American Health Information Community

Work Group Consumer Empowerment Web Conference

February 21, 2006

4 hours, 9 minutes

\>\> Scott, your line is open. Please go ahead.

\>\> Matt: Okay, Dana; we've got the public in now if you want to go
ahead with your introductions and your opening.

\>\> Dana: Hi and welcome, everybody, to today's call to the Work Group
Consumer Empowerment. What we'd like to begin with is roll call. With
me, I have Kevin Hutchison, Ross Martin, Sue McAndrew, and Davette
Murray. And Matt, who else do you have on the call?

\>\> Matt: Also on the call, we have Loraine Duke, Scott Serota, Donald
Mott, Charles Safran, David McClain, Tim Smokoff, Nancy Nielsen, Robert
Kolodner, Kat Mahan, and Robert Tenant. And we have our Co-chairs: Nancy
Davenport, and sitting in for Linda Springer today is Dan Green. And if
I can make a quick note to all the members, we\'ve got the same
procedure in place as we did last time, which means that your lines are
set to listen-only and if you want to make a comment, you need to press
star 1.

\>\> Dana: Also, the public will be able to call in at the conclusion of
the meeting. So with that, Nancy and Dan, I turn the call over to you.

\>\> Nancy: Thank you very much, Dana; we appreciate that. Matt, thank
you for also conducting our roll call on the phone, and Dan, thank you
for being on, representing Linda Springer. And before I begin my formal
review, are there comments you would like to make to the group, Dan?

\>\> Dan: No, I just want to express Linda Springer's appreciation for
you chairing the meeting in her absence. She will be joining us if
possible during the conversation.

\>\> Nancy: Thank you. As we look at the agenda for the afternoon, we
will see quickly that after our opening remarks, we will move to a
review of action items that are a result of the first meeting that we
had, as well as overview of background materials and meeting format. We
will also be joined this afternoon by a number of speakers who have
participated since the last call in developing materials that are being
reviewed today and will be available to first conduct the review of the
materials and then to answer questions and to take comments relative to
those items.

I\'d like to, by way of review and reminder, review again the broad
charge of the Consumer Empowerment Working Group, which is to make
recommendations to the community to gain widespread adoption of a
personal health record that is easy to use, portable, longitudinal,
affordable, and consumer centered. We also were given a very specific
charge: to make recommendations to the community so that within 1 year,
a prepopulated, consumer-directed, and secure electronic registration
summary is available to targeted populations. Additionally, to make
additional recommendations to the community so that within 1 year, a
widely available prepopulated medication history linked to the
registration summary is deployed.

As a result of the discussion that we had just 2 weeks ago with our
working group, there were a number of action items that were to be
developed for the February 21 meeting that we are convening today, and
those include the following. Guiding principles: Using the Markle
Foundation's principles as a template, ONC will develop this document.
Number two, an inventory of tools: ONC will begin the process of
identify cataloging tools already on the market. ONC sent out the CMS
inventory of 65 personal health record products. Blue Cross Blue Shield
also sent information that is under review at this time. Additionally,
there is an inventory of tools -- evaluation matrix. ONC will develop a
matrix to assess the tools contained in the inventory -- issues list
including barriers and policy issues. And today, we\'re actually going
to have a presentation around what some of those barriers of policy
issues would involve.

Additionally, we were charged with looking at breakthrough project
options. ONC will identify options for the who, what, and how of
possible breakthrough projects in the area of consumer empowerment.

I think as we look at the action steps that we were charged to address,
I would also like to acknowledge that a number of persons working in the
working group have, for the last 2 weeks, been supplying us with
information around principles that need to be considered, registration
data points that need to be reviewed, and summaries of barriers that we
may encounter as we are moving forward in trying to meet the charges
that have been given to this group. There is available for review a
summary from the last meeting that does go through the guiding
principles of review of our workgroup charges. And within that review,
there is a section entitled Creating an Electronic Registration Summary
and Medication History, Challenges and Action Steps and Possible
Strategies to Address Them. If you look at the grid that has been
provided in this section of the review, it is divided by item, and we
first have identified the challenges and then the actions to meet them,
beginning with the lack of commonality and the action needed to review
that inventory of tools and an inventory of tools matrix, time
constraints, and addressing needs and the strategy is to look at,
quote-unquote, the good enough model, which was brought forward in the
last call that was convened.

Dana and Kelly, I would certainly invite either or both of you to make
specific comments you would like to around the matrix that has been
created as a part of that section for the group.

\>\> Kelly: Nancy, this is Kelly. I would just want to point out that
CMS did actually highlight some the functions in their matrix that are
applicable to our specific and broad charge. So you\'ll notice whoever
does have access to it now that there are functions specific to
medication history and medication management, as well as eligibility or
registration information. So we have that as a starting place. It\'s not
an exhaustive list of functionality, but it does at least give us some
idea of what's out there across 65 different products.

\>\> Nancy: Thank you, Kelly. And certainly, for those of you who have
not reviewed this document, you may want to go to the Web site and take
an opportunity to review it. It is a very well-done document.

In keeping with today\'s agenda, I would like for us to turn our
attention to the first action item that we were charged with in the last
call, which was to collect several suggestions for principles that
needed to be considered. And to that end, David Lansky is going to be
with us this afternoon to review the principles that have been advanced
by the Markle Foundation. Is David currently on the call?

\>\> Matt: Yeah, David actually just walked in, and he\'s with the ONC
folk over at the Humphrey Building. David, are you close to a --

\>\> David: I\'m right here. Thanks.

\>\> Matt: Okay.

\>\> Nancy: David, this is such a pleasure to have you is an area in
which your group have worked for a sustained period of time, and you
have wonderful published reports. We welcome you to the call this
afternoon and look forward to your review of the proposed principles for
our group.

\>\> David: Thanks, Nancy.

\>\> Nancy: You're welcome.

\>\> Kelly: Nancy, this is Kelly. I just also wanted to mention the
principles that we provided the group reflect some of the comments that
we got back on the draft principles that Markle had put together a
couple years ago that were sort of a higher-level set of principles. We
have since incorporated a much more refined set of principles that not
only apply to personal health records but also apply to the general
concept of health information exchange within our specific charge. And
they also reflect input from Blue Cross Blue Shield Association, which
works with their members and also the members of American Health
Insurance Plan, to make sure that the plan perspective was incorporated
into this master set. So I think they represent a really good
comprehensive list of principles that really touch on a lot of the
policy issues that we\'re likely going to have to talk through today to
come up with our recommendations to the community on March 7.

\>\> Nancy: Thank you, Kelly.

\>\> David: And Nancy, can you -- or Kelly, can you give us guidance as
to what actions you\'d like to take with regard to this document today?
Is this for review, for approval, for selective approval, or what do you
hope to achieve today?

\>\> Kelly: Yeah, Nancy, in communicating about this over recent days, I
think it would be ideal if we could get consensus around a group of
principles that could be, you know, sort of the first part of our
recommendations to the community. And I think they will also help shape
the work that\'s going on within the NHN consortia and some of the other
contractors working with ONC. In terms of timeline and process, it would
be very helpful for the workgroup to get some consensus around these
principles today.

\>\> Nancy: And David, I would certainly concur.

\>\> David: Well, I\'m happy to walk us through these materials and
explain where they come from. I will say that -- well, let me do a
little bit of background. First, on the top of the handout you have that
is labeled Principles for Personal Health Records, derived about 2 years
ago from a working group of PHR developers who had some experience in
the field and wanted to capture what they felt to be ideal states --
ideal attributes of personal health records. They weren\'t really
developed to be principles to guide immediate deployment of a project or
projects, but they were idealized, which -- we may want to endorse them
as ideals, but they were not really developed to be practicable. Second,
the set that comes below that, Principles for Information Access and
Control and so on, is a blend of work that has happened over several
groups over a couple years. And the caveat I want to put on the table
for us is that there are a group of consumer organizations who are
footnoted at the bottom of this page and have continued to work over the
last 6 months or so to, in light of everyone\'s growing experience in
this field, to rethink exactly what is important to them and what they
recommend to groups like us. So that work is in progress, and there is a
new draft, which I frankly find a lot more understandable and focused.
So as we go through these, I think we should review them, see if we
agree on them, but recognize there is continuing work going on by other
interested groups in some of this.

With that set of caveats, let\'s look at the set on top. It says
"Principles for Personal Health Records," and note first of all that
it's for personal health records, which is a broader domain than we are
tackling in this process this week, and secondly, it is meant to be
idealized. We should discuss, while we may agree, the ideal principles:
do we think they are requirements for the immediate year or two in front
of us?

I don\'t know that I want to beat every one of them or go through them
individually. Do I think we need to, Kelly?

\>\> Kelly: Yeah, I think there is a positive amount of feedback.
(indiscernible --- away from mic) --

\>\> David: Why don\'t we ask if there are questions, comments,
questions, concerns, about any of these that should be noted?

\>\> Matt: Reminder that any members of the workgroup, if you want to
make a comment, star 1. When I see your name, I will ask the operator to
open your lines so you can speak. But we\'ve got nobody waiting to make
a comment now.

\>\> David: No comments in the room that I can see. Yes.

\>\> Kelly: (indiscernible --- away from phone) --

\>\> Matt: People on the phone, could you hear the question?

\>\> David: It was a little quiet, Kelly; maybe you could get closer to
the phone and say it again.

\>\> Kelly: I was saying -- sorry. Okay. This is with Blue Cross Blue
Shield. I want to raise the point on just transparency point that the
thought is that it\'s not a record that shows every single person that
asks who it was, when it was, where it was. Just -- there can be some in
a broad view, as HIPAA does, knowing that there was an entity that did
look at this more broadly defined than it was -- a real detailed audit
trail, per se.

\>\> Matt: Operator, can you open Loraine Duke\'s line, please?

\>\> Loraine: My comment was for people in the rooms to get nearer the
phone so we could hear them and they won\'t have to repeat. Sorry about
that.

\>\> Matt: Good piece of advice. Please open Robert Tenant\'s line.

\>\> Robert: Hi, there. Can you hear me?

\>\> Matt: Yes.

\>\> Robert: Great. I'm with the Management Group Association. The one
thing that strikes me: I like the principles. I\'d like to have
something in there that would allow the PHR to be read and updated by
practicing physicians that don\'t have EHRs, because our own studies
show that currently only about 14 percent of practices have EHRs, and we
don\'t want to make that a barrier.

\>\> David: This is David again. On the last couple comments, just to
add some information, the Principles that was originally drafted did
have a strong audit requirement. The patient groups have voiced this --
and by the way, I don\'t know, Kelly, if it is still in this draft; I
didn\'t quickly see it -- that a person -- the first top-of-page-2
person shall have the ability to review who has access to personal
health information and so on. There has been, to his comment, a feeling
the technology does routinely provide for that auditing and that audit
should itself be available to the patient whose information has been
disclosed. We can discuss that, obviously, but that has been the view of
the patient advocate.

\>\> Kelly: -- onerous, (indiscernible) that is important point, but you
don\'t want to (indiscernible).

\>\> David: The second point, about the practice access: I think the
principle here that might address that is the one that indicates that
people, the patients, have the ability in this personal health record
world to determine who can see and receive access to their personal
health records, so distinguishing that from the electronic health record
that providers may or may not have. So in this model, I think the
patient can say, "Here's to the physician who doesn't have an EHR," in
this example. I\'m going to issue that person a password or credentials
to access my PHR, regardless of whether that doctor has an EHR, so it is
patient controlled that capability would be there. Does that answer the
question you were raising earlier, Robert?

\>\> Robert: I certainly see where you are going with it. I am not sure
it is explicit in that particular definition, though.

\>\> Nancy: This is Nancy. And David, from my review of your bullet, if
we look at the last two bullets under the section where we\'re currently
talking here on the top of page 2, people must have the ability to
designate and withdraw -- designate from proxies who have full authority
to manage their personal health information on the network. And after
that, people must be able to choose whether or not their information is
shared for the purposes of the breakthrough across the network in whole
or in part at any time without coercion or pressure. And also, even
above that, in your bullet -- that was bullet number two at the top of
the page -- people should be able to supplement or annotate their
personal health information. All self-reported data should be identified
as such in order to help ensure state of quality. Even above that, each
individual or entity assessing personal health information over the
network should have access authority and be authenticated. I think in
combination, those four points seem to address a fairly well-structured
process of the consumer being in control of who is going to access their
information and what steps it\'s going to take to do it.

\>\> David: The last point on the entire list, this would permit
patients to transmit information to their health care providers as well
as receive information from them?

\>\> Nancy: Uh-huh.

\>\> David: Implies that that capability is something we would hope to
achieve?

\>\> Nancy: Absolutely. I think the fact we talked about the authority
and the authentication processes, that is very integral to the
discussion.

\>\> Robert: Unless you wanted to add the word \"all\" to that last
bullet point. Patients transmit information to all their health care
providers. That real gets to the point of access to all the providers.

\>\> Kevin: It\'s their choice, right?

\>\> David: Kevin is asking --

\[laughter\] --

\>\> Kevin: It's their choice to give all access to their physician or
partial access. By having it within their control, they would get to
choose, right?

\>\> Nancy: Yeah, that is correct, Kevin.

\>\> Kevin: All right.

\>\> Nancy: I think -- from the patient perspective, I don\'t know that
inserting the word \"all\" is what the patient would want. I think the
patient would want to reserve the right to determine what health care
providers are indeed going to have access to their information. And
there may be some that indeed they were not going to give access to.

\>\> Ross Martin: -- (indiscernible-away from phone) I hear not exactly
an issue coming up about -- while we give patients a right to access
information, or the patients can get other providers right to access
that information, are we identify figure they are allowing them to just
see it or incorporate it into their record because once it is in their
medical records, as, for example, I\'m seeing a patient and they give me
their personal health information from their PHR, now it is part of my
record. I\'m not going to give them an audit trail that goes back to
their personal health record of every time somebody within my
organization necessarily looks at that, processes it, has to do
something with claims or something related to that. I\'m not -- I don\'t
see a clear breakoff point. And this is what is different about
electronic information versus, you know, the paper, the record. We
don\'t have one record anymore. We have as many copies as is necessary
to provide care. So I don\'t see that clarity in here yet and maybe
that's a point of discussion to help alleviate those concerns about the
extensiveness of the audit trail.

\>\> Kelly: Is there a way to propose a less onerous, but still
comprehensive account of who has viewed or who has --

\>\> Ross Martin: Well, I guess that matter -- if we can be explicit
about the information a patient is giving for their record, are they
giving a permission to view it, but not incorporate -- not extract the
data for their own records. Or are they giving them a copy -- basically
a copy permission and they are getting an instance of it that goes on?
Along with that permission, it is kind of an implication that they\'re
not going to have full control over that -- they're not going to have
the audit information about that copy necessarily, and is that something
that we\'re comfortable with?

\>\> Nancy: If we look at -- this is Nancy again. If we look at first
two bullets under Principles for Information Access and Control, people
must have the ability to control who has access to their personal health
information over an electronic health network, either directly or
through the action of designated proxy or by choosing not to exercise
that control. This control can be exercised in whole or only with regard
to selected elements of their personal health information. And the
second one: at a minimum, the structure and rules of the breakthroughs
must facilitate the ability of people to exercise their personal health
information right under the Federal Privacy Regulation mandated by
HIPAA. Do we not feel those combinations, those comments in combination
with others that we have called out would address the concern that you
were addressing, perhaps?

\>\> Matt: Kevin Hutchison has a comment.

\>\> Kevin: I guess on this topic, the differentiating point we are
trying to make -- is this data that is the accessible on the network, or
is it data that resides within an individual\'s application? Because
from an audit trail standpoint, I would agree, it\'s going to be very
difficult to submit backup to the PHR every time a physician may access
a patient\'s record in their own EHR system. But if we\'re -- I think
we\'re just dealing with a network registry in this particular instance,
right, with respect to access to medication history and registration
information.

\>\> Nancy: Kevin, that is my view of this issue, particularly when I
look at the fact that the individual that\'s accessing the personal
health information over the network, as we state, is going to have to
give authority and be authenticated to do it.

\>\> Kevin: Yeah, but so we're not claiming that once the physician --
say a patient gives Dr. Jones the ability to view and incorporate their
information, which is a subtle difference between view and actually
extract.

\>\> Nancy: Uh-huh.

\>\> Kevin: They give the permission to do that. Once the information is
extracted in their EHR, I don't think there is an expectation that there
is another audit trail that comes back up from the EHR each time that
they access. I mean, basically that information is now the physician\'s
information within their own charts.

\>\> David: It is still covered under HIPAA, and they have to protect it
appropriately. It\'s just that question of auditor, and that is exactly
what I\'m trying to get at to establish. I can read that interpretation
into this, but I don\'t think it's explicit.

\>\> Nancy: Is there a recommendation of wording that you think would
make it more explicit?

\>\> Kevin: Can I think about it and not spend our time wordsmithing it?

\>\> Nancy: Sure.

\>\> Matt: Please open Kat Mahan's line.

\>\> Cat: I\'m not sure if the line is open.

\>\> Matt: Go ahead.

\>\> Cat: Hi. I also had additional comments or maybe clarifications for
what\'s -- regarding, you know, the patient\'s consent in terms of who
-- whether it is accessing the data or consuming the data within their
own systems. In the principle for information access and control in the
first bullet point, this control can be exercised in whole or only with
regard to selected elements of their personal health information. Is it
also encouraging the notion of selected participants in terms of who can
view, or should the patient's users be only able to select certain
elements, or should they also have some ability to restrict certain
viewers, so to speak?

And I think my other point, kind of, for discussion for the group was
under the same section, Principles for Information Access and Control,
bullet seven. The breakthrough must provide a sound method for allowing
secure access and authentication -- and patient users that does not
require physician or institutional mediation. Have we eliminated totally
the idea of some type of identification or authentication via card or ID
from the provider of care, or has that been eliminated completely, or
are we to determine the sound method through this call? Thank you.

\>\> Nancy: I\'d open the floor for discussion.

\>\> David: Yes, I was going to respond to those two. This is David. The
first phrase in the first bullet: "People must have the ability to
control who has access to their personal health information." That was
meant to indicate that there is that selectivity as to which people can
access my personal health record, as well as to the second part you
pointed to, around selected elements within the full record. On the
other point you raised, about alternative methods for authentication, I
think the intention behind the principle was, there may be a wide
variety of methods available for authentication, and they should all be
explored, and the principle doesn\'t recommend one over the other. It
only says that shouldn't be a case where the way a person can see his
own information is by going through a doctor or health care institution.
We can probably think of 20 other ways of doing it. And we should when
we get to operationalizing all of these ideas: we will think about
those, but the principle was, one need not require the patient to go
through physician or hospital as a way of getting at -- looking at their
own information.

\>\> Nancy: Okay.

\>\> Matt: Please open Robert Tenant\'s line.

\>\> Robert: Quick question. This is my first meeting, so I apologize if
this was covered in the first meeting. What I have heard in the last few
minutes suggests that this PHR would be available only on an electronic
health network. I know that there is many models of a PHR, not least of
all one that could be contained on a Smartcard or even on a cell phone,
and it would be very portable, and I\'ve seen the word "portable" here
in the first set of principles. And to me, that first bullet under
Principles for Information Access and Control only suggests "electronic
health network." I just wanted to get clarification there.

\>\> David: One comment about that. These principles came from a
workgroup working on the subject of health networks and that -- so there
is a natural blurring of that. The phrasing in this particular bullet, I
will just mention, means where the information is going across a
network, these are principles that should apply. I think if it is on
Smartcard, flash drive, PC, different principles might be necessary.
Kevin, I think, wants to comment.

\>\> Kevin: I think there is a (indiscernible) EHR, the application
itself is on the network, but what -- we\'re really talking about the
data that is on the network. The EHR may be a client server-based EHR
like Microsoft or quicken application. I think we are trying to deal
with, as a group, the data and the network itself and the use of that
network versus actually where the PHR resides. Am I correct in that or
off on the assumption?

\>\> Kelly: I think that's correct.

\>\> David: Thank you.

\>\> Kevin: So if the wording is such that it implies the PHR is on the
network, I think that is the point being made. We should make sure there
is focus about the patient information on the network versus the
application itself.

\>\> Matt: Loraine Duke's line.

\>\> Loraine: I wanted to go back to one other item that someone had
brought up earlier about the authentication issue and the access
control, so later on down that first list. And probably most of you have
already looked at some of the PHRs on the system and experimented
yourself. If you haven\'t, by all means, do that. But the access
controls that many of them do offer has to do with literally give you a
user ID and a password to give to the person that you want to see the
record. So, for an example, you would take that to your physician, and
they would keep that in your medical records so that they would be able
to look at it. And a couple of them are -- actually operate similarly.

And then we -- you know, getting to this network issue and the
electronic network and interoperability (which is probably taking us too
far), the PHR by definition, I think we have to keep reminding
ourselves, is consumer driven. It is the individual, so what is in there
and who see it and what gets done to it is absolutely driven by the
individual, and I think we have to keep reminding ourselves of that for
this particular initiative.

\>\> Nancy: Thank you, Loraine.

\>\> Nancy: Any other comments or questions? David, other remarks you
would like to make about these principles?

\>\> David: I think it would be useful for us over time if we -- it
sounds like we have broad agreements about some of these elements to end
up with a refined document that we can, at some point, look at as a
single piece of work and which is relatively understandable to the
larger community around the country who may be interested in this work,
and perhaps evolve this into something that is more user friendly --
would be a worthwhile thing to take on once we think we have general
agreement.

\>\> Dan Green: This is Dan Green. I second that notion that these
principles are a good starting point, but they do need to be bedded and
discussed and thought about rather extensively and should be -- this
should not be considered the final word.

\>\> Matt: Someone here has a comment.

\>\> Just to add on to that last comment about -- that these need to be
bedded more extensively. One of the things that I struggle with coming
from a DOD environment: as we do our records, the goal is basically,
from cradle to death, that every single piece of information to do with
your health care is in the system. And we don\'t really make a
distinction between electronic medical record and PHR, as the group here
appears to be doing. Basically, right now, for me, PHR represents that
delta that currently isn\'t in our system. As I read the literature, you
made a distinction about labs and radiology and pharmaceutical and
things of that nature being events that would be in the electronic
health record. And so, I just want to -- as a point of clarification, do
we see an evolution over time as we go through this process that the
personal health record and the electronic health record will be one in
the same eventually? Or are they going to be separate? For instance,
electronic health record is a subset of another organization of
something that they did to you, and your personal health record is
supposed to collect some of the electronic health record information as
it travels through and merges with all these different entities.

\>\> Kelly: This is Kelly Cronin. Just to respond to that comment, I
think it\'s premature to assume that the PHR will create -- will have a
set of data elements that would be identical to an electronic health
record. And you know there is a lot of work that is already going on to
define that -- what is the dataset. And I think that is sort of outside
of our purview. I think it would be helpful if we could try to figure
out what is the set of principle that is we feel, you know, comfortable
enough at this point that is specific to our specific charge, because if
we want to go through a more thorough vetting process, which seems
appropriate, it is going to take us some time, and we are -- we have to
think about what we might be able to actually accomplish and recommend
on March 7. So it might be helpful to identify the principles that we
think absolutely need more vetting but then agree on the ones that we
think are reasonable and ones that we could support as, you know, part
of an early set of recommendation.

\>\> Nancy: And Kelly, this is Nancy. I would certainly concur with the
recommendation that has just been made. And it seems to me -- and I
would invite all on the call to help us here, but it seems to me that
few areas that I have made note of that callers this afternoon have said
we need to look at -- is, we need to look at developing more explicit
language around the issue of accessing and/or consuming personal health
record information and make a better distinction with that.

Also, that we need to be very specific with regard to the authentication
process of who it is that is trying to access the information and the
process just being used.

On balance, the other comments that have been made, I think, certainly
bear review and comment, but I don\'t know that I\'m hearing things said
that would imply that, fundamentally, the principles before us don\'t
represent, in a universal manner, universal principles that may work
well for our group. That being said, I think there is one area that I
would want to call to everyone\'s attention on behalf of consumers, and
that is that within the principles, nowhere in the principles does it
say that consumers have a guaranteed right to their own personal health
record. And perhaps that needs to be a foundational premise, that as we
try to just work on the other two areas, we incorporate that as a
fundamental premise for all of the principles. Then, indeed, our
consumers have to be guaranteed a right to their own personal health
record.

\>\> Matt: Please open Robert Kolodner\'s line.

\>\> Robert: Yeah, can you hear me now?

\>\> Matt: Yeah, we can.

\>\> Robert: To elaborate briefly on a comment that was made a couple
comments ago, I think it is important, you know, as we define what is in
the PHR, what is in the EHR, that the personal health record is more
than just a subset of the encounters with providers. With 85 percent of
health having to do nothing to do with health encounters, the PHR really
provides something that may include encounter information, but there\'s
going to be more there than just the things related to my intersection
with my providers. The other aspect is that the electronic health record
obviously has things that are unique to a particular care provider, and
some of those may be the information about the patient, but some may be
something else. So they're probably going to be more like a Venn diagram
as we sort that through. I do agree the principles -- what I suggest we
do to move forward is that we call these working principles while we do
a further vetting so that we can proceed and not wait, but we also
acknowledge that they may evolve as further vetting occurs. Thank you.

\>\> Matt: Jodi Daniel has a comment.

\>\> Jodi: Yes, I just wanted to comment on a comment made previously
about the control of or the access to the personal health record. And I
want to -- I see in the principles that there is one of the principles
that the person would control his or her own PHR, which seems different
than being able to access or -- well, it is not clear if you were
talking about whether or not somebody needs to get access to the
information to populate their personal health record versus access to
the information that is in the personal health record. And I just
thought that should be clarified.

\>\> Nancy: Jodi, I think -- this is Nancy, and the comment that I think
I was trying to make: consumers need to be guaranteed a right to their
own personal health record, and therefore, if they would have a right to
that record in whole\...

\>\> Jodi: Okay. And the only -- the point of clarification is, under
HIPAA, there is a right of access to health information that's held by a
covered entity. Most providers would be covered entities. So there are
some -- there are some provision for that already under existing law for
access to health information. So I just wanted to make sure that we were
-- we were calling on something that was already a right under existing
Federal law.

\>\> Kelly: Is it also the case we need to have a principle that would
support what HIPAA has already created, such that on a operational
level, consumers would truly have access to their information, because
it is their right?

\>\> David: David again. Just the principles consumer groups have been
developing are more explicit on this question. And for example, one of
them as an individual should have access to all electronic records
pertaining to themselves. Individuals should have a means direct secure
access to electronic health information. Individuals should be able to
access their personally identifiable health information conveniently and
affordably. These are all dimensions of this larger topic. Whereas the
topic is larger than yes or no. And so, as we do more vetting or
refinement, we may want to come back to elements of this larger
principle. But HIPAA may provide formal, nominal access but not
effective access. Naturally, this electronic networking may permit
regular people to actually get their hands on this information more
conveniently.

\>\> Matt: Loraine Duke's line.

\>\> Loraine: Yeah, hi, again. HIPAA does access, but again, remember
the PHR is created by the individual, and so they\'ve put in all of that
information. If they then are working with a physician-managed personal
health record or physician-provided personal health record, and that
provider office supplement the office with additional information --
because I agree with the other caller; there is a bucket of other very
valuable information that the individual enters from advanced directives
to all of their insurance information or their family information and
emergency information -- but if a physician populates the PHR, then
certainly the individual should be able to see it, but it would also
have access under HIPAA. By and large, we at the outset are expecting
these to be populated by the individual, because we don\'t have
sufficient mechanisms right now for physicians to build these things and
automatically populate them. And perhaps that's what we\'re talk being
building.

\>\> Matt: Charles Safran\'s line.

\>\> Charles: Hi, this is Charlie. I wanted to come back to the
principle of transparency that was brought up before, which states that
consumers should have -- be able to view who has accessed part of their
PHR. And I wonder whether that's sort of a vacuous principle, in the
sense that this gets back to the issue of chain of information, which
is, you can -- you explicitly allow someone to access your information,
so you give it to a physician for them to use. But -- so really the
consumer has control over who gets it. But once it is given, there\'s no
mechanism for knowing who is actually accessed that information
afterwards. And so, either we need to do a better job of explaining the
limitations of transparency, which basically means there is no real
audit of what happens to this information, it is just that you are
giving permission one on an outgoing basis, and then you lose control.
Or we ought to -- you know, I\'m concerned that it\'s such a broad
principle that we\'re not going to be able to realize.

\>\> Matt: Kevin Hutchison has a comment.

\>\> Kevin: I guess two comments. One was getting back to the idea that
the patients are manually entering all of this information, which is
absolutely true in today\'s world. But I think what we\'re trying to
create are principles for what you mentioned, you know, for the future.
But actually, in today\'s world, you can get information, specifically
medication history, from PVMs as well as from pharmacies. We\'re talking
about finding other sources -- payers, PVMs, pharmacies, hospitals,
other entities -- that do have electronic data on patients and
prepopulating these health records. I think specifically, for this
charter group, we\'re focused on medication history and the sources for
the medication history. But it would not necessarily be all patient
entered, which is why there is so much sensitivity to information being
shared: because it's not all patient entered.

\>\> Matt: We\'ve got one more comment in the queue. David or Nancy, do
you want to stop and address some comments, or should we keep moving
forward through the rest of the members?

\>\> Nancy: I think we should move through maybe just for a few
additional moments, Matt, and then we need to try to come to some
consensus about next steps with the principles.

\>\> Matt: Robert Kolodner\'s line.

\>\> Robert: Hi. I think one of the things we need to be very careful of
-- well, two things. One is, we may want to do just enough principles to
get us through the breakthrough and make sure that we have those in
agreement before we go to the next one. The medication profile may not
be the issue, and even the demographics may not raise some of these
issues. But as we are wresting with the issue of audit trail and where
does the information go, I think, at least in VA, what we\'ve tried to
do is parallel in the electronic world what is currently accepted in the
paper world. So if a patient had note they wrote down and they handed it
to their provider and the provider put it into their record, then it is
handled, and in a certain way, their including it may be released to
others. And I\'m just very reticent to add lots of new layers, because
the information happens to be electronic, unless we do the parallel
change in the paper world, as well.

\>\> Nancy: Thank you, Robert.

\>\> Matt: Nancy, the queue is empty if you want to try to wrap this up.

\>\> Nancy: Okay. Thank you. I would like to go back to you, David, and
see if at this point we might be able to get a degree of consensus. I
think you\'ve had a recommendation made that we perhaps view these as a
set of working principles that would imply that there is additional work
to be done. By moving to that designation, it would allow us to advance
these as working principles and to continue with the process of
addressing some of the concerns identified this afternoon. There may be
other suggestions relative to this. And so perhaps we need to take those
and try to get a motion and move forward.

\>\> David: That sounds fine, Nancy. You identified a couple areas that
need more refinement in your earlier comment. So why don\'t we ask if
the group as a whole is willing to accept these as working principles,
recognizing they will go through more refinement over time?

\>\> Dan: This is Dan Green. I agree with that, I think we should call
for consensus.

\>\> David: Justine has a comment.

\>\> Justine: I think that makes sense. Do we want to look at
streamlining and simplifying these as we go forward with what we are
doing here?

\>\> David: That is good. I like that.

\>\> Matt: Robert Tenant has a comment. Please open his line. As far as
consensus on this, since we are deal this closed line system, we'll
assume if nobody calls in, their silence implies consensus. So please
open Robert Tenant\'s line. Go ahead, Robert.

\>\> Robert: I agree with the last couple of comments. I think these are
far too explicit to be principles; they are almost getting into the
weeds. My suggestion would be -- and I don\'t know if it is within the
purview of the workgroup, but to assign maybe a subworkgroup, just a
couple of volunteers, to work on streamlining these -- use these as the
working principles, but have the subgroup come back to the larger group
with a streamlined set.

\>\> Nancy: Robert, thank you for your comments and recommendations. And
David, I\'d like to defer to you in terms of -- it is my assumption that
the principles we are reviewing today are indeed our first attempts at
taking multiple principles that had been submitted and trying to
streamline them for the discussion this afternoon. Is that a correct
assumption?

\>\> David: Yes.

\>\> Nancy: And the recommendation is we take these and move to a
process where we would have a subworkgroup that would move through a
second iteration of trying to streamline these. And David, I think I
would ask you, because you certainly have worked with us consistently in
this area, if that is a process that you would be willing to lead, but
to lead it in a very short time frame so that when we go before the
group on March the 7^th^, we can be as clear with them as possible as
what we have agreed to here.

\>\> David: Yes, I think we have heard enough today to take another step
forward.

\>\> Nancy: All right. And for those on the call, I would like to ask if
we could get a more streamlined set of principles turned around this
week and get your comments back. Would it be possible to get your
comments back so that we can have consensus to get more streamlined
principles for the March 7 meeting?

\>\> Matt: Scott Serota has a comment.

\>\> Nancy: Hi, Scott.

\>\> Scott: My only comment was, I support what you just said. I was
going to suggest that the streamlining and making these more user
friendly was a critical piece of this.

\>\> Nancy: Okay. We will make the attempt, Scott, to get these
streamlined out to everyone on the call this afternoon for your comments
and suggestions so that when we go on March 7, we can deliver as part of
our breakthrough a streamlined set of principles that our working group
does support.

\>\> Scott: That would be great.

\>\> Nancy: Okay. Thank you so much. And again, Matt, I like your
suggestion: if we do not have folks call in, the silence would imply
their agreement with the process that\'s been identified.

\>\> Matt: Yeah, looks like we have silence right now. So I think you
are good to move forward.

\>\> Nancy: I would like to thank everyone on the group, and David, we
would like to work with you in finding others that would like to work
with you in that streamlining process for a job well-done, David. Holly,
we would like to recognize you now to review the policy issues and
barriers that you have proposed for the afternoon discussion.

\>\> Kelly: Right. Nancy, we are having some internal discussion here in
the Humphrey Building, mainly because we want to make sure we are
absolutely being SACA compliant. Typically, when a subcommittee, which
this workgroup is actually considered to be, a subcommittee under a full
SACA committee -- when they make recommendations to the full committee,
it has been fully vetted and I document through public document that the
work could support. I think we could move through that in this public
meeting on March 7. The deliberations of this workgroup will be
presented in a set of working principles that could be refined and
streamlined in the next week and a half; that would be great. But we do
need to circle back with you in case there are any issues or sensitivity
surrounding SACA compliance, and we will suggest an alternative process
itself.

\>\> Nancy: That would be great, Kelly.

\>\> Kelly: Okay. In terms of the policy issues and potential technical
barriers, our specific charge, I want to start off by recapping --
(audio cut out) -- some of these issues are so applicable to our
specific or short-term charge and also applicable to our broader charge.
And if we can think collectively on how we need to differentiate,
really, something we need to address in the short term to realize a
successful implementation of our specific charge, then it was good to do
that, but also recognize what is going to take a little bit more time
and is really absolutely necessary for broad acceptance of PHR. I also
think it would be helpful, after just going through these list of
issues, to also open it up to comment as to any additional policy issues
or barriers that we did not discuss at the first meeting. And then
perhaps, if time allows, Nancy, it would be great to recap on these
toward the end of the meeting because I think these will become much
more clear to us as we have more context around what we're really going
to try to do with this specific breakthrough.

The first one in the briefing paper on this that was discussed before is
the lack of interoperability between personal health records and
electronic health records. As you know, right now, we have the
certification commission for health IT that is working towards
finalizing standards and a certification process for ambulatory
electronic health records that have interoperability requirements built
into that. But we do not yet have the mechanism to identify
interoperability requirements for personal health record or a process in
place -- or a mechanism in place to ensure there is interoperability
between PHRs and EHRs. So one question to the group would be, do PHRs
need to be certified to make sure they meet not only interoperability
requirements, but perhaps other requirements that will be important both
to specific and long-term charge -- i.e., privacy and security and
functionality requirements? So that is one issue.

Another one that was, again, discussed previously was the need for
identifying whether there are family members and caregivers that should
have access to personal health records authorized by a patient. I think
that this is very desirable from a variety of perspectives, and perhaps
this is one of the issue that we need to more carefully consider as we
get into what we are going to try to accomplish over the next couple of
years. For example, if we decide that one of the subpopulations of
interest is the elderly, then caregivers might become much more
important and we may need to specify the need for proxies and how that
would happen. The third issue is sort of a legal and a policy issue. You
know, how do we currently protect personal health information in PHRs?
Do we have the current authority, and is our authority clear on how we
would actually protect personal health records that are maintained in
personal health record? So I think we'll have a lot more discussion on
that as we get more clear on what our real scope is. And the fourth
issue is the concept of liability. If there is inaccurate information
that is presented to providers that is made available through services
or related to a personal health record or from an actual personal health
record, if that leads to a medical decision that is the cause of a bad
health outcome, is that provider liable for that bad outcome? So I think
we need to have more of a discussion around whether or not that is a
significant liability issue, and if the group feels it is, then what are
some of the potential ways we could address this issue. Perhaps this is
not a Federal policy issue, but some of the provider organizations that
are represented in the workgroup might have perspective on defining this
issue and also figuring out whether or not they can identify any
solutions on how it could be addressed.

And then the last issue is the fact that we -- it is more of a technical
issue. There are policies interrelated or related to it. We don\'t have
a unique identifier right now for all patients, everyone knows. But we
do have mechanisms that are being tried now and are, you know, a part of
the scope of some of the contract work that ONC is sponsoring. And so,
how can we reliably match patients to their health records? You know, is
there a need for a standardized approach to a master patient index? And
we did actually write up a separate background paper on this given the
complexity of the issue. So I think, again, we can probably address that
towards the end of the meeting with a little more context after we\'ve
had a chance to go through some of the options for what the breakthrough
will actually entail.

So, Nancy, if it is okay with you, I think it would be good to get
people\'s feedback on any of this right now and then try to revisit it
after the discussion on all the options for the breakthrough.

\>\> Nancy: Kelly, I agree. Matt, if we can begin to take comments and
questions from those on the call -- and we\'ll just begin with the lack
of interoperability -- how can we ensure interoperability between the
EHRs and PHRs? If there are comments around that issue...

\>\> Matt: Looks like we are waiting for people to queue up. Star 1.
David Lansky wants to make a comment.

\>\> David: Thanks. I have a -- I guess, going out to at least 5,000
feet from this list of issues. I think the ultimate challenge to all of
us is creating a trustworthy system in the minds of the American public
all those issues are elements of achieving that objective. I -- the
process we used to -- we can\'t possibly list -- there are dozens of
issues that will surface as this breakthrough begins to be realized. And
we can\'t, here, in a week or two, come up with answers to these
questions.

Some of them are philosophical. Do we think the markets can correctly
resolve these issues through innovative product development, or are they
public policy issues that need to be spoken to by groups like this and
essentially mandated through implementation of applications that touch
Federal money or managed data? That is a big issue we should take some
time and discuss. Which issue can be addressed in which of those ways?
Because I think public trust is a critical outcome of this process. Some
of these things we failed authentication methods might suitably be done
by individual companies. If there is a weak link in the network, then we
are all at risk, and therefore, it becomes a public policy question. So,
some of you know, health has spent 4 years working on these issues and
they are very hard. And I think we should not try to address them
individually but develop a process by which, throughout the work of this
breakthrough, they can be address-- have all the people concerned about
the issues together to discuss them.

Last point I want to make about that is that the choices that are made,
technically, that we're going to talk about later today -- the dataset,
population, settings, models so on, all of those -- is -- have
implications for these questions, and how we choose to architect the
technology will itself either create more or less trustworthiness in the
system. We shouldn\'t -- while I think the process by which we deal with
these issues very seriously -- we shouldn\'t bifurcate this from the
technical process, and it needs to be woven together over time. In
short, I'm acknowledging against haste. If we do this wrong on any one
of these questions, entire national enterprise of wired health care
system will be destroyed because of newspaper headlines.

\>\> Matt: Kevin Hutchison, go ahead with your comment.

\>\> Kevin: Well, my first comment would be, I agree with everything
David just said. I think we need to take our time as we work through the
process of how we begin -- to that. I think we would all agree with
that. With respect to the elements themselves, item number one, I know
that certification commission does not have this on their radar screen
for PHRs. But if we were to head down that path, it seems most logical
that we would require a certification process through the certification
commission for health can the IT that we\'ve already established. And I
know -- and I\'m sure that David is online and he can comment on the
line -- I can tell you, from a data source standpoint, without a doubt,
they require certification process and around authentication,
identification, and a lot of other things before they\'re going to
provide data. I\'m sure the payers are the same way. PVMs are the same
way. Pharmacies are the same way. It would be nice to have some comfort
in that this has also been certified or this process has been certified
by another entity, you know, like a certification commission. It would
take on these tasks because we have certainly requirements that have
been put on us of what we have to certify in the vendors before we allow
any of them to have access to medication history. Yeah.

That\'s my only comment on number one. I have other comments on the
others, but I would hold it.

\>\> Matt: Justine Handelman, go ahead with your comment.

\>\> Justine: I agree with what the other ones said, too. One thing, too
-- and Kelly, I know you touched upon it -- there is the HHS contract,
that hits the -- I can\'t remember the acronym off the top of my head,
but I think it would be useful to see what are they looking at in terms
of standards. Have them come back to this group. Are there common
standards? What exists? What doesn\'t exist? And we need to really look
at the standards, because that is critical part: you need standards for
this to be portable. And what is out there? And where are their gaps?
And if we could have a presentation or report back, that would be
helpful.

\>\> Kelly: Yeah, I think we do know from some of the support that has
been done just for this workgroup. And in fact, Don Monn, I don\'t know
if you are on the line now, but there are people that have been involved
in the standard development organization on figuring out what is a
functional model or requirements for a personal health record. But it
hasn\'t gotten to the point where it\'s a fully approved draft standard.
And it hasn\'t really been discussed in any great detail in terms of,
you know, potentially adding it onto the scope of the certification
commission. I think, from Kevin\'s comments, it sounds like this is a
short-term issue that's relevant to the specific charge so that it would
be important for us to, you know, go back and think about how we can,
you know, address if that is one of the recommendation, how we could
potentially address it.

I also wanted to offer a clarification that, in terms what have -- we
need to present as a workgroup to the full committee on March 7. I think
we really just need to identify the big policy issues and try to
describe them to the best of our ability, but that we\'re not expected
to really, you know, present any solutions or how specifically we\'re
going to address them. We really just want to try to, you know, give the
full committee an understanding of what we believe to be the most
pressing policy issues and barriers for the specific charge.

\>\> Matt: Don, your line is open if you would like to speak to what
Kelly just said.

\>\> Don: Thank you very much. Thanks, Kelly, for references the work
that is out there. First, in O\'Hare Airport here in Chicago, there is a
HIPI technical committee meeting going on for the next 3 days (today,
tomorrow, and Thursday), and the consumer empowerment technical
committee is developing a use case to submit to this workgroup. As for
the -- so that was point number one. Point number two is, as far as the
certification commission, it is true our original contract calls for the
ambulatory EHRs to be certified for the first year, inpatient acute for
the second year, and real or network infrastructures in the third year,
but in order to align with the AHEC process, one way that PHRs or the
clipboard can be certified would be to see how it interacts with the
EHR. So what is the linkage between the PHR and the EHR? What is that
data exchange? And that we might be able, or -- there has been some
discussion about whether or not we can accommodate that in our
contractual guidelines.

The third thing is that if you do go down that route of linkage between
the EHR and the PHR, there is some work that is already being done, and
Kelly mentioned it a couple times. There is a workgroup within the
health level-7 electronic health record technical committee that is
taking the good work that Connecting for Health did 2 years ago and
developing a PHR functional model. And they\'re developing -- excuse me,
they're updating that functional model and developing standards
conformance criteria about what you would have to do to comply or
conform with the exchange of health information between the PHR and the
EHR. So those activities are going on right now and may be capitalized
on in this next year. Thank you for the time.

\>\> Matt: Russ Martin, go ahead with your comment.

\>\> Russ: Don actually covered a lot of the territory I was hoping to
cover. I'm on the board of the HIT Standards Panel and should be in
Chicago were it not for this meet -- a couple of others that are very
inconveniently misaligned, I guess. But they made a clear request to be
able to feed information into this committee and into this workgroup, so
I\'m hoping that that can happen sooner than later, and I\'m hoping that
we can really make sure that those lines of communication are made
strong. There is a difference between the dataset of the -- I guess I
would characterize it as who catches the football, the electronic health
record, and what the criteria are for certifying electronic health or
electronic health record on the doctor's side as a receiver or a
contributor to a personal health record and the actual personal health
record itself, which would be more like the quarterback, I guess, if I
want to stomp the metaphor into the ground. That is a different
certification process along with perhaps the whole question of what is
the dataset that is being exchanged between the two. It is probably not
necessarily a certification process but more a selection of set of
standards for that.

\>\> Matt: Please open David McClain\'s line.

\>\> David: Just to reinforce some of the things that have already been
said, I think, as I look at the six items, and to reinforce David
Lansky\'s suggestion about a process here, I would definitely think
that\'s appropriate, and Kevin\'s comments about certification are ones
where, again, I think, as I look at those six things, there are examples
that are in use today that I think ought to be looked at, talked about,
and some maybe debated. But I think there are lessons that can be
learned from what has already been done in each one of those as we think
about kicking a process out that can be done fairly quickly to make use
of what has been established and may be in use in the industry and not
to necessarily, you know, duplicate what may already exist, but rather
to learn from that. So how can this be more applicable? But I think --
as a process, I think there is real lessons that can be had as we look
across the industry for all six of those things. Thank you.

\>\> Matt: Kevin Hutchison has another comment.

\>\> Kevin: Expanding on Kelly\'s comment -- actually coming up with
elements to make sure we have the right focus on which policies need
addressing -- there is two things that jump out at me that are not
addressed by the six items, unless I am misinterpreting them. One is
around authentication, and to me that is more critical, especially when
you're talking about PHRs and consumer-empowering information, because
there is two specific issues with authentication. There is the original
ID, the original authenticating that the patient is who they say they
are. There is the ongoing authentication that when they are asked
information, who they are and where they are. But the original
identification of that patient with some level of second-level
authentication or visual authentication by a provider, although that
will make it very slow for some, process that needs to be used to make
sure we are passing out the right IDs and password, even temporary ID
password, as they move on.

I know from a source that\'s very much of a concern from people that are
providing the data. How are you identifying that person when they
originally sign up? And it's the second piece would be the variation of
the State-level policies. And we\'ve already run into this with Katrina.
We've run into this in this environment, as well, where on a
State-by-State level there are variations of the types of information
that can be shared, and that really complicates the technology, the
infrastructure, the network of how to manage, and you end up going to
the common denominator of the most conservative process, unless you get
into a RHIO and let them handle all of the issues at State-level RHIO.
The State-level policies and even the Department of Health policy
sometimes dictate it in some States versus the State law or even
pharmacy boards or medical boards dictate some of this new information,
as well. And that does vary on State-by-State basis, as you all know.

\>\> Kelly: So the last -- just to clarify the last comment, the issue
is that the State-level policies and laws could be barriers to
exchanging certain types of medications and -- but that there needs to
be recommendations that we need to understand so that we could be
sensitive to the State laws. And I think, also, the principles address
their concept of being able to share in part, you know, perhaps segments
of your history. So if there was sensitive information, you could
sequester or filter that out. So that needs to be addressed in the short
term.

\>\> Matt: No other comments in the queue right now.

\>\> Nancy: Okay. Dan, any comments you would like to make at this
point?

\>\> Dan: No, I don\'t think so.

\>\> Nancy: Okay. And I think in terms of those that have shared ideas,
David McClain, we certainly agree that we don\'t want to duplicate the
issues. Kevin, we certainly agree that we want the right policies and
the issue of authentication is very important. I think, within item
number three, "How do we protect personal health information in PHRs?",
I don\'t know if that question is designed to get us to the issue of
privacy or not, Kelly, but certainly the issue of privacy is a major
issue to the consumers. And perhaps when we present to the committee
what our major issues are, we need to use that particular term to
characterize concern and at the same time perhaps make the committee
aware of what HIPAA can and cannot do, address that issue of privacy. So
there will not be those on the committee that have a sense that HIPAA is
going to address all of the privacy needs that may be of concern to
consumers.

\>\> Matt: Nancy, I\'m sorry. As we moved on, a couple comments jumped
on. David Lansky, go ahead.

\>\> David: Thanks. I was following Kevin\'s lead, adding a few items to
our list of priorities we may want to bring to the full commission. I
think the larger question is whether the principles we talked about a
minute ago should become policy. And how do we go from -- the principles
sound good, but this one that was just mentioned of allowing individuals
to manage sensitive information and decide who sees what, whether it is
because State law requiring control of sensitive information or because
of my personal preference, is it a policy that we would require anybody
participating in the breakthrough to enable that feature? We haven\'t
said that, but that is something that we should sort out. There are a
couple others that should be considered for the list to be brought
forward.

Many of those who operate personal health records and similar services
are not covered entities. Once the patient has requested their
information and then provided it to this software company or vendor, it
is no longer covered by HIPAA. But there are no policies governing what
secondary uses that company might make of that data. So a consumer may
willfully provide information to a software company in terms who tries
to sell it to a direct marketing firm or drug company. Are there
policies to address around secondary uses of data in this breakthrough?

Second issue is, in the case of a violation patient privacy is breached,
only a few States have notification lines that we regard as policy
decision that any violation of patient privacy by someone managing this
data should result in notification or some sanctions, consequences for
those who violate privacy breakthrough.

Another issue is an area of error detection and correction. If a patient
discovers a mistake in the data stream that becomes available through
this breakthrough, is there any recourse? Who do they contact to seek a
correction? Now there are several steps removed from the original source
of the data, making three or four steps removed by the time they have it
in front of the patient. I think those should be considered mostly
privacy issues that we may want to add to the list.

\>\> Nancy: Thank you.

\>\> Matt: Ross Martin has an additional comment.

\>\> Ross Martin: When I look at these issues, and when I put the lens
on that, this is a consumer empowerment issue. I think a lot of these
can be addressed if we kind of steadfastly maintain that the focus of
this is in giving the patient control, I'm not sure -- or maybe there
are some State laws or other issues that prevent me as a patient from
telling my doctor that I have HIV or that I have -- whatever, the thing
is that under normal circumstances, in terms of provider exchange of
information, they may be limited, but that doesn't put the same
restriction on my communication with them. And that's what we're trying,
to confer power upon the consumer to do just that, to have power over
their information and provide it out. Now, I know that that does provide
some issues around how information gets in, but again, I think there are
probably very limited situations where there would be restrictions on
what a provider could share with a patient. Given that we know that they
are who they say they are and they are registered, you know, initially,
as Kevin was pointing out, and then reidentified as being that same
person later on, which are, you know, legitimate issues.

But even taking those issues as, well, if we can say, for example, if a
patient is actually the one giving -- I'm just going to call it token
for a moment -- but a way of verifying identification of themselves when
they are encountering a clinician and saying this is how -- if somebody
ever comes up talking and they present you with the other part of this
token, you know it's me asking for this, because it's encrypted and I've
established this. If we give them that kind of power, I think it can
bypass a lot of the challenges of the network-centric -- of the
system-centric types of identification that we do. I know we\'re going
to get into the patient identifier issue a little bit later in a more
comprehensive fashion. But I think the summation of this is, if we can
put that lens of that conversation, and if people agree that that\'s the
principle, may be able to reinforce this notion if we\'re going to do
these complicated audit trails and things like that. If the patient is
in control of it, if they truly have the reigns on it, a lot of these
things will be taken care of because of that.

\>\> Nancy: Thank you, Ross. Any other comments from our group, Matt?

\>\> Matt: Not presently.

\>\> Kelly: Matt, Nancy, this is Kelly. I just wanted to follow up on a
comment that David made, because I think it is an important point that
could be either part of the refined principles or we could articulate it
as general policy issue on the 7th. And that is that the concept of
requiring that patients should be able to not share sensitive
information. Whether or not that\'s, you know, as he said, originating
from the State-level requirement or it\'s, you know, from the -- just
the willing of patient, I think that that could either be a refinement
of one of the disclosure and accountability principles having to do with
people having control over whether or not to make certain personal
health data available, or we could really, again, highlight it as a
general policy issue that can be, you know, addressed in a process we
all agree to.

So perhaps what we could do is suggest that the subgroup that is going
to work on the principles contemplate that more, and if there can be
something articulated in the form of a working principle, then we can
readdress that as a group the next time we meet.

\>\> Nancy: Thank you, Kelly. Are there other suggestions in support of
Kelly\'s recommendation?

If not, are there other comments from the working group as it relates to
items 2--6 in the background information around the barriers that have
been identified?

I will take silence as an indication, perhaps, that we have universal
agreement that we\'ve identified the primary barriers and would be able
to add to the barrier those that have been identified within the
discussion this afternoon. If that observation is correct, we\'ll have
silence, and if there are other comments that anyone on the call would
like to make, we certainly invite you to do so at this time.

\>\> Matt: The queue is empty, Nancy.

\>\> Nancy: All right. Thank you, Matt. We will take the silence as
meaning that we can move forward. Kelly, are there further comments you
would like to make concerning your document before you move forward? It
sounds like you got all of the issues fairly well-defined.

\>\> Kelly: Which is great, yeah. And we will certainly do a better job
of summarizing them and circulating them to the group so they know what
we\'ll fold into recommendations. I did want to just recognize, we had
Dr. John Luntz here with us today in addition to Jodi Daniel, and they
direct other offices in ONC, as you may know. John is in charge of
interoperability and standards and overseeing the work that the Health
IT Standards Panel is charged to do. And I thought it might be helpful,
since there was a lot of discussion just now on the relationship between
the workgroup and the Health IT Standards Panel, that he could comment
on how the two groups -- how we can relate to that group.

\>\> John: Thanks, Kelly. And I just did want to make sure it was clear
that everyone understood that there is a relationship between these
breakthroughs and activities that are respective of the HITSP as well as
the NHIN processes and that we are here, and with the intent of trying
to make the next step processes for those groups be as coherent as
possible with the work of the working group, as expressed through the
recommendations to the American Health Information Community. I think
that most of you by now are aware of a use case process that has been
going on to help try to detail some of the specifics of activities that
can be considered under these broad auspices. There will be a harmonized
use case that is presented to both the HITSP and the NHIN processes for
their consideration, as outgrowth of the recommendations of the
community.

And so there is really a process going on here that we -- with the
intent of tracking the community recommendations in this regard and
trying to make those next steps in the processes be as coherent and
related to it as possible.

It was mentioned that HITSP is having technical meetings this week, and
they are, and they\'re working on the general area of standards --
high-level standards, we would call them -- in the context of, among
other areas, this one, in terms of what data may be relevant. They\'re
really working from the six broad use cases that were submitted by
different groups as part of a very broad survey of the possibilities in
this area. There are expectations that as things proceed, they will get
into much more specific standard harmonization around standards needs
for this particular area as well as others, and we would be very
interested in facilitating communication with the working group around
progress in those areas.

Similarly, the NHIN, which -- the Nationwide Health Information Network
prototype architectures will be working on four architectures that will
also be expected to implement some of the considerations to this
breakthrough. Now, these are prototype architectures. They are not
implementation-level architectures, but there will be sessions emanating
from those architectures, public sessions where there will be additional
opportunities to talk about the particular architecture issues that
relate to this breakthrough in this area, as well as others in that
public setting in working toward a harmonized architecture as outgrowth
of that.

So those two activities both, I think, are -- have expectations of being
aligned with the -- this breakthrough, this working group and the
activities as they are expressed through the community. This will
obviously be an ongoing activity. There will be needs for communication
in both directions, and we\'re very interested in trying to make sure
that happens in a coherent way.

I just wanted to say those words. I would be happy as issues arise or
questions arise to try to address them as this working group proceeds or
in other settings.

\>\> Nancy: Thank you for the comments. Are there other comments or
observations that we would like to have shared at this point?

\>\> Matt: Nancy, there are a couple people here have comments.

\>\> Nancy: Good, thank you.

\>\> Matt: Kevin Hutchison, go ahead.

\>\> Kevin: Just for clarity, but on the standards work, there is not
any work going on around standards for a standard process for
authenticating a patient's right or authenticating a position or
standards work going on around -- standards way of doing patient
matching, as an example. The standards that we\'re looking at are
existing standards during the industry today and on how to harmonize
that information to allow a common set of standards to be used for
exchange of information. Some of the things we are trying to address on
those topics, they are usually not standards going on around those
topics, are they?

\>\> John: The sequence that's laid out in these particular contracts
has these general areas going forward to both the HITSP and the NHIN as
areas for next steps. From an NHIN perspective, what that will look like
is four architectural proposals for how to address some of the varied
needs that you have just been talking about. Those architectural
proposals would be brought into the NHIN flora, where there would be a
process for harmonizing those and coming to a shared view on an approach
to move forward with them. In the context of standard harmonization,
that's architecture. In the context of standard harmonization, those
architectural products would then be offered to the HITSP, for example,
in the context of the identification of appropriate standards to support
them.

\>\> Kevin: Okay.

\>\> John: So, it is a little -- it actually makes sense from technical
perspective to work through that process and to have things sequenced in
that way. But that is the sequence that is laid out, and it does involve
more than just one group in moving that forward.

\>\> Kevin: Okay. Good.

\>\> Nancy: Okay. Are there other comments at this point?

\>\> Matt: David Lansky has a comment.

\>\> Nancy: Hi, David.

\>\> David: Hi, Nancy. This is for John and for us as a whole. I think
several people on the last round of discussion on the policy memo in --
the memo itself recommends process to identify the policy issue within
our breakthrough period. But I'll ask John, too, for the other
networking policies he just described where some of these same issues
surfaced, as Kevin raised the authentication issue. Two questions for
us. One, for us, Nancy, is whether we are recommending on March 7 any
particular process by which these issues will be addressed over the next
6 or 12 months as they continue to surface and be developed within this
breakthrough area, and the -- today's brief memo said that we should
undertake a process, but we haven't really said what that is.

\>\> Nancy: Absolutely.

\>\> David: And then secondly, I guess for John, in terms of the other
parallel tracks that are going on, summarize where similar issues are
emerging. Are they also recommending any kind of process to address
these issues? So many of them come across contact areas, whether it's
public health, consumer empowerment, or EHRs, by which all of these will
be addressed in a comprehensive and multistakeholder way.

\>\> John: There certainly seem to be some commonalities from the
different working groups and the different aspects of the -- just
general NHIN infrastructure, for example. And there certainly would be
every effort and desire to try to have those addressed as consistently
as possible and where there is an opportunity to leverage one activity
into another. One of the areas that seem to have come to the floor is
this: What data are appropriate for consideration for doing patient
matching? And we really need to get to clear language in this regard,
because there is the issue of authentication, but then there is the
issue of both -- of pulling data to match against a patient or data that
get pushed to match against a patient. They each have their unique needs
and their considerations, some of which are around data and some of
which are around what are the interactive steps in that process and what
is appropriate.

And I know that many of you know that, but those issues, some are
architecture and some of them are data. It would certainly be the hope
they could be teased out and addressed from an architecture standpoint
in a shared way, from a data standardization or technical standards
harmonization standpoint in a shared way, and I think the HITSP is
interested in doing that as consistently and as efficiently as possible.
It is our hope, coming out of the recommendations to the community,
there will be some consistent themes across some of the groups that
could be addressed as such.

And as you know, relative to the -- your comments about the openness of
the process, the HITSP is -- the panel is open to many different
participants in this in the health information community and is open to
ongoing participation in that regard. The working groups have been
largely voluntary, and the meetings are open to the public. The NHIN
flora will also be public meetings where people can come and participate
in -- those people that are interested in advancing those areas.

\>\> I understand that. I think it is fine, but I think I would hope
that our workgroup would advocate to the community as a whole that there
be a more rigorous public process for discussing these essential privacy
and policy issues. I don\'t think the HITSP, which has very important
purpose, that should happen. I haven\'t seen a time or process set aside
yet where the issues will be fully discussed, and my concern honestly
is, and obviously, associated in part with one of the end projects. I
think that is going very well, too, but it is also not the right set of
players to be discussed these basic values of privacy and how we conduct
ourselves in our society. So I think I hope we encourage the community
itself to develop another process which is devoted to these issues.

\>\> Kelly: Nancy, this is Kelly. I think it would be helpful, as we
develop a more detailed timeline of everything we hope to accomplish as
a workgroup over the next year, that we identify a process to set
agendas and to really work to try to address some of these -- address
and readdress some of these policy issues as they are more carefully
defined and as they are addressed by not only the Federal Health IT
Policy Council to the extent necessary, but also as they\'re addressed
by the contractors. And we can figure out a mechanism to get periodic
updates on what the NHIN consortia and the Health IT Standards Panel are
doing so that we can make sure there is compliance to principles we all
agree to and we feel that, you know, the public interest is being
well-represented.

\>\> Nancy: Kelly, I think that probably those of us on the call would
concur with your observations. I do want to go back to something David
Lansky said and comment because, David, I think you are absolutely
right. I think there has to be a process through which the consumers are
very directly involved in the process of defining what are the barriers
that we are -- confront what are the appropriate steps to take in order
to make recommendations of how to deal with them. I think, specifically,
the comment was made earlier today in the call about the variability. I
think Kevin Hutchison made the observation about the variability of
State law and State regulations and how that impacts many of the
obstacles and barriers that we\'re talking about here. And I think when
I look at the work you did, Kelly, where you talk about the process
should be based on -- and then you give us a series of mini-bullet
points around what that process needs to be. The fundamental process
needs to be one in which the consumer voice is represented in all
discussions, all levels, when we\'re going through the process.

So when we look at what HITSP is doing and what other groups are doing,
I do think that is important so we\'re not duplicating. But at the same
time, I think it is very important we make certain the consumer voice is
heard. And I think for those of us serving on this particular panel, we
have the opportunity, if we are in agreement that these are the primary
issues that need to be looked into, that our working group again can
provide information and feedback directly on each of the subjects that
have been identified as problematic in terms of the process that we
would recommend be used for addressing them, and at the same time, once
those recommendations have been made, that we share them with the public
for further recommendations that may be accrued to that process so that
by the end of this year, we indeed have made steadfast progress in what
are the recommended solutions to the problems that have been identified,
whether the solutions are coming from existing contractors and
committees that are in place or whether they are coming through a
collaborative effort of the consumers, the public, and the appointed
member of the consumer empowerment working group.

So, if we could find out if we have consensus with those on the phone
today that, indeed, we have identified the problems correctly, and that
now we have the responsibility to provide individual reflection on what
the appropriate process is that should be taken to identify specific
strategies to deal with each of those obstacles, I\'d like to have any
comments about that. And lacking any comments, we'll feel those on the
call are in agreement that we have a responsibility to now provide
recommendations of how we satisfy the 10 process statements that have
been made on the second page of the narrative here so that we can move
forward.

\>\> Matt: Nancy, Russ Martin has been waiting a while to make a
comment. Mr. Martin, is it still relevant or covered at this point?

\>\> Russ: I hope it is relevant.

\>\> Nancy: Okay. Hi, Ross.

\>\> Ross: Thank you. I\'m wondering, based on what David has been
articulating and Nancy, your followup, if we can make recommendation
about policies and principles that, as they feed up to the community
level, that they can do sort of a harmonization process of those and
feed them back and say we understand that all these workgroups are
coming together with these observations about how they\'re trying to --
you know, we\'re talking about principles that would apply to personal
health records. It\'s not a guarantee that they\'re fully compatible
with the principles for biosurveillance or for, you know, chronic care
management or some of the other issues that are going to be percolating
through the community over time. And I would like to know that we\'ve
established that full check that there is a harmonization of those
principles and the related policy implications of those principles, so
that we may also be able to say, "Here are ones that are specific or
particular to the personal health record that is not common to the
others." I think we\'ll find that probably they all have implications,
so I\'m hoping that will be one of our recommendations.

And second, just going back to Dr. Luntz\'s comments on the
harmonization process and how these sort of moving parts of working
together, I\'ve been a little concerned about the time -- this is all
being done under a number of constraints that are challenging at best
and daunting, and I think daunting is more appropriate in terms of the
expectations on this whole process. We\'re trying to do many, many
things at once. And one observation in the -- for example, in the use
case is for personal health records and medication history. Every one of
the use cases, part of the instructions for all of the contract system,
they provide use cases that have preconditions and what happens during
the use case and then what is a result of the use case. So the
postconditions of the use case.

And under those preconditions for the use cases for personal health
records are a whole lot of very complex, presumed things that occur in
advance of the personal health records working. And the ones that Kevin
has brought out already of authentication process, identification
processes, it's just one among many. And I am concerned that we have to
slice those down to the ones that are essential for our small -- not our
broad charge, but our narrow charge, and that we can really understand
that these are getting processed in a timing that will allow us to
achieve the goals that we\'ve talked about in this short term.

I wonder how that\'s going to happen. I\'m still -- I understand what
you just described to us of the process that\'s going on, Dr. Luntz, but
I don\'t -- I\'m -- I don\'t want to say I\'m dubious, but I question
that it\'s ready, that it\'s going to work that way as expected.

\>\> You are dubious. Dubious light. \[laughter\]

\>\> John: I think -- and I guess I can speak without -- this is John
Luntz. So I guess there are a few different issues that you just raised,
and they\'re all good ones. One is the sequences of events. Another is
just general: how much can be accomplished in what time frame? And it
certainly is incumbent on this group to think about something that can
be accomplished in its stated time of the year.

If you remember the use case process, as it was recently originated, the
community did not play a huge role in it, and because the community has
advanced, because the working groups have advanced so rapidly, because
there has been such great progress in these areas, we have reoriented
that process so that it attempts to be even better aligned with these.
But that doesn\'t mean that all the issues have been completely worked
out of the system, and I think that if you\'re dubious, and if you have
suggestions about particular activities, that it is certainly part of
the working group\'s purview to make recommendations for what -- of what
may need to get done to move things forward faster.

But, you know, there is, I think, a very good series of processes that
are being put into place to meet both general infrastructure needs in
the long term and also try to address some of the needs that emanate
from the breakthroughs. And obviously there\'re going to be times when
those things rub up against each other, but it\'s clearly the working
group\'s purview to try to make suggestions what it sees as needs being
met in overall process.

\>\> Matt: Kevin Hutchison has a comment.

\>\> Kevin: Getting back to what Nancy was asking about the 10 elements
on the second page of the document. And one comment I would have -- I
always think is absent in some of these discussions is actually having
some of the technology providers -- some of the technology --
participate in sharing their own experiences. I mean, some of the
organizations -- there is a number of personal health record application
vendors out there, some better well-known than others, but who has
really a lot of experience in working through some authentication issues
through position offices, working with patient groups and privacy
groups, and just to include them as a key interest group, I guess as the
technology providers themselves to share their experiences of what
they\'ve seen on the field. So --

\>\> Nancy: Kevin, are there particular groups that you could recommend
to us that we need to contact in this regard?

\>\> Kevin: No. I think the work that Markle and the AMA has done and
the other physician groups that are associated with that are really key.
I think some integration work that Cat Meds has done with some other DHR
vendors and how they've integrated their two systems together and work
that Relay Help has done with employers in the deployment of some PHRs
through employer networks, those are three -- you know, I'm not
endorsing any particular product, but those are three that come to mind
that have experiences in different areas.

\>\> Nancy: Thank you, Kevin. I think it's a good suggestion. Others on
the call, any additional comments?

\>\> Matt: Jodi Daniel, go ahead.

\>\> Jodi: Yes, I just want to make a comment about this process issue.
The one thing I'm thinking of, where I'm sitting, is that you do have
this process, obviously, and you have the contract. We have, you know, a
lot of different processes in place right now, and what was possible is
rather than thinking through what is another process to put in place to
look at these issues, whether or not there is in fact the HITSP is
looking at identification or authentication, if there is some element
that's missing from that process that considering or kind of looking at
what are the issues -- what are the, you know, the different principles
of what we are talking about -- and looking at whether or not that is
something we can incorporate into this process or one of the other
processes we have other than proposing additional processes for looking
at some of these issues.

I'm just concerned that we may end up having, like, the HITSP tripping
over the new process that we put in place or that -- that kind of thing,
and it would be helpful to identify if, in fact, there is something that
we should consider with the existing processes or if there are issues
that may not have been on the radar screen that would identify those,
rather than making recommendations about additional process.

\>\> Kelly: Yeah, this is Kelly. Just to add onto Jodi's comments. I
think the process that we all want to agree to is the one for this
workgroup to address these issues. And I think that we just need to
ensure how we're going to make absolutely positive that we are in synch
with these other groups as they move forward in parallel and that
whatever process we complete over the next, you know, year, you know,
starting very soon, it will ensure that the consumer voice is
represented through every step.

So I don't think -- I don't think we're talking about something new
beyond any of the existing mechanisms; it's just the process by which
this workgroup is going to really, you know, flush out these issues.

\>\> Nancy: Comments from the members of the working group to this
issue, or do we feel that we are ready to have a formal motion of what
we would like to do as a next step?

\>\> David: Nancy, I have a comment. It's David.

\>\> Nancy: Okay, David.

\>\> David: This is only our second meeting as a workgroup, so I don't
know what our trajectory looks like for the next 6 months or 3 months or
whatever it will be. I don't think we were constituted, and I don't know
whether the process, the rules under which we should operate, FICA
rules, will lend themselves to the deliberation that is needed to
develop these policies for this breakthrough, and they may. I don't know
if it doesn't. I think there should be an analysis as to how this group
itself does or doesn't address the challenges that we've begun to list.
And I haven't seen us do that yet. I think the larger concern is, in the
AHEC charter itself, the number one commitment is to deal with these
issues, and except for a contract that was let out on a slow timeline
through State-level reviews, there is no process by which these issues
are formally addressed. And the composition of the various entities that
have been launched with the other processes for the most part are not
constituted by people who have spent their lives working on this set of
issues and bring that set of concerns and expertise to the table.

So, I don't think the processes have been available to us now -- to my
knowledge are appropriate for addressing this issue. That's why I think
we need to advocate something additional be done. But if our adequate --
I think we should examine them and confirm that they are adequate.

\>\> Nancy: David, I think what I hear you asking for is clarification,
perhaps from Kelly and her office, in terms of the process that we can
use as a working group to correctly embrace and deal with the issues
that we've been charged to deal with in this section.

\>\> David: Thank you, Nancy. I think that is right. The only thing I
would add is that I would be concerned that we not let technical issues
get ahead of these issues.

\>\> Nancy: Okay.

\>\> David: To say we'll let a contract or set a specification and
identify the standard and then we'll get around later to deal these
policy questions. It is very important the policy questions be done
actually prior to and then in parallel with the technical decisions.

\>\> Nancy: So, Kelly, I think what I hear David asking for -- and I
think perhaps the balance of our working group would find helpful -- is
a point of clarification in the process that our working group can
engage in to address each of these items that are so important to
consumers relative to the policy questions. And to -- once we can have
that clarity, then our working group can immediately begin that process.

\>\> Kelly: Okay. That's good. I'll make sure that I circle back to the
workgroup before the March 7 meeting and work with the other ONC
Directors to make sure that all of the processes are clarified and that
we propose a process for the workgroup that will ensure that the way
that we set agendas and the way that, Nancy, you act as a Co-chair will
ensure that the consumer voice is represented and that we address these
policy issues in a sequential fashion so that, you know, we feel we are
meeting all of the goals of the process that are articulated in this
background paper.

\>\> Nancy: I think I speak for everyone that is on this working group
to say, I think everyone has agreed to serve because their desire is to
accomplish what we have been charged to accomplish. And we just need to
understand how to do that, because certainly, within the construct of a
4-hour phone call twice a month, we can't solve these issues. We have to
have additional time and process available to do that.

That being said, I think I hear universal agreement that the issues have
been correctly identified and that now our charge is to shape a process
that will allow the consumer working group that is appointed, and those
that they may choose to engage as recommended today, to supply
additional information to now address the process we're going to use in
finding solutions for items 1--6. And silence will indicate that
everyone is in agreement with that.

\>\> Matt: One last comment, Nancy, and then it is closed out. Davette
Murray, go ahead.

\>\> Nancy: Thank you, Davette.

\>\> Davette: I just had a comment; it sort of adds onto some comments
that Dave made earlier. It may fall under the -- on the last page, under
Accountability or Transparency in Open Processes. I think one of the
biggest things that we probably need to consider is no matter how well
we define this system and have the consumer's best interest, there's
going to be issues where misuse of information happens. And I think that
what's very important here, is what is our process to be responsive to
misuse of information to the consumer. And I think we should look at the
credit industry as assuming better than that. Because right now, if your
credit information is misused, you the consumer are pretty much on your
own to clean up your credit, and it takes about 10 years to do that. And
if we're after people to trust us with their more sensitive health
information, I think it's very important that, up front, we tell them
how, if their information is misused, what is the process for them to
address that. And not only what is the process: it needs to be
responsive, because what we don't want to have happen is -- there is
misuse, yes, but I think the key for people to be willing to continue to
use the system is how that is addressed if there is a situation of
misuse. And I don't really see that flushed out here. It could fall
under perhaps a subcategory of accountability of a stakeholder or, as I
said, the transparent and open process of presenting the process to the
consumer.

\>\> Nancy: Thank you, Davette. Matt, any other comments?

\>\> Matt: That's it, Nancy.

\>\> Nancy: All right. Thank you. And we will construe that, if there is
no further comment, that the observations made prior to the last
caller's comments are consistent with the desires of the group, and we
will move ahead based on those. And Kelly, we thank you for your
leadership in this discussion today and for getting back to us as it
relates to a process we can engage in to go to the next step.

And now moving ahead with our agenda, we would like to represent Don
Monn, who is here is review options for data elements and sources. Don,
we welcome you to the call; thank you.

\>\> Matt: Your line is open, Don. Go ahead.

\>\> Don: Thank you. Principles to data elements -- we are approaching
our first down-to-the-earth issue of implementation. We have to specify
the data elements that will be exchanged at the registration summary --
within the registration summary and the medication history. So in
specifying these data elements and data sources and other issues, we ask
the first four questions: "What are the minimum data elements and the
data sources for the registration summary and medication history? What
are the objectives of the registration summary and medication history
from a clinical, business, and consumer standpoint that would say,
'These are why the data elements should be included in this data set in
year 1'? And then, what is the best approach for consumers to control
and manage their health information and at the same time maintaining
high data quality and data validity?"

It's been said time and again on this call that privacy is the principal
design issue and any time we talk about health information. And so we
established here that consumer privacy is the most important principle
for guiding the selection of the data elements and the data sources, as
well as the process in which the health information is collected and
exchanged.

Once we have decided upon the data elements and the respective data
sources for the reg summary and med history, then there are a number of
other practical issues that have to be addressed. And those are the data
sources that you see listed in that table that I sent you. Our near
potential data sources -- we certainly have to look at who's ready out
there as an available data source to effectively create an
implementation project.

So what's feasible in 2006 and what's -- while facilitating the path to
the broad charge of widespread PHR adoption, what are the significant
barriers that can be resolved in this breakthrough process? What
delivers the most value to the consumer over the next couple of years?
How do we leverage the various stakeholders and align with their various
breakthrough activities?

At this point, I want to call your attention to the Appendix, which we
distributed alongside this data element. And let me just kind of go over
the structure. There is obviously the data elements list, Column A on
the very left side. That is the union of all the contributions that have
come forward from the payer community, the consumers, as well as the
clinicians and IT and health information management professionals that
have weighed in on this. It's a heavy list. There are -- in the
registration summary section, there are 130 data elements, much -- not
including the parents' data elements where it says "Name." But if you
include the child's names like last name, first name, and so on, there
are 130 data elements in the registration summary, of which 68 of them
are initially classified as minimum and 62 that are initially classified
in the optional dataset. In medication history, there are 44 data
elements, of which 25 are initially classified in the minimum data sets
and 19 within the optional.

So you can see that there's 174 data elements that would comprise the
medication history and reg summary. Certainly a daunting task to try to
implement all 174. Could possibly be done, but because it numbers 174,
we thought to provide that as an option to this group as -- and by
breaking them down into minimum versus optional. You will see the
optional in Column B, the suggested data elements for being -- excuse
me, for the suggested data elements for the minimum dataset in Column B,
the suggested data elements for the optional dataset in Column C, and
then we added a Column D, which is -- there are -- some data elements
that have been suggested that are in the current climate are now being
frowned upon, and that is the Social Security number. A lot of
institutions have been using Social Security number extensively. But
because of all of the privacy concerns, it is the one right now that is
in that Column D, which we called -- we considered that as a data
element, but did not think to put it in the -- as one of the datasets.
And as we go through this process, there may be other data elements that
would also go in Column D, depending upon how you vet them and make your
decisions.

The other thing to consider is that the registration process is an event
and when we hear a lot of people submit or talk about their data
elements for registration summary and medication history, it's not
entirely clear that they're talking about reg as an event so that, when
you present at a physician's office or at a hospital, that a transaction
is occurring. So what is the minimum number of data elements to support
that event? It sounded like a lot of who are coming with -- or coming
forward with their data elements were offering more of a wish list. And
so what we need is the justification, which goes back to question number
three in the section above: "What's the drivers? Why don't we need that
data element in the registration summary and then history?"

And so then, when you take a look at Columns B--G, you'll see that we've
taken a crack at some of the potential data sources, and the key point
to make about the data sources is that if we think about this as an
event that has a workflow, then the data elements can be -- can come
from the natural plumps in the workflow. And we gave a scenario as an
example here. This example is checking the insurance benefits at first
visit, where the patient presents with a PHR. And in this instance, when
the patient presents with the PHR, there may be demographic information
that's on the PHR, and the PHR could be on one of a -- one of those USB
sound drives, or it could be on a Web model. And if that is the case,
then the exchange of demographic information can occur between the PHR
and the EHR. The insurance -- the PHR, by all accounts by everybody's
input, has suggested that it needs to contain insurance data elements
such as insurer, the plan number, the group number, ID number of the
individual, but not necessarily the data elements on the plan's coverage
and the benefits. Thought it would be good information, but it is
extremely useful information and necessary information. The question is,
is that something that goes in the PHR? Because if it goes in the PHR,
then what we are encumbering or may encumber the consumer with just the
responsibility for maintaining that information on an annual basis, plus
it increases the store's requirements for that PHR.

If, on the other hand, the -- that kind of plan and coverage
information, which is needed at that transaction, is stored on a payer's
Web site, then the PHR merely needs to say, "Here is my plan and my --
whether or not I'm on a PPO plan with this insurer or on the HMO," and
then the provider's EHR goes up to the PHR and checks and sees the plan
and covered benefits. And in that instance, what it does is it relieves
the responsibility of the PHR to have that and the consumer to maintain
that information. The payer has the most recent information on that Web
site. And plus, they're motivated for getting the correct information to
the clinician.

Let me take a pause here for a little sip. The other -- so there are
some advantages, and we just put that out there as a scenario, not as
something cast in stone, but just to illustrate the fact that the health
information exchange in something as simple as when a person presents at
registration, but that the data sources could be come from a couple
different places. It could even be that if the patient doesn't have a
PHR but that demographic information in the first bullet point is up
there at the provider's secure Web site, then there would be an exchange
between that payer's Web site and providers of EHR. So there are
multiple ways to exchange the health information in the transaction as
simple as this.

The other key information that we felt compelled to point out is that by
some accounts, the PHR is not a legal record like the EHR is, and
therefore, it makes the PHR a separate record out of necessity. The
electronic health record at the hospital or the provider or the
physician must go through all of the Federal rules of evidence and
health information management practices to -- for discoverability and
submission into court evidence and those kinds of things.

But we wouldn't want to encumber the consumer with that kind of
responsibility. And therefore, as has been discussed and gotten
consensus agreement on FDHL-7, PHR/EHR linkage workgroup -- at least
that set of folks has agreed that the PDR can't be a legal record. What
does that mean for a data structure as the standpoint? It means that --
and the PHR there has got to be basically two regions to put it
conceptually simplistically. In the protective region, when an EHR
downloads information to the PHR because the consumer can't modify
those, then it has to stay static within that record so that when the
health information exchange occurs, the next provider -- then there is
reliable information should the exchange go from PHR to EHR. It's not an
issue if it goes from EHR to provider EHR. But that is really the
implication when -- for the data elements, when you consider that the
PHR is not a legal record.

Somebody on the call earlier made the point that something like 85
percent of the information in the PHR doesn't come from an EHR. And so
it's all that information that we're talking about that would go in the
unprotected area, the journals, the diaries, the patient's own version
of what he or she thinks was the diagnosis, and so on.

And so that leads us to two options. And first, there is a caveat. The
caveat is that the assignment of the data elements in the minimum and
the optional columns is still very flexible for discussion, and so there
may need to be a discussion within this workgroup as to whether or not
these are truly the workgroup. The minimum data elements are not. And
the reason to make that the first decision point is because it then
plays into the two options, because in the two options, the notion is
that we may not be able to get to all 174 data elements, and so in order
to break them up in the first year, let's break them up into the minimum
and the -- and optional.

So the first option would be, then -- that is being just thrown out
there for discussion is to implement the minimum datasets for both
registration summary and medication history for a limited stake for the
stakeholders and not the entire U.S. population, but a subpopulation in
year 1, and then include other stakeholders and implement optional
datasets and after year 1. And the second option would be to implement
all the data elements, both the minimum and the optional datasets, for
registration summary and medication for, again, a limited set of
stakeholders and then include other stakeholders after year 1.

And we don't need to necessarily go through the pros and cons of each
approach, unless, Nancy, you feel like it needs some review. But I think
we can stop here and ask for some discussion.

\>\> Matt: Please open Robert Tenant's line.

\>\> Robert: Hi. First of all, I just want to commend you. It's really
an exhaustive list of -- very impressive. I had a couple of concerns,
and I guess the broad one is, there's an awful lot of data here for one
thing. I think a lot of it probably could be either switched over to
optional or probably eliminated. Things like hair color -- I'm not sure
if that really particularly important. But I had a question about things
like work e-mail, which is listed as minimum. One of the concerns raised
by patients in regards to these types of records is, they don't want
their employer to know. And if it's forced on them that they have to
give up their work telephone and work e-mail address, that might be a
barrier.

Second is, it's fairly rare that a physician will want a patient to have
their cell phone number, unless they specifically give it to them and
potentially e-mail address as well. But I think you're going to run into
some pushback from physician if that is included as the minimum. Again,
it might be better placed as optional.

\>\> Don: First, you make some very good points there. And I'm not
needing to defend the assignment of minimum versus optional. The reason
that the list is so long is, this is union of everybody's input. And so,
once we get everybody's input, the list just kept growing and growing.
So that's the reason why there is 174 data elements.

As for their assignment between minimum and optional, we just basically
took a crack based on the input that came in, and we may not have did it
correctly, and so we're freely -- we're happy to, you know, work with
the workgroup to change the assignment from minimum to optional based on
the question number three: "What are the drivers for doing so?"

A couple of interesting things that came up that were, you know, kind of
surprising to us. Things like eye color were -- was in the corrections
world -- was listed as a patient identification feature, though we --
you know, those in acute care settings and the ambulatory care settings
would probably not be concerned about that. Actually, we didn't even put
in some of the other things that came in from the correctional
facilities. They were going by things like tattoos and other body
markings, in addition to physical body traits like eye color. So those
are the reasons why something like eye color and hair color were put in
the minimum column. But, again, they -- depending upon the scope of this
project and depending upon how this workgroup vets it, something like
those things could easily go from minimum to optional. Did I explain
that -- so I hope I just explained the process.

\>\> Robert: Yeah, I think the other broad issue is one of medical
specialty. What is not important for one patient may be critical to
another. For example, patient birthweight or something like that. And
immunizations are critical for them and not personality for others. At
some point, we may want to approach some of the specialties, and again,
it probably will make the dataset larger, but it might be more valuable
in some regard.

\>\> Nancy: Thank you for the comments. Are there other comments?

\>\> Matt: Kevin Hutchison has a comment.

\>\> Nancy: Thanks.

\>\> Kevin: Just a couple things. On page 3, under Personal
Identification, there's -- "Social Security Number" is listed twice. Not
included in one time in the minimum dataset. I'm not sure if that is a
mistake or that was intentional, and the same thing on ethnicity.

\>\> Don: That was just a typo. That's an error on our part. We will
correct that, thanks.

\>\> Kevin: The same thing on ethnicity. One time it was optional and --
in same category. On the data sources, are you including for prayers
anyone who provides health care like physicians or pharmacies or the
specific physicians?

\>\> Don: No, we generalize that to -- otherwise, too many columns there
to the right.

\>\>: Kevin: Okay. And I guess the third comment would be, isn't the
data element work -- should be within a standards group on exchange of
the information? Or is that -- is this being tied to what HITSP is
doing? Or -- for example, I know on medication history exchange, it's
already in the Federal regulations, the pilot, the NCPDP scripts
message, which includes medication history and the data elements, are
defined within that standard; they have to be piloted. And that is being
used today from pharmacies and from PBMs: medication history
information. Is this somehow lined up with that, or are we doing
different work on data elements associated with standards?

\>\> John Luntz: This is John Luntz. It is, I think, assumed that HITSP
will look in this area.

\>\> Kevin: Correct.

\>\> John: I'm not completely clear where this exercise is going from a
functionality standpoint. I mean, if it is driving particular
functionality or a model for how these data are useful or how they were
from where they would come, all those things could factor in. But
perhaps one level off in terms of consideration of broad types of data
instead of -- that are necessary instead of data elements, which seems
pretty specific in detail.

\>\> Nancy: John and Don, this is Nancy Davenport. And I had a few
observations I'd like to share in reviewing the work that you have done
here, Don, and thank you for giving us your verse stab and bring before
this group today so that we could share our observations.

I think -- as a number of comments I would make -- I, too, had marked
the Social Security issue, and so we would want to look at that. I think
when we consider patient treatment considerations and the issues of
advanced directives and power of attorneys from a patient perspective,
that information is extremely important in any PHR. It's important that
we begin educating consumers to the fact that these are documents they
need to have at the time they do become ill, and their families need to
be informed, and if we are developing this for the United States and
setting it as a standard, there may want to be some consideration of
moving those patient treatment conditions' points into hopefully ones
that will be included at a minimum.

I think when we get to the information about health plans and benefits
from that health plan, because of what we do here every single day of
our lives, we do find that an overarching concern for Americans, whether
they are insured in the private or public sector, is indeed what
benefits do they have and what type of plan are they in, and reporting
that information in your PHR becomes a foundational step that has to be
in place in order to move forward with concerns that you may have once
you are into the health care system.

If we look in the care setting division under Column A, where we have
hospitalization, we show medical and surgical. I would add to that
radiology or radiologics, because we do now have certain regimens that
do require in-hospital stays for that treatment. So I would consider
adding those.

I think under the medication history, for the sake of the patient, there
needs to be a section in which the patient can record adverse events and
they can record them very concretely as part of their medication
history, so that when they do go to an institution to be hospitalized or
to be treated for the first time, there is an immediate reflection of
what they've already had spent and how to deal with those.

And the section that deals with over-the-counter medication, there may
be an opportunity to add information that includes references where we
show medication needs. We need to let consumers know that that include
what types of vitamins are they on and/or what types of herbal therapies
are they on. Because we certainly know those therapies can often work in
concert against a prescribed medication. And I'm thinking particularly
in the field of oncology care and treatment.

So those are the comments. And going back to the comment made earlier
about immunizations, I think certainly our group has had a rather -- an
amount of discussion about the fact that we have a sense that personal
health records will be fairly quickly embraced by young mothers who are
having to maintain all of these records for children that are in stages
where they are getting all of these immunizations and shots. So we may
want to consider moving all that immunization record information from
optional into the minimum requirement so that it would help those young
moms that are trying to keep that information. So those are just a few
comments that we may want to review.

Are there other comments?

\>\> Matt: Yeah, there are several comments actually. David Lansky.

\>\> Nancy: David.

\>\> David: Thanks, Nancy. Back to the scope of our charge for this
group. And I think, John, I really appreciate what you did and the work
you have done, and the background work is really helpful to start think
being how we structure this. It seems to me that we should define a
scope that is somehow mapped to the breakthrough itself. And because it
is a huge prospect to take all these data elements and decide which ones
to keep or not keep and prioritize, doing some kind of additional
discussion with ourselves or with outsiders about the -- Nancy started
saying what the user requirements are. If we are able to deliver a
registration summary and medication history to people in the next year
or two, what value does that give them? What risk does it create? For
example, medication allergy system, a subject we talked about a good
deal. Should allergies be a higher priority either in the optional or
required category? Because we are now delivering medication data to the
patient. And I think if we triage the list a little bit based on
functions associated with the sequence of breakthrough rollout, that
would be good.

To me, it breaks into three types of data -- Don's point: demographic
data, insurance-related data, and clinically related data. And as you go
down that tree, there is greater sensitivity and greater need to address
the privacy issues that become triggered by the availability of this
information moving across the network. But I think it is good that we
should therefore not confine our attention to just the top of the tree
or the bottom or whatever it is. We shouldn't only deal with
demographics and insurance data; we should also deal with some of the
data which discloses sensitive health information so that we do test in
terms of our goals. We want to test some features of this model which do
subject people potentially to exposure of their personal information, so
that we can try to put in place infrastructure that protects those
patients.

In terms of the -- I think we should make a distinction, Don, in your
list between the list of data elements and the availability of standards
to characterize those, which Kevin pointed out regarding NCPDP. And my
point is, there may be vendors out there who want to make use of many of
the items on the list in the services -- the value-added services they
provide to a consumer. That's great.

Today, they have almost no standards to draw upon for most of the items
on this list. It would be a service if HITSP or someone else began to
propagate data standards for the items on this list, even though we may
not prioritize all of those elements for immediate adoption in a uniform
fashion. That is, we might say, "Here is the minimum list of elements,
and we certainly have to offer standards for those. Here is the
supplementary list of elements which we are not going to require or call
minimum, but which we think are so important we would like vendors to
start deploying (indiscernible) durability they have to be standardized
now." So reporting medication allergies or advance directives -- how
advanced directives to be stored -- to Nancy's point. There may be
vendors who are able to offer that service right away, but they don't
have the standard to do that arean.

So I would (indiscernible) several things. One is to define the scope in
terms of demographic to include some of the clinical -- to ask consumers
which clinical items they want to prioritize, advance directives or
allergies, take those priorities based on the use case itself so that we
are prioritizing items that are germane to the application.

And the last point I want to make about all of this is the question of
truth. Despite the fact there are many data sources, they will probably
differ on most of these items and what they capture today. And they will
certainly change week to week and year to year over time. So we have to
somehow develop a process by which we either allow the patient to
declare what is true or to have different truths for different purposes,
which people may want to disclose information -- not disclose it in some
circumstances, disclose it in others: the sensitive information. For
example, on this list, Don, you have previous hospitalization, previous
treatments, previous diagnoses. Some of those will be things people will
certainly want to withhold, not consider automatic treatments for mental
history, reproductive health issues, whatever. We shouldn't default it
to assume that everything we think of as minimum as opposed to
transferred upon request. And in fact our research says that some people
will want to have several versions of the truth be used in different
circumstances.

That's a lot of complexity in that set of issues, and I think simply
enumerating the list of data elements won't take us far enough down the
process. We should probably inform the larger community that another set
of layered issues will have to be tackled.

\>\> Don: Nancy, if I -- may I address some of the points?

\>\> Nancy: Absolutely.

\>\> Don: Okay. Thank you. Quite a few valid points have come up in just
the last few minutes, and all of them are absolutely (inaudible) and the
point about whether or not are the standards organizations -- yes, there
are already transactions, and there are clinical documents and other
types of records that have these kinds of data elements within them. But
the pragmatic issue is what I think needs clarification, from where I
sit. Now, as Vice President at HIMA, we are alone -- look at national
policy and so on. But we are also working at the standards level and so
on, and so what I'm seeing is who answers the following question: The --
when we talk about the registration summary and the medication history
as the breakthrough project, what's the metric for success there such
that when we know by year's end, we -- that health information got
exchanged, we need to know what health information got exchanged that is
called the reg summary and called the med history, so that we can call
this a success.

The dilemma is that the standards organization has things like
transactions and clinical documents, and they'll say, "This is our
registration history, and this is our medication -- or reg summary and
medication history," and somebody will have a different definition of
that. Is the measure of success the fact that any one of those can be
exchanged by year's end seamlessly and interoperably, or is it that we
specify a specific set of data elements that gives guidance to the
standards industry and says, "Okay, now we know that these are the data
elements that have to be transferred; now I know what I'm going to hit."
Because otherwise, what I'm a little bit fearful of, having worked, you
know, in the standards world these last few years -- and Ross, tell me
if I'm wrong, because I see you there at these same meetings as well --
is that absent that kind of specific direction, then the -- anything can
be claimed as success. And that worries me just a little bit.

\>\> Matt: Please open Robert Kolodner's line.

\>\> Robert: Yeah, I think, as looking at -- getting started and going
through, I think we need to make sure that the minimum set really is the
minimum set, even if it is going to grow over time. And I just want to
make sure that we do make progress and that it is useful enough in terms
of minimum set.

But some of the things we may want to leave in phases and do chunks of,
looking, for example, at the hospitalizations and some of the other
things, you know, there're going to be multiples, and you are going to
have to add things to it -- level of complexity. We may want to start
with what is the core demographic information we want to get, then what
is the next most important, next most important, and see if we can get
it started so that it saves some of the time but doesn't start with so
big a set that we're going to find that people -- either it gets too
complex, too expensive, or takes too long to get it started. Thank you.

\>\> Nancy: Thank you, Robert. Other comments?

\>\> Matt: Yeah, Ross Martin has a comment.

\>\> Nancy: Okay, Ross.

\>\> Ross: When I look at our charge for this group, I see that we are
supposed to be delivering two core solutions. One is kind of the wrapper
-- I'm going to call it the wrapper -- or the architecture for a much
broader vision of the personal health record. And the other one is this
-- very short-term goals, but the second one is the short-term content,
registration summary, and medication information. In that context, we
are going to want to, I think, do a couple of things and maybe
specifically looking at this conditional or required versus optional, or
minimum versus optional in the dataset. How I'm interpreting this is not
your minimum as in "required for the patient to always have this content
in their PHR delivering mechanism in order to be valid," but a minimum
in terms of our short-term scope that that element is there, whether
it's filled in or not. And maybe that's somebody else may have a
different interpretation of that.

It also may be useful for us to have another category called
conditional, meaning it really depends upon the specific situation. As
somebody already brought out, if you are not focusing on a child and
immunization records, that may not be the particular issue.

I'm going to just run through a shortening of things here to, of other
issues, the list itself, sort of flat versus accessible. What I mean by
that is, if I were creating a more generic type of list, it would say
something more like, "Here is the medication, and here are the
characteristics of the medication that I'm delivering," and included in
those characteristics are things like whether -- what the mode is and
whether it is an immunization or not. I wouldn't, you know, specify
particular immunization; that's part of the medication. Those are just
sort of examples of what I mean by a repeatable thing that's extensible
versus a flat one or that's generic versus exclusive. It also -- as I
look at this list, it looks to me like it's deposing a very disconnected
environment where I may want to have something instead of the
prescribing-physician-specific information. I may want to have that -- a
link to that prescribing physician's provider identifier that we're
starting to dole out now, or something or the equivalent of that that is
also updated in a real-time fashion or a fashion that says, "Here is the
person," or, "Here is the relationship." But I'm not just trying to tie
to the static information that point in time, but another data source.
And I thought that would be a thing that we could talk about a little
bit.

And the last -- the last thing is this notion of the extensibility of
the whole thing, and this gets back to the first point I made about the
wrapper versus the specific charge. I do think that we want to leave
room for anybody who's using this, and I think this is something alluded
to in earlier comments: anybody who is using this to, yes, address the
minimum dataset that we define but also have within that wrapper other
things that, in a business arrangement or whatever it might be, be able
to do more with it. Because I think it will be ultimately useful if all
these parameters around it are usable in other contexts as well for
greater purposes, like excluding radiology information or if the events
directive don't make it into our cut, that somebody could put that in,
and with the patient's agreement and consent, if they use PHR facility
in their environment, they could do that as well.

It is going to be very important for us to look at this list again when
we've gone through the scoping exercises, figure out what target -- what
population we're targeting and what environment we're targeting, because
the minimum dataset may be very different depending on what we choose
for that.

\>\> Nancy: Ross, I certainly think your comments are well-described and
well-taken. And I think if we look at the short charge -- short-range
charge that our group has been given, and if we look at the proposed
data element that Don has supplied us with this afternoon and we think
in terms of a prepopulated registration form, and if we think in terms
of a medication history, then any of us on the call this afternoon were
to just simply go down the list and check what we would see as standard
data field areas that would have to be included to deliver either one of
those short-term charges that we've been charged with meeting. I suspect
there would be much similarity with what all of us are saying, and that
may be a process that we could use that might be helpful for us in
trying to go through this exercise this afternoon so that we can advance
a recommendation with consensus on Monday, March -- or on March the 7th
-- Tuesday, March the 7th. So I think if we consider for a few moments
just the issue of prepopulation registration form and we looked at the
work that Don has done and we asked ourselves, "Would the registration
information as presented as a minimum be required?", I suspect most
persons on the phone this afternoon would agree that indeed it is, as
well as information such as emergency contact.

So I wonder if there is a process this afternoon where we as a group
could try to come to consensus around the global categories that Don has
presented to us this afternoon and agree that these are global
categories that need to be included and advanced as such, and that there
may be other categories that, if they are not included this afternoon,
we would like to recommend on March the 7th be shown as optional with
further opportunity to expand moving forward.

So, with that recommendation on the floor, I'd like to entertain
comments and questions.

\>\> Matt: Please open Kat Mahan's line.

\>\> Nancy: Okay, Cat.

\>\> Cat: I think Ross stole my fire, because most of what I was going
to say, Ross probably repeated. But I think -- I would agree with Ross
in some of the information within the medication history. It is a bit
flat, and I think I got the gist of what Ross meant. But I would move
for the group if there is consensus to agree on a minimum truly required
dataset in terms of patient demographics. Because without that, that
actual minimum set, there you can't really progress any further.

In terms of, you know, whether we actually get to the point of saying in
medication history this is required or this is conditional, I do think
some interoperability needs to be looked at through the other standards
that are being addressed by the other workgroups. But I would say that
for truly required minimum set, got to have a patient demographic. And I
would also add that for the medication history information, some of the
fields in there make a lot of sense, medication listed. But I'm not sure
why there is one medication name area and then there's past medication
separated out. And I think that is where Ross is going with, in terms of
data being flat, is that if you include some type of date of medication,
you don't have to separate those two. They just can become identified by
the type of date they're listed with.

And in lieu of -- you know, again, of an MPI that's nationally agreed
upon, I think the minimum dataset demographic seems to be the way to go.
And I was just going to also add on what somebody else said: I had
medication allergies versus environmental to be listed out, which I
think somebody said ADEs listing those.

And I would hate to see that, you know, we get lost in this kind of
data. I think this is a really good piece of work and definitely
identifies several topics. Maybe if we can stay at that level, we can
make progress. I certainly hate to see the standards not be considered,
because there are standards being utilized to do a lot of this
information today. Maybe not with a patient focus, but I would hate to
see progress be forwarded, but I don't feel that we can't move on
without taking some consideration what is in use today. That's it.

\>\> Matt: We've got a bunch of comments, Nancy, so I will keep moving
through them until you stop me.

\>\> Nancy: That's a good thing, Matt.

\>\> Matt: Open Charles Safran's line.

\>\> Nancy: Charles.

\>\> Charles: I want to second what Rob had said about both the need for
a minimum -- truly minimum set for what I think this is -- a little more
extensive than it perhaps needs to be. And the idea that rather than
minimum and optional, there might be some grading of data elements on
some sort of scale (one, two, three or one through five) as to how --
so, for instance, the color of someone's eyes, which no one in any
system that I know of in any health care setting actually collects,
perhaps maybe some ophthalmology systems that I don't know about, would
be a hard thing to automatically populate.

So when you ask someone a question like that, it takes 7 seconds for
each one of these 100-some-odd questions that you could ask the question
in closed form on a computer system. If you have to get someone to type
it, it's more. So the obligation of time to things that couldn't be
automatically populated are -- make these systems less user friendly by
patients, and we know this from lots of experience.

So again, I would just urge that this set really needs to be pared down,
and we ought to perhaps at least add one more level of -- from truly
absolutely required for the -- you know, the minimum charge of our group
to things that would be nice versus things that could be nice, so some
more granularity of importance of the data elements.

\>\> Nancy: Charles, I have a question. Thank you for your comments
first. And the question would be, is it not a foundational premise that
if our job is to try to create a prepopulated registration form, that
there would be some need to be consistent with what our Nation
historically has collected on those registration forms? From your point
of view and for the organization that you represent?

\>\> Charles: Absolutely.

\>\> Nancy: That -- I think that's consistent from me. I would love to
hear from others in the working group because we would come back to the
issue of insurance, for instance. I know of no registration form in the
country that does not require a lot of information around that to the
point of even making copies of insurance cards to further support the
information collected on the registration document. And so, while I
think we do know there are some data elements, and I concur with you
absolutely correctly around the length of time it takes to get this
data, we have 200 data fields each with pull-down boxes that -- some of
those can have thousands of pull-down options. It does take a while to
go through it. Color of hair, color of eyes, color of hair -- a lot of
consumers will answer by saying, "Which week?" and probably won't give
us information that would be dependable from one time frame to the
other. Color of eye could be another. So, we may need to grade down data
elements and pare them down. But I'd like to see us stay very consistent
with -- historically we need to capture on registration forms in the
past. Thank you, Charles. Other comments?

\>\> Matt: Ross Martin, go ahead.

\>\> Nancy: Ross.

\>\> Ross: Very quickly, I think echoing what Cat was saying. And John
mentioned the notion of functional specifications, and I do think that
is how I would like to look at the -- in terms of if we are going to
endorse this sort of categorical list, I would kind of -- if we were
endorsing the full name level, I would say, "Yes, let's endorse this at
a functional level," meaning these are the things that we think are
important to collect. Again, reviewing it after we've gone through the
process saying what are we going to try to do in our short-term
objective, that scope will really have an impact on this in terms what
have we require versus conditional versus optional. But say, "Yes, we
think that, on a functional level, we should be collecting the
demographic information that relates to somebody's address, the
demographic information related to somebody's information." But leave
the specifics of that, the technical specification of that, to the
standards harmonization process. That's what I would be comfortable
with.

\>\> Nancy: Can you specify more about the list of functions that we
want to focus on? Or do -- we can get into that as we develop
conversation.

\>\> Ross: To me, that depends on what we choose as our focus. That
would make it more clear. If we go with the pediatric population, we're
clearly going to want to make sure immunization are front and center on
that. Some of the other -- my child employer is not as critical at that
point. \[laughter\]

\>\> Matt: Okay. We've got at least five people in the queue; everybody
please be patient. Kevin Hutchison, go ahead.

\>\> Nancy: Kevin.

\>\> Kevin: Just a real quick comment -- on the data sources, I guess
I'm concerned. I'm trying to reconcile this with -- my head is lumping
all health care providers under "Provider." I guess you are lumping can
upon PVMs under "Payers," and I think the concern I have with that is,
there are different data elements that are available from different
types of providers, additions -- as an example, by the type of physician
or pharmacy as a provider under the category of being a provider. For
example, the reason for prescription at a minimum dataset: it's for what
issue? Well, that condition might be in a payer database, but
specifically not going to be in a preponderance PVM database.

One missing element in this is also under "Provider" -- is the SIG. You
know, the instructions that go along with the medication are enormously
important to providers as well as to patients so that they can track and
schedule their medications they should be taking at certain times during
the day within their PHR system. And a SIG is available from pharmacies
but not necessarily the SIG in payers' database. So it varies by data
sources.

I think we got to be careful about lumping all of the providers into
that. Maybe we should also name potential data sources versus the data
sources that we would gather from. It is really going to be a
combination of all of these type of data sources that will give you this
level of information on the left, and there is a checkbox sometimes
underneath a provider that information exists in all provider databases.
It does.

And date dispensed is also a key, especially when you are talking about
medication and compliance: you want to know the date the patient picked
up their medication. Just different than some of the dates in -- your
start date and end date for the prescriptions and so on. Those are all
part of the script standard but would be nice to add into this element.

\>\> Matt: Davette Murray, go ahead.

\>\> Davette: As we discussed -- and people were discussing how the
patient would necessarily release the information to different
populations -- I think one of the things we might want to discuss is
maybe a default release profile for the first-of-all record. In this
sense, if you had a patient who really wasn't computer savvy and you
look at this litany of information on the personal health records, who
is the most likely recipient of certain types of datasets? And set the
default up that automatically, if the patient didn't set up profile,
that information would be released to a certain kind of individual that
would need in it default setting of business process to meet that
information. So you set up a certain level of protection for the patient
in the sense that if they say, "Okay, my information can be released,"
but they didn't set up a profile for themselves, that automatically all
this information doesn't just go to any -- the whole record of their
information doesn't go to just someone who doesn't really need it. I
mean, you know, if I'm an insurer, I don't necessarily need to know that
you have a will or whatever, what your last rites are going to be, your
preference. I don't necessarily need to know that information. What is
the information I need as an insurer? What is the information I need to
know as your pharmacist? That would be sort of level of protection for
the patient also.

\>\> Matt: Karen Bell, go ahead.

\>\> Karen: Thank you very much. As I have been listening to the
conversation, I started thinking about this from the perspective of --
that supports -- serves both the clinician and the patient. And the
reason I'm coming at it from a physician point of view: there are
750,000 practicing physicians in the country, not counting the ones
working for the Federal Government, and at the average of 10 to 15
patients a day, we're talking about 10 million encounters or
opportunities for this kind of information to be useful. And what it
really comes down to: there are three critical functions. One is,
physicians use that clipboard to gather clinical information and put it
in their medical record, because that's how they can justify they have
done a review of systems for patient purposes. So you have to do that on
-- essentially every time the patient comes in. So it's a way of
gathering information in the clinical record that can lead to
reimbursement. So reimbursement is a big chunk of this.

And the other big chunk of this also relates to reimbursement -- is
needing to get the insurance information which many of you have talked
about. Clearly, the medication list is important, but we all recognize
that the there is a huge disparity between what is dispensed and what
patients are taking. So 30 percent disparity so that you do need
information beyond which can be prepopulated on a medication list. So
patients do need to be able to make some modification. You want to know
they've made it, but some modification to the medication list that not
only include over-the-counters that you were talking about for a little
bit, David, but to also demonstrate yesterday they may have filled it,
but it didn't work or for whatever reason they are not take anymore.

So, in essence, it is those three things that keep the clipboard going
and keep its happening 10,000 times a year -- I'm sorry, 10 million
times a year. And I'm just suggesting that as you think about how to
really move this forward, really start from those basics -- what are
those three critical things that keep the clipboard going, and what are
the basics you need to support that? -- and then let it grow over time.

\>\> Matt: Thank you so much, Karen.

\>\> Matt: Please open Robert Tenant's line.

\>\> Robert: Speaking of that, I like that last comment, because she's
asking, you know, "What is the purpose for the PHR?" And I'll take that
a step further. Is the PHR to be used for treatment, or is it to be used
for payment? If it's for treatment, then I think we can probably safely
remove the insurance coverage and subscriber employer information. For
example, the insurance coverage you have as a minimum -- I'm not sure
what the purpose is; is this to replace the HIPAA 270 272 transaction?
We all know that eligibility information is suspect at best. And the
only way that a provider is going to feel confident with that
information is if they do a real-time transaction with the health plan.

So I'm not sure what the purpose of having, you know, group number,
policy number, this type of information on a PHR. It all can be done
through another transaction. We don't need to duplicate things for the
providers. And similarly, with the employer, who's going to be updating
that? Folks change jobs all the time. Are we going to expect dictation
to be updating all this information on a timely manner? And then what is
the purpose of having that information in the PHR?

\>\> Matt: David Lansky, go ahead.

\>\> David: Thanks. To Sharon's comments on the clipboard. I think a
good place -- earlier discussion -- clipboard is a large metaphor or
maybe a goal. I think if we keep that in mind, it is really helpful. I
went out and pulled about 10 clipboards to see what was on them. I know
there have been occasional -- I'm sure others in the group know
societies to develop a standardized intake form or standardized history
and physical form or some medical summary form that would be a way to
move this process, make our jobs a lot easier, and I wonder -- one
little research test we might be is see what the state of development
common clipboard form -- whatever we want to call that -- and take that
as best practice or maybe encourage HITSP to standardize that.

I think if we thought about our work, not only in terms of technical
implementation but identifying places where standards would be useful --
to Karen's point about the 10 million clipboard entries -- if they were
a standardized format for the 40 percent or 70 percent that is uniform,
that would be a big win for everybody, providers and for patients. And
it would then make our job much easier -- let's take the 40 percent,
whatever it is, and implement that in technology. So it will be -- also
be implemented in paper uniformity at that set of data requirements.
Find that as objective for ourselves -- and I think, Charlie -- and
other points earlier, there should be a very minimalistic view.

But I would say, when I polled the 10 or so clipboard, such as my own
look, with almost universal is the family history stuff and the patient
history of medical complaints. I think those are things that are not at
all standardized. It would be very useful simple contribution to this
process, which is almost --

Second thing I wanted to say to Ross's point: I really appreciate it. If
we set the scope of our project in the next few minutes as to
pediatrics, seniors, or illness, whatever it is, I think our next step
should be to go talk to patients and can them what is valuable to this
component. The is the consumer empowerment strategy. What we need to do
is asking people sit nothing waiting rooms and examining rooms across
America, "What can we do with this technology to make your life easier,
better, safer, by delivering this information around?" They may say it
is advanced directive, or they may say it is -- or I don't know what
they will say. Always parents of young children have a different answer
than seniors with multiple chronic conditions.

So I think fairly early, once we set the scope parameters that Ross
described, we should do quick -- 1-week, not just focus group and
interview -- get some real data for what we can do to empower them in
the course of getting their care.

\>\> Matt: Justine Handelman.

\>\> Justine: Thank you. I just want to -- I agree with many of the
comments said around the table, too, and with what David just said, I
think it is important to define a population, and at that point, it is
hard to go through and identify what those elements are. But you know
there are broad categories. I think it needs to be ongoing market work;
it can't be something we decided on today, but rather look into the
population (indiscernible) revisit this and connect in with HPSA and
touch -- field of what the value is and how they'll use this. Because if
we put all this information out there and it is not used, what purpose
does it have? We want it to be something that is valuable to the
consumer and provider so that it is (indiscernible).

\>\> Matt: Nancy, looks like we have made it through the queue for now.

\>\> Nancy: Good. We have had so many great suggestions that have been
made, and Don, I have to say to you, you have stimulated great
discussion with this group, which is a major accomplishment and one that
you should be very proud of.

I think what I would like to do in summarizing some of the discussion
points that we have heard this afternoon is that I think there are
universality in the desire to have these elements pared down to be
reflective of both the broad and the short-term charge that our group
has had. There has certainly been great discussion this afternoon around
the need to set our scope.

For whom are we developing this information? Is it for the parent that
has young children? Is it for the chronically ill? Is it for the senior
population? And, again, Kelly, it goes to the process that we're allowed
to engage in as a working group so that we can indeed establish a
process and format that allows us to answer some of those questions.
Because that will shape the ultimate product that we can deliver out on
the 7th day of March. So we do need to set that scope.

And I think that David's suggestion that we get on the phone and we do
some focus group work with patients is extremely appropriate. Because at
the end of the day, if we want this to be a consumer-driven initiative
as Secretary Leavitt makes reference to and as Dr. Braler makes
reference to in every presentation they give, then where better to start
with that leadership than to get the consumers on the phone at this
point and find out if we can deliver to you a prepopulated registration
history and medication history. What would be important to you to have
on that form? There might be a process available where those of us that
serve millions of patients within the course of a year could actually
run the survey online and with Don's agreement consider putting the
major categories that he has, maybe not the boxes to the right, but what
the categories are, and let some of the consumers begin to identify what
are the categories that they feel would be most important, moving
forward so that the public can be a part of the process in helping us to
identify that.

In order to have our work complete for March the 7th, it seems that in
the very near term, we must do two things. Number one, we must pare down
the list and come back with a recommendation that the members of this
working group can sign off on at the beginning place. And to do that,
number two, we must define the scope and for whom we're preparing the
document. And number three, once we have identified what the scope is,
it does indeed seem that we have the opportunity available to reach out
to constituents from that particular population and conduct the
one-on-one interviews and/or surveys with them to find out from them
what is important so that we can be well-prepared on March 7. So if
there are those on the call that agree with the strategy as described in
the three steps as described, if you are in agreement with that, we will
take your silence as agreement.

Also, if there are those that have questions, further comment of
clarification, or amendment to process that they would like to offer at
this time, the phone lines will be open for you to make those
suggestions.

\>\> Matt: Kevin Hutchison, go ahead.

\>\> Nancy: Kevin.

\>\> Kevin: Nancy, the only thing I would add: I think we should also
look at the data sources that may be -- clarify those a little about the
-- and maybe divide them up and not put them in general buckets.

\>\> Nancy: All right. And Kevin, if there's any further clarity that
you can give to that around data sources, please feel free to do that. I
concur, and that can be part of the paring-down process that we're
asking Don to do here.

\>\> Kevin: Okay.

\>\> Nancy: Okay. Other comments or questions?

\>\> Kelly: Nancy, this is Kelly. I just wanted to echo something that
Ross had proposed, which is to get a consensus to have as a part of our
recommendation inclusion of data elements at the bold category level. I
think it's most important to follow through with what you already
articulated. To the extent that we need to have one recommendation that
we can feel good about at that point in time -- do you feel there is
enough to focus on the broad category level and get agreement on
including that within the specific charge?

\>\> Nancy: Kelly, I think there is certainly the opportunity for us to
do that. I think -- having said that, would it be further enhanced if we
at least submitted some degree of narrative that would detail some of
what we had consensus around today beyond just the broad category?

\>\> Kelly: Okay.

\>\> Nancy: I'm asking the question, Kelly, and if you feel that no, we
just need to stick with the specification of broad categories are
knowing this is going to be a process we continue to work on in the
paring-down process, we can recommend the broad category with the caveat
that we will be coming back to them in the future with more details for
each of these.

\>\> Kelly: Yeah, I was thinking the latter would be the most realistic.

\>\> Nancy: That's good.

\>\> Kelly: But I think we could get a lot done in the next week and a
half. It's just the cumulative work we're all going to have to do might
end up as putting a lot of version on the next week and a half to
produce a lot when I think the workgroup does have a little bit more
time to really flush out more details.

\>\> Nancy: I agree with you, Kelly, and what I would like to do --
because you know my goal here -- is to see that we get these broad
charges and short-term charges met. I think we can agree on March 7,
that we would move forward with the bold categories with the caveat if
there is significant work accomplished between now and March 7 in
defining the scope and/or details of any of these individual categories
and sources. We would also offer that on March the 7th.

\>\> Kelly: Sounds great.

\>\> Nancy: Okay. And again, I'd like to pause for just a moment to see
if there are any additional comments and again, we would take silence as
a sign of agreement.

\>\> Matt: Davette Murray.

\>\> Nancy: Davette.

\>\> Davette: I just want a point of clarification: when you say "broad
category," (indiscernible) as being the category?

\>\> Nancy: I think, Davette, I heard that the recommendation was, it
would be the broad category which would be read and everything that is
in bold, which would mean registration summary to include name, address,
contact information.

\>\> Davette: Thank you.

\>\> Nancy: You're welcome.

\>\> Ross: This is Ross. Just from my perspective, it is okay if we
include -- if we classify the subgroupings or the sub-items as
representative, but not conclusive, because it really is dependent upon
the deeper dive that has to happen.

\>\> Nancy: Good observation, Ross. Thank you. Any other comments?

If not, we'll take silence as the agreement of our group, and thank you
so much, Don, for conducting a wonderful discussion, and thanks to each
of the members of the working group for your willingness to jump in and
to make your comments known.

I'd like to recognize now Kelly Cronin, who is going to be discussing
with us review options for breakthrough models. So Kelly, thank you.

\>\> Kelly: Nancy, we are short on time, so I thought it might be
helpful to walk through the options on how this project might be modeled
-- the breakthrough might be modeled and then consider what is most
important for the group to contemplate at this point. And I think that
given some of the conversation already today, there might be a variety
of models that would be appropriate, but yet perhaps the most important
point that we need to come back to is that all the principles -- working
principles will have to be met, and the policy issues that we lay out
will have to be addressed adequately to enable any one of these options.
And I think that also, with some of the comments around functionality
that might end up being an important short-term consideration, that will
drive a lot of the decisions or definition around any one of these
options.

But just to start off, I wanted to point out that in the first page of
the options paper on the subject, there is critical criteria that I
think we all need to keep in mind as we come up with specific
recommendations for the overall community. The one is that whatever we
decide is appropriate, it is feasible to implement in 2006 as our
starting or baseline year, that we can accomplish the specific charge of
immobilizing prepopulated registration summary and medication history
linked to it as appropriate or as feasible, but doing that in such a way
that we are going to facilitate the most direct path to widespread PHR
adoption. We should also think about which of the options will address
the most significant barriers that have to be resolved in order for us
to really achieve a broader set and then make sure whatever options we
think are appropriate also deliver value to the consumer over the near
term that we leverage the ability of all stakeholders while trying to
balance expectations, responsibility and authority across the board. And
then that we also consider how we might align with some of the other
breakthrough activities. One that we might want to be mindful of in
particular is the chronic care workgroup that is focusing on secure
messaging, which could be one potential function of the PHR down the
road.

So in moving to option one, this would involve trying to build off of an
existing regional health information exchange. There's several in the
marketplace now that are operational, and as we all know, the NHIN
prototypes are funded, and by the end of this year, they will be in a
demonstration phase where they will have the ability to show some of
health information both within their market and the cross-markets. So
there is potentially a good option to consider from the perspective of
-- that there is some existing infrastructure we can build off of. And
there are already processes underway to try to identify how to
authenticate patients, and there is a record locator services that are
going to be part of the demonstration or that are already operational,
for example, in Indiana.

I think that's one of the things we probably need to think about, is
whether or not the current system that's being used by providers that
has sophisticated security features -- whether or not the addition of a
consumer interface might increase the risk of compromises to the
security of the network. This is more of a technical, you know,
consideration, but there could be some perceived risk or actual risk
that would involve compromising the security of a network that is
already functioning or is just demonstrated early on. So this -- that is
one model.

Another model that I think people are probably very familiar with is
katrinahelp.org, which involves using a variety of data sources and
having sort of a Web-based access to medication history. Now, if this
model were to be more fully explored, we'd have to figure out how we
would prepopulate registration information and make that available
through the Web. I think that there were a lot of good that was
demonstrated through katrinahelp.org and certainly serving an important
purpose when there was a lot of evacuees around New Orleans that were
displayed. But one of the things I think we need to consider is that the
-- having just a Web-based services didn't make it very easy to
integrate into a clinician's workflow, and if this information is going
to be made available through just one Web-based service, then we need to
figure out what would be the practical application of that in the office
and could we improve upon what was demonstrated in katrinahelp.org.

I think we also need to be mindful that there was only read-only access,
and if we wanted to consider this more fully, we'd have to figure out
how this system could be designed to allow patients to update their
information and have it be more perhaps interactive. But I think that
there were certainly a lot of limitations that have been realized with
this one particular model.

And another model really is involving PHR vendors, which all of these
could potentially involve. But this particular option would be more
specific to vendors being connected to one or more intermediaries that
would supply the registration summary and medication history. So, for
example, a patient could just click on a button and it would direct
information to be downloaded on, you know, their medication history into
their PHR application.

And then a fourth model would be a chair or employer-based model where
they would be providing information from their databases to prepopulate
a personal health record application. But that, you know, there would
also have to be some level of consumer control in that process, some of
the pros or -- that this is already really being done and it can -- this
data can be easily prepopulated. The Medicare program in particular has
a beneficiary portal that it will be rolling out nationally over the
next year so that data will be made readily available.

There are some rather significant concerns with this option in that
there are many consumer groups that feel that there may be a lack of
trust between patients and their payer or employer, and that may not be
sort of the ideal provider of these services, given that there might be
potential secondary uses that would result in either a higher cost of
insurance, a loss of insurance, or perhaps, you know, a loss of
employment. Of course, we could be, you know, addressing the principles
and the policy issues around this to address this issue, but I think
that there's a fair amount of concern in general around the player --
payer and employer role in providing these services.

And then, another issue is just around the data quality. If payers and
purchasers could be prepopulating data that is largely claims based or
administrative data, there may be errors in that data. It may not be
clean to the point where it is reliable and the quality that it should
be to be used in a personal health record.

So, all of these are options, and I think it would be helpful to get
some discussion around whether or not several of these might be
appropriate or what sort of we could feel comfortable recommending given
that we will be continuing to work on the principles and refining and
streamlining them and also be addressing the underlying policy issues
that are related to some of the negative aspects of these options.

\>\> Kelly: If, you know, folks could comment on what they think to be
sort of the appropriate option or set of options now, I think that would
be great, and then we could try to quickly move on to the next issue.

\>\> Matt: Justine Handelman, go ahead.

\>\> Justine: (indiscernible) -- short on time.

We have a couple concerns really limiting and having the group decide
what model or what option is best way to go. I think from our
perspective, really the consumer that should choose who should be the
author of HR. I think, as many of you know, health plans already are
offering -- I think we think that our data is pretty accurate and
reliable. I think for providers at least in the models that is we've put
out and have been doing and using are relying on the data that we are
providing because payers and PVMs have valuable data right now that is
successful and doable. So we wouldn't want to limit -- and I don't think
it is the charge of this workgroup to really limit the choices that
consumers would have, but rather there should be, you know, multiple
choices how they want to go about choosing a PHR supplier and who they
are most comfortable with, be it a vendor, be it a payer, a provider
that might offer a PHR.

But in terms of, I think, effective ways when you are thinking about the
breakthrough being something in short order, I think when you look at
what is being done now, you want to ensure clients that if you are going
to ask the consumer to choose a vendor themselves, have to go out and
populate going to be much more difficult. If you want to do something in
the short term, I know from at least a payer point of view you have a
lot of data to prepopulate readily update it when there is new
information that comes in and keep that up to date, it is easier for the
insurer, in terms of ensuring clients that is extension of the rule that
payers is already providing.

I think payers have established relationship providers, so there is a,
certainly, level of trust there. And another thing I'd point out is that
I think at least payers and what they are doing now have clinical
decisions and support tools. They are there at the point of care and can
provide that in an easier fashion. So I just point a few of those things
out. I think the important thing for this workgroup -- and I know we
touched upon before -- is determining what the minimum elements are
working through the issues down the road as we have discuss identifying
the standards needed and talk body that already. I think we don't want
to limit any type of model or choice consumers have comfortable
(indiscernible).

\>\> Matt: David Lansky.

\>\> David: I really agree with Justine's comments. I think we should
sharpen our role. Standard of importance for policy report and then
recognizing the different people of the country will have different ways
of meeting their needs, different products, solutions which the market
will generate.

So the two things that are really missing to make this happen, one is
what is called orchestration, and the other is a business model which
motivates people to offer up creative solutions to this environment. I
guess our infrastructure problem's architecture of standard policy --
then there will be a response by people in the market to offer
application in the market to do good things for people.

And I think the transitional step -- we should address what kind of
demonstration or orchestration or environment for laboratory do we want
to create in the next year or two, which when we put in place enough of
these standards and policies that are fairly robust, then we invite the
developers and the officers to play in that laboratory and we try to see
whatever we need to understand from a policy point of view that makes
that work. So I would say all these solutions that are in the memo are
viable. And maybe there are others, but at least four models we could
create environment where all four have an opportunity to be exposed and
see if they work with us, keeping an eye on that and seeing how it goes.

\>\> Matt: Kevin Hutchison.

\>\> Kevin: In looking at the options, I would say -- and I would agree
with everything that was said, that I don't think we should -- it might
be interesting to find out which path going to take in a way. But option
one, my concern with the RHIOs -- and we are engaged with every one of
them -- and exchange of information. It's primarily so focused on
getting inform at the hand of physicians and physician communication,
and they are starting to add some element of consumer. I think it is
huge distraction for them to try to -- like you say in your comments, it
could be all kinds of distractions on security and other things like
that. I do think that every one of these scenarios, which -- still one
of the authentication process -- I know: broken record on that.
\[laughter\] But it is a huge concern of mine.

But number one might actually work well where there are RHIOs that have
PHRs integrated with EHRs. And there are some of those. There are some
physicians' offices that have integrated to EHR and patients using EHR.
Regional environment where some of that might exist -- it might be
interesting impact study on that level of exchange of information;
should be interesting.

Option two, I -- being involved with katrinahelp.org, I think whatever
we do should be scalable. And whatever we demonstrate to do should be
scalable. As much as we enjoy doing this and helping out, this is not a
scalable solution. I think we should focus on how it is something we
could demonstrate would be a long-term, more scalable one.

Option three and four are very interesting, because both of them are now
happening in 2006. So you have intermediaries connecting to PHRs that
are going to be changing medication information. Not all of the data
elements that are described in here in the back of here, but you have
payers that are actively involved in rolling out a personal health
record portal for access to that level of information. So I think three
and four are going to happen no matter what this committee does. It will
be interesting to look at the study impact now to see how effective
those are. So one, three, and four have promise. Three and four probably
have more probability of happening in '06.

\>\> Matt: Ross Martin, go ahead.

\>\> Ross: I have a question about bachelorette number three.
\[laughter\] It seems to me that if I were shaping this slightly
differently, where it talks about the centralized data repository, if I
could shape that as being the -- a data pointer repository, let's say,
or a data connection repository, but not actually the data itself, that
to me is a very appealing one, because it enables any of the other
options plus a few more.

I would like to see it if -- I agree with the earlier comments that it's
not really our job to choose a model. We do want to study. We have to
study something and we have to enable something specific for 2006, and
it may be one or two of these models. But if we have -- and this gets to
David Lansky's point earlier about orchestration and business model -- I
think option three, if it were a pointer intermediary, would be creating
that playing field, which to me is the combination of the orchestration
and the business model. If it were supported by the micropennies
exchange of all the different players who have an interest in this. It
would also allow for one of the element that is missing in all of the
current implementation, which is the easy transportability from one
model to another.

If I'm with a payer right now, yes, I can get a personal health record
from them whether or not the data is high quality. Let's just assume
that it is all high quality. It is not easy for me to take that and go
somewhere else and put it somewhere else and use it in a different way
right now. And having an intermediary that provides a facilitation for
that, even if my primary relationship is with that payer or with a
provider group or with my employer, then I got something I could have a
lot more confidence in.

\>\> Matt: Please open Helen Burstin's line.

\>\> Helen Burstin: Yes, hi. I just want to make the point that I think
a lot of what we're talking about is linking nicely to the next
discussion, which we probably don't have very much time to have, about
specifically target population and geographic scope. And in some ways, I
think, if you read through about models, it's not necessarily, you know,
choosing one over another, but instead having an opportunity. In fact,
get some evidence of which of these models work best. You could then
apply some of the ideas in the population and geographic population
paper to just kind of think about ways to come up with a couple of
different pilots that might be able to get some evidence on which of
these models in fact work best.

\>\> Nancy: Helen, this is Nancy Davenport-Ennis. I could not agree with
you more. In fact, it seems to me that probably I like options one,
three, and four, perhaps with the guidance that you are giving us and
perhaps the document that you have prepared around targeting population,
we could pilot all three of those and try to do it and correctly
identify the population to capture some information that would be
significant.

And I think because we are so tight on time this afternoon, I would like
to ask if we have consensus around the concept and indeed the four
different pilots that have been proposed. Our group does not want to see
them limited, that indeed, there may need to be more than one process
available to consumers in these areas and perhaps the best process to
use to determine which would have the highest likelihood of success
would be to identify correct pilot populations in which we could then
pilot and conduct demonstrations for options one, three, and four.

Option two, we had concern voiced that perhaps that was not a scalable
option, and so if we have consensus with the group that at this time,
perhaps, we don't put two in the cycle for demo with a targeted
population, but rather we try to focus on one, three, and four, and then
our recommendation on the March the 7^th^ is that each of these options
have great validity, and now they need to be tested in the American
marketplace. And again, silence will indicate agreement, and if there is
comment that anyone would like to make, the lines will now open.

\>\> Matt: Nancy, we had a few comments in there before you just
addressed the group about the consensus on that issue. Do you want to
take further comment, or do you want to try to keep moving forward?

\>\> Nancy: If the parties feel that they would like to make comment,
certainly. If not, we will keep going.

\>\> Matt: Okay. We'll open the line quickly and we'll see. Robert
Tenant. Please open Robert Tenant's line.

\>\> Robert: Yeah, the models are interesting. I don't think any one
really jumps out at me as being the model. It might be a combination of
one or more that works, or it could be all of the above, where there's a
singular dataset but multiple ways to get at that dataset. The last
thing is, I wonder if there's not an option five, which would be more
position-centered. Because you look at all of the other options and you
ask yourself, "Who is the patient going to trust with this data?" They
certainly don't know RHIOs or Katrina Help. They are certainly concerned
about vendors, and they are very concerned about employers and insurance
plans.

So, in general, in the health care field, patients trust their
physicians more than anybody. And I don't see anywhere in these models
where the physicians and the patients have the central relationship. And
for example, I see a potential way of doing this, as Justine said, is,
you know, you get the data from the health plan, obviously Medicare,
maybe through a pilot. But you work through the physicians. They can
better educate the patients, alleviate their fears, and ensure that at
least the health care data is as accurate as possible. I wondered if we
want to think about that a little bit.

\>\> Nancy: Robert, would it satisfy the recommendation you're making if
the three options were expanded to include language such as "in
coordination with physician input" or "physician involvement"?

\>\> Robert: Yeah, I will just give an example. There is a couple of
very excellent PHR systems in place now. I will give you two examples.
Cleveland Clinic and Brown and Poland in San Francisco. Both of them are
group practice centric and have met with a lot of success.

So I just think there is more than one way to skin the cat here. And I
wonder if you really want to put up a fifth option, which is practice or
physician centric.

\>\> Nancy: I think I'd like to hear from the group as to whether they
want to propose to have a fifth or whether they would like to integrate
language that includes physician to the models that have better than
proposed.

\>\> Matt: Please open Tim Smokoff's line.

\>\> Tim: The last comment: I think that if we look at breakthrough
models, we may want to consider one in which the PHR is not in the
clouds, but the consumer has more direct access to control of that PHR.
Say on a storage card or a USB port or interesting models out there that
the financial institutions are driving today related to health savings
accounts and debit cards, including tips on (indiscernible). I think I
would like to propose that there is a fifth model that allows for some
of that information to be transferred by the counsel summer.

\>\> Kelly: Nancy, this is Kelly. If it's okay, I would like to address
the last two comments.

\>\> Nancy: Sure. Absolutely.

\>\> Kelly: I think in terms of how a PHR would be offered, whether it
be a Web-based tool or something more clever like a debit card or a
memory stick, I think that that could be incorporated into any one of
these models. And I also think option three could lend itself to a
provider or group practice-based PHR, as well. I agree, Nancy, with what
your original proposal was to make sure we incorporate one of these
options, incorporate sort of a provider orientation and perhaps work off
of a group practice-based model.

\>\> Nancy: Thank you, Kelly. With Kelly's remarks, I would like to see
again if we can get to a point of consensus, only because we do have
Helen Burstin ready to present to us and we only have 21 minutes for her
to do that. So with that being said, I'd like to propose we go back to
the original proposal that was made, again noting that how the PHR is
addressed can apply to any of the proposals that have been made and that
we can certainly include the physician into incorporated into any of the
models and particularly into number three.

So if we could have agreement that we will advance to the AHEC that we
feel the models one, three, and four each have merit, make the
modification to three to include that of physicians inclusion, include a
statement addressed at process allowing the process statement to apply
to all three that we are advancing. This group could indeed move forward
with that if we continue our further work in the weeks on exactly how we
actually are going to do this.

Again, we would take silence as concurrent, and if anyone would like to
make a comment further, we would open the phones to do that.

\>\> Matt: Nancy, we have several comments queued up in the Humphrey
Building. And I will just direct to all the members, if you feel like
you agree with consensus and we can move on, then you don't need to make
a comment. If there is something you feel like you need to put in, speak
up now and I will let you queue yourself up.

\>\> Justine: This is Justine, and I had one comment (indiscernible)
caveat or have something written on the model that a PHR can be offered,
and here are more examples -- (indiscernible) either for example of ways
out there.

\>\> Nancy: Yeah, Justine, perhaps make a global introductory comment
that is introducing the three, having all leaders understand they are
not endorsing, they are not exclusive.

\>\> Kevin: I would -- I would agree that -- on the PHR, the comment
made about the PHR. I think that's absolutely a trusted source that
patients are more like to go through, and item three can't exactly
demonstrate that or even item one in a RHIO environment, where
information is being delivered to a physician's DHR. DHR then slivering
it onto the PHR system on both of those. Point of clarification that I
would like to make so we don't confuse three and four: in three, we use
as an example source system at PVM. In four, the source system is the
payer. And I think at three, what we're talking is a variety of store
systems which could be pharmacies, could be PVMs, could be a number of
other; I guess what you're saying is non-payer sources. Technically,
PVMs are acting on behalf of the payers, but you get the point: where
there's different type of intermediary, where there is not a direct
relationship, I guess with the consumer in that regard, like the payers
have a direct relationship.

\>\> Nancy: Thank you, Kevin.

\>\> Davette: I also agree with the comments that have happened so far
also. The only thing I would also add a caveat to is looking at our
scope and what we are supposed to deliver. I think in the long term, we
don't want to pit certain process of how this is done. I think in the
short term, we may be asked, "Out of all these options, which of these
options could be done within 2006?" So while we wouldn't endorse a file
option out of these options that are on the table, which is the most
viable that could be done within 2006? And maybe prioritize them for
consideration.

\>\> Nancy: Thank you for the comment. And perhaps we could go back to
the concept that we could seek to identify correct populations so that
we could recommend a pilot, which with each of the free models to see
how they're going to work.

Other comments? If not, we have noted the recommendations have been made
by the callers, and we would now suggest that silence would mean that we
have come to consensus with our previous recommendation on noting the
comments that Justine has made, comments that Kevin has made, and the
final comment that we need to remember what our scope is and perhaps
order these and order our priorities in terms of which one we think we
could have implemented in 2006.

Matt, I would suggest that we have consensus, and I'd like to thank the
group for their discussion. And Kelly, thank you for walking us through
your introduction and allowing such robust discussion around it.

And with that, I'd like to introduce Helen Burstin. Helen, you are our
final presenter for this afternoon. And I think we are all eager to see
what you have to say around the issue of target population and
geographic scope segue you provided for us in our last discussion. So
welcome to the call.

\>\> Matt: Nancy, we have Helen queued up and ready to go. But just with
the interest of time to allow for public comment at the end, I just want
to let members of the public know, I will put the call-in number on the
Webcast now and let members of the public start queuing up now so we can
address the comments immediately when the time comes.

\>\> Nancy: All right. Thank you, Matt.

\>\> Matt: Helen, your line is open. Go ahead.

\>\> Helen: Great. Thank you. I think we can make this fairly brief.
Most of the information is in the handout. I worked this document with
Kelly Cronin and Paul Tang and couldn't join us today. I think the basic
idea as we think about -- as we just talk body models and pilots of
different kinds of models, is there a opportunity to think about whether
or not there might be -- (indiscernible) -- for pilot testing?

I'll just quickly run through the target population very fast. Certainly
the first one would be children. A lot of incentives -- and going back
to the earlier point about moms who want immunization records, as a mom
of two toddlers, I would vote for that. Kids often computer savvy --
beginning to be evidence that children with PHRs have better outcomes,
at least with one condition. In terms of thinking market perspective, we
already have a large contract in the State of Colorado heavily focused
on children and health information exchange.

On the (inaudible) obviously only benefits the truly sicker pediatric
patients, who are truly in the minority, and some issues around privacy
and some State law inhibiting parental access.

The second major option here, under Patient Population and Patients of
Chronic Diseases, particularly those, the very pro on them is population
most in need of this kind of data, most in need of having that
information as they go through multiple providers and being on multiple
medication to help enable communication, and they tend to see providers
more frequently -- could also -- convenience of this kind of.

On the negative side, this is very, very limited view of what a personal
health record could be, with -- the medications in particular would be
somewhat limiting for them. And being able to show an impact probably
would be difficult with just medication and registration information.

That is kind of all we thought about in terms of -- again, these are
just examples. We're certainly open to any other ideas; for example,
part of the health IT policy council. Sam brought up how useful this
would be for patients on methadone. So there are even subsets within the
subsets that I think we could certainly entertain.

The third option, thinking about it in the context of Medicaid and
Medicare, as we heard earlier from the -- Loraine, you -- the CMS
Beneficiary Portal is a possible option around demonstration for 2006.
Many Medicare patients in particular are often on multiple medication,
which may be a benefit. If you could certainly link in eligibility and
benefit information -- certainly, as a clinician here, probably increase
the likelihood of somebody using the system if they thought they would
actually get that kind of information as well. And one option might be
with the new welcome to Medicare visit, whether there is a way to tie in
PHR to all those for the visit.

On the negative side, certain on will Medicaid side, many Medicaid
programs don't have the resources to be able to do something like this
even though they might find it very attractive.

Option four, the populations would be looking specifically at --
"uninsured," it says here, but I think in some ways, both uninsured and
underinsured and the safety net patients utilize the safety net. On the
positive -- certainly allowing emergency department personnel to have
access to this health -- patients and -- may often times find themselves
getting care in emergency departments.

CHS community health care is certainly a possibility here, and CHC
network might be an opportunity for us to look at a pilot in that arena.
On the negative side, some of these data will be difficult to obtain,
and many of these patients may not have access to computers or the
Internet. Although some data suggests when they have it, they do just as
well.

Option five is caregivers for the elderly. I think being able to
demonstrate value to caregivers and phone numbers could be really
useful, and it is probably more relevant to the broader charge overall.
Option -- in terms of beyond patient population and geographic scope,
you know, again being able to demonstrate a real impact here -- if we
could, for example, protect States that may have the infrastructure or
organizational capacity to pull off a pilot in one of those manners that
we suggested earlier, there's certainly lots of pros there. For example,
we find six States currently doing health information exchange across
the U.S. They've already begun to learn many of the important lessons
around health government, as well as the way to, in fact, begin doing
this kind of work. We could build on existing infrastructure, set
vision, and rules. And in addition to our six States, there are 30
States that now propose tax legislation about health information
exchange. So there may be a ready audience who might be interested in
help this.

On the negative side, States are big and messy, and one option might be
to think about a smaller geographic area. And certainly the State
privacy and security laws can be barriers to implementation as something
being studied through a large archive ONC contract. Second option, which
ties into some of the models that Kelly presented earlier, might be
looking at regions that have large employers or plans to offer programs,
being able to leverage the private sector here, providing more immediate
access to distribute the PHR specifically on the employer side.

On the negative side there, we would really probably only choose who
insurers, and we may not be able to integrate a lot of the information
from other providers and use that in the workflow if they don't see a
majority of patients in that particular employer. As I think was raised
earlier in this conversation, there may be privacy concerns about having
this information through your employer that may be a barrier.

And finally, the last geographic option is regions that have a
operational health information network, the end prototypes that were
discussed earlier, give more of a local health care market. And some of
these health information exchanges are really beginning to be
operational and could begin to add the technology and the functions
needed to also let us look at the value of these emerging RHIOs, as
well. On the negative side, there are very few that are truly functional
at this point, and instruction would be ready for prime time in 2006.

With that, I will close and take any comments or questions.

\>\> Nancy: Thank you, Helen, a very nice review and the floor is open
for comments.

\>\> Matt: Open Robert Tenant's line. I think this might be an old
comment. Go ahead, Robert, if you have something to say.

\>\> Robert: I appreciate that. I don't think we really dealt with an
earlier issue, and I wanted to bring it up. I know apparently we had
consensus, but I think it is difficult with this type of format with the
queuing to really get that type of consensus. But when we're doing
pilots -- and I agree with -- there is a lot of options here in terms of
the population to survey. But I'd like to offer that when we're doing
pilots, we might want to look at various transmissions' mediums. For
example, a Web portal or a flash drive or something like that. Because I
think we should be casting the delivery mechanism as well as the
contents and the population. But I just didn't want us to forget that
point; I thought it was very important.

\>\> Nancy: Thank you, Robert.

\>\> Dan: Nancy, this is Dan. It occurs to me that this is the half of
the discussion that we just had over the options for breakthrough
models. And if we're -- the target populations and geographic areas need
to fit the three pilots. I suggest what we need is a matrix that would
show which ones would be feasible for which of the different pilots and
that we not select any one group or limit the groups at this juncture
and that rather we go back and take a look at which populations would
work best with which pilot models.

\>\> Nancy: I agree, Dan. Do you have a recommendation of when you would
like to see that matrix developed, and are you hopeful that it can be
completed so it can be reported out on March 7 at the public meeting?

\>\> Dan: My suggestion is that we not try to do that, that we set --
instead ask for some assistance from ONCHIT to help prepare some
discussion so that we can discuss this again at our next workgroup
meeting.

\>\> Nancy: Okay. And what I'd like to do, Dan, is to proffer your
suggestion before the group again using the same process that we have:
silence will mean that we concur, and we will schedule this as a
discussion item with the matrix enhance for the next call.

And if there are those that would like to make a comment at this time,
we would open the phone lines to do that.

\>\> Matt: David Lansky has a comment.

\>\> David: I was going to speak directly to the suggestion, although it
is, I guess, the -- if we take the given that we have been asked to work
on the medication use case, and we should target a population of people
for whom that is a high-value dataset, and there is opportunity for
improvement to the safety gain. So my bias would be that we take a
population 45 and above, roughly, who are higher medication users almost
like definition of high medication users for office two category; that
is why they are taking medication. So then, many of them, when they are
older, do have caregivers who are engaged in their care. So I think
there is sort of a zooming-in logic to this to me that says we can start
with medication requirements we have been given, and that tells us we
should work with an older population of heavy medication, heavy
utilization generally; we should speak to the registration case and then
ask the matrix question. If people agree to that general direction,
which data architectures or infrastructures are in place that would let
us in 2006 permit the different models to be applied to that population?
And maybe it is a State; maybe it is RHIO; maybe, I don't know, a
certain market area for a vendor; some set of conditions which are most
likely to allow us to test the other things we talked about today. The
matrix should focus on that. I would personally say we should take off
some of the populations where high medication use and high medical
utilization is not common.

\>\> Nancy: Yep. Good suggestion, David, and certainly it is congruent
with what our charge has been as we are moving forward.

\>\> Matt: Kevin Hutchison has a comment.

\>\> Kevin: This may actually fit into option two and option three on
this geography, but something you want to keep in mind is, as you are
selecting geographies, there are certainly geographies that actually
have better access to data than other geographies, and I think that is
something we should consider. When you look at plans or PBMs or
pharmacies that are participating in medication history information,
there are certain geographical precincts where they have begun the
process that actually is a large percentage of population that can be
covered in that geography. So if we take that -- maybe a survey is not
the right word, but a look at the different organizations that are able
to provide that data and where they're able to provide it, you're going
to find some natural crosses in some of those geographies that work
well. Thanks.

\>\> Kelly: Nancy, this is Kelly. I'm just wondering if we could
identify perhaps a mechanism for how we could do what Kevin has
suggested through using all the resources available through the
workgroup members.

\>\> Kevin: As an example, Cleveland -- someone mentioned Cleveland
Clinic and Brown and Poland -- because of their great work in this
particular area, there is also now others outside of those that surround
those organizations that are also great geographies for that work. It
kind of fits into the FACT network in the area, and now there are more
sources of data coming into that geography.

\>\> Nancy: I'm sorry, Kevin. That suggestion would be consistent with
options for geographic option one in terms of States with
infrastructure, and you're expanding it beyond the State with the
infrastructure, but large treatment organizations and/or businesses in
that area?

\>\> Kevin: It's more focused on the State, more focused on the sources
of the data. There are plans that are further along and able to provide
this information in certain geographies, PVMs that are further along,
pharmacies further along in providing the data, and they have strength
in certain geographies and other --

\>\> Nancy: And so, as we relate the use of those stronger plans and
pharmacies as an example, would you still recommend that we could do
that consistent with the population that would be option two, patients
of chronic diseases, which have been suggested earlier by David Lansky?

\>\> Kevin: Um, well, I think my suggestion is not more targeted to
population as much as under the geographic scope.

\>\> Nancy: Okay. So you want to stay under geographic scope, and your
suggestion is plans and pharmacy?

\>\> Kevin: Sources.

\>\> Nancy: Sources of information?

\>\> Kevin: Right, and where there may be strength in those sources of
data. That is why I struggle where it could fit. It could fit in one,
two, or three.

\>\> Nancy: Yeah, I agree. And maybe, indeed, that is what we should try
to add it to as we have done with other things. Rather than limiting
options, we are trying to expand them to see where we get the best
return.

I think for the working group this afternoon, then, we've had two
different recommendations made. One is that we focus our attention on
the development of option two and expanse. The other is that we move to
options for geographic scope and that we have one that would look at the
sources of information, particularly focused around plans and
pharmacies, as well as other, with the addendum that perhaps that
approach could be integrated into each of options one, two, and three,
within the geographic scope section.

So I think at this point, we'd like to have some input from those on the
working group in terms of which of the two proposals would be more
consistent with what you would like to see our next step be.

\>\> Matt: Ross Martin has a comment.

\>\> Nancy: Ross.

\>\> Ross: We are quickly running out of time on a -- I think probably
the most important thing we have to talk about today, which is thinking
about how we're going to position this in this very first round in terms
of deliverables for 2006, and that concerns me. I'm -- I'm very
sympathetic to the notion that David talked about, about the most the
people who will most benefit from this. I wholly agree that people with
chronic illnesses, high medication users, will most benefit. But I kind
of have taken a different way of thinking maybe I can be persuaded
differently. But one of our goals in this -- I would say our primary
goal, not necessarily to service those that we're -- that we're going to
be targeting in our pilots, if you will, in the initial phases, but to
generate the consumer awareness and the consumer endorsement of this as
a notion in general. And also to do something that's straightforward
enough that we can actually get it done in a very effective fashion. And
when I think about pediatric population for that, it seems to me that
that's a -- the model of that example. Something where there is no
complex medical history prior to where the delivery of that information
is fairly straightforward. The immunization -- the universality of
immunizations among the pediatric population is something that -- yes,
it is not a bunch of sick people but something everyone has to do and
has to deal with -- really open up a lot of options. Also, you have the
opportunity for it not to just be -- this is true for any of the
options, but if you can set the -- establish the parameters around which
others could develop applications for this sponsored by employer groups,
sponsored by communities, sponsored by whoever might be wanting to do
that, philanthropists. You could have a lot of people jumping on to this
and demonstrating it within the parameters that we described, whichever
one. I would think that again, the pediatric population would be one
that a lot of groups would willingly support an infrastructure developed
for that in the very short term without having to spend Federal dollars
on that. So maybe that's a contrarian view to what we've heard, but I'm
concerned about the time limits here.

\>\> Nancy: Okay. Ross has put yet a third recommendation forward that
we consider the pediatric population, acknowledging that this is a very
important issue we're trying to address this afternoon, and we're at the
end of the call. So I think -- and we do need to have time for public
comment. So, having said that, what I would like to do is ask this
generic question: Do we feel this afternoon, in the time that we have,
that the members of the appointed working group for the empowerment --
consumer empowerment committee can indeed resolve to support one of the
three global proposals before us -- pediatrics, age 45 and older, high
drug use, or geographic scope -- where indeed we would be focusing on
plans and pharmacies for majority of information?

So generically, silence will mean, "Yes, we can come to consensus." Or,
"No, we need more time," would mean someone would open the phone lines
and say, "We need more time." So if we think that we can come to
consensus this afternoon, silence would indicate that.

\>\> Matt: Nancy, as far as the public goes, we have given them plenty
of time to call in. We will finish up with them, and I don't think we
will give them extra time. I have had the number for 10 minutes.

\>\> Nancy: Thank you very much.

\>\> Matt: Couple of comments on the line. Open David McClain's line,
please.

\>\> Nancy: David.

\>\> David: I'll be quick in regards to, Nancy, your last comment. I
think this is -- I don't think these things need to be separate. I think
Kevin's comments earlier in terms of the geography, in terms of the
importance of where there is already some established dominance of
population sources that are there -- that comes from the payers and the
pharmacies. There are very rich sources that do that, and once you have
that base and have that data available, then you can go off, and you can
do the pediatrics, and you can do the chronic illnesses, and you can do
it much more completely, because you've a rich source there. So I don't
think these things are mutually exclusive. I think they are very
complementary.

\>\> Nancy: Thank you, David. I think we can also add to that providers,
such as Cleveland Clinic, that also have fairly rich database of
information that could be helpful here. So, having said that, David, do
you feel confident that we can reach consensus this afternoon and we
need to simply determine if we're going to look at this in that
pediatric population or the 45 years of age with chronic illnesses and
high consumption of pharmaceutical agents moving forward?

\>\> David: Oh, this is David McClain. I'm very comfortable with that.

\>\> Nancy: Okay. Other comments?

\>\> Matt: Open Loraine Duke's line.

\>\> Nancy: Loraine.

\>\> Loraine: Hi, thank you very much. I just wanted to confirm -- I
would be remiss if I didn't support something for the Medicare
population, and so one of our option system -- in fact, I just heard you
say 45-plus with chronic conditions and multiple medications?

\>\> Nancy: Correct.

\>\> Loraine: Okay. Super.

\>\> Nancy: All right.

\>\> Loraine: Thank you.

\>\> Nancy: You're welcome. Any other comments?

\>\> Matt: Empty right now, Nancy.

\>\> Nancy: Then let's see if we can get the consensus this afternoon.
Are we in agreement that the focus of this group will be to examine the
issue that is proposed in option two, which is the 45-year-plus person
with a chronic disease, and that's the option we wish to explore moving
forward? Silence would indicate yes. And if you're not in agreement with
that, we would like to record those not in agreement.

\>\> Ross: Nancy, this is Ross. I was had the contrarian. I am very
comfortable with targeting that if that is what we're wanting to -- if
that is our intent that we want to go after that most challenging, but
you know, most important frankly for this purpose target population. I
have no objection.

\>\> Nancy: Thank you, Ross.

\>\> Kevin: Nancy, this is Kevin. I would just like to echo Dave
McClain's comment, though. If -- and clear on what we're trying to do --
if we actually big say six geography that has had very strong sources of
data for medication history, I'm not sure that we have to make a
decision right now to limit that to a particular population or type of
population, because at that point, you could hit pediatrics or over the
age of 40. Because the data is available for the population, and it is
in that -- are geography, not just a certain sector of that geography.

\>\> Nancy: I think that is true, David. With data, we know that can
work both ways. We can either have the selection of the fixed primary
data sources and then we can get any data that we wish to have beyond
that, or we can identify that it is the 45-year and older target
population identified as the chronically ill in option two, for which we
would then collect data from those six universal data sources. Either
way could be effective for this group. And so we can certainly reshape
the recommendation that is before this group to include not targeting
the 45-year-old that is chronic, as proposed in option two, but rather
targeting geographic where, indeed, we will simply identify major
pockets of payers, pharmacies, and providers that can provide a wealth
of data that can support for us what the medication experience is with
the chronically ill, no matter what the age of the patient.

So silence would indicate your desire to conform to the latest
recommendation before the committee. And if your preference is not to go
with that but an earlier recommendation, we would open the lines for
your comment.

\>\> Dan: This is Dan Green again. I again believe that trying, at this
point in time, to pick a particular population is not what we should be
trying to do, especially since that could be at odds with the choices
for the delivery mechanisms that we were talking about earlier.

\>\> Nancy: Okay. So we will not go with a particular population, Dan,
but rather we will consider --

\>\> Dan: Consider all of the three that we -- the three major ones we
have been talking about as we pick -- go through and select a pilots for
each of the three options that we talked about on the breakthrough
models.

\>\> Nancy: So we'll take those three options that we supported on the
breakthrough model. We will look at research, provide afternoon on the
target populations, and internally determine which of the target
populations will be most appropriate for the three models earlier agreed
to?

\>\> Dan: Correct. And if there are geographic -- you know, if there's
-- turns out to be a geographic area where these are most feasible for
early implementation, then that would be considered as well.

\>\> Nancy: Yeah, that's very good. Thank you, Dan. Silence will
indicate that we concur with the recommendation that has been made by
Dan, who is here this afternoon as Co-chair in lieu of Linda Springer.

\>\> Matt: The queue is empty, Nancy.

\>\> Nancy: Thank you, Matt. Having no further comments, then, we will
indeed adopt the recommendation that was made by Dan Green and proceed
in that manner. And I would like to thank each of those who have been on
the call this afternoon. And Kelly, I would like to open the floor for
any summary remarks that you and Dana would like to make to the group
before we adjourn the call.

\>\> Kelly: Thanks, Nancy. This is Kelly. I think what we will try to do
over the next few days is quickly summarize what we heard from the
workgroup and input today and come up with a preliminary set of
recommendations to more fully vet with the group. But I think that
there's some explicit action items that have to also take on parallel.
We conclude identifying a subgroup of people to work on streamlining and
refining these recommendations that not only we have in the documents
that we reviewed today, but I think that Markle is also working on
actively with consumer groups.

So I want -- one of the short-term views is to try to get that process
in place as quickly as possible, and if timing allows, we'll distribute
a more refined, streamlined version of that within the next week and a
half prior to the March 7 meeting -- but that we did, I think, agree
that we would consider the draft background paper of principles that
were reviewed today as sort of group of working principles that we are
going to start with as a basis for refining and streamlining.

And then, I think, in terms of trying to revisit some of the data
elements and the data sources, we can likely get to that in a more
detailed way once we have finished the matrix that clearly identifies
what the potential geographic areas are for this -- for the
breakthroughs and, in doing that, also identifying which patient
populations could be easily reached within each of those geographic
areas, and also consider how readily available and how rich the data
sources are in those geographic areas. So as that is done, I think we'll
be more carefully defining the patient population of interest and then
to take the second crack at refining the list of data elements and data
sources that would be available in the geographic scope or the scope of
a set of pilots that we might agree to.

So I think we'll have a fair amount of work, and we'll need the support
of all the workgroup members to get that done over the next week to two
weeks, and I think in particular Blue Cross Blue Shield Association,
with other sister health plans that you have access to, and our
insurance group have a wealth of information in terms of readily
available data sources. So it would be great if we could work with them
over the next week to get that flushed out. I think I'll circle back to
Helen in terms of geographic areas so we sort of have a good
understanding of what existing funded health information exchanges we
could potentially build off of and if other workgroup members have
knowledge or access to knowledge on where other existing models might
lie across the country they could get back to the folks in ONC and let
us know, we will incorporate that into the matrix.

But I think probably one of the most important things in the short term
is really trying to recap on everything that we've discussed today to
make sure that we have sort of preliminary set of recommendations, even
if they high level at this point. And then we really need to continue
with all the work to get through the refined, streamlined set of
principles and more carefully identify policy issues and the process to
address those policy issues moving forward. And then we'll also be
getting hopefully a lot more background information to the workgroup
preparation for the next workgroup meeting, including the matrix as soon
as possible.

\>\> Dana: And this is Dana. I just have four items. First of all, I
want to thank the workgroup members that came today in person and any
other workgroup members that would like to. I think there is a different
chemistry that happens when you look face to face. So I would encourage
that if that does work for you. Also, I would like to remind you all
that the next workgroup meeting is March 20. The next community meeting
is going to be March 7. And please note that the April community meeting
has been cancelled and will be rescheduled to May 26 -- May 16; excuse
me. Thank you all, and Nancy, I'll turn back to you and Dan for
conclusion.

\>\> Nancy: Thank you. Dan, are their comments you would like to make?

\>\> Dan: Yes. I'd like to thank you, Nancy, for such a wonderful job
and chairing our meeting today. Linda Springer was not able -- I got a
message during the meeting; she was not able to join us. Her plane was 2
½ hours late. But I think you did a wonderful job, and on behalf of her
and the rest of the workgroup, thank you very much for your leadership
today.

\>\> Nancy: You're welcome, Dan. Thank you. It's my privilege. And I
think leadership is made easy when we have a working group of leaders,
and certainly thank each of you for leading the discussion this
afternoon, sharing ideas, and trying to move the United States to a
much-improved status of health information technology. And a special
thanks to Kelly and to Dana and to the staff and to each of the
presenters who presented their study and their work to us. Young men's
work was done by David Lansky, Ross Martin, Kevin -- you made
significant discussion throughout the afternoon -- and David McClain;
much thanks to each of you. So I thank you. I look forward to the next
meeting that we have and to the next call. Thank you very much.