American Health Information Community

Biosurveillance Workgroup

June 22, 2006

1:00 p.m. EDT

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> \>\> Hello everyone. Welcome to the Biosurveillance Workgroup meeting.
> I would like to do a roll call of who we have on the phone. We have
> Co-Chair Mitch Roob. We have Larry Biggio, Leah Devlin, Thomas
> Frieden, Brian Keaton. We have John Loonsk in the room. Adele Morris
> is on the phone. David Parramore is on the phone. Laura Conn is on the
> phone.
>
> Did I miss anyone on the phone?
>
> And Michelle Miggs is covering for Scott Becker, and we have Dr. Anand
> Parekh.
>
> \>\> ANAND PAREKH: Hi. This is Anand Parekh from HHS, on the phone.
>
> \>\> Okay. And then in the room, we have Co-Chair Chip Kahn, and we
> have Kelly Cronin, our ONC Director.
>
> \>\> CHIP KAHN: Great. Are we ready? I apologize, but I am ready to go
> and I will call the meeting to order.
>
> Let me say and make sure that I get my procedures right here, in terms
> of the discussion, I will, obviously, begin the agenda and go through,
> and then those who are listed as members will be those who will take
> part of the discussion, and then, obviously, at the end of the
> meeting, we will have an opportunity for the public to comment.
>
> On the one hand, we have a lot to ‑‑ in terms of the introduction of
> the participants, we have done that, right, the roll call.
>
> And I am hoping that ‑‑ it\'s about 1:10 Eastern Daylight Time; I am
> hoping that we can probably take about two hours in the discussion
> that we are going to have. It could take longer, but, obviously, we
> are now at a transition point in our work.
>
> Since we last met, the American Health Information Community met with
> the Secretary and the Community approved the recommendations that were
> made from our previous meetings. HHS is now working to organize the
> data steering committee, which is one of the primary components of the
> recommendations, and that will be focusing on the data requirements,
> breakthrough initiative so as detailed in the specifics of the
> structure that we set up under the charge ‑‑ for the immediate charge.
>
> Many of you, I am sure, will end up being directly involved in the
> Data Steering Committee in one way or another over time.
>
> So now we will move to another stage of the activity, and in a sense,
> we started off with a mission to meet the Secretary\'s immediate
> mandate and agenda fairly rapidly and to respond directly to the major
> information with health concerns that the Secretary had in terms of
> collecting real-time information as the Data Steering Committee will
> get into to get sort of (indiscernible).
>
> Now, we are going to go beyond that and the discussion that we are
> going to have in a few minutes, and we will go more in line, I would
> say of the general discussion in the overall ‑‑
>
> \>\> ADELE MORRIS: Hey, Chip. I am sorry. This is Adele. I hate to
> interrupt, but there is something going wrong with your speakerphone,
> and I don\'t know if other people are hearing this, but it keeps
> cutting off and I can hardly understand what you are saying.
>
> \>\> We are hearing about every third word.
>
> \>\> BRIAN KEATON: Yes, this is Brian, and it\'s the same thing on my
> end.
>
> \>\> CHIP KAHN: Okay. We are working on it. Is there something I can
> do different?
>
> \>\> I don\'t think so until we actually get another phone and block
> off this line.
>
> I think there is interference from the projector and the phone. I will
> try to turn it off. I don\'t hear the ringing as much as before.
>
> \>\> Can everyone hear me?
>
> \>\> CHIP KAHN: Can you hear me now?
>
> \>\> Yeah.

\>\> CHIP KAHN: Okay. The important point I am trying to make is ‑‑ so
if you heard the word \"transition,\" in the every other word you heard
from me, we are now transitioning, and I hope our discussion today,
which I assume will sort of begin at 50,000 feet, and then we will have
to sort of work it down, is about how the prospect of public health
reporting and the needs of sort of public health surveillance and
response to both threat and ongoing needs that the public health
community has regarding information; how that will evolve with the
evolution of the interoperable health care infrastructure that the AHIC
generally and NAHIT has been tasked to either set up or at least
facilitate.

> So anticipating that EHRs will be adopted over time across health
> settings and that the NHIN architecture will be agreed upon and that
> there will be interoperability, the question is: How should public
> health event monitoring rapid response management fit into that.
>
> Now, that\'s a tremendous topic. It\'s both a technical topic as well
> as a scientific topic and a political topic.
>
> And I think at the beginning of our discussion, I would like to sort
> of keep it open and get everyone\'s sort of general views about
> conceptually where they would like us to go.
>
> Before I turn to the group, let me describe in two other areas
> something that I think is comparable to this in the work.
>
> At the last HS meeting, there was a presentation from the Youth
> (unclear) Association regarding the use of sort of clinical
> decision-making systems inside electronic health records.
>
> And there, they talked about sort of an interactive questioning that
> could happen when a physician or other healthcare professionals, nurse
> practitioner, goes through a record creating a history, going through
> the diagnostic process and then coming up with some solution for a
> patient.
>
> And parallel to that is another issue, which I have been working very
> hard on, which is the concern that the current EHR architectures are
> not user‑friendly for the measurement demand and reporting that are
> coming online in hospitals and will be coming online for physicians,
> and part of the reason in both of those cases, so the clinical
> decision-making decisions and measurement is the complexity of the
> kind of information feedback loops that are necessary to make those
> work.
>
> And in a sense, it seems to me we are dealing with a third sort of
> parallel issue here with public health because the question is: What
> are the kind of information that either through some kind of data
> mining or other kind of reporting that might be second level data
> complaints, price of diagnostics as well as, obviously, things that
> are numbers and quantitative.
>
> Would you want to have, as you sort of wash through data that might
> appear at a hospital or other center at a given time and then come to
> public health, whether it\'s at the national level, the state level or
> the local level, so that you can be better, those of you who work in
> public health, can be better informed to meet your needs?
>
> And ultimately, whatever the certification requirements are for these
> EHRs that, hopefully, will be interoperable, we are going to have to
> fit into that in some way.
>
> I hope that was not too long‑winded of an introduction, but I think
> our mission at this point is to think broadly about the application or
> all the other aspects in a sense of AHIC and talk about how once we
> have interoperability as certification gets developed, technically,
> and otherwise, how our task will fit into that.
>
> \>\> We need a backup phone.
>
> \>\> Yeah, we really do need it.

\>\> CHIP KAHN: Did everyone hear most of what I said?

> \>\> We caught most of it.

\>\> CHIP KAHN: Okay. Kelly, do you have anything to add before we sort
of go through the discussion?

\>\> KELLY CRONIN: I think that was great. I would add that, unlike the
last 5 months, we now have more time, and we really are looking at this
call as sort of a planning session because we want to know over the next
6 to 12 months what we really should be focused on so at the end of the
call today, staff can go back and start to work on our work plan with
your input to figure out what are the critical components that we need
to prioritize and address over the next 6 to 12 months.

\>\> CHIP KAHN: We do have sort of a layout of a process, but I think we
really need to talk substance for a few minutes, and ultimately, as I
said, we will have to narrow it down to three or four items that are
doable from all of the discussion that we will have.

> But I guess I would like to begin with to get your general notions of
> how the information you need to fit into the process, and then we will
> sort of try to narrow it down into a couple of points that we can
> proceed on.
>
> \>\> TOM FRIEDEN: Hi, this is Tom Frieden in New York City, and in
> about 10 minutes or so, I am going to have to step off the call, but
> Rick from New York City will be representing me beyond that.
>
> I guess it would be helpful to me to understand process wise where we
> are because I am not at all clear, and it\'s possible I missed
> something here.
>
> But I keep coming back to the way I see it; there are several
> different related, but important, initiatives. One, that we\'ve spoken
> about some, is some sort of national (indiscernible) med utilization
> and med capacity monitoring system, and in our view, in New York
> anyway, it can be done very simply and give information that would be
> very useful in an emergency.
>
> It can be something as simple as a Web-based, once-a-day, two- or
> three-data points manual entry. I understand that does not meet
> everyone\'s needs, to be excited about something that is unique in
> terms of IT, but it\'s doable and it\'s potentially quite useful.
>
> And the second general area has to do with biosurveillance, very low
> intensity, well‑defined syndromes; evaluating that but building on
> what are already existing, more than a hundred systems around the
> country, including ours in New York City, that look at things like
> hospital emergency department chief complaints and other possible
> data.
>
> The third is, I think, the most challenging, and it has to do with
> getting information out of electronic health systems, including the
> very important data that\'s been outlined now of trying to make sure
> that as standards for national electronic medical records are being
> set, they are set with a view toward ensuring that public health
> reporting is facilitated by that in a way such that when you build
> those systems, you don\'t have to go back and rebuild something to get
> the cognizance of and reporting to a local public health.
>
> Those to me seem to be three different areas, and I think, perhaps,
> best thought of in terms of a work plan on each of those three
> separately.
>
> \>\> You know, I apologize, I missed ‑‑ we had a cut out here. I got
> the hospital, the collecting information on the hospitals first.
>
> And I got the last one, which was the integration of information ‑‑ I
> mean, integration into whatever kind of VHR process we have to sort of
> mine the information we need.
>
> What was the second one? I missed that.
>
> \>\> TOM FRIEDEN: The second one had to do with using existing
> biosurveillance systems from around the country to get up and running
> in a reasonable amount of time, systems that use volume‑based
> reporting, whether that\'s emergency department chief complaint or
> fever from ‑‑ measured fever from different providers or well‑defined
> syndromes, whatever the result is, there are currently more than a
> hundred jurisdictions around the country, including North Carolina and
> us in New York City, that have systems up and running.
>
> And nothing in this area is going to be easy, and the BED (phonetic)
> system might be the easiest, but it does not mean it is going to be
> easy and getting these systems aggregated so you can get a regional
> and national perspective, which is what I heard the Secretary wanting
> up and running in a reasonable time period, is going to take a lot of
> work in terms of standard setting, transmission issues, definition
> issues, case definitions, kind of maintaining the system, and so that
> was the second item.
>
> \>\> Let me sort of respond in two ways, and I will ask John to
> respond, also.
>
> My sense is that in our first take as a workgroup and the
> recommendations, that the first two items you mentioned would be
> issues taken up by the Data Steering Committee to decide whether those
> are items that would be collected for the purposes of the sort of
> immediate collection of information for monitoring.
>
> And I am looking at John and Kelly; is that correct? So that would
> be ‑‑ so in terms of our agenda, we have moved that off to the entity
> that is set up under the recommendations from this Workgroup that the
> AHIC accepted, and the third item would be the item that we would be
> talking about but, John?

\>\> JOHN LOONSK: Yes, I think I can add a little too that. So there are
definitely other things that are going on in parallel to these
activities, and the initial charge that came to this group from the
American Health Information Community was to target the connection, if
you will, of clinical care, existing clinical care data.

It really was specific about not talking about additional reporting
burdens, but existing clinical care data for public health
biosurveillance purposes. Each of the different American Health
Community working groups developed a breakthrough priority and a used
case was developed from that which has been advanced to a number of
different groups that are working on some of these things for this
National Health agenda.

So one of them, for example, is that the used cases from each of the
different breakthrough areas has been advanced to the Health Information
Technology Standards Panel with an eye toward developing the standards
necessary to accomplish those activities.

> Similarly, those used cases were advanced to the Nationwide Health
> Information Network process, which is looking at how the Nationwide
> Health Information Network should be architected, and as Tom
> suggested, to keep in mind and, in fact, have prominently in mind that
> public health surveillance is an important architectural consideration
> as to how that proceeds.
>
> I think there is a general view of the fact that, eventually, the
> Nationwide Health Information Network is going to have to be and
> should be an appropriate conduit for some of the data that we are
> talking about in the context of the longer term implementation.
>
> Chip mentioned the Data Working Group, which is also looking at our
> Steering Committee that will, also, be looking at some of these
> activities as well, but I just wanted to make sure that those were on
> the table.
>
> I think that relative to Tom\'s other comment, there is a hope, I
> think, that many of us who have been working in public health
> informatics for sometime have that, eventually, we can induce the
> clinical care community to auto create an appropriately populated case
> definition for a notifiable disease that can go to local public health
> and can be advanced to state public health and can be part of the
> voluntary Nationwide Health, National Notifiable Disease System. So
> that\'s the target.
>
> The issue has always been that it\'s either manually implemented or,
> and with the low actual incidents of reporting that that involves,
> whether it\'s manually implemented into a web system or manually
> implemented in a paper system.
>
> So the opportunity to take advantage of extant clinical care data, to
> some degree a surrogate, to some degree to accelerate was what the
> initial breakthrough activity was about, but now it\'s an appropriate
> time to think more broadly and to think about how this would relate to
> the traditional Public Health Surveillance Systems. Some of the issues
> there are in support of both and some of the activities that have
> already been described around the different types of needs that public
> health has for systems and data.
>
> \>\> CHIP KAHN: My sense is that what we are looking at in terms of
> the provider community that actually interacts with the patients that
> we want to know about is making sure that behind the architectural
> curtain of the EHRs, there is the possibility for seamless mining of
> the information that is necessary so that when you go to the providers
> to ask for it, they still can say no, I suppose in some cases; and in
> some cases, they may not be able to say no, but that it does not add
> any extra burden to them because it\'s in the packages that they are
> buying.
>
> \>\> Well, I think, you know the vision I was trying to articulate
> that it is certainly not my origination but has been around for
> sometime, is that when mature EHRs are in place, that something
> equivalent to an existing case report, which takes data from a variety
> of different sources potentially in the clinical care environment,
> whether it be a lab result, some clinical symptomology, but achieves
> that case definition of a disease, could be automatically generated
> and would be then a feeder into the public health system that would
> not demand a burden of reporting on the clinician in accomplishing
> that which would hopefully increase the appropriate capture ‑‑
>
> \>\> And the difference about what we are talking about now, and
> Tom\'s first point, which I guess will be taken up at other places, is
> that we are looking now at the EHR, not at all the information a
> hospital might have about activity.
>
> This is the EHR part of it, which would be, I mean, there is nothing
> in the EHRs, there is not going to be anything in the EHRs about the
> hospital\'s load. I mean, that is hospital data in the hospital system
> and not in the EHR. So this is really patient‑oriented information we
> are looking at.
>
> \>\> Well, the term \"EHR\" was used here very broadly to incorporate,
> and at times, it is used to incorporate any system that is in the
> hospital setting. And so the important intent ‑‑ the important
> differentiation from that vision I just described was this that
> breakthrough was focused on using as much as possible clinical care,
> data that are part of the clinical care process to meet public health
> purposes and partly is just strategic from the standpoint of
> recognizing that it will be sometime before clinical care systems can
> be induced to both accumulate and automatically report a much more
> refined product, which could represent an actual public health case
> report.
>
> \>\> MITCH ROOB: Hi, this is Mitch Roob. I do think that Chip has a
> really important distinction here, and from, I think, the way the
> evolution of the software industries here have gone is really an
> important distinction to make, which is, the hospital data will not be
> in that EHR, and people who have tried to create ‑‑ having been down
> this path of trying to create an electronic health record, there is
> also your financial ‑‑ providing the kind of management information
> needed to run a hospital from an operating standpoint, which is not
> necessarily clinically based information as you want to get into EHR.
>
> I mean, I have not seen those work in concert well. In fact, they seem
> to work very poorly; neither master effectively. So if we are going to
> go ‑‑ the point that Chip is making is really important.
>
> If we believe from a public health perspective that capturing data
> about the goings on, the operational goings on inside the hospital is
> important, then we are going to have to get it from the management
> information systems of the hospital, which are not necessarily the
> same as the clinical medical record.
>
> \>\> Yeah. I think that\'s absolutely true, but hospitals, also, put
> out data that comes from a variety of systems and deal with them all
> the time. You know, integration broker technology or interface engine,
> or what you want to talk about, is a technology that is commonplace in
> hospitals, which allows them to hook up a variety of different
> internal systems to manage data between those internal systems.
>
> We know that some of the data that we have been talking about will
> reside in electronic ‑‑ in an emergency room electronic health record;
> we know some of the data that we have been talking about would reside
> in a lab information management system in a hospital, not ‑‑ you know,
> we talked about lab results that may come from the hospital, plus lab
> results that may come from external labs, but certainly, hospital labs
> are part of what has been discussed and was part of what was initially
> discussed in terms of the charge, and indeed, ADT systems in the
> hospital are a suitable target as well.
>
> The work that\'s been done on chief complaints almost exclusively
> comes from ADT systems in using chief complaints and syndromic
> surveillance. So I think the incarnation, as I understood it, from the
> standpoint of the initial charge from the AHIC was focused around from
> getting data from the clinical care environment and not as narrowly
> focused on the EHR, per se, recognizing that clinical care
> environments have tools at their disposal that can bring data from
> divergent systems to put them out.
>
> \>\> It seems to me, moving forward, this is sort of one threshold;
> this is a threshold point that I would like to hear from the group.
>
> I mean, in a sense, are we talking here about EHRs simply, which is a
> complex subject all into itself, or are we talking about both levels?
>
> And there you get into the aggregation. I mean, obviously, at some
> point, whether it\'s the point of the hospital or the doctor\'s office
> or the Public Health Department, there has to be an aggregation of the
> data from the EHRs to get to the kind of stuff that you are talking
> about.
>
> \>\> BRIAN KEATON: This is Brian. There is one other level of
> complexity or data source that you need to throw into here, and
> that\'s the fact that the emergency care systems across the country
> and across regions work in just those systems; the hospital, regional
> and state governments have gathered to create systems that look at,
> for example, bed availability, ambulance diversions, emergency
> departments on closures, capabilities that exist across the region to
> guide that system of care.
>
> And there is a lot of valuable data there that you will miss if you
> try to pull things out of individual institutions or individual
> offices, and we have to include those regional. We have almost half of
> the emergency departments in the country linked together in those
> systems now.
>
> \>\> And there is an analogy to that in the context of labs as well
> where a reference lab or lab outside of the clinical environment may
> be doing testing for a variety of different clinical care environments
> and may be willing and be a participant in helping public health with
> that, but it\'s crossing multiple jurisdictions.
>
> The used case that was advanced to ‑‑ out of these activities, and it
> was shared with this working group when it, in that process, actually
> names those two parallels. One is where data comes from an individual
> clinical care environment, and the concept there was that it was
> coming out of the aggregate systems of that clinical care environment,
> but another, and equally important consideration, was where there was
> some sort of data aggregator that was spanning a number of clinical
> care environments to carry out a particular function, whether that be
> provision of an emergency room system that was used in a variety of
> different settings, whether it was some hospital systems have data
> centers that support them in those settings or whether it was a
> regional or national lab that was getting tests and performing them
> across a variety of jurisdictions.
>
> So both of those models are important to work with and were
> implemented in the used cases that I mentioned and was advanced.
>
> \>\> TOM FRIEDEN: One second. I will have to step out, but again, Rick
> will stay on the call, but if we could just be kept informed of the
> work that has been, I guess, delegated to a group in the areas I
> outlined, because that would be helpful.
>
> \>\> Sure. We can do that, Tom. We can have periodic reports and
> whatnot.
>
> \>\> CHIP KAHN: Let me go one step further, though, and I think that
> Brian sort of ‑‑ I mean, the question, though, in terms of our mandate
> or as we are going to determine our mandate in terms of our work here
> though, obviously, we want the EHR to feed these aggregators, but is
> our work focusing ‑‑ and let me ask whether I am asking the right
> question: Is our work ‑‑ should our work most appropriately focus on
> the EHR aspect of this and how the EHR can best serve whatever
> aggregators there are or whether it\'s the hospital associations or
> public health departments or whomever, or are we worrying about in our
> work here not just the EHR serving those aggregators or are we worried
> about sort of the whole package, the EHRs and what aggregators are
> important and what aggregators should be out there? That\'s a
> question.
>
> \>\> Sorry. Go ahead.
>
> \>\> I was going to say, just to inform the discussion a bit, to go
> back to the wording of the broad charge. I mean, I think we are
> looking at the information tools and the business processes that are
> needed to enable real-time public health event monitoring and rapid
> response management.
>
> So to the extent that EHRs are one information tool out of probably a
> collection that might enable real-time or automated case reports or
> notifiable disease reporting or various types of functions that this
> group might identify, I think we need to probably be focused on not
> just the one, perhaps, main tool of the point of care, but the set of
> information tools that could be used to serve the public health
> functions that we identify.
>
> \>\> Let me throw some things on the table in thinking about moving
> forward with a broader charge because there are some areas that I
> think come to mind.
>
> The one way of thinking about moving from the specific charge to the
> broader charge is to think about broadening the kind of data and the
> functionality and thinking about the notifiable disease reporting is
> absolutely a way that that could be talked about. And another way of
> thinking about broadening the charge is this issue of the
> bi‑directionality of data flow and information flow that has been
> referred to several times in these calls, but we have not really
> drilled down to it more specifically, and some aspects of that relate
> to, I think, a desire by our clinicians to understand better than
> their clinical activities in their environment. So if the flu has
> reached their region, they want to know; do they know how it\'s
> spreading, and things like that, and clinicians need some of that
> information, but some of that, also, may relate to the alerting and
> communication of process information.
>
> So, in other words, sending information out to the clinical care
> setting in an alert form or a warning that says that there is
> something going on and you need to be paying attention to it. Is
> something else in the bi‑directional flow capacity that, certainly,
> public health has been thinking about and working on, to some degree,
> but could be scoped into it.
>
> A third area is, potentially, the initial charge was all about the
> interface between clinical care and public health, and thinking about
> public health systems, I think, is another area of potential expansion
> into the broader charge.
>
> There is no certification commission for public health information
> technology. The public health systems are relatively well‑known to
> have generate ‑‑ have developed on a disease‑specific basis with a
> lack of integration and a lack of data sharing.
>
> And so I think some have interpreted the broader charge to then, also,
> look at the fact that public health systems need to be ‑‑ there needs
> to be some confidence people have that public health systems are
> interoperable, can work together with each other and with clinical
> care settings.
>
> And we know that the certification commission on public health
> technology is beginning to address some of those needs in the clinical
> space, and the only certification that I am aware of in the public
> health space is work that the CDC has done for the public health
> information network, but that does not necessarily have the broader
> input of a variety of different levels of public health and others
> that might be eventually desirable in that process.
>
> So those are sort of three different areas that one could add to the
> considerations.
>
> One is the whole area of notifiable diseases. There are lots of
> different types of public health surveillance that are based on
> specific types of information. There are issues that arise when there
> is a problem with a medical device that can cause an issue. There are
> issues that arise in other domains that can be considered part of the
> public health surveillance milieu. Certainly, the most obvious one is
> the reportable disease system. That\'s one area.
>
> Another area is, indeed, the public health systems themselves and how
> we are making sure that they are interoperable and can work together
> and accomplish this, and then this bi‑directional aspect of alerting,
> collaboration, and making sure that that is standardized. And one of
> the issues there, for example, is how do you know who the clinicians
> are that you are trying to communicate with?
>
> If you are trying to send them an e‑mail, for example, how do you
> know ‑‑ how do you maintain that list? How do you know that that
> information is going to get out? How do you deal with the
> jurisdictional issues, making sure that it\'s regional specific to
> accomplish the information sharing necessary in a local jurisdiction?
> These types of issues.
>
> \>\> BRIAN: This is Brian. One of the things that I think we need to
> stay focused on, and this was part of the premise from the beginning,
> is we have a stage creation, but we need to do something good, not
> something that is perfect.
>
> Now, we may in 6 months face SARS or face a biological attack or face
> a pandemic flu, and we need to have something substantive or the
> Secretary and the President needs to have something substantive out of
> this group to say we made it easier and better able to manage these
> episodes.
>
> \>\> But I think what you are describing there is what the Data
> Steering Committee is going to be looking at in terms of the immediate
> public health threats.
>
> \>\> Once they identify what those data points are, we need to have
> some strategy as to how those data sources will get together and what
> the communications will look like to allow us to use that data
> effectively.
>
> I see that more as what we are trying to do in this broader scope
> here.
>
> \>\> CHIP KAHN: I guess my presumption is, and let me look at John and
> Kelly to make sure I am right, but my presumption is that CDC will
> work with the state and local ‑‑ I mean, the people representing the
> state and local public health agencies to work out that, and then,
> obviously, the right entities are going to have to go back to the
> hospitals and the other reporting entities that will report on
> whatever the three or four or five data points they decide we need to
> be looking at.
>
> I think that\'s not a perfect process, but isn\'t that what will take
> place in terms of those immediate threats?
>
> \>\> Essentially, to add to that, what AHIC has asked of the working
> groups is to now move and look at the longer‑term picture and to
> prioritize the next steps in getting there.
>
> So recognizing this has to be incremental, what is the next chunk that
> should be addressed? Is it notifiable diseases, and to make a road map
> that would show what this working group and what the AHIC should think
> about in the context of moving forward over sometime because that road
> map is going to be critical in coordination of the next step processes
> in other venues.
>
> And so each of the working groups has been asked to come up with a
> road map that will identify these next step activities.
>
> \>\> And I think that the Data Steering Committee, if it works, is
> going to look at the horizon of immediate today threats and come up
> with just sort of whatever the best solution is for getting the
> information to the CDC and the Secretary on that.
>
> And, at least, I think our charge here is to really look beyond that
> and to say if the environment of electronic records actually is going
> to change radically over the next 7 to 8 years, how do we make sure
> that what we need over time is integrated into that?
>
> I think that\'s our charge.
>
> \>\> Just to make it, also, a little bit more explicit, what is
> prioritized by this Workgroup, as we identify these critical
> components, there is then an opportunity to come up with the high
> level use cases that will then feed into the Health IT Standards
> Panel, the Certification Commission for Health Information Technology,
> and the requirement for the Nationwide Health Information Network.
>
> So it\'s important for us to really think and deliberate on what are
> the priorities. What are these critical components that will then end
> up informing and prioritizing the work of these other organizations?
>
> \>\> CHIP KAHN: Why don\'t we go around the phone a bit here and
> just ‑‑ I will sort of start at the middle of the list here.
>
> Leah, are you there? Leah Devlin?
>
> \>\> JOHN: She has to be at the legislature so she was on her cell
> phone at first, but she may not be on right now.
>
> \>\> CHIP KAHN: Okay. Are you there from North Carolina?
>
> \>\> JOHN: Yes, I am. My name is John.
>
> \>\> CHIP KAHN: Do you have anything to add at this point or do you
> think she would?
>
> \>\> JOHN: I think you have to define actually how the charges
> changed, and I personally have missed some of the calls, but I
> understand what we heard from New York City, we started from or, I
> guess, for those of us who are closer to the field, a simpler
> approach, and if not, it\'s shifting to what are the priorities that
> are needed or the critical components. It helps me to understand
> exactly what needs to be done now.
>
> \>\> Adele Morris, are you there?
>
> \>\> ADELE MORRIS: Yes, hi. Thank you so much. Kelly, building off
> what you just said of kind of at the end of the day, if what this
> thing we bring forward is going to result in use cases that go to the
> HITSP and so on, then it strikes me that what we ought to do is,
> first, list what some of those items might be and then decide on how
> to prioritize them.
>
> And I think I have heard a couple already today, including the need
> for public health systems to be able to communicate with each other,
> and that might be a critical part of event monitoring. And, let\'s
> see, what is the rest of the broad charge?
>
> That might be one, and then another one might be what we were talking
> about earlier, of getting more aggregate data from in‑patient
> settings; then another one might be getting individual patient level
> clinical data from electronically enabled clinical settings and so on.
>
> So for me, what\'s helpful is if we list all of those things, and then
> we say, okay, well, where do we think the greatest benefits are going
> to accrue; you know, how do we really set our priorities, and then how
> doable are those things, and then, do our best to rank them.
>
> That\'s how I would do it.
>
> \>\> So I would add to that list \"case reporting.\"
>
> \>\> ADELE: Right. Definitely the case reporting in an electronically
> enabled way, right?
>
> \>\> Right.
>
> \>\> ADELE: And then there would be various options on how we might
> propose that it should be done.
>
> \>\> Some of the bidirectional communication issues.
>
> \>\> Is that public health?
>
> \>\> This is public health providing information to clinical care,
> whether that be in the form of alerts or feedback loop.
>
> \>\> ADELE: Right. Right. In terms of providing, for example,
> instructions or we have learned this about such and such situation
> that tells us the clinical care should look a certain way.
>
> \>\> Sometimes it\'s been expressed in the context of just clinicians
> knowing ‑‑ having, for example, maps of where infectious diseases are
> in their community, and there are different ways of sharing that
> information that is useful for clinical providers in that context.
>
> \>\> ADELE: Oh, definitely. And this can, also, be feedback loops from
> different levels of government to public health. Maybe there are
> already structures to do that, but let\'s say one level of public
> health has realized that a condition is spreading through schools.
> What\'s the best way to very quickly and efficiently give that
> information to the other levels and the clinicians.
>
> \>\> Boy, let me ask you a question, and then I will ‑‑ well, actually
> before, let me ‑‑ David Parramore, are you on there? Are you on the
> line?

\>\>DAVID: Yes, I am.

> \>\> Let me run through everybody. Do you have anything to add right
> now?

\>\>DAVID: Not so much to add. I appreciate the discussion. I guess from
a DoD perspective, some of the things that we really focus on in systems
development are the keys are interoperability, of course, and then a
clearer definition of the business process that we are trying to
achieve.

> I think you\'ve addressed both of those here, and we have done a
> pretty good job so far outlining those in our discussions.
>
> But as we offer systems, like Essence and others into this, hopefully,
> the way ahead, interoperability with those systems will be a key facet
> to success, but I really appreciate the discussion so far.
>
> \>\> Is Michelle, with the Association of Public Health Laboratories,
> Michelle, do you have anything to add?
>
> \>\> MICHELLE: Yes, here I am. This is extremely interesting to me as
> well looking at it from the narrow scope of the laboratories
> perspective, and I have actually been involved with the Electronic
> Health Record breakthrough Group as well, and one of the main issues
> there is dealing with standardization of laboratory data coming into
> an EHR, which would then be forwarded on to a biosurveillance
> workgroup.
>
> And I really appreciate being able to listen into this call and to
> kind of understand how you are going to hone the scope of this whole
> process.
>
> So I am sure I will have more to add as I learn a little more and
> listen a little more, but this is very interesting.
>
> Thank you.

\>\> CHIP KAHN: And Mary Brady. Did I miss anybody?

> \>\> LAURA CONN: Hi, this is Laura Conn from CDC.

\>\> CHIP KAHN: I apologize.

> \>\> LAURA CONN: No problem. I think we started to scope out what our
> thinking would be, public health monitoring and response manage or
> something similar to that; that is in the wording of the scope of the
> charge. I think that\'s a helpful start, and we should probably try to
> put some more specifics on that and get that on paper.
>
> We have listed things like notifiable diseases and alerting. There is
> a few other things that come to mind, potentially around
> immunizations, adverse events, and allocation and distribution of
> pharmaceutical and prophylaxes within response in management that
> might also be added here.
>
> \>\> (Indiscernible)?
>
> \>\> Yeah. I think the discussion is really helpful. I think folks
> have already made the major points. Reading the charts to support
> real-time nationwide public health, event monitoring, and rapid
> response management, I guess four issues come to mind. The first is
> what are the threats and what is the data for the threats to detect
> and monitor them.
>
> And I guess that\'s what the Data Steering Committee will do, and we
> have a notifiable disease set already at CDC.
>
> I think that first task is, there is a vision there, and then the
> other three areas that I see need to be worked on, and these can be
> prioritized in any which orders, okay, the first one was what\'s the
> minimum data set, and what are the threats, and what\'s the data for
> them.
>
> And the second one is, how do you transmit that data from clinical
> care to public health.
>
> And as John said, bi‑directionally, as well, realizing that a lot of
> the data out there is in hospitals and may be with VHRs, but many of
> which are interoperable and, also, an external lab; that is one ‑‑
> that could be the next broad focus.
>
> The third focus could be then, great, public health will get all of
> this data, but how do they analyze this data and you can look at the
> hundred ‑‑ as Tom Frieden said ‑‑ you can look at the current system
> in the country and how are they analyzing the data. So that could be
> the third focus.
>
> And, I guess, the fourth is, and this has been already been mentioned,
> and how do you then connect all the public health systems, and does
> public health really want this, and they probably do, and what do they
> want this for, and as John alluded to, should there be a certification
> process for the public health systems.
>
> So I just, logically, from the broad charts, it seems like the first
> is, what are the threats and what\'s the data. And it seems that you
> have already started very well towards that, and then two, three, and
> four is transmission of data. Then analysis of data, and then
> connecting public health system education.
>
> So I think you all have really outlined the major areas in terms of
> the broad road map. It\'s just a matter of what you want to take on
> next.

\>\> CHIP KAHN: Let me respond to that. First, I think in terms of what
we did in the previous recommendation and the work that we have done
from that, as far as I understand it, we have set up a recommendation, a
real minimum dataset to be developed based on immediate threats, but
it\'s sort of more immediate threats that CDC, the Secretary, and the
state and local public health need, and my sense is that that will then
be worked through the various bodies, CDC and the public health
departments, and they will figure out what is the best way to get
whatever that minimum data set in real time is to CDC, and then it will
be distributed somehow back to the public health departments. That\'s
sort of my vision of what we agreed to previously.

> \>\> I think the one variance I would point to in that was that the
> data flow that was described was not to send the data to the CDC but
> to send the data to local, state and ‑‑

\>\> CHIP KAHN: In real time.

> \>\> ‑‑ to support the needs of each of those levels.
>
> \>\> CHIP KAHN: But that, in a sense, by its very nature, is
> short‑term because we want to come back and back fill, and that\'s
> what we have been discussing in the long run.
>
> What I would like to do, I guess, now, and I really appreciate sort of
> the structure that Adele gave us, is let\'s sort of spend the next few
> minutes to go back and create the list, and then we will drill down.
>
> Because I am a little troubled by this list because it just seems so
> broad, but the Chair should not bias the discussion here because I am
> not sure anybody else agrees with me. (Laughter).
>
> So I guess, let me sort of repeat back what I heard and then let\'s
> see where it takes us.
>
> First is this issue, and this may not come back exactly in the same
> way, but I want to make sure that we have everything on the table that
> everybody has been thinking.
>
> The first is the connectivity between public health entities, the
> state, local and Federal, for all the reasons that you would have
> connectivity, and included in that is, and I don\'t know if it\'s a
> subset of it, but some kind of feedback loop to the provider
> community. And is that one of the things?
>
> \>\> I think those are both ‑‑ those are two somewhat separate things;
> both important, but I would suggest naming them separately.

\>\> CHIP KAHN: Okay. The two things on the table is one, the
connectivity of public health broadly, and two, the feedback loop from
whatever public health produces or has alerts about that goes back to
the providers.

> And let me say, let me sort of ask a question of my public health
> officers here, because I am not sure I know the answer, so let\'s say
> in the current world, there is an article this morning in the Wall
> Street Journal that says that there could be a real problem with drug
> alluding stints. So when that occurs, and FDA is collecting
> information presumably about that; is that sort of correct?
>
> \>\> Yes.

\>\> CHIP KAHN: And so the feedback loop to cardiologists and other type
of cardiac interventionalist is right now?

> \>\> KELLY: For example, there could be a safety alert that would be
> distributed through the med watch system and there is also the
> opportunity through the health alert network to disseminate messages,
> but you could argue there could be better communication through
> signals that are detected and, perhaps, even stratifying the
> significance of the level of threat of those types of risks.
>
> \>\> As Kelly suggests, there are some ongoing efforts in this area.
> One of the things ‑‑ they suffer from two things, potentially. One is
> that they are not necessarily all coordinated and they move forward,
> and the second thing that is, as we develop the Nationwide Health
> Information Network, the kind of ‑‑ some of what they need to carry
> out their activities will be inherently integrated into part of that.
>
> So if you need to be able to communicate with a clinician as part of
> the Nationwide Health Information Network, that is really core to the
> kind of capabilities both the FDA and the CAC are interested in in
> terms of getting that information back.
>
> It has been problematic so far to have the kind of reliable list of
> phone numbers, fax numbers, e‑mail addresses, of clinicians to
> accomplish that.
>
> \>\> So tell me the feedback loop both in terms of issues, which I
> will for purposes here call \"public health,\" which are medical
> practices issues, because in a since, the drug alluding stint is a
> medical issue. It is not like a public health threat like some kind of
> infectious disease.
>
> \>\> But the jurisdictional issues ‑‑ I am just sort of separating it
> out ‑‑ are the same, but it seems to me if we are talking about the
> feedback loop here, we want the feedback loop to include both that as
> well as the conventional public health threats. That if there is a
> heightening of certain infections in a certain area, or if you are
> seeing from your data that there is certain bacterial infections that
> are appearing in hospitals, and you want all the hospitals in a given
> area to know that they better be looking out for \"X\" because only
> such a such antibiotic will work for \"X.\" Those are the kind of
> things we are going to want.
>
> \>\> ADELE MORRIS: Can I just expand the vision one step even more,
> and that is, if you have an adverse event report of some sort, is it
> possible to have the possible health authorities responsible for that
> report to populate EHRs of relevant patients?
>
> \>\> Well, this is an interesting thing, and I sort of think about
> this, which I will get to next in sort of terms of Norton, Norton
> virus. I mean, Norton virus scan, as long as you are pushing the
> button every day to update, they send you whatever the latest is, and
> it\'s all invisible to you.
>
> But it comes into your computer, and then it\'s there, and if a virus
> pops up that is subject to the scan you got last night, then you will
> get a warning about that virus, and in a sense, it\'s the same kind of
> thing that you are talking about.
>
> \>\> ADELE MORRIS: Yeah. And I like what Kelly was saying about having
> them ‑‑ having various kinds of adversities ranked. For example,
> let\'s say there was a recall on a pacemaker, or something. I don\'t
> even know if I would use that word.
>
> \>\> This then gets back into the other issues that I raised when I
> started. If you have perfect interoperability and EHRs that all meet
> standards regarding clinical decision making, then presumably, if a
> doctor puts in some note in the record that says that this person has
> got a blocked vessel and is going to need X, then there is going to be
> some trail of questions or something that will come up on the screen
> and what we are talking about now is having those be dynamic so that
> as new information comes out, if all of a sudden there are new
> indications about picking a metal stint verses a drug alluding stint,
> would it be available to the cardiologist?
>
> \>\> ADELE MORRIS: Well, I would even do it slightly differently in
> that if somebody already has got a stint that is model number ABC that
> we know is a problem, then the physician is alerted. Say, you have a
> patient in your ‑‑ your EHR records show that you have a patient that
> has a stint.
>
> \>\> That\'s a good one, too, because they then may want to do
> Coumadin or something.
>
> \>\> We have to come up with the right language for this, but they are
> sort of flip sides of the same issue and one is an alerting base.
>
> \>\> ADELE MORRIS: A forward looking thing and one is a backward
> looking thing.
>
> \>\> Yes. And then the issues around who gets notified to that. So one
> is more of a CPO, or computerized patient order entry issue, and the
> other is more of a query of EHR data based on a new alert or
> information.
>
> \>\> And there is real examples that exist in EHR systems that have
> been implemented and, for example, when Vioxx was withdrawn from the
> market, some systems around the country had a way of automatically
> alerting physicians when they tried to prescribe. So it\'s out there;
> it\'s just that it\'s not systemwide.
>
> \>\> BRIAN KEATON: This is Brian. I think we are treading into a real
> dangerous area here. Talking about Big Brother watching and a push
> back that will shut this whole activity down. Give the Federal
> Government the right for whatever reason to go in without permission
> or without direct permission to search physicians\' records for
> individual patients with individual criteria.
>
> \>\> Let me just clarify because that is not what I was trying to
> suggest. That could be done, and there is absolutely no reason why it
> can\'t; it has been done in some circumstances where that information
> ‑‑ that query that should be done is advanced to the clinician.
>
> \>\> Let\'s go back to my virus scan example. If I have a virus and
> Norton does not know whether I have a virus or not, Norton just knows
> there are 10 new viruses they want me to know about. So they send
> those to me and they get integrated into my system. I assume there are
> ways that once that virus is detected, if I remember, you then get
> some query boxes that you can send it back to Norton.
>
> But in this question, but to answer your question, there is no reason
> necessarily that you have to have the second point.
>
> It just means that every EHR would be re‑populated every night with
> whatever the latest clinical decision making it is. And then, I mean,
> it would be, in a perfect world, we would have the feedback, but to
> protect privacy, we might not have the feedback, but still, that
> physician has access and the patient has access to the latest medical
> practice data that they would need inside their EHR.
>
> \>\> ADELE MORRIS: And the EHR vendor can design the product such that
> whatever that alert is, they have some kind of interface that deals
> with that information, whether it\'s pop‑ups when the clinician first
> logs on in the morning or just a note that goes into the patients\'
> records or what have you.
>
> \>\> Right. So the one thing I was stressing, though, was from a
> patient\'s perspective, and from a private perspective, we got to have
> a hard wall that it may be the patient that gives permission or it may
> be the clinician that gives permission, but it can\'t just be a free
> reign for public health entity to say, hey, there is a real need here
> and I need to search your records.
>
> \>\> There has actually been a fair amount of work that is being done
> there, also, and I will add to the mix here in the consideration of
> personal health records where it is ‑‑ there are methodologies that
> are being considered for how a consumer could have a personal health
> record and can be notified of current information related to their
> medical context without their medical context being shared necessarily
> with others.
>
> So I mentioned that because I think that there is important work that
> is going on in that regard, but I, also, mention it because the
> personal health record is not ‑‑ is another place where some of these
> same considerations ‑‑
>
> \>\> CHIP KAHN: Let me suggest ‑‑ I think in terms of the feedback
> loop, we have a lot of issues out there.
>
> Let me go on to the next issue because I would like to define, if
> it\'s okay with everyone, our task today to at least get this list out
> there. Whether or not we narrow down the list today ‑‑ when is our
> next meet?
>
> \>\> Not until July 27.

\>\> CHIP KAHN: Okay. We can talk about in a few minutes once we get the
list out how we want to deal with it, but I would like to get the list
out.

> The next item that I thought I heard was the aggregation in various
> ways of the data for public health use.
>
> \>\> Chip, can I just ask ‑‑
>
> \>\> CHIP KAHN: Yes.
>
> \>\> How did you record? What were the buckets that we put on the list
> from the last discussion?

\>\> CHIP KAHN: On the last discussion, I put on the feedback loop with
providers, and I divided it into sort of the public health aspects of it
and the medical practice aspects of it. Although, those two can ‑‑ and I
was sort of dividing it that way, but I can divide it another way if you
would like me to.

> \>\> Well, I think that it was a great discussion, and we teased out a
> little finer granularity with some of that and the whole CPOE aspects
> from a public health standpoint are important because not just what we
> talked about with new alerts, but because reminders, for example, on
> treatment ‑‑ on preventive actions that have not necessarily been
> taken. The classic one is immunizations, and things like that, but we
> can tease that out.
>
> \>\> CHIP KAHN: I think we are dealing with here is notification, and
> I think because of the privacy issue, what I am hearing, in a sense,
> we may end up with dead notification, and what I mean by \"dead\" is
> the information goes into ‑‑ sort of goes back to the record and
> informs the record so that the users of the record are informed but
> does not mine the information necessarily from the record and take it
> back to the entity that sent it.
>
> That\'s the privacy wall, I think, right? Did I say that right? Was it
> Brian?
>
> \>\> BRIAN KEATON: I think you are on with that.

\>\> CHIP KAHN: Did that get enough out there?

> Now, the aggregation, and I guess Bryan was the one that brought up
> aggregation, and there is all different kinds of aggregation.
>
> How many aggregations do we want to have on our list?
>
> \>\> BRIAN KEATON: I thought we were sort of breaking that down by
> data type instead of by aggregation verses non‑aggregation, public
> health function, and one of the things we had not talked about
> heretofore was really in-depth with notifiable diseases and case
> reporting, which is another type of reporting.

\>\> CHIP KAHN: Let me make another suggestion because the way I see it
is, and going back to Tom\'s point a while ago, and obviously, the Data
Steering Committee will come up with some limited data set, but there
are a lot of places where there is healthcare interaction, and it seems
to me in terms of aggregation, I was hearing ‑‑ I mean, there is one,
there is use of the EHR in terms of getting the information that would
then be aggregated, and there is integral activity, and whether it\'s a
ER or clinic or a hospital itself or doctor\'s office where entity level
and maybe stuff would be integrated at that entity level and sent to
public health.

> That\'s one of the things we discussed, right?
>
> \>\> ADELE MORRIS: That\'s sort of what I was talking about when I was
> talking about aggregate data. It was going more towards capacity
> utilization and stuff like that.
>
> \>\> Is that where you are, John?
>
> \>\> JOHN LOONSK: Yes. I think there are, at least, three models.
> There is one that is the individual EHR. There is one that is the
> hospital or clinical care site as a data provider, which drives data
> from a variety of different internal systems, which I think that was
> in part of the initial charge as well.
>
> And then the third area that was talked about was multi-jurisdictional
> or data aggregators or functional data aggregators, and you can think
> of a functional lab or hospital system or other things where they are
> aggregating data to pursue a purpose, but those data may be of value
> to public health.

\>\> CHIP KAHN: The other one that I heard, because those are private
systems, and then the question is: Is a hospital association or another
entity that is going across these sort of entities that you are talking
about includes, that would be a fourth, right, or is that in the third?

> \>\> ADELE: I am getting a little confused, though, because my
> understanding was the point of getting this data ‑‑ now here we are
> talking about the more raw data from the electronic systems or when
> you start getting to these multi-jurisdictional or multi‑entities
> aggregator, then you are not collecting that type of data anymore. You
> are collecting something else, which is semi‑process data, but I think
> we want to be careful.
>
> \>\> Adele, that\'s not actually quite true. One of the classic
> examples in public health is the national labs that do testing on
> notifiable diseases, and the results they report are individual
> results; for example, a positive tuberculosis test or you choose a
> test that is notifiable in a particular jurisdiction. It\'s not
> aggregate data, but the question is: Do you need to go back to the
> clinical care site to get those data.
>
> In fact, many of the national labs have been great participants in
> public health and that individual level data.
>
> \>\> CHIP KAHN: They send data in to whoever they send data to without
> any connection back to the patient. We have done X number of TB tests,
> and they were 3 percent or 5 percent positives, which is like off the
> charts, so people have to react.
>
> \>\> No. They send patient level data. They send patient level
> results.
>
> \>\> ADELE MORRIS: So how do you avoid double counting if you collect
> it both from the national labs and from the EHRs?
>
> \>\> That\'s where the patient identifier may come in here.
>
> \>\> Yeah, it\'s a complicated issue. The porosity of actual reports
> to public health have made it relatively moot, to be honest, and so if
> you got notifiable disease reporting that is in the teens, for
> example, you are not so much worried about double reporting as you are
> general reporting.

\>\> CHIP KAHN: And I think, and I was sort of joking, but actually, I
was not joking at all. I don\'t think, in the bright future, that would
not be an issue because if we are talking about individual patient level
data, they would be an identifier and the identifier ‑‑ so they would
not be double reporting because the identifier would tell whoever it is.

> \>\> I think another way of articulating that would be in the eventual
> and architecture, there should be a way to eliminate double reporting
> and still be able to correlate the different information from
> different sources without having a patient identifier.

\>\> CHIP KAHN: That\'s much more delicately put.

> \>\> That functionality will probably reside within RHIO.

\>\> CHIP KAHN: It could. I want to try to get to my list. I think I
have the aspects of aggregation, and part of my objective here is to
narrow this list, and it\'s good thinking, but I wonder if we are just
taking on too much.

> \>\> We are just making a list.

\>\> CHIP KAHN: I know. I understand. Then we had the case reporting
from the electronic.

> Well, I guess, really, under the aggregation was case reporting from
> the electronic case records.
>
> \>\> I think case reporting bears individual identification by itself.
> There is a huge infrastructure and mostly manual in this country
> around notifiable disease case reporting, and it really needs to be
> considered as to how it factors into these activities. So I would ‑‑
> it\'s not really an aggregation issue. It\'s ‑‑ this is the way a lot
> of public health reporting is done, and so it should ‑‑ I think it
> stands on its own.

\>\> CHIP KAHN: The question there would be a lot of it\'s already done.
How will it change or should it change with VHRs?

> \>\> In fact, many of the issues here are the issues that we have been
> touching on, and most of the systems that have been developed for
> notifiable disease reporting are not initially timely. The systems
> rely on manual reporting; the issues of ‑‑ the rap is that they are
> disease specific, and so you have one system for Tuberculosis and
> another for another disease and another for another disease, and that
> they don\'t share information and people have to enter the same
> information over and over again.
>
> So I think there is a fair amount of discussion in just that area.
>
> \>\> Then a somewhat related issue that we have not previously tabled,
> but I am sure the FDA would want this on the table if they were on the
> call, is adverse event reporting.
>
> It\'s not necessarily exclusive to medical products, drugs and devices
> and biologics, but it could also be a different type of patient safety
> and those with common infections and other types of adverse events.

\>\> CHIP KAHN: So I would sort of word this as adverse event reporting,
and here, we are talking about medical practice and patient safety.

\>\> Medical products, yeah.

\>\> CHIP KAHN: Well, I was saying medical \"practice\" because if the
products are part of it, but right now, there are no feedback loops on a
lot of surgeries that may or may not actually include products.

> And it seems to me if we are going to reach for the stars here, that
> would be something that we would really want.
>
> \>\> I think I would like to follow‑up on that, if I can have Chip\'s
> forbearance to talk about an area, which is ‑‑ and Laura Conn talked
> about it earlier, is one of the needs that we have seen historically
> in a number of different scenarios is around the response management
> piece.
>
> And it starts to get at this adverse reporting as well. So I will pull
> it back around to that, but wherein, you know, usually treatment is
> provided, prophylaxes is provided as part of routine clinical care;
> when there is an emergency, some of those information flows and some
> of those activities goes into the air, and an example of this, for
> example, the small pox vaccination program where the need was to try
> to vaccinate clinicians in some sort of time frame to be able to track
> it versus advance associated with specific lots of vaccines and to be
> able to determine who was vaccinated, or at least to ensure that
> certain people who are eligible to be vaccinated had their information
> passed on to the vaccination process so that they could be vaccinated.
>
> Another example of this is in the flu situation; a couple of seasons
> ago where a major vaccine producer ‑‑ the vaccine was no longer
> available. There was limited vaccine supply, and there was a need to
> consider the data management needs of apportioning and distributing
> that counter measure, as we would call it, in the context of meeting a
> real need.
>
> That was sort of a non‑emergency situation, I think, one could
> express. It was emergency in some context, but it is important to
> understand that, in fact, the stockpile that is supported by Health
> and Human Services and other counter measure activities are very much
> dependent on surveillance to know where do you deliver the counter
> measures to accomplish an appropriate response. They are dependent on
> knowing how that surveillance activity is changing, so is your
> response actually helping, and that those activities, too, around
> counter measures are also heavily data intensive.
>
> They overlap the clinical care system and the public health system,
> and at times, it\'s hard to separate out the incoming data from the
> outgoing distribution.

\>\> CHIP KAHN: And you described a situation that was immediate because
of infections or the threat of small pox.

> It\'s my impression that Mark McClellan is now, basically, inviting
> but requiring new devices to participate in registries, which in a
> sense, plays a similar kind of role potentially.
>
> I guess what occurs to me is the following: We have created a list
> with around six different sort of topical areas, and under each of
> these, whether it\'s connectivity, the feedback loop, case reporting,
> adverse advance reporting and response management, and I think that
> roughly catches everything. There is a tremendous amount that is done
> now.
>
> Not much of it is electronic other than by e‑mail or other kind of
> communications, which is really just a variant on the telephone, and
> the aggregation is probably not dissimilar.
>
> I guess I wonder whether we should do the following, and I just have
> this tendency to narrow, but I am wondering whether to have another
> conversation; we really need to have each of these areas sort of
> explored with an outline that sort of outlines ‑‑ I mean, we have been
> talking and talking, but it seems to me that if the staff could accept
> this assignment, and maybe under each, work up the issues.
>
> For example, there are a lot of things that are happening now, and
> it\'s hard to visualize where we want to go unless we sort of know, at
> least in terms of a list, sort of what is happening now and what we
> are building from.
>
> And I would like to narrow this, but I think I am reticent to even try
> to do that until we have this sort of worked out and have it on paper.
>
> And so I guess my request would be is ask the indulgence of the
> Workgroup, would be to have all of these fleshed out what the universe
> is.
>
> \>\> So we can talk about it in the same way.

\>\> CHIP KAHN: Yes, and then we can proceed from there. Obviously, that
would mean you would all have to go off and do that and then come back
in a few weeks and do that.

What do you think about that?

> \>\> I think that\'s a great idea. If we have a month before our next
> call, what we could potentially do then is share that more detailed
> outline that incorporates what is already ongoing or funded across
> agencies and jurisdictions, and then ask people to rank them on their
> own and then we can look and see what the ranking is before our next
> call, which will then help us at least do some preliminary planning or
> to figure out what we need to be teeing up first, second and third.

\>\> CHIP KAHN: I will go back to it, I think the fundamental question
once we see all of that that we have to face is that either we are going
to think about considering all of these possibilities, what the role of
the EHR, the individual EHR is in all of this, or we are going to ‑‑
that\'s going to be a subset of a broader agenda that talks about all
kinds of different electronic communications, which connects with all
different kind of feedback loops that are implicit here, and if we
choose to go that other route, that\'s fine.

> But in a sense, we are going in terms of the whole route in the
> communication loops inside the public health, and if that\'s what we
> want to do, we can do that, but it seems to me we cannot even respond
> to that question until we see everything and determine how big the
> universe is.
>
> \>\> Public health is not carried out exclusively in public health
> organizations. And clearly, a lot of it is carried out in clinical
> care, and I think that what we see is, as we move to the electronic
> world, that those lines are blurring still further, and for the
> better, and it\'s just that much more critical that we are coordinated
> between public health and clinical care to help with some of this
> vision.

\>\> CHIP KAHN: Is that okay with everybody on the phone?

> \>\> ADELE MORRIS: This is Adele. I definitely think this is the path
> because my sense is it\'s way too soon to start narrowing.
>
> I think we need to kind of gather information and understand ‑‑ I will
> talk like an economist because I can\'t help myself, but just the
> cost ‑‑
>
> \>\> There is medicine for that (laughter).
>
> \>\> ADELE MORRIS: We all wish (laughter).
>
> The cost and benefits of one thing, one approach versus another and
> all of these things on this list, but there is nothing I have heard in
> our discussion that you say: Oh, man, that\'s a really low priority.
> We can take that off.
>
> They all strike me as things that are going to be needed to be dealt
> with. It\'s a matter of what you do first.

\>\> CHIP KAHN: And I think from my view, ultimately, I think we have to
have some criteria what we can physically deal with in the time that we
have. Not that everything does not need to be dealt with, but that\'s
down the road, and I think we do that in the next few meetings and
decide if we needed to make that decision or not once we have seen the
universe.

> I think we have a pretty full list, and that list will evolve, I
> assume, as you guys go back and actually fill it out with an outline,
> and you may change the topics around, and, obviously, you are free to
> do that and we may not have articulated or written or labeled all of
> these things exactly right.
>
> So that would be my proposition, and then we come back on July 27, and
> you will be in communication with everyone prior to that with whatever
> you have produced.
>
> So depending on the work schedule of the staff, we may have sort of
> iterations and responses prior to the next meeting. And the next
> meeting is at 1:00 o\'clock on the 27th.
>
> And I guess we need public comment, don\'t we?
>
> Well, does anybody have anything to say before we go to public
> comment?
>
> Okay. Thank you, all. And let\'s open the phones now to public
> comment. Operator?
>
> \>\> OPERATOR: I am receiving no questions at this time.
>
> \>\> CHIP KAHN: I\'m sorry?
>
> \>\> OPERATOR: I am receiving no questions at this time.
>
> \>\> Let\'s give it about 3 minutes to allow people to get the chance
> to dial in, and those of you who are on the phone, if you have been on
> the phone, please just press Star 1 to indicate you have a question,
> and if you are on the Web, you will see the phone number on the slide
> in front of you, and you can dial that number and get in the cue for a
> question.

\>\> CHIP KAHN: Let me say before anyone comes on the phone, if they do,
that when the staff prepares this outline, they will make it in a format
that we can do some preliminary rankings, and it would be great if
everyone participating ‑‑ and this will all be explained in e‑mails
going out and can get back with their rankings and it can really help
our discussion along.

> \>\> It does not have to be sort of a final determination, but I think
> it will probably help us to at least get an initial impression of what
> people are thinking.

\>\> CHIP KAHN: Right.

> (Pause)
>
> Okay. Three minutes can be a lifetime (laughter).
>
> Although, three minutes is a lifetime in basketball. Actually, five
> seconds is a lifetime.
>
> \>\> Three minutes is a whole game.

\>\> OPERATOR: Just so everyone knows, we have nobody dialing in on the
line now.

\>\> CHIP KAHN: I think since we have no public comment at this point, I
think we probably waited sufficient time, why don\'t we just reconvene
on the 27th, and Kelly and the staff will be in touch with you regarding
the progress on the outline in the meantime.

> Thanks a lot, everybody.
>
> \>\> I didn\'t hear at the beginning, the way the phone was broken up,
> have we put the Steering Group together, the group together in terms
> of the data?
>
> \>\> CHIP: That\'s being put together.
>
> \>\> KELLY: Yeah, we received a lot of recommendation on who should be
> on the committee, and we are now trying to sort of verify
> availability, and we will be probably scheduling our first meeting in
> the next week.
>
> And we are, also, working on finalizing a charter. So we are well on
> the way. We are just trying to sort of take care of some details at
> this point.
>
> \>\> Can that information be shared with us with the Workgroup here?
>
> \>\> KELLY: Sure. We can give an update as needed.
>
> \>\> Thanks.

\>\> CHIP KAHN: Thanks a lot, everybody.

> \>\> Thanks.
>
> \>\> Thank you.