American Health Information Community

Biosurveillance Workgroup #8

August 24, 2006

**Disclaimer**

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

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

Okay, we\'re going to begin with a roll call of the Biosurveillance
Workgroup members and designees, then I\'ll turn it over to Chip Kahn to
make his opening remarks. Joining on the phone today we have David
Parramore from the Department of Defense, Edward Sondik from CDC,
Richard Heffernan is a designee for Dr. Frieden from New York City
Health Department. Leah Devlin from North Carolina Division of Public
Health. Mark Rothstein from the University of Louisville, Edward
Barthell is here for Brian Keaton from the College of Emergency
Physicians. Laura Conn from the Center for Disease Control. Brian Carnes
is in for Mitch Roob today from the State of Indiana, and Scott Becker
from the Association of Public Health Laboratories. Are there any
additional Workgroup members on the phone that I\'ve failed to announce?

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

This is Leah Devlin. I\'ll be here about 45 minutes, and Dr. Jean-Marie
Maillard is here with me and will continue on the call.

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

This is Chip Kahn, and we\'ll start. Let me say that \-- and I guess a
brief review of our call-in procedures. Our call-in procedures is
everybody is on the phone, the public is on the phone, and at the end of
the meeting the public will be able to comment.

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

Yeah, we have open lines for all the members to access.

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

And we\'ll have a give and take with the members obviously through the
agenda.

And we should probably go around the table here, just so that everyone
here is introduced. Why don\'t we start with \--

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

Yeah, I\'m Kelly Cronin from ONC.

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

John Loonsk from ONC.

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

Judy Sparrow, ONC.

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

Last meeting we went through a set of issues, and I would like to say
tentatively discussed and came to some priority setting. Let me say that
today, what I\'d like to do, to start off, is make sure that the group
is comfortable both with the priorities, and comfortable \-- and works
together to develop its common understanding of what the definition of
those priorities are, sort of what the substance is behind the words
that describe it, and \-- at least in general terms, and to have a
discussion, at least a preliminary discussion, of the scope.

I look at this process as sort of organic, or evolving. And I think
it\'s very important, particularly since we had I think some people on
the phone we had before, and there are some people on the phone who
didn\'t have an opportunity to participate before. I\'m going to just
lay out where we ended up in the last meeting, but I really want to
stress \-- and I think our agenda allows this \-- to re-adjudicate these
priorities.

I want to \-- I can\'t overstate that that last conversation was
extremely useful, and got us to some consensus, but I think in a
sense \-- and I hope to not spend too much time doing it unless there\'s
tremendous disagreement, but that we have an opportunity today to
re-adjudicate that so that no decision is made until it\'s made by the
group, and we haven\'t. So I want to start with that.

Second, what I\'d like to do briefly, before we open up, is just provide
my memory of the priorities. And then for the two top ones, I\'m going
to look to John to describe at this point his understanding of what the
\"it\" is behind the two primary areas that the last conversation
settled on.

So case reporting and bidirectional communications were the top two. I
think response management was next. And then there was a lot of
discussion around adverse event reporting, data aggregation, and
connectivity, but those sort of fell out lower. And what I\'d like to do
is get John to talk about bidirectional communications and case
reporting, and at least give his perception of where we were in the last
meeting. And then open up to a discussion of \-- and a measure to access
the comfort level of those on the phone, as to whether we want to begin
from where we ended last week, or whether we need to sort of go through
it all again.

But let me turn the phone over to John, let him describe it, and then
open it up to the group to decide whether we can proceed to the next
point, or we need to have another discussion about the items.

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

This is Ed Sondik. Could you answer a question for me, which is why are
we ranking these? What are we going to do with the ranking?

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

Well, at the end of the day I don\'t think we can \-- we have one, two,
three, four, five, six on the table. If we can\'t do all six, we\'re
going to end up I think doing one or two, and so the ranking is \--
it\'s not a question of ranking, it\'s the question to assess at the end
of the day of deciding on what are the two or three areas that we can
really put our focus on. So that\'s really the issue. I\'ll turn to
Kelly to comment, too.

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

Yeah, I think it\'s a really good question, and one we need to clarify
across all the workgroups.

We are looking at this as a priority setting process that will not only
focus the Workgroup activities and deliberations and recommendations
over the next several months, but also focus the work \-- at least used
to inform how the work goes along the contractors and the standard
\[indiscernible\] process, the NHIN consortia, and the Certification
Commission. Their priorities for the next year, in 2007, will be
informed by the priority setting that\'s done by the Workgroups in AHIC.

So I think that we need to think about this not only in terms of how
this could be impacting or prioritizing the standards harmonization
process and certification of software, but also how could we focus our
own activities so that policy considerations, architecture
considerations, operational issues, can be focused on by this Workgroup
over the next several months, so we can start to really focus and get
some momentum around some important or what we consider to be really
priority areas.

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

So \-- this is John. So having the priorities of this Workgroup brought
together with the priorities of the other Workgroups at the American
Health Information Community level, we hope to get a high-level road map
of areas of attention overall that many people have been asking for, and
also will help us plan out activities of the various contractors and
processes that Kelly mentioned.

So the discrete task here, it\'s a little hard to do, is to come up with
some chunk of work that could benefit from the attention of this working
group, benefit from thinking about potential recommendations that could
be made on that area of work, and to be able to describe it in a
discrete way so that it can be considered in this overall prioritization
process. And road-mapping process.

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

Does that answer your question?

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

No, in a way, it really doesn\'t. But maybe we really need to go through
it. And I guess the reason that it doesn\'t is I\'m not really sure in
this whether we\'re focusing on the particular critical component, or
aspects of it that are important in order to move this, for lack of
another term, biosurveillance field forward.

In other words, is it specifically case reporting that we would focus
on? Or is it the HIT aspects of case reporting, which in fact might be
very similar to HIT components related to adverse event reporting?

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

It seems to me your question is partly are we asking the right
questions. And in thinking about prioritization, you\'re then sort of
separating and saying, are we making a broad policy about where we
should be going, reporting, regarding sort of public health policy
versus just an IT aspect. And then we fall into the problem of
expediency, sort of like what we can do, and can do fast, or do within
the context of AHIC versus what we really \-- whether that is or is not
consistent with what we ought to be doing.

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

And I think just to add to that, that it is not \-- many of us are aware
of the fact that there are commonalities between some of the HIT
components of these different activities. And the Office of the National
Coordinator, for example, is very interested in trying to leverage them
off of each other, to make sure we have consistent infrastructure that
can support the broad activities.

It is a little hard to do that in every working group, and so we have to
have some coin, some way of describing an area for which the
functionality supported by health information technology can be
described, can be talked about, where policy issues can be referred to.
But it doesn\'t mean that it\'s not going to be considered in a broader
context, as well, it absolutely will be. It\'s just that we need to have
some coin that we can use to talk about it here, to talk about it at the
broader community level, and to try to get to a broader road map.

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

And if you remember, back to the meeting before the last one, we got to
this prioritization because I think we had a broad discussion of all the
different things we could do, and then we tried to categor \-- and then
I asked at the conclusion of that meeting that we sort of try to
categorize them or lump them in terms of what\'s sort of needed by the
public health community to do its missions, or what kinds of things
would be helpful, in light of our agenda, or I mean our context, which
is to help with the IT part of it.

So I think that\'s how we got to where we are, if I could reconstruct
that.

So it wasn\'t that \-- we had that broad discussion to begin with, and
we\'re not \-- and these priorities, or these areas, didn\'t just come
out of no place, they came out of a discussion of \-- from a policy
standpoint, what\'s important to public health. If I \-- I hope I\'m
reconstructing that right, but I think that\'s how we got to where we
are right now.

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

And I think, Ed, too once we get into the conversation today about a
working definition for these priority areas, we can start to scope out,
as Chip already referred to, what we really mean by and what we intend
to probably focus on in these different areas.

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

That\'s fine. I think we sort of have to plow into this, and one
possible \-- one thing we might want to do is combine some of these
areas. But that depends on sort of on just how they\'re defined. But
I\'m struck by the adverse event reporting, to me, seems to overlap \--
not overlap, but have many of the same elements as case reporting. An
example.

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

Yeah, I think actually, Ed, that I would suggest that we don\'t overly
lump like that. Because in fact adverse events reporting might have more
in common with secondary uses of data in other contexts than it does
with case reporting. Unless we have that granularity, it\'s going to be
hard to overrationalize more of these things together. And some of that
spans this working group. So at least we have to have that description
of detail, you know, if things are lumped, that you can at least tease
them out and consider them.

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

Let me suggest, understanding all the issues you\'ve raised, why don\'t
we go to John, and let John try to explain where he thinks we were on
those two issues. And then let\'s open up whether \-- well, we\'ll
probably end up discussing that, what he lays out. And then let\'s sort
of go back to the priorities just for a moment, to see whether we need
to sort of reassess everything before we go forward, to try to define
which area \-- define the substance. To sort of answer, I think,
hopefully, your questions, Ed.

So John?

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

So I do think that at the last call-in before that we had talked about a
lot of things, and so these are not air-tight descriptions, by any
means. But I\'d like to just touch on some of them, and then touch on
sort of where borders may be. Because I don\'t think we really defined
those borders well.

So starting with case reporting, the area here is \-- there is a
substantial amount of activity that goes on in public health at the
local, State, and national level around reporting on notifiable
diseases. It\'s usually done by law, a State law that\'s requiring
clinicians to fill out certain amount of information on the disease when
they see it.

The system is traditionally paper-based. There has been some efforts in
the National Electronic Disease Surveillance System and other areas to
develop ways of making that electronic, which could include developing a
Web system, for example, where you \-- the clinician would input those
data, or a public health person would input a disease report.

The disease reports themselves are \-- are different, depending on the
State, that the Council on State and Territorial Epidemiologists works
in conjunction with the CDC and other groups to identify nationally
notifiable disease reports, and that are shared at a national level and
published in the *MMWR*, the CDC publication. The system also
traditionally lags behind, it\'s not a very quick, fast system, it
is \-- but CSTE is responsible for defining \-- working on the case
definitions, and determining what is a \-- and working with the CDC, as
I said, to determine what is a nationally notifiable disease.

That\'s one part of case reporting. That\'s sort of the more routinized
part. But when there is an emergency there is great focus in a
particular area on collecting good quality case data on how many cases
of that there are.

During the anthrax attacks, clearly there was a focus on how many cases
of anthrax there were. Where they were. And collecting at least the
generalized case report, so that one could, usually by lab confirmation,
but determine that a case was indeed present.

And taking that as another example, during some of the exercises that
public health goes through around emergencies like top-off, or
top-officer emergency training, where all levels of government are
involved in trying to work through an emergency event, there can be
thousands of these case reports that then need to be exchanged and
shared and worked and considered and confirmed, and reported on so that
people know the extent of what the problem is, know where it is, know
how it\'s spreading, and can take response actions to try to minimize
the morbidity and mortality associated with that.

So really, at a high level, a well ensconced system for notifiable
disease reporting manifest in law, manifest in a system for national
reporting of those and sharing of those data, and then more of the
emergency response activities.

Clearly, some of the things we were talking about in terms of
biosurveillance were \-- there\'s overlap in the data between, say, an
emergency response or a case report.

For some, the holy grail of informatics has been considered to be
getting a clinical care setting to report a full disease report, fully
populating the entirety of the disease report, to make a fully
legitimate case report from electronic clinical systems.

No one I think sees that as an immediate outcome. It\'s still a goal
that some people have, but it involves bringing together many different
data types. And you can sort of look at some of the biosurveillance work
that we have been talking about, as getting clinical care data
surrogates for disease information.

I guess the other thing to say about case reporting is that not
infrequently the lab result is done by a public health lab or sometimes
by a clinical lab, is \-- is a substantial portion of that disease case
definition. So not infrequently, when you have the right lab test
result, that can act as a reasonable surrogate for at least the
initiation of a case report on \-- for like a communicable disease.

Borders of this include mass casualty activities, whether the system is
largely \-- notifiable diseases is mostly about diseases, communicable
diseases, and there\'s also the \-- in the emergency preparedness
there\'s also the case of chem and rad issues around mass casualties,
and obviously mass trauma is another consideration. And then from there
you can sort of go into traditional disease \-- traditional registries
of injury that are \-- and other activities that are used in more
routinized fashion around events. When there is a mass, a large event,
there\'s usually a registry effort that follows it.

So after 9/11 in New York, a registry activity surrounded the \-- those
who were exposed, the emergency responders, and their exposures to the
dust and particulate matter and just \-- so you know, there\'s also a
time sequence, the time between registry activities and reporting.

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

John, we can \-- are those divisible between \-- and you just described
one in your example \-- something that is either episodic or related to
some event or occurrence, versus what you described I think as
traditional, where \-- you know, whether it\'s I guess it\'s been \--
certain kinds of venereal diseases or other things that, you know, that
may be outlined in State law, and obviously CDC is interested in, that
are just routine, we report it, reportable. And in the architecture, one
of the things that this could lead to is that when we talk about the
specifications for ultimately for the certification of EHRs, I don\'t
know how \-- I\'m not quite sure how to deal with, easily, with the
events side.

But with the routine side, you could have in the EHR, at a minimum, some
requirement for things that are routine that \-- you know, a flag comes
up and tells the doctor he\'s supposed to do something. Which he or she
should know anyway, but may not.

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

I think it is helpful to talk about the routine and the emergency
separately at times, but it is important to do so recognizing that in an
emergency you don\'t want to be inputting new \-- developing new
infrastructure. You can\'t do it during the emergency very well. And so
even though the emergencies are periodic, they need to be considered as
routine \-- from a routine infrastructure side.

The other thing to say here \-- because \-- in response to one of your
comments, is huge amount of this, if not the overwhelming amount of
this, relates to daily activities that local and State health
departments do in different contextS as well, whether it be a food-borne
outbreak, and following up on that, and managing the outbreak, and
trying to track it, doing traditional epidemiology and determine what
the source was, determine what the cause was and minimize \-- you know.
So the things we talked about in biosurveillance and the great amount of
work that\'s in there for local and State health departments to do
around an outbreak, a lot of this is core to that. Not necessarily the
notifiable diseases, but sometimes some of these other related
activities.

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

I was only separating them because I think the issues regarding criteria
certification around one are a little bit different than the other. Then
the question is going to be do we envision, in however these systems
work, that there\'s some kind of two way communication that would allow
for things to be picked up on the first \-- but what you\'re arguing is
whatever the architecture, it\'s got to anticipate both if it\'s going
to be useful.

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

I think it does, and there are many examples where when something
happens, take SARS for example, at the outset you don\'t have a defined
case. Or what the case report fully is is not yet defined. You\'re
aggregating some different data together. Eventually, it becomes \-- if
it\'s prominent, indeed one thing, it becomes a reportable disease. But
it takes awhile to work through that process, and you need to \-- public
health needs to understand the disease immediately if they\'re going to
be able to respond to it and understand the parameters of the outbreak.

And then the other issue is here is just that no one has ever viewed it
viable to have two systems, two \-- an emergency system, and a routine
system, and that the emergency systems, to function, need to be used
almost every day, people need to understand how to use them and use them
as a regular part of their regular workflow. That\'s why the construct
has always been tools used in the consideration of this \-- the
infrastructure, so that it could \-- used every day for routine
activities, but can sustain the dynamic and testing aspects of an
emergency as well.

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

John, this is Ed Barthell. I just want to second that, because working
in emergency environments, I can guarantee, the more chaotic it gets,
the more people fall back to their routine. And all the systems we\'ve
been trying to push for, they have some component that becomes routinely
used, and you can always have a dynamic component that just kind of
leverages that routinely used system. But I completely agree that you
don\'t want to have things sitting on a shelf collecting dust and then
expect people to know where to find them during some kind of chaotic
event.

So what characterizes this one, then, even though we haven\'t talked
about the others, is the focus on the individual person, and their \-- I
don\'t know, the health characteristics of this person, right? The
transmission of that.

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

I would say it\'s usually \-- you know, you can think of a case report
as a token of discussion here, because there\'s a formalism around what
they are. They are, I think, almost uniformly person-centric, but there
are several data parameters that are considered in constituting a formal
case report in a routine fashion. You really strive for as many of those
as you can get. In an emergency sometimes you\'ll take what you can get
in terms of helping to populate that and make that determination.

But it is \-- you know, a case.

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

Or a reportable event.

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

A reportable event.

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

Right, I got it. But on an individual, I guess that\'s what I was
focusing on, and not necessarily the demographics associated with the
individual, but something having to do with their health state.

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

Okay, so it\'s a little broader than that, because, you know, frequently
there are vectors involved. So sometimes the \"it\" is \-- you know, and
this perhaps is \-- the \"it\" could be a white envelope, or an envelope
that has a white powder in it, and then you have to organize around
that. Who had exposure to it.

Sometimes the \"it\" could be a rodent that was shared at a \-- these
are all real examples \-- rodents that were shared at kindergarten
classes that had communicable diseases. And so the \"it\" of it, in
terms of tracking it, is not \-- you know, you develop subsidiary cases,
but you also have to track that vector.

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

But. But, then we get into scope. Because in terms of getting back into
what the AHIC can do for us, the things you\'re describing need to be
done, but I\'m not \-- they may be out of scope.

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

Agreed.

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

I almost thought you were going to say a rodent shared at lunch. I was
eating \-- I was a little turned off by that, I want you to know.

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

Rodent before lunch. And then it was all over their hands when they went
to lunch. I\'m sorry.

Here\'s a better example to try to keep it in scope. More in scope. An
airplane as a site where people may have been exposed to a disease, and
you need to track those who were on the plane who may have had that
exposure. And they\'re not cases at that point, you could call them, you
know, possible cases for exposures. But it\'s just \-- it\'s a little
broader.

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

On to the next one.

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

Okay, bidirectional communications. I think this one means several
different things potentially as we were talking about it and as others
have talked about it.

One thing it means to some is \-- is just \-- is sending information to
the clinician from public health, where \-- so the bidirectional comes
from the second direction. Instead of the reporting and report burden,
information dissemination piece, which can include at times e-mailing
alerts, it can include e-mailing of \-- it can include collaborative
technologies which are used for more discussion-like exchange. It
potentially can include Web pages that are either secure or publicly
available to disseminate information, and all permutations in between.

There is \-- the other thing that at times it means is to provide
information on the basis of the data that are collected by public health
to the clinician, to assist them in decision-making. So if the clinician
knows whether the flu has shown up in their region, that is useful for
them in the context of making clinical decisions about treatment in that
context.

So that\'s another component of it, of the bidirectional communication
piece that I think is talked about not infrequently in terms of making
the public health data accessible to people in different regions in ways
that support their public \-- their clinical care activities. You could,
I think, and we have, taken this at times to the point of even
potentially, you know, advancing public health algorithms that could be
instituted in clinical care decision support environments, where the \--
you know, disease prevalence or reminders about prevention activities
would also be integrated into the health \-- into the clinical care
environment, or into personal health records in the context of
accomplishing public health outcome.

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

The way I at least, in terms of \-- the way I think about this, although
I\'m not sure whether \-- what the entity is, I sort of think about
this, like the role Symantec or McAfee play. They\'re like watching all
these viruses, and if you\'re hooked up on the Web, then it gets \--
then they send you a notice, or you\'re checking in, and you pick it up,
and so you get information. I mean, in the case here we\'re talking
about information, in the case there you\'re talking about
underlying \--

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

It\'s a \[indiscernible\] information.

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

It really could be done in the same way, and you could require vendors
to have such a function, if they\'re going to be providing certified
EHRs. That\'s the kind of thing we do here.

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

That\'s one part of it, but there also have been systems at local,
State, and Federal levels where there\'s a need to communicate to
clinicians in a rapid fashion, and where there are not accessible
registries of e-mail addresses, for example.

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

I guess what I\'m saying here, though, is that the EHR and the advent of
it offers a new portal. So the question I would sort of \-- I think we
need to think about when we get into a discussion of this, is are we
talking about maybe taking other existing modalities and trying to make
those work better, or are we talking within the context of what AHIC is
mostly focusing on and making those adapt to the needs? And that\'s just
something we\'ll have to discuss.

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

Right. Just to add one more aspect to consider as we get more into our
conversation. I think in terms of safety alerts or coming up with
directories for e-mails for those alerts, there\'s applications beyond
traditional public health, and I think \-- for example, at a SIM
conference a few years ago there was an interesting example brought up
in Nebraska where they sent out an e-mail to all nephrologists about a
recall of an ESRD device that was timely and relevant and urgent to
public health, but it was really more a health care issue, and in
particular important to FDA.

I think we need to think about perhaps some examples as we go through
the scope discussion.

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

And the pharmaceutical industry for example has great interest in being
able to communicate product recall information this way instead of the
FDA. And there are some interesting areas there where probably more
could be shared.

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

Going back to my virus example, if you had an EHR for your entire
practice, and we did the scan and the information came in, then it could
put up a red flag on every person in your \-- you know, that got that
prescription.

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

That\'s right. That\'s right, and that was done, or has been done.

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

Should I talk about response management?

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

Well, I guess those were the primary two. So I guess before we go \--
John has a desire. You can talk about it, John.

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

This is Leah Devlin, I just have a quick question. They all said that
case reporting and bidirectional communications, which is what we\'ve
been talking about, were the top two?

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

In the last discussion they were, but \--

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

I look at these rankings, and it looks to me like connectivity between
public health was the highest ranking. And it had the lowest score. I\'m
just wondering why we\'re not talking about that.

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

Well, let me say that one we had \-- and it\'s unfortunate \-- we
re-ranked \-- this was the original list, and then we ranked it, and we
discussed it, and at the end there was a consensus around.

But I don\'t want to tie us to that consensus if people want to break
out of it.

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

I think we really need to review that here.

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

But that was where the \-- everybody voted, but then we sort of talked
about it, too. So if there\'s discomfort with those conclusions \-- with
our sort of conclusion from that meeting, then, you know, the phones are
open, we can re-adjudicate it.

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

I also thought that we had this \-- around that one, perhaps, we had the
least clear connection about what we were talking about, there were at
least two things being described, and that might feed into further
conversation. One was sort of common infrastructure around connectivity,
which could support a variety of different functions. And which \-- but
doesn\'t follow the functional description we\'re trying to get to,
here.

But then the other one was just data exchange between public health
organizations, and that that is an area that I think is about \-- very
much about case report \-- exchanging case data. Exchanging, you know,
biosurveillance data in appropriate ways and, you know \--

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

I just \-- I guess my other question would be \-- and maybe Ed sort of
really brought this up, maybe it\'s implied in his questions at the
beginning, is, you know, sort of what\'s important as a public health
function, and how would you look at these lists in that context.

And then \-- or, what\'s important in terms of this list vis-à-vis the
agenda and possibilities of things that can be done in the context of
the AHIC. And I\'m not sure that those two questions will get you to the
same answers. I mean, you could argue that connectivity is like the most
important thing, but it may not be something that we can deal with well
in the AHIC context.

And I think that may be one of the reasons that we ended up where we
did. But as I said, I don\'t want to \-- I don\'t want to stop the \-- I
mean, say that\'s definitive, that was just a preliminary conclusion.

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

Yeah, perhaps we do need more of a discussion around \-- and a common
agreement about what we mean by connectivity between public health
entities. Because we could \-- there is a possibility where we could be
thinking about the NHIN or existing health information exchange
infrastructure as enabling the connectivity, so that there are ways we
could \-- if we could clarify our thinking, we could revisit how that
pertains \-- or how that relates then to the other priorities.

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

And let me also say that under bidirectional communications one could
actually put connectivity in some way. Depending on how you defined it
and what kind of scope it had.

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

I think it\'s also a good reason to \-- to eventually talk more about
response management, because of the substantial overlap that has with
ongoing clinical care activities in treatment, prophylaxis, and related
areas.

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

Leah, could you say what you think you\'d want to see happen through
better connectivity between public health entities, and perhaps that
would allow us to focus a little bit.

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

Well actually I\'m okay with \-- I don\'t want to rework the work of the
last committee meeting. So I think that connectivity between public
health entities \-- that\'s Federal, State, local, that\'s State to
State \-- I think that you can include that in one and two, and that we
just need to be clear about definitions.

But I just don\'t want anybody to think \-- and I don\'t think anybody
does \-- that we\'ve fixed all the connectivity between public health
entities.

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

This is Ed Barthell. I guess my sense is connectivity between is \-- is
not really a function of public health, it\'s the coordination between
the State, local, and regional public health authorities that we\'re
trying to accomplish with all these other functions. It\'s more of a
concept that we want to intertwine into the various functions, how we
define the systems that will be utilized to address those functions.

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

Certainly those seem to be a very prominent need in the previous
discussions.

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

And let me say, too, in the other \-- in the recommendations that have
already been approved by the AHIC, and in the working of that other \--
that \-- are we calling it a Workgroup, the signing on the
particular \--

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

The Steering Group, yeah.

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

The Data Steering Group, in a sense they\'re going to be focused, but
they\'re going to come up with certain things that we want looked at.
And integral to that is going to be the connectivity, when those pieces
of information are reported. Between the public \[indiscernible\] I
mean, obviously it\'s only a piece of this, but we\'ve already dealt
with connectivity at least in a limited fashion already.

I can go through the list of people. Does anybody \-- where does \-- let
me just ask the group, do we need to have a discussion about the \-- and
Leah was bringing up the one. Do we need to have a discussion about
these other items, or can we proceed with talking about the scope for
the items on the table? I guess I just \-- how do people feel about it?
If there\'s silence, we\'ll proceed. If there\'s not silence, obviously
we\'ll listen to whoever makes a point.

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

This is Ed Sondik. I was impressed with John\'s discussion or overview
of these two. I think spending a few minutes on at least some of the
others would be useful, because I felt that the priority setting at the
last meeting didn\'t exactly leave me with a feeling of the wisdom of
the group, so to speak.

And I find this extremely useful, though.

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

Let\'s do that. Let me ask a question of the group before we do it, and
I\'ll return to the point I made a moment ago in terms of what the group
feels is our mission. Is our mission to meet the most urgent needs along
these lines of the public health activity, or \-- and the trouble is
these aren\'t too exclusive, but they\'re a little different \-- or is
the criteria for our decision whether or not the areas that we decide on
fit into the context of the AHIC, in the sense that something could
happen by the work of all the consultants, and the process of the AHIC,
that would actually help this area change or improve. Based on putting
it on the agenda of the AHIC.

I think the two \-- I mean, they\'re not mutually exclusive, but they
really are different criteria. And I just want to make sure that
everyone is comfortable, because I would make the proposition that our
role is the second, is to decide within needs of public health, that we
work within the context of what the AHIC is generally doing, to make
sure that within the AHIC agenda we\'re doing the best we can for \--
from important public health areas. But everyone may not agree with
that, and I\'m just offering that up. But I think we have to have some
way, some criteria. Otherwise it\'s hard to debate \-- I mean, you\'ll
get into a different debate as to which should be where.

So how do people feel about that proposition?

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

This is Rick Heffernan from New York City. I agree with that. I think
there\'s lots going on out there in all these areas, and our challenge
is identifying what recommendations within the AHIC context can make a
difference. That\'s sort of how I interpreted your second point.

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

That\'s right.

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

And I \-- for me, the concrete examples that we heard today, we heard a
few in the last call, I think we need more of those to start getting our
minds around this. I\'ve been trying to communicate the discussion to
people internally here, and I think it would be helpful to have more
concrete examples of \-- I think as Kelly put it, aspects that can be
enabled through health IT.

And our discussion has been sort of more general, but I think we need
some more specific examples of recommendations we can make that can be
enabled through health IT, and make a difference in public health.

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

Okay. So I guess what I\'m hearing, then, is if we went down each and
just \-- and I\'ll sort of look to John to visualize. If he could
visualize under each what would be an example of something that
would \-- could be affected by AHIC kind of policy, that would \--
let\'s say with adverse \-- I mean, I just wonder if we should go
through each \-- to sort of meet Ed\'s objective of sort of going
through each.

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

Yeah, and I think you actually teased out two issues that are related,
but also slightly different. One is what can health IT do, and then the
other is the constraint within the AHIC recommendations, what \--
because what can the suite of processes do in the context of HITSP and
the NHIN, and generally the things that the Secretary can do in the
context of that. Maybe those aren\'t completely separate, I just wanted
to name them both. I think health IT is changing many of these
processes, and it\'s good to think about them in that way as well. In a
much more general way, which is what I was hearing Rick sort of was
talking about. But so those are just two facets of that.

So what would you \-- would you like to further discuss the different
areas?

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

Well, and maybe I\'m putting too much burden on you. If we went \-- I
guess Richard put sort of a set of \-- he described what you just
described, sort of this. And I guess to meet those criteria, what\'s an
example that anyone could pose. Let\'s \-- and we already sort of talked
about them a little bit with bidirectional and case reporting, so why
don\'t we focus on the others just for a moment so we can envision \-- I
mean, envision what it would mean that the AHIC could do, so that we
could decide whether that\'s something that maybe we have not
prioritized that we should.

I think that\'s the discussion that Ed wants to have.

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

Fine. I do think it will be worth revisiting case reporting and
bidirectional in that context.

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

Sure. I just want to get those on the table and come back to those.

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

Sure. So response management, the general area, most of the case
reporting and a lot of the bidirectional communications, a lot of
surveillance activities, are inherently focused on doing something about
it when you see it. And knowing what \-- and then the classical response
activities of public health fall into certain categories.

Some of it is just information, sharing information, whether that be
prevention behavior, but some of it falls more concrete into traditional
means of treatment, prophylaxis, whether it be vaccination or chemical
prophylaxis, isolation and, slash, quarantine, whether that be forced or
voluntary. And at times taking something off the market, or other
activities that could be removing the threat.

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

So actually as I hear you again, the question is if we all \-- whether
it\'s a priority or not, we can all agree that bidirectional
communications of one type or another probably fits in an AHIC context.
The question is beyond the bidirectional communications aspect of
response management, are there other things in the IT area that we can
visualize response management. Or does it get into the other kind of
functions that you\'re describing that need to be done, but there are
lot of other ways to do that?

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

But in fact there are IT opportunities in those other areas. And one of
the problems is, going back to emergencies, is when there is an
emergency what \-- first of all, a lot of these activities occur on a
day-to-day basis in public health, in public clinics, in clinical care
settings, in terms of vaccinations in doctors' offices. This is a
transcendental activity. But when there\'s an emergency frequently the
considerations change. So taking an example of an emergency, when there
was a shortage of flu vaccine and there was a need to consider how to
apportion that on a national level, health IT actually helped, and a
system was developed to help State and local health departments
understand what vaccine they were going to get, when they were going to
get it, and helped them work to deciding where that would go, and
address the mal-distribution of the existing vaccine.

So here\'s a \-- you know, vaccine is a common thing, usually occurs in
the clinical care setting, but during an emergency it can be very
different. Similarly, there is a pharmaceutical stockpile, it has a
variety of different treatment and prophylaxis and other resources in
it, and in an emergency there\'s a need to distribute those things.
There are some who think \-- who say that, you know, in that emergency
you\'re just going to throw them out there and people are going to come
get them, and in practice actually it\'s more complicated in that. In
every emergency we\'ve seen, there have been heavy data management needs
associated with that kind of distribution.

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

That gets back to the issue, Kelly said a second ago there\'s always a
scramble. People do have e-mail addresses now, that offers such an
opportunity, rather than telephone numbers. But it seems to me that
beyond the opportunity \-- I\'ll go back to \-- I\'m stuck on this a
little bit. Beyond the bidirectional communications that theoretically
EHRs might provide, if vendors are required to meet certain standards
about ongoing communications between some sensors and the providers that
are using the EHR, what else can we do?

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

Well, I think they\'re \-- I think it is more complicated than that. For
example, although though there is a stockpile, the majority of
prophylaxis is in the commercial sector and in the supply chain at any
given time, and the pharmaceutical industry has that information.

And actually, in the flu vaccine shortage there was a critical need
to \-- you know, Santa Fe was outstanding in terms of working with
public health to recognize and work with some information that is
potentially commercial proprietary information about supply chain. But
to use that for public health purposes, because that\'s where the
vaccine is. It\'s in the supply chain, it\'s in the systems that they
have. They know where it is, and if you were going to try to get it out
and effective, in public health outcome, you need to know where that is.
There\'s a huge supply that\'s also publicly funded in vaccines for
children program, and a lot of infrastructure.

Some of these are dedicated \-- these are systems that serve specific
functions, but need to be reconsidered in the context of a public health
activity at the time of that emergency. Or, better still, reconsidered
in that possible emergency function so you can anticipate it and get a
better infrastructure in place.

It\'s not just a question of only getting information out to the
individual clinician.

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

I understand what you\'re saying, I\'ll just be \-- I\'ll get off the
point, let me just do it one more time, though. In terms of what the
AHIC can do, not in terms of the \-- you\'re describing things that
ought to be done, and there are all kinds of information systems that
drug companies have about their supply, and everything else. But what\'s
the AHIC going to do regarding \-- in our criteria, in our certification
criteria, what are we going to do that would affect their systems?
Unless I\'m missing something, I don\'t see it, unless we want to \--

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

Well, standardizing the data exchange associated with a lot of vaccine,
such that when it\'s distributed, whether it be in a routinized way to a
hospital, or distributed to public health, or public health emergency,
those data can immediately be exchanged between the appropriate systems
so that you can effect a potential outcome, would have a significant
effect on the industry.

So you know \--

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

It\'s like \-- it\'s not only you need product identification, which has
been \-- you know, accelerated through recent regulation, but you could
be looking at that more broadly to a broader set of biologics or
devices, in addition to the interoperability between maybe registries
that exist and NHIN. But that would all stem from a use case that would
spell out all the processes involved in response management, and in
particular, highlight what the Workgroup would feel would be
particularly important to the value to public health.

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

So take during Katrina, I think one of the very positive stories to be
told was the fact that because there was a degree of automated
immunization registries for children, when there were evacuees, they
were displaced, those data were available and could be shipped to their
new locale. So that they knew who had been immunized to what. And in
that kind of \-- you know, it\'s not just a routine issue at that point,
when you put people in tight quarters you have very significant problems
potentially with some of those diseases

I think that\'s another example. And the data are not always just needed
by clinical care, at times they\'re needed by public health to effect
response.

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

And this all may be \-- you know, as we finish our discussion, you know,
about how HIT or \[indiscernible\] relate to these areas, that may be
number 10 on the list. But if we\'re just trying to describe more
discretely what exactly a recommendation from this group could result
in.

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

Okay, have we sufficiently described that, and can we go to the next one
or are people requiring a little bit more? I\'m just going to ask people
on the phone.

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

I thought that was a good discussion.

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

Which one do you want to go to next?

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

Data aggregation. I thought this feeling of the group was that this had
a lot of overlap with what we had been talking about. And I didn\'t \--
you know, I must say I didn\'t fully understand how to differentiate it.

There are \-- you know, data aggregation is a critical functional \-- a
critical activity necessary for a lot of these things. It\'s certainly
an issue in terms of privacy and confidentiality, but I didn\'t
really \-- and you know, you can sort of \-- I have a mind view of data
being aggregated many different points, because public health actually
gets carried out across the spectrum of activities.

But certainly, there are data that are aggregated at all levels of
public health necessary to accomplish these things, and data aggregation
is kind of \-- inside of clinical care settings could be increasingly
valuable in the context of more real-time public health prevention,
surveillance activities, as well.

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

I think it was maybe a more discrete example, there has been some
preliminary work done on trying to aggregate data from electronic health
records for the purposes of data mining or signal detection for drug
safety.

So that\'s one sort of discrete example of how you could be aggregating
data from existing software or data sources, and doing data mining for
probably a variety of purposes that could be looking for new case
reports, or notifiable diseases, or an adverse drug event.

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

And you have exemptions. From HIPAA, so you actually could do it.

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

Yeah, but here\'s part of the complexity here, too, you know, the
notifiable disease reporting system is not where the heart of most
public health is carried out. I\'m not saying it\'s not important, but
that there is a tremendous amount of surveillance that occurs across a
wide variety of different activities.

And it\'s sometimes hard to anticipate what those data will be, whether
it\'s a product that malfunctions and causes disease, or whether
it\'s \-- you know, a new collection of symptoms that \-- and so, you
know, there are \-- public health people sometimes do surveillance in
very specific \-- or a lot of times, in very specific areas to carry out
a particular investigation or activity. And, you know, there are just
thousands literally of examples that can be made in that regard.

And so in the context of that, you know, data are important to public
health in general, but there are, you know, these ongoing issues about
how they\'re used in other contexts. And even with the public health \--
how public health is enabled in HIPAA, in fact, there are still lots of
HIPAA angst \-- HIPAA anxiety issues. Certainly of public health
authorities and just general concern about aggregating data that
regularly impact public health activities.

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

But I guess \-- let me be rigid again. But in terms of the context of
the EHR, or the personal health record \-- but the personal health
record will \-- the EHRs, the question is obviously a lot of the
ways \-- we\'re not going to define public health, here. I mean, the way
they do business. We\'re just saying there is now or there will be, with
the proliferation of EHRs, a new resource that can provide information,
at least theoretically, in a different way than was provided previously.
So I think the question in data aggregation is, in going to the farming
issue that Kelly raised, is that something that we want to think about?

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

It\'s a good question, and I think that in many ways what needs to be
done to advance part of this would be to implement structured
terminologies in electronic health records to make the data mining and
analysis more robust, because natural language processing is not a
perfect solution.

But that means looking at SNOMED and structured terminologies in
general, to figure out how quickly can we advance the implementation or
to require through certification the use of structured terminology, when
it could actually hurt adoption in terms of the burden it might place on
providers.

That\'s really a global issue that impacts this and many other things,
like clinical decision support. So I think what we could \--

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

And product clinical measurement support

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

Absolutely. It has so much utility, but when you balance it with
adoption, it becomes much more tricky.

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

However, you could say in this area that my presumption is that there
could be some fairly simplistic and quantitative pieces of information.
That if you ignore HIPAA for a moment, and under bidirectional
communications, you could \-- I mean, if you\'re just looking for, you
know, white blood cell counts or a few other things, you could do this,
and it wouldn\'t get in the way of the \-- other than somebody might not
like the fact that there might be somebody coming in and doing the data
mining, other than that, you could \-- it would not necessarily add any
burden to the people that had the EHRs or the health professionals that
had to use the EHRs. If it\'s very simplistic stuff that\'s going to be
there anyway, and it\'s quantitative, rather than qualitative.

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

So we\'d agree on an early set of structured terminologies that would be
most meaningful to public health, perhaps? That wouldn\'t be overly
burdensome to \--

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

The issue I think is the getting of the information, not \-- you know,
and that may be \-- that may be a big hurdle, not the existence of it,
if it was simply quantitative information, that any record would
have \-- I mean, whether it\'s \-- if someone is in the hospital,
whether it\'s \-- you know, a temperature or a blood count or whatever,
those are going to be quantitative things.

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

Right. Right.

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

Let me just take that to an extreme, because I think you could also
differentiate what you\'re saying, which is in biosurveillance we\'ve
been talking about making use of clinical care data for public health
purposes, but not really impacting it.

At the extreme, if you take a case report, there are some who would
suggest that it would be great if an EHR, if it smelled a possible case
report, would pop up a form that you would fill out that would then, you
know, force you to make that case report. Let\'s just state that.

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

That\'s what I was thinking.

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

But there\'s an intermediate space that I thought you were talking
about, which was how could we influence the extant clinical data so it
can better be used strategically for public health purposes without \--

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

That\'s what we were just talking about. But when we were talking a few
minutes ago about the traditional reporting, like venereal disease or
whatever, that\'s where I thought \--

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

But there are two approaches \--

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

It\'s automated \--

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

Let\'s just differentiate. Let\'s say that it\'s a tuberculosis case, or
let\'s say a case report, communicable disease. There\'s two ways
potentially of doing it. One is it smells there may be a case report, it
pops up a form, and the clinician has to fill out that form.

The other is where, by virtue of data that are housed from many
different systems in the clinical care setting, the lab result, the
clinical care data, and the other part of the case report are
automatically constituted into that case report as a substitute for the
clinician having to do it.

Those are two different things \--

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

I\'m sorry, as a substitute \-- could you say it again?

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

So in terms of \-- what public health would like to have is a
well-formed case report. There are two ways of getting there. One is to
try to get the clinician to fill out that public health form, and it
could be done electronically as part of the EHR, when you want to force
it, you know, when you think they need to do it.

The other is more of an automated process, whereby inside of the
clinical care setting, the different data types could be brought
together to make that report without the clinician having to do it. So I
just want to name those two things, I\'m not trying to \--

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

And I think those are questions that, one, we can\'t really answer right
now. Those are the kind of questions that I think would \-- in our next
work, assuming those areas fell under our priorities, that we would have
a discussion about. And it seems to me that at the end of the day
you\'re going to have an issue between what law and tradition requires
versus workflow.

But the thing about law and tradition is that they can bitch about it
being in the \-- you know, that form coming up in the record, but they
knew they had to fill out that form if in a paper record they saw the
person had tuberculosis. So \--

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

But in fact, the reporting is very poorly accomplished now.

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

Right.

**[\>\> JEAN-MARIE MAILLARD:]{.underline}**

This is Jean-Marie Maillard, I\'d like to add something from our example
in North Carolina. I was a little uncomfortable about naming the \--
what we have as our early event detection system, as aggregation,
because I felt it was misleading. And going back to what John was just
describing, it\'s a fairly flexible system that allows us to do
surveillance for new events or conditions that we need to rapidly start
doing surveillance on.

Which we can do that with the early event detection system, because we
just make a new filter on \-- and granted, it\'s just on the emergency
department patients, but we cannot do that with the case reporting
system, which is kind of set in a much heavier manner, and people only
report what\'s reportable.

I think the case reporting is still very interesting in the sense that
with added laboratory results reporting, that\'s fast and broad
coverage, so that\'s very valuable. But in our experience in North
Carolina, we\'ve been able to do a better job, for things like SARS,
like evacuees after a disaster, on the fly, and it takes us very little
time now to be able to do that. I just wanted to put that in.

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

I think that\'s very helpful and it sort of shows the transitional
possibilities for some of the secondary use. As opening up other
opportunities, as well.

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

Let\'s go through the whole thing, and then see \-- 

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

Just briefly, to finish up our conversation of the existing priority
areas we started with, critical components as we initially described
them, for adverse event reporting and patient and product safety, I
think in many ways that the existing systems suffer from some of the
same problems as case reporting, where it\'s predominantly manual, it
requires clinicians to recognize that there is an adverse event, whether
it\'s a nosocomial infection or a medication error or adverse drug
event, that they need to actually use their clinical judgment and take
time to complete a form. Sometimes it\'s electronic, sometimes it\'s
not.

So the big problem here is that there\'s a severe amount of
underreporting. There are some \-- some data suggests that as many as,
you know, 10 percent of adverse events get reported, but that\'s really
never been confirmed.

So the idea of what HIT could enable is similar to what we were just
discussing. We could actually down the road see algorithms built into
electronic health records that would automatically link a certain
condition that is suspected, or has a biological basis, to be an adverse
event to a particular exposure. Whether it be a drug, a biologic, a
device, a vaccine, or perhaps it follows a sort of a known sequence of
events for a nosocomial infection. So that data could be automatically
perhaps prepopulated into an electronic adverse event report. That could
then be perhaps shared with clinicians so they could use their judgment
and look at the temporal sequence, look at the biological basis, look at
potential causality, and then make a determination about whether or not
they think that it is worthy of submitting to a public health agency.

Or, you know, something around those lines could happen. I think in
general there\'s potential to improve automated reporting in some
fashion.

There\'s also a lot of other aspects of patient safety more globally
that could be enabled, but I think much of it is covered in the other
categories that we talked about.

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

Any discussions? Okay, so we\'ve gone through the list. And sort of
dealing \-- what I\'d like to do is just sort of outline the way the
Workgroups have worked, generally, and then the understanding is \--
because I think we do need to, you know, fish or cut bait here \-- is
that you come to a working consensus, which is our opinion, our
position, a decision we\'ve reached, our recommendation. And that it\'s
accepted by the group as a whole, and we have general agreement and
accord with it.

And I guess I\'d like to review \-- we\'ve now gone through all five.
One of the things that is clear to me from all five \-- I\'m sorry, all
six, is that there\'s tremendous interaction between all of them. So I
was struck by bidirectional communications actually being an
underpinning of all the \-- almost all the others. I guess not
necessarily the connectivity between public health entities, but other
than that, at least in terms of some functions.

And it really led me back to \-- and I\'ll be \-- my rigidity. And let
me be rigid for a moment, and see whether there\'s a consensus around my
rigidity, which is that whichever areas we decide in a few moments to
pursue, that it\'s done within the context of what at least we perceive
the AHIC might accomplish, considering that the kind of entity it is,
with basically having this consultancy and work being done to support
the certification \-- the criteria for and certification of EHRs. And
not that there aren\'t other side projects, but that basically is what
we\'re about. I\'m looking at Kelly and John to make sure that\'s
correct.

So with that being understood, one, can we accept that as a context? And
if it is, then I\'ll go back to the issues and sort of say okay, now, if
we accept that, how does everybody want to come out on these items.

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

I think you can encapsulate a lot in terms of the end product being
certification of the EHRs, and inducing potential functionality,
interoperability, and security. Which is the tenets of that. And that
would include inpatient and ambulatory care EHRs. I just would like to
also \-- and maybe we get at this with the interoperability, but maybe
not \-- introduce that an outcome here could also be impact of the NHIN
as an initiative, and that maybe is a little broader than the EHRs,
because it could include data flows, and connections, and ways in which
public health activities can be fostered as well.

So I would just make the friendly amendment that \--

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

And we\'ll accept that.

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

Confidentiality as well, given the new group.

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

I\'m sorry?

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

Shouldn\'t we also include confidentiality in that? Given that it\'s a
new subcommittee, or whatever we\'re calling these groups? When you said
security \--

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

Security and confidentiality, sure.

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

Thanks, Ed.

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

Okay. So with the friendly amendment, with that as sort of the
underlying principle, then going back to adverse event reporting,
bidirectional communications, case reporting, response management, data
aggregation, and connectivity, I\'m going to make a proposal going back
to what I think Richard sort of implied. Which \-- and maybe just sort
of meet Ed\'s concern.

I\'m just going to \-- bear with me a moment. I\'m going to propose
that \-- the proposition that maybe what we ought to be about is not
going through the process that Ed was having problems with, of
prioritizing each of these. But instead, to assess the aspect of each of
these that we could recommend that would fall within the context that I
laid out.

And I think if we did it that way, sort of think about it as a matrix,
it actually narrows the scope to something that we might be able to work
on.

And the reason I offer that up is because I guess I\'m really stuck on
this point, that the notion of bidirectional communications becomes the
underpinning of so many of the others. Now looking at John, and he\'s
not going to agree to that, but I\'m just throwing that out, and let\'s
see \-- for discussion, and let\'s see what you all think.

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

I\'ll jump in. This is Ed Sondik. I think that\'s a very good idea. I
actually was drawing a matrix as John was going through these. And I had
something approximating the dimensions, if you will. I had something
related to standards, taken broadly. Then enhancing emergency health
records, or EHR \-- not emergency health records \-- electronic health
records. I put in incentives, I actually thought the AHIC could do
something recommending incentives. I thought linking the sectors was
really interesting, talking about prescriptions and so forth. Statutes,
we could also recommend laws, et cetera, where necessary.

But I actually think \-- I actually think you\'re right on with this,
and I think you put your finger on really what has troubled me about
this. Is that I see aspects of these that are very similar. I mean, if I
had to pick the three to me that \-- where I think we could concentrate,
they\'re in adverse event reporting, bidirectional communication, and
case reporting. And I think the others are kind of, for lack of another
term, derivative. Or they relate to that, to those three, in a \--
whatever issues we deal with, it seems to me, with those three, would
also have impact on the others, as well.

But I must say, I really \-- this appeals to me, the way you\'ve
proposed it. That we pick out specific aspects of these that the AHIC
can concentrate on.

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

I just want to \-- glad you were saying that, Chip. I think it\'s great
to focus on certification of EHRs, I think that\'s a very important
part. But I agree with some of what Ed was saying, I do think there are
some other things within our reach here that we can effect, and I just
wanted to name a couple of them. One of them is \-- to take your
favorite, bidirectional communication, is actually a communication
between the public health system and a clinical care system.

And to have a communication, you need to standardize both. Both sides of
that. And so it is important to note that actually public health does
not immediately have a certification group that, outside of the CDC,
that certifies public health systems. And I want to point that out.

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

IT systems.

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

IT systems, right. So if you need to have both sides standardized, it is
important to think about standard terminization in the context of the
kind of HITSP work that is being done, because there\'s not an analog to
that, that\'s just for public health systems. I\'m not trying to suggest
that public health should have a separate one, but I\'m just naming that
it\'s not there. And the certification that has been considered in
public health has been via programs started by the CDC. But that\'s
not \-- and I will say that they involve local and State authorities in
that, but it\'s not the same as having an independent body that does
certification of public health systems.

So I think those are examples. Ed\'s examples of regulatory impact,
suggestion, there are some other things that we can consider in terms of
outputs.

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

Let me ask a question, as an aside, to Kelly. Ed brought up the issue of
legislative recommendations, because some of the things that we\'re
talking about now could be outside existing authorities. Is that \--
this is just a question, I want to make sure we\'re \-- is that within
the scope of the AHIC process, to make recommendations of need a change
in laws to accomplish A, B, and C?

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

I don\'t think we\'re prohibited from going down that path. I think
essentially the work has to decide on what are the enablers of what we
want to accomplish, and if in fact there\'s a lack of clear authority in
either the Public Health service act or in State statute to enable
automated reporting, for example, then that could be a recommendation
that Congress investigate this, and look into it.

So I don\'t think we\'re prohibited. I mean, again, this is an advisory
committee to the Secretary. The Secretary cannot take action on
legislation, but at least it raises the issue.

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

That\'s good. So I wonder if we\'re accepting, with the amendments, the
model, I guess I\'m \-- we then in a sense are into the matrix.

And I\'m thinking out loud, here. I mean, we can go on discussing it,
but I almost wonder \-- I\'m wondering out loud, primarily to Kelly \--
I almost wonder whether if the group agrees with the criteria I laid
out, as amended by John, and looks down this list, whether it almost
would fall back to you guys on the staff to think through a proposal as
to what would be the workable things to put along the other side of the
matrix. And then for this group to come back and explore that and
examine it, to decide whether or not \-- because in a sense, it becomes
almost project areas, I guess. Whether that\'s what we want to \-- where
we want to go.

I mean I\'m just \-- we\'ve really \-- I mean, a lot of examples have
come up. I think now that we\'ve had this discussion some of the members
\-- I guess Richard, you mentioned that you went to your staff. Now that
we\'ve \-- if we sort of approach it the way I\'ve suggested, then you
all could explore that, too. And then we come back in the next meeting
and look at these areas to make a final decision on which of them we
want to sort of jump into in terms of project time and workgroup time.

Does that make sense? I mean, I hate to put things off, but I think
we\'ve \-- in a sense today, I sense that we\'ve moved towards sort of a
new structure. And we\'ve clearly laid out, I think, criteria for that
structure. But when you get into the specific \-- and we\'ve laid out
some examples. But at some point we\'ve got to say, well, these are the
five things that we want to \-- that we\'d like to focus on.

And I just wonder whether we in this conversation can start from where
we are, we almost need to have somebody go back and think about what
we\'ve said and recreate \-- and create that. Does that make sense? Does
that fit with what you want to do?

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

It\'s really what you all want to do is what we want to do.

But I would just like to revisit what Ed proposed, that the top three
categories are perhaps seemingly the most tangible to the group at this
point. But I guess I\'m asking the group to \--

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

What I heard from Ed, although the last item that John said may throw
back connectivity between public health entities back in, in a sense, if
you think it\'s within our scope to have some kind of certification of
information systems \-- public health, then obviously connectivity could
be part of it, because coming up with criteria for IT would obviously
have the support for connectivity. And communications.

So I guess what I\'m \-- what I heard Ed say was not limiting it to the
top three, but looking at each one, and then deciding what discrete
project area under each would make sense for us to explore. So that
we\'re not \-- in a sense we\'ll end up setting priorities around
discrete project areas that we think we can get into within the scope of
what the AHIC can do and within the time and limits we have, rather than
trying to decide we\'re going to do case reporting versus connectivity.

So that\'s where you are, Ed, right?

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

That\'s correct. I really think that these things are related, and
they\'re related in terms of exactly what you said, that there are
elements that cross them, that are contained in each one, that we could
work on, or recommend that the AHIC in general focus on.

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

So what we\'re saying is these are all important public health
functions. Instead of trying to prioritize public health functions,
we\'re prioritizing within the context of what AHIC could do, things the
AHIC could do that are supportive, or would aid, or provide tools or
whatever, for each of the public health functions.

So that\'s the limiting thing, is what is within the AHIC\'s purview
that would be relevant there. And then once we \-- let\'s say there are
10 things along that other axis. We may in our next meeting have to say
well, gee, those are all 10 good things, but we just don\'t think we
have time and the energy to get into John\'s favorite of certifying
public health \-- we may decide we would \-- but public health IT.

I\'m just saying so that \-- and I think that will be easiest for us to
decide, because \--

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

Or bidirectional communication.

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

Right. Right. But then we can \-- then we\'re making a decision, though,
on things that we can\'t \-- you know, that we can decide we can do
within our scope. And then that way we\'re not limiting public health
function, because all these overlap.

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

I think that makes a lot of sense. I am a little concerned that
without \-- you know, some of the next steps that we were envisioning
for the working groups was more thinking, more testimony, more
discussion on some of these focused areas. And I think we do have a
pretty good tool set. And it would certainly make sense to go through it
at an initial level and, if you will, gain the system a little bit to
think about which would have the most impact from the \-- given the
immediate tool set.

But I think there are things, if we think about these long enough, that
we\'ll come up with that we could make recommendations on, that could be
substantive in every one of these areas.

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

Right. We could sequence them throughout the next year.

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

It\'s a tension of those two things.

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

As I hear you though, I guess I\'m wondering whether we ask you all to
go through the exercise and take the examples and things, and we create
the matrix. And then what I\'m also hearing you say, though, is that we
don\'t necessarily want to limit ourselves to \-- there may be other
things on the axis that we\'re missing. And so I guess what I\'m
wondering is whether we went through \-- whether for the next meeting we
not only \-- you not only created that axis, but we did it \-- we
sequence it in such a way that those on the phone would have time to
take those materials and think through, as Richard said he was having
his staff do, what other things should be on the axis. And we could
distribute it to however you distribute things, and ask for the
public \-- I mean the entities to respond to us, and collect
information. And we would just \-- we would use what work the staff
would do as the beginning point.

And the discussion would be around these discrete items. And yes, some
might be added, some might be dropped. And then we probably then have
that discussion at the next meeting, and I would argue then we
shouldn\'t set priorities in the next meeting. We might have another
meeting to account for all that discussion, and then \-- is that too
many meetings?

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

The only pressure we have right now is in terms of the NHIN consortia,
the Health IT Standards Panel, and the Certification Commission \--

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

What are my dates?

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

That\'s it. In 2007 we need to give all these organizations a heads up
in what they\'re going to have do in the next year, so we need
priorities to transfer to them that\'s going to actually allow for
people to do the heavy lifting and drafting the use cases.

We were hoping to get that done this fall. Which means we need to \--

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

Let me ask a question. If \-- and it may not be possible. Is it possible
to have a meeting in September, which would mean the work I described
would have to be done enough before the meeting that people on the phone
and those not on the phone would have enough time to look at it and
scratch their heads and decide whether they would add things?

And we have that discussion in September. Actually \-- and then let\'s
say we could even have a meeting the next day. We could have a meeting
over two days. Have a few hours one day, and go over our lists, have all
that discussion. Then next day come back and let\'s say we just do it
for an hour and a half or something, but say we\'re going to have a
discussion the next day of the members of the Workgroup and we\'re going
to go over the discussion of the previous day and we\'re going to try to
hammer out a consensus of discrete areas that we want to go through.

If we could do that in September, then we move ahead from there. Would
that give you \--

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

I think that would be great if we could try to accomplish it in
September. I guess I\'m also thinking if we \-- just from a process
perspective, try to get that matrix out with some discrete potential
projects or examples as, you know, HIT enablers, so to speak, that we
could perhaps allow enough time for people to noodle on it and add their
own ideas, and then come to the meeting really with a pretty good idea
of what their a priori prioritization might be. And try to hammer that
out in a four-hour session. Only because we have seven of these public
meetings going on each month, and our schedule is getting very
complicated.

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

We could make it a long meeting, then.

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

I think you\'re right, though, that the more we can do \-- separate out
the prioritization from the thinking about this, and some of that can be
done electronically.

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

Because I\'m a little concerned \-- I guess my concern is we want to get
all the good ideas on the table, and if you try to do both in the
same \-- I understand your constraint. But if you try to do both in the
same day, I mean \-- it could work. We could try it. I mean, I\'m game
to try it. And maybe we could do the following, which is we say we\'re
going to spend \-- we\'ll take four hours, we\'re going to spend two and
a half or three hours on the matrix. And at the end of that time, we\'ll
come up with a new matrix.

And then for that last hour, we will \-- I\'m just being arbitrary here,
obviously \-- we will discuss our initial prioritization of that matrix.
And then we can say we\'re then going to go \-- and I\'ll sum up that.
And then we can say look, we\'re going to give everybody a couple more
shots, but we\'re going to do it all by e-mail, because we had the
discussion. And then we go by e-mail, and have votes like we did here.

And I think they\'ll be easier votes, because it will be more discrete
things that we\'re setting out. Because I understand, I really
understand now Ed\'s initial concerns.

And then we\'ll try to hammer it out, you know, maybe one wave of
e-mails or two, and at the end I\'ll just say this is what appears to me
to be the consensus according to the way we come up with consensus in
these workgroups. And if anybody really, really objects, we\'ll \-- you
know, press the red button. But otherwise, we would then proceed.

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

I think as long as we do that \[indiscernible\] publicly since we\'re
under FACA rules, right?

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

Exactly, we\'d have to come back and talk about it.

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

Where are we right now?

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

The 21st of \[indiscernible\] I think that allows a good three to four
weeks.

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

Does that give you enough time to do \--

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

Yeah I think we could wrap up our end of the matrix and give people, the
public at least two weeks to think about their own ideas, and vet it
internally to the extent they need to.

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

You said the 21st?

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

1:00 to 4:00, or make it 1:00 to 5:00?

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

I think we ought to make it 1:00 to 5:00. I\'ll move my 5 o\'clock call.
And I think \-- is that agreeable with everyone on the phone? That we
proceed that way?

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

That\'s okay with me.

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

Makes sense.

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

Yes.

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

Obviously we have tremendous resources on the phone, and I think if we
can get this out there \-- I think the other thing we\'ll need to
decide \-- and maybe, Kelly, you and I can talk about it \-- is in order
to make that really work well, it seems to me that we get your document
out, and if it\'s out early enough, then we ask people who want to come
back \-- Workgroup members, that want to come back formally with other
suggestions, that if they could come back prior to the meeting, and
maybe we set some kind of deadline, then that could be added to what we
have on paper that day to discuss.

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

That would be great.

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

Right, public documents.

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

Right, and that way we would at least have it all arrayed for the
discussion. You know, and obviously \--

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

Set some tentative dates. I mean, I think we could shoot to get
something out no later than September 6th, and if people could get back
to us by the 18th or 19th, that would allow us \-- actually no, we need
to post information on the Website. So I guess if we it got out by the
6th and back by the 14th?

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

Can you do it by the 15th?

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

Oh, sure. Sure.

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

I think you need to give people at least 10 days.

I almost think on that one, why don\'t you figure it out and we\'ll let
people know, but let\'s \--

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

We\'ll follow up by e-mail.

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

We will say that we will do the best we can to give you as much time as
we can. But I think it\'s really important to get this \-- and that we
really \-- we do need to fit the criteria obviously of all the
requirements, and it\'s going to help us all if we can array it. If
it\'s arrayed prior to. So people can think about it.

And I think that when you prepare yours, if you could put in some
criteria as to what a discrete project \-- how it should be described,
or how \-- so if people offer others, we have some definitional stuff so
they at least make it apples to apples with the kind of projects you put
up. I think if you can do that in that e-mail, that would be good.

So just to review, then, what we\'ve agreed to is that basically we\'re
working on the major public health functions that we\'ve identified
within the context of how the work of the AHIC can best service,
support, those areas. And we\'re going to \-- we\'ve asked the staff to
prepare a model set of discrete projects that would be AHIC-appropriate,
that would fit under each of these items. We\'re going to get that out
early enough for all the Workgroup members or their organizations to see
whether they would develop other discrete projects that they think
should be on the matrix.

We\'ll get those back hopefully early enough that we can then array
them, so that when we have our discussion on the day \-- on the 21st,
we\'re going to go through all those items, and have sort of a full
discussion of them, and then hopefully those will be arrayed in such a
way and discussion will be full enough that we can then in the last hour
or so begin to set some priorities.

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

Can I ask you just one clarification?

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

Yes.

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

To be anal-compulsive. You said projects. By projects do you mean
specific aspects of the six components that we\'re currently looking at,
or new ideas, if you will? The way I took it was there are specific
aspects to policies.

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

I think it\'s \-- well, I think we have agreed that the six are the
functions that we\'re looking \-- we\'ve been talking about.

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

Okay.

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

It would be the toolset we have. What could be done to effect outcomes
on those different areas.

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

Right, and since we\'re going to be doing a matrix there may be some
that would affect the \-- you know, it might affect bidirectional event
reporting, it might affect a number of them, and I think actually some
of the things that have been suggested would.

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

I think that\'s great, that\'s fine.

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

And Richard, I think we\'re trying to do what you were trying to do with
your staff, which is actually \-- I mean, we\'re visual \-- the staff
will help us visualize what we\'re actually going to be talking about,
here.

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

Yeah I think that sounds good.

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

Okay, well, if that\'s okay, then we\'ve got a plan and we know how
we\'re going to proceed. And I really appreciate all the work that the
staff has done to get us to this point. And I guess we sort of turned it
a little bit, but I think this is going to be something that the AHIC
can digest. And we can digest it as a Workgroup.

Does that cover everything?

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

I think so. I just wanted to also give folks an update, that this
Biosurveillance Data Steering Group has been convening throughout the
summer, and just had a good all-day meeting on Friday. And they are
planning to update this group during our meeting on September as to
their progress. And I think they\'ve come a long way, and are going to
start sort of in a feasibility assessment process now.

But I think there will be two chances for you to keep up to speed in
detail on what they\'re doing. This upcoming meeting in September, and
then again when we meet in October. I think we\'ll at that point
hopefully \-- at least they\'re shooting to have some draft
recommendations that we can all give feedback on, and there\'s a goal
then to make some final recommendations on October 31 to the Secretary
and the AHIC.

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

Thank you. And I appreciate everybody bearing with us through this
process, I think we\'re obviously all trying to see how we can best fit
in, and I actually think we\'ve had two good \-- really good meetings to
get us to where we are.

Are there any other comments from the Workgroup itself before we go to
public comments?

Hearing none, let\'s go to the public input, and then we\'ll conclude
the meeting after that.

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

Okay, the phone numbers for public input are up on the Web, we\'ll give
it one minute for people to get through, then after that we will leave
an e-mail address up to submit comments and questions that way.

It doesn\'t look like we have anybody calling in.

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

Okay. Well, that being the case, we appreciate the public helping us
getting our meeting completed. And if there\'s no objection, we will
adjourn until September 21, with the plan being set pretty clearly on
staff\'s responsibilities, and our hope that the Workgroup will come
back with more good suggestions, and we\'ll do our prioritization at the
next meeting. Thank you.