American Health Information Community

Biosurveillance Workgroup

February 24, 2006

1:00 p.m. EST

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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.*

\>\> OPERATOR: Mr. McCoy, your line is open. Please go ahead.

\>\> MATT: Okay, Dana, go ahead.

\>\> DANA: Hi, this is Dana Haza, and I\'d like to welcome everyone to
the Biosurveillance Work Group on this Friday afternoon. We will begin
with roll call and I\'ll begin with who is here at the HHS Building. We
have Rick Friedman and David Parramore. Matt, who do you have? Oh, and
John Loonsk.

\>\> MATT: We have Gavin O\'Brien, who is sitting in for Edward Sondik
today; Michael Barr; Larry Biggio; Timothy Smith; Adele Morris; and we
have both our Co-chairs, Mitch Roob and Dr. Gerberding.

And the only change we are making: for workgroup members who were on the
call last time, we started out with muted lines and people had to queue
up. This time, everybody in the workgroup has an open line, so if you do
want to speak, you just need to chime in. We only ask that when you\'re
not speaking, you keep your phone muted, and you introduce yourself
before you say something.

\>\> DANA: Matt, thank you. And as a reminder, only workgroup members
should be speaking on the call, or their designee if the workgroup
member cannot be present or needs to step out. Also, we\'ll invite
audience input at the conclusion of the call. With that, do we have
Mitch on the call?

\>\> MITCH: Yes.

\>\> DANA: Hi, Mitch. And Laura, it\'s my understanding that Dr.
Gerberding will be joining us in a little bit. Is that correct?

\>\> LAURA: That\'s correct.

\>\> DANA: Okay, great. So with that, Mitch, I turn it over to you to
begin.

\>\> MITCH: Well, thank you, and I do have to step out to a meeting here
in just a little bit, but I have Jeff Wells with me, who has been
working on this, so he\'ll be here in my absence.

Really would just like to thank all the folks at the ONC, who have been
working very hard to put together a lot of the preparatory materials for
today, and just to reiterate, as I did on the first call, the importance
of focusing on sort of the realistic attainable 1-year goals. We have a
lot to get through and, I guess as I said, focus on not letting the
perfect be the enemy to the good. I think I\'ll try and say that on
every call.

And with that, be happy to turn it back over to you, Dana, or whomever
else.

\>\> DANA: Okay. Kelly?

\>\> KELLY: This is Kelly Cronin. Thanks, Mitch, for getting us started.
I think that it might be helpful just to briefly review some of the
materials that were sent out for the meeting, so folks know what we\'re
going to try to accomplish today.

First, you probably all received the final scenarios. If Laura Conn is
on the phone, it would be helpful, perhaps, to start off by reviewing
those scenarios so that everyone knows that\'s the set of scenarios that
inform the analysis or the comparison across the biosurveillance
programs that we initially reviewed on our first call.

We then can go over the background paper that explains the minimum
dataset and the target dataset, based on those scenarios; then go over
the potential options for how data would flow from health care providers
on to local, State, and Federal public health agencies; and then go over
some of the issues around anonymized data and how to ensure privacy and
securities; and then move on to the discussion around the scope of this
breakthrough and consider what we might be able to accomplish, both in
the near term and then as we move forward, based on existing programs
and what we know about various activities going on across the country.

And then finally, we would like to address some sort of overarching
policy issues or barriers that we see in order to fully understand what
we need to address as a workgroup over the next year to make sure that
we can have a successful implementation of the breakthrough project.

And then, if time permits, we can recap on what we\'ve discussed and try
to get some confirmation or validation on what we think a reasonable set
of preliminary recommendations are that will be presented actually to
the Secretary on Monday afternoon, so we have a very tight turnaround.
Unfortunately, out of the four workgroup meetings this last week, we are
the last up, and that presents us with a challenge of trying to get some
information synthesized very quickly and turned around for the Secretary
on Monday.

But luckily, I have to say that we are a well-organized workgroup, and
so far, we have been able to make good progress, and I think we\'re
well-prepared to have a really good discussion today and come up with
some preliminary recommendations that will be meaningful.

So with that, perhaps I can turn it back to Laura so she could go over a
brief review of the scenarios that, again, inform the analysis and
determination of what a minimum and target dataset could be.

\>\> LAURA: All right. Thank you, Kelly. This is Laura Conn from the
CDC. And if you recall from the last phone call, we decided that perhaps
one approach to going about determining what the minimum dataset should
be for this activity was to talk about what different scenarios we might
be needing to cover in the biosurveillance area.

So we took a stab at a couple of scenarios, sent them out for comment
and input, and then took the input from all of the workgroup members to
put together the scenario document that you have. And I\'ll just run
through the high-level business scenarios, and then we can answer -- or
ask and answer questions if there are any.

So 1.1 is Identifying an Event; 1.2 is Confirming the Existence of an
Event, and there are a couple of examples of the types of events that we
might -- or information that we might use in confirming an event;
Monitoring an Event; and Responding to an Event were the four
overarching business scenarios. And since you\'ve had a preread of this
information, I won\'t move through the details here, but could open it
up for discussion if there are scenarios that we have overlooked that we
should add, and then talk about how this has led to the identification
of a proposed minimum dataset.

\>\> BRIAN: This is Brian Keaton. Let me throw something out here at the
beginning. Can you hear me?

\>\> LAURA: Yes.

\>\> BRIAN: In 1.1, for Identifying an Event, you state, "Potential
event is identified using data mining or other methods." The majority of
events are actually identified by those other methods, and most of them
are through clinicians. The data mining usually isn\'t the way an event
is identified. It\'s either so big that it slaps us in the face and you
can\'t miss it, or it\'s a doc that realizes he has a case of anthrax.

So I think we may want to spell that out specifically and make sure that
we give enough credence and provide enough mechanisms for those
identification modalities to quickly feed into the system for
confirmation, other things like that.

\>\> LAURA: Thank you, Brian. I completely agree with you and was
actually surprised that we didn\'t have more, and maybe because it\'s an
obvious one; people didn\'t send that input in. But we can expand this
area to reflect your comment.

Other comments? Okay, hearing none, I\'ll move on to the next document,
which is the Biosurveillance Data Elements Matrix, dated February 21.
And what we did was pull together the data elements that were being
collected by the three systems that we heard about on the last call, and
also included the Frontline system that Dr. Keaton spoke about on the
last call as well, to give us a basis of -- just a sense of where some
of the systems are. And then we used that, along with the scenario
document, to drive to what might be a minimum and a target dataset for
this.

So this has "draft" on it; it\'s very draft. We pulled together this
information from a number of different sources and don\'t want to, in
any way, indicate that this is written in stone, and would be happy to
have corrections from those folks that are represented here if need be.
So this is just sort of a background document. I don\'t think we need to
go over this in detail, although it does allow to you look across the
project and also at the minimum and target. But probably the bigger
document, or the next item to look at, is the options briefing paper
that says Minimum and Target Data Element.

\>\> BRIAN: This is Brian again. One thing that I would throw in here,
as you look through this list, is to realize that an integral part of
our being able to respond to an episode that's identified is to know our
capacity. BioSense has a number of those data points and, quite frankly,
weren\'t that important to us when we did the Frontline's work, because
the capacity issue hadn\'t risen to the level that it is now. But we
would be very supportive in the emergency medicine community to be able
to not only tie the identification of an event, but also to be able to
tie it to the assessment of what is our capacity to respond to it. They
come from the same datasets.

\>\> LEAH: Thank you. Hi, this is Leah Devlin. And we\'d like to, at the
right time, maybe through the e-mail, just give you some feedback on
what data points that we are getting from the NC system, because this
isn\'t exactly quite right.

\>\> LAURA: Great. Thanks, Leah. I think we took most of this from your
presentation last time and obviously realize it was short.

\>\> LEAH: Right, we\'ll get that back to you over e-mail.

\>\> LAURA: Great, thank you.

\>\> LEAH: Thank you.

\>\> LAURA: Are there other questions or comments on the matrix, before
we move to the options paper and have a broader discussion of where this
work should go in this workgroup?

\>\> LARRY: Hi. This is Larry Biggio. I just have a general question.
You talked about identifying capacity response, and is that going to be
in some way geographically limited or qualified?

\>\> LAURA: I think that\'s the topic of another discussion a little bit
farther in our agenda, which is scope, which can be geographic scope or
elsewise.

\>\> LARRY: Thank you.

\>\> LEAH: This is Leah Devlin again. And maybe I\'m asking the same
question, but the way I have it framed is more about the role of States,
the role of cities, the role of CDC. Clearly, you know, the North
Carolina hospitals are reporting into North Carolina, and we can have
that conversation and have had a little bit of conversation with CDC
about how that data can be made available. But is it the expectation
that States -- major cities are going to be the primary lead on
biosurveillance, with CDC as backup? Because that\'s certainly not the
way that BioSense works. And so I think that a chart like this needs to
have a little more in it about roles and responsibilities.

\>\> LAURA: Thanks, Leah.

\>\> LEAH: You\'re welcome.

\>\> LAURA: I agree that this is a topic that we need to work out as
this workgroup moves forward. I think we\'ll get to some of these issues
as we walk through some of these decisions, including data flow and
who's getting what data when, and perhaps we can -- and other workgroup
members can chime in and -- about what responsibilities lie in -- at
what levels of public health.

\>\> LEAH: Okay, thank you.

\>\> JOHN: This is John Loonsk. I think it will be very helpful, too, if
we sort of separate out the issues of data from the issues of function.
And one of the things that would be useful in the scenarios is
potentially to further establish different functions as they occur at
different levels, because that\'s about business function and needs for
public health. And if we\'re not careful, we get the data flow issues
mixed in with business and response issues, and they\'re both important,
but both probably their individual discussion.

\>\> LAURA: I agree with that, John, and I think it was Brian that
mentioned the astute clinical provider earlier, and you know, we\'re
always going to rely on that astute clinical provider to pick something
up and pick up the phone and call -- an astute public health system. And
we\'re never going to be able to get a surveillance out of every private
doc\'s office. So I think that\'s another role clarification that we
need to talk about as well.

\>\> BRIAN: This is Brian. The other thing that comes out of that from a
function standpoint: I don\'t know about your hospital, but the first
thing that happens in my community when somebody knows there\'s a
disaster or potential disaster going on is, everybody in the hospital
calls out; everybody on the outside comes in; the hospital trunk is
dead. We have a separate line that links the emergency department in the
community, but I would think this also argues for the ability for public
health to communicate securely one to many in terms of asking for
information. And many being able to come back to the public health with
that two-way communication that should be part of the function of the
system that we put in.

\>\> LAURA: Thank you, Brian. I was just taking notes. So you\'re really
talking about person-to-person communication, not system-to-system
communication, in your latter comment?

\>\> BRIAN: I think you\'re talking about being able to -- for example,
if the problem that somebody has is manifest by spots on the face, then
a communication can come from public health after they have been
notified by an astute clinician or by BioSense or by whatever system is
there, that "We\'re concerned about the possibility of this; please be
on the lookout for patients with these problems, and if you do, notify
us back immediately," at which point in time the information comes back
to public health. A message comes back and says, "We are suspicious of
such and such problem. The next 10 patients that come with this, we want
you to get this additional test." And you have that message and can go
back and forth, the same as our kids do with instant messaging every
day.

\>\> JOHN: I think this is an important area -- this is John again -- an
important area of discussion and that we are clear in scope relative to
surveillance versus alerting or collaboration and communication
technologies and not diminishing any of them in their importance. We
have to, as we proceed with this, consider what is in the scope of this
breakthrough and what isn\'t, and what may be going on in other realms
that is applicable to those things as well.

\>\> BRIAN: My comment to that was the fact that about half the
emergency departments in the country are already using that two-way
communication in their monitoring of ambulance diversion and emergency
department diversion and those type of problems.

\>\> RICK F.: This is Rick Friedman with Centers for Medicare & Medicaid
Services. This is my first time with the workgroup. It seems to me that
the real issue is what\'s the right data elements, what are they to
collect, and the focus on what the minimum set is, then to having
understood the scope of the data set -- figure out who is in the best
position and how does it work, but to remain focused on the data
elements from the perspective of physicians and others that know this
stuff. And then we can go from there in terms of the next steps.

\>\> ADELE: This is Adele Morris at the Treasury. Let me just ask about
this focus on data elements. Is it important to get the tightest,
narrowest set of data element that\'s functional? I mean, what\'s the
marginal cost of an additional data element? Am I making sense? In other
words, ideally what you want is all the data elements such that the cost
of collecting it is greater than -- or is less than the benefit of
collecting it, right? So it\'s helpful in deciding the appropriate sets
of data elements to think about both the benefit and the cost of it.

\>\> KELLY: Adele, this is Kelly. You\'ve spoken like a true economist.
\[Laughter\]

\>\> ADELE: Well, that\'s my job here, I think.

\>\> KELLY: I\'m probably not of the best person to respond, but I think
that a lot of this proposed -- the proposed minimum and target dataset
were not only based upon ongoing biosurveillance programs that have been
created, you know, based on meeting specific public health needs, but I
think there\'s also a feasibility element to this. During one of the
preparatory calls of the Co-chairs, we had a discussion around
temperature, for example. It\'s not feasible to get some of these data
elements, like temperature, from some of the health care providers,
because it\'s just not available. So it\'s not so much of an incremental
cost in sort of an absolute term. It\'s more of a matter of, "Is the
data in electronic format, and then can it be provided in a standardized
way such that it could be well-utilized?"

\>\> ADELE: Well, I guess that\'s what I really need in this context. So
as we discuss, you know, the appropriate set of data elements, I guess
my basic point is that we want to have an appropriate balancing of the
value, the data, and the feasibility. But it sounded like you guys have
already sort of worked that out.

\>\> KELLY: Not entirely. I think that\'s part of the reason for the
discussion -- you know, to consider what\'s feasible and what\'s really
needed.

\>\> LAURA: Kelly, this is Laura. I think that\'s a great lead-in to at
least taking a look at the data -- the minimum and target data elements'
options briefing, because [\[inaudible\]]{.mark} information there the
first bullet is what\'s feasible to implement this year. In addition to
that, what accomplishes our charge? And we should probably take a look
again at our specific charge that says that within 1 year, essential
ambulatory care and emergency department visit utilization and lab
result data from electronically enabled health care delivery and public
health systems can be transmitted in standardized and anonymized format
to authorize public health agencies within 24 hours. So across all of
our discussions today, if we can just, again, keep that in mind.

Moving on, eliminate the significant barriers that must be resolved in
order to achieve this breakthrough.

And we\'ll talk a little bit more about those policy barriers in a
subsequent agenda item that will deliver value to the consumer and
leverages all of our stakeholders.

Those overarching principles in mind, if we can open the discussion of
the minimum and target datasets that are just proposed here and talk
about if we think these are feasible and if we think they meet the other
criteria that we just discussed --

\>\> ADELE: This is Adele again. Is this -- I would guess that the
feasibility depends -- varies a lot by what hospital system or other
health care provision entity you\'re getting the data from. So is it --
so are we thinking that -- in just understanding the term "minimum" and
"target," are we thinking that minimum -- everybody\'s going to at least
have to provide these things, and then that the target is, everybody for
whom it\'s feasible to provide these other things are going to do it?

\>\> LAURA: That\'s a pretty good description. Obviously, we -- what
we\'re trying to get in the minimum is the data elements that can
actually specifically point to the charge, in representing the elements
in our charge. Now, obviously, there\'s emergency department data that
is not in the minimum that would be nice, including some of the
vital-sign data. And some of this -- you\'re right; it does depend on
the information system and the particular data or clinical care setting,
and we\'ll have to work through that. But I think we\'re looking for
consensus on what it is we think we\'d like to see within the first year
and then with a target, if we can get it within the first year or moving
forward, to meet our broader charge of data that can help us answer and
meet some of the questions that we have before us for the functions of
biosurveillance.

\>\> BRIAN: And from an emergency department standpoint, I think it
doesn\'t collect ADT data (admission discharge and transfer) at the time
that the patient presents to the department. That provides you with
identifiers in terms of the hospital, the time -- the identifiers in
terms of the patient. And it also provides you with a narrative of their
chief complaint, which a number of groups, from RODS to New York, and a
number of different studies have been able to cross-walk to surveillance
systems.

Now, that data, I think, exists universally, and from what I understand,
most of it is fairly easy to get to. So I think that would be the
absolute minimum dataset that you would want to work from.

\>\> LAURA: Brian, are you suggesting that some of the data elements
proposed here we should potentially move only into the target?

\>\> BRIAN: [\[Inaudible\]]{.mark} with something that exists and is
doable and doable pretty quickly -- that, you know, RODS has been pretty
successful, as have a number of the other programs that have focused
their attention primarily on chief complaint. And the ADT stream is
where most of that comes from. There are consolidators in this country;
I think a large percentage of the country runs through the facility in
Melvern, PA, through the old SMS and now Siemens. You might be able to
intercept a large amount of that data which is going through there doing
registration.

\>\> JOHN: This is John Loonsk. It certainly is true that ADT and chief
complaint data are readily available. I think that\'s certainly why a
lot of people have looked at them. There\'s also, though, in that
consideration, a tilting toward, I believe, the initial detection
components of consideration versus some of the other components that we
have identified as being important for public health management of an
event, outbreak management, and response. And so I absolutely agree that
there\'s a need here to look at what\'s available, but my fear is that
the chief complaint data are ambiguous in their utility, in some
respects, and are largely focused on initial events detection in terms
of how they have been utilized and that it seems like the task here is a
little broader than that.

\>\> MICHAEL: Michael Barr from the American College of Physicians. I
hear what you\'re saying; again, my bias is also from small practices
and just symptom complex as a chief complaint. We could actually get
them to report a lot of that data via an Internet-based type of system
into this, as opposed to relying on electronic health records. And I
know it\'s a challenge in the small practices, but I think we need to
consider, in the minimum dataset, alternative pathways for those kinds
of practice to contribute to this.

\>\> KELLY: This is Kelly Cronin. I think one of the things we need to
go back to pretty consistently is our parameters within the specific
charge, because if we want to consider alternative methods of capturing
data, I think we need to be realistic in terms of what can be done
almost on a real-time basis and automated, because we\'re expected to
have data to be reported within 24 hours of the event. And I think the
only issue is that, as with a lot of voluntary reporting systems, at
least the Federal ones that we have a lot of experience with, when --
there\'s a lot of underreporting that you struggle with. So we may not
understand the extent of that underreporting if we are going to open
something up to perhaps a Web-based reporting system.

\>\> BRIAN: Kelly, I think the important difference here is, you want
all that background noise to disappear. What you want is, if you have a
clinician that says, "Hey, I think I have anthrax in my office," to be
able to make that report and make that report quickly, not to request
that every physician who sees a patient in their office report data on
that patient. I think that was the point that was being brought up.

\>\> JOHN: So that, then, is in the area of case reporting, or that\'s
how I would refer to it. This is John Loonsk. And that, again, then --
there\'s a whole separate discussion, important, about how to -- how the
process for electronic case reporting is becoming electronic. But, you
know, I was not sure that that was in the scope of this particular
breakthrough or not. I think it is a scope issue, but there is obviously
opportunity to talk about the notifiable disease-reporting systems, the
electronification efforts in those regards, recognizing that those are
dependent upon the clinician or a public health person initiating a
report. And I had viewed the scope of this activity as being more
narrowly focused on what benefit can be accrued from data that pre-exist
in health care settings.

\>\> LAURA: John, in fact, the charge actually does specify
electronically enabled health care delivery in public health systems. So
not to say that, moving forward in our broader charge, longer term
shouldn\'t include strategies of how to get the other types of data or
other mechanisms for getting other data in, but I think we probably do
need to stay focused on existing data that we can tap into to make use
in public health.

\>\> ADELE: This is Adele. On the other hand, when we discussed 1.1 in
our scenarios, I think it was Brian made the point that astute
clinicians are the ones most likely to identify the event. And we all
thought, "Oh yeah, that belongs in here." And so I guess the question
is, is it already electronically enabled astute clinicians? Or are we
contemplating a portal for those who don\'t already have PHRs as part of
this exercise?

\>\> RICK F.: This is Rick Friedman again. I\'m just wondering if we\'re
getting the cart before the horse. We need to figure out what is the
minimum data that we need, having gone through that minimum dataset with
various criteria. We can then figure out, is it available? And if not,
what\'s the penalty and what are the sources, etc.? But we have a
proposed straw man here in terms of the minimum dataset. I would propose
that we sort of stick to that, look at that. Under Institution Data, we
have four data elements. You can match that up against the matrix that
was put together in February 21 that shows the same kinds of elements
for New York City, North Carolina, BioSense, Frontline, etc. The issue
that pops out in my mind is that the first two elements are true in all
those cases and are available. The location, address, and number of
facility beds, however, are not in most of the other systems.

The issue, then, in my mind is, so these incremental columns that have
been added above the core set; how valuable and important are they?
Would clinicians and emergency room people, people who know this stuff,
believe that if they could get their hands on a location address, which
isn\'t apparently collected in some of these other systems, or the
number of facility beds -- those are the two that have been added above
and beyond the core -- how critical are those? And if they represent
something that people absolutely critically need to have, that\'s
important and ought to stay in.

On the other hand, if they say "Nah, New York City is able to figure
this stuff out," and not collect it, because they\'re only collecting
hospital system and main facility or North Carolina or Frontline, then
we can drop those and make it more minimum. We'd sort of stay focused on
the straw man and sort of go through this relative to what\'s the core,
what\'s incremental, what\'s the criteria, once we get the core set as
to whether or not we collect it.

\>\> LAURA: Thank you, Rick.

\>\> BRIAN: I hate to keep beating on this, but I\'m trying to
understand what we\'re trying to accomplish. I read the specific charge
of the workgroup. But as I understand it, the concept: that we wanted to
detect biologic events, manmade or otherwise, as quickly as possible and
respond to it appropriately to help us do that. Yet if we just do data
mining, we ignore the tool in our process. I think we\'re hamstrung. I
mean, how many biologic events have been identified in a reasonable
period of time by purely data mining? The answer is very few, and most
of them have been after the fact where it\'s existed for quite some
time.

The place that these systems really have their benefit is once there\'s
an identification --

[\>\> KELLY:]{.mark} Brian?

\>\> BRIAN: Yeah.

[\>\> KELLY:]{.mark} We thought we lost you.

\>\> BRIAN: No, I\'m here.

\>\> JOHN: This is John Loonsk. I\'ve been hearing a consistent theme
here about the importance of the subsequent -- that initial detection of
the event is not the place to focus, from a practical standpoint. We
recognize the fact that the clinician is the best detector that\'s out
there right now, and some of the data mining for initial detection is
potenti-- is an interesting area for additional work. But that we all
recognize the fact that clinician is still on the front line, if you\'ll
forgive the expression, and that their identification of the event is
the principal focus for initial detection.

I think that a lot of the consideration of these other scenarios around
what some people call situational awareness -- in other words, you know
an event is occurring; you need to know how big it is; you need to know
what -- how many people are involved, what locations are involved. You
need to be able to surveil the environment to see additional cases that
may not be diagnosed if it\'s, you know, an encephalitity and you
suddenly have some information that there may be something going on that
may not have been viewed in the clinical care setting as that problem,
because they didn\'t have the context for it. All those things speak to
having more information coming from the clinical sector for the
subsequent activities. Then you get to outbreak management and the needs
for, indeed, following up on those circumstances where there is
something significant and public health has to follow up. And then how
do you coordinate your response activity? So for me, there was a -- I\'m
hearing a lot of consensus around the fact that getting clinical --
pre-existing electronic clinical care data from clinical care sites is
not going to be the substitute for initial detection. But what I was
thinking the charge of this was intended to be -- and maybe that\'s
wrong -- was that these other uses of this data are very powerful, and
there are these recognized needs as per the scenarios that have been
addressed for establishing these connections, and there\'s an apparent
synergy between the work and the electronic health care -- health record
community, moving toward electronic health records and that synergy with
public health needs overlaps in this area of not mandating additional
reporting on the physician, but indeed on taking advantage of some of
the existing clinical data for these other purposes. And so, I mean, for
me, that\'s sort of where a lot of us are all in that same space, and
we\'re sort of feeling our way around what is the scope of this
particular breakthrough, and for me, that\'s what I interpreted the
scope to be. But maybe others could clarify.

\>\> LEAH: This is Leah Devlin. I agree with that completely. And I
think that we do need to go with what\'s available. We need to get
started; we need to get focused, as someone earlier said, on the straw
man; \[[indiscernible]{.mark}\] as we go, and the thing that this is
going to be available for in addition to the scenarios is the outlines,
and we don\'t even know yet. We\'re using even the dataset that we\'re
getting in North Carolina, which is 22 datasets for all conferencing in
our daily work in public health. [\[Indiscernible\]]{.mark} beneficial.
So I just don\'t think we have all the answers yet. So we\'re not going
to replace the person that identifies a potential anthrax case, picks up
the phone. That\'s what they\'re going to do in the private sector: pick
up the phone.

\>\> RICK F.: This is Rick again. I think it is true; the person picks
up the phone. But the question is, what does the person say once they
pick up the phone? What are the critical pieces of information that
would be useful to people up the food chain? And I think that\'s in part
what the dataset is about. It\'s really not related to data mining, but
what are the critical elements that clinicians ought to say in some way
that\'s consistent and everybody knows that's the core set of
information that would be useful in such event.

\>\> BRIAN: A lot of health departments have, for call-in and actually
for Web-based entry, traditional case report forms, which evoke specific
data reporting around a notifiable disease. And I think those data are
pretty well-articulated, and there\'s a good sense that when the call
comes from the clinical sector, or if they do have -- you know, get on a
Web page to do that reporting, that those data can be an effort to evoke
them. What Kelly referred to is unfortunately the norm, which is that
the great majority of that -- of the reporting of that does not actually
occur. And it\'s this initiation step, this volitional step of
initiating the report, that is so problematic, that so many efforts in
public health have been focused on, and so I think it\'s certainly -- I
think it would be a very useful activity for this working group to get a
sense, as we move forward, for activities -- related activities -- that
are in the area of alerting and communication and bidirectional flow,
and in terms of traditional case reporting, if you will, to
differentiate it, or the electronification of case reporting and efforts
in that regard. I think that would be very helpful to the group.

I\'m concerned about our immediate time frame of deliverable to the
community and that those things are related. It\'s important that we
work with them in moving this forward but are not immediately in the
scope of the task in front of us.

\>\> KELLY: Yeah, this is Kelly Cronin. I just want to sort of
reiterate, too, what the community already agreed to and what they
really told us our specific charge is, which is to really focus on
capturing the ambulatory care, ED visit, utilization, lab results data
from the -- an electronically enabled health care delivery process. So
we\'re talking about what data is out there that we can automatically
capture. So while I think, you know, we can revisit a lot of these
issues as we move on, for the purposes of trying to get some, you know,
consensus today on how we can define or better define our specific
charge, I think it would be good to just confirm that we\'re all in
agreement on how we\'re interpreting this specific charge.

[\>\> BRIAN]{.mark}: This is -- I\'m go along with that, just so long --
I felt it was important that you understand my concern that the actual
specific charge that we have doesn\'t necessarily accomplish what I
think was intended to be accomplished. Given that, I\'m more than happy
to take it through the list of data points.

\>\> MICHAEL: Michael Barr from ACP. I guess I didn\'t read
"electronically enabled" to mean electronic medical records, so maybe
it\'s my faulty interpretation of that phrase. I think Internet-based is
electronically enabled for many of our practices, and maybe that\'s just
where I\'m coming from in terms of the kinds of practices we represent,
the small and medium-sized practices that most patients get their care
at.

\>\> ADELE: This is Adele. What\'s the current status of case reporting?
Is it possible for physicians now to do case reporting over the
Internet?

\>\> KELLY: Adele, this is Kelly. It is possible for reporting to FDA or
various public health agencies who have case reports that are, you know,
Web enabled. But I think, again, we need to really focus on what our
specific charge is today, because we have a lot to accomplish.

\>\> ADELE: No, I know. I\'m just saying, well, you know, maybe that\'s
a problem that\'s already been solved. And so it\'s not necessarily the
case that if this group doesn\'t address it, that it hasn\'t been done.

\>\> KELLY: So in other words, whatever is happening now across local,
State, or Federal public health agencies is going to continue, and
really we -- what -- our activity is going to be complementary to
anything that's, you know, Web-based case reporting.

\>\> JOHN: Again -- this is John -- again, I would suggest that we get
an update. It would be a reasonable thing to get an update on the status
of that at a subsequent workgroup meeting.

\>\> ADELE: Yeah, I second that. Because, I mean, it strikes me as
reasonable: if it\'s not possible to do case reporting by Internet, then
that\'s not a good thing. And somebody, if not us, should do something
about it. But if I assume people are already working on it and it\'s an
empirical question what they\'re doing --

\>\> DANA: This is Dana. The one thing that I think that\'s important --
we can\'t change the charge at this point, and what the charge is is the
framework from which we need to move forward. So in light of that, why
don\'t we go on to the next point?

\>\> LAURA: This is Laura. Thank you, Dana. I think if everyone is in
agreement, we\'ll take Rick\'s approach of just trying to walk through
these data elements, and Leah, I\'ll ask you to weigh in, since we know
that we probably haven\'t captured all of the North Carolina elements
exactly right, and others, if you have experience of how these data
exist in clinical systems, to weigh in. And we\'ll just try and march
through here pretty quickly and move through our agenda.

The first few sections on the minimum and target list are to address the
part of the charge around utilization. And so there\'s information about
the institution, daily facility summary, and then census by unit. And if
we could get input on those elements, that would be helpful.

\>\> DAVE: This is Dave Parramore, Department of Defense. Number 4
there, the number of facility beds -- it\'s our experience at the DoD
and Iraqi Freedom: sometimes it was helpful surveillance to indicate the
type of bed, ICU bed, intensive care versus just the number of beds.
Because in that target, where you need to send our patients and what\'s
available in terms of the type of care --

\>\> LAURA: David, was that easily obtainable?

\>\> DAVE: It was. Yeah, we have systems in the DoD to track not only
the number of beds but the type of beds that we have. That's it. It\'s
really the transaction layer of data entry.

\>\> LAURA: So you\'re suggesting it should be in the minimum and the
target dataset, then?

\>\> DAVE: I would offer it just as a thought for the group. It
certainly -- as you look at surveillance, it might be something that\'s
helpful that as we not only look at the number of beds but what\'s
available in each community as we try to ideally suit a patient to a
bed.

\>\> LEAH: This is Leah. I have a question. It gets back to my earlier
question about roles and who is doing what. And it\'s really hard for me
to understand how we can REALLY have these discussions and make
decisions without that being part of it. Because, for example, in our
State -- it would be different in every other State -- we have another
technology system that gives us bed availability by type any day. But
it\'s not in our routine background surveillance. For
\[[indiscernible]{.mark}\] is for example. So that\'s what our State is
like.

Now, the next point for us is, we -- ours is only hospital emergency
department. The data comes through; we know the address, and we know a
lot about that hospital, because it\'s a hospital in our State. So if it
was going up to another spot without coming to us or didn\'t come to us
first, whatever, then I can see where people would need to have that as
a minimum dataset piece. That\'s just part of the framework I\'m trying
to visualize this in.

\>\> ADELE: I guess -- this is Adele. I\'m confused about the first --
the institution data in the sense that we\'re going to have a list of
entities that report, right? And we\'re going to know from whom we\'re
going to get data. So these would be -- there would be facility
characteristics that are pretty much held constant. They might be
updated. But I would assume that you don\'t need the location address
every time a hospital reports, right? So it seems to me there\'s sort of
fixed data and then marginal data. And you know, I guess --

\>\> JOHN: I guess my interpretation of that is that, you know, it\'s
obviously a complicated environment out there, and what this is
targeting is the minimum set of information that needs to be extracted,
and there may be circumstances where that gets mapped somewhere else.
But we have to talk at a cogent level about what data are needed for
public health response, and that that -- you know, you need to know
where the facility is. And that\'s why it\'s here.

\>\> ADELE: But then, I guess -- so what you\'re saying is, then,
separately you decide the frequency of reporting.

\>\> JOHN: I think that there are a lot of nuts-and-bolts issues under
the covers that need to be considered, and it\'s my interpretation of
where this working group should be -- is that it should be focused on
the conceptual issues, since this is a fairly pressing need, and
there\'s an opportunity here, as Secretary Leavitt views it as perhaps
the most pressing of all the breakthrough activities. And, you know,
from my own personal experience, I know that a lot of these data that
are available are not flowing to public health. And I know that when
they do flow to public health, they usually get in one level and they
don\'t flow appropriately to other levels to meet other needs. And so my
suggestion would be that we try to attack this from the standpoint of
the functional needs, and I think it\'s helpful to think at a data
element level to get a concept, but we can also leave some of the
specific nuts-and-bolts details to next-step activity. I mean, that\'s
my impression.

\>\> RICK F.: Yeah, John, this is Rick. I\'d go along with that. I mean,
I think the core set is to try to figure out what is absolutely critical
that we need to have. Second-level issue, once we arrive at the core
set, is, "Okay, how much of this is actually available in the current
systems, and are there other systems that can be tapped into?" But
we\'ve all agreed that, for example, location address, number of
facility beds -- if people feel this is absolutely a critical piece of
information to have, it\'s not as important in my mind that it\'s in one
system and not another so long as we\'ve agreed that we don\'t have
that. We\'re not going to have a complete picture at a time when we need
to have it. So we then need to figure out where it is and where we build
the bridges and all the rest of it. But the first question is, what\'s
absolutely critical? And if I didn\'t have that piece of information, is
that so important that it would do serious damage to my understanding
the situation? So I think the second level is to figure out where it is
and how we get it.

\>\> JOHN: I agree, Rick. I also think -- just to follow up on one of
the points you made -- that there\'s a push and a pull in this, and
it\'s very reasonable to look at what\'s available now and what can be
accomplished in the short term. But this is a real opportunity for
public health to potentially express the data it needs to accomplish
some of these functions, and there may be levers that can be used to get
-- to actually do work to get even better data out, and that we
shouldn\'t miss that push part of this as well, because these
opportunities will not come around frequently.

\>\> RICK F.: Yeah, we shouldn\'t be constrained by our current
limitations.

\>\> BRIAN: This is Brian. Just a practical question. The first section
on institutional data. \[long pause\] have all of their information
about them and their characteristics, their location, etc. attached to
that number. Do we need --

[\>\> DANA]{.mark}: Brian, you broke up in the middle of your question.

\>\> BRIAN: Let me try doing it this way. Can you hear me?

[\>\> DANA]{.mark}: Yes.

\>\> BRIAN: Hospitals have an identifying number, because they
participate in Medicare. And Medicare has the tables that have their
numbers of beds, their facility locations, and those type of things. Do
we need to collect more than their ID and just be able to link to the
Medicare table, which I would think would be pretty easily available?

\>\> ADELE: Certainly one possibility to explore. You know, there\'s
questions like "How often is that updated?" and yadda yadda, but we can
take that as a next step to explore. I mean, I don\'t think what you\'re
-- that we\'re at a disagreement about what these key elements are, that
would be needed to help drive us toward utilization and this institution
data. I think we\'re now sort of starting to get into how would we get
it and where can we get it from.

\>\> JOHN: This is John Loonsk. Is that number at the physical,
individual building level, or is that at a broader organization level?
Would be another question to follow up on. Just, you know, because I
think what\'s needed here is to the level of the facility, and -- but
otherwise, that would seem to make a lot of sense.

\>\> BRIAN: I\'m not -- this is Brian. I\'m not exactly sure how that is
compiled. My only ­question was, I would like to limit the number of data
points we collect if we have a static table we can link to.

\>\> JOHN: Makes sense.

\>\> DAVE: This is Dave Parramore again. Just a thought in terms of
DoD\'s mission to deploy a homeland in a crisis. A lot of our hospitals
don\'t have a fixed address \[[indiscernible]{.mark}\] to deploy to a
location, and in that case, we would have to collect that data on where
that hospital is physically located, which probably wouldn\'t be in the
database that \[[indiscernible]{.mark}\].

\>\> JOHN: Are pediatric hospitals covered by Medicare? That'd be in the
assistant pamphlet.

\>\> JEFF: This is Jeff Wells. Mitch has stepped out for a meeting, but
I was going to, I guess, on his behalf, offer -- kind of follow up to
Rick\'s point on process. Going back to deciding which of these data
points is sort of essential or critical would, to me, put it under the
target category. And then what\'s either extremely critical or realistic
to do in a year would go understand the minimum category. And I think
from a time standpoint, it would be helpful to try and move through this
list if we can, I guess, with that kind of -- type of a process, to try
and decide which of these to keep so we can kind of move through it.

[\>\> LAURA]{.mark}: The next section, then, is the daily facility
summary, which gets to the utilization of the beds that we\'re talking
about and the institutional data section. You can see the four proposed
elements there.

\>\> RICK F.: This is Rick. Just a question. When you look at what the
other systems collected in that matrix back on February 21, it doesn\'t
appear that even New York City, North Carolina, or Frontline collect
this information. I\'m just curious: does that mean that this
information is really not that critical and therefore we can drop it? Or
is it that there are -- everybody believes it\'s critical; it\'s just
there are other systems they can tap into?

[\>\> LAURA]{.mark}: Leah, can you speak from North Carolina\'s
perspective?

\>\> LEAH: Which ones are you talking about? The
\[[indiscernible]{.mark}\] unit?

[\>\> LAURA]{.mark}: No, the daily facility summary. I mean, it's like,
perhaps you get some of this information from another system?

\>\> LEAH: No, we do not. We would get the date and time of the report,
and we get the disposition from the ED, like where they were admitted or
discharged or when the ICU -- we get that kind of thing. But we don\'t
get a daily -- we do not get these 1 through -- we don\'t get 2 through
4 for the entire hospital.

\>\> BRIAN: This is Brian. I can\'t speak to other hospitals, but mine
is, like, 1,000-bed tertiary care facility, and a lot of this stuff is
still done by hand. And they don\'t have it 2 days afterwards. To figure
out what your sense was Monday, you've got to wait 'til Thursday.

[\>\> ADELE]{.mark}: My question, then, is, what are the data elements
that will help us get to the utilization component of our charge? And
are you saying that you don\'t think that those components are available
within 24 hours?

\>\> BRIAN: That\'s not what I just said. In my experience, in my
location, they haven't been available. I can tell you, if they were told
the day it was reported, they\'d get it done.

[\>\> ADELE]{.mark}: Okay.

\>\> BRIAN: It just hasn\'t risen to the level of being that important
to them.

[\>\> ADELE]{.mark}: So is there agreement that these would be the
element that we would like to see in order to capture a complete
utilization? Or are there other elements?

[\>\> LEAH]{.mark}: What was the rationale for putting those in there?
That\'s a lot of data.

\>\> JOHN: This is John Loonsk. I think I can speak to some of the
conversation that occurred around this at the American Health
Information Community, which was that there\'s -- the goal here is --
there was actually notice of the fact that static utilization capacity
that was generally available, but that there were needs to have more
dynamic -- to be able to map available capacity in the context of
response and management of response in a large-scale event, and that
that was one of the -- that was the driver of the discussion in this
area.

\>\> BRIAN: This is Brian. There may be a different data source than the
hospital for this. And again, I go back to the systems that are used to
track ambulance diversion and ED prodding. Two of those three or four
vendors, but two of the vendors that I know of for sure, actually
capture this data for each of the facilities that they service, and in
total, those vendors cover 50 percent of the emergency department visits
in the United States now.

[\>\> ADELE]{.mark}: My question is, what does Item 2, Daily -- what
does that group Daily Facility Summary give you that the next group,
Consensus by Unit, doesn\'t give you? We do get that in North Carolina.

[\>\> LEAH]{.mark}: I think if you get that, then you can analyze the
data to get to the data in the facility summary. We -- it\'s just -- it
may be from experience that we can make that the minimum, and then we
can \[[indiscernible]{.mark}\] these other elements from that. It's --

[\>\> ADELE]{.mark}: Okay, because it seems to me that one of our
principles was -- I thought -- was to -- if we\'re going to do something
in a year, was to get things that are already electronically captured by
hospitals. And I do think that that\'s important. I mean, maybe there\'s
a thousand hospitals in your system. I\'m not sure who said that, but
they would collect it if you told them they had to. I don\'t know that
it's going to be that be easy in a lot of hospitals.

\>\> JEFF: This is Jeff Wells again from Mitch Roob\'s office. When we
had discussed with our State Department of Health what they\'ve been
doing, and they also indicated they do not collect this information
under the daily facility summary, except, I guess, the date and time of
report, as Leah mentioned, and that they thought that would be
challenging from a feasibility standpoint on the part of providers and
may be difficult to do in a year. And so I guess I would recommend that
we consider not asking for this information as a minimum dataset, but
would want to make sure that everyone agreed that would still fit the
specific charge.

[\>\> LAURA]{.mark}: Jeff, do you have a sense that they could do the
census by unit element?

\>\> JEFF: I don\'t know specifically know. I can\'t really say.

\>\> RICK F.: This is Rick. It seems to me that what we ought to -- our
first question is, is this information critical? The second question is,
is it currently available? And if so, where? And if not, can we get it?

We can -- if we arrive at a minimum core set that people around the
table believe is absolutely critical, we can then begin to look at how
available is it. And it may be that some of this stuff isn\'t available
across the country, and that might move to a target. But we would still
say that up front, this is absolutely critical information that we need
to have. And it may be that we could survey major systems and other
folks to see where is this information. But we would have reached
consensus around what the core set that positions and other
knowledgeable people think is absolutely critical. Then we can worry
about where it is. And that would certainly affect if we can achieve our
first-year target or not. And we can have a note or something that says,
"This would be nice to have, critical to have in fact, but it simply
isn\'t available widely." On the other hand, it may be someplace, and
therefore we ought to make sure that it is. But if we don\'t arrive at
the core set, I think we're going -- we go through this process figuring
out, "Is it available today, or isn\'t it?" I think that makes it really
difficult.

\>\> JOHN: Yeah, I mean, I -- this is John. I would follow on that by
saying I read utilization to be in our charge. And if we have to go back
and say we can\'t do utilization because the data are not available, or
that that\'s an issue, that\'s exactly the kind of thing we should take
back to the community and say, and -- but that we were asked to do this.
We were asked to have these data to meet -- some data, not these data,
but some data to meet dynamic utilization, to get a picture of dynamic
utilization. So for me, I\'m with you, Rick: I think we need to think
about what we would need to accomplish -- to do to accomplish the
charge, and then we can parse up, you know, availability issue, and some
of that falls into the category of data that may be readily available.
Some of it falls into the category that data may not be readily
available but with some push could be made available, and some of it is
in the category of, "It is so hard to get that we have to go back and
say that\'s -- you know, we don\'t see this happening in this time
frame. But we have to go back and tell them that and why.

[\>\> LAURA: (indiscernible)]{.mark} to -- coming to an agreement of
what the target elements would be in order to achieve utilization, and
then we can have an action item followup to determine how easily these
data are available. And do these elements, either in Section 2, Daily
Facility Summary, or the Census by Unit, capture the data that we need
in order to answer the dynamic utilization question?

\>\> BRIAN: I think there\'s one other question that needs to be in
there, and that\'s, "How many patients are being boarded in the
emergency department?"

[\>\> LAURA]{.mark}: Okay.

[\>\>]{.mark} BRIAN: My census almost always matches available beds. So
what\'s not counted on the census is the 22 patients that are boarding
in the emergency department waiting to find a bed upstairs.

[\>\> LAURA: (indiscernible)]{.mark} addition?

\>\> LEAH: This is Leah. I just think we need to keep this as simple as
possible to get this started and rolled out. So I really urge that.

[\>\> LAURA]{.mark}: So what\'s your proposal, Leah?

\>\> LEAH: Well, where we\'ve been so far -- I mean, I think that
institution data -- all of that needs to be somewhere in some kind of
registry somewhere, and obviously you\'re not going to report that in --
I mean, the hospital will come in with the identifier number, and you
don\'t have all this other stuff reported every time, obviously. I would
skip the whole next set, because it sounds like nobody really gets it,
and just go to whatever is available by the census by unit.

\>\> RICK F.: This is Rick --

\>\> LEAH: Availability by unit. And I don\'t know about the ED part. I
think that\'s an important question. I hope that would come up in bed
availability. But I think we've got to keep this very simple, or it\'s
just never going to get off the ground.

\>\> RICK F.: This is Rick. And I\'m for simple, but I\'m also for
what\'s critical. And I think it\'s important that we not be constrained
by the data that\'s currently available in certain systems. We ought to
figure out what we really need to have, and we can then parse it out
according to its availability, as John laid out earlier.

\>\> LEAH: I agree with that. So wouldn\'t you say what\'s critical
would be the target and, at a minimum, we got to go with what we\'ve got
available within a year?

[\>\> JOHN]{.mark}: I was interpreting what Rick was saying to mean we
should identify the data we need to accomplish the charge, and then that
is our proposed minimum, and then we can look at those in the context of
grading them relative to what\'s easily available and what\'s not. But I
think, given the charge that\'s been expressed, if we\'re going back to
the community and are going to say that these are the -- you know,
we\'ve identified what data we need, and the data are not adequate to
beat the charge, we are in a precarious situation. So we either have to
say, "These are the data we think we need to accomplish the charge, and
we think we can get them," or we need to be able to say "These are the
data we need to be able to accomplish the charge, and these data --
these particular data are not going to be necessarily available to
accomplish that, and we need your help in -- if you expect us to
accomplish this charge, to get those data."

\>\> LEAH: Well, I think we\'re saying the same thing. I\'m just urging
a lot of practicality to this.

\>\> JOHN: Yeah, I think we all agree, but maybe what we should do is
look at these as sort of in the minimal context relative to
accomplishing the function. So we\'ve gone through; we've identified --
we\'ve talked about the issue of institution data. We all agree that if
there\'s a code we can use that gets us the granularity of the
individual facility, we\'re good. And then we don\'t have to ask for
that again.

We talked about dynamic utilization. I think -- it\'s my reading of the
charge that we have to do something in that area, and so I thought we
got to some consensus about the fact that these are generally the kind
of data we need with the addition of people waiting in the emergency
room.

And sort of carry that theme on through the rest of this, where we\'re
saying, "Are these the right data to meet the functional charge?", and
always to be as parsimonious as possible when asking it, but make sure
we have what we need to accomplish the functional charge.

And then we could call them the proposed minimum, and then we could also
address in that report to the community that these parts of the proposed
minimum are going to be hard to get, and that the potential impact of
that is, it would affect some aspect of dynamic utilization or some
aspect of this or some aspect of that.

So, you know, I mean, we\'re down to the meaty part, which is the
clinical data, and obviously, that\'s where some of these issues are
even more murky in terms of utilization and specific data needs. But
perhaps we could just think about the minimum dataset here as identified
for these next large settings and see if -- is there something obvious
that can come off, because -- not because it\'s not available, but
because it\'s not needed for the function. Is there -- and then look at
these data in the context of, "Is there something else needed here to
accomplish that function?" And then we can come back around and talk
about availability in the context of other time on this call or other
time on subsequent calls. I think we\'ve well-established the fact that
there are concerns about the data availability. And in terms -- I can
see how we could go back to the community and say that, you know, these
are the data we\'d like to have, but we have concerns about the data
availability in several of these areas. And we sort of can touch on that
at that level in our initial report and leave the door open for those
considerations without coming to closure on which data are immediately
problematic, which are most problematic, and which are not problematic.
Because I think that actually is going to take a lot more consideration
and perhaps data than we currently have at hand to make those
determinations.

But, you know, given the report that\'s due to the secretary on Monday
and to the community thereafter, and given the fact that we haven\'t --
you know, this is just one area. I would propose that we accept that
that -- just go through this that way and do it at a high level.
Because, you know, that we look at the patient data now, then we look at
the lab data, that lab micro, and just say, "Is there something that, to
achieve this function, is not necessary?"

[\>\>]{.mark} I\'d certainly second that, John. I think we ought to move
ahead here; the clock is ticking; we have work to do. I think there\'s
core set -- consensus on what we\'re trying to do. Why don\'t we talk
about patient data?

I had two questions. One, the randomized data linker: yeah, I know this
deals with privacy and security, and that\'s covered in a white paper
that was included. I guess the assumption is that that\'s the approach
that one is going to use, and therefore it\'s the way to go. I don\'t
have any problem with that, but it seemed to me that that, at least, was
a proposal within one of the white papers.

Whether it\'s the randomized data linker or some other way to identify a
patient that would cover privacy and security concerns, I think that\'s
what that really means. So it\'s not as important that we reach that
conclusion that that\'s the solution as the fact that you need to be
able to tell who the patient is, obviously, and that\'s what the data
element means. Is that fair?

[\>\> LEAH]{.mark}: Yes.

[\>\>]{.mark} Okay. I was curious: I know this isn\'t politically
correct, but I notice, in the minimum dataset, race is not included as
part of the minimum dataset, but it is part of the target. I was just
wondering: is race a critical factor for people in the public health
emergencies? I think about New Orleans, people winding up in the
football stadium, whatever stadium that was, and there was a tremendous
amount of fallout associated with the fact that it seemed to be a lot of
racial issues that came up. Now, that probably doesn\'t have much to do
with somebody\'s health, but it might be a factor in public health
emergencies that one would want to track.

It may also be related to illnesses and health problems that I don\'t
know enough about. So I\'m just wondering -- I know we want to keep this
at a minimum, but the question is, should race be included as part of
the minimum as well as part of the target or not?

\>\> BRIAN: This is Brian. From a clinical standpoint, I mean, there is
disparity in terms of health care provided that clearly falls on racial
lines. There are disease entities that fall on racial lines, but I\'m
not sure any of those are the type of biosurveillance issues that we\'re
concerned about, whether it\'s a predisposition to get avian flu or
become infected with anthrax. So I wouldn\'t think that race would
necessarily be part of the minimum set, but it might be part of the
target as you try to expand out the public health utilization of the
dataset.

\>\> RICK H.: This is Rick \[[indiscernible]{.mark}\] from New York
City. I\'ve been sitting in for Tom Frieden. I agree with that. I don\'t
think race is needed as part of the minimum dataset. Probably going to
be very incomplete even if collected as part of the target dataset, so I
wouldn\'t focus on this one too much.

\>\> RICK F.: This is Rick. Let\'s move on.

\>\> BRIAN: Can I ask a question on this randomized data linker? I\'m
not really familiar with how that concept would work. Is this item
somehow going to resolve the problem of five people reporting the same
case versus five cases?

\>\> JOHN: This is John Loonsk. I think that that\'s one of the other
discussions that\'s queued up for -- and what was basically being said
-- that this is a placeholder, at least, for figuring out what that
should be. And we could probably push that back to the -- it\'s either
that the next item --

[\>\>]{.mark} \[[Indiscernible]{.mark}\] privacy and security
discussion.

\>\> JOHN: Yeah.

[\>\>]{.mark} And there\'s a white paper on that. And I think we can get
into the nits and grits on that, but I think if we just take that as, as
John said, a placeholder --

\>\> BRIAN: That\'s all I wanted to make sure, is that that was what it
was there for.

\>\> JOHN: Yep.

[\>\>]{.mark} Okay.

\>\> JOHN: So are there other comments on the -- sort of in the concept
of just thinking functionally about the minimum dataset for patient
data, things that really shouldn\'t be there to accomplish the function,
or things that should be there that aren\'t there?

So I would suggest we move on to lab and radiology test orders and --

[\>\> DANA]{.mark}: John, there\'s a \[indiscernible\] --

\>\> JOHN: This is, I think, a somewhat still developmental area in
terms of thinking about the utility of orders as a determinant of public
health activities. And so I guess one kind of discussion that could be
had there is whether lab and test orders themselves are appropriate in
this context. I think one of the reasons that they\'ve been considered
in other settings is because they are generally available in electronic
form, so it is opportunistic.

\>\> JEFF: This is Jeff Wells. I was just going to add, did we go over
the clinical data piece?

\>\> JOHN: I thought the patient -- oh, clinical data -- I\'m sorry; I
was interpreting clinical data as part of patient data, and I didn\'t
mean to jump ahead. Did you want to make a comment on the top of page 3
related to the data -- minimum data set identified there?

\>\> JEFF: I was just going to communicate feedback that we had received
here that the information other than chief complaint may not necessarily
be critical and may not necessarily be a minimum target -- or a minimum
-- a part of the minimum dataset in the first year. I\'d be happy to
hear if anyone disagreed with that.

\>\> BRIAN: This is Brian. My one comment is that from a practical
standpoint, diagnosis injury coding, diagnosis type -- those type of
things are done as part of the billing process, and unless you want to
change the entire way medical records and billing process takes place,
you\'re not going to get that data in 24 hours.

\>\> JOHN: This is John Loonsk. So let me frame the question this way:
Are you expressing that to accomplish the function of public health
surveillance, if these data are available, you don\'t think they\'re
needed?

\>\> JEFF: I guess, yeah, I would suggest that they may not be critical
and you may be able to get the same functionality out of just obtaining
the chief complaint. But I would like to hear experts speak on that.

\>\> JOHN: Okay. I think that my eval-- you know, the evidence I\'ve
seen is equivocal as to the utility of chief complaint and its
appropriate mapping against IDC codes, and that it is important where
possible to have a clinician in the loop of evaluating a patient in
terms of the content of the data. And that\'s certainly true in the case
reporting realm.

\>\> LAURA: This is Laura Conn from CDC, and we have had some success in
being able to get this data in a pretty timely way, so I would suggest
that we should keep it as something that is indicative of diag-- a
clinician seeing the patient and having more validity than a chief
complaint.

\>\> JOHN: You know -- this is John -- this could be a perfect
opportunity where a report out cites this as being an obstacle, where
the IDC-coded data are not tradit-- in most settings are not available
in the context of extant workflow in process --

\>\> BRIAN: I mean, once you move to a fully electronic health record
where this takes place as part of the disposition, suddenly it becomes
immediately available.

\>\> JOHN: Right, and you know, I think there\'s still discussions that
need to be held around the scope of this. Some of the other workgroups'
scopes are focused on those kinds of environments precisely. So, you
know, my feeling for this is that the Secretary\'s intent is that he\'s
trying to get to as much progress as possible, as soon as possible. But
it is certainly the case where other working groups have suggested that
the most appropriate scope is in a setting where there are mature
information systems available to make those data available in a timely
and consistent fashion.

\>\> JULIE: This is Julie Gerberding. I think there\'s also, you know,
opportunities here for some evaluation as we go forward with the systems
that exist now in terms of what is the validity of that input, and how
does it correlate with, you know, the other data elements, so that we
could learn something about whether it\'s a helpful component or not.
And that\'s probably true of a number of other elements. We\'re kind of
starting here from what we assume or what we believe, from a consensus
perspective, are critical, but there\'s great opportunity to refine that
as we go forward.

\>\> LEAH: This is Leah Devlin. We are also getting electronically the
initial temperature and the initial blood pressure. And we also have a
way -- and I\'m not technically versed on this, but
\[[indiscernible]{.mark}\] way of standardizing the chief complaints and
improving that as a data source.

\>\> JOHN: Julie, this is John Loonsk. I don\'t know when you came on
the call exactly, but what we were in the process of doing was just
thinking about these data elements at a functional level and trying to
determine do they -- are they important or critical even in the
accomplishment of the functional goal and with a good healthy discussion
of the fact that some of them are more available than others, but what
we were talking about doing was describing going through there in a way
that described sort of the minimum set from a functional basis and map
that against the charge given by the community, recognizing that we may
have to go back to the community and say that these -- you know, there
are some pockets of these data, some pieces of data that will be harder
to get out of critical care environments than others, and the community
has to understand those.

\>\> JULIE: That makes sense, John; thanks.

\>\> BRIAN: This is Brian. One comment on the clinical data here. We
last year dealt with SARS. And CDC provided a case definition that
included pieces of clinical data, \[[indiscernible \-- pulse
ox?]{.mark}\], temperature, those type of things. If we anticipate SARS
as one of the items that we\'d like to know about and be able to monitor
it, it may well be incumbent upon us to make sure that those are part of
the minimum dataset that we\'re collecting.

Now, within the health care community, every -- at least to my
knowledge, every machine that\'s used to do temperatures now is digital.
And they all have a USB port that goes off to interface with something
that just -- we don\'t do it. The same with blood pressure, the same
with \[[indiscernible]{.mark}\]. If it\'s something that we require, or
if we\'re in a period where we really need that, then particular
attention can be shined on it. But it may be incumbent upon us with
things like SARS that we already know what our case definition is that
we be sure that we make that part of the minimum dataset.

[\>\>]{.mark} Are there other comments on that suggestion?

\>\> JEFF: This is Jeff Wells. I guess I would just add trying to
understand where we want to get in the long-term and how to get there
versus, you know, what\'s realistically actionable and feasible to do
within 1 year and then within 2 years, etc. And I know that there\'s
probably some variability among providers and their readiness to change
their workflow and processes and procedures as far as get something of
that information into some type of an electronic format for transmitting
it. So that would be my only caution.

[\>\> JOHN]{.mark}: So would that be a suggestion that it should go into
the target versus the minimum?

\>\> JEFF: Yes.

[\>\> LEAH]{.mark}: We have temperature and blood pressure and target
already. I was hearing we add pulse OX?

\>\> BRIAN: That was part of the data definition for the case definition
for SARS.

[\>\> LEAH]{.mark}: Okay.

[\>\>]{.mark} Well, I\'m sorry I skipped on past -- are there other
comments on the clinical or -- which -- or the patient section down
through number 15 in clinical?

\>\> RICK F.: Did we reach a decision relative to the discharge and
diagnosis information as opposed to just getting the chief complaint?
Did we resolve that? I guess what I heard was the consensus was that it
was important to capture all those items that are marked here.

\>\> BRIAN: Not that we would recognize that how we might get the
initial pass is going to be chief complaint.

\>\> RICK F.: Right.

[\>\> JOHN]{.mark}: Does anyone want to add comments to the laboratory
and radiology test orders?

[\>\>]{.mark} Just one question. We don\'t want a uniform patient
identifier, so we put a random identifier in, but the order number is a
patient identifier. That maps back directly to an individual patient.

[\>\> JOHN]{.mark}: Okay. Yeah, that\'s a very important point, and I
think let\'s note that and then also talk further about those issues in
the context of -- the privacy and security context that's so noted.

Are there other comments about lab and radiology test orders?

Hearing none, then, this is -- lab and microbiology results are another
sort of a knotty issue, because micro results -- although lab results
are frequently in electronic form, micro results are among the least
consistently formatted results. But I think that this is here because of
the obvious importance the public health activities and lab results and
micro results in that context. Are there comments about this suite of
data?

\>\> BRIAN: This is Brian. Just a question on this. I don\'t do this
stuff, so I\'m not that aware. Are labs pretty good about reporting
reportable stuff to you?

\>\> JOHN: There's -- you know, it all depends on the lab. And so much
of lab testing is done in clinical care settings, hospitals, and/or
doctors' offices. There has been a lot of work done on working with
national labs in terms of working to make just positive notifiable
disease results available electronically. But it\'s still relatively --
I would say that the -- there\'s still many States and local
jurisdictions that don\'t get them. So I think that it\'s important to
recognize that there has been a lot of goodwill on the side of the
national labs to try to make data available, and it\'s progressing.
It\'s generally in the context of only the positive for notifiable
diseases in those jurisdictions, and so there are considerations in
regard to this discussion where not all the data here are of that sort
as well, and that\'s not something that has generally been -- that these
labs have been engaged in, if that was clear.

\>\> BRIAN: I\'m confused, though. Are you now asking for every bit of
laboratory results on every patient that passes through an emergency
department or an ambulatory care center? That\'s what it looks like.

\>\> JOHN: So I think the question on the table is not to any particular
person. It\'s to the -- the aspects of what data are valuable to public
health in terms of accomplishing that and how is it balanced against the
burdens of reporting, and the -- and some of the privacy and secur-- and
sensitivities as well. What I can express is that the tradition in
public health, from a lab result-reporting standpoint, over the last few
years has been mostly around the traditional process of case reporting,
where a lab identifies that a result relates to a notifiable disease,
and it\'s reported to the jurisdiction of record in that regard. That is
certainly not -- that\'s at one extreme. At the other extreme, I don\'t
think anyone is really considering getting all lab results that are
being supplied. And so one of the things that are potentially available
-- and one of the things that people do consider in this regard is to
look at a set of lab results or lab -- even lab tests that are being
done for some -- and that\'s I think why this middle section is here --
that relate to a broad array of symptomology and/or diagnoses in
relevant areas.

So it\'s a bigger set than the national notifiable disease set but is
not still inclusive of -- usually, there are certain things that are
excluded from it, particularly like HIV results and STD results and
things of that ilk. And the way that that set is frequently determined
is from a set of lab tests that are relevant to the broad area of
biosurveillance.

\>\> BRIAN: I\'m still confused. If you\'re going to get -- I\'m trying
to rationalize this in my mind. There\'s 114 million patients each year
that go through the emergency department. Those are all being evaluated,
in theory, through these surveillance mechanisms, and of those 114
million, they probably average five lab tests apiece, which have any
number of results depending upon how you break them out. So now you\'re
talking half a billion to a billion potential results coming through. Is
that really what we\'re asking for?

\>\> JOHN: I think this is a great area for discussion, and there are at
least several components to it. One component to it is repeat testing.
One component to it is what the appropriate set of results are to send
forward, because it\'s clearly not all sets. You know, everyone
recognizes it\'s not all. People generally recognize it\'s not just the
reportable disease-positive results. But that middle ground is not one
that has been well-established, and so I think it\'s a great area for
discussion in terms of what lab tests are being reported in this
context. I think it\'s a complicated area, and it\'s something that we
may want to have further discussion on in regard to this working group
to be sure, because I think most people don\'t feel that that number is
either appropriate or sustainable. But in general lab, results are of
such value from a public health standpoint that it is a critical data
source.

\>\> BRIAN: The other question I would ask, if we do identify this data,
why not get HIV and sexually transmitted diseases, in terms of
prevalence in the community?

\>\> JOHN: So, I mean, I think it\'s important -- there are some great
considerations around the area of the identification versus
anonymization. And, you know, having been involved in some of the
systems related to HIV reporting, it is a very complicated area, and
there are many levels of sensitivity. It is certainly another
perspective, which is that --

\>\> BRIAN: It\'s a question for another --

\>\> JOHN: -- \[indiscernible\] minimum dataset or what lab results are
reported. But maybe we should postpone that discussion until after
we\'ve talked more -- gotten a little more formal about what kind of
data are being reported and whether -- and what ability there is to
trace them back in the context of an authorized public health
investigation.

\>\> BRIAN: Again, my questions were just trying to understand the scope
of the request.

\>\> JOHN: Sure.

\>\> JEFF: This is Jeff Wells from Mitch\'s office again. I would just,
I guess, encourage the group to consider a very narrow scope initially,
because once you build the infrastructure, it seems to me you can always
add on more easily than if, I guess, you start too broad to begin with.
But that would just be my recommendation.

\>\> JOHN: So did you -- were you talking about that in the context of
one of these particular data areas?

\>\> JEFF: Well, just with respect to the laboratory and microbiology
results. I think as you were talking, you said it would need to be
determined which group of orders or which groups of tests would be
included, and I would just encourage it to be, I guess, a smaller set to
start with.

\>\> JOHN: I understand. So in terms of the quantific-- what types of
tests are being reported in that area, you\'re encouraging minimalism as
possible?

\>\> JEFF: Yes.

[\>\>]{.mark} This is \[[indiscernible -- Jean Marie]{.mark}?\]. I just
have a technical inquiry because I\'m not familiar with the practical
aspects of data acquisition. If the data exist up front, is there any
technical cost to pay for getting it? And is there a technical cost to
pay for deciding later to go back and get it at a later point in time?

\>\> RICK F.: This is Rick. I think it depends upon what specific data
piece you\'re talking about, where it\'s located, and what the relevant
costs are. I think the real issue is, is it the right data to collect in
the first place in terms of the minimum core set? If you can arrive at
that, then you can sort of tease it out relative to its location and
cost.

[\>\>]{.mark} I guess I\'m sort of thinking that if this started out as
a focused approach -- let\'s say on, you know, emergency health threats,
for example -- but subsequently it was intuitively obvious to people in
public health that it would make sense to have the other microbiology
data relevant to reportable diseases. For example, you know, would
having a two-set data acquisition process make sense, or would it make
sense to just generally say that it\'s fairly confident that these are
the data that a public health data system would want, so why don\'t we
get it while we\'re setting it up in the first place?

\>\> BRIAN: This is Brian. The issue that you\'re going to run into is
the same one that we\'ve run into trying to build a RHIO. It is that a
sodium isn\'t a sodium isn\'t a sodium; a salmonella is not a salmonella
is not a salmonella. Each system that you\'re coming from has a
different way of describing that data element, so that then you have to
be able to map apples to apples and oranges to oranges and then be able
to deliver that so that you can compare and move across the continuum.
That\'s the technological challenge or one of the challenges that we
face in creating a RHIO. I don\'t know that we want to duplicate that in
our first pass through here.

\>\> RICK F.: This is Rick. Just relative to the lab and micro results,
it looks like the elements on our chart here that are minimum and the
ones that are target -- we have Xs in both boxes except for one of them
at the tail end. And if what we\'re really trying to do is arrive at a
minimum set, I was looking at a couple items on here in which North
Carolina apparently doesn\'t collect but BioSense does. And I\'m just
wondering if we looked at those and asked ourselves, how critical is it
to have these? If it\'s good enough for North Carolina not to collect
it, is it good now for everybody else? Or maybe I\'ve misinterpreted
what they\'re collecting. But I\'m looking at element number 7 and 8,
the specimen site and the specimen. I\'m also looking at 14 and 16, the
result unit and the susceptibility test interpretation. Are these four
pieces of data actually critical to have at the outset? Or is it
something that could be slid over to target? I don\'t know the
information well enough to answer my own question.

\>\> LEAH: This is Leah. Can I just explain one thing about the North
Carolina system I think would answer part of that question? When we see
something in our 22-data set --data element set that indicates that
there\'s something that a public health -- further look is needed, we go
back into the hospital with a patient identifier number, and we pull
anything that\'s electronic on that patient: any lab result, any
radiology, any nurse note. We have a two-part system. We don\'t do all
of it on the surveillance piece. Pick it up on the investigation piece.

\>\> RICK H.: This is Rick \[[indiscernible -- Heffernen?]{.mark}\] from
New York City. I think North Carolina -- I mean, we see that as a model
system, because those extra data elements certainly can be useful in
certain situations. But to collect them routinely means you have to deal
with a lot more data and process a lot more data, and it also opens up
the problem of backlash if people think that there\'s too much data
routinely flowing to public health without a good rationale for it. And
I don\'t know where that balance is, but it\'s -- that\'s part of the
discussion here of identifying which are key elements at the outset and
then which would be useful in the course of an investigation.

\>\> JOHN: So I\'m -- this is John. What I\'m hearing is that maybe
those should be moved into target, and -- because we\'re not hearing a
strong rationale for pulling them immediately. And --

\>\> LAURA: Rick, can you go over those elements one more time, 7 and 8?

\>\> RICK F.: 7 and 8, specimen site and specimen; 14 and 16, result
unit, susceptibility Test Interpretation.

\>\> JOHN: Hearing no other comments on that, I think maybe we should
take them out of the minimum set and keep them in the target set.

\>\> JULIE: John --

\>\> JOHN: I\'m sorry?

\>\> JULIE: This is Julie. I -- the issue on susceptibility test results
flew by me. We\'re not getting susceptibility test results?

\>\> JOHN: I think that the suggestion was -- the question was asked
whether that was -- susceptibility test interpretation needed to be in
the minimum set; North Carolina is not including it. And then we didn\'t
hear a strong articulation of it needing to be in the minimum set, so
that motion was made that it be in the target set but not the minimum.

\>\> JULIE: I\'m just a little concerned about that from the standpoint
of event surveillance and response planning. The sooner we have a handle
on that, the better we can do with things like stockpiled decisions and
interim guidance and things like that. And trying to aggregate that on
the fly is pretty tough.

[\>\>]{.mark} Then let\'s include it.

\>\> JOHN: Okay. Are there other comments on the lab micro area? I --
\[Kelly speaks\] Move on?

\>\> KELLY: Yeah, this is Kelly Cronin. I think it\'s important to use
our next hour and 10 minutes to try to move efficiently through the
options for data flow and then revisit some of the issues around the
randomized data linker, and in particular, you know, agree on what we
think would be an acceptable approach to ensure privacy and security
with anonymized data. And then talk about various considerations around
how we can define the scope in this first year and then also plan for
what we might be able to accomplish in years 2 and 3. And then, if at
all possible, we should probably try to reserve a fair amount of time
for policy issues and barriers, since I think, moving forward, this
workgroup is going to be asked to really consider those in much more
depth and try to focus on those over the next several months. And it
would be preferable if we could, you know, result in a discussion where
we can get some preliminary recommendations that identify what they are.

So with that, Dr. Gerberding, if you'd like, we can turn it back to you
to go over the options for data flow, or either Laura, John, and I could
lead the discussion.

\>\> JULIE: You know, I guess, I\'m assuming everyone has the document
in front of them that has the three options listed, so -- and the pros
and cons are nicely laid out. I\'m going to go through these one by one,
or if people just want to chime in within things that missing from the
pro and con list of each of the options.

\>\> RICK F.: This is Rick. It\'s probably easier just to go through
them, take one option, kick it around, go on to the next option.

\>\> JULIE: Okay. So I read the first option. Is there anyone who
prefers this option?

Let\'s look at the second option. Any comments on this one?

\>\> DAVE: This is Dave Parramore, Department of Defense. Apologize for
being a little bit slow. I just gave some more thought to Option 1. Just
something to think about in terms of how we deploy to a crisis event,
particularly, for example, Katrina. If we deployed a DoD facility into a
community to provide health care, would we want to report our
information to the local public health or directly to the Federal in
that case? And that might be a con in our case that typically we would
report to DoD and Federal versus trying to link in to the local public
health.

\>\> JULIE: Other comments on Option 1?

So let\'s then talk about Option 2 in terms of, you know -- I assume
everybody understands this, and -- any additional pros or cons that we
should be thinking about?

\>\> RICK F.: This is Rick. I\'m not sure I exactly understand it,
although I\'ve read it. It says that clinical care basically flows to
all levels of the public health simultaneously. To me, that looks like
an exploding bomb in the middle of a room. I\'m just wondering is that
practical and whether it represents all levels of public health
simultaneously.

\>\> JULIES: It\'s probably technically not simultaneously, since light
does move at 186,000 miles per second. \[Laughter\] I think we\'re just
trying to make the point that wherever the source data are, that you can
move them through the system instantaneously from Point A to Point B, so
in reality, everyone receives the information at the same point in time.

\>\> ADELE: Hi, this is Adele. I think one thing I\'m having a hard time
evaluating these options, because I\'m a little stuck. When I go back to
the business scenarios, and I\'m looking at who -- what\'s going to
actually happen to this data? I mean, raw data by itself is not that
useful. And so, for example, when we\'re confirming the existence of an
event, what we have in our scenarios right now is all passive voice; the
data are monitored and analyzed. We don\'t know by whom and we don\'t
know exactly what happens once we have this monitoring and analysis. But
to fulfill the charge, okay, what we care about is that analysis and
what happens to the analysis and someone being in the position to take
action on the basis of the analysis.

So when we\'re looking for options for data flow, in light of the charge
of this group, we don\'t so much care about who all -- you know, what
the universe of people who get the raw data is. What we care about is
that somebody gets it who can do the right thing with it. And it strikes
me that the important question, then, is, who is the right -- who are
the right people to get it, to do the thing with it that fulfills the
charge?

And I don\'t have an opinion about that, because I don\'t know enough
about it. But in a way, I would rather focus on the accomplishing of the
goal before I worry about, you know, the technical details of how many
people get it and when they get it.

\>\> JOHN: This is John Loonsk. I think one of the things that was
explicated in the original communication to the community and into the
-- on this area of biosurveillance, which -- I don\'t know, Adele, if
you\'ve seen that presentation --

\>\> ADELE: Yeah, yeah, I did.

\>\> JOHN: That there are needs for different activities that occur at
different levels of public health, and that, in fact, there are needs at
local, State, and Federal levels around different scenarios. And I think
that was part of the effort of the scenarios, was to try to elucidate
some of those needs. But those needs are sometimes different, but I
think what was part of the community conversation was that there are
needs at all those levels, and that one of the obstacles now is that
these data are not flowing to all the different levels in general. They
don\'t flow between public health jurisdictions, so if one jurisdiction
gets them, they\'re not shared with another jurisdiction. And that
that\'s a problem in terms of the different levels accomplishing their
needs. The needs may vary depending upon which level you\'re at.
There\'s certainly local and State public health have a huge role in
outbreak management and investigation that isn\'t -- always occur at the
Federal level. Sometimes in an emergency, it does, but it\'s certainly
not the routine.

And then at the Federal level, there -- and national level, and at the
State level, there are huge needs for population-level view on when an
event is occurring, where it\'s located, how it may cross jurisdictional
boundaries, how are response resources appropriately distributed to
respond to that. So I think what has been discussed and somewhat
established is, there are needs for these data at all levels of public
health, though those needs may vary.

\>\> ADELE: I guess, well, here's -- maybe I\'m asking a different
question, though. We\'ve gone straight from the discussion of raw data
to the data flow. And I guess my question is, do all levels of public
health need all of the raw data? Or is it the case that what some levels
need is information derived from the analysis of the raw data? Are you
saying that local public health authorities want to be in the position
of analyzing all the raw data? I mean, maybe that\'s the case.

\>\> LEAH: Well, this is Leah Devlin. And from -- I can answer from a
state and local perspective in one State. And it is going to vary State
to State. But we have our system set up so that we see -- the users are
defined by their role. We at the State -- our State epidemiologists on
the surveillance would see the statewide data. We have epidemiologists
in hospitals that can see the hospital data. We have some regional
epidemiologists that can look regionally, and the local health
department can have the data if they have a user and epidemiologist (and
most of them do) for their county-level data. So that\'s the way our
surveillance system is role based. And we have begun the conversations
with CDC about how and when and if we can make this information
available in a surveillance way to CDC on a national level.

But the way public health works is that -- on the ground, is that it\'s
one Federal, State, local system, and it\'s going to work better in some
places than others. But when the local health department gets the call,
their next call is to the State. If we get the call, our first call is
back to the local. If it\'s odd, if it crosses State boundary, if it\'s
big, we\'re overwhelmed, we bring in CDC. And it\'s worked very well.
But the transparency of the system between local, State, and Federal is
very important. And it\'s almost like redundant communications. So it is
pretty fluid, and it\'s redundant.

\>\> RICK F.: This is Rick. Just to muddy the waters still further, it
seems that in terms of the options -- when I first read the data flow, I
was thinking of these as mutually exclusive choices, and we're trying to
pick out the best choice. I\'m just wondering if -- depending upon what
the data is and its use, if we would actually use some of these under
different circumstances, such that it would be appropriate to do the
sequential Option 1 or maybe deciding whether or not this is a critical
emergency. I don\'t know. Or some other reason. It seems to me that
Option 2 -- if all levels are looking at stuff simultaneously, there may
be a lot of false positives. A lot of people may get unnecessarily
excited. It could create more problems than it\'s worth. But under other
circumstances, it\'s absolutely critical that all public health sees it
at the same time. We haven\'t gotten to 3 yet, but maybe this is going
along the lines of what the earlier speaker was talking about, is it
would be helpful to think about this relative to either types of data
that we\'re talking about or its uses, and to see these as possible
options depending upon what the answers are to those first two
questions. I don\'t think one size fits all, in other words.

\>\> ADELE: I think what we might be doing here is getting a little bit
of apples and oranges between, you know, what is the direction of
information flow, which has been an issue in some of the prototypic
systems that have been set up, where there were concerns about deviating
away from sequential, nodal data flow to the more simultaneous data
flow, with a very important question, which is how our data processed
and which data make it through to the ultimate or proximate destination.
So maybe a separate set of questions needs to be developed around, you
know, what windows into which data will various nodes in the system, you
know, be able to look. I\'m not saying that very well, John, but I think
you probably know what I\'m talking about in terms of, you know, what --
is it acceptable at the local level, where there is public health
authority, to take certain kinds of public health actions and to be able
to delve deeper into the data -- may not be the same robust information
that makes it, say, to a Federal level.

\>\> RICK F.: Yeah, the two complicating factors in this regard, because
it was otherwise pretty clear, are that, one -- I mean, view the
patchwork of the country in terms of local capacity and State capacity
and then, you know, multiple different programs at the Federal level,
and the fact that the weakest link in that chain breaks it. And so, you
know, I think that is a major issue. And that has to flow -- factor into
the consideration here.

And then the second factor is that, largely, you never want to be do--
from an information systems standpoint, it\'s always problematic to
change something during an emergency, and that you establish the flows,
you have to establish the infrastructure to sustain your emergent need.
You want to use it on a routine basis so that it\'s readily available
and people are comfortable it. And the last thing you want to do, from
an emergency standpoint, is actually have to make changes in that
emergency to sustain your information needs. And I think that\'s a
second critical factor that has to be considered in all of this.

\>\> ADELE: Do we have any more comments than need to be made on Options
1 or 2 before we move on, to make sure we\'ve carefully considered
Option Number 3?

\>\> JEFF: This is Jeff Wells. I mentioned I'd met with a group of State
public health and informatics, I guess, officials, probably from about
13 States or so. Also talked with our -- some of the local health
departments around here, and their recommendation was -- I guess would
really be relevant to either Option 2 or 3, but they didn\'t think that
the linear flow of information was -- added much benefit at all. So the
recommendation, I guess, from them would be not to do Option 1. And they
said that really the -- whether the data flowed simultaneously to all
three or whether it went through an intermediary to do more or less the
same thing didn\'t much matter to them. I guess the only concerns were
that the local, State, and Federal health authorities would have
appropriated equal access to that information. I think it\'s mentioned
under the cons of Option 3. But I think no matter how you do it,
there\'s going to be some kind of security measures for how people
access it, and so the local health departments want to make sure they
have access to the data as well as State and so on.

\>\> BRIAN: This is Brian. My only comment would be that Option Number 3
is going to deal with data that has not been deidentified. And before it
is deidentified and sent out, it has the ability to collate data so that
suddenly you know whether you have one case reported five times or five
separate cases.

\>\> JOHN: I -- this is John. I think that whole issue is one that is
not necessarily specific to a particular data flow option, as they\'re
articulated here, as more generic option that needs to be considered in
terms of how data from a particular patient is combined, which is
obviously -- there\'s an important good in that from a public health
utility perspective, versus the issues of privacy and -- but I think
it's -- I don\'t see that as specific to -- necessarily to one of these
data flow options as much as it is to the methodology of anonymizing the
data and that other -- that area of discussion.

\>\> BRIAN: The reason I point to it is that it is an absolute
necessity, from the RHIO standpoint, that when you bring data together,
that Jane Smith is Jane Smith is Jane Smith and that data all belongs to
that same patient. So that from a practical standpoint, there\'s going
to be a lot more information that has to be applied to either the
algorithms, the identifiers, etc. before it\'s deidentified, so -- I\'m
just saying that may provide a useful option, rather than the public
health people having to do that.

\>\> JOHN: I see. I understand. And what I tripped over was that what
you\'re actually saying is, those data are -- have patient names
associated with them.

\>\> BRIAN: Or identifiers, or they\'re using the connecting for-health,
11-item algorithm to be able to reach 99 percent confidence level that
this patient is indeed the same patient when you start matching records.

\>\> JOHN: Right. So, I just -- from a terminology standpoint, it\'s
going to be important for us to get our terms down as we talk about this
area, because I, you know -- and just for -- and there are probably
better ways of describing it, but I would call that named data or
identified data. Deidentified data usually has a HIPAA connotation where
it has a specific meaning in terms of the elimination of an array of
different data elements, including the locale, and I think that\'s part
of the next discussion. But that\'s what we typically think of as
deidentified. And I think what this material talks about is anonymized,
which is somewhere in between. But I understand your point. You\'re
talking named data in the value in that regard.

\>\> BRIAN: That\'s correct.

\>\> RICK F.: This is Rick. Just comparing Options 2 and 3, it seems to
me that the value add of Option 3 is expressed in the pros, in which
basically the difference between 2 and 3 is with the intermediary
organization, you have the advantage of being able to customize the data
and triage it. You also have a technical steward that sits on top of the
data. The advantage of Option 2 is, while you don\'t have those
advantages in 3, everybody gets it at the speed of light. So the choice
really is, do you want to get it quickly, or do you want somebody to, in
effect, scrub it, triage it, and set it up and have some sort of
technical expertise in the middle of this? The price of that is that it
may slow it down.

\>\> JOHN: That\'s a good point, Rick. I think in our experience, the
public -- particularly if you\'re talking about a minimum dataset, the
different public health jurisdictions want to get those data, that there
is an issue there around formatting of the data, but not essentially
scrubbing and eliminating pieces of data. I think where this dynamic
comes about is -- and it's important thing to consider -- is that some
-- for example, some data providers are multijurisdictional
definitionally, or that\'s how they organize themselves, at least. So if
you look at a Kaiser or an HCA or a hospital system or a health plan or
a large lab, that they frequently have already aggregated data from
multiple jurisdictions. And then what it does is, it just flips around
the data flow, and they don\'t then, at that point, necessarily want to
have a data exchange interface with every possible jurisdiction that
they are engaged with and at the same time that one is trying to
facilitate the access to those data. So that\'s a component of Option 3
that needs to be considered. And I think you\'re right that not all of
this -- these are not mutually exclusive options necessarily in that
context.

The other context here for this is that many -- just many too many data
connections are complicated. So if you\'re trying to facility clinical
care settings -- individual clinical care settings providing their data,
it\'s relatively easier for them to provide it to one organization who
can then dispense it to other organizations and that the burden of that
data provisioning is not held by the clinical care provider, because
that obviously -- we\'re trying to optimize the data out of that
setting.

\>\> BRIAN: Right.

\>\> JOHN: So those are the two different scenarios -- aspects of
Scenario 3, I think.

\>\> ADELE: I\'m not sure what the requirement is at this point, whether
we\'re to actually select an option right now by vote or just put
forward these various options for decision at some other place in the
organization. But I think what I\'m hearing is that there\'s not really
support for Option Number 1 and that the concept of data flowing
throughout the system simultaneously is generically appropriate, but
that use of some intermediary organizations for certain kinds of
information isn\'t necessarily precluded. There could be a combination
of Option 2 and 3.

\>\> BRIAN: The realistic thing is, there are very few RHIOs that
actually, in the next few months, will be able to handle the kind of
data and the data flow to support this. So that may be part of the
evolution that takes place after the immediate benefit.

\>\> JULIE: That makes sense.

[\>\> LEAH]{.mark}: I like the way you describe that, Julie.

[\>\> JULIE]{.mark}: Do I take that as consensus from the group? All in
favor?

\>\> BRIAN: It's good by me.

[\>\> JOHN]{.mark}: Sure.

[\>\> LEAH]{.mark}: Aye.

[\>\> RICK F]{.mark}.: Aye.

\>\> JULIE: Okay. Let\'s go for it.

\>\> ADELE: I\'m not clear what we need to do next. So I think I have
another -- I'm sorry; I\'m just reaching for the next briefing document,
which I believe is the privacy and security issue. Is that correct?

[\>\> KELLY]{.mark}: Yes, that\'s correct.

\>\> ADELE: Okay. And again, the background information here is fairly
well-specified. What are the specific discussion points you would like
us to pursue?

[\>\> JULIE]{.mark}: I think what\'s been coming up on the call is the
use of a randomized data linker as a tool for this purpose. And maybe
that\'s specifically what we need to be discussing.

[\>\> KELLY]{.mark}: Yeah, I think folks in Washington would agree with
that.

[\>\> JULIE]{.mark}: Yeah, basically the issue here is that
biosurveillance data not come in with identifiers but to come in with
the randomized data linker. And I guess what I\'m not really clear about
is how much technical depth we need to be providing around this. Our
charge was to provide data in a standardized and an anonymized fashion.
So is it really -- are we the right people to really make the technical
decision about how that anonymization occurs? I\'m unclear as to this
task here.

\>\> JOHN: This is John. I think it\'s absolutely valid to suggest that
there may be other technical fora that are -- we\'ll be talking about
some of these issues, and I think that the conceptual issue here that\'s
framed is not -- this is not done in a consistent way, that there are
traditionally issues around local public health wanting to make sure --
and/or State -- that they get named data in accordance with reportable
diseases where, by law, they need those. That -- and there\'s this --
certainly this high priority to make sure that patient confidentiality
is maintained, and so I think that the discussion point here at a higher
level to not get into the technical details is probably around just
developing -- you know, some sort of shared knowledge of the fact that
this kind of approach exists and that, indeed, it looks like something
that the group might want to recommend to avoid, you know -- to find a
path down the middle of those two areas.

\>\> BRIAN: This is Brian. I mean, I think the bottom line is, we\'re
all comfortable saying that trends should be anonymized. But there has
to be some way to link back and use the HIPAA exclusion for public
health and national defense to be able to say that if we identify a
problem, there\'s got to be some way, then, to track it back even if
it\'s just to track it back to the local hospital that it came from. And
they should then be able to identify, from their records that are not
anonymized, who these source cases are so we can continue through that
process. Is that correct?

[\>\>]{.mark} That\'s helpful, I think.

\>\> JOHN: I think that\'s helpful. That the next level down, without
trying to get technical, is related to the -- traditionally the issue of
the need to associate data around a particular patient. And you can
certainly visualize this from one end, where if you get the data that
was in the minimum dataset that we just talked about, and you couldn\'t
associate that with the same encounter, that those data would be
significantly reduced in their value. So I think that puts, you know,
sort of a minimum on the way those need to be linked. And so if you have
a linker, that at least, in a minimum fashion, has to associate data
from that particular encounter. What some people in public health
consider is that that doesn't help if they're coming back a second time,
if it's just -- you relate it to that encounter, that you indeed need to
have more a longitudinal consideration in that regard, and that what
that sometimes leads to is the patient linker being associated with any
encounter of that individual at that hospital while -- or that clinical
care setting while not being identifiable in the context of it being a
medical record number or a patient name. And that these are just some of
the examples that -- these are the two biggest issues that are not
pursued consistently in this regard. And they have substantial public
health import in terms of the relevant value that is derived from doing
the different approaches.

\>\> JULIE: So, John, are you really saying that what we need to do is
just make clear that we specify use of a consistent approach and that
this is one example of an approach that meets the criteria that we think
are important?

\>\> JOHN: I think that would be helpful. I think it would be helpful if
there was some sentiment about the importance of -- for biosurveillance
purposes, of being able to have data associated at least at an event
level. Because I think just getting random data without being able to
compare the temperature with, you know, the chief complaint, or to --
makes that data very limited.

\>\> JULIE: Got it. Thank you.

\>\> RICK F.: I\'ve got a question. Are there randomized data linkers,
is that something that\'s commercially available and it\'s only a
question of looking at the 16 of them and picking the best out of the
lot? Or is it really just a general concept that says we\'re going to
use this approach? The reason I raise it is, as Kelly would say, we\'re
looking at the specific charge. Specific charge for our group here says
that within 1 year, we not only identify all the data that we just went
through, but that it can be transmitted within 24 hours. To actually
pull this off, if we\'re supposed to have a little model 12 months from
now, it would be critical that we have noodled out this RDL in such a
way that there is a solution. Or it\'s not out there and it\'s a couple
of years away, and therefore we ought to be able to tell the committee
that, having looked at the marketplace, while this is a critical piece
of the puzzle, it\'s not really available, or it is but there\'s so many
choices we need to have somebody else go who is technically sound to
look at the different choices and make some recommendations to us.

\>\> JOHN: I think that\'s a good question. I think I can -- this is
John -- address it. This is generally not a commercial product. It\'s
generally not a major technical feat. It\'s generally something that is
more -- that we have to agree on a process for this, so since there will
be many people participating -- organizations participating in this, and
there hasn\'t been agreement, but it\'s largely -- it is a small --
relatively small technical task to just associate a number with that
that enables someone to go back to that originating institution and make
that look up.

\>\> RICK F.: I\'m just suggesting it\'s the weakest link in our chain
if we don\'t figure it out 12 months from now.

\>\> JOHN: And that this is, in fact, what some of the existing systems
are doing, and so there\'s ample evidence to talk about what is needed
in that regard, and it\'s my experience that it\'s not a major thing.

\>\> JULIE: So can we just, then, you know, emphasize our support for
this position with those caveats and move on to the next item on the
agenda, or do we need to say more about this particular issue?

\>\> RICK F.: I think that covers it.

\>\> JULIE: Okay. Then the next item really relates to creating a scope
context for what we are doing, particularly looking at whether or not we
really can define a scope that is feasible in the context of our overall
charge and the timeline in which we expect to be working, and this
briefing document starts out with a mention of BioSense and where
BioSense is today and what the expected scope of coverage would be in
2006 in terms of hospitals. This is not really defined in this document
in terms of population coverage or sector coverage, for example; those
information data points could be made available as we harden the
commitment to participate in BioSense to actual plans and more
demographic from the catchments that we\'re including, but I think it
also specifies sort of the -- more or less the inclusion criteria for
the locations that are expected to be contributing to BioSense in the
near future. Then this information relevant to trauma centers --
level-1, level-2 trauma centers that would obviously be fairly important
nodes in the context of a health emergency or a health event of a
variety of different types.

So really not sure specifically what we need to hone in on here, but
these give some sense of the complexity of defining scope and the need
to think of the population that\'s included; the geographic area that\'s
included; how do you get the biggest bang for your buck, so to speak, in
terms of knowing that whatever connectivity is achieved, it\'s going to
be phased in, and it comes with some cost; and then looking at scope in
the other dimension, which is what kind of patient access are we looking
for, ambulatory care in a nonhospital setting, versus emergency rooms,
ICUs and acute care, and then finally, you know, are we at a point where
we need to be at least discussing what is the vision of the broad
national coverage that we would like to see phased in, you know, over
the next several years.

So I just kind of open this up for some discussion and some maybe
concrete suggestions on how to define the near term scope and then
perhaps the long-term scope through 2008.

\>\> KELLY: Dr. Gerberding, this is Kelly Cronin. I just wanted to let
you know that Mitch Roob actually specified last week that he was
interested in looking at trauma centers and trying to get some idea of
exactly how many level-1 and level-2 hospitals there are, thinking that
they tend to be a little bit more electronically connected than perhaps
other subpopulations of the hospital universe.

But that\'s not to say that we have to, you know, define in great detail
what we think would be appropriate at this point in time. It was just
one additional sort of subset that we could consider incrementally if we
want to go beyond the goals of BioSense in the short term.

\>\> JULIE: I think we would certainly, from a -- wearing my CDC hat and
not my egghead hat -- that from a CDC perspective, we would definitely
want to support going beyond the focus goals of BioSense for this
enterprise. I don\'t know, John, if you agree with that, but we think
that\'s a good idea.

\>\> BRIAN: This is Brian. Just a comment. We started this discussion
early on trying to identify what were we really trying to accomplish --
not what was AHIC directing or what did we want to be the final perfect
picture, but what do we want to accomplish in the next 6--12 months? And
I think the answer is, we want to be able to deal with SARS; we want to
be able to deal with avian flu; we want to be able to deal with the
eventuality of a biologic attack from a terrorist standpoint. And what
do we have on the ground that\'s in place? What do we have that we can
put together and mobilize in 3, 6 or 12 months to be able to start to
give us that capacity, the capacity to respond to it? And then I would
think we would build around that Band-Aid, if you would, to actually
build the system that we think we should have from here into the future.
Is that unreasonable?

\>\> JULIE: It seems reasonable to me. What do others think?

\>\> JOHN: This is John. I think that makes a lot of sense. I think one
of the tradeoffs here is sort of between the traditional bioterrorism
perspective where major metropolitan areas are a large emphasis; early
detection and detection of early cases is an important event. And then
the counter-- the other perspective is more on the pandemic side or, you
know, a larger-scale event, where it emphasizes much broader national
coverage needs and more utilization in the context of response and
monitoring of the activities versus early detection.

\>\> BRIAN: I mean, if we were able to put a system into place that only
monitored presenting complaint, which is readily available through the
ADTVH emergency for hospitals that do registrations, if we tied that to
a simple messaging system to say, you know, "We\'ve identified a
problem; if you\'ve got people coming in with purple dots on their nose,
we want to know about it," and if we then tied that to the system that's
currently in place, and half the emergency departments in the country
are ready, that's looking at ambulance diversion, even using that as a
channel to make some of those things take place. Would that be a
deliverable that would have value in a 6-month or 12-month time frame?

\>\> RICK H.: This is Rick from New York City. I think I\'m correctly
representing Tom Friedman\'s view and the department\'s view in
suggesting that broader coverage and a more minimal dataset would go
further in the short time frame that you\'re talking about, in having a
useful system where you could monitor things like influenza-like illness
and sort of broad-brush syndromes. And the more detailed clinical --
collection of more detailed clinical data is really, you know -- it
hasn\'t really been shown in what way that\'s going to be useful. And I
think it will be useful, but I think figuring out how to make it useful
and how to make it work is going to be a big challenge, and to think of
that in more of a pilot phase, work out the details and the operations
before expanding broadly. I think that is a recommendation that we\'ve
made. And I think that goes along -- I think that\'s in line with what
you were just saying.

\>\> JOHN: Julie, this is John. I would also add that it would seem like
it could be important to have as a metric of accomplishment something
related to the exchange of data that are already being accumulated by
different public health jurisdictions as well, and that I think that was
part of the charge, and that because these activities are occurring in a
number of different areas, but that they\'re not -- the data are not
flowing to meet other needs, that I would suggest, or at least put on
the table, that some elements of the scope should factor in that issue
as well.

\>\> JULIE: I appreciate that, John. I think that speaks to the previous
comment that if we\'re, you know, trying to learn as we go and optimize
the system, that the sooner we take advantage of the information we
already can fairly readily access, the sooner we\'re going to be able to
evaluate and understand what data are useful and how to make information
out of these data. So I would certainly support inclusion of that in a
scope.

\>\> LEAH: This is Leah Devlin, and I was wondering if we shouldn't have
the whole issue of clear protocol on how all this will be worked and how
communications flow. Wouldn't that be something else we would want to
say is important as we roll all of this out?

\>\> JULIE: I think what we\'re really struggling with here is, we\'re
sort of trying to craft a scope with a set of ideas, but we probably
need to just take a stab at writing a draft scope and letting people
respond to those elements that they think need to be included or
excluded -- probably pretty good articulation of the general concepts
here. We all agree one is necessary. We all agree we can\'t do
everything at once, and focusing on the priority things in the short run
and the expansion in the long run, and also taking advantage of existing
information resources that have already been aggregated at some level in
the system to try to connect them and share them in a multidirectional
way.

Is that agreeable as a next step?

\>\> JOHN: Good by me.

\>\> BRIAN: Makes a lot of sense here.

\>\> JULIE: Great. Thank you.

I think the next item on the agenda is our policy issues. It\'s not
clear to me exactly what the policy issues we need to address today are.
Does anyone have specific policy issues that haven\'t kind of been
embraced by the items that we\'ve discussed already?

\>\> ADELE: This is Adele. One of the issues we were to grapple with, I
think, was do you discuss sort of what would make this happen. What is
the policy driver for health care providers to provide information that
they\'re not already providing? There\'s going to be a burden associated
with this information collection that\'s going to fall to somebody. And
that\'s going to be a function of how the policy\'s implemented. So it
strikes me there are some options there.

\>\> KELLY: Yeah, Adele, this is Kelly. I think what\'s been alluded to
in the past when we\'ve discussed this is the need for incentives for
providers, or in particular hospitals, to participate if there were, you
know, an expanded system set up over the next couple of years. And you
know, there\'s been some early considerations around that, what would be
the right either financial or nonfinancial incentives.

But -- I guess that\'s an open question. Do we actually need incentives
for providers to participate in a program?

\>\> ADELE: Yeah, I guess just looking at the policies within the near
term -- in, you know, our one-year time span, if we came out and said,
"Okay, now we have this reporting mechanism; gee, we\'d like you all to
provide us these minimum data elements, or not us necessarily, but
whatever entity we decide need to be reported to," you know, what sort
of take-up rate would we get in the absence of any accompanying policy
aside from our announcement that now it\'s available that they can do
it?

\>\> JULIE: In a sense, this is the subset of the larger issue of
transitioning to a standards-based health information technology
platform in the broadest sense, so one of the things I think we\'ve
learned in the pilot phase setting of the connectivity with BioSense is
that it\'s surprising how many hospitals, at least, actually want to do
this and how, at a community level, it\'s regarded as value added to the
enterprise and to the community. So there\'s a certain amount of
altruistic incentive that seems to be helping us at least with the early
adopters as we go forward.

[\>\> DANA]{.mark}: Yeah, and I realize that -- you know, you read the
charge; it just -- it says that within a year that this reporting
capacity is made available, that it can be reported. It doesn't say that
it will be reported. But in terms of this question about policy options,
I think, you know, we\'re sort of in -- if we don\'t address this
question, we\'re sort of implicitly making a policy decision that we\'re
not going to provide any requirements or inducements other than sort of
civic goodwill.

\>\> JULIE: You know, Dana, I think you probably need to speak for the
Secretary here, but you know the whole concept of the AHIC is that the
60 percent market share of the Federal Government will drive the market
here, and in a sense, that is the macro policy decision that we\'re
making and how we choose to leverage that economically and through the
regulatory process, the reimbursement process, these, etc., I think, are
parts of the overall community work. And maybe you and David have a
better sense on how we could address that in the context of this
particular subcommittee.

\>\> JOHN: You know, it certainly has been my experience that many
hospitals are interested in trying to help. And that their ability to
try to help, though, is somewhat related to whether they\'re associated
with a chain or a hospital system and have the kind of technical
expertise that they can afford to array to do. There are some technical
needs that have to occur inside the hospital, and that while they\'re
interested in doing that, sometimes getting that done in a timely
fashion relates to them actually having resources that they can own that
can be used in that regard.

Another barrier that sometimes occurs is not so much HIPAA, but is about
concern about HIPAA. And the feeling -- a defensive posture that also
occurs in the hospital setting where they perceive risk to themselves --
and this sort of combats their goodwill -- where they perceive risk to
themselves, unless they dot the I's and cross the T's of assurances that
this is something that they can do. And so it usually involves cycles
with attorneys and cycles with, you know, developing MOUs and things of
that ilk, because of those concerns. So it's -- you know, there\'s a
barrier there minimally of HIPAA angst, perhaps, and that relates to
this. And I think that that\'s a pretty consistent one, even though some
can overcome it pretty -- you know, some can overcome it rapidly; some
have much more trouble with that.

The other -- you know, another barrier is that -- I think that it\'s not
clear to everyone the format they should be providing these data in. And
that because that hasn\'t necessarily been standardized and that
standard hasn\'t been accepted, then that is an obstacle, because it
impedes the sharing of data in many different levels. So that\'s another
example of a barrier that is not purely cost-related, but that I\'ve
seen in different circumstances as well.

So those barriers -- the issues of who does the work of delivering the
data from clinical care is a big one, because most hospitals don\'t let
anyone work on their systems. And so if, you know, one is considering an
induce-- some sort of incentive for this, how that incentive is situated
is critical. Because largely, what the hospital wants is -- they want to
have people inside their setting who can -- who are -- you know, have
gone through all their processes, are familiar with their systems, they
know won\'t break them, and can spend some time in making it happen, to
allow those data to be provided. And though at times, you know,
resources are available from public health in some limited quantities to
do this, there\'s an obstacle of getting the resources to the people who
can actually do them, you know. And it may just be a logistical
obstacle, but it\'s another obstacle that has been seen out there in the
past.

And that -- I don\'t have policy-level suggestions for how to attack
those issues, but I think that those are the kinds of things that we may
want to spend a little time talking about.

\>\> BRIAN: This is Brian. Let me ask a question, and I\'m not saying I
stand behind this, but I want to raise the question. It's kind of the
nuclear option. If we discovered that we had avian flu that was
transmitting person to person tomorrow, would it not clearly be in our
interest to mandate that this data is submitted and identified the
absolute smallest critical set that gives us a handle on the spread of
the illness? If that\'s a valid argument or a valid response to that,
then given the fact that we believe that avian flu is inevitable and
that at some point in time that we don\'t know, we\'re going to have
that problem or a similar or like problem, is it unreasonable to find a
way to mandate that that data will be submitted, period, in the interest
of the national security and the public health?

\>\> JULIE: What I\'m sensing is that we need to flesh out some options
for the policies to rounding participation in this process, ranging from
totally voluntary for those that want to do it, all the way to mandated
requirements for reporting of certain data elements, which, you know,
would be unprecedented in a sense for public health data at a Federal
level, but certainly there are precedents for it at the State level. So
I can see lots of interesting and very long conversations that can ensue
from this that will involve many lawyers and other people, as well as
those of us on this call. But --

\>\> BRIAN: I just wanted to put the nuclear option on the table so we
have the full range of --

\>\> JULIE: No, I mean, I think it\'s really important, and there
certainly -- we\'ve been having similar discussions to that in other
domains at CDC in the context of pandemic planning. So it\'s actually
very, very -- in my opinion, a very valid perspective. But do we have a
-- I mean, are we at a point -- and I guess I\'m kind of asking for
guidance from the Department on this -- are we at a point and are we the
right group to be addressing these issues? Or is there some other
process under way that will be taking them on?

\>\> KELLY: This is Kelly Cronin. I think that in our subsequent
meetings, we\'ll have probably a more defined process on how we are
going to be trying to really more fully vet these barriers, which are --
you know, some are technical and others really are about policy and/or
legal authority. But we\'ll try to, you know, provide the necessary
support and sort of a framework to work within as we really dig into
those.

But I would say the only other one that I think we haven\'t mentioned so
far -- and this is really more of a long-term issue, but as we develop a
sustainable business model for the Nationwide Health Information
Network, and perhaps as we consider, you know, maybe combining our
Options 2 and 3, in terms of data flow, and move into some operational
RHIOs within the next couple of years, I think we need to take on the
issue of who is going to finance the transactions, or the data flow
specifically, for public health. A lot of the focus right now has been
more on how will this business model work for health care operations, or
for health care treatment, or health care delivery more broadly. And
public health is going to be an instrumental component of the network,
yet I don\'t think we\'ve really mastered sort of what is the role of
government here and who really could be taking on not only the cost of
operations, but even -- you know, partially is there a role for
government in the infrastructure?

\>\> ADELE: Yeah, Kelly, this is Adele. I think that\'s right. I would
even expand what you\'re saying, because as we formulate views on who
ought to do what, like who -- what governmental entities are in this
chain of data flow and who is going to be responsible for doing
analysis, we have sort of institutional questions and financing
questions. And to me, they come under the heading of policy, because,
you know, it\'s possible some Federal agency will get some new mission
mandated to it, that it\'s got to do something different than it was
doing before. And there are going to be different options for how those
policies could be implemented, and advantages and disadvantages of doing
it different ways, that at some point somebody\'s got to be in the
position of analyzing.

\>\> KELLY: Dr. Gerberding, I think we\'re just expected really, in
terms of briefing the secretary and the subsequent presentation to the
community, to really just lay out these issues. We don\'t have to have,
you know, any answers at this point. We just need to be sort of
describing what we think the landscape of barriers are.

\>\> JULIE: I think we can come up with, you know, a landscape of
barriers, for sure.

\>\> ADELE: So are we ready to move on to the last agenda item, which is
basically a review of the sort of preliminary recommendations?

\>\> RICK F.: This is Rick. Just one point on the policy issues. I think
that we have a lot of information around, especially around Katrina and
other disasters, that, if we paid some attention to, might provide some
valuable lessons on what to do and what not to do, such that some of the
policy that -- issues that we would be putting on my parking lot might
stem from that relative to communication breakdown and other things. So
I\'m just suggesting that perhaps the President\'s report that came out
recently on Katrina -- we could read that through the prism of
biosurveillance and ask ourselves, "If there were a break, some sort of
a breakout like this, are there problems that occurred which are
mentioned in that report, or others, that we ought to pay attention to,
at least to raise them as areas needing policy?" We wouldn\'t have to do
it ourselves, but at least we can flag them.

\>\> JULIE: Maybe there would be some folks on the committee that would
be willing to read that report and kind of maybe introduce the next
workgroup meeting with a, you know, 5-minute overview of what lessons we
might learn from comparing the President\'s report to the task that we
have at hand. Would anybody be interested or willing to do that?

\>\> RICK F.: This is Rick, and since I suggested it, I'd be happy to
take on. If anybody else wants to take it on, that would be great.

\>\> JULIE: It would be interesting.

\>\> ADELE: Thank you. If anyone wants to help him, I\'m sure he\'ll be
grateful for the input. \[Laughter\]

\>\> RICK F.: Absolutely. I\'ll never volunteer another comment.
\[Laughter\]

\>\> ADELE: I don\'t mean it to be a punishment.

\>\> JULIE: Okay, let\'s go back through the agenda, then, and just make
sure that we have a sense of what we\'ve agreed to today. I think we\'ve
agreed to the elements of a minimum and target dataset, at least for a
good-enough-to-go approach. We\'ve agreed that our data flow options
should be supportive of simultaneity in multidirections throughout the
system, but we\'re not ruling out the possibilities of the utility of an
intermediary data processing entity as they come online and there\'s
value added. We\'ve agreed that the privacy and security issues are
important and that the concept of randomized data linkage or randomized
number as a data link makes sense as long as it is linked across the
elements in an event, and that we can be sure that we can simultaneously
see a demographic variable and the relevant clinical information as a
record as opposed to as nonconnected events in the system.

That we have agreed we need to specify the scope in draft form and in a
near-term and a long-term horizon, and we can circulate that for
additions and corrections to the scope as we go forward.

And lastly, there are many policy issues and barriers that need to be
delineated. Chief among them may be the incentives and the strategies
for encouraging or motivating or requiring participation in the system.
Have I missed anything?

\>\> BRIAN: This is Brian. The only thing that we had talked about early
in the call -- and I would like to make sure it fits someplace; it\'s a
little bit outside of the charge, but I think it\'s critical to the
function -- is that we look at -- when we talk about the activation part
of it and the cycle of communication, that other than the standard
telephone, we look at the communication tools available on the Net to be
able to link public health directly to the folks in the primary care
physicians' offices and the emergency department that will be
immediately making the diagnoses and dealing with the consequences of
these.

\>\> JULIE: I\'m sorry; I missed that. So someone else will have to
chime in on that. What I think I hear you saying is that while our
charge from AHIC is to create a system that allows us to conduct
surveillance and monitor events, that you\'re proposing we add a mission
to include alerting in the system?

\>\> KELLY: Dr. Gerberding, this is Kelly again. I think what we did get
to consensus on is that we have to stick to the specific charge, which
is really more about mobilizing anonymized data, sort of as a direct
stream from the delivery of health care, so it\'s really from sort of
electronically enabled parts of the health care system. But that we --
there was a lot of discussion around how we could also do Web-based case
reporting, so that that could supplement our specific charge. And there
was a fair amount of discussion around how that\'s already happening at
a State and Federal level and perhaps at a local level. And we just
needed more information to find out to what extent it was really already
available. So I think as an action item, we were going to try to
schedule a briefing to get a better sense of how common Web-based case
reporting is.

\>\> BRIAN: Hey, again, I\'m talking about the ability to do two-way
messaging back and forth between the people on the ground and the people
that are trying to figure out what the heck is going on from public
health standpoint.

\>\> JULIE: I think -- so you mean human-to-human communication?

\>\> BRIAN: Human-to-human communication that takes place across the
same tools that we\'re building.

\>\> JULIE: I think we all agree that it's critically important. My
sense is that\'s probably a different scope of work than we\'re focusing
on in the committee, but maybe we can put that on the table for a later
discussion as we mature this particular task, since there would
obviously be some functional overlap in these systems.

\>\> BRIAN: I just want to make sure it doesn\'t get lost, because --

\>\> MITCH: This is Mitch Roob. Actually, I raised this question with
the Public Health Directors at a meeting of about 10 Public Health
Directors from different States as well as our own State, and they
viewed the cell phone as probably the near-term answer to that problem.
So while I think it is a long-term issue, it is kind of outside the
relatively narrow scope that we have on this workgroup.

\>\> JULIE: This is for those who haven\'t been connected to your
computers during this call, I just received a note that the judge has
denied the injunction against Blackberry, so that our service will be
continuing for at least the foreseeable future.

I think we\'ve come to a point where we can adjourn the call and agree
that we\'ve got a lot of work to do between the time of today and the
next time we get together. But we have a good-enough-to-go sense to
report back to the Secretary on Monday that we\'re making some progress
here, and I appreciate the work that\'s gone into this. I\'m sitting
next to Laura Conn, who has certainly done a huge amount of work to
support this and is, you know, basically putting words in my mouth as
I\'m talking today. And I know there\'s a lot of work going on elsewhere
today, Mitch, I thank you, too. So let\'s congratulate ourselves for a
pretty big step forward.

\>\> RICK H.: This is Rick from New York City, Dr. Gerberding. Could I
just relay a brief message from Dr. Frieden, who apologizes for not
being on the call? He\'s been involved in the local anthrax case that we
have in the city. And he just wants to say two things: that the current
case of anthrax was reported by a clinician, as many have said all along
is going to happen in a case like that, but he did find it reassuring
that the syndromic surveillance systems, primarily the emergency
department system, you know, don\'t show any general increase in
illness. And he just wanted to pass that along.

\>\> JULIE: We appreciate that, although as we do the tick-tock between
the time when the blood cultures were ordered and the results were
available from the LRN \[laughter\], we can argue about whether or not
electronic reporting would have made a difference. But Tom is up to his
ears in alligators. I know there\'s a big HIV issue going on, so we
fully understand why he is putting other priorities ahead of this and I
look forward to talking to him in person.

Thanks, everyone.

\>\> KELLY: Can I just -- this is Kelly again. I think we are obligated
to take some public input. So I just wanted to check with Matt and see
if we have anyone in the queue for public input.

\>\> MATT: Yeah, that\'s right, Kelly. We just put up a slide with the
phone number on it for the public, so maybe we should hang on 2 minutes
to see if anybody calls in. And if there\'s members already on --
members of the public already on the line, press star 1 if you'd like to
make a comment.

[\>\> JULIE]{.mark}: While we\'re waiting, I'd like to make a couple of
announcements: that the next Community meeting, of course, is March 7,
and that the April Community meeting has been canceled and rescheduled
for May 16, and that the next meeting of this workgroup is going to be
on the 23rd of next month. So thank you all, and with that, Matt, I give
it back to you.

\>\> MATT: Yeah. We have a few comments. Operator, can you open Alan
Zelikoff, please?

\>\> JULIE: This is Julie. I have to interrupt you, because I do have to
go to another meeting, so I\'m going to pass this baton back to Mitch.
Thank you.

\>\> MITCH: Thank you. I\'ll stay on till it\'s over.

\>\> JULIE: Thanks, Mitch.

\>\> MITCH: Bye.

\>\> MATT: Mr. Zelikoff, go ahead with your comment.

\>\> ALAN: Hi, this is Al Zelikoff out in Albuquerque, NM. I have with
me T.G. Ward from the Lubbock Department of Health, and I had sent to
Julie, after the last teleconference, a package of information with
regard to our approach out here in the -- in flyover country, with
regard to surveillance. And we have a -- I would invite people to write
down my e-mail in case Julie was unable to pass that information along,
and I\'ll be happy to send it. But I think we have a system that -- it
does not address 100 percent of all the issues that were brought up but
certainly addresses 85 percent of them. And I wanted to have T.G. Ward
from the Department of Health in Lubbock on the line so that she could
answer from a true practical perspective how we solved many of the
problems that were brought up today. And we\'ve been functioning now for
close to 5 years with the Cirrus system and its predecessor with not
only the ability to detect data -- disease outbreaks early but also to
protect patient confidentiality and avoid the false-positive problem. So
my e-mail address, if anybody wants what I sent to -- the package I sent
to Julie 2 weeks ago, is zalan8587@qwest.net.

And I don\'t know if the operator can do it, but is it possible to get
T.G. on the line so that she can address this from the perspective of a
real-world public health official rather than from a developer?

\>\> MATT: Yeah, we can do it that. We only have about 2 minutes per
person per comment, but if she wants to speak for a couple minutes,
operator, would you open that line as well?

\>\> T.G.: Hi, can you all hear me?

\>\> MATT: We can.

\>\> T.G.: Great. This is T.G. Ward, and I\'m in Lubbock, TX, and I am
part of the local Lubbock health department. And we\'ve been using a
clinician-driven syndromic reporting system called Cirrus for close to 2
years, and we\'ve had experience with clinician-driven syndromic
surveillance since 1999. I\'ve listened with great interest, and most of
the issues and concerns that you\'ve raised with regards to what data is
out there that clinicians can tap into immediately -- I felt like
screaming, "We have such a system." Cirrus is Web based. It\'s real
time. Our clinicians in the emergency rooms have used it. In 2003, it
allowed us to identify precisely when the onset of our flu season began.

It allows for the two-way real-time communication, Brian, that you spoke
of frequently in this conference call. In public health, when the
clinicians report their syndromes that they\'ve identified, I can
respond on screen to them immediately. All of the clinicians who are
part of the Cirrus community also see this feedback real time,
simultaneously, such that the dialogue is ongoing with the clinicians.
One of the great features that we experienced with Cirrus was that in
our Katrina response, we were able to take Cirrus out to the field, to
the hangars where our health clinics were, and the clinicians were able
to identify those syndromes which affected the evacuees real time.

The good news is that we were able to identify the absence of problems
as well as any potential syndromes they may have identified.

You\'ve mentioned realistic, obtainable 1-year goals. It took us less
than a few months to implement the system here in Lubbock County. And
Cirrus is also being used in the region, in the West Texas panhandle,
which is approximately 41 counties up here in God\'s country. So I urge
you to look at clinician-driven syndromic surveillance in addition to
the data-mining systems that you are already looking at. One of the
problems that we\'ve faced with clinician -- with the syndromic
reporting is that many of the data-mining systems by definition are
retrospective. By the time all of the data are compiled, it is well
after the event. We need, in local public health and in the hands of the
clinicians, a tool which will allow them real time to identify their
astute clinical findings.

\>\> ALAN: Am I still on the line as well? This is Al Zelikoff again.

\>\> MATT: I'd say you\'ve got about 1 more minute, maybe.

\>\> ALAN: Okay. Is anybody listening? Are the panel members still
there?

\>\> MATT: The workgroup members are still on the line.

\>\> ALAN: Okay.

[\>\> JOHN]{.mark}: I\'m still heeerrrrre!

\>\> ALAN: Great; glad to hear it. I wanted to address the issue of how
we decided on what the data elements are, since you spent a lot of time
worrying about that, as you should. And what we did for our data
elements was to just interview dozens of public health officials in both
the veterinary as well as clinical community and then infectious disease
experts in veterinary medicine and human medicine with one charge, which
was, "What\'s the minimalist amount of data that you need in order to
make a binary decision?", which is, "I need to worry about this case
right now," or, "I can afford to sit back and wait." And the point is
that I -- while I don\'t think anybody will ever get 100 percent answer
and we\'ll spend the rest of our lives doing that, we have a system that
works. We don\'t claim that it is perfect, but it has identified disease
early, and it has in fact even ruled out a bioterrorism event, and we
think we capture all the diseases of public health importance in both
the veterinary world as well as the human world. Cirrus includes
veterinary surveillance. None of the other systems that I know of do.

And second, if you believe that the marketplace is an arbiter of
cost-effectiveness and quality, Cirrus is the only system that I\'m
aware of that has actually been licensed by local public health offices,
who don\'t exactly have a lot of money, and they\'ve re-upped for it
every year.

I have no financial interest either in Cirrus or in the company that
owns it. I\'m just telling you what the actual marketplace reality is.
So while I\'m not here to tell you that we\'ve answered all of the
questions that the Committee is challenged to answer, I do think we\'ve
answered the vast majority of them. It\'s practical, it works, it has
been working, and it\'s spreading by word of mouth very quickly, and
I\'m absolutely certain it\'s going to continue to grow in the
Southwest. And oh, by the way, Cirrus is being used by the CDC\'s Border
Epidemiology Early Warning System in Southern California, simply because
the other existing systems that were out there were completely
inadequate to what they needed, and I believe they\'re very happy with
it, and they paid for it as well. So drop me an e-mail if you\'re
interested. I\'ll send you the package that I sent Julie, and I\'ll be
happy to -- I'll show you how to -- you can download Cirrus and play
with it yourself and then convince yourself as to whether or not it
answers most -- not all, but most of the questions that came up today.

\>\> MATT: Okay. It looks like that\'s the only public comments we have,
so Mitch, if you would like to adjourn it now, we can do so.

\>\> MITCH: Well, thank you very much for your participation. And we
will look forward to seeing some of you in person on the 7th. You can
dial in or watch on video cast the scintillating day that we\'ll spend
in Washington, DC. And look forward to being with you all again on March
23, which will be the second day of spring, I believe. Thanks so much.