or a third consideration here, as we do craft a recommendation
around this. The way he phrased it was to ensure that new data
collection initiatives are developed in a way that enhance rather than
compete with or undermine existing \-- I guess it could be
biosurveillance (indiscernible) or existing public health informatics
initiatives, which I think everybody would be supportive of.

**\>\>** Well, I was going to say let\'s get the whole thing on the
table.

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

Okay, great. And the third major issue that has been \-- you know,
discussed and described also in some of the letters are the technical
specifications with respect to the data elements and data standards, the
technical standards. We have grappled with this at a Workgroup level,
and recognize that we probably need to, in our recommendations,
recognize that the right public health experts need to more carefully
refine the specific type \-- or data elements, and standards. And we
recognize that health IT standards panel is set up as a harmonizer, and
through contractual obligations they will be naming data and technical
standards for the biosurveillance use case, so we can rely on them to do
that.

However, we do need public health experts to take this to the next
level, and we\'ve talked about earlier, there needs to be filtering. So
we may agree that there has to be laboratory results, that we need to
identify the codes and the types of laboratory results that are going to
be meaningful for the public health function that we agree on. We
probably need to have more conversation about this when we get to our
draft and outline recommendations, but I think on a conceptual level we
want to craft a recommendation that recognizes the right outside group
to take this on and refine it.

Then finally, I think we already touched on the need today that we need
not only set outcome, that directs outcome measures for program
evaluation, but we also need to be clear up front about what our goals
are for biosurveillance breakthrough. And there\'s already centers of
excellence and informatics that are considering some of these issues,
but we should probably be thinking about specific recommendations around
program evaluations to make sure that we are going to build the evidence
base that will demonstrate the value of perhaps our two different
prongs, or just a general approach that we\'re going to have to our
biosurveillance breakthrough.

Finally, we recognize the importance of not just having academics to do
program evaluation, but also engage, you know, the program managers and
epidemiologists who are really doing the work, so both at the level of
study design and also implementation and data analysis there\'s work
that\'s getting done that\'s really relevant to biosurveillance programs
that are going to be in the field.

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

Okay. I guess one thing about \-- let me just go back to Mark just for a
second. I\'m more than happy to have us consider alternative titles, but
simply considering what Leah said and going back to some of Tom\'s basic
concerns, just to sort of move one thing off the table. Can I talk you
into biosurveillance? If for no other reason than it actually
narrows \-- we were offered a relatively narrow mandate, and it narrows
the mandate. And even if it\'s not the perfect words for the public, it
does in a sense, I think, address some of the issues that have been
raised about concerns about this effort being too broad.

I mean, the word "surveillance," on the one hand you could argue sounds
threatening. On the other hand, in the disease context, it seems to me
it\'s a word that says we\'re just sort of watching the environment, and
looking for signs.

And I\'m just worried that \-- I mean, I really do want to draw this
bright line that Tom has been so \-- I mean, rightfully emphatic about,
and Leah has well described between investigations and surveillance.

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

Well, I felt compelled to raise the argument. I don\'t see a groundswell
of support for it, and so I am prepared to chug ahead under this title.
I would prefer something else, but if you want to drop my objection, or
have me drop my objection, I mean, fine.

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

Okay, is there \-- are there any other thoughts about it? Because I
really \-- and I don\'t want to abuse you, Mark, but I sort of want to
use this as a way to set a framework for everything else, because
it\'s \-- because when we get to the substance of each of these items we
respect what everybody has said, because we want to do something here,
we want it to be actually relatively narrow and focused. Both because we
don\'t want to step on other people\'s toes from the Federal to the
local to the State, and second, because if we\'re too ambitious we\'re
not getting anything done anyway.

So if that\'s okay, then let\'s proceed. And I guess I\'d like to
proceed with a little discussion on #2, and then we can come back, I
want to sort of proceed through each of them, have a little discussion,
and we\'ll come back and see if we can get an agreement on it. And I
guess I\'ll sort of say \-- Tom, you had a number of line corrections on
2. Considering what Kelly said, where do you want to go?

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

I didn\'t hear any disagreement with the suggestions we had. So I don\'t
know whether there are any issues that need to be worked through.

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

Let me say that I think in terms of your corrections, to clarify, the
CDC as not a first responder or interpreter of data derived from
biosurveillance breakthrough projects. And then we get, and that only
State and local public authorities can engage in police power
epidemiological investigations. which obviously we\'re all agreed to in
substance, but going back to the point that Mark made, do we want to
have \-- once you use the word "police power," it\'s a little bit
inflammatory.

Second, there may be some investigations, I don\'t want to go there,
that CDC actually at least gets invited into, and I just wonder, do we
need that language, can we just make it clear that we\'re just talking
about \--

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

I\'m fine. I\'m fine with that not in.

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

Okay. And then in terms of the next point, ensure that new data
initiatives are developed in a way that enhances rather than competes
with \--

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

Can I just back up to \-- this is John \-- to 2B. The one concern I have
with the language is just around \-- so to clarify, the CDC is not the
first responder or interpreter, I think there will be circumstances
where data are interpreted at the CDC, and that the CDC then as its next
step contacts State or local health department, and that that\'s a valid
activity, and it doesn\'t seem to be included in this language. And so I
just wanted to make that point, because I think we should clarify that
that is a valid flow of action.

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

This is Leah, and I\'d like to comment on this, on A and B. I\'ll start
with B, if that\'s okay, that\'s kind of what we\'re doing right now.

Is there a way that we could do this in a more positive way by saying
what the Federal role is versus the State and local role? You know, CDC,
we are all partners in this, State, Federal, local. And we have had
great experiences in our history where CDC is invited in, asked to come
in, we invite them in, they are here as adjuncts in support
in (indiscernible) capacity, we value that very much. So I guess what
I\'m thinking is that I do believe the issues we talked about related in
#1, the confidentiality concerns, the further that the public sees the
Federal Government in the background, the better. Is what I think.
Because it\'s further from home.

But that the role of CDC is to do \-- you know, redundant observation,
backup observation, you know, they\'re there to help us in this
surveillance work, as a \-- we talk a lot about redundant
communications, but redundant surveillance. They are there to look State
to State, they\'re there to inform surveillance in the country from what
they\'re finding in our borders, nations, and in other nations. So that
is the role I see for CDC. Support of the State, interstate, and
international.

Then you could say the State and locals have the primary lead
responsibility for early detection and rapid response, which includes
this traditional public health investigation. I like saying it more
positively. And then, Number A, I just have a question about the word
"simultaneous." I think that that needs to be defined at least for me,
because simultaneous I think in that sense means that if you hook up a
hospital, and as soon as the State is getting the specific hospital\'s
information so does CDC.

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

Actually I\'m happy you brought that up, because in terms of the \-- not
that the commission lays down the constitution for all this, as my
understanding is, as the discussion went \-- as the AHIC itself, the
notion here is that whatever the information is, you know, whatever
metrics we decided are going to be reported under this program, that
they would go \-- I\'m trying to think of the word other than
"simultaneous." I mean, everybody sort of get the aggregate \"it\" at
the same time. Now, it will come \-- it may come in a different form,
and I assume that the software would have to make that so, so that you
would get the information with an identifier, presumably, and whether
it\'s State and local would get it I or whatever, I guess would depend
on your own rule. And then the Federal would get the same
information \-- and that was the whole notion of electronic, was that
one, you had the power of software that could modify certain things, and
two, that it was a press of a button, basically. Or a simultaneous
action.

So if the word "simultaneous" is problematic we can sort that out, but I
think in terms of at least our mandate, our mandate was \--

**\>\>** Hello?

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

\-- that this happens, and real relative \-- as close to real time as
possible, and that sort of everybody gets it. That\'s a thought, I\'d
throw that out

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

Chip, this is Mitch Roob. I\'ve been listening for awhile \--
(interruption) actually, it\'s not on mute. Just kind of reading through
and listening to the conversation here, versus the conversation we had
at the last AHIC meeting, I think the general tone \-- the tenor of this
has gotten \-- and I made the point very clearly, that I thought
governors \-- you know, working for a governor currently and having been
a local public health official, that it was very important that we not
create a Federal only mechanism here, and not get in the way of the
traditional flow of data. But I do think that maybe the tone of this has
gone a bit farther than the AHIC group thought in terms of being now not
a Federal response. I mean, I guess I think that the role of CDC is a
bit broader than \-- and I think that \-- I don\'t want to speak for the
Secretary at all, but in speaking for myself, I think CDC\'s role is a
bit broader than not being the first investigator.

I\'m not sure that\'s \-- I\'m not sure that\'s the intent, and I think
that the simultaneous \-- the speed of those data flows, CDC needs to be
telling \-- creating a minimum dataset, which I think we\'ve done, and
that minimum dataset initially \-- I mean, that\'s what the CDC seems to
feel it needs, and if it\'s not going to get that from the
traditional \-- from all the States traditionally, I think we need to
know that and I think we need to make appropriate modifications to that
data flow, to make sure we can get that information.

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

Let me \-- this is Tom Frieden in New York, I think part of what Mitch
and Leah are saying I think everyone agrees with. Let\'s state this more
positively in terms of core competencies and capacities and roles,
because they are absolutely interconnected and interdependent, and there
are many important roles as each level. And so I think the idea of
rephrasing this much more positively is a good one.

At the same time, the issue of minimum dataset is \-- and that kind of
bumps into the whole technical specifications issue, is not only a minor
technical issue, it\'s kind of a large part of this discussion that in
the view of many, myself included, what is currently being collected in
the kind of first prong is potentially very valuable, but completely
unproven.

**\>\>** I guess the question \-- I guess I had been under the
impression that we had come to some consensus on what that minimum
dataset would be.

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

No, we circulated and North Carolina circulated detailed comments
line-by-line on that proposal with \-- disagreeing with actually the
majority of the items in it.

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

This is Laura Conn from the CDC. But subsequently to that, Tom, in the
subgroup call we did go back through that minimum dataset, and that\'s
where the pronged approach came, sort of borne out of that. And I think
we were still coming to agreement in that subgroup of the minimum
dataset that would be relative to the Prong 1, which is the deeper,
although maybe narrower in geographic scope. So I think we have moved
forward with additional discussions on that minimum dataset.

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

Laura, did we talk about the minimum dataset, that feedback, was that
Friday?

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

We did in the call before that. The first call.

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

Oh.

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

I think probably there\'s a distinction between \-- and this gets into
kind of the 4C that we added, which may be an important issue to touch
on. There\'s one thing to do a project, rigorously analyze it, see
what\'s effective, and then expand it. I think all of us would agree to
that. There\'s another to keep rapidly expanding something that\'s
unproven, and potentially problematic in various ways. And I think
that\'s where is the minimum set for Prong 1, is it Prong 2, is it for
the first phase of Prong 1, is it for all of Prong 1? Those are some of
the issues that I think are swirling around.

Just specifically the 4C that we have added, is that large-scale
implementation should be limited to approaches with demonstrated value.

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

I don\'t think we disagree, I think we have to get something underway in
order to evaluate it. So I think the crux of #4 was to identify the
objectives and metrics in which we could evaluate this after we get
started.

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

I\'m sorry to interrupt here for a second. Operator, I\'m seeing that
Kelly Cronin line is muted, that needs to be open. There are several
people speaking in the Workgroup that are using that line, so please
open that right away.

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

Sir, it is open now.

**\>\>** I\'m sorry, can people hear Chip?

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

You\'re back on.

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

Okay, I\'m sorry, I was saying that I agree completely with that last
point, because I sit on the hospital quality alliance and, you know, we
are constantly bombarded with expectations of doing all kinds of
measures, and the utility of measures and the ability of the collection
of measures is a constant debate.

So I think at the beginning we\'re going to be limited no matter what. I
don\'t think \-- whether this is all feasible or not we\'ll find out,
but whether it\'s going to get out of hand in terms of the amount of
information we ask for initially, I have my doubts, because I think it
will be modest. I\'m looking at Kelly to \--

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

Yeah, I think in part we thought if we are going to be leveraging off of
the resources that are made available through BioSense, and there\'s a
possibility of reaching up to 350 hospitals in the country this year,
that we would like to potentially exceed, that, you know, we\'d still be
talking about, you know, a subset of \-- you know, the universe of 5,000
hospitals. Or, you know, we may not get all reference labs or we may not
get \-- you know, all local and State jurisdictions that would be within
the hospitals that could participate. But that we did want to have \--
you know, a sizeable pilot that we really could evaluate. And have sort
of a rigorous analysis to find out if there\'s unintended consequences,
to really demonstrate the values of various types of public health
functions that we\'ve agreed on.

So while I think while we clearly don\'t want to do large-scale
implementation, meaning nationwide, we do want to have sort of realistic
goals that are not just BioSense, this is not a program that was
directly BioSense, it\'s distinctly separate. And I think we need to be
really clear about that.

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

Well, I mean in the sense of the commission, BioSense was not in the
minds of any of the commissions and Secretary when this came up as one
of the themes.

Let me say on #2, I\'m sensing the following, that we\'re sort of agreed
to move it to the positive, to say what kind of surveillance and
supportive role that the Federal Government, primarily CDC, plays in
this, and that whatever we do respects the accepted jurisdictions and
responsibilities of the local and State entities, and that nothing we do
would interfere with their ability to carry out their authority.

So something along those lines would be #2. So now let\'s move \-- and
we\'ll come back to that, I just sort of throw that on the table.

So then on #3, Tom was sort of into \-- was sort of on the prong, and
I\'m a little new to this, so I\'m a little confused between the first
and second prongs, but where we want to go \-- and I\'ll hand it back to
you, Kelly. If we\'re looking for something that every \-- knowing what
we\'ve had in the discussion, something that people would be comfortable
with, where would you suggest we go with 3? Considering the discussion
we just had, then we\'ll discuss that.

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

Okay, I think it probably would be helpful for us to \-- you know, agree
that we\'re not going to be able to make all the decisions on, you know,
specific data elements for Prong 2 in the Workgroup. So in our
recommendations when we get to actually thinking about what we actually
want to recommend specifically, we need to think about how do we charge
the right group of public health experts to come up with the set of
detailed data elements that can then allow HITSP to do their work in
naming the technical standards.

But I think that in our previous meetings we did get the consensus about
the high-level data element in the minimum dataset, and we did verify
that consensus at the subgroup level. So for that Prong 1, I think it
would be good to just have us all \-- you know, come to agreement again
that we are okay with the minimum dataset for Prong 1. Let HITSP do
their work to enable that, but to really again focus our efforts and get
the right public health experts engaged in really defining what this
Prong 2 will be at a more detailed level.

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

There also is this code issue, and if we don\'t like surveillance, we
may not want codes, per se, to be the term of art. What\'s in the
filtering, what is supported and what is not. That really meets the
public health \--

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

I guess it\'s a little unclear to me, this is Tom Frieden, what Prong 1
is, I guess. Because I understand that there was a prior discussion of
the minimum dataset, but I certainly don\'t agree with the extensive
dataset that\'s being presented as minimum.

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

Well, Tom, I think to address your concerns, we tried to \-- I think you
were the only person who dissented, in terms of \-- you know, the
consensus we reached earlier, but I think we tried to address it with
agreeing that we would have a broader approach that would follow what
you would think would be appropriate. In a larger \-- in a number of
jurisdictions in a larger geographic area.

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

This is Leah, I think I must have missed a meeting or an e-mail. But did
you all send out the minimum \-- the revised, or maybe it\'s the same,
did you resend the minimum dataset elements after this group reached
consensus?

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

We did, we sent out both the target and the minimum dataset, that
was \-- after it was discussed, I think, in two different Workgroup
meetings, that it was disseminated. Laura, you may have more of a
specific update.

**[\>\> LEAH:]{.underline}**

When was that? Tell me the date, I\'ll try to dig that out, because I
really have missed that, I\'m so sorry.

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

Tom, can you tell me what is your \-- this is Mitch Rove. I don\'t \-- I
just want to make sure \-- I\'m not saying you\'re wrong, I just want to
understand what are your reservations about the minimum dataset.

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

Well, having done biosurveillance in New York City for 5 years with
millions of data points, I don\'t think it\'s a minimum dataset. I think
it\'s a wish list of a large number of things that mixes things that are
of proven utility, things that are likely to be useful, and things that
may or may not be useful. Of the things that are proven utility are
definitive diagnoses, and I think that\'s probably best approached by
trying to get electronic laboratory reporting up and running nationally.
That would be a win for everyone.

The things that are of probable utility are things like bed utilization.
Which we know we would need in an epidemic, ICU and bed utilization, but
for which probably a different and simpler system than what\'s currently
being envisioned might be more reasonable and workable approach. And the
third are a large number of things which are by all means worth
investigating, but which I don\'t see as minimums to scale something up.
And I guess part of what I don\'t get is what is Prong 1? Is it 10
hospitals, is it 100 hospitals, is it 400 hospitals? And what\'s the
time frame for that. Because I think if the promise from this minimum
dataset is that we\'re going to address the Secretary\'s charge of
having something that\'s useful up and running in a reasonable time
frame. This minimum dataset is not going to get us there.

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

I\'m sorry, Tom, I\'m looking at it now, so your argument is that
there\'s too much on here, that some of the things don\'t have utility,
and that other things could possibly be collected in an easier and
simpler way, like bed utilization, is that what you\'re \--

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

Yes.

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

Because I know that in New Orleans right now they\'ve got a pretty
amazing utilization system, it\'s on a simple Web site and it would have
been unheard of before Katrina, because nobody would have wanted to give
that data in. But now everybody knows what the bed utilization, bed
availability is in New Orleans, and \-- Jackson Parish, it\'s beyond
that. Anyway, pretty simple system and everybody is so desperate down
there they\'re willing to comply because everybody is at 110 percent
occupancy.

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

This is Laura. I guess I\'m a little bit concerned that we may be
wavering off of our specific charge, and might ask Kelly to remind us of
that again. Because I think it specifically said that we should use
electronically enabled data, and I have concerns with asking this group
\-- or I have concerns with this group recommending to the community a
separate system, and a stand alone manual entry system to address any of
this.

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

You know, the dilemma though we have, and I guess here I need to put on
my provider hat for a second, the dilemma we have here is that these are
apples and oranges, and the information that Tom is talking about is
really institutional information. It doesn\'t have to be tied to any
individual case, I mean, it\'s just institutional information. And most
of the other information that\'s being asked for here is \-- you know,
really tied to a person.

And you know, I understand what you just said about not doing two
systems; on the other hand, on the institutional side, you know, every
hospital in the country at a certain time of day knows exactly what the
facts are about how many beds are filled, what their capacity is. I
mean, to handle anything, at a given time.

And boy, I don\'t want to jump off the \-- I\'m a little bit \-- I\'m
just wondering whether it makes sense to try to do everything under the
same envelope, when it really is a separate kind of thing. Does it? I
mean \--

**\>\>** Well, specifically on the bed utilization issue, what utility
is that to CDC? I mean, is that helpful particularly to CDC? Because I
think that was \-- if I remember correctly, that that was about the only
institutionally based data \--

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

I guess I would make an argument \-- let me put on a hat I don\'t have,
let\'s say if I was Secretary Leavitt \--which I\'m not, it\'s
presumptuous for me to think I was, and we have any of the crises that
are at hand, you could argue that that\'s something I\'d want to know.

And I \-- just from my own experience, and it\'s really a bit difference
experience and maybe that\'s not the right metric to point to, but I
just think he doesn\'t \-- I mean, if I put myself in his place, I
don\'t think he wants to fly blind on that, which he does now. And it\'s
not reasonable for the Secretary of HHS to want to have those numbers at
hand, it seems to me. Now yes, there are emergency systems already that
are in place, that hospitals sign on to, when you\'ve got your State
hospital associations that go into motion. But, you know, if we run into
some problems, it\'s going to be the Secretary that gets blamed. You
know, much like Mr. Brown, it\'s not going to be the governor or the
mayor.

And that\'s what\'s going through the Secretary\'s head. I mean, I
don\'t think it\'s \-- it doesn\'t take rocket science to say that, and
we just had an experience with that. So I guess I think this has got to
be in the mix. I think capacity is too much discussed, and people will
expect the Secretary to know. If we don\'t give him the capacity to
know, you know, it\'s going to be shame on him.

But at the same time this issue of how it\'s collected I think becomes a
different issue. And maybe we need to be flexible on that.

Does that make sense?

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

Well, we certainly didn\'t want to preclude those who can automatically
advance those data to do so in an automatic fashion.

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

Right. Right.

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

I think there\'s so much of rich history in public health reporting, of
non-reporting due to manual requirements, that I think that there\'s a
sensitivity to the burden of reporting public health records.

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

The thing that\'s nice about the hospital figures, and I\'m not
suggesting this, you could make it a condition of participation that at
a certain time of day all the hospitals had to report. And everybody
that did Medicare Medicaid business would do that. And they could report
it in to CMS, and the Secretary would know every day what the hospital
capacity is. And that\'s \--

**\>\>** Exactly.

**[\>\> CHIP:]{.underline}**

\-- not an unreasonable thing.

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

From a practical standpoint a lot of the next steps that need to occur
are exactly what\'s being described here. We need to standardize what
those utilization data are, we need to identify the terminology that
will be used in numbers, and what the codes are for \-- and we need to
have it so that it can be automatically sent for those who \-- who can
do it.

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

The whole issue what\'s a real bed.

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

It\'s not trivial.

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

That\'s the thing, it\'s not a trivial issue and you have to have common
definitions. I wasn\'t going there, I was just simply saying that
you \-- that having a system that reports to everybody on individual
patient information does not have to be identical with one that\'s
institutional, but actually, it could get started a lot faster.

**\>\>** So I guess to your point, Chip, isn\'t it easier for most
hospitals to report \-- I mean, isn\'t the clinical database in there,
that database, that we would be pulling that information now, isn\'t it
going to be resident in two different systems, or likely to be resident
in two different systems? And you\'re right, probably the place to
deposit it is at CMS, not at CDC.

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

Yes, possibly. And I\'m just saying right now, you are not \-- you would
be malfeasant as a hospital administrator not to know, based on some set
definitions of protocol, this information right now, at a certain time
of day. You know it. And we can work on the definitions and protocols.
Whereas all this other information is going to be a lot \-- you\'re only
going to get hundreds of hospitals to comply, because of the difficulty.
And I guess the question here is, do we develop a system that would get
us almost a full sample, versus one that might get us \-- you know, 700,
800 hospitals. If we can do both at the same time.

**\>\>** I hate to throw this in here, but \--

**\>\>** Well, is that easier for your members to deal with? Is it
easier \-- what\'s easier for your members to \--

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

Let me say first that my members aren\'t going to \-- I think there will
be great reticence about this being public because I go back to my New
Orleans example, and from a market standpoint the only reason they\'re
doing it in New Orleans is because they\'re still under a public health
crisis.

But if it was kept confidential so it was just something the Secretary
said, I think people could do it now.

Now, I haven\'t gone to my members, and they might say why did you bring
that up. But I see it \-- I see this capacity issue, depending on the
definitions, as a really essential thing for the Secretary to have.

**\>\>** And Tom, what\'s your opinion of that?

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

I agree completely. That\'s what I\'ve been trying to say, I clearly
haven\'t been saying it effectively enough until now.

**\>\>** Okay, so you want to do this in \-- I mean, do your members
want to do this in a separate data stream? Because as I remember, the
minimum dataset you had, that \-- Tom, is there other institutional
things that were on that known dataset?

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

I think, you know, there are things that are actually \-- we thought
fundamentally, and definitions better done by people who understands
hospitals better than I do, but basically, how many people do you have
in beds, how many people do you have in ICUs, and what\'s your excess
capacity. That, or what\'s your available capacity.

There are not \-- there are, as everyone has agreed, there are
complicated definitional issues, so that it\'s apples and apples.

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

Let me say I don\'t think we can define \-- I don\'t think we have a
competency to define that right here, and there are accepted definitions
that are used. And obviously in New Orleans they\'re using some set of
definitions, I guess we can work on that.

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

Yeah. I mean \-- we may want to be thinking again in terms of our time
frame, our obligation to the community and the Secretary, about, you
know, who is in charge, the right group of people, to go off,
definitively agree on the specific data elements, and make sure that we
set the direction in terms of public health functions. That if we agree
like we did up front that we want this for event detection, we\'d like
it for situational awareness, for outbreak management and response
management, and they can start with our high-level minimum dataset, that
another qualified group in the next State 2 months goes off and really,
really digs into this, identify what\'s absolutely necessary based upon
again the four public health \-- biosurveillance programs we initially
looked at to come up with this list, and fine tune and report back to
us.

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

That\'s the language we have on #3, convene the right group of public
health \--

**\>\>** Do we still agree that this minimum dataset, the initial one is
going to be limited to just hospitals?

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

Well, I think \-- well, including labs and  \--

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

Yeah, I mean  \--

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

\-- what sort of settings you want \--

**\>\>** Right. Right. But not physician offices.

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

Right. I think basically we haven\'t talked probably enough about this
particular issue of ambulatory care, but there\'s not that many
physician offices that have electronic health records that could
probably export the data that we\'re interested in, and we haven\'t
probably had a thorough enough consideration of what even a data element
might be that would be unique to electronic health records.

So given where we are right now, I think we\'ll have time to revisit the
idea of getting additional data from ambulatory care as we see
necessary, but through reference labs and \-- you know, perhaps in Prong
2 as we get into more opportunistic data like claims clearinghouse data
we could consider other sources of ambulatory care data.

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

Let me say in the short run, I wonder whether we should \-- I mean,
let\'s take Kaiser Permanente, for example. There are, on the Permanente
side, I mean, they should be able to come to some compliance with this
on the ambulatory side. And I mean, not that \-- and they actually have
pretty good cross-section of people in that State they\'re in. Or Mayo
or some other places have the capacity.

So I think as we talk through this we may want to say it\'s going to be
large groups generally that have the capacity, why shouldn\'t we offer
them some kind of ability to get into this. At least it\'s a place to
start. And I think then we meet our mandate. Kaiser alone is millions
and millions of people.

Let me also say just to go back to the area of my interest we were just
talking about. We really want to keep it to where you were talking
about, Kelly, the strong preference on the hospital side would be at
CDC, not CMS, the information. CMS has other missions.

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

This part was particularly articulated by Dr. Gerberding at the
community, and required part of a response.

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

We want to keep it on the response side, not on the payment regulatory
side. That should be noted for the record. Anything else? Okay.

Let\'s go to 4, or let me see if I \-- let\'s go to 4, and then we\'ll
work our way back up to the top. I think we have \-- we have an hour,
and we\'ll spend a few minutes on 4, and then maybe we\'ll try to bring
it to a close. At least if we can.

Where do you want to go on 4?

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

I think we all probably agree that we need the metrics, and clear goals
for this breakthrough. And you know, I ran through sort of our specific
conditions earlier, does anybody have any objections with what\'s been
proposed?

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

I think, Tom, in terms of your points, we compensated for some of those
in the discussion we just had, I think.

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

Yes, to \-- demonstrate value before we do large-scale or nationwide
implementation?

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

I think we have to revisit what it is, if that \-- you know, that\'s
like constraint, in terms of the process, because I think there\'s
actually been a lot of demonstrable value from many aspects of the
different data that are being described, here. And, you know, that\'s
something that can be discussed.

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

You know, we haven\'t \-- in all fairness to our processes in the last
couple of months, we haven\'t had a lot of testimony on \-- you know,
case studies or anecdotal data or even published literature around, you
know, biosurveillance programs that are in the field. So it probably
would be smart for us to get additional testimony in the short term in
this area. But at the same time, recognizing we really do need to make
sure that there\'s some kind of rigorous program evaluation built into
anything we do.

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

Absolutely. I think it\'s important to put on the table some of the
needs that have been represented in different emergencies. There\'s a
rich history of those, unfortunately, in the last few years. In getting
some input from some of the needs that have been articulated it would be
very helpful for the process.

That doesn\'t speak to not needing evaluations, but it speaks to the
fact that there have been already examples of utility that have been
expressed from (indiscernible).

\>\> I have to confess I am a little confused about what\'s being
discussed with \-- in terms of Prong 1, or large scale. I just don\'t
know where we\'re going. As I read the minimum dataset that was
circulated, it would include all inpatient medications, procedures,
diagnoses, and laboratories. So I think that there really are some
substantive issues in terms of clearly defining what our goals are, and
then determining whether or not the systems that are piloted or put in
place are reaching those goals in whole or in part.

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

Well, we\'re going to have \-- we\'ve going to come up with filters, and
also, we\'re going to be \-- to be realistic, I mean, we\'re only going
to be on with a limited number of institutions that can do this. So that
presumably, we\'re going to be thinking about the technical side, when
we\'re \-- when the experts are finalizing this, so they will know
whether it does only take a few buttons and some extra software to get
this done, versus something that\'s burdensome.

But I think your point about whether we need that information \-- we
need to think about the burden side, and then, you know \-- but I assume
the experts are going to go through this and decide and \-- have the
experts decide on which is the information that  \--

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

The simple answer was that I don\'t think there was ever any intent that
all of those values be transmitted, but that many times those data
elements are what are available in some capacity, and can be an
indication of activity. But that those should be filtered to represent
specific diseases and/or presentations of interest to biosurveillance.

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

Hi, this is Adele Morris at Treasury. I had the same reaction until I
learned about these filters, and can we talk for a second about \--
about the burden and to what extent the filter does or doesn\'t reduce
the burden. Because I can imagine it could work two different ways. One
would be that the filter actually put an extra burden, because the
health care provider has to maintain this system that weeds out data
from this fire hose of stuff. Or it could be \-- or it could reduce the
burden because it limits the amount of stuff that actually gets
transmitted.

Does anybody have any insight on that question?

**\>\>** Well, I think that from a practical standpoint there is a step
that needs to be taken whereby there\'s an active filtering of data, and
that that\'s an appropriate step to take to make sure that some data
don\'t make it out, as we recognize there may be billions to billions of
tests that are being \-- and/or data elements that are otherwise being
described, and not all of them are appropriate.

But it\'s an automated filter, and it\'s not \-- the work that\'s been
done in other circumstances is that that is not highly burdensome in an
ongoing way, that it doesn\'t burden clinical providers in any extent,
and to the extent that this can help eventually substitute for manual
reported it\'s actually assistive to them in terms of the reduction in
reporting.

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

Okay, let\'s \-- let me go back \-- I guess let me ask a question of
Kelly. We\'re at 10 after 3:00. We are supposed to end by 4:00, and we
do need time for public comment, is that correct?

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

We do.

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

How much time do we need for public comment?

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

It hasn\'t been that much in the previous calls, so less than a few
minutes.

**[\>\> CHIP:]{.underline}**

\-- question then I\'ll look at Kelly to \-- we really thoroughly
examined I think these four items. I think we have had a coming together
on some language on each of them, and I\'m almost a little hesitant \--
and I know you and others have taken careful notes \-- I\'m almost
hesitant to have us go back and try to wordsmith, because I wonder
whether, since we have the extra time, is it possible for us \-- for you
guys to go back with what you\'ve heard \-- I mean, for example, #2
needs to be recast. I\'m still not exactly sure where we are on #1, but
I think we\'re moving towards something. As long as we say, you know,
we\'re going to protect everything and only have limited information,
and we can set some criteria for that.

Would it be worth it coming back with some new language, and then next
week have everybody, when they\'re fresh, go over the new language,
which is in light of what we just had in our discussion, and see if that
meets the needs? Since we\'re not \-- since we don\'t have to have
this \-- you know, we have until, you know, a few weeks. Does that make
sense? Because I think we\'ve had a good discussion, I think we\'ve
really come together, but I\'d hate to try to in a short period
wordsmith stuff that I think would take people around this table to do a
draft and then get back to everybody. If that\'s amenable \-- is that
amenable to people on the phone in?

**\>\>** Yes.

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

Yeah, I guess I\'d just add that we can start to, as we reword this and
try to take into account all the feedback we\'ve heard today, and
address everyone\'s concerns to the extent feasible, that we actually
craft this more in the form of recommendations to the community, so we
can then turn this into our letter, and help it shape our presentation
on the 16th.

We don\'t have to have the letter ready on the 16th, but we can at least
give a good update on \--

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

Actually I would suggest that, because in a sense what the discussion
has done \-- and I think actually, you know, in a sense, this was
written, and then Tom commented on it \-- this was written, though, as
issues. So that some of the things were done in the negative to assure
people \-- to try to define what we weren\'t, so people would feel more
comfortable. Now that we know from this discussion what I think we
generally feel we are, then I think you go ahead and do that.

So all of this can be written in the positive, anyway. Albeit implicit
in that will be all the protections for State and local authorities and
their prerogatives. If we do that, and go back to the agenda, we now
then \-- and this is really the guts of what the recommendations are
going to be. So the next will be #7?

So we reviewed the outline for recommendations. So what is that
considering, what we just laid out for our task for next week?

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

Yeah, I think we tried to put together sort of a logical format for a
letter of recommendation based upon what the three other workgroups have
already done. And much of what we just discussed would be filtered into
this, or put into this format, so that there\'s sort of a logical flow
to the issues and the recommendation.

So Laura, since you \-- a few of us sort of worked on sort of what would
be the logical format. I don\'t know if you want to take a \-- sort of a
high-level overview of what we think probably needs to be described in a
letter?

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

Sure. And I do think a lot of the issues that we just talked about will
get factored in, so I don\'t want to get bogged down in the details of
the language and agree that we can do that offline.

So just essentially, the first four items are sort of overarching
background information, things we discussed in this Workgroup as we went
along that have informed where we\'re going to go with recommendation,
so the context of what are we trying to achieve and why we even started
this.

The second is the definition of these functional needs, and how \-- and
the very first meeting we got to defining biosurveillance through the
scenarios between the first and the second meeting, through the scenario
document, to include initial event detection, situational awareness,
outbreak management and response management. I think we need to have
some language around what the definitions of those are, and how that
comes together.

Differentiate between traditional disease surveillance and using the
existing health care data, so that folks who aren\'t as close to this in
the community have a sense for what it is we\'re talking about.

And then the fourth is to describe existing activities and capacities
that are ongoing in this area, both informed by the results of the ASTHO
and NACCHO surveys that we heard about today, but other ongoing
initiatives in this area.

So and then going from 5 on, really, 5 relates to our issue #3, in the
technical specifications and convening the right group to really define
what the right data elements and the filtering issues would be about.

Six is where we describe addressing the scope issue with this pronged
approach, and we talked a good bit about that.

Seven is around data flow, and the appropriate roles. We talked about
both of these issues in #2 on the issue list, so we\'ll feed this into
that.

Eight is obviously privacy, we probably want to change that based on the
conversation today, the confidentiality, but taking into account the
discussion we had on the issues #1. And then 9 is around the evaluation
of the data, which was Issue #4.

So I think, you know, our issues discussion actually mapped very closely
into the areas of where we\'ll end up having recommendations. This was
sort of a background, or just a first stab at making sure that we were
going to be working towards recommendations in the key areas that the
Workgroup has addressed.

So we\'ll continue to flesh this out and share it at our meeting next
week.

**\>\>** Any questions?

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

I guess I would just \-- this is Tom Frieden again in New York. I would
just highlight again the further definition of Prong 2, which I think
needs to be thought through more. And agreed, because I think there is
value there.

I\'m not sure all the issues that we raised that we all agree should be
reflected here, such as role and specification, are reflected, but
presumably it will be in the graph version that we all see.

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

Tom, let me just \-- just so we get that on the table now, so we know
what we\'re about in this drafting. Kelly, what needs to be done on
Prong 2, so we can make it clear to everybody?

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

Yeah, I mean, I think in our subgroup conversations we only really
started talking about Prong 2 at a conceptual level. And we recognize
that, you know, if we had the time today and next week, we really should
talk about, well, what opportunistic data or what data sources are
available, and what would be meaningful to consider for Prong 2. With
the intent that this would really be much broader than Prong 1, we\'d
reach a larger geographic area, and potentially engage \-- you know,
larger numbers of local and State jurisdictions. So, you know, what
we\'ve listed in the outline sort of talks about the broad sorts of data
we could be considering, you know, not just what we\'ve been talking
about from hospital systems, but there might also be claims
clearinghouses that would have some data available that could be timely.

Traditionally it has not been timely, but from what we understand the
turn-around time there is getting much better, with automated billing.

There could also be, you know, readily available data from, again,
reference labs. We could be considering chief complaint data. So I think
we need to more clearly specify what are the opportunistic data sources,
and out of those data sources, what do we think would derive the most
value in a broader data strategy.

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

Could I ask a question? If we \-- talking about our utilization issue,
is that really a Prong 2 issue? If THE data source is whatever we invent
for hospitals to report to CDC on, rather than a part of the other
source, which is something that is part of the whole dataset and
everything we\'re talking about a few minutes ago? Would it be looked
upon that way? I mean, because I guess there is reticence around the
table \-- going to another  \--

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

Sounds good to me, from New York.

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

I\'m sorry, but \-- don\'t you think?

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

Well, I think that we may need to sort of consider what the
(indiscernible) are here, because what Kelly was describing, and what
the working group was talking about on Prong 2 was more opportunistic.
And what you\'re describing from the utilization standpoint is more
directive.

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

Maybe \-- maybe we need Prong 1, Prong 2, and Prong 3. And your current
Prong 2 is Prong 3, and Prong 2 are things that we can find electronic
ways to access. But that the infrastructure you build under Prong 1
might not be the same system. I understand the driving need here to make
it something that is automatic, and I believe we might be able to do
that. But under Prong 1 you\'re only going to get hundreds. Under my new
Prong 2, you ought to get 2,800.

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

I think talking about a different sort of data might be appropriate. I
do want to emphasize the specific charge, there are many systems
involved here already, and this is not about one system, but is about
that interface between clinical care and public health, and trying to
foster that data delivery. So \-- I mean, I think that\'s completely
compatible with what we\'ve been talking about in this regard. There may
be a way of articulating the \-- you know, the readiness of delivery of
utilization data, or the willingness in the way that can separate these
things out.

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

I think, you know, when you think about it \-- and this is one of the
issues \-- even though they\'ve got one computer, you know, some stuff
is in the administrator\'s office, and is reported under one format, and
some stuff, everything else clinical, is going to be in a whole
different place. Not that you couldn\'t get to it from the
administrator\'s computer, but that\'s not what happens in that office.

So I think we need to think about that a little bit, and actually not
only between this week and next week, we\'ll go up and talk to people
about that, to see and maybe come back with some ideas.

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

Can I come back to the minimum dataset concept? Because we seem to be
moving down the path to accept thoughts on what the minimum dataset is.
When we \-- when we visited this at one point in time, the CDC was \-- I
guess I concluded that the CDC wanted enormous quantities of data.
And \-- I mean, is that \-- I mean, what\'s the CDC\'s position on this?

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

I\'m not sure our target is enormous quantities of data, but what we
tried to do, in looking at finding the minimum and then the target
dataset, was take into account the specific charge that we\'ve been
asked, look across the existing activities, including the New York City
system, the North Carolina system, and come to consensus in this group
about those minimum data elements that would meet the specific charge
and provide data relevant to the scenarios that we agreed on that would
answer the questions and cover the functional needs that we agreed were
biosurveillance.

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

This is Mark. Let me suggest that the dataset that we come up with now
doesn\'t have to be sort of frozen in time. And I would suggest that we
follow a strategy of coming up with a dataset that is the minimum now
that we know we can justify, that we think would be most receptive to
the public as well as people who are going to have to use it. And then
if we have evidence that we need to add more elements, then there\'s
going to be some mechanism in place to add those elements. I think  \--

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

Yeah, I really think, Mark, you brought up a really important point. And
I guess I would like to put in the \-- when we redraft the
recommendation, two notions that you bring up. One is that there will be
sort of periodic reevaluation, and that we will institutionalize \--
that that ought to be institutionalized in some way with some set of
people and somebody has responsibility for. And two, we really need \--
and this is obviously a subset of that \-- we really need the notion
that these reevaluations are \-- you know, assume this is extremely
dynamic in the sense that we will not be shy about throwing stuff out
that doesn\'t seem to give us information that\'s useful. And obviously,
we need to add information with care, that we\'re asking for, because of
the complexity of it. It\'s easier probably to throw stuff out than put
stuff in.

But I think both of those should be \-- this is an ongoing process, and
whether it\'s every 6 months or whether it\'s \-- whether it\'s periodic
or there\'s some other kind of way to do it, we need a monitoring \--
there needs to be a permanent monitoring committee. We need a committee.

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

Yeah, to me that sounds like exactly what is in large-scale clinical
research, data safety monitoring boards. It would be perfectly
appropriate for perhaps not only have the certain data steering
committee that would be recommended up front to help refine some of the
data elements, that they be the same experts to continuously evaluate on
some interim basis, you know, the value of the data that we are
collecting, and then recommend appropriate modifications.

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

And obviously, when we hit some crisis, which we hope we won\'t hit, but
we inevitably will, unpredictable what it is, then you\'ll know why.
Learn a lot.

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

I think the important context for that that makes a lot of sense is to
also look at the crisis we already hit. Because we have an unfortunate
sort of history of becoming quiescent during times of non-crisis, and
looking at the crises, and looking at the data that are needed, you
can\'t build new systems during the crisis. You need to really have the
capacity in place. And that\'s one of the \-- one lens that we have to
use in looking at this, is to make sure we\'re accommodating not just
what you need between crises, but what you need in a crisis. And that is
something that we have \-- you know, a fair amount of evidence on.

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

Kelly, have we given you enough as a group to have you go back and
redraft \-- is everybody on the phone satisfied that at least at this
point we\'ve had enough discussion to give staff the opportunity to go
back and draft something and give it back to us for our consideration?
Okay.

**\>\>** Yes.

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

I accept that, and the next step, then, is obviously for the staff to go
back and draft some recommendations, and this is now pulling into the
letter itself, so that at the next meeting we will consider the language
of the letter, of the recommendations, themselves. And, you know,
obviously, some points of controversy may arise at that time, but
hopefully the discussion today is minimized. That, and the staff is
pretty knowledgeable now about the what the committee \-- what the group
would like to work with, would like to see.

As I said, the June date is our deadline date, but I would hope that on
May \-- May 4?

**\>\>** Yes, May 4, Thursday.

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

May 4, which is from 1:00 to 4:00, that we can bring most of this to
conclusion, and then I guess begin to think about the next page of work,
which obviously is to get experts together, and start thinking about
what we do to put the structure together.

That all being said, without any objection I guess I\'ll move to the
public input. And at this point of the meeting, is there anyone from the
public \-- did they queue this up?

**\>\>** Yeah, Matt will.

**\>\>** Matt, will you go through the procedure you go through for the
public to let somebody in, if there is anybody?

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

Absolutely. If members of the public already called in and listening to
the meeting by phone, you just need to press star one to make a comment.
If you\'re following along via the Webcast on your computer, you\'ll see
instructions on the screen now for calling in and making a comment. I
think as always for this we should wait about 2 or 3 minutes to make
sure anybody who has a comment can work his or her way through the
operators. If we don\'t have anybody at that time, I\'ll let you know
and we can adjourn the meeting.

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

As we wait for public comments I wanted to offer a couple of details
that might help people understand what we actually have to accomplish in
the next 2 weeks. We\'ll do our best to try to capture the conversation
today, and some preliminary recommendations that are specific to the
issues we talked about today.

And I think that will be a good start at having some draft preliminary
recommendations for the \-- you know, as to discuss more completely next
week.

But we won\'t actually have to deliver our full letter of
recommendations on May 16, we can continue to refine, then, in the month
of May. But again, you know, we want \-- I think, you know, Chip already
outlined, really try to press to get as much agreement as possible next
week on our definition of Prong 1 and Prong 2, and any other \-- you
know, aspects that we talked about today that aren\'t described fully in
the draft preliminary recommendation.

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

Are there any comments from the public, Matt?

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

Not yet, do you want to give it maybe 30, 40 more \-- we just got one.
Operator, will you open that first comment in the queue, please?

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

Mr. Hague, your line is live.

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

Hi, this is Jim Hague at North Carolina Hospital Association, thank you
for letting the public comment. It\'s a tremendous discussion, and I\'m
sorry I haven\'t been participating in your earlier meetings.

As to the privacy issue, I really don\'t know what HIPAA was for, and I
don\'t know what the National Health Information Infrastructure \--
National Health Information Network, however it\'s called, is for,
except but to allow the free flow of private medical information with
the privacy rule and security rule that determines, and tells hospitals,
providers, other providers, and other entities, who can access what
information at what level.

And so I really don\'t think that this group, for purposes of
bioterrorism surveillance in public health, needs to be concerned itself
with actually, limiting data items so that people \-- people who should
have access to them cannot have access to that information, because
it\'s not collected.

Otherwise, I just don\'t know what HIPAA was for. And I don\'t know why
we\'re doing a National Health Information Network. The Biosurveillance
Workgroup is one of four workgroups, all of which there\'s a beautiful
chart in the community materials that shows how they all \-- it\'s a
matrix, and shows how they all interrelate. And the whole point of this
is to get the information out there, and then control it through
security and privacy enforcement.

And this is being done, hospitals have invested many millions of dollars
in this, and it\'s all waste if it\'s not going to get used. And other
covered entities, and public health may not be a covered entity, but it
certainly is, as other speakers were commenting, it certainly is a group
that knows the importance of protecting health information.

So I really think that that whole discussion is really unnecessary for
purposes of this Workgroup. Let\'s get it all out there, and let\'s let
the security folks and the privacy folks figure out who can access it,
and for what purpose, and they\'ve already done that to a great extent.
Let\'s use that work, let\'s build on that, let\'s not have that go to
waste.

And secondly, as far as the bed capacity. Bed capacity is important, and
at various State and local levels that\'s been emphasized by various
systems that have been created. A national system, fine. But what this
group is looking at is a \-- looking at clinical elements of data. And
if you try to put bed data into that, it\'s just going to throw a wrench
into the works, and this is going to take an extra year or 2 to roll
out. And I don\'t think that\'s what you want, but I think that\'s a
discussion that can be had separately, either concurrently or at a later
time. Thank you.

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

Matt, anybody else?

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

No, there\'s not. And as always, for members of the public, we will
leave an e-mail address up on the Webcast. So if do you want to submit a
comment or question that way, it will be online for another hour or so.

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

Thanks. I guess since there\'s no other public comment and no
objections, we will adjourn. So we\'ll see everybody next week.