American Health Information Community

Biosurveillance Workgroup

March 23, 2006

1:00 p.m. EDT

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by the U.S. Government.*

> \>\> Operator: And Matt, you're live.
>
> \>\> Matt McCoy: Okay; thank you. Go ahead, Dr. Gerberding.

\>\> Julie Gerberding: Good afternoon, everyone. Thanks for joining.
We\'re here to continue our dialogue around the public health
surveillance connectivity and the AHIC project. And I think we probably
need to start with the roll call.

\>\> Matt McCoy: Kelly, are there any Workgroup members in the room with
you before we go over who is on the phone?

\>\> Kelly Cronin: Just myself and Dr. John Loonsk.

\>\> Matt McCoy: Okay. Joining on the phone, we have Jean-Marie
Maillard, who is filling in today for Leah Devlin; Michael Barr;
Dr. Gerberding; Jeff Wells; Adele Morris; Brian Keaton; Dave Parramore;
Tom Frieden; Edward Sondik.

Is there any other Workgroup members on the phone whom I missed?

\>\> Tom Frieden: I'll just comment \-- this is Tom Frieden \-- that I
have to leave at 2, and Rick Heffernan is with me and will continue to
represent me after that.

\>\> Matt McCoy: Okay. If we didn\'t miss anybody, I\'ll quickly go over
the call‑in procedures for today and turn it back over to Kelly and
Dr. Gerberding.

As we\'ve done in the past, everybody who is a Workgroup member has an
open line today. We ask that you keep your phone muted on your end when
you\'re not speaking to cut down on the chatter.

If you\'re logged into the Web interface, please don\'t touch any of the
controls, because the changes you make will be streamed across the Web.
And, lastly, for members of the public listening, during the meeting,
only Workgroup members will be speaking, but at the end, we\'ll reserve
15 or so minutes for public comments if anybody is interested in making
them.

Kelly, Dr. Gerberding?

\>\> Julie Gerberding: Thank you, I think everyone who has participated
in the call understands the agenda and the objectives of the meeting. If
there are any questions about those objectives, chime in.

But just kind of to put this in context, if you remember, at the last
AHIC meeting, we were asked to really seek input about the
responsibilities of our Workgroup from a variety of factors. And so the
main purpose of our call overarching the specific objectives is to
provide an opportunity to really hear from some of the critical
stakeholders in this process as we move forward.

So we have several people lined up to give us their views on where we
are and where we\'re going. We also have a number of different documents
that have been circulated to people, including the notes from our last
call, the validation paper for the minimum data elements, a summary of
the Katrina report, and some information about harmonized use case for
biosurveillance.

And I think John Loonsk is going to specifically frame for us the
discussion of the harmonized use case documents and how it would really
mesh with our Workgroup recommendations.

John, are you on the call?

> \>\> John Loonsk: Yes, I am. On Sunday evening, three harmonized use
> cases were distributed representing three of the four breakthrough
> areas.
>
> The input into those use cases came from a variety of different
> groups, including the Health Information Technology Standards Panel,
> the Certification Commission, the four consortia of the Nationwide
> Health Information Network Contractors, and also input from the
> proceedings of this working group.
>
> The concept of the use case is that it reflects at a high level the
> functional needs of a breakthrough area with enough specificity that a
> series of different groups can advance different activities based on
> it.
>
> So it has to have some specificity. The Nationwide Health Information
> Network Contractors will endeavor to prototype an architecture for how
> that could be implemented. The standards harmonization group, the
> HITSP, will work to harmonize the standards in that area and to
> develop implementation-level guidance based on that. And eventually,
> the certification commission will, in the long run, consider methods
> of certifying to that type of activity.
>
> That all being said, the use cases were an effort to not describe
> models for PIC approaches any more than had to be the case in terms of
> specifying in adequately detail the functionality that these groups
> needed to carry forth with to pursue their missions.
>
> The harmonized use cases for biosurveillance is or will be available
> to this group for consideration. If there is a desire to have a
> further discussion on that in this setting that would be very
> appropriate. But I think you\'ll find that it parallels in great part
> the discussions of this group, but offers the specificity for these
> next-step activities of these various contractors.

\>\> Julie Gerberding: Do we have any questions or comments about that
concept from the Workgroup?

If not, then I think we can move on to the next agenda item, which are
really the presentations.

> \>\> Tom Frieden: I\'m sorry. Julie, I'm sorry to interrupt. This is
> Tom Frieden. I don\'t know how long the presentations are going to
> take. And I have to say that I do have some very fundamental issues
> with the summary of the last conference held on February 24. And I\'m
> not sure when we\'ll get to the minimum dataset discussion, but I have
> issues on that as well.
>
> \>\> Julie Gerberding: The order of the presentations is relatively
> fixed today, but we can certainly take your comments on the summary
> notes.
>
> \>\> Tom Frieden: Yeah. I guess just in terms of process, it\'s very
> hard to get this volume of documents 24 hours in advance of a meeting
> and give them any thoughtful review. Also, we didn\'t hear about the
> scheduling of this call until about 48 hours ago. So for the future,
> it would be very helpful to get stuff scheduled in advance and then
> materials well in advance. But in the summary, there\'s a statement
> that the ‑‑
>
> \>\> Julie Gerberding: Tom, you know, I think the meeting schedule has
> been set several months ago. They\'re very far in advance. So maybe
> you didn\'t receive the initial ‑‑
>
> \>\> Tom Frieden: I think there\'s been some gaps, at least from my
> side. So if my ‑‑ but if someone could just resend that, that would be
> helpful.
>
> \>\> Julie Gerberding: Absolutely. I'm sorry about that. We can
> certainly send out reminders as well.
>
> \>\> Tom Frieden: I think that there are a couple of things: one on
> the minimum dataset and one on the options, which I think is on page
> 6, item 5 of the summary.
>
> I just have to say that I disagree with this decision vehemently. I
> don\'t think that Option 1 is either ‑‑ I think it\'s the preferred
> way to go. It could go \-- also there are ways that \-- think of ways
> it could go in parallel to different groups, but I can\'t agree with
> that conclusion. It\'s certainly not a unanimous consensus of this
> Workgroup.
>
> \>\> Julie Gerberding: Any comments from the Workgroup? I think
> there\'s probably been a change of some who were on the call last time
> to this time.
>
> \>\> Rick Friedman: Yeah, this is Rick Friedman, as one of the
> members. I think it\'s certainly worth kicking around. But I was just
> thinking that it might be best, so that we can all be on the same
> page, we stick with the agenda and make sure the presentations, since
> I\'m one of them, goes fairly quickly so we can get into this. But
> I\'m, frankly, a little discombobulated relative to the order of
> things. So my suggestion is to go back to the agenda, follow it.
> We\'ll get to this, because it\'s part of the revised minimum dataset
> discussion, and we can talk about it at that point.
>
> Tom: I guess the only thing I'd ask is that, if the summary is in the
> form of a minutes, usually in a meeting, you would kind of confirm the
> minutes of the prior meeting. And I would just say that there\'s not
> consensus that Option 1 is not a viable option. And I just can\'t \--
> I can't be considered to have agreed with what this says I agreed with
> last time.
>
> \>\> Ed Sondik: This is Ed Sondik. I think one of the problems with
> the way the options are actually spelled out is that to really
> understand them, it takes a bit more detail. For example, it\'s
> important to know whether there\'s a stopping point in the flow, for
> example, in Option 1; whether there\'s an option, for example, after
> information go into the local public health agency; whether it ever
> goes on, for example.
>
> I took it to be, actually, that this was the flow and it happened to,
> essentially simultaneously \-- so I didn\'t see a great deal of
> difference between Option 1 and Option 2.
>
> And I\'m not sure how Tom is interpreting Option 1, or anybody else
> for that matter. But it would be useful for ‑‑ I think this is an
> important point, and I think a bit more detail on it would be useful.

\>\> Tom Frieden: I don\'t want to derail the discussion or delay the
meeting at all, but I guess it really comes down to page 7, where it
says, "The Workgroup members decided against Option 1. And without being
clear about what it is and what it means, I just \-- I can\'t
participate in a workgroup if I\'m being represented as having agreed to
something that I haven\'t. That\'s my point.

> \>\> Julie Gerberding: What we can do, Tom, is clarify that it was not
> a unanimous decision.

\>\> Kelly Cronin: Tom, this is Kelly Cronin. I just also want to point
out that I think you had a representative on the call last time when we
did reach consensus. And it\'s unfortunate that you weren\'t part of
that process. But we did have a more detailed discussion and background
paper that was presented that described the various options as we went
through them. So if we can\'t get closure on this today, perhaps it
would be useful to go back to that document and we could, you know,
explore your concerns in more detail at the appropriate time.

> \>\> Julie Gerberding: Does that work for you, Tom?
>
> \>\> Tom Frieden: Yeah.
>
> \>\> Julie Gerberding: Thank you. So let\'s move to the agenda and
> initiate the first presentation from NACCHO.
>
> \>\> Paula Soper: Actually \-- this is Paula Soper with NACCHO. I\'m
> trying to locate our presenter at the moment, Bill Stephens from
> Tarrant County. So why don\'t we go ahead with the scheduled first
> presenter? I apologize.
>
> \>\> Julie Gerberding: Okay. Bill, are you ready from ASTHO?
> Dr. Hacker?

\>\> Kelly Cronin: Julie, Rick Friedman is here and ready to go and was
originally scheduled first. But we just had a last minute request from
NACCHO last \-- yesterday evening to go first because of their time
sensitivity. But given the challenges, why don\'t we ask Rick to get
started?

> \>\> Julie Gerberding: Thank you. Go ahead, Rick.
>
> \>\> Rick Friedman: Okay. This is Rick, and I had foolishly
> volunteered to read a report and report on it in this meeting.
>
> The report actually was written by folks in the White House relative
> to Katrina. And it\'s called the Federal Response to Hurricane Katrina
> Lessons Learned. I thought there would be real value in looking at the
> work that others had done relative to emergency situations to see if
> there were any lessons learned there for us.
>
> I highly recommend folks taking an hour or so to read this report.
> It\'s really well written. It is in no way a whitewash or anything
> else of Federal activity. It\'s very constructive and I think it has a
> lot of lessons learned. Consists of 228 pages. There's seven chapters
> and five appendices.
>
> I boiled it down repeatedly in different attempts and finally wound up
> with small enough font that I could get stuff onto an eight-page
> summary.
>
> And I looked primarily at three chapters and the appendix relative to
> recommendations. The three chapters were Chapter 2, about national
> preparedness, a primer \-- I found that to be very useful; I\'m sure a
> lot of you on the committee and around understand all of this much
> better than I do, but I found it very helpful \-- Chapter 5, about
> specific lessons learned; and chapter 6, Transforming National
> Preparedness \-- I thought had a lot of relevance for us. The
> recommendations really are specific to Federal agencies, and I\'ve
> copied them onto this eight-page summary, the last three pages. They
> really relate to the Secretary\'s mission of HHS and others. And I
> just extracted them so we had a complete record. But I didn\'t see
> them as directly applicable to our particular Workgroup. I\'m sure
> I\'m sawing sawdust and that a number of people are familiar with
> these anyway.
>
> With regard to Chapter 2, the National Preparedness, it basically
> talks about how this system is supposed to work. And that is that
> traditionally, States and local governments respond first and then the
> Federal Government plays a supporting role.
>
> A plan was developed, a national response plan, and also a national
> incident management system was put together by 2004. One caveat: This
> report really speaks to the Federal side of the equation. It does not
> focus on the State or the local activity around Katrina. I think it
> was an attempt to try to get our arms around where some of the Federal
> support needed to be strengthened.
>
> So it doesn\'t have a direct one‑to‑one relationship, I don\'t think,
> but there\'s a lot of background material here that\'s useful. It
> speaks to effective incident management reporting and, obviously, the
> importance of coordination across a number of different agencies. And
> it says that one of the reasons \-- I\'m on page 3, Item Number 10 \--
> is that one of the fundamental issues around Katrina was \-- why
> things didn\'t go as planned \-- in part was that there was a lack of
> understanding on the parties of what a national plan was. Obviously,
> in the absence of understanding the plan, they couldn\'t practice it.
> And I think it speaks to our concerns relative to whatever we come up
> with, datasets and other things, that a broad community of people
> understand it and to the degree that it could be implemented or
> practiced, I think that\'s a lesson across the board.
>
> Obviously, there were a number of public health issues around Katrina,
> which may or may not be applicable in our situation. I\'m on Item 13
> and 14 on the third page of my little summary. And it just talks about
> the kinds of challenges that people were facing in dealing with
> identification and triaging folks that were acutely sick, managing
> chronically ill people, assessment communication of public health
> risk, and providing assistance to State and local health people.
>
> Chapter 6 speaks to \-- I\'m on page 4 \-- about transforming the
> national preparedness. What this is, is sort of changing the culture
> in which people as a nation, regardless of where you live or what
> level of government or the private sector, that people start having a
> shared vision of a commitment to preparedness, and I think that\'s as
> much as applicable in our situation as anybody else\'s; that it really
> is important that there is a lot of feedback and periodic reassessment
> of the processes that are put in place, and I think that would
> probably be applicable in our situation as well.
>
> They use a model here of national preparedness, and they speak about
> it in the context of the military. I don\'t know if that makes any
> sense for public health or not. That\'s not really the planet that
> I\'ve lived on for the past 30 years, but it speaks to folks in the
> military situation, at least having a commander on the ground who is
> able to utilize services across different agencies, and that may or
> may not be applicable in our situation.
>
> That there needs to be \-- on page 5, Item Number 23 \-- a culture of
> preparedness. And again, this goes to sort of changing the whole way
> that we look at these kinds of situations so that people at all levels
> are cognizant of it and feel that they have a specific pull, that
> metrics are very important in determining our success or failure, and
> that there be feedback loops built into the whole process.
>
> That really amounts to my summary. As I say, I\'ve included the
> agency‑specific recommendations with specific lessons learned at the
> department level, but I think others in HHS and elsewhere are
> certainly taking to heart. I won\'t reiterate them in the interests of
> time. But by \-- one reiteration is that I would strongly urge anybody
> to take an hour out of your busy day and read this report. It\'s on
> the Web. The location is cited in the summary. It\'s very well-written
> and, I think, quite applicable. Thanks, Kelly.
>
> \>\> Julie Gerberding: Any questions or comments? And thank you for
> that excellent summary.
>
> \[No response.\] If not, we could call again for Dr. Hacker.

\>\> Bill Hacker: Julie, I\'m here this time.

> \>\> Julie Gerberding: Okay. Thank you. Sorry about that.

\>\> Bill Hacker: Well, I somehow got dropped, and I apologize; it may
have been a button I pushed here. Before I begin, I want to thank you
for coming to Frankfurt on January the 20th for our summit. Just as a
followup for your information, as you may remember, I challenged the
local health departments to duplicate a similar summit in their
community. We currently have scheduled, as of today, 40 different
summits in Kentucky covering 104 of 120 counties and \--

\>\> Julie Gerberding \[cutting in\]: Wow.

\>\> Bill Hacker: \[Indiscernible\] percent of our population.

\>\> Julie Gerberding: Wow, that\'s incredible.

\>\> Bill Hacker: We\'re off to a great start. We've done enough \-- or
we\'re having between 50 and 250 people showing up. And so it is \--
we're very \-- I\'m very proud of our local health department's energy
in the pandemic summit planning.

\>\> Julie Gerberding: Congratulations.

\>\> Bill Hacker: I appreciate the opportunity to respond on ASTHO \--
for ASTHO on the \-- your telephone conference call today. I\'ve been
asked to summarize the ASTHO's position on biosurveillance. I \-- my
background is \-- I\'m the Commissioner for the Department of Public
Health in Kentucky. For those folks who have been around, I\'m the guy
that followed Rice Leach, which is a difficult act to follow, but I
appreciate the opportunity. I\'ve been with the Commissioner for a
little over year and a half. I\'m also the Chair of the ASTHO \-- always
forget the title \-- it\'s the Public Health Informatics Policy
Committee, and we had a nice meeting in Indianapolis in February.
Secretary Rhodes joined us that evening, and our group, which included
folks from around 10 States, including Gifford, the Commissioner from
Rhode Island; Judy Monroe from Indiana; and myself and others as well as
someone from NACCHO \-- we discussed biosurveillance and looked
particularly at the Indianapolis model of how they have their RHIO set
up and some of the problems they have in sharing of information
electronically. It was a very good evening for us.

The biosurveillance paper then passed our committee on February the
27th. It was reviewed and approved by the ASTHO Preparedness Policy
Committee on February the 28th and was reviewed and approved by the
ASTHO Executive Committee on March the 17th.

ASTHO certainly understands the importance of biosurveillance, and we do
support these efforts. Some background points of view from our
organization: Biosurveillance really ties in two different surveillance
methods. One is standard public health epidemiological investigation,
and we want to remind folks that there\'s a human component in addition
to the electronic sharing. The second biosurveillance component is
automated systems, which do expedite in a timely manner sharing of
information that \-- and data that may preliminarily identify an issue
that requires more prompt response.

The States across the country are implementing biosurveillance programs
at various stages. I know in Kentucky, for example, since 2002, we have
a biosurveillance activity in the Jefferson County area around
Louisville dealing with the Derby season. And for you folks out in the
country that think the Derby just happens on the first Saturday in May,
that\'s the actual Derby date. But the Louisville community has hundreds
of thousands of visitors from around the world that show up a week
before, and it\'s actually a very long, very festive occasion with lots
of folks coming into our area of the United States. It runs for about 2
weeks, and so we call that the Derby Season.

Since 2002, we\'ve been collecting emergency room chief complaints from
16 hospitals in the greater Louisville area, including southern Indiana.
That\'s data electronically submitted from each emergency room to the
local health department in Louisville, which then does surveillance
looking for any peaks. And what we\'re building is a background database
of what\'s the average load of fever or chief complaint in Louisville,
KY, the first week of May, as an example.

But in our State, that\'s the most intense biosurveillance program
we\'re dealing with, and other parts of the State, which is primarily
rural, we don\'t have nearly that mature a process. But we are building
it.

And I suspect that it\'s true across the United States. So the diversity
of where different States are probably needs to be recognized from our
point of view that not all States are equal. It\'s self‑evident, but
it\'s probably \-- at least we\'d like to have that on the record.

We also want to point out that different organizations are working on
the same concepts as we speak and that developing a Nationwide Health
Information Network, the Council on State and Territorial
Epidemiologists are involved.

I think everyone would agree that what we\'re trying to get accomplished
is something that adds value to the public health system and more than
just being an activity but actually has the deliverable outcomes that
are value added.

Our positions \-- there are four simple ones. One is establish
protocols. It\'s obviously necessary to have appropriate protocols to
facilitate sharing of information; to identify the legal authority of
each of the partners, whether it be State, local, or Federal, as well as
the private sector; access to the data, and I have the little protocols
in place to share the information. And then what do you do if something
pops? What\'s the consequence management? And what are the expectations
and the requirements of either the public health world or the private
health world in responding to some flag that goes up? And then how do we
coordinate our communication across all these different partners?

The second major category is system integrity, and the subtitle is
science‑based. And again, I think for this audience I\'m speaking with
today, y\'all understand all this. But we still need to say that any
kinds of biosurveillance systems need to be based upon strong science,
science that\'s demonstrated a value to the public health, you know,
goals of our country and reduces the possibility of false positives (we
don\'t have excess staff to be chasing down those if we can avoid them),
and evaluate the systems to be conducted ‑‑ evaluations need to be
conducted to be built in as this biosurveillance program matures over
time, as it will, both in terms of technology and software and
investment in research.

Third category, as I\'ll briefly mention, is timeliness of information
sharing. This probably goes back to the discussion earlier about Options
1, 2, and 3.

How local health departments are brought into the loop is critically
important. And our system, just like I described in Louisville \-- it\'s
the community level, going to the health department at the local level,
then connects to the state health department, and we would connect to
the CDC. That's the traditional process. I would encourage, at least
from my \$0.02, that at a minimum, we at least maintain that system.
It\'s okay if we share it instantaneously so that if there\'s a State or
Federal sharing of information as it\'s collected, because it will be
electronic, that\'s okay, but I would strongly encourage that the system
not be put in place where a community hospital sends information to a
Federal agency, which then, in turn, screens it and then sends it back
if there\'s something showing of concern. That bypasses the traditional
ways and, I think, undermines some of the relationships and partnerships
we\'ve been working very hard for the last 5 years to develop.

And then lastly is the appropriate safeguards to protect patients\'
confidentiality and to decrease, you know, any concerns we would deal
with \-- public concerns over privacy issues.

That\'s our position statement. I think my summary is that ASTHO
certainly supports this. We appreciate being a partner, working with the
various organizations and helping develop it. We would be available in
any way to assist if there\'s an opportunity for us to be a player in
the future.

With that, Julie, I\'ll turn it back to you, unless there\'s any
questions.

\>\> Julie Gerberding: Thank you very much. Are there questions or
comments? \[No response.\] I guess you said it all.

\>\> Bill Hacker: \[Laughs\] Come back to Kentucky in the springtime.
I\'ll show you beautiful weather and get you to a nice horse race.

> \>\> Jeff Wells: Actually, I have one question. This is Jeff Wells
> from Indiana.
>
> \>\> Bill Hacker: Yes, Jeff.
>
> \>\> Jeff Wells: I wanted to thank you both. Great presentation. And
> also, Mitch isn\'t here today but, I\'m sure, would extend his thanks
> again for your input when you guys get a chance to talk when you are
> in Indianapolis. The one question I have is if you have a sense
> nationwide of the readiness capability of the local and State health
> departments for receiving electronic information from their community
> hospitals or other data sources.

\>\> Bill Hacker: I can speak from Kentucky. We \-- all of our local
health departments have the Internet \-- have, you know, computers.
We\'re wired that way. So if the information gets to me through the
Health Alert Network or through FEX or whatever the mechanisms, I can
electronically notify the local health departments, and I \-- of course,
I have all the contact information at the community level and can run
them down even to the local ballpark if I need to.

I\'m not ‑‑ we don\'t have systems ‑‑ we don\'t have software systems in
place, for example, to capture \[indiscernible part of word \-- sounds
like "CDs"\] \-- complete blood counts or blood culture results and
electronically share that between one hospital on one side of the State
and the local health department in another. We\'re not that mature. But
we do have the ability to communicate. I may not be answering your
question directly, but that\'s ‑‑ and I really probably should not try
to respond to the rest of the country. I\'m just not familiar with it.
And I\'ll let Julie or someone else do that.

> \>\> Rick Friedman: Bill, this is Rick Friedman over at CMS. It
> sounded a little bit like you had a presentation that you were
> referring to. It would be helpful if we could get a copy of that. I
> talked to the ASTHO folks here, and they said they would send me one,
> but I suspect everybody on the committee would benefit from one.

\>\> Bill Hacker: I\'ll ask Mary Shaffer or Angela Fix at ASTHO to send
that to the appropriate person. I assumed that you all had that. So it
is a position paper by ASTHO. I think they\'re on this conference call.

\>\> Matt McCoy: They are. They\'re sitting in the audience.

\>\> Bill Hacker: Okay. With your concurrence, I\'ll ask them to
distribute that to the appropriate people, and then you\'ll let me know
if it doesn\'t occur.

> \>\> Brian Keaton: Bill, this is Brian Keaton. I'm with the American
> College of Emergency Physicians. I share your love of Louisville, by
> the way. My son pitched for the Cardinals for several years, and we
> enjoyed the Derby Season up there.
>
> One of my concerns has been that first mile from the identification of
> a communicable disease or something like the pandemic flu or SARS or
> those bioterrorism concerns that we have \-- that those cases will
> first show up in our rural areas along migratory birth pathways and
> things like that.
>
> What\'s your gestalt or your feeling in terms of our abilities to
> reach out to clinicians and connect with clinicians who might be
> seeing the first cases to the public health network, both to sound the
> alarm, to identify the \-- what it is indeed \-- is an issue or not,
> and then to provide them with the guidance that\'s necessary as we
> mobilize the rest of our forces?

\>\> Bill Hacker: Great question. Let me begin with a real example. May
the 17th, 2004, a truck driver, who was a native of Trinidad, who was a
citizen of Canada and a current resident of Atlanta, FL, had driven his
rig from Atlanta up to Boston over into Canada; was driving on I75,
heading home to Atlanta; came in with a 104 fever; pulled his truck off
the road at a small town called London, KY, which is halfway between
Lexington and Knoxville on I-75. It was a classic "Mayberry RFD"
community. The emerge\-- what he presented with \-- he was Black. He
presented with a vesicular rash, as all the same phases. The emergency
room physician became concerned that he may in fact have a case of
smallpox. Fellow spoke broken English \-- he was primarily French
speaking \-- and said he had had chicken pox 10 years earlier. The way
that was responded to was a phone call.

And so we had a clinician, an emergency room physician, saying, "Gee,
this is something unusual." He called the local health department, who
called us, and we ended up dealing with Ed Thompson on Julie\'s staff.
And it ended up going to the White House situation room, because they
did lock down the hospital for about 4 hours.

Outcome was, he had varicella, not variola. But I think that it was a
real example of a small town in Kentucky where somebody with something
unusual ‑‑ we\'ve done \-- we\'ve been successful in getting these rural
small-town physicians to be aware that bad things do happen and to let
us know. So at least in Kentucky, I feel like we have a good
relationship between local health and local primary care and specialty
physicians.

My sense is that it\'s a bell‑shaped curve across the United States.
I\'m proud to say I think that I would put Kentucky on the rise side of
that bell‑shaped curve. We're certainly not perfect. But I'm \-- I fully
believe, though, that the physicians and their relationships with the
clinical world are going to be as valuable and more valuable than the
electronic syndromic surveillance that we have to do, but it\'s not the
only way to deal with this.

\>\> Rick Friedman: Thanks.

\>\> Julie Gerberding: Other comments or questions? \[No response.\]
Then perhaps we could move on to the NACCHO presentation. Is Bill on the
phone?

\>\> Bill Stephens: Yes, I\'m here.

> \>\> Julie Gerberding: Hi, Bill.
>
> \>\> Bill Stephens: Hello.

\>\> Julie Gerberding: Thank you for joining us. We look forward to
hearing your comments.

> \>\> Bill Stephens: You bet. Are we ready?
>
> \>\> Julie Gerberding: We\'re ready. Go for it.
>
> \>\> Bill Stephens: Okay. Well, I\'m Bill Stephens. I'm with the
> Tarrant County Public Health \-- actually unit of Tarrant County
> Public Health, the advanced practice center here. That is one of seven
> advanced practice centers around the Nation. And one of the things
> that we\'ve been doing over the past couple of years here under our
> grant program is in syndromic surveillance that\'s gradually expanding
> to more of what I would call a broader‑based health surveillance type
> of program as we started out with some basic tools and we\'re now
> expanding with actually two of the major syndromic surveillance
> systems, both ESSENCE as well as RODS.
>
> And we\'ve been really supporting the initiative here over the past 6
> months to expand some of the BioSense sentinel hospitals into this
> area, because we\'ve actually already got a significant relationship
> that\'s been established over the last few years through a very strong
> hospital council that works across this entire Dallas/Fort Worth
> Metroplex area as well as with most of the major hospital systems
> across here. So at any rate, we strongly believe in a collaboration
> here between the BioSense initiative and the things that we\'ve
> already started and you know, some of the things that we\'ve observed
> in some of the initial rollout here with the BioSense project that
> hopefully can help steer us into a more collaborative or synergistic
> kind of relationship. You know, I mentioned it a minute ago that we
> view the critical importance here of the relationship between the
> local health department and all of the different reporting points. And
> we started out with the hospitals, but we\'re already working through
> medical society contacts as well as clinician groups, infectious
> disease groups, professional groups, and so forth, and we see that
> really a huge part of this, besides the data in the systems, is
> managing this relationship for a variety of reasons that, probably
> most of which are very evident.
>
> But it\'s the local health department that really has sort of the
> position as well as what we\'ve learned is the expectation from all of
> the stakeholders here, to be that sort of that focal point that they
> want to deal with and have some interaction with. So again that\'s,
> one of the reasons why we wanted to leverage that relationship for the
> benefit of the expansion of the BioSense program.
>
> Some of the other things that have come up, you know, in terms of our
> own syndromic surveillance program \-- and when we have something like
> 36 hospitals that are reporting 24/7/365 with automated \-- basically
> what we\'re capturing so far is chief complaint. We\'re going to be
> expanding that in the next year here with some new modules that are
> going to be installed at several of the hospitals for collecting
> mature data such as laboratory reports, radiology reports, medication
> requests, and that sort of thing, again, which will enhance our
> ability here to establish context, really, of the syndromic
> surveillance and, again, what I call the health surveillance types of
> systems that we\'re developing here.
>
> We\'ve seen a huge amount of variability already in even the basic
> datasets that we\'re capturing. And again, there\'s so much
> interaction that we\'ve had to conduct here with the hospitals and
> some of the other providers \-- data providers here that we think is
> extremely critical, especially as the system and as the data
> requirements become as complex as the BioSense system is
> contemplating.
>
> So those are some of the key things that we\'ve seen. A number of
> other things that involve really what we call the next level \-- once
> you\'ve got the data, the consistency, the data validation, and the
> relationships going, you really have to push on what we call the
> protocol development, when things do occur, alerts, aberrations,
> whatever you want to call them. Again, context is so critical here.
>
> And that context so far \-- even though we may automate in the future
> these protocols and these response mechanisms, a lot of that today
> really is being defined and developed and really innovated between the
> local health departments. And by the way, we\'re working with four or
> five health departments here just in the north central Texas region,
> and we see that as becoming a more critical linkage, then. to really
> establishing the effectiveness of the system and what we really want,
> which is the situational awareness of really what these alerts or
> these aberrations really imply.
>
> Solving these things in a \-- or figuring these things out in a fairly
> expeditious way really requires such an incredible collaboration and
> cooperation between multiple entities, all of which start with, you
> know, this local interaction and expanding to the regional and the
> State levels and all the way up, obviously, to the national level.
>
> So those are some of the high points. There are a number of others,
> but I think that really captures some of the things that we\'ve
> learned in the 2 years that we\'ve spent so far in expanding this
> system.

\>\> Kelly Cronin: Thank you. Questions or comments? \[No response.\] I
guess if all three of our presenters are still on the phone, I might
just ask them if there are any, you know, important potential pitfalls
that we should be paying attention to as we move \-- you know, move
forward in this initiative or maybe the thing that you\'re most
concerned about in terms of potentially challenging our success.

\>\> Bill Stephens: Well, I would just reemphasize really two things.
One is to make sure there\'s a well-coordinated, you know, collaboration
there with the local health departments, to whatever extent, you know,
or whatever capability exists in the local health department. And I\'m
talking about more than just, you know, sort of a data dump, but, you
know, again, in this relationship management and sort of protocol
response definition.

And then the other thing we\'ve observed is to make sure that it\'s very
clear as to what that interaction is between the BioSense system and the
local health department interaction, because we\'ve already seen, even
in this large area with fairly sophisticated hospitals and health care
providers, some confusion or maybe even some perception that there\'s
even competing interests here, which we've tried to emphasize over and
over again that these are all going to be, you know, completely
compatible types of systems. But, you know, even at this point, you
know, there\'s been some confusion as to, you know, where the \-- sort
of where the decision process is going to go here with the data that\'s
being reported and how these systems all tie together.

So minimizing the confusion and, again, keeping the local health
departments involved are, I think, two key things to the success of this
program, basically making it a win‑win. You know, BioSense wins, you
know, the local health department systems and processes also win, and
there\'s sort of a mutual enhancement of the two.

> \>\> Bill Hacker: This is Bill Hacker. I concur completely with just
> what was said. I think that\'s an excellent summary. I would add, my
> observation is, there are lots of layers from the local to the Federal
> level trying to make decisions and do the right thing. But it does
> complicate the timeliness. I\'m trying to think of ‑‑ I understand the
> strategic national stockpile program and decisions being made based
> upon the information. We just did an S&S exercise here today, as a
> matter of fact. And we were able to identify issues that still have
> been made completely at all three levels or may be changed.
>
> And one of my concerns ‑‑ I think one of the concerns of the \-- at
> least of members of my committee is that in trying to do the right
> thing, there may be a tendency to overreach what is not accomplished,
> what is not achievable in the short‑term, just because we have to rely
> on this whole movement of biosurveillance, BioSense, the other
> programs, and all the preparedness activities going along.
>
> And then there\'s a capacity issue as we deal with pandemic influenza
> issues today, and there will probably be some new bug this summer that
> \-- seems like every year, we deal with some other public health
> urgency that slows us down.
>
> Our \-- my caution would be not overreaching. Take what\'s available,
> even though it\'s not ideal, and build on that rather than shooting
> for a more mature process.
>
> \>\> Tom Frieden: Thank you. This is Tom Frieden. I just want to note
> that both of the last two presentations are very much in line with our
> perspective as well, in terms of the need to really work towards a
> synergistic relationship, the need to focus on the relationships
> between health providers and the local and State health departments as
> well as between all the different levels of government. You need to
> focus on evidence and implementing things that we can analyze and
> evaluate and then hone what works and improve that.

\>\> Scott Becker: Hi, this is Scott Becker. I was wondering, from
Tarrant County in Dallas, what your experience has been with health
systems and in particular the laboratory data. Because I remember on the
first call when we talked about the New York City experience, that was a
challenge. I was wondering what experiences you had there.

> \>\> Bill Stevens: Yeah. This is Bill Stevens. We are just at the
> leading edge of that right now. We're \-- our plans here in the next
> couple of months is going to be to put in what\'s called the HSRC, the
> Health System Resident Connection. One of the things that we think is
> going to streamline this is \-- and I\'m not sure how New York City
> did this, but we have a resident application there, if you will, that
> sits on some of the hospital servers that will extract that data from
> existing databases. And the key there is, we\'re not trying to put it,
> you know, in our public health servers, but they\'re going to be at
> each one of the hospital servers to sort of maintain this connection
> and to extract the data as needed, rather than something that provides
> a massive pipeline that just uploads everything.
>
> And it\'s our belief that, you know, with this architecture decision,
> it\'s going to be a much more reliable way of getting it and should
> simplify the upload of the data when we need it.

\>\> Scott Becker: Thanks; that\'s helpful. You know, in terms of the
flow of data, I was thinking about this from the laboratory perspective:
either Option 1 or Option 2, the flow up through the system or
simultaneous \-- it really doesn\'t matter, because you have multiple
people waiting for the data. And I think in different circumstances
based on the submitter, be it FBI, be it local law enforcement, be it
local health department, etc., you're just going to have a different
scenario. So I\'m supportive of the decision that was made before.

> \>\> Julie Gerberding: Any other questions or comments for our
> presenters?

\>\> Jean Marie Maillard: This is Jean Marie Maillard from North
Carolina. I just wanted to comment that this is \-- we\'ve built a
system that we call Detect, and the first data feed we plugged in was
from emergency departments. And as we\'re working and adding hospitals,
we\'re also working on the same lines as the last two presentations,
because we\'re trying to improve the quality of the output by working on
our case definitions, working on what we can do with the data we
collect. And we\'re also building up on \-- trying to make sure that, at
the regional and local level, that the data can be made available as
well.

> \>\> Julie Gerberding: Thank you for that.
>
> I think we can probably move on to the next agenda item, which segues
> nicely from these discussions. This is just a review of the minimum
> dataset that we agreed to at least conceptually last time we met. I
> hope everyone has this document in front of them. It\'s entitled
> Biosurveillance: Validation of Minimum and Target Data Elements. As a
> reminder, the concept here is that the minimum data elements are those
> things that we will try to get early and get fast and ultimately shoot
> for the target data elements as quickly as they come on board. But as
> the Secretary continuously says, we don\'t want the perfect to be the
> enemy of the good here.
>
> So getting something going is really our highest priority. And if you
> noticed, there are a set of specified data elements that not only deal
> with individual patient data but also unit data and facility data on a
> fairly short list. And it\'s also, I think, very possible that
> facility data and census data may be easier to get in some cases than
> the more specific clinical data.
>
> But we obviously like to have as much of these come on board as
> quickly as possible. So I\'m only bringing this up since we\'ve
> already gone through these in, I think, substantive detail, just to
> give everyone a chance to sort of respond to the question of, "Is
> there anything on here that very specifically could not or would not
> be helpful?" If there\'s any data element here that you feel
> definitely is not likely to be value added, it would be helpful to
> know about it now, because less is best, and the more we can
> streamline this, the better.
>
> But just ask for, you know, specific comments on that at this point.
>
> \>\> Tom Frieden: This is Tom Frieden. And I am sorry; I will have to
> leave at two for another meeting. But I don\'t think we\'ve really \--
> in New York City, neither I nor Rick, have had really sufficient \--
> to go through these. We do have some real concerns.
>
> I think if we look back to the mandate of what\'s doable in 12 months
> \-- and I would add to that what\'s doable and likely to be useful \--
> a broader, simpler system really keeps it much simpler than this \--
> looks at, for example, flu‑like syndrome counts, aggregating up from
> chief complaints or looks at chief complaints in terms of the illness.
>
> And in terms of the facility data, I think it would be very useful to
> think of that as a \-- potentially a separate system that might be
> very useful. When I\'ve heard the Secretary talk about what he sees as
> the need, you really want to keep it extremely simple: basically, how
> many people are in your ICUs, how many people are in your hospitals,
> and what\'s your excess capacity, though that\'s a very difficult
> number, because people take beds off line. But roughly speaking, you
> know, what\'s the surge availability?
>
> Some variant of those four basic numbers, I think, is something
> that\'s doable and can happen. The \-- you know, getting to the
> specifics in terms of the census stuff, deaths could be very useful,
> but that is a whole new level of interest and whole new level of what
> the implications may be.
>
> I don\'t know that you really need admissions and discharges, though,
> you know, that\'s not impossible to get. CMS, I would think, might
> have a way of kind of insisting on this, but the key would be to keep
> the burden, I would think, on health care facilities as minimal as
> possible.
>
> In terms of the patient data, I think we have to step back and say, "A
> minimum based on what?" I think many of these will be very difficult
> to collect, very difficult to assure quality and completeness, very
> difficult to analyze, and a questionable utility. In addition, I think
> many of them will trigger very significant privacy concerns, because
> even if you take out the name, if you have month and year of birth and
> zip code, you know, you can identify someone pretty easily.
>
> So there are really serious privacy concerns of this. I think some of
> them, like discharge diagnosis or discharge disposition, come much
> later, and you may get a lag in terms of the kind of data you\'re
> looking at.
>
> In terms of test ordered, you know, you could be looking at just
> massive amounts of data, again of questionable utility there. And in
> terms of the laboratory data, I\'m sure there we know this is very
> useful, but I would reiterate that it\'s really difficult. We\'ve been
> working very hard on this for many years, and we\'re making progress,
> and this would be, I think, an area where there is a real synergy. If
> an investment in electronic laboratory reporting could be made and
> could be standardized nationally, such that reportable disease
> information goes to State and local health departments and that that
> is also aggregated in an anonymized way in terms of syndromic
> reporting or biosurveillance reporting with specific diagnosis, that
> might have a great value both for biosurveillance and for routine
> public health surveillance. But I would not underestimate the
> difficulty of it given both diversity of testing methods and the
> diversity of information systems in labs.
>
> So I have, and New York City has, a lot of concerns about this minimum
> dataset. And I think probably going through it item by item and having
> a discussion isn\'t something that would be a productive use of this
> conference call. It is something that should be done, maybe with some
> exchange of some written comments and maybe a subgroup or whatever you
> want to do.
>
> \>\> Julie Gerberding: Tom \--
>
> \>\> Tom Frieden: But I think there are some basic issues.
>
> \>\> Julie Gerberding: This is Julie. We actually did go through these
> items one by one last \-- on our last call, you know, item by item.
> And so I think that, you know, we\'re just \-- probably didn\'t
> reflect that adequately in the summary of the call. But we had some of
> the same discussions that you\'re having right now. And I think we can
> certainly turn around and revisit them at a future date. But I just
> wanted to let you know that we didn\'t just come up with this without
> any discussion.
>
> \>\> John Loonsk: This is John Loonsk. I wanted to add, too, that in
> the context of the discussions, we're \-- at times, we\'re floating
> back and forth between just considering data necessary for initial
> detection of an event, which many people do call syndromic
> surveillance, and this broader activity of biosurveillance, which the
> group had talked about and reached consensus on as including not just
> initial event detection but also issues around outbreak management;
> issues around situational awareness of how big an event it is, where
> it is, how many cases there are; and also issues around supporting
> response management in terms of the needs at the different levels of
> public health.
>
> And I think it\'s important to just go back there and remember that
> that\'s what we were talking about in terms of the specific charge and
> \-- that we\'re trying to address.
>
> \>\> Julie Gerberding: Other comments or concerns?

\>\> Jean Marie Maillard: This is Jean Marie Maillard from North
Carolina. Not too much to remove from the list, but what we found to be
maybe a couple of qualifiers for one field census by unit. We feel the
staff beds, rather than the number of beds available, is more useful to
know for a real appreciation of surge capacity.

And after chief complaint, we feel that ‑‑ we find very useful to have
access to the initial nurse of triage nodes. That allows us to deal with
a lot of false alerts that pop up in the system. It\'s an additional
field, really.

> \>\> Julie Gerberding: Thank you. That\'s an important point.
>
> \>\> Adele Morris: Hi, this is Adele Morris at Treasury. One of the
> things we haven\'t yet talked about in addition to the data elements,
> at least not to my knowledge, is the frequency of reporting and if and
> when any particular data item might be taken as a sample rather than
> every single, for example, cholesterol test. Do we necessarily want
> every single cholesterol test orders to be reported to the Federal
> Government?
>
> At some point ‑‑ part of the reason I raise this now is, at some
> point, this is going to have to come under review under the Paperwork
> Reduction Act and because it\'s a Federal information collection. And
> somebody is going to be asking questions like, "Well, okay, what is
> the practical utility for all this stuff? And can we show that the
> Federal Government needs to know about every single cholesterol test
> in this, you know, universe of reporters?"
>
> So I don\'t know when we have that conversation.
>
> \>\> Julie Gerberding: Thank you. You know, the issue of the review of
> the data from OMD perspective is something that we could probably
> circle back to in our policy discussion, which is coming up next.

\>\> Adele Morris: Fair enough.

\>\> Julie Gerberding: Other questions or concerns? \[No response.\] All
right. Let\'s move on, then, to the discussion about the data gathering
that we would need to inform the recommendations that we\'re expected to
produce to the Secretary this spring, and we have a number of components
of this. And I\'ll start with Laura Conn, who will talk about what
we\'ve learned about trauma centers and seaports, etc.

\>\> Rick Friedman: Julie, this is Rick. Excuse me. I was asleep at the
switch when you went on. It seemed to me that we hadn\'t quite resolved
the minimum dataset issue. It sounded like there were a number of, you
know, very strongly held opinions and legitimate concerns. I\'m just
wondering if there would be any value in having a sub-workgroup or
something else that you would think about to sort of get folks\'
concerns that were raised here today that didn\'t have the opportunity
to participate last time. I hate to open up a can of worms, but I think
it\'s important and the committee members feel pretty strongly about
some of these issues.

> \>\> Julie Gerberding: Any other perspectives on that?

\>\> Tom Frieden: I would just reiterate: I\'m just having to sign off,
but I do ‑‑ Rick will sign back on on a different line \-- but I do
think it's essential. I can\'t really continue my participation in this
process. What I would agree ‑‑ well, I\'ll summarize some of my concerns
in a letter within the next week or so. But I do think there are
important issues that need to still be hashed through.

> \>\> Julie Gerberding: Tom, do you have a proposed mechanism for
> hashing through them? That\'s what we\'re trying to get to, because I
> think there\'s a sense from the people who have been on the conference
> calls that, you know, we thought we did have a hashing through, and
> it\'s unfortunate that not everyone was able to participate in that.
> But your perspective is very valuable to us. So is there a better way
> to do this that you can suggest?
>
> \>\> Tom Frieden: What I can offer to do is put together some concerns
> on paper; send those around so that there\'s the opportunity to
> comment; and then, before the next conference call, suggest that there
> be a subgroup to go through them and see if we can reach consensus on
> some of them.
>
> \>\> Julie Gerberding: Okay. Do we have some volunteers to participate
> on that subgroup?
>
> \>\> Brian Keaton: This is Brian Keaton. I\'m not an expert on the
> data itself, but I would certainly be willing to bring somebody from
> my organization who does most of our surveillance and front line work
> to participate in that group.
>
> \>\> Julie Gerberding: That would be very helpful.

\>\> Tom Frieden: Maybe North Carolina.

\>\> Brian Keaton: Yes.

> \>\> Jeff Wells: This is Jeff Wells. I would also agree that it seems
> like some of the concerns were coming from the folks representing the
> States. And so I would be more than happy to get with the folks here
> in Indiana at that State level to provide feedback, and I would be
> happy to represent on that workgroup.
>
> \>\> Julie Gerberding: Thank you.

\>\> Dave Parramore: This is Lieutenant Colonel Dave Parramore. We've
got some experts here at DoD that deal on this subject, and I\'ll be
glad to engage them and get them to support this Workgroup.

> \>\> Julie Gerberding: Sounds like a pretty good group. Does that
> satisfy you, Tom?
>
> \>\> Tom Frieden: That sounds great. Thank you so much. I\'ll brief
> Rick, who went to take the call on the other line, because he\'ll be
> inheriting a lot of this.

\>\> Julie Gerberding: Thank you.

\>\> Tom Frieden: Thank you.

\>\> Julie Gerberding: Any other discussion on the minimum dataset? \[No
response.\] Okay. Then we can, I think, move on to the next agenda item,
Laura.

> \>\> Laura Conn: Thank you. I just wanted to give you a brief sense of
> some of the data that we are collecting in the background that will
> help inform some of the scope decisions and targets of where we\'ll be
> collecting this data as we go forward. We\'ve been collecting data
> both on level 1 and level 2 trauma centers looking at that, you know,
> what city and State they\'re in, also top population centers as well
> as rural population centers. The decision is to grow broad. We\'ve
> been looking at seaports and cargo ports and trying to put all of this
> information together in a coherent way so that we can present it back
> to the group on the next call to help inform some of the decisions
> that would need to be made.
>
> We're \-- have proposed to work with ASTHO and NACCHO to do a very
> quick turnaround on data collection efforts to determine what
> capabilities and needs exist in State and local jurisdictions, what
> \-- related to who has RHIOs, who has some of the early event
> detection systems in place, and what kind of data that they may or may
> not be able to receive at this point.
>
> So I just wanted to give you an update that this is ongoing and we
> plan to have a broader discussion of this on the next call. If you
> have comments of other data sources that we should be looking at to
> form these decisions, we\'d be happy to hear your input on that.

\>\> Julie Gerberding: Comments or suggestions? \[No response.\] Then
maybe we could talk a little bit about the data collection efforts that
NACCHO and ASTHO have agreed to contribute to us.

\>\> Laura Conn: I don\'t know if we have more at this point. That\'s
just talking about pulling that together in the next week.

> \>\> Julie Gerberding: Okay. Oh, that\'s not part of the ‑‑

\>\> Laura Conn: We can move on to the policy issues.

> \>\> Julie Gerberding: Okay. Then let\'s go ahead and move on to
> policy. And Kelly, are you on?

\>\> Kelly Cronin: Yeah, I am. I\'m right here.

> \>\> Julie Gerberding: Can you take this on?

\>\> Kelly Cronin: Sure. I just wanted to recap on items that we had
talked about during our last meeting by way of background and also to
sort of tee up the issues that we\'ll hear more about from HHS, Office
of General Counsel, and then as well as Jeffrey Wells from Indiana on
the role of the RHIO, and then finally from Roslyne Schulman from the
Hospital Association, who will talk about the hospital perspective.

But as you probably recall, the last Workgroup meeting, we did talk
about the potential need for incentives for hospitals or labs or
ambulatory care to participate in a BioSense program or a
biosurveillance program, particularly if, in fact, our charge and our
consensus is to go for a broader‑based program that would reach, you
know, as many sites or providers as feasible.

So I think there needs to be, you know, a deeper discussion around,
well, what kind of financial or nonfinancial incentives are necessary.
And I think that in part, Roslyne will get into that issue and then
perhaps be able to report back to us with more detail at a later date.

We also talked about the concerns that hospitals have regarding HIPAA
and the need for them potentially to be reassured that sharing data with
public health is appropriate for the context or for the purposes of
biosurveillance. And then we also touched on how hospitals \-- in order
to participate in a timely fashion and meet the 24‑hour turnaround in
the specific charge, they might need some additional resources to be
able to provide that data on a timely basis. We also got into issues
pertaining to voluntary submission of data versus other potential
requirements down the road if, in fact, voluntary participation is
insufficient.

And then finally, we also talked about the role of government in terms
of what the role of the Nationwide Health Information Network will be
over time if it, in fact, ends up enabling the transmission of this
data.

But since HIPAA was touched on in the previous meeting, we thought that
it would be helpful to have a general discussion around what authorities
do exist right now under the Public Health Service Act and under HIPAA
to provide this data. So with that, I\'ll turn it over to Deb from the
Office of General Counsel.

> \>\> Deborah Tress: Hi, I\'m Deborah Tress. I'm with the General
> Counsel\'s Office of the CDC branch of the Public Health Division of
> HHS.
>
> And as I was requested by Kelly, I\'m going to provide a very sort of
> high-level overview of the public health‑related provisions of the
> privacy rule and then discuss some of the authorities as structured in
> the Public Health Service Act and other relevant legal framework.
>
> So the HIPAA \-- many of you probably heard the full-blown HIPAA
> privacy rule presentation, so I\'m not going to go through all that.
> I\'m just going to focus in on the relevant provisions.
>
> \[Lost audio\] \-- national standards for protecting the privacy of
> protected health information and regulates how covered entities, which
> are health care providers conducting certain electronic transactions
> for clearinghouses and health insurers, use and disclose protected
> health information. Any information can only be used or disclosed with
> patient authorization, unless it\'s required or permitted by the rule.
>
> And the disclosures include provision \[lost audio\]. One is that a
> covered entity may disclose protected health information if it\'s
> required by law. So if a Federal or State law requires a disclosure
> for public health purpose, then that\'s permitted under the rule. In
> addition, a covered entity may disclose protected health information
> to a public health authority that\'s authorized by law to collect or
> receive such information for the purpose of preventing or controlling
> disease, injury, or disability, including but not limited to the
> reporting of disease; injury; vital events, such as birth or death;
> and the conduct of public health surveillance, public health
> investigation, and public health interventions. And there are
> additional provisions, but that\'s the primary substantive one.
>
> The public health authority is defined as an agency or authority of
> the United States, State, Territory, political subdivision of a State
> or Territory, or an Indian Tribe or a person or entity acting under a
> grant of authority from or contract with such public agency \-- is
> responsible for public health matters as part of its official mandate.
> And a public health authority is not necessarily covered by the rule
> but must be in a position to respond to the concerns of the covered
> entity that is covered and be able to provide information to document
> that what\'s being requested is the minimum necessary to accomplish
> the purpose of the disclosure: to verify their identity and status as
> a public health authority and verify the legal authority that they\'re
> collecting the information under.
>
> And the phrase \"authorized by law\" that's in the provision is not
> interpreted in the actual regulation but was addressed in the 1999
> preamble to mean that a legal basis that exists for the activity and
> includes both actions that are permitted and actions that are required
> by the law doesn\'t necessarily require a specific law for that
> disclosure recognizing that public health authorities often operate
> with broader, more general mandates to protect the public health.
>
> So the \-- sort of the next step, once you\'ve established sort of the
> HIPAA provisions, is then to look at what is the underlying authority
> of the public health authority. And from a CDC perspective, looking at
> the Public Health Service Act, there are general, broad authorities
> under which CDC conducts activities to address public health matters.
>
> There\'s also specific \-- more disease- or condition‑specific
> activities where CDC is funding surveillance by the States and local
> health departments or conducting them directly. Examples include
> childhood life poisoning surveillance, birth defects and disabilities,
> and asthma surveillance.
>
> In addition, in some of the 2002 enacted provisions of the Public
> Health Service Act, there\'s a provision related to the establishment
> of national communications and surveillance networks that authorizes
> the Secretary to establish or provide funding to establish an
> integrated system or systems of public health alert communications and
> surveillance networks between and among Federal, State, and local
> public health officials; public and private health-related
> laboratories, hospitals, and other health care facilities; and other
> entities determined appropriate by the Secretary.
>
> The States then would be relying on their own substantive public
> authorities to collect information or maintain information that they
> may receive. Once the information leaves the HIPAA-covered entity and
> is in the hands of a public health authority, then it\'s generally
> covered by the legal framework that applies to that entity, to that
> jurisdiction, particularly those related to privacy, confidentiality,
> and use of the data and information in their possession.
>
> So that\'s kind of, in a very small nutshell, the overview of the
> HIPAA and relationship to the other authorities.
>
> \>\> Julie Gerberding: Thanks, Deb. Are there any questions from the
> Workgroup members specific to what Deb mentioned?
>
> \>\> Rick Heffernan: This is Rick Heffernan from New York City. I
> wondered if you could comment: does this kind of surveillance \-- does
> it really come down to how we define minimum data necessary?
>
> \>\> Deborah Tress: In any disclosure by a covered entity, being able
> to define the minimum necessary for that to fulfill the purposes of
> that activity is all \-- you know, is always a requirement. So that
> certainly is one element.
>
> \>\> Rick Heffernan: I guess \-- I think it\'s been established that
> some surveillance activity like this is authorized. So I \-- it seems
> to me that it comes down to how much data are necessary to conduct the
> surveillance and that that\'s really the crux of whether this is legal
> or not. Wonder if you could comment on that.
>
> \>\> Deborah Tress: I don\'t know that ‑‑ I think you also ‑‑ I think
> that is, as I said, an issue. I don\'t know that that\'s going to be
> the only issue. And I think that there is a provision in the rule that
> allows the covered entity to reasonably rely on the representations of
> the public health authority, that \-- as they\'ve defined the minimum
> necessary, that that\'s what it is.
>
> \>\> John Loonsk: So in other words ‑‑ this is John \-- in other
> words, it\'s public health that\'s determining the breadth of the data
> necessary to accomplish that purpose?

\>\> Deborah Tress: The covered entity doesn\'t have to accept that, but
they\'re authorized to reasonably rely on that.

> \>\> John Loonsk: And the other thing I heard in your comment \-- and
> I think this is an area where there is confusion, so it might be
> worthy of you reiterating or pointing out that there are some who
> believe that there needs to be enabling State legislation to do this
> reporting. And what I thought I heard you say, Deborah, was that, in
> fact, that need not be the case.
>
> \>\> Deborah Tress: Well, I think that, you know, it\'s up to the
> States to look at their own authorities and determine whether this
> type of surveillance is covered by a specific or by their more general
> authorities. But that \-- the language in the preamble does indicate
> that they\'re not looking necessarily \-- that they\'re not using that
> term, "authorized by law." to mean that you have to have a very
> specific legal authority to collect that body of information.

\>\> John Loonsk: Thank you.

> \>\> Julie Gerberding: So are there any other comments or questions
> about the privacy or HIPAA‑related issues regarding biosurveillance
> and our charge?
>
> \>\> Rick Friedman: This is Rick. Would it be possible to get a
> written summary of what you were talking about? I find this all rather
> confusing, and I would appreciate having something I could refer to.

\>\> Deborah Tress: Sure, and there\'s also some reference material that
CDC has put together and published specifically on the privacy rule as
it relates to public health. So I could provide a link to that.

\>\> Julie Gerberding: Yeah, the MMWR article, I think, was a pretty
comprehensive overview. It didn\'t specifically focus on
biosurveillance. There is another ASTHO white paper on biosurveillance.
But we\'ll follow up. We can get more materials out to the Workgroup.

\>\> Rick Friedman: Super. Thank you.

> \>\> Brian Keaton: That's Brian \-- this is. That would be very
> helpful. My \-- the furthest thing away from a lawyer, and my eyes
> just glaze over when we start talking this stuff.

\>\> Julie Gerberding: \[Chuckles\] Okay, great. Well, I didn\'t mention
in my comments earlier that we did have a pretty substantive discussion
around the role of the regional health information organization. And I
think it was not only discussed as an option for data transmission in
the context of having an intermediary or another entity to perhaps
receive data prior to going on to local, State, and Federal public
health departments, but I think there are some actual real-world
examples of Regional Health Information Organizations acting in that
capacity.

And since Indiana is one of the most advanced areas in the country, with
regional health information exchange, we thought it would be helpful if
Jeffrey Wells were to talk more about the program in Indiana so we could
get a sense of what other areas of the country might be able to evolve
into.

So with that, Jeff, could you give an overview of what\'s happening in
Indiana?

> \>\> Jeff Wells: Yeah, I\'d be happy to, Kelly. Thank you. And I guess
> I\'ll mention up front that I\'m not intimately involved with either
> of the organizations that acts as our RHIO or with our State health
> department. But I\'ve worked with the folks at both of those
> institutions and hopefully will be able to effectively communicate
> what they have going on the ground. First to provide a little bit of
> background of the Regional Health Information Organization in
> Indianapolis that \-- the infrastructure is based sort of out of the
> Regenstrief Institute, which is an internationally recognized
> informatics and health care research organization. It was established
> with a philanthropic grant in 1969 and has an annual budget of about
> \$12 million. Initially, at the core, it provides a robust electronic
> medical record for one of the local hospitals. It\'s affiliated with
> Indiana University School of Medicine.
>
> In addition, over time, it\'s grown so that it really acts as an
> information exchange sharing data among \-- I think \-- I believe
> it\'s 14 hospitals in the city. So if you end up in the emergency
> department of any of those institutions at those 14 hospitals, you
> have access to laboratory data, radiology data, admission and
> discharge summaries, and the like.
>
> So that\'s the exchange. And then sort of sprouting out of Regenstrief
> is an organization formerly known as the Indiana Health Information
> Exchange. It's a nonprofit that was founded with a large collaboration
> of stakeholders, including the universities, the hospital systems, the
> State government, as well as the State Department of Health and then
> Marion County Health Department, which is the county here in
> Indianapolis.
>
> And then, as far as using that infrastructure for surveillance, the
> State Department of Health and the Marion County Public Health
> Department have worked to get information from across the State using
> the Regional Health Information Organization as an intermediary.
>
> So currently, they have 45 hospital emergency departments across the
> State from urban centers to rural areas in multiple different counties
> sending information to Regenstrief, and then that information is
> further standardized in the appropriate formats and aggregated and
> then sent on simultaneously to the Marion County Public Health
> Department as well as the State Health Department.
>
> From looking at it in a sense of a model, it would be, I believe,
> talking with the Regenstrief folks, very easy to additionally send
> that information on to the CDC. And I\'m not sure exactly how much of
> that information currently is sent to the CDC and in what form.
>
> And just, I guess, a couple other pieces here on some of the more
> technical infrastructure: The hospital emergency departments establish
> their IT connectivity with Regenstrief through an HL7 format, and they
> used basically a standard VPN over the Internet, which is fully
> encrypted.
>
> And I guess the last piece I would mention is that in addition to the
> emergency department information, the State Health Department receives
> information from over‑the‑counter pharmacies, as well as from the
> State poison center, and they do get some information from schools
> based on school absenteeism.
>
> Hopefully, that\'s a decent overview of the organizational structure,
> and I\'d be happy to try and entertain any questions.
>
> \>\> Julie Gerberding: Thanks, Jeff. Any questions from any of the
> Workgroup members, or comments?
>
> Jeff, I was interested to know whether or not it would be possible in
> the context of a breakthrough demonstration to perhaps look at how
> Regenstrief and Indiana Health Information Exchange could actually act
> as an intermediary for the Federal Government, too, so it would be
> actually working to serve local, State, and Federal needs. So I wonder
> if we could follow up and have the, you know, appropriate discussions
> to explore that.
>
> \>\> Jeff Wells: Yeah. I know I would be happy to work with you to get
> some folks from Regenstrief and the Indiana Health Information
> Exchange to explore that in detail or put together some kind of an
> architecture or proposal or concept paper.
>
> \>\> Julie Gerberding: Okay. Great. Thank you.
>
> \>\> Brian Keaton: There\'s one other comment that ‑‑ this is Brian
> \-- that I\'d like to add to the mix here. RHIOs usually deal with
> data before it\'s de-identified or in that process. One of the key
> things from an incident occurrence standpoint is the question of "Do
> we have 10 different providers or entities reporting one case, or do
> we have 10 different cases?" And I think a RHIO may hold real value
> for us in terms of being able to answer that question up front.
>
> \>\> Julie Gerberding: Yeah, thanks. That\'s a really good point. I
> think it also highlights the need for \-- if the RHIO is going to be
> acting as an intermediary, they would have to anonymize data obviously
> before it would be then transmitted to local, State, and Federal
> public health.

\>\> Brian Keaton: Which is what they do now.

> \>\> Julie Gerberding: Right, right.
>
> Okay. Great. I also wanted to just briefly mention that there are
> other regions of the country that we could further explore if we were
> interested in having this be, you know, a definitive part of our
> recommendations.
>
> We know that Utah Department of Health is working with the Utah Health
> Information Network on a series of projects. They aren\'t necessarily
> focused on, you know, the minimum dataset that we\'ve been discussing.
> They, I think, have a set of priorities including immunization and
> neonatal screening. But we could probably follow up with the more
> mature RHIOs if, in fact, there was interest at the workgroup level.
>
> \>\> Brian Keaton: Julie, this is Brian again. One of the other hats I
> wear is, I sit on the board of the e-Health Initiative in the
> connecting communities. Right now, I\'m on a sabbatical setting up a
> RHIO in northeast Ohio. So if you want somebody to participate in that
> process, I\'m more than happy to do that.
>
> \>\> Kelly Cronin: Okay. Great. Brian, this is Kelly. We may want to
> follow up with you and talk to you about that and see if, you know,
> the various organizations that are working on collaborating with RHIOs
> might be able to help us.
>
> \>\> Brian Keaton: And between that and the group from HIMS, I think
> we\'d have more than enough people to do what we want.
>
> \>\> Kelly Cronin: Yeah. Right.
>
> \>\> Adele Morris: So Kelly, this is Adele. I\'m trying to identify in
> this discussion around RHIOs what exactly the policy questions are.
>
> \>\> Kelly Cronin: Well, I think that we've touched on or alluded to
> the fact that they are already acting primarily as an agency or an
> organization that deals with health information exchange for the
> purposes of informing clinical care. So it\'s traditionally a more
> provider orientation. If in fact they were to operate, like they do in
> Indiana, to also serve public health, then, you know, they could be
> recognized in various ways under current law, either through HIPAA
> potentially as a business associate of various covered entities that
> participate in the RHIO, or perhaps they could also be viewed as an
> agent of public health under Public Health Service Act or the
> authorization that exists under public health for the purposes of
> surveillance.
>
> \>\> Adele Morris: So the policy measures that we might have to
> consider would be possible regulatory changes to make sure RHIOs are
> qualified to be viewed as these public health organizations under the
> statutory authority? Or would they be recognized under existing regs?
>
> \>\> Kelly Cronin: I think what we\'re suggesting is that they
> probably would be recognized under existing law and if it would be
> helpful to RHIOs that are emerging or operational interested in
> participating in public health to have some clarity around how they
> would be recognized by both public health and health care entities,
> then we could follow up and provide that clarity, perhaps in the form
> of recommendations or a letter to the overall community.
>
> \>\> Adele Morris: Oh, thanks; that\'s helpful.
>
> \>\> John Loonsk: Kelly, this is John. You brought up the possibility
> of RHIOs, which I think would be great to consider in terms of the
> models for moving some of this forward, and I think the other thing to
> consider is \-- potentially to work through as part of the
> breakthrough \-- is how a multi-jurisdictional organization like a
> hospital system or a health plan could also contribute. And I know
> that a number of them are interested in the kind of activity, and I
> think it\'s another good example where there are frequently data that
> are available relatively early because of some of the advanced systems
> that some of them have implemented, but that it\'s good to work
> through the issues of data provisioning to make sure that, for
> example, the \-- it\'s the local jurisdictions get the data, and the
> States get the data they need, and the Federal issues are addressed,
> and that in multi-jurisdictional setting \-- organizational setting,
> those things are important to work through.
>
> \>\> Kelly Cronin: So in your example, a large hospital system that
> has market share in various different markets would then inevitably
> have to grapple with these issues if they wanted to participate?

\>\> John Loonsk: And I think that they could potentially be good
partners. They tend to aggregate data in ways that aren\'t necessarily
jurisdictionally oriented, so working through the issues to make sure
that all the components' jurisdictions' needs are met would be a good
step forward.

> \>\> Kelly Cronin: Right. Okay. And then I think the other thing we
> touched on as well in terms of policy issues around the RHIO (and it
> also relates to the Nationwide Health Information Network) is, what is
> the business case, or who would potentially finance health information
> exchange or transmission of data as it relates to public health?
>
> And we do have the NHIN consortia through the contracts looking at
> business models and sustainability of health information exchange. But
> that\'s underway. There\'s other organizations interested in this
> issue, but the jury\'s really still out on what are the right type of
> financial models for really clinical data exchange or health
> information exchange, and I don\'t know how many folks have really
> thought carefully about how that really pertains in terms of public
> health.
>
> \>\> Adele Morris: Do we \-- one question that\'s sort of been in the
> back of my mind is, do we know \-- let\'s imagine that we have a
> hospital that\'s fully electronic, has all their data electronic in
> the ER, and that data resides somewhere. We\'ve sort of been assuming
> that someone in that hospital would have the responsibility of pushing
> that data out to whatever entity is responsible for the
> biosurveillance function. But one can imagine a pull instead, where
> that hospital somehow has granted electronic access to its data to
> this entity and at virtually no cost to the hospital, but then he goes
> and pulls the data that they need.
>
> \>\> John Loonsk: Adele, this is John Loonsk. I think that, you know,
> some of the experience in this area points to a number of lessons
> learned, one of which is that hospitals are very particular, for good
> reasons, about who is operating on their information systems on their
> data in their settings. And that goes to two points related to your
> comment. One is that, indeed, just from the standpoint of funding this
> activity, there\'s a critical need to, at times, help the hospital to
> put toge‑‑ do the work, because they don\'t ‑‑ they can\'t really
> allow and have difficulty allowing others to do work on their systems.
>
> So just from the dynamics of how to advance the activity, it\'s
> important to think about the fact that hospitals at times \-- this is
> a burden in some respects, and just about those dynamics of them
> actually being able to support some of the time and attention of their
> people or their contractors to work on getting the data out.
>
> From the standpoint of the push-versus-pull model, I think it\'s been
> pretty well-determined that this is mostly a push model from the
> standpoint of the same sort of issue, but taken to the area of
> querying and retrieving data from a clinical care setting \-- is much
> more difficult than from the same considerations in terms of what data
> are being received, what the scope of them are, how fixed are those
> lines, etc., and that the push model has been \-- has people much more
> comfortable.
>
> \>\> Adele Morris: Is it \-- but to me \-- I mean, I have no idea to
> know whether that\'s necessarily the case moving forward as technology
> improves. But I can imagine a case where a public health authority has
> developed some sort of macro that works on the system of the hospital
> and virtually fully automates the push then.
>
> \>\> John Loonsk: Yeah, I think, you know, there\'s this dream that a
> lot of us have that eventually there will be algorithms running behind
> the clinical firewall that could aggregate appropriate data and even
> compile it \-- a full public health case report and report it
> appropriately. I think what I\'m expressing to you, though, from a
> practical standpoint, because of these issues of access to systems and
> of code and whose code is running in what setting, that from a
> practical standpoint, code and access to data are really critical
> elements of the hospital\'s domain and dominion. And though they may
> be very eager to help in a public health context, it\'s important for
> them that they are the ones that are owning the code, if you will,
> and/or owning the people with hands on inside their hospital systems.
> And that\'s sort of a lesson that\'s been learned a number of times
> over.
>
> \>\> Adele Morris: Yeah.
>
> \>\> Brian Keaton: This is Brian Keaton again. One of the attractions,
> if you would, one of the potential strengths of the RHIO, is to
> understand that the RHIO in its essence is a political entity that\'s
> designed to build trust to create policies, to create procedure, to be
> able to share some of that responsibility in terms of the data
> systems. It\'s a very challenging task to bring these normal
> competitors together and have agreements to share those things that
> they hold most sacred. I think it\'s important \-- and we\'re
> experiencing it right now in my region \-- to be sure that public
> health is at the table from the very beginning and is an active
> participant in those discussions. Otherwise, they\'re forgotten. And
> as we try to create that trust, they need to be part of that trusted
> entity.
>
> \>\> Adele Morris: I guess what I\'m looking for are policy options
> that can minimize the burden and maximize the utility of the data. And
> yes, I guess ‑‑ here are my thoughts. There might be strategies, for
> example, working with the vendors of the systems that hospitals and
> other providers purchase, and having the vendors build in easy, you
> know, push-a-button kind of thing that can allow the health care
> providers to send that \-- the appropriate information in the
> appropriate format in.
>
> \>\> John Loonsk: This is John again, Adele. I think that's \-- it\'s
> a good idea that people have been thinking about for some time. I
> think one of the outcomes of having a use case that\'s put before the
> Health Information Technology Standards Panel, for example, is that
> the goal here is to identify the standards for these data reporting
> and to do it in an unambiguous way so that vendors and hospital
> systems and others can start to understand what those standards are,
> build them into their product, and/or build them into their hospital
> system.
>
> So that\'s very much what, you know, part of the goal or effort is, is
> to identify the data standards and message standards so that this
> interaction can become more embedded in the commercial products and in
> hospital systems.
>
> \>\> Julie Gerberding: Yeah. And the Certification Commission for
> Health IT will be following the same use cases. So when it comes to
> not only ambulatory electronic health circuits, but then this year
> their focus will be on inpatient electronic health records, they
> should be, you know, looking at functionality and requirements that
> will be enabling our biosurveillance charge.
>
> \>\> Adele Morris: Yeah, I\'m real conscious of the short time horizon
> on our breakthrough, so I know, you know, you can\'t develop this
> technology overnight. But it goes to the need of how much persuasion
> or incentives or financing it\'s going to take in order to get the
> data that we need. So obviously, the lower cost you can make it, the
> less work we need to do to induce folks to do it.
>
> \>\> Julie Gerberding: Right. So reducing the burden or the cost of
> participation in a program from a provider perspective is obviously a
> key goal, and then what other specific enablers to reach that. And I
> think, you know, longer-term \-- you know, all the standard
> harmonization efforts and certification efforts will pay off. I don\'t
> know that we\'re going to see an enormous change in the market in the
> first year or 2, but we\'ll be getting there. We\'re at least laying
> the groundwork and the foundation and the mechanisms necessary to
> realize greater efficiencies over time.
>
> But I think in terms of, you know, what the necessary set of things to
> create the environment for broad participation over time \-- I think
> that actually will be up to \-- in part for us to learn more about
> what the hospitals really think and want and need, as well as labs and
> ambulatory care providers, to the extent that they\'re directly
> engaged.
>
> But I did \-- before we go back or we go to the talk or before Roslyne
> gives comments from the hospital perspective, I did want to go back to
> something that Brian Keaton mentioned, because I think it\'s
> important. I think we should think about it potentially in the form of
> a recommendation. If in fact we all ‑‑ at least there\'s a few of us
> that probably think that public health really needles to be at the
> table as these Regional Health Information Organizations are forming,
> then I think our recommendation to support that to the community would
> be meaningful. And I think that certainly, there\'s been a lot of
> discussion about this for the last year or 2, and Robert Wood Johnson
> Foundation is funding fellows and funding staff at a local level in
> several places around the country to enable public health to have the
> resources to make sure they\'re engaged in this planning phase as
> RHIOs get established.
>
> So it would be helpful to hear more from the Workgroup to see what
> their thoughts are regarding that specific point that we might be able
> to craft a recommendation.
>
> \>\> Rick Heffernan: This is Rick Heffernan from New York City. I
> think we would support that recommendation \-- RHIOS are developing
> anyway \-- and to recommend that we look for opportunities to engage
> public health in that and support those efforts, because I think
> they\'ll have a big impact on local public health. I think I would
> recom\-- I would certainly support that.
>
> \>\> Kelly Cronin: Okay. Great. And just to give some context on sort
> of what we\'re expected to deliver in May in the form of
> recommendations, Dr. Brailer has been opening most of our calls this
> week and trying to tell the various workgroups under the Community
> that there\'s an expectation that we\'re going to be somewhat
> directive in developing our recommendations and telling or
> recommending to the Community that certain organizations or entities
> take on specific action items, so we would say to ‑‑ maybe not a
> specific funder, but say to a specific organization like the Health IT
> Standards Panel that they should develop implementation guides to
> enable our specific charge. So if we can say who should do what by
> when in our recommendations, I think they\'ll be more meaningful and
> perhaps we'll be \-- we\'ll get more traction.
>
> So with that, we can revisit sort of what we think, you know, the
> group thought in \-- so far in terms of early recommendations, but I
> do want to give Roslyne Schulman a chance to share her thoughts on
> what\'s important from the hospital perspective.
>
> \>\> Roslyne Schulman: Thank you. Kelly, this is Roslyne. Can you all
> hear me?
>
> \>\> Kelly Cronin: Yes. Please go ahead.
>
> \>\> Roslyne Schulman: Right. I just wanted to wish you all a good
> afternoon. And I\'m Roslyne Schulman. I'm Senior Associate Director
> for Health Policy at the American Hospital Association. And on behalf
> of our 4,800 hospitals, health systems, and other health care
> organization members as well as our 33,000 individual members, we do
> appreciate this opportunity to present at least our initial views on
> the ability and willingness of hospitals to participate in a
> biosurveillance program that would involve the transmission of a
> minimum dataset to local, State, and Federal public health agencies.
>
> And I will also comment per Kelly\'s request on the need for
> incentives for voluntary participation in such a program and some of
> the potential options for incentives that might be attractive for
> hospitals. And then finally, I\'m going to share with you very briefly
> some of the anecdotal information I\'ve obtained since \-- in the last
> week or so, when I first was asked to present before you about the
> types of biosurveillance systems that have been adopted in hospitals
> and what some of the barriers and incentives have been in those
> systems.
>
> Before I get started, I want to provide the caveat that we don't
> really \-- AHA doesn\'t track \-- we haven\'t been collecting
> information about how many hospitals are involved in developing
> biosurveillance systems within their communities and how many are
> reporting to public health authorities. It\'s not just something \--
> it\'s just something that we don\'t currently track. But I\'ve done a
> lot of scrambling in this last week or so, and I\'ve been using some
> of the very close linkages that AHA has with our over 60 affiliated
> State, regional, and metropolitan hospital associations. And I\'ve
> been able to get some very limited and kind of anecdotal information
> that I\'ll share with you and that I\'ll summarize for you. But I do
> look forward to maybe a future opportunity to provide more detail and
> maybe some more concrete kind of comments in the future, hopefully.
>
> Just as background, sort of where we\'re coming from, as you all know,
> over the past 5 years, the entire Nation has focused on strengthening
> our emergency readiness and security. And as part of our health care
> infrastructure, of course, hospitals do play a central role in that
> effort. And it\'s a role that\'s been growing, and it\'s sure to
> continue to grow as we move forward.
>
> AHA is very supportive of the developing of \-- the development of a
> community-wide perspective and broadening the scale and the scope of
> hospitals' disaster plans so that they link with and they involve
> other community partners, and especially involving open and ongoing
> relationships with their public health department and its leadership.
> And establishing \-- and this is something that we\'ve been really
> encouraging our members to get involved in, and they have been over
> the last several years \-- and establishing these kinds of
> community-wide relationships can serve readiness by facilitating
> exactly the kind of thing we\'re talking about here, which is the
> creation or linkages of data or reporting systems to provide
> community-wide views of health needs and health care resources and
> what\'s going on within the health care system.

And we do strongly support improving the capacity of hospitals and
public health systems and labs and clinicians to engage in
biosurveillance and disease and syndromic reporting, just in order to
improve our readiness. But also, you know, it\'s not just a matter of
readiness. This kind of \-- these kind of surveillance systems, of
course, can also serve to improve the health of the public in other
ways, in the future, such as tracking population health status and
health service utilization. And there\'s a lot of other benefit to it
that we think is worth pursuing. But we do need to recognize that in
order to facilitate this kind of level of readiness, that hospitals and
public health departments really do need to have adequate resources and
significantly upgraded surveillance systems in order to really
accomplish what we\'re setting out to do.

And so one of the things I sought input for from our State and regional
and metropolitan hospital associations are what are some of the
challenges that they\'ve seen in their forays into this area for
hospitals in implementing health information and technology systems and
implementing biosurveillance systems.

And what they wanted you to hear was that it is critical that you all
recognize that there are multiple challenges facing hospitals that will
impact upon their willingness and their ability to participate in this
kind and other emergency readiness initiatives.

And as you all know, emergency readiness really does require significant
investments in staff and resources. But the ability to meet these kinds
of investment challenges are \-- is really compromised by some of the
significant financial pressures that are facing the hospitals today.

As you may know, a third \-- one out of every three hospitals lose money
on their operations with Medicare and Medicaid underfunding being a real
key driver of that. And on top of underfunding by government payers,
hospitals are facing all kinds of other financial pressures. There's
pressures related to labor costs that are continuing to rise as
hospitals increase wages to attract scarce workers; the number of
uninsured patients is continuing to grow, and that contributes to
greater levels of compensated care that also undermine the financial
stability of hospitals; and just sky-rocketing costs related to medical
liability insurance, pharmaceutical, medical supplies. And with all
these kinds of financial pressures, the typical hospital \-- and you
know, in particular, we hear like from rural hospitals they have very
few reserves in place to overcome the kind of technology obstacles that
might be there \-- that might be necessary in order to overcome in order
to participate in a really comprehensive biosurveillance program. So
just \-- you really need to recognize the challenges that hospitals face
simply in just keeping themselves going from day to day.

So I guess, you know, to maximize the voluntary participation of
hospitals, it\'s just important that, in developing these systems, that
we accommodate the hospitals' needs and utilize appropriate incentives.
And here\'s some of the considerations that I heard from our members and
from our State and metropolitan hospital associations regarding the
development of biosurveillance systems:

First and foremost, there needs to be adequate initial and sustained
funding to hospitals to put these systems into place. So there\'s got to
be some sort of up front support to help them implement the system,
including offsetting some of the costs related \-- if there are costs
\-- related to hardware or software, testing the systems, and technical
assistance.

In addition, there has to be a commitment \-- even in addition to the
up-front costs, there has to be some sort of a commitment to provide
ongoing financial support for the longer-term maintenance of these
systems. A lot of systems have been set up in the past that got initial
support but then the support waned over time and the system sort of fell
apart. And so longer‑term maintenance costs need to be supported, as
well as the ability to fund any kind of additional hospital reporting
requirements that might come down or other kinds of mandates that might
come down. "Unfunded mandate" is a word I hear a lot.

Second, in order ‑‑ there really can be added value to the system by
providing an opportunity to get useful data back to the hospital in
return for their voluntary participation. That is, the data collected by
many hospital surveillance systems, as I mentioned, has uses far beyond
disease and syndromic surveillance. It can also be used to implement
things like pay‑for‑performance or for improving the quality of care or
for benchmarking or for, you know, a variety of hospital kinds of
research purposes.

And so, you know, a very powerful incentive is the promise and ability
to report system data back to the hospitals that volunteer to
participate.

And then third, I\'m going to echo some of the comments that we heard
from NACCHO and ASTHO, and that is close collaboration between all the
different partners within the Community. In particular, we heard that
there\'s got to be close collaboration with the local hospital
associations, the State hospital associations, or the metro hospital
associations \-- is in the development. They got to be at the table from
the very beginning, at the get‑go in the development and implementation
of biosurveillance systems. And it's then official, because these
associations have very strong relationships with their member
institutions. And they can help, and they, if they are bought into it,
will help to secure support from hospital administrators. And without
that support, you\'re never going to get volunteers. So it\'s really a
key to system adoption, and you\'ve got to get the local hospital
associations vested into this process from the very beginning.

And I think \-- as you\'ll hear in a moment, I think that those States
in which they have very successful comprehensive programs \-- I think
they did do that. They did bring their hospital \-- community hospital
associations into the process very early on.

In addition, working with the State hospital association does provide an
opportunity for the public health department to leverage existing data
collection initiatives that many of these associations already have in
place. And I think that has occurred in some States as well. I mean,
these State hospital associations and metros already collect a great
deal of data, and you can link into that if you involve the associations
from the very beginning.

And now I\'m just ‑‑ and then \-- I\'m going out of order here a little
bit \-- and then another point, maybe the fourth point here, is that you
need \-- we did hear that there needs to be, to the maximum extent
possible, automated data submission. A successful surveillance system
has, to the maximum extent possible, to utilize and build upon sources
of information that are already collected by hospitals and their
emergency departments and not attempt to alter the processes or
procedures that are already in place within hospitals.

Essentially, the ideal system would be invisible to the hospital, with
data obtained from the hospital system in the manner that doesn\'t
require any change in the provider\'s daily internal process, no
additional forms to be filled out manually, no additional fields added
to the computer screen at the provider level. Further automat‑‑ you
know, automated retrieval and automated transmission of existing data
from clinical databases in hospitals is, of course, preferable to
systems that require manual entry of data and really might be the best
solution, of course, to a rapid development of surveillance systems and
providing surveillance data to public health departments.

And this kind of an automated system should, I think, also ultimately
prove to be less costly for providers as well as less burdensome. And
just to put this into context, you know, we\'ve done some research
looking at paperwork burden in an environment in which every hour of
patient care provided in a hospital emergency department results in 1
additional hour of paperwork. It\'s difficult to justify adding a burden
through any kind of new or manual data collection. So again, automated
data submission is key.

Another point we heard back is that at least for your short‑term charge,
related to getting things in place within 1 year, really do support
whoever it was that was saying that the minimum dataset really has to be
a minimum dataset, as minimum as possible, based on really only those
value-added data elements, the critical ones, the ones that are based in
science, because every data element you add to it is going to add a
level of cost and a level of complexity that\'s just going to make it
far less likely that you\'re going to have a significant number of
hospitals that are going to be able to really participate.

Of course, as others have said, data security, data privacy needs to be
ensured. Hospital data has to be obtained, processed, transmitted,
analyzed, stored, and used in a manner that\'s compliant with Federal
law, with HIPAA, and with any kind of State information privacy and
security regulations.

And then, last but not least, we did hear from a few of those States
that \-- or \-- and those metro areas that did already have very
comprehensive systems in place, and they\'re kind of worried. And they
want to avoid ‑‑ they want me to tell you to avoid redundant data
requests. That is, in order to encourage voluntary participation, they
think that this Federal initiative should be willing to take data from
whatever source can make it available. So if that\'s directly from
hospitals, that\'s great. But if you can get the same data directly from
State or local health departments that are already involved in
collecting this data from hospitals, then they would suggest taking that
route.

And then, just briefly, I did, as I mentioned, seek input from our
State, regional, and metro hospital associations within the last week. I
got \-- about 16 States responded to me and two metropolitan areas
responded back to my request for some information. And I\'m not going to
go over in any detail what I was told, although I did summarize it here
in my paperwork, and I\'ll send it on to Kelly maybe for your
distribution. I\'ve got a lot of materials here that came through. But
just very briefly, I wanted to sort of summarize my perception of where
these 16 plus two Metro area\-- where they are in terms of developing
any kind of comprehensive automated electronic biosurveillance systems.
First of all, it\'s a very mixed bag out there. I mean, some systems are
way ahead of the curve, and they\'re the ones you already know about,
the ones that we\'re speaking up on this call, places like North
Carolina, New York City, and Florida and Indiana and Pennsylvania. Those
are \-- and Kentucky \-- and those are areas where they are either, have
already put into place very comprehensive systems that involve all of
the hospitals that have emergency departments in their States or have
pretty comprehensive systems in place for some subset of their
hospitals.

However, in other areas, in other States, we\'re really ‑‑ we have a
very long way to go. Many of them are still using only paper‑based or
fax‑based kind of manual reporting systems. Some of them are just
reporting notifiable ‑‑ you know, it\'s all I heard back from some
places, that they\'ve got certain notifiable disease reporting
requirements, and they do it again through faxing or phone calls or
paper based, and many are not even close to real time.

So, you know, there certainly is quite a challenge out there in terms of
the direction that we need to go. But I think, you know, the AHA really
strongly supports moving in this direction. We recognize the benefits
that, you know, the initiative that you all are working on could give,
but just want you to recognize the sensitivities from the hospital
community about costs and about burden, and that\'s ‑‑ just happy to
answer questions. I think that\'s all I\'ve got right now.

> \>\> Julie Gerberding: Thanks, Roslyne. We appreciate all of your
> comments. Are there any questions or comments from the Workgroup
> members?
>
> \>\> Adele Morris: Yeah, hi. This is Adele. Thank you so much for that
> very helpful presentation. I\'d like to ask Roslyne if she could kind
> of give us a sense of the tradeoffs that hospitals face when they are
> trying to do the public spirited things and report data. We heard that
> there\'s going to need to be funding for the systems, but then we hear
> that people are already doing this and already have some systems in
> place. What\'s your sense of what \-- kind of the way I look at it is,
> is there an increment that folks could do that would be fairly
> costless or not that hard and then you kind of, you know, march out
> the cost curve \-- well, you could do a little more, but it could be a
> little more expensive \-- and so on? Could you give us a flavor of
> kind of what that \-- those incremental things might look like?
>
> \>\> Roslyne Schulman: You know, I \-- as I mentioned, we don\'t
> really collect data on this \-- haven\'t been tracking it in a
> comprehensive way. But I think in some communities, what has helped is
> maybe not complete underwriting of the costs of doing this, but there
> have been \-- in some communities, there was some assistance provided
> \-- some offsetting provided through Federal funding through the HRSA
> funds or the CDC funds or home loan security funds to put these kinds
> of systems into place. And the hospitals do recognize the public
> service they provide, you know, as part of their mission to protect
> their communities.
>
> And so they \-- but the issue is ‑‑ I mean, what they\'re facing is a
> situation where, you know \-- are they going to purchase a new
> technology that\'s going to help, you know, diagnose a new kind of
> technology to diagnose cancer or to address some particular need of
> their community on an everyday basis, or are they going to be putting
> the money towards a system that might have, you know, longer-term
> impacts but not maybe immediate impact in the health of their
> community? So they\'re having to make choices about purchasing
> technology for a variety of different purposes, all of which are
> admirable, but not all of which can be funded given the sort of
> precarious financial situation that many hospitals find themselves in.
>
> And I think I would sort of reiterate what I said earlier, and that
> is, to the extent that this kind of an initiative can really focus on
> what the key data elements are, the really minimum dataset to get you
> started, to get the system into place, as minimum as you can make it
> and still make it useful and get us on the road, I think that that
> would be helpful approach. Take small bites of this as opposed to
> trying to bite it all off in one ‑‑ at once.
>
> \>\> Kelly Cronin: Roslyne, this is Kelly. I was curious to get your
> thoughts on what subset of hospitals do you think that already have
> electronic health records implemented and have a pretty high level of
> connectivity across the hospital setting \-- do they ‑‑ are they more
> willing or more able to participate in these programs? Because as I\'m
> sure you know, the adoption rate among hospitals is much higher than
> ambulatory care in terms of electronic health records.
>
> \>\> Roslyne Schulman: Right. You know, I\'m not really the expert
> within AHA. That may be a question that I can better address to one of
> my colleagues who really works on this exclusively in this area of
> health IT. But my \-- I think my impression is that hospitals that are
> part of large systems, that are academic medical centers involved in
> research, that \-- you know, that already have these kinds of \-- that
> already are in other areas perhaps moving forward in the health IT,
> are the ones obviously who are going to be more likely to \-- you
> know, to move forward on this kind of a system that we\'re talking
> about today.
>
> But I could try to get ‑‑ I could see if there was something else that
> my \-- one of my colleagues, Chantal Worzala, might be able to provide
> as far as, you know, whether we have a sense of, you know, which
> subset of hospitals might be set up to perhaps do this sooner \--
> early involvement as opposed to later involvement.
>
> \>\> Kelly Cronin: That would be really help.
>
> \>\> John Loonsk: This is John Loonsk. I remember that NCHS did a
> study where they looked at number of hospitals that have electronic
> ambul\-- emergency room systems, and it was much higher than I had
> anticipated. And we all have this picture of patchwork and of the
> difficulties that many hospitals face. But maybe \-- I don\'t know if
> Ed Sondik's still on, but maybe he could comment on that or he could
> \-- we could get that presented, because it was \-- I think it was
> more substantial than people think in terms of electronic emergency
> room systems that could be assistive in this area.
>
> The other point I wanted to make is that \-- I wanted to sort of talk
> a little bit about the tension that I heard in this presentation. And
> you know, I think it was a really great job of describing the
> patchwork of capabilities that are out there. And we know this
> patchwork exists at the local and at the State level. And the desire
> to go for utility \-- I mean, everyone has expressed their concern
> that we want to get data that are useful, but that this other concept
> of sort of taking whatever data are available and that, in fact, these
> two concepts of utility and taking what data are available are
> somewhat in conflict, particularly as one is thinking about looking
> across different hospital settings.
>
> There\'s no question but that the utility of the data in these types
> of systems and these types of capabilities very directly relate to the
> consistency with which they are accumulated. Having apples from one
> source and oranges from another, and perhaps no fruit at all from a
> third, is a typical thing to navigate when you\'re trying to look at
> some of the capabilities that we\'re targeting here.
>
> So I think it was a great presentation on the patchwork. I think this
> issue of utility and the need to drive toward more consistency in the
> data is one that bears further inspection as well, though.

\>\> Ed Sondik: John, this is Ed Sondik. I\'m trying to actually bring
up the specific information on my computer. But I think you\'re right. I
think the figures were actually higher than I would have anticipated.
And I\'d be happy to send out the report to the Workgroup.

> \>\> John Loonsk: Thanks, Ed.
>
> \>\> Kelly Cronin: Dr. Keaton, I don\'t know if you\'re still on the
> line, but you may know from your perspective as President‑elect of the
> organization that represents emergency physicians whether or not EDs
> are more or less capable to participate and advise around the program.
>
> \>\> Brian Keaton: There\'s really two different sets of systems that
> exist in the emergency department. Being hospital‑based, we\'re
> dependent upon the enterprise systems. But most of the results
> reporting, the x‑ray images, the printed reports from laboratory and
> surgery, and admission discharge exist within the hospital
> environment. We make use of those.
>
> There\'s a separate set of systems that are increasingly becoming used
> in the emergency department that focus on a lot of the operational
> issues: where are patients, where are they tracking orders, and those
> type of activities. That\'s growing by leaps and bounds. It used to be
> that the older systems tried to incorporate both of those, and as
> hospitals become more and more sophisticated, we\'ve started to focus
> more towards being able to make the two work together.
>
> I think as a bottom line, we\'re much better off today than we were 5
> years ago, but I think we have a long way to go in terms of being
> universal with that.
>
> \>\> Kelly Cronin: So in order to get a more precise estimate of
> capacity when it comes to emergency rooms, perhaps trauma centers or
> hospitals in general, does \-- do any Workgroup members have any
> feedback to give Roslyne in terms of what do we need to know to make a
> good recommendation on what a short‑term and perhaps a long‑term goal
> should be for the scope of this breakthrough?
>
> \>\> Brian Keaton: This is Brian again. Roslyne ‑‑ actually, I know
> Roslyne from way, way back \-- I would be willing to put together of
> the folks that do this from the emergency room standpoint and people
> from AHA to be able to come up with a recommendation that makes sense
> from both groups.
>
> \>\> John Loonsk: I\'m not sure what that recommendation would exactly
> be that, in terms of ‑‑ I think there\'s still a little bit of sway
> around what the target is. Potentially, we get a further discussion of
> what exists out there from an information standpoint about the
> existing systems. That might be a better posture to work from in terms
> of next steps for that consideration. I don't know. It\'s just a
> thought.
>
> \>\> Kelly Cronin: Yeah. I mean, it does \-- it makes sense if we did
> have sort of the \-- a better idea of what the universe of hospitals
> with emergency rooms that are \-- that have the appropriate systems
> for participation. That would be step number one. And then the
> willingness to participate would be, I guess, a separate subject.
>
> \>\> John Loonsk: I mean, it is \-- the first is a very complicated
> issue, because it does relate, as was suggested, to some free‑standing
> emergency rooms or relative free‑standing emergency rooms, some more
> integrate hospital systems, some systems that might provide data that
> span multiple hospitals, or \-- and so it gets complicated fast. I
> think it\'s worth doing some surveillance, if you will, on what
> already has been done to evaluate that.
>
> \>\> Brian Keaton: What I can do is enlist the help of the informatics
> section from ACEP, which is over 500 members, and we also have a very
> active vendors' group that could probably provide us with some of that
> data in terms of whether to install that.
>
> \>\> Rick Friedman: This is Rick, and I think that also dovetails with
> the issue about what the minimum dataset is. I mean, you can cast a
> pretty wide net relative to capabilities or to organizations' system
> capabilities, but \-- and what we'll come down to is, given this
> dataset, can those systems collect that information and send it around
> to various groups?
>
> So I think the two areas are related. I don\'t know if you can do
> these in parallel or if they\'re sequential. But just doing it in
> general I don\'t think is going to be terribly helpful.
>
> \>\> John Loonsk: Well, I think that\'s a good point, Rick, and that,
> you know, where we started with this was to define what the functions
> were that need to be addressed. And, you know, it was pretty
> unambiguous from the charging of the Secretary at the Community that
> he sees this as a priority to address these biosurveillance needs. We
> talked about the functions. They\'re not just initial detection.
> They\'re about a whole suite of activities around them. So, you know,
> to think about this from the standpoint of "Here are the functions;
> these are the data that we need to address those functions," which is
> what we did at the last Workgroup meeting, and then to \-- from there,
> to say, "Well, these are the gaps we need to get to in terms of
> getting those data," I think, would be a very constructive way of just
> pursuing that. And those are all related.
>
> \>\> Adele Morris: I guess \-- this is Adele. I was sort of looking at
> it a little differently in that I do think that the problems are
> simultaneous, in that if we put a minimum data element on our list,
> and that\'s a data element that a certain set of even the
> electronically enabled health care providers can\'t feasibly provide,
> then we just, you know, reduce the size of people we can include. So
> it strikes me that there can be a very direct tradeoff between the
> scope of reporting and the depth of reporting. And that\'s ‑‑ I think
> we need to tee up for the Community kind of where those tradeoffs
> might lie.
>
> \>\> Julie Gerberding: Yeah, I think we do need to come back to the
> recommendation from the Community that, you know, for this Year 1, we
> need to, you know, transmit it \-- we have a relatively narrow charge.
> And the consensus at the last meeting, the feedback that we got from
> the last Community meeting on March 7, was to go broad with a minimum
> dataset.
>
> Now, our charge now is to really fine-tune that. And I think that, you
> know, since we\'ve agreed on a subgroup to look at this issue more
> carefully, that they could perhaps, you know, have a more detailed
> discussion, again, of all the data elements that I think everyone
> agreed would actually enable the functions related to the scenarios we
> had consensus around, so they can further refine that list based upon
> some of the concerns that were expressed earlier, but that we still
> have this obligation to think through, "Well, what realistically can
> be done within the short term to meet our specific charge in the way
> of scope?" So how many hospitals across the country, what geographic
> areas, or what emergency rooms and what lab facilities.
>
> So I would think that since we\'re only going to have perhaps one more
> time to meet in a lengthy meeting to go through these issues, we\'re
> going to have to rely on people working offline to really address
> these issues. So, in part, I think we probably need to be clear in
> determining whether the American Hospital Association and Brian Keaton
> representing emergency room physicians and the other organizations
> represented have enough information to go back and determine capacity.
>
> \>\> Rick Heffernan: This is Rick Heffernan again from New York City.
> One of the points Roslyne made about avoiding redundant data requests,
> I think, is important. Even at the local level, we run into that,
> where, you know, there\'s many different programs at the health
> department all having good reasons to request a variety of data. And
> sometimes we bump into each other at the hospital.
>
> And I think the Workgroup needs to think about what our recommendation
> is when there are existing systems that inevitably are probably
> collecting data that\'s a little different than the dataset that we
> come up with as a workgroup, but yet there they are. They\'re in the
> hospitals. They're, you know \-- in New York City, we contact IT staff
> with some regularity for missing data files and broken connectivity
> and that kind of thing. And we\'ve made an effort locally to
> streamline for electronic laboratory reporting. Hospitals report only
> to the State, and then the State parses the date out to local versus
> State cases.
>
> We\'ve tried to use the same NMS data transmission software so
> hospitals are only supporting one software. So one of our concerns
> that we\'ve expressed to the BioSense group is that they\'re going to
> be talking to the same IT staff who we struggle to get their
> attention. And I think the Workgroup has to think about that in our
> recommendation and how we think it should be handled when there are
> already existing systems in place.
>
> \>\> Kelly Cronin: Okay, well, that \-- thanks very much. I still want
> to get back to a point, though, just to make sure that we know that
> the respective Workgroup members have enough information to walk away
> and either work under \-- in the context of a subgroup working on the
> minimum dataset or that we, you know, have the right request from the
> American Hospital Association and the emergency room physicians to go
> off and do what they need to do and report back to us so that we can
> make an informed recommendation to the Community about the scope of
> the breakthrough.
>
> \>\> Brian Keaton: This is Brian. As I understand it, there\'s really
> two questions being asked: one in the minimum dataset, but the
> second question is, what data points can we agree upon that are
> collectible \-- are indeed indicative of what our capacity and surge
> capacity is? Is that correct?
>
> \>\> Kelly Cronin: Yes. I mean, I think that there\'s a general
> question around capacity that would be perhaps more specific if we had
> a better idea of exactly what the minimum dataset is.
>
> But at this point, you know, there is obviously some outstanding
> controversy over what exactly, you know, our final recommended minimum
> dataset will be. So in absence of absolute consensus, what can we
> obtain in the short‑term to get a sense of capacity?
>
> \>\> Adele Morris: Kelly, this is Adele. So you\'re talking about
> capacity to deliver the data, right?
>
> \>\> Kelly Cronin: And to participate.
>
> \>\> John Loonsk: This is John. Let me follow up on a second on this.
> I think, you know, from having heard the Community meetings and
> participated in this discussion at that level, I think we are obliged
> to express to the Community what data are necessary to support the
> needs of biosurveillance. That is, I think, within the scope of our
> responsibilities to the Community.
>
> If, then, we can then express to the Community, "This is what is
> needed to support these various activities that we developed consensus
> on," then these are the data that we think are \-- potentially match
> against the existing capacities and systems as we look at them. And
> that\'s what I thought the capacity issue was that was being addressed
> \-- was, "What\'s the status of systems in emergency rooms and in
> hospital settings and potentially in labs and in ambulatory care
> settings in terms of their ability to deliver the data?" Then that\'s
> a filter; that's a mapping against those data. The data that we need,
> the data that are accessible \-- both things are reasonable to
> express, because what we\'re trying to do here, I think, as I
> understood the charge, was really to make recommendations to the
> Community as to how to bridge those gaps and how to address the other
> issues about how we can support this \-- these biosurveillance needs
> at State, local, and Federal levels.
>
> So from my perspective, there is a real need here to be able to
> express to the Community \-- and, you know, I was under the impression
> that that\'s what we had done with our last working group meeting \--
> that these are the data we want, these are the data, and then
> potentially that the next useful step in that regard would be to map
> that against existing capacities: "This is how many hospitals have
> electronic emergency room systems that could provide these data; this
> is a gap data type which will be harder to get," and that \-- just to
> suggest to them, in terms of their decision-making, what might be
> involved in policies or incentives for trying to get those data to
> meet the charge.
>
> \>\> Adele Morris: I guess \-- one thing I\'m struggling with is, you
> give somebody enough money, they can report anything. So, you know, it
> seems to me what we kind of need to tell the Community is \-- okay,
> depends on what resources are available. If you\'re saying, "Okay,
> what kind of data and provider population can we put as part of this
> program?", if there are zero new resources, okay, then that\'s one
> answer. If \-- or you could have a gold‑plated version, but it would
> take a lot of resources.
>
> \>\> John Loonsk: I think that\'s a reasonable way of articulating,
> perhaps with a little more granularity than that.
>
> \>\> Adele Morris: Yeah, but you know what I\'m talking about. I\'m
> not comfortable with one particular presentation to the Community
> saying, "Okay, this is what we need, this is the minimum data
> standard, and we need all these resources in order to make that
> happen." I would not be comfortable with that being the only
> presentation.
>
> \>\> Kelly Cronin: Well, I think, in part, if we were able in the next
> several weeks to get a better handle on what data we could get from
> emergency rooms and labs across the country, then we would have our
> sort of reality check with saying, "Okay, in the current environment,
> this is what we can do this year. And if we want to expand on it to
> fully meet the charge of the Community, this is what we would need."
> So we would be giving both sort of a realistic "This is what we can do
> given the short time frame and, you know, whatever resources we have
> available to us" and "This is what we could do with the resources that
> would be necessary to meet the specific charge."
>
> Does that sound like a reasonable ‑‑?
>
> \>\> Adele Morris: Yeah, I just \-- well, when I read the specific
> charge, it doesn\'t give me much information about scope. It just
> says ‑‑ it doesn\'t say from all electronically enabled systems. It
> just says from them. And so sort of our job to say, "Okay, well, we
> can get this many with almost no new resources with this dataset,"
> which can tell us ‑‑ we haven\'t quite, I don\'t think, crafted the
> message of exactly what benefits would derive from these minimum
> datasets. I mean, we kind of talked about it and said, "Okay, this is"
> \-- you know, we need this, but I\'m not sure we\'ve yet expressed the
> functionality.
>
> \>\> Kelly Cronin: Well, I think, Adele, we did talk about the
> scenarios in not only event identification but outbreak management and
> \--
>
> \>\> Adele Morris: That\'s true. I guess what I\'m saying is that for
> the Community, we want to talk about both costs and benefits. Okay,
> for this cost, you ‑‑ and I\'m putting time in that basket \-- you can
> get these benefits. For these costs, you can get these benefits.
>
> \>\> Kelly Cronin: Yeah. I mean, I don\'t think that we\'re going to
> have time to do sort of an economic analysis.
>
> \>\> Adele Morris: No, no. I'm just talking conceptually.
>
> \>\> Kelly Cronin: But I think \-- no, I think that, conceptually,
> that there will be \-- you know, that the benefit is better
> preparedness across a greater number of geographic areas, if in fact
> we could make recommendations or if resources were available to fully
> meet the specific charge across a larger geographic scope and a larger
> group of providers participating and local, State, and Federal health
> \-- public health.
>
> \>\> Adele Morris: And I guess my main point is that I want the
> Community to be in a position to decide whether the incremental
> benefits are worth the incremental costs.
>
> \>\> Kelly Cronin: Right. And I think that\'s really just sort of a
> qualitative or, you know, sort of a ‑‑
>
> \>\> Adele Morris: Qualitatively, yes.
>
> \>\> Kelly Cronin: Yeah. Well, I think what we just discussed, the
> approach of trying to figure out, you know, the subset of data that we
> need to meet the scenarios, which we\'ve already done, and then to
> sort of map that against the data that we could feasibly get now from
> emergency room departments and hospitals and labs across the country
> so that we\'d have sort of our realistic "This is what we could do
> this year," and then in the process of making that judgment, if we
> could get feedback from the groups represented today on what
> additional resources they would need to reach a broader representative
> group of hospitals or emergency departments or labs, then they can
> report back to us on what is that incremental difference, what
> additional resources or incentives or whatever they need \-- that
> could really be the basis of our final recommendation.
>
> \>\> Rick Friedman: This is Rick. I\'m just sort of here fidgeting a
> bit. And I\'m a little concerned. We can be driven by the constraints
> of today, or we can figure out what\'s actually needed and then work
> towards that by identifying the gaps.
>
> I had understood the charge \-- I think we all see this slightly
> different \-- was for clinicians and other people knowledgeable about
> this stuff to define an absolutely critical core dataset that one
> needs to track and pay attention to.
>
> Having identified that core dataset, it has to be put within the
> context of what the Secretary had laid out relative to different
> parameters. And having then come down to that core, what we ought to
> do is go out to all of the folks, not just hospitals, not just EDs,
> but laboratories and all the other players, and ask them, "Relative to
> the score dataset, what is your current capability to do this relative
> to that?"
>
> So I\'m just afraid that if we go running off after trying to figure
> out what the lowest common denominator is for hospitals and EDs today,
> we won\'t really have met the charge that we were asked to fulfill,
> because we may not actually be collecting some of the most critical
> things.
>
> On the other hand, it may be a very narrow set. That\'s why I think
> Tom\'s comments at the beginning are very important. Go back and
> revisit it with his perspective and other people that are going to be
> on that group, but that starts the ‑‑ that\'s where we start from. And
> then run it by these different systems relevant to their capacities
> rather than starting with what are their capacities and what we wind
> up as the lowest common denominator. It may never reach the objective
> that we were set to try to achieve.
>
> \>\> John Loonsk: I think, you know, that well parallels the path that
> this group has tried to set out. We talked about scenarios. We talked
> about the breadth of activities. We talked about the fact that the
> breadth of activities is different at different levels of public
> health. And so we then went and we looked at what data was New York
> City collecting, what data was North Carolina collecting, what data
> was the BioSense program collecting in the way of looking at what data
> would be considered in meeting those functions. And that \-- it\'s
> certainly not a complete sample of the country, but those were
> programs that were participating in this discussion and brought that
> to bear.
>
> Last meeting, I thought we went over those data to, you know, a fair
> degree of detail about the kinds of capabilities that existed and \--
> or what the needs may be, recognizing that it doesn\'t mean that
> everyone can provide those data now. And I think that, for me, that
> makes \-- along the lines of what you said, Rick, it makes a lot of
> sense about how we can articulate the capacities to present those data
> now on the basis of those discussions, and that seems to be where we
> are.
>
> \>\> Kelly Cronin: So based upon those two comments, do the other
> Workgroup members agree or disagree with what are appropriate next
> steps?
>
> \>\> Brian Keaton: \[Lost audio\] \-- Brian. I\'m still trying to
> digest \-- as I understand it, we\'re all saying the same thing, but
> in different ways. We need to identify the ideal. We need to identify
> the doable within the time frame. And we need to identify the gap
> between what exists right now and what we need to meet both of those
> needs, both the short‑term and the longer-term ideal.
>
> \>\> Rick Friedman: Brian, this is Rick. I would take issue of the
> idea of the ideal. What I think is what is the absolutely critically
> minimal that \-- need to have, and the ideal is the target. So we\'re
> really talking about both minimal and ultimately what the more robust
> ideal is. But I think you\'re right in terms of \-- we\'re all sort of
> touching different parts of this elephant together.
>
> \>\> Adele Morris: I guess one question I have is, you know, how do
> you define capacity? There's what they could do for zero cost, what
> they could do with some medium incentive or technical assistance, and
> what they could do with very substantial technical assistance, all
> within the same time frame, right? So I guess what I\'m saying is,
> when we go out to assess capacity, let\'s be clear exactly what we\'re
> asking them, what they \-- you know, what they can do. And they\'ll
> say, "Given what?" And we\'ll have to say \-- have an answer.
>
> \>\> Rick Friedman: This is Rick. From my perspective, what we\'re
> really talking about here is not just sort of capacity in a vacuum.
> Having identified the core dataset that\'s absolutely critical, the
> question for people with systems is, "Can you collect this stuff
> today?" And identify those elements which you cannot collect. They
> then represent the incremental difference between where we are today
> and where at a minimum we need to be. We can then take those
> incremental data elements or other aspects of this and attempt to sort
> of price them out or even array them in such a way that you could move
> ahead incrementally, that it won\'t cost much to get these six more
> elements; it will cost a lot more to do these. But the first step is
> measuring where are you today in your capacity relative to what the
> Workgroup has laid out.
>
> \>\> Adele Morris: But what they can do is not costless either, right?
> I mean, what you can do today is not a zero-cost thing to them,
> necessarily. Right? There\'s a technical question of "What does your
> system allow you to do?" And separately there\'s a question of "Well,
> would you need to hire somebody to do that? You know, how many person
> hours would it take to be able to operate your system and get that
> data to us?"
>
> I guess even the baseline case has ‑‑ there\'s a resource commitment
> to it that it\'s worth us knowing.
>
> \>\> Kelly Cronin: So perhaps we have the \-- you know, a series of
> questions that starts off with, "Can you share this data today with
> your current resources?"
>
> \>\> Adele Morris: Yeah.
>
> \>\> Kelly Cronin: And then perhaps a second question is, "Can you
> share this today \-- data today \-- participate in a program this year
> if you had, you know, some additional resources at a local or State
> level?" And I think we could probably, you know, sort of fine-tune
> what those set of questions would be offline and see if the American
> Hospital Association and Brian\'s group could perhaps go back and see
> if they could get, you know, some data for us so that we can really
> make some informed recommendations.
>
> Does that sound reasonable?
>
> \>\> Adele Morris: Yeah. It does to me.
>
> \>\> Brian Keaton: Good by me. This is Brian.
>
> \>\> Rick Friedman: Sounds good to me.
>
> \>\> Kelly: And Roslyne, are you still on, by any chance?
>
> \>\> Roslyne Schulman: Yeah, I'm still here.
>
> \>\> Kelly Cronin: Okay, great. I know you guys currently have a
> survey in the field, so we may have missed our opportunity. But maybe
> there would be an informal way of you to circle back with your
> membership.
>
> \>\> Roslyne Schulman: I\'ll tell you, though, that surveying
> hospitals is a very tricky business at the American Hospital
> Association. There\'s always \-- it\'s not just a survey in the field.
> There\'s lots \-- always lots of surveys in the field, and hospitals
> don\'t appreciate getting too many at the same time. And we have sort
> of a very ‑‑ the process we have in place to determine whether we\'re
> going to do a survey and how long it takes to prove it through ‑‑ I
> mean, there\'s a process. I don\'t know that we would be able to
> collect anything really valid in a real\-- in a very short period of
> time. I mean, that\'s something we'd have to ‑‑ it would all depend on
> what you\'re asking. But there \-- you know, just keep in mind that
> it\'s a tricky business, at least within my organization, to do a
> survey. It\'s pretty tightly controlled.
>
> \>\> Kelly Cronin: Okay, so \[garbled by overlap\] \--
>
> \>\> Adele Morris: Is there a secondary way to get information? For
> example, if we know that this such and such a set of hospitals has the
> system from vendor X, then we can infer from that what their
> functionality is?
>
> \>\> Rick Friedman: I think it\'s a lot more complicated than that.
> Some hospitals have clinical repositories where it\'s integrated; some
> are participating in \-- have self‑developed systems. So it\'s a much
> broader issue than that, I\'m afraid.
>
> \>\> Jean-Marie Maillard: This is Jean-Marie Maillard. I\'m rereading
> the charge, and I really ‑‑ when we start looking at the ability to
> submit the data, I'm wondering \-- I think we\'re going beyond the
> charge. The charge is really, you know, from electronically enabled
> health care \-- \[indiscernible\] electronic health systems, and so
> the charge has more to do, I thought, with defining the essential
> datasets. Minimum and target would be one way to fraction it, but when
> we go beyond that to say \-- and we\'ll extend that to say what\'s
> visible today and where are the gaps, of course it\'s important that
> it's \-- if we consider that \-- what\'s happening on electronic
> systems, I don\'t know. It seems we're \-- to be able to go around
> this charge within 1 year, I think it can complicate things when the
> economy aspect is added to it.
>
> \>\> Kelly Cronin: I think that\'s an interesting point, in that
> really the subset that we\'ve been asked to really look at and focus
> on is hospitals that already have some degree or are electronically
> enabled in some way, or not just, you know, emergency rooms but, you
> know, other, you know, lab providers or, you know, to the extent that
> we will consider ambulatory care, what ambulatory care environments
> could we be getting data from that are already electronically enabled.
> So, for example, if we take the universe of 5,000 hospitals, and we
> know that approximately, say, 2,500 may have some, you know, degree of
> electronic health records, then it\'s really that subset that we have
> some level of interest in.
>
> And perhaps there could be some very sort of crude data available from
> the, you know, care surveys at NCHS to get a listing of, you know,
> hospitals that might be the total universe that we\'d be interested
> in. And then there could maybe be, in an informal way, a process to
> reach out to a certain number of providers to figure out whether or
> not they would be actually able to provide the data in our minimum
> dataset.
>
> But I understand, Roslyne, that it would be very difficult to field a
> survey and get your leadership to buy in on the short term. So I\'m
> just trying to figure out if there\'s an alternative mechanism to sort
> of set our sampling frame and figure out, you know, what is realistic
> to gather over the next 3 weeks.
>
> \>\> Brian Keaton: This is Brian. I\'m back on the call. Some gremlin
> on the line threw me out. \[Laughs\] Technology, you know.
>
> \>\> John Loonsk: Kelly, I thought that was a great way to
> articulating the steps. I think the other information that could be
> contributed is that \-- those that are doing this now and their
> experiences relative to being on the ground and getting some of the
> data, and I know that that would include, you know, the BioSense
> program in North Carolina and others like that. So \--
>
> \>\> Julie Gerberding: You know, I'm \-- this is Julie. I\'m listening
> to this. I think this has been exactly the kind of granular
> conversation that helps us really get below the surface of what we\'re
> talking about. I think that harkens back to the discussion about the
> data elements earlier. Perhaps what we could do at this point is to
> summarize this discussion in an e‑mail and identify the key points
> that we need to really come to a decision on and perhaps try to
> communicate by e‑mail or perhaps even a very short conference call, if
> necessary, before our next large-format meeting, so that we know where
> we are right now and we can really take this to the next step. Does
> that seem like a reasonable way to go forward?
>
> \>\> Adele Morris: Yes.
>
> \>\> Kelly Cronin: Sounds good to us here in Washington.
>
> \>\> Julie Gerberding: So why don\'t we have that plan? We\'ll try to
> get an e‑mail back to you within a week that really gets at these
> issues in a categorical basis. And, you know, where we have decisions
> to make, we can spell out the options and the choices that we\'re
> looking at.
>
> \>\> Ed Sondik: This is Ed Sondik. I was off the line for a while and
> came back when I heard \"sampling frame" and, of course, perked my
> ears up. But if there\'s something that we at NCHS could do to help
> define an appropriate sampling frame \-- and I didn\'t get the purpose
> just before that, so the context is lost \-- I would be happy to
> discuss that here and get that out to you all.
>
> \>\> Julie Gerberding: Thanks, Ed. That \-- if that comes up in the
> context of this e‑mail, that \-- we apprec\-- thank you. We appreciate
> that offer.
>
> I think where we are now is really coming to the end of our formal
> agenda before we take an opportunity for public input. And we do have
> a time line of next steps. And I just wanted to make sure that
> everyone was aware that we would summarize the outcome of all of this,
> as I mentioned, by next week. The week of April 3, ASTHO and NACCHO,
> we hope, will be able to do some field survey work and get the
> high-level recommendations from their input back to us. The following
> week \-- actually the following 2 weeks to synthesize this data and
> again pull it into our first draft of high-level recommendations that
> we would ultimately bring back to the committee.
>
> But in between that time and the next AHIC meeting, we\'ll have
> another public Workgroup meeting to really make sure that we\'ve come
> full circle on these recommendations. And if we need any additional
> work following that, we\'ll have to see if we can prevail upon your
> time or on the time of a subgroup to really make sure that we\'re
> ready to finalize our recommendations on May 4.
>
> So it\'s this very aggressive agenda these next couple of months, and
> I really appreciate people\'s commitment to taking us to the next
> level. We\'re trying to balance, you know, the robust discussion that
> we need and the input that we need with the sense of trailblazing
> urgency that the secretary has asked us to commit to. And I think
> keeping to his principle that we don\'t want the perfect to be the
> enemy of the good, we may have to take a stab at some of these things
> and get them going, and we\'ll no doubt learn and evolve as we go
> forward.
>
> So if people can tolerate some degree of ambiguity and uncertainty,
> hopefully we\'ll be able to take this project to the next step and
> really feel good about the progress that we\'ve made. Even though this
> is difficult, this is also groundbreaking work and the first time
> anything like this has ever been attempted. So I really appreciate the
> enthusiasm and the thought that everyone has put into it.
>
> Any comments or questions on that timeline?
>
> \>\> Kelly Cronin: Julie, this is Kelly Cronin. I just wanted to point
> out that the Workgroup members got an e‑mail this afternoon to find
> out about their availability for a Workgroup meeting on several dates
> late in April.
>
> We will likely still have our May meeting. I think we\'re scheduled on
> May 3 to meet again. But that would ‑‑
>
> \>\> Julie Gerberding: That was May 4, but I could \--
>
> \>\> Kelly Cronin: May 4; I\'m sorry \-- and it would probably just be
> to sort of recap on a final letter of recommendation, and hopefully we
> could, you know, minimize the time that would be necessary for that.
> But the longer meeting that we\'re hoping to schedule based upon
> people\'s availability would be in late April.
>
> \>\> Julie Gerberding: Thank you. I appreciate that clarification.
>
> Do we have members of the public who would like to contribute at this
> time?
>
> \>\> Matt McCoy: We just put up the instructions on the Web. So give
> it 2 or 3 minutes to see if anybody calls in. And if there\'s members
> of the public on the phone right now, you can just star-1 to make a
> comment.
>
> Operator, can you please open Rich Lawlor\'s line? Go ahead, sir.
>
> \>\> Rich Lawlor: Yeah. Can you hear me okay?
>
> \>\> Matt McCoy: Yeah.
>
> \>\> Rich Lawlor: I apologize. I\'m on a cell phone, and it\'s a bad
> location. But I also did not attend your prior Workgroup meeting. So I
> apologize if this is off base, but I listened to your conversation
> today. I thought it was excellent, and however, I\'m looking at the
> electronic health records' ability to support these kinds of
> biosurveillance. Although our primary target for implementation is the
> physician or small clinic setting, I wanted to ask if, based upon all
> the discussion that was going on today relative to the hospital and
> the emergency room area, is this minimum dataset that you\'re talking
> about the same one that would be expected and/or feasible from the
> small physician office or clinic? Because just vaguely on my mind,
> I\'m wondering that the next issue would be compatibility and
> standards-mapping needs needing to be reviewed before the universe of
> data is essentially harmonized from all the different clinical
> settings.
>
> \>\> Kelly Cronin: John, I would have to defer to you on that.
>
> \>\> John Loonsk: Well, it\'s certainly in the charge to talk about
> ambulatory care, and I don\'t think that the datasets that were looked
> at were really focused on that. So it\'s probably a good point that
> that should be a focus of additional discussion, because it certainly
> isn\'t \-- that dataset is not oriented to ambulatory care provision.
>
> \>\> Rich Lawlor: Okay. I just \-- I appreciate that you responded in
> that manner, too, because we\'re looking at it from the opposite end
> of spectrum and need to look at it from the hospital side, which is,
> again, why I appreciated your discussion today. And I do think that
> there will be lots of elements that are \-- fit within perhaps a chunk
> of the field you want to get out of the hospital and then perhaps vice
> versa, so as long as the standards or whatever, the architecture
> eventually led out of this, turns out to be that they could both play
> in the same reporting stream.
>
> \>\> Brian Keaton: This is Brian. Along that same line, the comment
> kind of points to the fact that we\'re focused on the specific charge.
> And as we move out to the broad charge, it\'s going to involve other
> means of communication, other means of activation, notification, that
> we really haven\'t touched on up to this point because of our focus on
> the specific charge.
>
> \>\> Rich Lawlor: Mm-hm. Thanks for taking my question.
>
> \>\> Matt McCoy: I see from the operator that there\'s nobody else
> calling in right now. So we\'re probably safe to adjourn if you\'d
> like to do so.

\>\> Julie Gerberding: Thank you so much. At this moment, we will
adjourn the meeting and thank everyone for their participation and their
patience. Talk to you soon.