Health Systems Research-EV

Consumer Empowerment No. 3

March 20, 2006

1 p.m.

\>\> OPERATOR: Mr. McCoy, you\'re now in conference.

\>\> MATT: Okay, thanks. Dr. Brailer, if you want to start with your
comments, you can go ahead and then we\'ll go into a roll call when
you\'re finished with that.

\>\> DAVID B.: Okay, great. Thank you, and let me thank everyone for
being on this call or in the room and for taking time wherever you are,
for being part of this endeavor.

That not only goes to the workgroup participants who have given up, I
think, now as much time in the past 3 months, probably, we said would
take in the course of a year. Also to the Co-chairs, who really have
brought (inaudible) and vision to what we\'re trying to do. I\'d just
like to also call out and thank the staff who have worked very hard to
make sure that the \-- not only the mechanics of the workgroup flow, but
there\'s good information and good organization to support the process.

This hard work, I just want to comment to everybody, is well worth it.
This is not an exercise where we believe the output or the actions here
are optional or superfluous in any way. In fact, we have invested a huge
amount of our plans in the success of the workgroups and the success
that the areas that the breakthrough topics are focused on. We\'re using
these again to make sure that we\'re just not thinking big thoughts and
planning for what the world looks like many, many years from now without
attention to how do we get there in a set of very pragmatic steps. That
pragmatism is as much the work of this workgroup than the grand soaring
visions we\'ve talked about in the past.

The discussions to date have been very helpful. They\'ve been a good
foundation, and those who tuned in or came to the American Health
Information Community heard a substantial discussion on each topic,
including this consumer empowerment topic. That really is beginning to
set the stage not only for broad education of public and decisionmakers,
but of constantly refining and narrowing of our focus of how to get
policy changes and business practice changes needed to get the results
done.

We\'re now turning our attention to recommendations. The workgroups are
groups who, in the end, can do one thing that no other body can do,
which is have discourse in the public sphere and to make unbiased
recommendations to the government and other players in the industry
about what it takes to accomplish the goals that we\'ve set out for
ourselves.

This set of recommendations that you\'re working on will be turned over
to the American Health Information Community at the main meeting. And
these recommendations are going to be critical to the realization of the
goals that we set out for the short-term breakthrough and certainly
setting the foundations for the long-term breakthrough in each
workgroup. And those, remember, are things that we want to have under
way within a year. So the recommendations coming forward in May are
critical to being able to have something go through the government
process in time to have changes made for that to happen.

That doesn\'t mean that your only bite at the apple, if you would \--
you have time to come back for other recommendations as you further
refine your work later in the year. But we\'re hoping the big rocks can
get identified here so we can start use the lever arms to move them. I
hope you\'ll focus on any constituent player in the industry to make
recommendations about what they should do to achieve your goal \-- not
just government, but certainly I would not ever exclude government from
your key focus.

The reason we chartered the workgroups with the specific accountability
for delivering recommendations for the short-term breakthroughs is so
that we could keep all of us focused on this pragmatism of what does it
take to move this forward, getting our heads out of the clouds and
focusing on pragmatic things. So I hope that you will join us as this
next piece, this 60-day effort between now and early May, to identify
what does it take to accomplish the goals and how is it we go about
making the changes to get there. I\'m glad to participate. I\'ll be
listening on the call as long as I can before I get called off to the
next thing. But let me just say, again, thank you all very much, and I
look forward very much to hearing not only the discussion but what it is
that you come forward with in May to help us understand how to make
these breakthroughs come to be. Thanks a lot.

\>\> MATT: Okay, Kelly and Dan and Nancy, I\'ll go through the call-in
procedures and take a quick roll call of the workgroup members, and then
I\'ll turn it over to you, if that works for everybody.

\>\> Thanks.

\>\> MATT: Okay. Just to remind the workgroup members who are on the
phone, we\'re still using the remote queuing system, so your lines are
set to "Listen only" for the duration of the call. If you want to make a
comment at any point during the call, press star-1 on your telephone,
and that will put your name in a queue from which we can recognize you
for comment. A few other pieces of business. If you\'re logged in to the
Web interface and looking at the slides, please don\'t touch any of the
controls. All those changes will be streamed live to everybody else
watching it. As for members of the public who are listening in to this,
not members of the workgroup, you can\'t speak or give any input until
the close. We\'ll save time at the end of the meeting for input, at
which time we\'ll put a slide up on the Webcast that will give
instructions for calling in and making your comments.

With that, I will take a quick roll call of those on the line and in the
room and then we\'ll get started. On the line, we have Lorraine Doo;
Patrick McMahon, who is sitting in for Steve from Microsoft; Scott
Serota.; Ross Martin; J.P. Little, sitting in for David McLean; Robert
Tennant; and Helen Burstin. And I think in the room, I\'ll give the
names. If I\'ve missed anybody, please chime in. In the room, we have
Jodi Daniel; Kat Mahan, sitting in for Kevin Hutchinson; David Lansky;
Davette Murray; Charles Safran; and Myrl Weinberg; Linda F., who will be
sitting in once Robert Kolodner. leaves the call. Anybody else in the
room I\'ve missed?

\>\> Justine Handelman from Blue Cross \--

\>\> MATT: Co-chairs and Kelly, if you\'re ready to go, I\'ll turn it
over to you.

\>\> KELLY: Okay, great. I\'ll just defer to Nancy to get us started.

\>\> NANCY: Thank you, Kelly. I would like to welcome everyone to the
call this afternoon, and Kelly, I\'d like to begin by thanking you and
your staff for the work that you\'ve done in preparing us for this call
this afternoon. I\'d also like to invite everyone who has joined us to
review with me for just a moment what the agenda for today\'s call will
be so that we all know what it is that we\'re trying to accomplish
during this call-in.

We are certainly going to be reviewing the action items from the last
meeting and the feedback from the Community meeting on March the 7th. We
will also have David Lansky reviewing with us streamlined principles
presented at the last AHIC meeting. Additionally, we will discussion of
a road map to achieve the goal of submitting concrete recommendations to
the Secretary and the other AHIC members at the May meeting. We will
have a workgroup meeting of development of timeline based on road map
and hopefully be able to engage many of you who are participating today
in volunteering to help us in the development of that timeline.

We will also review the matrix and discussion of priority areas and
preliminary recommendations on who, what, and how to meet the specific
charge as we are now moving into a very rapid 6 weeks of trying to
complete the work of making firm recommendations to AHIC on what the
recommendations points are we feel need to be collected and what is the
information we feel needs to be collected within the medication history,
where do we think in the United States, what populations and
geographically should we initiate a demonstration or a pilot, should
there be more than one. And in order to answer some of those priorities,
it is going to take the work and input of everyone that is on this call
with us today.

We are also going to have a review and discussion of barriers and policy
issues based on testimony, and Kelly will be leading us through a great
deal of that discussion. We will have an identification of additional
areas for policy analysis, testimony, and discussion of any preliminary
recommendations, and then we will certainly be trying to gain next steps
and assignments and timelines for developing recommendations to the
Community for the May 8 meeting. We will be seeking public input from
those who may be joining at HHS as well as on the phone, and then we
will adjourn this meeting. Dan, are there any amendments or corrections
to that agenda \-- or Kelly, from your perspective \-- that we should
review as a group at this time?

\>\> DAN: I just wanted to add that Linda Springer sends her apologies
for not being able to be here today. But she hopes that we\'ll really
knuckle down to it. We have a lot to accomplish in this meeting and
opportunity to get a lot of good information and move this cause forward
a bit. And so I just urge everyone to participate in the spirit of
moving towards our objective and thank you all for participating.

\>\> NANCY: Thank you, Dan. And Kelly, anything further you would like
to add to the agenda?

\>\> KELLY: Just \-- I just wanted to point out that a clarification \--
or propose, actually, a slight modification. When David Lansky leads the
discussion on achieving the goals of getting together, recommendations,
I think he\'s going to reach a point where he\'ll want to talk about
some policy issues, and it might be helpful to set some context to help
the work group think together and talk together about how best to
proceed. But to do that, it would be helpful to have a good
understanding of what is allowable under current law. And we have Sue,
our workgroup manager from the Office of Civil Rights, who works on
privacy policy for the department, and I think it might be helpful if
she could offer a few comments before we launch into some of the
challenging issues.

\>\> Kelly, where would you -- on the agenda, would that be in prior 2
discussion item 6?

\>\> KELLY: It\'s actually just in the middle of item 6. I think David
is going to go through a lot of different issues before we really get to
some of the tough policy issues.

\>\> It\'s Sue McAndrew, and she\'s a workgroup member and here in
person.

\>\> Great, thank you so much. We\'ll be certain that we do that when we
get to that point. And with those modifications noted, what I\'d like to
do is to review with you the series of action items from the last
meeting and feedback from the Community meeting that occurred on March
the 7th. The action items that we noted included organizing a panel
presentation for discussions related to the principles and policy open
issues to propose refinements specific to deploying a registration
summary and a medication history. Panelists would include a consumer, a
provider, and an IT expert. Kelly, are there any comments you want to
make about that panel?

\>\> KELLY: Yeah, I think we\'re actually trying to get that organized
for a subsequent workgroup meeting that we\'ll talk about later. We have
some logistical limitations right now with our schedule, our meeting
schedule. And we can get into the timeline of how we can resolve that
later in our meeting. But it might require another public workgroup
meeting in late April where we would have that panel discussion.

\>\> Okay, thank you so much. We also wanted to send out a matrix that
discusses opportunities related to data sources, geographic areas, PHR
providers, and target populations. And indeed, we have distributed a
copy of the matrix, and that will be reviewed with you later this
afternoon.

We agreed to process for policy recommendations, specifically the
recommendations meet agree to criteria. And likewise, another action
item is to prepare the timeline to meet the goal of recommendations to
the Secretary on May 16. And we are certainly going to make certain that
as we move through the discussion this afternoon, that those on the call
will help us need to do that.

We also have feedback from the meeting on March 7. The principles as
agreed to by over 70 organizations were presented and widely accepted by
the AHIC members. Several members suggested that they continue to be
refined and that additional principles might be added. And David, I
think with that summary of action items, it\'s the perfect introduction
for you to review the principles that you did present at the last AHIC
meeting on March the 7th and also to update for this group any
additional principles that have been proposed or discussed.

\>\> Do we have a copy of those principles?

\>\> We should have them.

\>\> DAVID B.: I apologize for those who don\'t have them. We talked
about them. I wasn\'t actually at the March 7 meeting of the full
Community. So maybe I\'ll defer to you for any comments that were raised
there. But as I recall, I actually have a copy of the slide that was in
the March 7th materials, and I can just \--

\>\> That is correct, David.

\>\> DAVID B.: I can just remind people what it says. If people don\'t
have that, should I read off the principles to refresh your memories?
Anybody who was at the meeting can perhaps comment on discussion there.
The slide presented to the full Community said there were, I think,
seven principles proposed for consensus discussion on our behalf. One
was that individuals should be guaranteed the right to access their own
health information. The second was that individuals should be able to
access their personally identifiable health information immediately and
affordably. Third, individuals should know how their personal
identifiable health information may be used and who has access to it.
Fourth, individuals should have control over whether and how personally
identifiable health information is shared. Next was systems for
electronic health data exchange to protect the integrity, security,
privacy, and confidentiality of an individual\'s information. And
finally, the governance and administration of electronic health
information networks should be transparent and publicly accountable.

So that was what we had discussed at our meeting about a month ago and
what was presented to the March 7 of the AHIC, and as I understood it,
there was not an action taken at the Community meeting.

\>\> That is correct, David. And I would also, David, as a followup to
your presentation of these consumer empowerment principles, call
everyone in the working group\'s attention to the American Health
Information Community Workgroup on Consumer Empowerment summary of the
Web conference held February the 21st, because in reviewing that
information, the principles for personal health records that David just
reviewed with us in this call do appear, but in this particular document
you will notice that the principles have been segregated into groups
that are principles for personal health records, principles for
information access and control, and principles for disclosure and
accountability principles.

David, do you have that document with you, or Kelly, with you? If so, we
might want to review each of those sections with the working group and
then open the floor to questions and comments.

\>\> DAVID B.: I assume that we had decided \-- I think after the last
meeting \-- that Justine and David were going to work together to try to
come up with a proposed streamline list, and that we did go through sort
of a process to come up with our sort of streamline list, which is what
was presented to the Community. But if we want to sort of reengage in a
more detailed list that would perhaps guide the further recommendations
for the breakthrough, yeah, we might want to consider revisiting that
when we have our panel presentation with the consumer technology expert
and a clinician who we can have a balanced discussion around, a more
refined list.

\>\> What I\'d like to do, Kelly, with that comment \-- let\'s open the
floor for questions and for comments and see if the members of the
workgroup would like to have a further review of the principles that
have been segregated in the report of February 21. Or are there comments
and questions to the six primary principles that David had just
presented to us? So the floor is open for discussion, question, and
comment.

\>\> JUSTINE: This is Justine Handelman. One thing, Nancy, I raise that
came up at the meeting, AHA, and we had raised a clarification of one of
the principles, and I don\'t have access of that, but \[indiscernible\]
use the information for treatment for health care, it seemed to be a
consensus that was agreed to.

\>\> Lynn, can you repeat that? Because as we were trying to hear that,
there was some interference on the phone line and it was difficult to
hear.

\>\> JUSTINE: Sure. I was \-- this is Justine Handelman. I was raising
an issue that came up at the full AHIC meeting, I know was raised under
access and control of information, just a clarification that nothing
would preclude current HIPAA operations for treatment, payment and
health care operations. That \-- the data could be used for those
purposes as defined under HIPAA.

\>\> Okay. We\'ll certainly make note of that. Are there others on the
call and in the HHS building that have further comment to that
suggestion?

\>\> I would like to summarize: when we do ask a question and we do not
have further comment or have questions, we will infer from the silence
consensus around what has just been presented. So having said that, I
would like to ask: do we have consensus around the principles that David
has presented this afternoon as the more refined list with the
additional responsibility to review the comment made by Justine
concerning access and control of information as it relates to current
HIPAA law?

\>\> MATT: Please open Lorraine Doo\'s line.

\>\> LORRAINE: Thanks. And yeah, I agree with Justine, and only caveat
being, depending upon what kind of PHRs are used \-- is that HIPAA only
applies to covered entities, so that would be health plans,
clearinghouses, and health care providers that are conducting the
electronic transactions. But a PHR vendor, not a covered entity or
business associate of an ever-covered entity, is unfortunately not under
HIPAA regulation. So it\'s just a clarification.

\>\> MATT: Please open Ross Martin\'s line.

\>\> ROSS: Good afternoon. I\'m calling from Phoenix. I\'m sorry I
can\'t be there in person today. I had a related question about aligning
HIPAA rules and regulations as opposed to aligning HIPAA principles of
privacy to noncovered entities. I\'m wondering if, in doing so, I like
the intent of putting HIPAA rules around things that are not covered
entities in terms of the principles. But I\'m wondering about some of
the administrative burden aspects of the HIPAA rules specifically that
may not transfer over as cleanly and may actually impose a greater
obstacle than is intended. And I think if we\'ve got our HIPAA lawyer on
the phone, maybe that\'s what she\'s going to cover to a greater degree
later on. But that\'s, I guess, my question or concern. I need to
understand that better.

\>\> Is there anyone on the call that would like to address the concern
that has been raised as it relates to an \-- aligning HIPAA rules versus
HIPAA principles that it may be indeed a more efficient process to align
the principles with the not covered entities, since the not covered
entities would not be governed by the HIPAA rules? Anyone on the call
that would like to add further clarification to that?

\>\> SUE: This is Sue. I don\'t know whether this would be an
appropriate moment to launch into a more generalized discussion of HIPAA
and how it may apply in these contexts.

\>\> I think you have a high degree of interest at this point. I think
as long as we have that interest, maybe we should capitalize on it.
Certainly give the floor to you.

\>\> SUE: Okay. What I thought I would do is try to quickly run through
sort of the "who," "what," and "hows" of HIPAA as it applies and then
try to focus some of that discussion on what the interplay would be in a
personal health record environment.

In terms of the general "who," this has been touched on by Lorraine.
Under the statute, HIPAA privacy and security requirements do govern
only a world that we call covered entities. And these are health plans,
health care clearinghouses, and health care providers, but only those
health care providers that engage in the HIPAA standardized electronic
transactions.

So there are going to be many, many types of entities that may have,
maintain, or obtain medical information about an individual that are not
subject to the HIPAA privacy rules. These would include employers \--
would include certain types of insurers, such as life insurers, worker
comp insurers, other kinds of liability insurers, as well as those
providers that do not engage in the electronic transaction. These would
generally be smaller providers, those that work on a cash basis and
therefore do not bill either a public or a private payer; as well as
banking and other kinds of financial institutions and many types of
governmental actors such as public health departments, those that
oversee either the provider community or the health plan community such
as insurance commissioners; and many others.

So when you think of HIPAA, you need to first remember that we do govern
just this one segment, entities that we call covered entities.

We also recognize that these covered entities may also engage vendors to
help them in many aspects of their business. These vendors themselves
are not covered entities, because they\'re not a health care provider or
a health plan.

Where a vendor needs protected health information to do the business
function for the covered entity, they\'re required to have a contract, a
business associate contract, which would restrict that business
associate\'s use of the information to the business function for which
it has been hired, and would also prohibit the business associate from
using the protected health information in any way that the covered
entity itself could not do. So you can\'t hire a business associate
contract to get around the HIPAA rules, and when you hire a business
rule associate to do part of your function, their use of the information
should be confined to what is necessary to carry out that function on
behalf of the covered entity.

Because they are not covered entities, business associates themselves
are not directly liable for the sanctions that we can impose on a
covered entity for misuse of the information. Those sanctions, both
civil and criminal, go only to a covered entity.

What we do require is that the covered entity act \-- if they find out
\-- if they know of a breach by the business associate of the business
associate contracts on misuse of the information, the covered entity is
responsible for taking action within that contract to correct that
mistake, and if they are unable to get the breach mended through the
contract, they are required to terminate that business associate, except
in instances where that termination of the contract is not feasible.

Where the covered entity has taken \-- has a proper contract with the
business associate and takes the actions that we require him \-- it to
take in response to a breach by the business associate of that contract,
we would not hold the covered entity liable for the misuse of the
information by the business associate. So the liability of the covered
entity for the acts of the business associate are limited to its own
responsibilities with respect to managing the business associate
contract.

In terms of what the HIPAA privacy rule covers, it\'s protected health
information, and that\'s individually identifiable health information.
That\'s information that identifies the individual or can lead to the
identification of the individual, his health information and
demographic. We protect that information in any form: oral, written, or
electronic. De-identified information, where those identifiers are
stripped out, is not controlled by HIPAA.

But the identified information is not going to be of much use in a
personal health record world, so we won\'t dwell on the intricacies of
de-identifying information.

How the information can be used, which came up in terms of what it would
mean to \-- what this means in terms of individual control, HIPAA \-- we
spent a lot of time \-- and the HIPAA regulations \-- in trying to
balance the need for individual control over his information versus the
needs of that information in a variety of settings.

And we did, in lining out what permissible uses and disclosures would
be, decided that treatment; payment; and health care operations, which
was mentioned as an exception here in the personal health record world,
should be allowed without the individual\'s consent or authorization.
These were the core functions for which the entity would have been
seeing a doctor or going to a health plan and would be anticipating that
their information would be used for those purposes. So we freely allow
the information to flow from covered entity to covered entity, from
provider to provider, for treatment, payment, and health care
operations.

We also do not limit the exchange of information between a covered
entity and the individual itself. And we also have a variety of
permissible disclosures, again without individual consent or
authorization, for a variety of public purposes, including public
health, research, law enforcement, health oversight, and a variety of
other functions.

Each of those functions, while it\'s without individual consent and
authorization, have other constraints on those types of disclosures,
whether it\'s a limitation as to to whom that information can be
disclosed or how much of the information can be disclosed or other kinds
of protections on that information.

I will say, however, that once that information is disclosed, through
one of the HIPAA permissions, to an entity that\'s not subject to the
HIPAA rules, there are no further restrictions that HIPAA places on that
recipient\'s use of the information thereafter. We would only control
the information when it is held by a covered entity and/or its business
associate.

The rules also provide a variety of rights. The most relevant ones for
the personal health record discussion would be the right to notice, the
right to access, and the right to amend their information. The right to
notice goes to \-- each covered entity is supposed to notify the
individual of how their information may be used and disclosed and what
their individual rights are under HIPAA and how to exercise those
rights.

With regard to access, the right is not absolute, I would note, but the
individual does have the right to access their information and to obtain
a copy of their health information that is in a particular important
subset. It would be what we call the designated record set, which would
include the medical record, their billing records at a health plan, and
any other information that the covered entity has that decisions are \--
that they use to make decisions about individuals.

These important record sets, the individual can obtain a copy of, the
entity has 30 days to produce that copy. The entity may charge a
reasonable cost base fee for that copy. But other than that, the \--
they can\'t charge just for the individual to see the record, but they
can charge for the individual getting a copy of the record.

In some of the scenarios that we have been talking about, there will be
distinctly different HIPAA impacts depending upon whether or not the
personal health record is being run or made available by a covered
entity itself or by a covered entity through a business associate. In
either of those two scenarios, there would be HIPAA controls over how
that information is used and disclosed, and I\'ll come back to that in a
minute.

If it is an independent vendor that is not in a relationship with a
covered entity but is marketing a personal health record to consumers at
large, that entity has no \-- it\'s not a covered entity, and so HIPAA
does not apply to that entity. The only HIPAA implication for that
entity would be how information would move directly from a covered
entity into that vendor\'s database. And right now, I would presume in
most cases that would require the individual to provide an authorization
to that provider or to their health plan to provide a specific set of
information to the personal health record\'s vendor.

Once that information moves from the covered entity to the vendor
through the authorization process, there\'s no further HIPAA protection
of that information. And whatever privacy and security is desired for
that information, and whatever is needed to be done in terms of
affording the individual with rights with respect to that information,
would have to be constructed outside of HIPAA. There would need to be
some sort of marketplace factors brought to bear in terms of how those
protections would attach to that independent vendor.

And so with that, if that answers some of the questions, I will step
back.

\>\> I think you did a magnificent job of giving us a overview of HIPAA.
There\'s one immediate question I\'d like to ask you to expand on just a
bit: Can you define examples of health care operations?

\>\> SUE: Health care operations will vary entity to entity, but broadly
speaking, it\'s what a provider would need to do to \-- a provider may
need to do to run their business. So is \-- it covers anything from, oh,
the making appointments with the individual; providing \-- if you\'re a
health plan, providing wellness exchanges with the individual; health
education materials; sending out \-- if you\'re a drugstore, sending out
reminders to refill your prescriptions; your billing functions; your
data management functions; if you\'re into \-- all of your patient
safety and quality improvement activities; any internal auditing
functions that you have; your licensing responsibilities. It does cover
a range of sort of back-office and even reception, front-office-type
activities. Anything that is not \-- they need to do to operate as
either a health plan or a provider other than their actual treatment
function, if they\'re a provider, or payment function, if they\'re a
health plan.

\>\> How are they defined again?

\>\> SUE: There are actual definitions in HIPAA for all three terms:
treatment, payment, and health care operations.

\>\> Thank you.

\>\> SUE: By and large, the data management function that is the subject
of lots of the infrastructure discussions are a health care operation,
how you manage your data.

\>\> The floor is open for questions and for comments to Sue concerning
HIPAA.

\>\> MATT: Please open Ross Martin\'s line.

\>\> Thank you.

\>\> RON: Thanks very much for that overview. That was really helpful.
It kind of, I guess, supports in my mind the reason for the question. If
I\'m thinking about this down the road, about what the implications are
of making a statement that we want to follow, HIPAA rules as opposed to
principles, that means we would need to open the books of HIPAA and laws
would have to be written and regulation related to those laws to expand
the coverage of that. And again, the principles of protecting that
personal health information, I think, is extremely important, and we
want to support those things. That mechanism in particular has a lot of
\-- I mean, I\'m going to use the word "baggage." I don\'t mean all the
negative connotations, but a lot of the payload that\'s associated with
it \-- it\'s a lot to think about. Most people \-- when they think about
HIPAA, they think of the form they have to fill out every time. But I
think about the transaction sets and data required, the standard
maintenance organization process and kind of drag that that\'s placed
upon the advancement of some of those \-- some of the ability to move
those transactions along. And I know that we\'re not talking about that
aspect of HIPAA, but I want to make sure that we\'re clear that we
aren\'t talking about that aspect of HIPAA, that we can still support
the innovation of how we transfer this information through standards
that maybe aren\'t as lock stepped into that HIPAA process.

\>\> Thank you, Ron. Additional comments? Or questions?

\>\> CHARLIE: I have one here.

\>\> Okay.

\>\> CHARLIE: Charlie Safran.

\>\> How are you doing?

\>\> Thank you.

\>\> CHARLIE: Can you explain what a clearinghouse is and whether any of
these PHR vendors might fall under the clearinghouse idea? So I\'m sort
of thinking by implication the drug falls under the clearinghouse,
because it\'s not a health plan and not a provider.

\>\> SUE: The drugstore is a provider.

\>\> CHARLIE: Okay.

\>\> SUE: Health care provider. Treatment includes the dispensing of
prescription drugs.

\>\> CHARLIE: And \[indiscernible\] would fall under a "clearinghouse,"
or "provider"?

\>\> SUE: Well, to the extent their function is not really as a
drugstore but as a pharmacy benefit manager, The PBMs to date have been
considered to be a business associate of the health plan. The health
plan hires them to manage their drug benefits. And so the information
that they obtain through the drugstores for that purpose comes to them
in their business associate role. But the drugstore itself is a
provider.

\>\> CHARLIE: To the provider of the PHRs, you know, there\'s a concept
of health data banking similar to a bank where you deposit your
information, or are they a noncovered entity, or do any of these \-- or
\[indiscernible\] that was on our matrix, as a personal health record,
gets contributions from all sorts of different entities and then
reparcels them back out to patients, do they fall under "clearinghouse,"
or what is a clearinghouse?

\>\> SUE: What is a clearinghouse? A clearinghouse \-- need to do a
little clearinghouse dance. Those on the phone won\'t be able to
appreciate.

\>\> But she\'s on table right now. \[Laughter\]

\>\> SUE: A clearinghouse is essentially a vendor that takes information
that is in nonstandard form and transforms it into standard form, or
vice versa, takes standard form and translates it into nonstandard form.

To be a clearinghouse, the standard that you\'re manipulating here has
to be one of the HIPAA standards. So if I am a doctor and I would like
to play in this electronic world but I don\'t want to buy a computer, I
can hire a vendor, turn my paper claims over to him. They would take
these nonstandard claims, work them into HIPAA standard claims, and
transmit them electronically to the health plan. Take the health plans
electronic response to those claims, work them back into paper, and send
the paper back to the doctor. That intermediary takes the paper and
makes it electronic or takes an electronic but nonstandard transaction
and transforms into a standardized electronic transaction, performs a
clearinghouse function.

So unless the standards for what is in a PHR becomes a HIPAA standard,
anybody who deals with that would not be a clearinghouse. In terms of a
business associate function, we do \-- if you are a business associate
of a covered entity or a multiple covered entity, you can engage in data
aggregation. So they can take \-- you know, upon an individual seeing
six doctors and each of those doctors has a business associate
relationship, they all come together and decide, "We\'re going to have
this personal health record vendor," they can, through their business
associate contracts with that vendor, allow that vendor to aggregate the
information by individual.

So aggregation can go on in the business associate context. If it\'s
just one of these free-standing vendors, then, you know, again, HIPAA
doesn\'t apply, so they can do whatever they need to do with the
information.

\>\> I think, to further clarify that point, there are probably some
vendors that may be seemingly somewhat independent in offering service,
but yet they may have mechanisms of providing some prepopulated data,
where they may have some arrangements through health plans or other
covered entity where they would be getting that data, but they may not
have sort of a traditional or informal business relationship with the
covered entity, so there\'s probably some gray areas with what\'s
happening in the marketplace now.

\>\> NANCY: Is there any further comment at this point of our
discussion? And if we know there are gray areas or we feel there are
gray areas, any recommendations, moving forward, of what may need to be
done here?

\>\> DAVID B.: Nancy, it\'s David. I\'m not sure my comment\'s on that,
but before you leave the topic of the principles, I would like to pose a
couple of questions to the workgroup.

\>\> NANCY: Okay. David, let me see if we have any further questions for
Sue, and if not, we\'ll move right back to your principles. Are there
other comments or suggestions as a followup to Sue\'s presentation
concerning HIPAA?

\>\> DAVID L.: This is David Lansky. I\'d like to make a comment.

\>\> NANCY: Okay.

\>\> DAVID L.: The principles that we\'ve talked about here are very
high level, and they were not generated specifically about personal
health records. They were broad principles. As we try to do the work of
this workgroup and address the launching of a breakthrough in the
consumer empowerment area, \[indiscernible\] where the HIPAA privacy
rules may affect the personal health record environment marketplace.

I think it leaves us with a challenge as we think about this
breakthrough, how do we put \-- what Sue said at the end of her comments
about the marketplace may address some of these open areas. I think to
act in a relatively rapid fashion, our workgroup needs to think about
mechanisms to establish privacy protections for users of whatever we
recommend that address \-- that are outside of HIPAA, specifically
addresses, as we\'ve heard. HIPAA was not \-- did not develop an
environment of electronic networks or personal health records. And
specifically to this issue of patient control, I think we should find a
way in our own discussions to be careful whether we allude to the
principles or the breakthrough, to understand whether we\'re talking
about instruments which are by definition under patient\'s direct
control, to in general a definition of a personal health record is meant
to be. It is that form electronic health information where a patient can
exercise control. Same with many other valuable forms of electronic
information.

I think we\'ll have to find a language to differentiate these
components, because it\'s easy to get them blurred and confused.

\>\> NANCY: David, I think your point is well-taken, and I think, again,
this discussion group this afternoon is going back to another area that
we\'ve gone to, I think, in every call that we\'ve had, and that is the
discussion of patient access versus patient control and/or ownership.
And I think in either definition, the issue of privacy mechanism that
will be more protected than those offered through HIPAA is indeed a
charge that the consumer empowerment working group is going to want to
address. And I\'d like to ask at this point if we have volunteers in the
working group that would be willing to work with us in preparing
recommendations that we can bring forward at the March \-- at the May
meeting of AHIC, so that we as a working group can understand what
privacy mechanisms we really feel need to be considered as we\'re trying
to give patient control of these records and assuring that they are
going to be maintained as privileged and personal.

Any volunteers for that task?

\>\> KELLY: Nancy, this is Kelly. I think certainly Jodi Daniel, who is
a workgroup member and also has a background in privacy, policy, and
Director of our Privacy and Policy Research Office \-- I\'m going to
volunteer her.

\>\> NANCY: Okay, Jodi, we appreciate the fact that Kelly has
volunteered you, and I know that Jodi will do an outstanding job. Is
there anyone else in the working group that would like to also
participate in the process, or \-- I would advise all members of this
working group, since Jodi has been volunteered for this \-- Jodi, you
may want to just forward a communication to each of us in the working
group so that we can have an open line of communication with ideas and
thoughts to you as you\'re doing that work.

\>\> MATT: Please open Ross Martin\'s line.

\>\> Hi, Ross.

\>\> ROSS: Just raising my hand electronically.

\>\> Okay, Ross. we\'re looking forward to your comments.

\>\> ROSS: I would also just look over to David Lansky, since he\'s also
done a lot of work in this area, and just wondering whether there\'s
anyone that you\'ve been working with through this workgroup or
elsewhere that would want to take the next step.

\>\> DAVID B.: This is David responding to Kelly\'s question. I\'m
certainly interested in working on this myself, but I think to me, the
larger issue we\'ll talk about today is what process we\'ll be using to
address all these questions. And they all interact with each other: the
design of our project, the scope of the data, who participates,
interacts with the question of what mechanisms we have available to
address this. So I\'m not yet prepared to volunteer for something until
I understand some context, I think, of our strategy as a whole. Our
experience for protecting health \-- we have a group of about 40 people
working for a year on these issues. So I want to make sure we take on
these issues with a realistic scope.

\>\> SUE: And this is Sue McAndrew. Probably myself, I cannot
participate, but OCR, we would like to have a staff member work on this
group.

\>\> Thank you so much, Sue.

\>\> SUE: Just \-- I think we\'d be interested to work, but we have to
see how it all ties in.

\>\> KELLY: Right. So it makes a lot of sense. I think both from the
sort of the consumer advocate and health plan perspective. If we have a
more systematic way of knowing how our other recommendations around the
breakthrough of technical and barriers relate to the process of maybe
expanding on our streamlined principles, then we can come up with some
probably more definitive action items for a subgroup.

\>\> NANCY: I think you\'re right, Kelly. And I do know that later in
this discussion today, we are going to talk concretely about some of the
obstacles that are facing us, and I think this may be one that can be
added to that list so that it will also be addressed later in the
discussion. But in looking over the members who are participating in the
workgroup this afternoon, certainly we have a number of agencies as well
as national corporations that I think could provide much insight to this
issue, and I\'m hopeful that later in the call today, we will have some
volunteers to work in this regard. So I thank you.

Is there any additional comment, David, that you would like to make
about the principles at this point?

\>\> David Brailer or David Lansky?

\>\> NANCY: David Lansky and then David Brailer \--

\>\> DAVID L.: I\'m all set, Nancy; thank you.

\>\> NANCY: Thank you. And David Brailer, thank you.

\>\> DAVID B.: And I apologize; I\'ve had to step off a couple of times
with calls. This is a critical discussion, and at the risk of
contradicting what I said earlier about keeping focused on the
short-term breakthroughs, I wanted to raise two questions that have come
up in my review of the principles with a variety of different parties as
I\'ve been out and about the United States. And I pose these \-- and I
would just hope that maybe the workgroup would discuss them and either
decide to pursue or not based on your own consideration.

The first is that one of the concerns that I\'ve had, after spending
some time looking at how the behavioral health substance abuse and
mental health treatment community look at health information and look at
the digital revolution in their own area, is the recognition that
clearly, there is a lot of law that is written there that protects
people from the stigma that could be generated by their health status
being revealed by people seeing their drugs or other things. And clearly
the principles are highly consistent with that spirit of protection.

On the other hand, there\'s a growing concern among people who begin to
see what the translation of safety, patient safety, and error reduction
mean in that world, that in fact the good intention could have a bad
consequence. And that bad consequence is that some of the drugs that
have the most significant and dangerous drug interactions are
psychiatric medications. And if we don\'t also recognize that there\'s a
fundamental need for patient\'s information to be made available in some
way, so that they don\'t become victim of drug errors or die because of
that, that we have maybe benefited them by not stigmatizing them but by
harming them medically or dying. And this concern I will not tell you is
widespread, because there\'s only a small number of people in that
community that understand the implication of these discussions, and
they\'re already facing significant barriers getting the key drug
information they need now to make prescribing decisions and other
things.

So I don\'t know if it\'s principle level, but I would just like to say
on behalf of that group \-- and I certainly think we could have that
group come and speak if you wanted to delve into this in more detail \--
that the need to have kind of a fundamental access to information in
terms of making treatment decisions is something that has to be an
offsetting consideration.

That\'s one. Secondly, one of the things that I was looking for here is
the "So what if \-- what happens if information goes out?" And one of
the things that we\'ve been looking at \-- and the administration has
been supported \-- is the genetic nondiscrimination act, because \-- on
the Hill now, because it recognized at least with genomic information,
if it did get out, we had to protect against the discriminatory uses of
it. And I didn\'t see something like that here that said individuals
should be protected from discrimination that can result from the use of
their health information. And again, I just throw that out, mostly to
make sure that the breadth of this topic is being discussed by the
workgroup at some point and certainly not to advocate a position one way
or the other. But I would hope that if those have already been
discussed, that that would be noted, and if they haven\'t, that maybe at
some point there might be some discussion offline about those, or in the
public eye, certainly.

\>\> NANCY: David, I think both comments are certainly very appropriate
and do indeed deserve review and comment. David Lansky, I would refer to
you to see if there are any comments that you would like to make in
response to these observations or as they relate to the broader group of
principles that had been earlier presented to our group in February.

\>\> DAVID L.: I think David\'s comments are valuable and important.
They have certainly come up in the previous discussions of the different
groups that have vetted principles. Some of you may have ruled that this
group of six or seven principles are a subset of about 18 that were
floating around about a year and a half ago. And some of those other
ones speak more directly, David, to the points you\'re raising and
proved to be more challenging when we brought them through broad
stakeholder discussions. I think it\'s worth \-- I think Nancy and
others have said for some time, the six or seven principles we have
before us now are the lowest-hanging fruit conceptually, and as we get
into either more precise specifications of the principles or additional
areas, we tend to find more complex discussions have to happen. So I
would take David\'s discussion heartening in the sense we need, and as
Kelly mentioned, maybe next month, we need to have a continuing way to
raise these issues and discuss them and finds ways to address them.
These principles by no means cover the range of concern people have
expressed \-- really a starting point.

I think the issue, I think, David alluded to on nondiscrimination is
very useful for us to think about. Whether remedies and protections
about use of information balance with securities, strategies, and
protections on the collection and management of information; how to
balance those; and how we put together a more balanced strategy is a
very important question.

\>\> Dr. Brailer, I think certainly I would concur, and Dan, any comment
that you would like to make concerning this? I do think it\'s an
opportunity for us to go back and revisit some of the more global
principles that have been discussed earlier to see if, indeed, we need
to go back and be thoughtful again about these two points.

\>\> DAN: No, I agree. It\'s one of the issues that perhaps we can help
shed some light on as to work through this and move towards our primary
goals.

\>\> NANCY: So we will put that on an \-- as an action step that we need
to follow up on in the coming weeks, and likewise, we will also have the
action step that we\'re still looking for volunteers that are going to
help us in identifying what steps need to be recommended as it relates
to further protection for privacy of these records.

Are there any comments from other others who may be there at the HHS
building, or have joined us by phone, before we move on?

I will take silence as consensus, and I will invite us all now to turn
our attention to the discussion of the road map that hopefully going to
help us achieve our goals of submitting concrete recommendations to the
Secretary and the other AHIC members at the May meeting. And we have
forwarded materials in preparation for this meeting that are actually a
series of slides that are identifying steps in the proposed road map
that we\'re suggesting. And essentially, what we want the working group
to do this afternoon is to have a good discussion about the recommended
steps that are being discussed in this location, with the goal that we
need to have volunteers who are going to be willing to look at what data
is needed for the preregistration registry. We\'ve had a formal proposal
on that issue, we\'ve had a number of ideas presented to us around those
data points. What does that medication history need to look like, and
what are the data points that will be collected there?

And what we also want to do is to make certain that before we leave the
call today, we\'ve identified who is going to work on that
preregistration recommendation, who will be working on the medication
history recommendation, and who are those parties that are willing to
work with us in developing the timeline of what we need to have
accomplished between today, March the 20th, and the meeting that we will
be having on March the 6^th^. And obviously, we have to get it completed
a bit in advance of that so we have time for vetting and distribution
materials.

And so I would like to turn to the slides that have been sent to each of
you for this meeting \-- and I think they may be entitled Road Map for
the Consumer Empowerment Workgroup \-- and basically cite what the
purpose of the road map would be. To organize a workgroup thinking into
a structure design, it would be more or less a fill-in-the-blank
template that would guide our work through May 6 around these two
primary projects that we\'ve been charged with, bringing concrete
deliverables for recommendation to the Secretary on May the 6th. And
perhaps the work that is done may be potentially used by ONC in future
procurement.

There should perhaps be within this road map a section that would
address the objectives of the consumer empowerment, the required desired
functions offered to consumers, in the registration information, and in
the medication history. We also need recommendations around the
populations that would be served and the special features that they may
need as it relates to population in which we would consider trying to
pilot or have demonstrations in the utilization of the recommended
registration information and medication history, as we deem it most
appropriate to be.

Would \-- we also want to look at the policies that are needed in order
to address barriers and concerns, what are the standards that need \--
are needed as it relates to dataset, to universal vocabulary, coding,
transmission, and again security, so this is another place where the
security issue would be addressed.

Within this body of work, we need to address the interoperability
requirement, the scalability requirement, and migration to PHR as well
as the evaluation and the performance criteria.

Sample objectives in this road map could be to create measurable value
for consumers for patients and families in terms of improved
\[indiscernible\] or convenience, to create measurable value for health
system participant, to establish first building block of the expanded
PHR availability and portability. And I think everyone in our working
group has agreed in previous discussions that if we can do our job well
in defining what the registration information should be, as well as what
the medications history information should be, and if we could have a
successful pilot or demonstration, that does support the fact that the
registration information is working well, the medication history is
working well, that we would have provided to this Nation the very first
building block to move forward with a more robust implementation of a
complete personal health record.

Enhance interoperability among PHR, EHRs, and other digital health
information systems.

In terms of the sample required functions to make this road map happen,
we would need to be concerned with authenticating and identifying
individuals uniquely to the satisfaction of all data suppliers. We would
need to provide secure download of registration or medication data into
a consumer-facing application. We would need to enable consumers to
append comment to professionally sourced medication data, enable
consumers to record adverse events associated with their medications and
to submit the information electronically to the prescribing clinician.
We would need to enable consumers to add other medications,
over-the-counter drugs, and supplements. Allergies and adverse reactions
history via a structured pick list and text fields has the simplest
possible user interface with translation into plain language and
integration of patient education materials.

As well as developing this road map that would contain condition and
problem lists with ability to designate linkage to medication, features
need to be printer-friendly options. And we need to enable consumers to
control when and with whom information in the consumer application may
be shared, which again takes us back to some of the HIPAA discussion
that we had earlier today, as it relates to business operations or the
health care operations features of any of the covered entity offices, as
well as being charged within the framework of developing this road map
to then identify sample populations that we feel served or through a
pilot. And these would be patients and caregivers of those with cancer
and other serious chronic illness; parents of children ages 0-12; and
medically underserved populations, including uninsured and users of
community health centers. And that\'s the initial recommendation that
has been discussed to some extent.

We also go on to talk about sample policies that are needed within this
road map. This group needs to be sensitive to identifying requirement
for authenticating individual consumer uses. Patient notification and
the consent process needs to be clearly identified. Requirement for data
management and consolidation (i.e., multiple prescription data records)
need to be identified, standards for patient source data requirement to
propagate patient interdata, methods for allowing consumers to permit
and control access by users such as providers and caregivers, policies
for secondary uses, a patient-supplied data, and policies for breaches
of private health information.

And I\'m certain here that the policies would need to exceed those that
we discussed earlier relevant to HIPAA, since we indeed feel that a
number of people involved in the PHR process are not going to be covered
entities as designed by HIPAA. So this is the next body of activity that
we\'d like to discuss this afternoon.

What I\'d like to do is go back to the beginning where \-- and just open
the floor for discussion of initial reaction to this proposed road map
process, and what some of the committee members\' thoughts are, and what
committee members might have looked at some piece of this road map and
said, "That\'s an area in which I know that we could bring meaningful
information to bear, and I\'d like to participate there."

So with those three questions open now for discussion, I\'d like to turn
to the floor for comment ask discussion.

\>\> MATT: Please open Scott\'s line.

\>\> NANCY: Thank you. Hi, Scott.

\>\> SCOTT: Hi, how are you?

\>\> NANCY: I\'m doing well. I hope you are. And thank you for your
forthcoming comments.

\>\> SCOTT: I am, thank you. My concern that I want to express, or a
suggestion/request, is that there\'s a lot of work that has been done by
payers and health plans in developing the criteria for registration and
medication history and developing products and to fill that gap. And I
want to be certain that payers are included in the research that\'s
being done and included in the process, because, one, we have a lot to
offer, and two, we have a wealth of data that we would like to
contribute to the process.

\>\> NANCY: Scott, with your permission, I would like to show you as a
member or your representative of the working group that will help us in
defining and making recommendations in May of what, indeed, those
registration fields need to look like and, indeed, recommendations
around the medication\'s history.

\>\> SCOTT: That would be terrific. Justine Handelman would be the
appropriate person.

\>\> NANCY: Thank you; I\'ve made note of that.

\>\> SCOTT: Thank you very much, Nancy.

\>\> NANCY: Thank you. You\'re welcome.

\>\> LINDA: This is Linda from the Department of Veterans Affairs, and
we will volunteer to be part of that group as well.

\>\> NANCY: I\'m sorry; it\'s a little bit difficult for us to hear. I
did get Linda, and the last name?

\>\> LINDA: \[indiscernible\] from the Department of Veterans Affairs.

\>\> NANCY: Thank you, and you will also be part of that. Thank you.

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

\>\> NANCY: I know you have done such a tremendous amount of work,
because you have your system in place. So that will be invaluable.

\>\> MATT: Please open Lorraine Doo\'s line.

\>\> LORRAINE: Hi again. Yeah, we, on behalf of CMS, would be happy to
be on that committee as well, because partly the work we\'re doing on
the personal health records and Medicare \-- so I will volunteer to
serve on that, if you need people.

\>\> NANCY: Lorraine, I think that\'s generous and certainly again you
really have a significant step forward in this area and will be bringing
in valuable insight to the process.

\>\> LORRAINE: Thank you.

\>\> NANCY: Thank you.

\>\> MATT: I believe Charles Safran has a comment.

\>\> CHARLIE: Yeah. I just actually sort of want to speak to the
timeline and the complexity of what\'s being proposed here. So the
sample \-- I\'m on the slide called Sample Required Functions, and I
think one of our hard choices is going to be which of these things we
don\'t want to do, rather than which of these things we want to do, each
of which, almost, we\'d be lucky if we could carry out in the time frame
of the breakthrough in and of itself. So many of these are hard, largely
unsolved problems that if we then need to put them in consumer-facing
applications, they\'re unsolved in the health care realm in general. So
if you want them in consumer-facing applications, you know, there\'s a
lot of work.

And so for instance, one that really just sort of sticks out as being
one that would be great if we could do, but is a really hard one, is
contain condition problem lists with the ability to designate linkages
to medications, so you\'ve already \-- this opens up the sort of full
complexity of both terminologies, both on the medication side, the
problem list side, having to deal with consumer health literacy, so
depending upon what population we choose to work at, what words people
use versus the ones that we choose to code internally with respect to
medications, adverse events, reason, and the like.

So this one probably is probably the hardest to accomplish of all the
ones that I sort of rapidly see. So one other slightly related but
\[indiscernible\] comment has to do with the sample populations to be
served. So about somewhere between 20 and 40 percent of our population
read at low literacy levels, and if you think about low health literacy
on top of that, the population that we might go after is easily probably
about 40 percent. That is that the language we use has to be at about, I
don\'t know, you know, roughly about a sixth-grade reading level. Most
commercial Web sites nowadays and health information probably is
somewhere between 8th and 11th grade.

So one, I just sort of bring out the issue of low health literacy and
low reading literacy as being challenges for us. And then I want to
bring up the issue of alternative languages such as Spanish, for one,
and 23 other languages that we might want to consider, depending upon
where we are. Are we intending to go after some other languages in
addition to English in the early phases here?

So those are more questions for us to grapple with than easy answers.

\>\> NANCY: Charles, I appreciate the questions that you brought for the
group. And let me ask you a question in return. I certainly agree that
the issue you cited from the sample functions of containing conditions
and the problem list with the ability to designate linkage to medication
is at the heart of part of the discussion that Dr. Brailer was having
with us just a few minutes ago, as an example of one of two community of
people who will be affected by decisions that this group is making.
Since you have cited this as a concern, do you have a resource in the
country that you would point us to that has dealt with some of this? And
I guess I would open this question to everyone on the floor. Do we have
a resource that we know we could reach out to for information that would
be helpful and helping us get this particular job done?

\>\> MATT: I believe David Lansky has a comment.

\>\> NANCY: Thank you. David?

\>\> DAVID L.: Well, if Charles wants to \--

\>\> CHARLIE: Well, I would just say that most people don\'t try to do
this because of the complexity, that you\'re pretty good if you could
either get the problem list or the medication list separately, requiring
an extra step in the process. So most of this is done on \-- in the
realm of e-prescriptions, and there are 3 billion, 3.5 billion
prescriptions written each year. So adding a step in a clinical system
of this kind of complexity really slows the clinicians down. I don\'t
know how this would be on the patient-saving, patient-facing side. But
on the clinician side, it\'s been a problem that has been a barrier, not
only the confusion that a medicine can be given for multiply different
reasons apparently not even related, but also that the time to do the
linking gets to be such that it gets to be very hard to build these into
the workflow of the clinician.

So most people avoid doing that. So I don\'t know of a good place in the
country that does that well.

\>\> NANCY: David Lansky, your comment. Thank you, Charles.

\>\> DAVID L.: I really appreciate Charlie\'s comments. I think this
issue of scope is essential. Part of where I think this workplan could
take us is to figure out where do we \-- where does this project add
value to what\'s already in place or will happen without us. And if
there\'s a role for a public interest activity of this kind under the
auspices of the government with collaboration by the private sector, as
distinct from what will happen in the marketplace without our
participation. So for example, right now, there are many health plans
offering personal health records, provider systems offering portals,
pharmacies offering medicine lists online. Today, most of us as patient
know our registration data in our heads. We don\'t strictly need a vast
national infrastructure to support that. And if we are using any kind of
online pharmacy, probably have access to our current medications online
through our Walgreens or PDM, Medco, whatever we\'re using. So I think
the challenge is where do we add value to what is already available
through the natural activity of the American marketplace.

And therefore, I think the way to get to that is to ask some of the
questions that are on these lists and do what Charlie just suggested. If
there\'s one or two or three things that we can do here that won\'t
happen by themselves, then we should focus our attention there and try
to calibrate what can we do in the time frame available, what can we do
that distinct \-- alternatively accelerates the adoption of this
capability, and add value to consumers and patients and families, beyond
what they can currently get, anyway.

So I think we should \-- and the issue Charlie raised about the scope,
in terms of language populations, literacy population, geography \--
again, I think we should figure out where are things that will \-- that
either could be accelerated by virtue of our action or could be expanded
in scope, for example, to low literacy, because we said that was a
population. Perhaps a company already serves the affluent, well-insured,
English-speaking population but needs to serve another population that
isn\'t served by a commercial enterprise. I think we should be very
careful to know exactly where we are adding value to the existing
environment and then take on something from these lists which can
address that.

\>\> NANCY: David, I thank you for your comments, and I\'d like to go
back to the comments that Charles made and then come back to your
observations for further comment by members of the working group.

Charles, when I look at the item that you pointed out to us in terms of
trying to contain the condition and problem list with the ability to
designate linkage to medication, I do indeed wonder \-- and I\'m certain
that our CMS representatives, particularly if there\'s someone on the
call from the coding area or our health plans, and their specialization
in the area of coding \-- it does indeed seem that the coding process is
one process that\'s already in the marketplace. That in and of itself
can link a definition of what the problem and/or illness is with what
the medication is that has been prescribed, or even in some cases other
protocols of care. So as I look at that, I ask the question, "Does this
working group have represented within it those specialists who, through
their own associations, could bring to bear an answer for that
question?" And if so, Charles, I wonder if there is the opportunity for
us to go through each of this and see do we have the expertise
represented by the groups that are a part of this working group to try
to get answers to a majority of these, or do we need to do \-- as David
Lansky has proposed, we as a workgroup need to look at this copious list
of about eight item, nine items; prioritize them; and then try to
attempt to get one or two or three of these done very well, with a
recommendation that others be deferred for later evaluation in 2007.

So I\'d like to open the floor for discussion and for answers to some of
those questions.

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

\>\> JODI: Yes, hi. I appreciated the comments that Charlie made, and I
think that we really need to prioritize and figure out what the
priorities are at the workgroup level. Both of the objectives and the
functions, and whether or not this is the right list, or there are thing
that need to be added or things we may not be able to accomplish within
1 year of the \-- but really maybe have a more thorough discussion of
the objectives themselves, and figure out what the priorities are with
respect to the objective, and maybe think about what are the functions
that could meet those objective and can meet those objectives in the
time frame we\'ve set forth.

And you know, I\'m not sure if \-- there may be an opportunity with some
of these. We may want to bring in some public input, which could help
inform some of the discussions here either by having \-- I know other
advisory committees have had public testimony, written testimony, or
like, if there is information that we need to gather in order to think
through some of these once we have some agreement at the workgroup level
as to where the priorities lie.

\>\> MATT: Please open Ross Martin\'s line.

\>\> ROSS: I really appreciate the comments of both David Lansky and
Charlie because they articulate this duality challenge, this balance of
needs that we have. And when I think about what this group and the whole
efforts of the Community can do that no one else can do \-- is begin the
process of providing that framework, that interoperability framework for
the national network. We can do that all by itself with no functions
attached, too, but then no one will use it, because it won\'t be useful.

In my thinking about this, we have to pick just enough functionality for
this initial breakthrough and attach it to the interoperability
framework so it actually could be used in any setting to facilitate
these many, many private initiatives that David pointed out are
happening, so that it can be picked up and that framework be used and
built upon both in terms of the things that we would do at a national
agenda level and the things that people would build onto that existing
framework, interoperability capability, with their own interests, with
their own \-- even proprietary mechanisms to do more things within that
context. Point is, we have to distill this down to what can we do
that\'s fully interoperable, that has just enough value that it will be
used by people and found to be useful. So I look at the things like, I
think the selection of the registration summary and medication history
as a bare bones thing is probably just enough, in my mind, to be
something that people would say, "Yes, I can use this." The things \--
other functionalities, like linking the problem lists to those
medications, is going to be critical to patient care, and there are so
many others: the public health things that we can do with those, the
research and innovation things that we can do with the information with
patient permission \-- all these things are extremely valuable down the
road but won\'t be very useful without the existence \-- without the
first breakthrough success. That\'s the filter that I\'m using, looking
at how we would prioritize these, not what is important and what is
truly valuable, because I think basically all of them are extremely
valuable. It\'s the question of what can we \-- what minimal amount can
we can get away with doing and still meet the objectives of the
interoperability framework.

\>\> NANCY: Ross, thank you for your comments; well-said. We\'ve had two
recommendations in this comment period: one from Jodi Daniel urging that
we prioritize what our objective are, defining what our function is; and
then based on that, moving forward. And I\'d like to ask the working
group \-- and again, silence will mean that we have consensus, and if we
do not, then the phones will be open for further comment \-- do we have
consensus that our primary charge from now until May the 6th is to
indeed have volunteer members of this working group identify for us to
recommend to the Secretary concrete registration data points for the
prepopulated registration history, as well as concrete recommendations
of what the medication history should \[indiscernible\], as well as \--
are there specific populations that we would recommend we have, as a
nation, a demonstration project in, or a pilot project in, to test the
validity and usability of those recommendations that we\'ve made?

\>\> MATT: To that, Davette Murray has a comment.

\>\> DAVETTE: On your comment that you just had about identifying
specific registration data points \--

\>\> Yes.

\>\> DAVETTE: \-- earlier when we first met, the group had some sort of
consensus about doing a \[indiscernible\] method of registration, but we
wouldn\'t make the final recommendations. Those would go to the standard
groups that would have access to all the other subcommittee groups so
that we\'re not duplicating work.

\>\> NANCY: Davette, you\'re exactly right. There was much discussion
about having a straw man, and I think from that discussion, we moved to
the point of saying, within this working group, that we have \-- we
still need to look back at the recommendations that were made around the
registration point and refine those to a very concrete list of
recommendations that we want to make.

Kelly, I certainly defer to you for any further discussion on this, or
to you, Dan, as it relates to the straw man.

\>\> KELLY: Yeah, I think it\'s probably the best use of the
workgroup\'s time to not focus necessarily on revisiting the data
element or the actual minimum dataset for a registration, but yet rely
on the health IT standards panel and other mechanisms that support ONC,
to do the fine \-- if you know \-- tuning there. But I guess \-- I
don\'t want to interrupt Davette\'s comment, but I would like to also
second David\'s comment and Jodi\'s comments and trying to figure out
\-- and move the workgroup\'s focus to prioritizing what we really need
to accomplish where, you know, the government in collaboration with
members of this workgroup and the private sector can actually do
something meaningful this year to address the most pressing issues
facing this specific charge.

So I think it would be helpful to circle back to that after we finish
our comments.

\>\> NANCY: Kelly, to clarify, you\'re making a further recommendation
that \-- as it relates to the registration information on the
prepopulated form, that there are those within the health IT panel that
can be constructive in helping us with that process, and that perhaps
they can work collaboratively with the members of the working group who
today have volunteered their time and their expertise in this regard to
develop a fully developed recommendation for the Secretary. And those
volunteers would include Scott S., Linda B. from the department of the
VA, and Lorraine Doo from CMS. Is that correct?

\>\> KELLY: Yeah, I\'m sorry; there\'s probably some confusion with my
comment. I was just really focused on the minimum dataset around the
registration summary, which is a pretty narrow issue. And I think that
there are processes that we could rely on outside of the subcommittee to
help refine that, and you know, I can circle back to the workgroup with
a more detailed, you know, recommendation on what that process would be.
But I didn\'t mean to suggest that the others who had volunteered to do
important work not do that. I just think we need to define what that is,
that we\'re expecting them to do.

\>\> NANCY: Okay. And Dan, any comments from you as it relates to the
issue of the registration information and/or any comments you would like
to make in opening the discussion in which we will prioritize
objectives?

\>\> DAN: Yes. Just to stay on the narrow issue about the data element,
I agree that we have obtained lists of what would be the data elements.
I don\'t think that it would be appropriate for us to spend the time
narrowing that down too much. I think we do have a responsibility in the
end to circle back and, before a project goes out, to make sure that it
meets the spirit of what our objective is, or at least what our
recommendations on that objective are. But it would be better spent, our
time, to look at \-- deal with the principles and some of these other
issues that we\'ve been talking about today.

\>\> NANCY: Thank you, Dan, for your comments. And as we do that
process, we will still engage those members from this committee who have
volunteered to help in that process.

\>\> DAN: Perfect.

\>\> And as we move to the discussion of prioritizing what our
objectives are, we do have in this road map information of sample
objectives we would want to obtain and sample functions. I would like to
open the floor to discussion about these particular issues.

\>\> Davette, about of go to the next workgroup member, did you have
additional comments, or were you finished?

\>\> DAVETTE: Yes, I had just one additional comment to piggyback off
Dave\'s comments about the prioritization. I think we need to do the
prioritization, but I also think as we think about the prioritization,
we need to think of in our earlier discussions about those policy and
laws that can or cannot be changed within the time frame, so that as we
do the prioritization, any recommendations that we should give should,
as much as possible, fall in the existing rules that would protect the
people. Like, if we\'re going to make a recommendation that we should do
this item, the item that we recommend should at least fall into the
current protections. If it\'s going to fall outside the protections,
then we need to inform the people that we\'re making the recommendations
to that we\'re taking a certain amount of risk, because we\'re going
into an area where the people have no protection with that particular
information item.

\>\> KELLY: Just to add on to that\-- this is Kelly \-- I think it would
be particularly helpful if we do a more careful analysis of what
activities related to this specific charge are covered under HIPAA
versus not being covered under HIPAA and what are the mechanisms in the
marketplace either through, for example, certification or through
contract law we can rely on to ensure some of the more specific
requirements or principles as they are developed.

So I think we need to clearly differentiate, as we move forward, what is
covered under current law versus what are the specific market levers or
tools that we can rely on to ensure the requirements or principles are
met from a consumer perspective.

\>\> MATT: Jodi Daniel has a comment as well.

\>\> Jodi?

\>\> JODI: Yes. I just wanted to add to that. I think when we\'re
talking about what we need to accomplish by May, I think one thing that
I heard David Brailer say which, from sitting in my shoes in the Federal
Government, I think is really important is that we really focus on some
of the policy issues and barriers that may be obstacles to us
accomplishing our charge, some of which may be longer term, and we can
figure out how to address those. But to the extent that there are things
that would be helpful in being successful in this breakthrough, this
group can be incredibly helpful to us in thinking through what those
issues are and where we should be focusing our efforts from the Federal
perspective as well as some of the effort of Kelly saying where the
market may appropriately be able to address some of those barriers or
obstacles that may \-- that may pose \-- may impede our ability to meet
the breakthroughs. But to the extent we can focus on the things that may
be difficult for us in meeting our breakthrough charge, I think that
those can be really \-- that would be an incredibly helpful output of
this group in making recommendations.

\>\> NANCY: Jodi, thank you for your comments, and Kelly, yours also.
And Davette, to follow on the comments that you made, it would seem to
me that in the initial discussion of what are our objectives, that
perhaps we need to put as a preface to those objectives \-- that we need
to address the issue of HIPAA in a more comprehensive manner, consistent
with your recommendation, Kelly, and that in doing that, we also have to
define, in a very specific way, what further protections are offered
through certification or contract law, as well as what policy issues may
be in place that either address that issue or that need to be addressed
through policy in order to provide more privacy and security for these
records.

Is there agreement that that would constitute one major objective that
we need to accomplish for the May 6?

\>\> MATT: Kat M. has a question.

\>\> NANCY: Kat?

\>\> KATE: Yeah, I definitely \-- for me, it\'s hard to step away from
the actual dataset, but I understand why you\'re not going there.
Hopefully we can get that minimal dataset \-- I think is a narrow issue.

But it\'s hard for know step back and say what can we do by May without
defining a system, because that\'s kind of where I go to at times. What
I see as the greatest barrier is being \-- is not the dataset, because
there\'s companies and people doing that, applications in place today
that have this capability. So if that\'s there, I don\'t think we should
try to define the application, how it\'s presented, but focus in on some
of the policy barriers or policy enhancers that could help the systems
already in place today. Get away from the dataset, but eventually at
some point, we'll have to address the standardization of those different
PHRs, but probably not our focus. So I think if we can tackle some of
the policy barriers and we can also focus in on helping to push
interoperability among those existing players, that\'s where we can be
useful. As much as I like to go down the application level and get down
to the technical level, I don\'t know if we need to do that. I think
that may have already been done: some of the things that would prevent
interoperability amongst these different systems in systems today; how
do we \-- you know, patient privacy may be one of these barriers
enhancements; you know, certification; is there some type of body that
exists today; C-chip, for people already have existing \-- policy and
barrier is good one; interoperability; and then also again consumer
campaign for me would be a huge one.

\>\> NANCY: Kat, could you repeat the last one you recommended?

\>\> KATE: Consumer campaign. I\'ll use that term loosely, because I\'m
not a marketeer. However, I do really \-- the internationalization hit
home with me. I speak several languages myself. I hear it every day. Can
we get patient instructions in Spanish? I think about the population
we\'re potentially looking at, and yeah, you know, how could I have
missed that? I did. And I think that \-- how do we get those people
engaged into this program? It will be tough \-- let alone someone who is
a Native English speaker in a demographic where there\'s a high literacy
rate. And how do we ensure we give access equally amongst all? That\'s
another barrier, definitely.

\>\> NANCY: Kate has made three magnificent recommendations.

\>\> KATE: I don\'t know if it\'s magnificent.

\>\> NANCY: I think, Kate, you really have clarified very well that the
paying attention to what the policy barriers are is very important as a
be objective, trying to define some of the features of interoperability,
trying to address the consumer campaigns. And then I\'d like to go back
up to \-- as well as the objective of getting further clarification
around HIPAA and what are the recommended next steps that we would make
as it relates to insuring the privacy that is needed to move ahead. All
of these seem to be areas of objectives that we need to look at.

\>\> MYRL: This is Myrl. I just wanted to comment on the last suggestion
about the consumer campaign. I think some of you all know we have in our
membership 50-some patient organizations like American cancer, heart,
diabetes, Alzheimer\'s, and they represent a large number of people with
chronic disease or disability in their families. And I just very much
support the groups \-- would decide to do to work with and through those
types of organizations from a national all the way down to the
grassroots, because we have already been discussing with them at the
very highest levels these issues, the need for urgency of the electronic
personal health records in particular, and done some research with
others on our own and around messages that would in fact raise awareness
overcome unnecessary concerns about protection of information while
recognizing real, viable concerns and having people understand and
expect to have the electronic personal health records and demand them
and know how to use them.

So I think that\'s the whole other side of everything that we\'ve been
talking about, and I would certainly support it. And that would be an
area where our organization and all of our member organizations would
have a particular interest.

\>\> NANCY: Thank you, Myrl. Well said. And certainly I know the work
that you do within the nonprofit community and concur with your
observations of that community and their willingness to support these
issues.

\>\> MATT: Please open Lorraine Doo\'s line.

\>\> NANCY: Lorraine?

\>\> LORRAINE: Thank you again. And this part of the discussion is very
interesting. I did want to just go back to one of the items that we were
talking about just prior to talking about the policies and
interoperability with respect to the data elements and dataset and not
duplicating some of the work that is actually going on that we could
leverage, including the work of the HL7 PHR committee, which is defining
the data element and the functionality for PHRs that will be balloted.
Also, as Scott was mentioning, Blue Cross Blue Shield Association, as
well as the American Health Plan Association, has been working on some
standards. And so \-- and there\'s another company \-- I don\'t know if
they\'re represented on this committee \-- called Med Decision that has
done tremendous work in the translation mapping arena of codes, medical
codes, into layperson\'s language that would be understandable by the
average individual.

And so I just wanted to support sort of moving in a direction where we
really use what\'s been \-- being developed and take the best out of
that, and then also focus on the other items that you all were just
itemizing.

\>\> NANCY: Lorraine, thank you for that. And I think again of wonderful
observation of work that is already in progress that could be helpful to
this working group moving forward. So thank you. And I would like, with
the permission of this group, to again include the comments that
Lorraine has made in the discussion that we\'re now having, as part of
the global prioritization that we have in defining what our objectives
are. And I think we\'re getting some very good suggestions from many of
you. The floor is still open for discussion around these objectives and
our prioritization of them.

\>\> MATT: Justine Handelman has a comment.

\>\> NANCY: Thank you.

\>\> JUSTINE: Thanks, and I agree with a lot of the policy issues that
need to be addressed. The one thing our health plan \[indiscernible\]
is, consumers really need to see value to use. Thus, while many of our
plans are offering PHRs, the uptick hasn\'t been as high as everyone
wants, and I think we have lessons to learn and to share.

I think the other important piece of this \-- for consumer value to be
seen, you have to have providers be able to \[indiscernible\] this
information and be able to use it. So I think it\'s critical, while the
consumer controls it and can authorize or bring that information, what
is valuable to the provider and how does it fit into the workflow and
make sense to them, because if the provider doesn\'t see value, I think
it goes back to the consumer. Will they see value? I think we need to
think with that in mind.

\>\> NANCY: I think your observations are so on target, as one who has
spent the last two weekends addressing national provider organizations
in this country on this very issue. I think the success that we are
going to have as a committee is going to be measured ultimately by the
consumer engagement with our recommendations and support thereof and
utilization of \-- and, I think, our community, defined not only as
consumers but also as providers. So as we were listening to
recommendations being made earlier around the consumer campaign that was
brought to our attention by Kate and also reinforced by Myrl Weinberg, I
think that consumer education also has to include the educational
component for the provider community. It\'s almost as though we need to
think of those in tandem thoughts.

Other comments from the committee?

\>\> MATT: Please open Mary Johnson\'s line, and Mary Johnson is here
today, I believe, as a designee for Nancy Neilson from the American
Medical Association.

\>\> MARY: This is Mary with AMA. I don\'t think this is mentioned, but
I could have missed it. One thing with regard to the HIPAA that may want
to be considered in an increasingly global market is the fact that
protected health information, when it\'s overseas, can be \-- that be
\-- can be tricky with regards to international and the way it\'s stored
electronically. That\'s one other area that the workgroup may want to
talk about.

The second thing is to piggyback on what Jodi Daniel said with regard to
barriers and the framework. One thing that also we may want to look at
is the financial impact to each stakeholder group.

\>\> NANCY: Mary, do you have any further comment to that? Because I
think you\'re absolutely right that the cost of implementation is going
to be a barrier. And so what are we doing in order to address that? But
I\'d love to hear further thoughts that your organization has on that
subject.

\>\> MARY: I just think, for now, I mean, with regards to \-- I guess
I\'m picturing a table in my head how this will get mapped out, but
knowing who will be the bearer of \-- where the financial impact will be
the greatest for each stakeholder group would be good. In the case of
the consumer, I\'m not sure how that would play out, for instance. But
you know, I don\'t know if that would be represented by more dollar
signs or just having some more discussion of that would be good.

\>\> NANCY: I think you\'re right. Good point. Thank you so much for
bringing it to your attention.

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

\>\> DAVID L.: Thanks. I\'m trying to come back a little bit to our
challenge of getting something done by the next 6 weeks or so, and
thinking about the template we were looking at today as part of the
slide under Workplan or Road Map. We had that list that Nancy read
earlier, under the Content slide, of things that might be in a template.
I guess what I\'m thinking about this \-- I could imagine, if we could
snap our fingers, that by early May, we would have at least a very
skeletal version of this template, this list, filled in and maybe half a
page or a page for each item, very simple, that reflects the consensus
priorities of this committee and does so in a way that reflects this
last conversation \-- that is, as realistic, distinctive value of public
interest role and so on \-- and points the process forward down a
narrower path than where we started, but more informed, and addresses
some of the different layers that are on the slide.

The place I think we tend to get hung up \-- and I do, at least \-- is
to Kate\'s point about the application versus the network and to
Justine\'s point about who is using the available PHRs now, or
medication list. Just take medication history component of this. There
are many services out there today that offer medication history to a
patient. Whether they provide value today or not, I don\'t know. I\'ve
not seen any evaluation data on how many people use them, what they use
them for, what benefits come to their health or their cost savings or
their ease of transactions. I just don\'t know. And certainly there are
many very large-scale offerings out there that do this.

So for us to initiate a new project of whatever kind without knowing
whether the existing offerings are adding value, or which features are
adding value, or deserve more investment or more attention or more
expansion, audience, etc., seems premature.

So to me, we have a challenge of laying out the landscape correctly,
understanding where the value is to users, and identifying what we can
do to accelerate that value being made available to more people or
increased in scope.

So where I\'m coming to is, we could simply focus on the network
functions. We could say there are data standards through HCSB, there are
network standards, privacy policies, and we could articulate that, and
that would be a valuable service. But it may not lead to any increase in
uptake because the functions available to the user aren\'t very
valuable, or it may create an environment in which creative, innovative
application offerings come forward and figure out where the value is,
and that\'s not our job. So I think we need a discussion among ourselves
as to where we add value. If we can add value without talking about
application, because we know that other companies will do that, that\'s
probably cleaner. But I suspect there\'s some skepticism around here
that we\'re at that point.

\>\> DAVID B.: Nancy, it\'s David Brailer. I\'d like to maybe jump off
from that, if other people aren\'t in the queue, because I\'ve been
forming an impression listening to the discussion about maybe not the
substance of it, but perhaps the process of it.

\>\> MATT: Dr. Brailer, we had one additional comment from Robert
Tennant, and if you would like to take that first \--

\>\> DAVID B.: Sure.

\>\> MATT: Please open Robert Tennant\'s line.

\>\> ROB: I appreciate that. Rob Tennant with the Medical Group
Management Association. I wanted just to return, to a second, to the
issue of education. In my mind, we\'ve got several audiences, and the
primary one being the consumers, for folks who had a chance to see the
March edition of consumer reports, where Dr. Brailer is quoted
extensively in an article that really questions the privacy and security
of health information in electronic form. I think we have to do a
proactive approach. I think we need to reach out to folks like AAFP, the
Consumers Union, and folks like that, letting them know what we\'re
doing, why we\'re doing it \-- again, try to engage those folks. Just
last week at the House Energy and Commerce Committee hearing on health
IT, 90 percent of the conversation revolved around privacy. So I think
we have to do a very good job of being proactive on this. And similarly,
I think the way to get to a lot of consumers, frankly, is through
provider offices. For example, the Part D program \-- many of the
questions are being addressed to physician practices, because they\'re
sort of gatekeepers to the health care system for most consumers.

So I would encourage us to develop a program to work with provider
associations to get a consistent message on what is happening, what the
goals are, and what are the practical applications of a PHR to both
providers and consumers. Thanks so much.

\>\> NANCY: Robert, thank you for your comments. And actually, within
the framework of the materials that we sent earlier for this call,
entitled Research to Inform Road Map Criteria, there are suggestions
made there that are very concrete to do exactly what you have described
in order to try to capture some of this information through the consumer
community.

Dr. Brailer?

\>\> DAVID B.: Thanks, Nancy.

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

\>\> DAVID B.: Let me perhaps step back and provide just a second of
orientation to the discussion. We chartered the American Health
Information Community and the workgroups, including this one, following
the Federal Advisory Committee Act rules, meaning that you are here as
an advisory body to the Federal Government. But if you read in the
charter, in the materials that surrounded, including the Secretary\'s
speeches and mine that were around the framing of this, it was very
clear to us that we wanted something more. You have to comply with the
fact of process. You have to give the Federal Government advice, and we
sadly need it. But we hope that you won\'t limit your advice to the
Federal Government, that you will look at the market, the players, the
participants, and to focus on what the industry needs to do, whether
it\'s public or private. And I think this group is uniquely situated to
be able to do that.

While the vocabulary of your work are recommendations, you\'re not
chartered to do projects or demonstrations or pilots. You\'re chartered
to do recommendations. I would hope that what you\'ll be able to do is
to say the Federal Government should do X, CMS should do Y, the health
plans of America should do Z, personal health record providers should do
A, whatever it might be. And in particular, we have a new class of
constituents for you to make recommendations to: the health information,
security, and privacy collaboration; the HCSB; the standards group.
Those are there as receptacles for advice, and we created them as
leverage points to be able to convene constituents in the private sector
to follow on this work.

So I hope as you think about the road map and your priorities, you will
really begin quickly translating them into the language of who should do
what, so we can begin not only taking them into the government but
having some standards for all the different parties to move this
forward.

\>\> NANCY: Thank you, Dr. Brailer. Are there comments following onto
Dr. Brailer\'s comments or subsequent questions to his comments? I will
take silence as meaning we don\'t have any questions or comments. And
let me move our discussion. We have had several minutes now in a
discussion to define what our objectives are and to try to prioritize
those. By way of summary, we started off with saying that perhaps one of
the major objectives we must address is the issue of HIPAA and
additional privacy concerns, both what is being done through policy,
what may need to be done through policy, what is available through
certification, what\'s available through contracting, to provide a
foundation of privacy and security for any recommendations that we make
moving through personal health records.

We also have the recommendation made that we need to focus some
attention to what can we recommend in the area of medication histories
and registration that will be fully interoperable. The suggestion was
also made that we need to look very carefully at what we\'re going to be
doing to try to define consumer campaigns, interoperability, as well as
defining again any barriers in the field of policy. We\'ve also been
encouraged to establish as an objective the need to look at what are the
issues we as a consumer empowerment group should be recommends in the
area of international use of the materials that we\'re developing. And
certainly since Spanish is such a prevalent language in this country, do
we want to make formal recommendations around all materials and
processes being available in Spanish?

Continuing to support the concept that within the consumer campaign, we
do have full community of nonprofit patient organizations
well-positioned to be supportive of recommendations that the consumer
empowerment working group makes around the educational process.

We\'ve also then reminded by Lorraine Doo at CMS that we do have many
existing resources that we can turn to to identify the data element that
we need to be delivering as recommendations when we get to that meeting
in May.

So all of these have been recommendations that we have heard this
afternoon as they relate to the objectives that we are trying to
accomplish. It seems that all of those have been presented in some
degree of prioritization. Dr. Brailer has encouraged that we not only
look at what it is that we need to do within this committee, but also
that we get very concrete, and which entities within the consumer
working group would be most well-equipped to be handling those areas of
responsibility, so that we can come forth to the Secretary with
recommendations that are not only driven by the government, that
genuinely represent every one of the stakeholders on this working group
this afternoon.

So I\'d like to pause at this point and ask do we have consensus that as
a working group, we concur that we need to address as one objective
defining better HIPAA and privacy; we need to address issues of
interoperability around any recommendations that we make; we need to
address as an objective what we will do to educate consumers across the
spectrum of both patient users and medical providers, and as part of
that educational component to make recommendations around the
international use of those recommendations. Do I have consensus that
those are initially the major areas of prioritization and objectives
that we as a working group need to attack, before we continue this
discussion?

\>\> MATT: Please open Ross Martin\'s line.

\>\> NANCY: Ross?

\>\> ROSS: Could you please repeat the \-- or did I miss your
recommendation for how we\'re going to handle the data element question?

\>\> NANCY: I think the recommendation that I made, Ross \-- I went
right back to comments that were made by Lorraine Doo from CMS, in which
she cited there are many data element resources which are available to
us for our use. I\'m saying this against the background of my earlier
comments that we have three very leading members of this committee that
have also offered to work in collaboration on the dataset information.

So those recommendations of those individuals, in combination with
Lorraine\'s recommendation that we can look at the HL7, PHR information,
we can look at the Blue Cross Blue Shield standards and recommendations
that the AAHPA \-- recommendation as a med decision \-- codes,
recommendations, as well as recommendations that would also be supported
and further enriched by staff in the form of Kelly and Jodi Daniel,
based on their discussion.

So I think the data element would be addressed through a broad coalition
of ideas and concepts.

\>\> ROB: I would like to suggest that that recommendation be modified
somewhat. I\'d like to see that if we can achieve consensus on that,
that the agency standards panel be a place for that. I think we\'ve
given high-level recommendations about what the general content of a
registration information consist of, what a medication history consists
of. We left those kind of bolded statements on our last meeting that
that \--

\>\> ROSS: We did; we just were not able to get consensus on those in
the last call, Rob.

\>\> ROB: Okay, I didn\'t recall that.

\>\> ROSS: In any case, when we get down to the actual datasets, the
technical components of \-- that all of those resources are extremely
valuable resources. To Dr. Brailer\'s point, we can make the recommends
that those other entities and HCSB was designed specifically for that.
We have a technical committee that\'s been designed for the purpose of
the consumer empowerment workgroup to do that work, and it\'s an open
\-- anybody can come, no admission required, no cost to the participant,
to be involved in those workgroups to do just that. And I do think that
that\'s \-- because of all that\'s been said already today, about the
priorities of these other things \-- that only this panel can make
recommendations about, effectively \-- HCSB wouldn\'t have any policy
and those type of things \-- educational component.

But they are designed for that, and I would like that to be the
framework for making the specific data element recommendations, standard
recommendations, because that\'s what they\'re for.

\>\> NANCY: And I think \-- Ross, thank you for that invitation \-- and
particularly, in light of the fact that your technical committee is more
than willing to have participants from this working group proffer
further suggestions to them in this regard.

So the recommendation is before us that we limit this to HCSB with the
invitation that any person from this working group that would want to
give additional information to their technical committee could also do
it. And that HCSB would be the one that would be providing the data
element for both preregistration information and the medications
history. That recommendation is now before the working group, and I
would ask if we have consensus.

\>\> MATT: Nancy, we have several members right now actually waiting to
make a comment. Myrl?

\>\> MYRL: This is not on that point. I would certainly agree with the
last point. I just want to go back a little bit, because we go back and
forth, it seems to me, in our conversation between this group trying to
do something, between now and the May meeting, versus what I heard Dr.
Brailer say \-- was recommend what should be done.

\>\> NANCY: Exactly.

\>\> MYRL: And so to me, there\'s a lot that we could recommend in each
of these areas, and as an example we could \-- when we talk about what
plans are doing, what providers are running into and what consumers and
patients are running into, we could probably come up with some very
specific recommendations about additional research that needs to be done
around the questions that we keep raising. So that we could focus in on
where are the issues, where should work be focused in the future, etc. I
guess I\'m torn between trying to do work on very limited issues versus
taking all the stakeholders and, from the patient\'s point of view, make
something recommendations about what should be done or what should be
researched that will really enhance and bring value to all the work that
I don\'t think anyone else is doing.

\>\> ROSS: Yeah, and I think, Myrl, that comment may hearken back to a
comment made earlier in the call when we were looking at the sample
required functions where we said we need to decide initially whether our
role is to really limit those and hone down to 2 or 3 or whether we need
give the opportunity for the people in the working group to look at all
of them and give us input accordingly. So I concur with the observation
that you\'ve made.

I\'d like to go back to the recommendation, with your permission, made
by Ross Martin, and see if we could finish that one piece of business to
try to move forward, because I think the working group this afternoon
needs to begin to coalesce around some concrete deliverables that we
agree that we want to complete to recommend to the Secretary in May.

So if I could find out from the working group \-- at this point, again,
silence will mean that we do have consensus on the recommendation made
by Ross Martin. And if your comment is relative to that, we would like
to open the phones and have those comments.

\>\> MATT: Nancy, we have a couple of people waiting to make comments,
and we don\'t know what they\'re willing to say until we open the lines.
Maybe you could ask them to hold comments if they\'re not applicable to
Ross\'s motion. David Lansky, go ahead.

\>\> DAVID L.: I\'ll wait until we finish Ross\'s recommendation.

\>\> Thank you, David.

\>\> MATT: And Kat Mahan

\>\> KATE: I don\'t believe to belabor this, but I guess I\'m trying to
put some structure around this. For example, with Ross\'s
recommendation, I feel like it fits into the three areas that we kind of
covered, but we seem to be going all over the place. I was trying to get
my hands around \-- it seems like we have some good ideas, but given
what I heard from Dr. Brailer, we have action items that need to come as
a result of these things that we\'re recommending, it sounds like, like
"The government should do, or HCSB should do, this." So if we took the
three areas we kinds of talked about, which is policy review, being Area
1, which can include policy, HIPAA review, cost \[indiscernible\]
private concerns, that could be one big bucket, and the second could be
interoperability where we look at a different standard or maybe make the
recommendation to say, "We are going to look to HCSB; HCSB should lay
down the line here," so that could come right out of that bucket. And
the third bucket would be the education. Example of an action item for
education could say, "The government should team with the American
Cancer Society, or etc., to come up with a consensus consumer education
program using the groups that are most representative of some of the
areas or study groups that wanted to focus in on." That\'s where I was
trying \-- because Ross \-- I think Ross\'s recommendation is excellent.
Maybe we can figure out, for structure purposes, these three areas
we\'re trying to focus in on, and maybe it\'s coming up with action
items for those three areas. And Ross\'s would be a great example of an
action item that would come out of the interoperability bucket, so to
speak. And I don\'t want to belabor \-- like, try to superanalyze this,
but I feel like we\'re going down to the task level and then we jump
back up to the 50,000-foot and then \-- up and down. My two cents.
That\'s it.

\>\> MATT: One final comment, Nancy. Please open Lorraine Doo\'s line.

\>\> LORRAINE: Thanks, and yeah, I don\'t know if this is in the weeds
or trees or the air, but I don\'t have a particular issue with Ross\'s
recommendation. Assuming that HCSB is taking into account the work that
has been done by those standards organizations, and I can\'t imagine
that they\'re not.

\>\> NANCY: Ross, can you give comment on that?

\>\> ROSS: Sure, absolutely. The fundamentals of the standards panel
that they don\'t make standards they acknowledge \-- they harmonize
standards, that\'s the purpose, they have to look at work that\'s been
done. They can also identify gaps where there are no standards in place,
where standards need to be made. But again, they\'re not empowered to
make standards. They would then seek out, through other standards
development organizations, the process of building the standards for
use.

I do think that there is \-- our problem is not \-- as is always the
case with standards, the joke is, there\'s so many to choose from. Our
problem is not the absence of standards. The problem is, we don\'t have
a particular, nationally endorsed core set of data that would be used.
From our conversation last time, and from my earlier comments about
making enough of an interoperability value proposition that\'s useful,
one of the things in that is to leave a bucket that says, "Here\'s where
you can use the same infrastructure to do things related to personal
health records that haven\'t yet been defined as concretely as we are
defining registration information, medication history."

\>\> NANCY: So Lorraine, with the comment that you have made, and Ross,
with your clarification that indeed HCSB does include recommendations
that have been made by others as they are developing their positions, I
would like to once again ask the group do we have consensus around the
fact that using Kat Mahan\'s idea that we will have three bucket, policy
review, interoperability, education, that the recommendation that HCSB
be the one to address registration and medication data, it would be
inclusive of ideas provided by other organizations such as those cited
by Lorraine Doo, would indeed be agreed upon by our group as one of the
objectives we want to agree to and it would be within the
interoperability category. Do we have agreement?

\>\> KELLY: Nancy, this is Kelly. I would just like to also second what
was already mentioned about the three priority areas. But I think that
it might be helpful to have some working assumptions based upon all our
deliberations to date. So the fact that we have been neutral in terms of
who provides a PHR, the fact that we have considered some sample or
target patient populations, all of which still seem perhaps reasonable
to pursue, that while we\'re not expected to implement a program or to
oversee a demonstration project, there will be something happening this
year that will hopefully be addressing a lot of the issues that we raise
in our recommendations. So if we recognize there\'s a lack of
interoperability between PHRs and EHRs, we come up with a solid
recommendation that addresses that and in the context of some kind of
breakthrough initiative that is addressed.

So I think that we \-- we\'re going to have to \-- as we move forward
with these recommendations and in these three buckets, we need to have a
working set of assumptions that sort of describes the context
sufficiently, detailed such that we can make some specific
recommendations.

\>\> NANCY: Thank you. Returning to the recommendation to consider Ross
Martin\'s proposal before us, do we have consensus on the role of HCSB
in this process? And again, silence will mean consensus.

I think we have consensus on that point. And so moving forward, Kelly,
I\'d like to go back and pick up with your discussion around the issue
of the three buckets. And I would like to pose to the group, before we
move in an assumptive manner, do we have agreement from our working
group that three fundamental areas of objective that we want to work in
are policy review such as the HIPAA and privacy that would fit squarely
into that category; interoperability, which would be addressed now by
the HCSB work that is being done there, as we define what those data
elements are going to be and how interoperable they\'re going to be; and
number three, universal education goals and recommendations that we
would make? Again, silence will mean consensus that these are the three
global categories. If there are those on the call that feel there are
additional categories that should be added, the floor is open for those
comments now.

We now have consensus on the three major buckets. I\'d like to commend
the group, and Kate, commendations, congratulations to you for
summarizing those and getting to the point where we have agreement.

With that, I do think there are other materials that need to be reviewed
by this working group this afternoon. And I think we need to look at \--
in trying to reach consensus, since it is now 3:20 and we have several
items to go through, I\'d like to call you back to the sample required
functions, and there was a recommendation made early in this call that
we need to maybe prioritize these or eliminate some. Charles Safran
started the discussion by saying the hard part might be having to
eliminate or prioritize. Are there any particular items identified in
this sample required functions that this group feels we need to pay
attention to within the three global categories that we have defined for
our work this afternoon?

\>\> DAVID L.: This is David Lansky; can I make a comment to that?

\>\> NANCY: Absolutely.

\>\> DAVID L.: This particular list \-- I think it was meant to reflect
functions that require interoperability. That is, they\'re not any given
enterprise offering a medication list or registration history without
needing to do all these things.

So I think the question, given our last discussion, if you want to
recommend \-- we do want to recommend elements or strategies or activity
which will further \[indiscernible\] the breakthrough as given to us, we
should think about which of these are most critical, which of these \--
I guess I want to go back to the comment about the HCSB, noting the data
standards themselves do not equate to interoperability. And a lot of
things on this list are actually instrumental to really achieving
interoperability.

\>\> NANCY: They absolutely are, David.

\>\> DAVID L.: To accomplish our interoperability bucket in Kate\'s
triad also means picking off some number of these or at least
recommending a way forward which other people may pick up after we
adjourn. But we should, I think, say \-- we should figure out which of
the things on this list \-- and maybe there are more things that should
be on list \-- would be most instrumental to achieve broader
interoperability of the medication history, registration \--

\>\> I think authentication is one that everyone talks about being
critical, and having some portability of that authentication credential
across different applications of vendors is something that the country
is sort of crying out for someone to speak to. Maybe we can recommend a
way for that issue to be advanced. I think the second one on the list is
really about standards and generating a way that all people
participating in this information flow can send and read the same data.

The other functions are actually more complex and have to do with the
network themselves. But it is where this question of adding value comes
in to the consumers, and we may not yet have any opinions about those.

\>\> From a consumer perspective, indeed, the ability to record adverse
events associated with medications and submit the information to their
prescribing clinician \-- if we were to poll 100 consumers this
afternoon, they would probably rank that particular item as very
important to them as we\'re moving forward in terms of the utility of
this interoperable resource that we\'re trying to provide to them.

And David, I\'d pose to you and other members of the working group,
absolutely you are completely correct that these functions relate to
interoperability, and I guess globally do we feel, as Myrl earlier said
today, we have a lot of people on this call representing a lot of
organizations that might like a shot at taking some of these and
determining how could we address them? And what information could we
bring back that would be meaningful on May the 6th?

So should we perhaps try to open the floor to see if we have members of
the working group that would like to address specific item in this list
and provide information that could be considered on May the 6th?

\>\> DAVID L.: This is David again. If I could finish where I was going
with that thought, there may be one or two item on this list \-- let\'s
say one item on this list \-- that we might agree is a recommendation
back to the Community and the Secretary, which gives weight to the
overall breakthrough. The overall breakthrough says, "Make the
medication history available."

\>\> Right.

\>\> To give it weight, we might \-- it is a function that should be
enabled in a desirable medication history or medication list display.
And all we want to say to the Community is we think, for example,
that\'s a really high-value thing to the public. And we would encourage
everybody who is offering a medication history application to implement
in a way that permit that \-- and we would encourage development of the
network requirements that permit that two-way communication to go back
to someone, provider, pharmacy, dispenser, somebody. If we could
identify a high-value function, our recommendation, back to David\'s
earlier point, would be that this is something which will provide value
beyond the display of the list. And we think that\'s where the
interoperability requirement, HCSB, will not, without our direction \--
adverse reporting from a consumer back to a provider. That\'s not on
their list, as far as I know.

\>\> Right.

\>\> If we were to say that\'s a high priority \-- I\'m not saying we
should say that, but if we were to pick any topic, that would provide
direction to HCSB saying the industry and the country would like to have
a standard for patient-identified adverse-event reporting. And we need
HCSB to declare that standard within a year or whatever we say.

So I think there\'s interaction between the function standards, the
network design, and what recommendations we want to bring forward. That
begins by us prioritizing what\'s of high value.

\>\> MYRL: Can I \-- this is Myrl. I want to follow up, because I
certainly support that approach and certainly that particular
recommendation. A couple of others on this list, when you think about
having added value that would really enhance the use and the
understanding \-- I think the fourth from the bottom \-- the first part
says \-- has the simplest possible user interface with translations into
plain language. And I think it\'s brought up here earlier about the
literacy, the cultural, all of those kinds of issues, and I think many
of us are aware that there is an industry around the use of plain
language. And one of the recommendations we might make is something
along the lines of seeing the way CMS has really been looking at,
through Medicare, how to deal with these exact issues of multiple
language, multiple cultures, the use of plain language experts. A
recommendation would be to sort of the right entity to do some research
about what has been done when you\'re dealing with large systems,
consumer information that is critical to their welfare, and how \-- what
have we learned about how to \-- in an easy way, a simple way as
possible \-- get these \-- get the material into languages and
prejudices and formats that really are user friendly and add value to
the end user, the consumer or the patient, using professional expertise
like plain-language experts.

So I just \-- I was looking at these, and I think two or three of them
make concrete recommendations about what might move it along, and
another which \-- and I apologize; I wasn\'t able to participate in the
earlier group, of this group \-- but enabling consumers to control when
and with whom information can be shared. Again, I think that there\'s a
lot being addressed now through a lot of the health plans and others and
to somebody to pull that information together. And maybe it\'s been
done, but a recommendation would be to really do an assessment of how
are the current electronic personal health records being implemented
around the issue of control, control of the information from the patient
or consumer\'s point of view. I think we\'d learn a lot if we could pull
that together and identify best practices and then have some further
recommendations.

\>\> NANCY: Myrl, I think your recommendations clearly address the
concerns of many of the consumer groups in the country. And David, in
having your comments about this, my take-away at this point is that,
certainly, authenticating and identifying individuals uniquely to the
satisfaction of all data suppliers is a fundamental component of
interoperability that has to be addressed for any consumer to feel
confident in the utilization of this tool once it\'s offered to America.

Being able to provide secure downloads, registration medication data,
and to a consumer-facing application also is an absolutely critical
process that has to be in place and that we need to consider as a group
making a recommendation around as it relates to interoperability and the
issue of security and privacy in HIPAA, which again takes us right down
to the final item on the bottom of this page, which is how are the
current EHRs being done so that there is control and so the consumers
are protected.

With regard to the education component, being able to report adverse
events and being able to have all of this work done in a language and at
a level that people with multiple languages can understand and many
different levels of learning can comprehend is important, and the
recommendation was made that we try to get expert in that field to
provide information to us.

So I think the question may be to the working group this afternoon: Do
we have volunteers from this working group that can take upon
themselves, and through their interconnectedness to America, the
responsibility for trying to bring back to us in the form of
recommendation next steps and action items that can be deliverables
around many of the issues identified in the sample required functions,
beginning with the first bullet, the second bullet, the fourth bullet,
the sixth bullet, and the eighth bullet, ninth bullet on this page?

\>\> KELLY: Nancy, I have a suggestion. There might be some experts who
would be willing to come in and give a presentation in April and sort of
summarize what is known in the literature, for example, around plain
language or what are current practices with industry right now with PHRs
providers in trying to develop interfaces that are sensitive to these
literacy issues.

\>\> NANCY: A great suggestion, Kelly. And I would ask, if we could
identify those experts, could we ask they submit materials for the
members of the working group to read and review so that after they have
made their presentation, we could have a follow-on meeting that would
allow to us then draft fairly concrete recommendations?

\>\> KELLY: Yeah, I think that\'s \-- that would be definitely doable.
We just need to try to find who those people are.

\>\> NANCY: And maybe, is there an opportunity for the members of this
working group to provide recommendations of these expert to you
directly, or if they have any that are immediately available this
afternoon that they want to recommend, we can get that information now?

\>\> KELLY: That would be great.

\>\> NANCY: Okay. Anyone on the call like to recommend an expert for any
of these areas?

\>\> CHARLIE: Well, Charlie Safran. Alexis McCrae, who used to be at
National Library of Medicines, now at the library at Harvard, is an
expert on health literacy. And then we held a conference at Emory, on
the underserved, and I\'ll get his name; there\'s a professor at Emory
University who has as his specialty literacy, and they\'ve done some
interesting research in terms of the clinical encounters and
communicating with patient. So there are a number of these folks around.

I wonder, relative to that, which sort of get into the \-- and I\'m not
sure which bucket \-- I don\'t think it falls into a bucket, but I heard
Kelly use the word "context," and if one of our recommendations is where
we might test out some of this, so I think the idea that there\'s a lot
of good research throughout is always a good inclination. But I think
the better \-- I think one other avenue we have to put this out in
interesting test beds \--

\>\> NANCY: I meant research about what\'s happening. I would not having
experts and academicians about the literature

\>\> CHARLIE: No, but what I was saying is, we\'ll actually learn \-- I
think a lot of this hasn\'t been done. So for instance, we know, for
instance, inner-city Chicago has 20 different languages; we pay for \--
government pays for 60 percent of the health care happening in
inner-city Chicago. We know that mothers in the WIC program speak 20
different languages; we spend \$200 million a year printing brochures
and multilanguages for mothers in the WIC program. It\'s a 9-month
window that they\'re pregnant, deliver a child, and then you have a
period afterwards that they have a 14 percent rate of giving birth to
low-birthweight infants and have outcomes you can look at. They\'re
expensive. It\'s multilingual; it\'s low literacy. I mean, you could
think of a number of interesting test beds around the country, or
medical problems that a relatively \-- have outcomes that you could look
at. They happen regularly. They\'re in the area of interest; they\'re in
New York City. Any inner city would give you that. And get back to
David\'s comment, which I resonated with, which we lost the thread of,
but what is it that no one else is going to do? And no one else is going
to take care of poor women giving birth. There are lots of examples of
this, and there are segments of our health care that people who are
looking to make money on personal health records \-- the industry, so to
speak \-- underinsured, or not insured \-- no economic model for where
the value is, yet we know that they run a large part of our health
budget and drive it by nonuse. It\'s paradoxical that you could get them
to use a personal health record. On the other hand, we require mothers
who want to give birth who are teenagers to stay in school. So there are
lots of test beds where some of this might be interesting.

What I\'m saying is, one of the recommendations might be if we were
clever about the context and the recommendations might be put forward.
We might be able to \-- in addition to going on knowing what\'s already
out there, that\'s great. I think we also might learn some interesting
things by constructing, or recommending that interesting test beds be
supported by the government, because no one else is going to deal with
these populations by and large, and we ultimately pay the cost. So I
think it\'s an interesting challenge. So it\'s sort of a fourth bucket
of what is it that we could do that no one else is going to do on their
own.

\>\> NANCY: So Charlie, to summarize, what we could do that maybe no one
else is going to do on their own is to make certain that we include as a
recommendation demos or pilots with these special populations.

\>\> CHARLIE: Correct.

\>\> NANCY: Okay. Thank you. Do I have consensus to accept that as a
fourth bucket that we need to be sensitive to and objective as we\'re
moving forward? Again, silence will signify consensus.

\>\> MATT: Nancy, we have one more comment that\'s been in the queue
now. Ross Martin\'s line.

\>\> NANCY: Yeah, who is that?

\>\> ROSS: Ross Martin.

\>\> NANCY: Okay, sure, Ross.

\>\> ROSS: And I think, as I understand how you worded that, yes, I
certainly \-- I\'ll be silent on that. I agree with you.

\>\> NANCY: Okay. Let\'s see. Do we have consensus on the inclusion of a
recommendation as one of our global objectives of demos and/or pilots
that would include special populations, as recommended by Charlie
Safran?

\>\> MATT: Nancy, it sounds like Ross has additional comments. If we can
hold onto those and quickly poll the other members waiting in the queue
and then get back to Ross for his additional comments, if that works for
the two of us \--

\>\> NANCY: Sure, absolutely, if it\'s fine with Ross.

\>\> MATT: Ross, is that okay?

\>\> ROSS: That\'s fine.

\>\> MATT: Operator, will you please hold Ross Martin\'s line open for a
second. Kate has a comment and then we have one more.

\>\> KATE: Not really a comment. Just a question. I heard Kelly\'s
injection of working with assumptions. Is that similar to what we\'re
suggesting right now?

\>\> Yeah, exactly.

\>\> So it\'s kind of like we\'re saying, "Here is our working list of
assumption; let\'s take this patient population; here\'s maybe some
patient population assumptions; here\'s some pilot assumptions." Is that
the same thing? Kate, in the comments that we\'ve had in a number of our
calls, we have been encouraged to make recommendations of what are areas
that we may benefit the Secretary may benefit from having us make
recommendations \--

\>\> KATE: Yeah, I remember.

\>\> \-- around special pilots and demos, and so I don\'t know that I
could characterize those as working assumptions. Perhaps I\'m not \--

\>\> Another list.

\>\> Within the agency, it may be referred to as a working assumption.
But I know that is a charge that we\'ve been asked to do this afternoon,
to deal with some discussion around what those pilots and demos would
look like. And I think Mr. Safran got to us that subject. And I think
while we\'re there, I\'m just trying to see if I can get consensus with
the whole group that we indeed do need to make recommendations in these
areas, and then, Kelly, we\'ll work with you to see if that will be part
of a working assumption paper or will be an independent recommendation
being made by the working group.

\>\> MATT: A few more comments on this point before we get back to
Ross\'s comments. Please open Helen B.\'s line.

\>\> NANCY: Hi, Helen; thank you for your comment.

\>\> HELEN: One brief comment in response to the point talking about low
literacy and limited English proficiency population, which I would
wholeheartedly agree with, to let you know that AHRQ and the
\[indiscernible\] sponsored a meeting a couple months back about how
health IT could be used to reduce \[indiscernible\] low literacy and
limited \-- we\'ve got proceedings we can share with the group as well
as offer where there are actually examples of work that\'s currently
being done for these populations funded by us and others that might be
opportunities for pilot centers with \-- we can build on work that\'s
been done for these population, really some test beds.

\>\> NANCY: Fabulous, and so as soon as we can finds out if we have
consensus on this issue, then Helen, we may be able to certainly do
perhaps two things. Kelly had recommended earlier that we try to get
some experts to come in at the meeting in May and to discuss some of
these required "if-you-thinks" that we had addressed, and certainly
literacy being one of those. So we could perhaps have a recommendation
\-- recommended person from this program come in as an expert, as well
as in the second step, which is to allow for the piloting recommendation
to include some of these populations that you have already worked with.
So again, are there other comments, Matt, still in the queue?

\>\> MATT: One more. Davette Murray, go ahead.

\>\> DAVETTE: How are you?

\>\> NANCY: Good.

\>\> DAVETTE: As we\'re having this discussion, one of the things I\'m
struggling with in my mind is like a crisp vision, as in the sense we
make these recommendations: what\'s the scenario or storyboard? Like, if
we were going to talk to someone on the street, and we only had, like,
60 seconds to explain what we\'re trying to achieve, what\'s the
scenario or storyboard that we would want to convey to them?

\>\> NANCY: Davette, would you like my version of an answer to that
question? And certainly, I invite every member of the working group
that\'s been on numerous calls with me and heard this before to jump in
here.

But in the area of demonstrations and pilots, what we were charged with
doing was, first of all, in our very specific charge to accomplish
before the ends of 2006, making recommendations around the issues that
HCSB is now going to be handling with us, around registration and
medications history. And that will be done in collaboration and concert
and support of those folks from this working group that have agreed to
work with them.

But the second step to that was that we need to make recommendations of
areas in the United States that we could try to pilot the resulting
products to test their interoperability; to test their efficiencies; and
to see if, in essence, we have gotten it right; and to look at lessons
learned from the demo or the pilot.

Within that, the discussions that we have had as recently as last week
was, perhaps we don\'t need to try to have one demo or one pilot.
Perhaps what we need to do is have very concrete populations that are
identified, and some of those are referred to actually in the slides
that we provided. Maybe they would be patients and caregivers of those
with cancer and other chronic illnesses. Maybe we would pilot it with
parents of children who are 0-12 years of age, and they\'re already
using personal health records, and they\'re interested in the
medications history. Maybe we would use them with the medically
underserved population, including uninsured and users of services
through the community health centers. And in that discussion we had
cited, we really do need to include in that pilot those folks that are
not speaking English, that really would be speaking Spanish or other
languages, so that we can see if we can have programs that are indeed
working effectively.

So the 60-second version of the storyboard is probably a minimum of four
demos or pilots in the country, pilots in the country, trying to
effectively place those pilots within either existing \-- with programs
going or within existing projects that would be easy for us to move
into, trying to make certain that geographically, we have one in each of
the four quadrants of the country: one that would focus on children
0-12, one that would focus on people with chronic illnesses, one that
would focus on patients from special populations, and certainly one that
would focus on the senior population in the country.

So that\'s the storyboard of what we are trying to achieve as it relates
to demos and pilot recommendations. And we\'ve got to have people from
this group that are willing to work with us and in defining what should
those pilots and demos look like that we would be recommending. And I
think the comment that was just shared with us by Helen B. certainly
gives me great hope that perhaps there\'s one opportunity that\'s
already being identified. And I know that with the other people in this
working group, we can find the appropriate pilot or demo recommendations
to make for the other areas.

Does that answer the question, Davette?

\>\> DAVETTE: Yes.

\>\> NANCY: Okay, thank you. Any other calls in the queue, Matt?

\>\> MATT: No, we just have \-- if you want to close out this issue, we
still have Ross Martin waiting to make \--

\>\> NANCY: I\'ll come right back to Ross, but I would like to find out:
do we have consensus that we, as a working group, are indeed going to be
responsive and add to that list of objectives that we need to accomplish
the fourth bucket, which would be making recommendations around the
demonstration and pilot, that would be able to reflect an actual
implementation when the Secretary and the agency determine that is
appropriate, that the work we\'re doing is indeed reaching the audience
it needs to reach in an effective manner, and that we have the outcomes
that we had anticipated? Silence will indicate agreement.

\>\> MYRL: This is Myrl. I\'m just a little confused about what those
recommendations might be, and I apologize for that. Are there going to
be recommendations from the other groups about pilots and specifics and
then they have to all be brought together for some number of pilot to be
done that the government is going to fund? All of our suggestions into
that consideration?

\>\> NANCY: Myrl, in our previous discussions, we have not had any
discussion that would reflect to us if the other groups were indeed
going to be recommending a specific number of pilot or demos. I think
what we tried to focus on is what do we working on the issues of
consumer empowerment feel would be appropriate for us to recommend as a
measurement of the effectiveness of the tools and processes that we are
advancing now through the policy review information interoperability and
education. And throughout that discussion, we have said that the best
tools to use to do that would be in recommending demos and pilot, with
the full reality that the Secretary and the agency may look at the
recommendation and feel that all could be funded, none could be funded,
or any number between 0 and the number that we recommend could be
funded.

But we felt our responsibility was to make the recommendation that they
be tested in some form of demo or pilot. I hope that answers your
question.

\>\> DAVID B.: This is David. If I could chip in on that as well \--

\>\> NANCY: Sure, David.

\>\> DAVID B.: I think this idea of the pilot is something that probably
has more resonance in this area than it does with others, because of the
very exploratory and open nature of the personal health record. You
know, some of the other fields in the electronic health record \--
clearly there\'s still a role for substantial research and evaluation,
but we have a lot of just practical experience in the industry now about
what\'s happening with them and how they\'re used and issues.

On the other hand, I would caution against the response to the charge of
coming back to say, "How do we get some breakthroughs in the short-term
\-- do a pilot?", because in some ways, it\'s tautological, pilot-based.
And I think the question is going to be really one of two things: How do
we finds projects that are already under way in the United States that
we could pay attention to and watch and evaluate, perhaps not
scientifically in a controlled sense but at least empirically? And
secondly, for the pilots, how do we construct them? Because they\'re
going to play out for a while. We\'re talking about probably monies and
outer fiscal years that would have to play out through a variety of
approval processes, but what are the key things we\'re looking for from
them, to test the principles, to test some of the things in the baskets
you\'ve talked about? Are \-- that would be helpful, but both of those
notwithstanding the issue of coming back and saying in a separate and
apart going from pilots, "Here\'s what it takes, Mr. Secretary; here\'s
what it takes industry, whomever, to drive personal health records
forward in the absence of that."

\>\> NANCY: Thank you, David. Absolutely. I think the recommendation of
a pilot will not be a recommendation without the full development of how
would it be implemented and where. And to your point again, David, and
to the point that was made by one of our callers, Helen B., I suspect
that indeed, as we look at the issue of pilots and demos, we can target
programs that are already in process that may serve as ones that we can
simply observe and report on rather than have to go through the full
implementation, could end up at the end of the day that it\'s a
combination of both.

\>\> DAVID B.: Right.

\>\> NANCY: So I will go back again to the question: Do we agree that we
do want to make a recommendation to the Secretary that in order for us
to be able to test the interoperability and the security and the privacy
and the accuracy of the data fields that have been identified, that we
do indeed want to have as part of our work the recommendation of demos
and pilot understanding that they could be within current programs that
are operating and we would simply assign a period of time for
observation and reporting, or indeed, they could be new pilots and demos
that would require funding and a long-term timeline for completion?

With silence, I will find that our group has consensus \-- found
consensus that that is one of the charges that we should look at.

Having done that, I would like us to get back to our agenda for this
afternoon. And I\'d like to have us spend time reviewing a matrix that
was forwarded to us for review. And I would invite David Lansky and
certainly Kelly to join me in this discussion. So if we can turn to the
timeline \-- and I think that I would probably use the words that Dan
Greene and I discussed earlier today, so Dan, I invite your discussion
of this point also. Maybe, Dan, you could introduce to the group the
issue of the matrix, and I would say, in our discussion, what we would
like you to do is look at this tool and understand it from our point of
view. This may simply be a pilot master. You may be able to look at this
information as a member of the working group and to say, "These are
examples of what is being done in other places currently, and this is
how they are doing it." And this information could be valuable to us as
we are trying to make recommendations around pilots and demos for our
particular committee.

So Dan, are there comments, or David, there are comments you would like
to make further about this matrix?

\>\> DAN: I defer to both Davids on their expertise own mine.

\>\> NANCY: David Lansky and David Brailer?

\>\> DAVID L.: Lansky defers.

\>\> NANCY: Okay, Lansky; there you go.

\>\> DAVID B.: I guess I can add that it seems as we were going through
\-- as my staff and I were going through this and we looked at this,
that it demonstrates just how much work is being done in the industry
already, and that there\'s a wealth of opportunities already existing to
test out and to document and to verify the recommendation that has come
from this workgroup, assuming, of course, they\'re adopted by AHIC as a
whole. So it seems to me that our responsibility isn\'t to worry so much
over the delivery mechanism. There are plenty of delivery mechanisms.
It\'s the content that is more important, and some of the issues and
barriers that we can probably spend our time addressing and that the \--
and rely on others to pick the particular vehicles or to get acceptance
from some of the others for the particular vehicle that accomplishes
those things.

\>\> NANCY: Thank you, David. Kelly and David \-- Dr. Brailer \-- are
there comments and questions that you would like to make about those
matrix?

\>\> KELLY: I don\'t know that David Brailer certify still on. This is
Kelly.

\>\> NANCY: Okay. Hi, Kelly.

\>\> KELLY: First, I wanted to thank \[indiscernible\] Blue Cross Blue
Shield Association and CMS for providing a lot of very useful
information. I think this is going a practical tool, not only for the
workgroup to sort of look through what\'s happening across the country
and what data sources are readily available in different regions, what
organizational capacity might there already be through a RHIO or other
emergency health exchanges and/or State-level activities that we could
leverage off of. I think that it would be helpful for workgroup to have
in mind what specific target populations we do, in fact, want to focus
on in making some determinations about what regions would be most
attractive to work with in the near term or look at either in evaluation
capacity or as sort of an organizational capacity in terms of what could
be built in the near term in the way of a new pilot.

So I think that there\'s a lot of information to digest here, a lot of
additional information we can get at. I got even some more information
over the weekend and from CMS regarding their beneficiary portal, as it
relate to the registration summary.

But I would suggest that we try to be clear, as we talk about this and
go through it, about what target populations we do want to reach and
what are some of the sort of, maybe Year 1 objectives in terms of either
evaluation or starting new efforts in reaching \-- or getting consumers
both medication history and registration summary.

\>\> NANCY: Kelly, are you posing to the group a question for their
input at this point concerning what target populations we might want to
identify?

\>\> KELLY: I think it would be helpful to have a brief discussion
around it.

\>\> NANCY: I think so, too. So the floor is open for that discussion.

\>\> MYRL: This is Myrl. I\'m trying to relate \-- skipping ahead to
trying to make such specific recommendations, which we certainly can do
\-- a bigger question that I think we were talking about a bit earlier
about the function and what\'s critical to know from the patient
consumer point of view. And so I guess my question is, if we\'re going
to make recommendations about specific populations, is it in light of
the fact that we would have recommendations about what seems to be the
most \-- what seem to be the most important things to look at in such a
pilot, and if I could, we were talking about having people come in and
testify or give experience one of the people that popped into my mind,
people like AHIC, plans out there doing all kinds of things and we heard
today there\'s some issue with having people really participate in the
electronic personal health records. If we had people come in and
specifically asked them to address certain questions about what do they
see as the issues, how are they handling recording adverse events, we
went back to our focus of how are they handling today, what do they see,
the issues around having the patient consumer record adverse events and
having them, how have they dealt with the plain language and how are
they dealing with controls. I guess I\'m trying to figure out if we do
that which \-- I think there\'s tremendous value and hearing from people
like that, and they are way ahead and all of these things, if we learned
more from them with them answering questions, that we pose about the
involvement and understanding and engagement of consumers and patients,
it seems to me that would feed into further recommendations about pilot.
So I\'m going to be quiet now, but I just want to say that I\'m a little
uncomfortable recommending specifics about populations until maybe
we\'ve learned a little bit more from the people on the ground where
they are finding the real problems and issues to be as they make every
attempt to engage patients and consumers.

\>\> DAVID L.: Nancy, this is David Lansky, I want to support Myrl\'s
comment. I think there\'s an empirical step we should take. For example,
not on this matrix are a number of other people who offer medication
list services today. If we poll the people who now offer this and can
them who is using it, I think, to Myrl\'s point, perhaps it\'s parents
of young children using these all the time, or perhaps it\'s caregivers
of frail elderly giving it all the time, or I don\'t know.

But rather than us deciding what we think is important, we could find
out from their \-- there are some very large populations that now have
access to these tools, which are certainly large enough to inform our
thinking as to where the value seems to be at present. And we should
know that before we do too much more. I\'d like to ask the ONC staff or
to commission outside contractor or poll the big provider organizations
in a structured way to do a little survey of them or something, to find
out what is currently valuable to people. I mean, it seems to me the
word "empowerment" should be the watch word of what we\'re doing here.
And rather than saying our goal is to display in front of people a set
of data they may or may not have any interest in, we should say what is
it people feel empowered by. And if there are a couple million people
with access to a medication list, I\'d like to know what they are using
it for and what they feel empowered by.

\>\> NANCY: It would be a fair statement to say, if we could go the to
the recommendations we made in the medication history and provider
section, where we talked about actually trying to get into some of the
medical offices in the country and to actually do some surveying of
patients, or trying to survey for the patient information through other
organizations such as those you were citing, to find out what they feel
is important to them in the area of health information, technology,
registration, medications records, that would be a useful step in the
process before just simply defining what the demo should be and how. Is
that correct?

\>\> DAVID L.: And I believe from conversations I\'ve had that many of
those organization have done that research in order to plan their own
program.

\>\> NANCY: And so I guess what I would be doing at this point is asking
do we have volunteers that would like to work on identifying who those
expert are and working with the staff to see if it is appropriate top
get those experts to come in and give a presentation before the AHIC or
to supply written information to us prior to the meeting in May that
would allow us to then make an informed recommendation to AHIC, because
we have both opportunities available to us. We could even construct one
of these conference calls so that the experts are on this call to
present to us.

\>\> MATT: Justine Handelman has a comment.

\>\> NANCY: Thank you. Justine?

\>\> JUSTINE: I wanted to also chime in. We have been working closely
with AHIC plans and we continue to work with them on looking at data
standards and \[indiscernible\] I think are useful to feedback into \--
we\'ve been involving HCSB members as well. But I think the idea of
where the value is finding out that information is critical. I agree
with \--

\>\> NANCY: And are you addressing that right now?

\>\> JUSTINE: It is something we\'re also looking at. We might be able
to help piggyback with some of what we\'re doing. I think we can be very
help informal in that area. I\'d be happy to work with you all and if we
can expand some of that, too.

\>\> MATT: Please open Lorraine Doo\'s line.

\>\> NANCY: Okay, Lorraine.

\>\> LORRAINE: Hi, again. I don\'t know if I had made this
recommendation to this group before, or if it was the HL7 workgroup, but
if everyone has not already tried to use either a medication history
that\'s available or a PHR, that are available free right now similar to
what we put on that list, they should definitely do it to really
experience it for real. And there are a couple of large vendor that may
be collecting data. I guess Justine may have some. But we would \-- and
no offense to anybody on the phone, obviously \-- we would want to make
sure to get real user data versus data that might be used for public
relations in terms of real use, and the frequency of use, what they\'re
getting out of it, how they take it to their providers. And probably
AHRQ may be looking at this. Helen, we\'ve talked to Carol a little bit.
And even in terms of doing a survey, there may be ramifications about us
reaching out to individuals, because by right, we wouldn\'t really know
who has a PHR. That would be something that would be coming out of a
physician or that particular software vendor. Just want to put those
caveats out there.

\>\> MATT: Linda F. has a comment.

\>\> NANCY: Linda?

\>\> LINDA: Thank you. To follow on comments earlier, we would be more
than willing to give a presentation on what our consumer experience has
been and what it is that does empower the veteran, as David said.

\>\> MATT: And Kat Mahan has a comment.

\>\> KATE: I was going to say from the perspective of SureScripts, we
certainly have gone down the investigatory path, and from our experience
also, we look for something that we can use in a standardized fashion.
How are we going to supply a medication history into these different
disparate systems? But we have done? Exploration. We do think there's
some general consensus emerging, and what if \-- we don\'t know what;
that will remain to be seen, but we try to contact some of our vendors
and say, "Would you be willing to come speak to this group to tell them
about your experience and, you know, what\'s worked and what\'s not,
from that point of view?"

So \-- but it\'s new to us, so we\'re developing \-- we know we need to
be ready before summer is out, but we\'re also waiting for you guys to
make some decisions. We\'re taking a lot of guesses at what we think it
will come out to be. But we know we have to be ready there, just not yet
defined. I\'d be happy to try and reach out to vendors that we work with
and currently do have \--

\>\> NANCY: Kelly, I would like to ask if perhaps this would be a good
place to recommend that you work with several people on this call that
have generously offered to provide resources and persons that are
currently involved in projects that would help us to answer some of the
questions of what populations might benefit from the demos and pilots
and would need to look like to get the best support from them, and we
either do one of two things: we try to have a conference call with the
experts on with us after we\'ve received written information about their
materials, or if we\'re going to be having another meeting in April,
perhaps there would be an opportunity for these expert to provide
information to us at that point and then after that we could sit down
and work together as a working group to try to identify more information
about these pilot, who should be included in the pilot, where they would
be, how many recommendations we would make, and how those pilots would
work.

If that\'s a recommendation that you are comfortable with and those in
the working group concur with, then perhaps we could move to that as the
next step and the empirical steps that Dave Lansky started this
discussion with.

\>\> KELLY: Yeah, Nancy, I think we probably do need to do an awful lot
of work offline. I\'m a little concerned about the timing, because we
can line up testimony for people that have readily available information
to share. To the extent that we do need to have more sort of true
representation of the consumer experience to date to determine valuable
functions and features, we may not have quite enough time over the next
4 weeks or so to really get at that. But I think I\'ll certainly work
with everyone who just mentioned \-- who is willing to provide
additional information to us to see what we can do in the short term.
And then maybe, you know, we can craft a recommendation around that with
the understanding that we might need a little bit more evidence to
really understand what the consumer wants and needs.

But I just would also \-- just to be completely transparent, I don\'t
have a staff yet, and I\'m trying to build the office. So if I\'m a
little bit \-- I would like to do an awful lot more to support the
group, but I really don\'t have that many resources to draw from. So I
probably will rely heavily on whoever has volunteered to.

\>\> NANCY: And I think that in the discussion that we just had, just to
summarize, Myrl suggested that perhaps Karen A. would be an ideal person
to contact to find out what type of experience their organization can
report around \-- for instance, reporting adverse events and how do they
handle reporting, what do their patients find useful for the health
plans that offer personal health records. We also had David Lansky talk
about perhaps the value of a survey instrument that would allow us to
poll patients, and I think that \-- I know that my organization could
work with you in order to set that up, if you decide to do that.

Justine Handelman has made the recommendation that perhaps AHRQ would
have information that could be helpful in this regard, as well as HCSB.
Lorraine Doo also stepped forward and said she could be a resource, as
did Linda with the VA. And Kate certainly spoke is SureScripts, and she
would be willing to look into their portfolio and see what resources
could be available that would be helpful in addressing some of these
subjects. And again, I think that there\'s the opportunity for us to
either get written information from some of these experts, allow us to
have that in advance and maybe construct a 4-hour call, or one of our
conference calls to be around that subject, if we\'re not able to do it
in the structure of a face-to-face AHIC meeting, Kelly. So that gives us
a bit more latitude and hopefully gives you more on the issues you\'re
dealing with.

\>\> KELLY: Thank you.

\>\> MATT: Nancy, Helen B. has been waiting to make a comment about, I
guess, AHRQ\'s further contribution to this. Can you open her line?

\>\> NANCY: Hi, Helen; thank you.

\>\> HELEN: Just to follow up, certainly the CAP survey used by most of
the commercial health plans and Medicare and Medicaid extensively in the
United States offers a lot of these kinds of patient responses, and you
could certainly look to see whether a health plan had a personal health
record available and how patients scored on some of these items, in
addition to the fact that we\'re certainly planning to develop a set of
items across multiple domains that would specifically try to get at the
issue of patients\' ability to reflect on having some of their own
information through a personal health record, for additional items in
CAP. So I\'d be delighted to help out and offer some of our CAP team as
well.

\>\> NANCY: Thank you very much.

\>\> MATT: Please open Ross Martin\'s line.

\>\> NANCY: Ross?

\>\> MATT: Ross, are you there?

\>\> ROSS: I apologize. I thought I was off. One of the points I heard
earlier that I thought was important was the notion that we have to
focus on things that only we can do on this national scale through this
vehicle. And when I think about aggregating a lot of those learnings
from current implementations, I think we\'re going to be getting
insights about what\'s currently available that\'s not necessarily
interoperable, and that these things would develop as they are
developing without a major intervention from our workgroup and from the
Community.

And if I were building something like this as a commercial strategy, one
of the things I would do would be to do some interviewer types that
really involve building these stories out with consumers and helping
them \-- helping refine kind of a product or product concept using some
market validation tools. What that means is that you don\'t show them
user experience so much as you talk about scenario \-- \[indiscernible\]
Community talk about this in the last AHIC meeting, they often referred
to the Quicken model or the Microsoft Money model. And this does not
really exist as an opportunity. And yet they felt that was a metaphor
they could use to see what sort of \[indiscernible\] they wanted.

So as much as I think some of this information could be useful, if it
doesn\'t focus on, at some level, this broader scope of thing that
don\'t exist or haven\'t been fully enabled yet, so people may not have
it on their minds as something that\'s a solution, I\'m not sure we\'re
going to get the answers that we\'re seeking. Does that make sense? Did
I communicate that well?

\>\> NANCY: Thanks, Ross. I\'d love to hear some other comments from
other members of the working group around your suggestion.
Fundamentally, I think Ross is saying if we look at existing programs
and existing experts and what they may have in the queue to report on,
we may be missing the opportunity to think outside those existing boxes
and to make recommendations that allow for perhaps a standard that would
be more consistent weapon that being discussed within the AHIC
commission \-- Community.

\>\> MYRL: This is Myrl, and I agree with that. I think it\'s sort of
parallel track, and I was seeing it more as one informs the other. But
certainly, we don\'t need to think inside the box and what just is being
offered today.

We have, at the National Health Council, done quite a bit of research
and are still doing it, around \-- with groups that have them, or
something like an electronic personal record, and now we\'re doing more
research with persons who do not have them. And we went from looking at
what their perceptions were and are, as to what they might value. Just
as an example, to support previous comment, one of the biggest values is
just convenience. If they really believe \-- if a person believes that
they can have a record that wherever they go in this world, it is
interoperable and they can bring up all their health information needed
at that moment in time with that provider, that is a huge value for
people with acute conditions, emergency situation to people with chronic
conditions. Things like Katrina really made the point for a lot of our
members.

What happened to those persons when their records were completely lost
and they had to start over again and go through medications, you know,
figuring out what they should take and what tests all over again, and
how wonderful it would have been be if they would it in their pocket, so
to speak? They could have pulled it down from the Web. I think that it
is \-- again, it\'s a combination of learning some from what\'s being
done and people that are trying things and finding out what people like
and don\'t like and what works, as well as looking where there\'s some
research that is being done or we can recommend to the group further
research to be done to find out things like the example I just gave.

\>\> NANCY: Thank you, Myrl, for your comments. I think it\'s a perfect
time to look at the information that has been sent out to you entitled
medication history consumers, medication history providers, and it\'s in
the section where we actually try to provide a bit of a road map about
how we might be able to get some of this information. The title of the
presentation is Research to Inform the Road Map Criteria Medication
History. Research with consumers, providers, vendors, may be available
from PBMs, etc. And the medication history with consumers \-- we were
talking about focus groups that you might be able to do survey work with
cancer and chronically ill patients, caregivers, patients of children
ages 0-12, users of provider portals and users of the PBM. If you look
at the questions that we were providing that we try to survey and get
answers from consumers on and try to get this in the short-term \--
because Myrl, I know with your organization represented and our
organization represented, we could certainly have a very strong sample
group to get answers from to these questions. It might help us identify
what is important to the consumer when you think about having a personal
health record.

And the questions here are very straightforward. We also suggested a
battery of questions that could be very useful if we could go into a
series of physician offices and ask these questions of the physicians
and providers about personal health records and electronic medical
records, to see if we are going to be addressing some of the concerns of
both these users groups ultimately. We suggested we talk about
physicians and pharmacists and several care patient settings and primary
care doctor, emergency recommend doctors, specialist in different
disease categories, assisted living, school nurses, and community
pharmacist. And our sense was that if we could do even the most simple
of survey work in these communities, with these very direct questions,
and even go to vendors and ask them the medication history questions
that you see here, that that would be real-time current information that
would allow us to see what people really are thinking about personal
health records and electronic medical records. And so I think to the
point that you were making, Ross, we would not just be looking at
existing material with existing projects, which I think it would be
great to do a combination of both, actually, but we would also have some
very current survey data that could be very helpful to us moving
forward. What better way to know what is needed than to ask the very
stakeholders who are going to be using the tools at the end of the day?

So the floor is open for discussion around the issue maybe of a
combination of getting some of these experts to give us information
about current programs that are under way that might be helpful in
combination with perhaps a series of very limited surveys, patients,
providers, and vendors that could answer some of the fundamental
questions about the personal health records and the areas that we\'ve
been charged with looking at through our group.

And I certainly think this could go into one of the major buckets that
we have embraced at our charge. And it would probably fall within the
education bucket as well as a demo and pilot bucket, because I think the
information you would get from this survey work would help us in both of
these areas. So the floor is open for discussion about trying to
recommend a combination of both and moving forward. And Kelly has agreed
that she\'ll work with us to try to get some of the experts, so let\'s
focus just a few minutes on our thoughts around trying to do some survey
work and in collaboration.

\>\> JUSTINE: This is Justine. I wanted to mention one thing. I notice
in both of these \-- the research criteria, medication history, and
registration summary \-- the payers weren\'t included. And I think there
is some valuable information that \-- I know we\'ve already talked about
this, and we\'re willing to help you, that you could learn from the
payers having done this what their experience is, what they know works
with information they include, so I recommend they be added as well. If
this is \--

\>\> NANCY: And Justine, what I would like to suggest is that,
certainly, payers absolutely have to be included, and perhaps we could
ask you to work with us in getting others from our working group to
supply us with a list of questions that would be appropriate.

\>\> MATT: Jodi Daniel has a question.

\>\> JODI: Hi, Nancy. I understand your suggestion in trying to get
information from these various differing constituents to help inform the
discussion of the workgroup, and I think that that\'s a great idea.

What I would recommend, given that this is an advisory committee and
it\'s an operational body, is that we call in those folks, either to
testify or to get input, written testimony, or the like so that we could
actually turn this around more quickly and to recommendations as well as
if ONC were to try to take on the role of doing surveys and the like. We
would have to \-- there are regulatory hurdles that we have to jump
through in order to do surveys, not to mention obviously financial ones.
But we have the Paperwork Reduction Act that we have to comply with, and
we have to get approval by OMB to do surveys. That is a fairly
challenging thing for us to do.

That being said, I think there\'s a great opportunity to get input and
information directly to the workgroup and either do that through having
folks come in and talking to us or asking folks to provide us with some
written information that would help support the goals and the
information needs of this group.

\>\> NANCY: Jodi, is it possible that we could actually try to survey
via Web activity, or is it possible that we could survey with a written
survey that goes out to selected groups of folks, that, as you had said,
we could get the written survey out and then get it back in?

\>\> JODI: If we\'re doing surveys, we have to comply with the Paperwork
Reduction Act, so that would require us to get approval of a survey
instrument through OMB, and that can be an extensive and time-consuming
process.

\>\> NANCY: So the only way to do a survey is \--

\>\> KELLY: I would say \-- this is Kelly. I think if Markle, National
Health Council, or whatever individual organization in their own
interest would like to do their own research that\'s not government
sponsored or really connected directly to this subcommittee, then
obviously it\'s their right to do such. And if they would want to do
that and then report back, and there\'s enough time to do that, that
would be great to inform final recommendations. But alternatively, I
think there\'s an opportunity for asking \-- saying we\'re interested in
these particular topic areas or this type of information, and you can
have people not necessarily fill out a survey instrument or form but
come in and give testimony or provide written testimony that addresses
some of the issues of what you\'re interested in and having more
information about.

\>\> MYRL: This is Myrl again. I think if we do have some people via
phone or whatever give us some additional information and we give them
very specific questions that we want them to address, one could be, from
where they are right now, what additional research do they think would
be needed again from the consumer patient point of view, and we could
wind one some recommendations that, for example, might go back to AHRQ
to say \-- is \-- as you move forward the industry, all stakeholders
have agreed that these are questions that, if you can, through some
funds, fund some projects to look at these questions that are from the
consumer point of view, that could be quite useful. And then the
research could be done legitimately over a long period of time through a
government agency like AHRQ, where we know it will be done in an
appropriate way and credible way and the information would be available
to all the stakeholders.

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

\>\> NANCY: Thank you, David.

\>\> DAVID L.: I hope the two halves of this data collection activity,
having people come in and testify about their experience to date and
perhaps somehow collecting data about what providers' plans \-- patients
are wanting, I hope we regard them both as formative to our ability to
make recommendations about a demonstration, or whatever we\'re going to
call that, to the Community. And the specifics on slides, I don\'t think
we should take too specifically.

Guess I\'m interested in whether we, as a group, think this is an
important activity. So we say we\'re going to somehow or other find out
what the both knowledge base is to date and whatever anyone knows about
the needs expressed by users, which could be, as Ross said, aspirational
rather than empirical. And if we make that effort, there will be a
variety of ways we can capture the data. But I would request, whenever
we report back in May, we have a way to comment back on what it known
and we\'re not working in a vacuum, out of our heads what should happen.
And then we could at some point have a little subcommittee or
volunteers, whatever we have, to try to flesh out some of these other
elements that are achievable in the short time frame. We don\'t need to
make this an immediately \-- at least, a huge, ambitious research
project. Just to try to say these are or they\'re not the kind of issues
we need to know about in order to plan a further project.

\>\> MATT: Kate has a question.

\>\> KATE: I would also agree with David in terms of being able to
report back to the Community to say what is known. And \-- direct
reportability from the consumers, I would probably say not. Maybe it\'s
through a simple, I don\'t know, list of things we know we\'ve come to
know as our group, our expertise. Maybe we\'ve polled some outside
people. But I would caution that line with forsaking timeliness of the
deliverables we have to do. It\'s May we have to come up with some
concrete stuff and to go out and survey. It\'s obviously
\[indiscernible\] out of the question. But maybe here\'s what we know
loosely, and we\'ve surveyed our internal expertise and some vendors and
research, and here\'s what we know and where we have looked. And
specific recommendation maybe would be to do a government-sponsored type
of research at a future date by AHRQ, but here\'s what we know right
now. Here\'s where we see consumers have repped their clinician, vendor,
whatever they want it. They love it; it was portable. They like it.
It\'s not really empirical. But given the time constraints, it may be
all that we have.

I don\'t know; I just \-- it\'s a tradeoff, I think.

\>\> KELLY: Kelly. I just want to say for what it\'s worth, I
wholeheartedly agree with Kate\'s assessment. And I also think that you
know, as a part of the consideration about what we need to do for the
specific charge versus what we can turn to and considering our broad
charge right after the May 16 Community meeting, we may be able to sort
of map out a broader either research agenda or just ways to really get
more information on all of our \-- all the issues listed in these slides
in a more thoughtful manner, and we can think \-- more comprehensive
manner about longitudinal PHRs as opposed to just this construct of
medication history and registration summary.

\>\> NANCY: Kelly, it may that be moving forward with the working group,
since we are the consumer empowerment working group, that what we would
want to do in preparation for the May 6 meeting is do what we can to get
some of these specialists here. If there are members in this working
group that know they have the ability to run even a preliminary survey,
with some of the questions that were presented in this document perhaps
supported by others, that if we can get that information, we will. If
not, we will be recommending that perhaps in the timeline that moves
from May the 6th forward to September, that will be one of our goals \--
will be to look at trying to complete some of the survey work. Meantime,
we can get some of the existing specialist and programs to come in and
give their views, as Kate was stating earlier. But I think, ultimately,
we have to do something to reach out to the consumers of America to have
their input on this issue.

And I think we do have people on the committee that can be very helpful
in seeing that we get into the consumer groups to do that.

As we think about the work that needs to be completed, whether it is on
this issue that we\'re discussing of demos and pilot \-- and certainly
we do view this, David, going back to your comment, that you hope we
view this as formulative to making recommendations to the Secretary \--
I think before we leave this discussion, I would just like to ask \--
and silence again will mean agreement \-- do we all agree that in order
for us to make a well-founded recommendation to the Secretary, we do
need to have a combination of information from existing programs, what
is happening and what is working well, and at some date also information
that is very current, collected from physicians and vendors and patients
that can give us direct input? And we understand that that type of input
we\'re going to need to be able to provide through the members of the
working group, and not as a formal survey that would require that we
have approval for that survey work to be done.

Are we in agreement that we need both sets of that information to make a
good recommendation to the Secretary moving forward?

And I will take that silence to mean, "Yes, we do." And Kelly, our goal
is going to be to get that first set of data, and then we will put in
our recommendation for May 6 that we will be moving forward with
exploring how it get this information from the survey instrument, moving
forward after May the 6th.

\>\> MATT: Nancy, Ross Martin actually tried to buzz in with a comment.
Please open his line.

\>\> NANCY: Sure.

\>\> ROSS: Sorry, Nancy. You just mentioned you \-- you didn\'t mention
the comment made before about payer input and other stakeholders, so I
wanted to \--

\>\> NANCY: Yeah, I actually had acknowledged Justine anticipate
comments about payers and had suggested that she would work with us as a
volunteer to work with others from the payers community to supply us
with questions. That would be appropriate. And then we\'d also have the
recommendation from Myrl that we could contact Karen A., which certainly
our organization works with fairly routinely, so that we could invite
her to be one of those experts. So we would try to get the payers
included in survey work, and we get the payers included from a
retrospective of what is already in place that they could report on.

Would that be sufficient, Ross?

\>\> ROSS: Thank you.

\>\> NANCY: Okay, you\'re welcome. Thank you, group, for the
recommendations around those areas.

We have been very, I think, cooperative this afternoon in having many of
you step forward to agree to donate time and energy and helping us to do
the work that has got to be done in the next 6 weeks. One of the things
we need to talk about now, for a while, is the issue of timeline and
moving forward with how this work is going to be done from today, March
the 20th through May the 6th. And I think that would give us 7 weeks, 6
weeks. We have to get it in early enough to get it reviewed and
completed. As we think about the work of HCSB, for instance, and the
information they will provide, the timeline that we think that will be
completed, David, do we have an idea of how long it will take us to get
that information from them and working with them on that piece of our
work?

\>\> DAVID B.: Nothing will be forthcoming from HCSB in this time frame.

\>\> NANCY: I think that this group could just recommend that HCSB take
on the charge of looking at the \-- identifying the properly data
elements for registration summary and medication history. And I think
that within the May time frame, we can include that in our
recommendation.

\>\> DAVID B.: Could we also reach out to HCSB to find out what is their
internal timeline for when indeed we think we would have that
information available to us?

\>\> NANCY: Sure, we can figure that out. I mean, I think they actually
just have made some public comments around that in the last several
days, so we can get back \--

\>\> DAVID B.: That\'s good. And then we\'ve got the responsibility of
the policy review as one of our bucket, and certainly the policy review
is going to include a far more specific identification of HIPAA and what
it will and will not do, but very significantly, recommendations of what
can be done to assure safety and privacy moving forward with EMRs and
PHRs and the registration and medical data. And we were going to look as
part of that into the contracting piece, and so, number one, who in the
team will be doing that work? And number two, what is the timeline that
we think we will have something to review and talk about?

\>\> MATT: Please open Ross Martin\'s line.

\>\> NANCY: Ross?

\>\> ROSS: Your question about the \[indiscernible\] be able to respond.
The next technical committee meeting is March 29 and 30 here in DC. So
they have more explicit timing about when their deliverables are, and
that\'s all available on the Web site in terms of specific time when
they cycle through their recommendations.

\>\> NANCY: Thank you, Ross. Going back to the question of the policy
review, I know we had Sue with us earlier, and she did cover the issue
of HIPAA. Kelly and Jodi, would it be our expectation that she may be
participating with us and providing additional information around HIPAA
and \-- as well as other privacy mechanisms that could be explored?

\>\> KELLY: I think \-- yeah, I think somebody from Sue\'s staff could
certainly be involved with that, and I can work with Jodi. I also think
it would be helpful to have maybe a couple of workgroup members to add
some context in terms of what\'s really happening in the market. And if
we, for example, were to go back to our options that we reviewed in the
last meeting, where we had various ways of providing the information,
whether it\'s a planned day PHR, employer \-- or a RHIO-based project,
that we might be able to sort of do an analysis under what would HIPAA
cover, what would be considered a covered entity versus, you know, what
would have to be done under, you know, more traditional market levers or
protections under contract, and something outside of Federal law to
ensure consumer control and meeting the needs articulated in the
principles.

So I think it probably would be helpful to find a couple other people
that would be interested in working on that kind of analysis and then we
could report back to the group.

\>\> NANCY: I don\'t know if Robert Tennant is still on the call.
Robert, are you still with us?

\>\> MATT: Yes, he is. Operator, would you please open Robert Tennant\'s
line?

\>\> ROB: Yep, I\'m here.

\>\> NANCY: Robert, you had actually brought to our attention earlier
this afternoon the issue of the need for proactive approach in reaching
out and looking at the privacy issues and had called our attention to
House energy and commerce health IT hearing that was recently convened.
I wonder if we would be able to volunteer you to work with us on this
issue and to perhaps provide additional materials that you may have, or
materials that you receive from the hearing that you went to \--

\>\> ROB: Absolutely.

\>\> NANCY: \-- to Kelly and Jodi. So thank you for agreeing to let us
volunteer you. Are there others on the committee that would like to work
with Kelly and Jodi in this particular work?

\>\> MATT: Please open Lorraine Doo\'s line.

\>\> LORRAINE: Hi again. I would be happy to work on that as well,
because one of the things that we\'re doing here that will have
applicability is identity management and access controls. Kelly had
mentioned earlier the Medicare beneficiary portal. And we are
investigating the best ways to do those for consumers \-- for
beneficiaries, for example \-- and for any of the population groups,
whether it\'s user ID and passwords, whether it\'s knowledge base, what
you know and who you are, and those kinds of things that for non-HIPAA
covered entities are going to be important for us to vet what assurances
they have. So that may be another piece on the technical standpoint that
we want to look into. And I\'d be happy to help on that.

\>\> NANCY: Thank you. And Kelly and Jodi, I think I can volunteer
without being at risk of life and limb here that our regulatory attorney
at NPAF, Diane O'Brien, may be magnificent in working with you to
identify what we know exists in other policy venues that does and does
not provide privacy adequately for patient records and transfer of those
records, as well as perhaps supportive help from Leslie, who works in
State government affairs in this area. So that would give you Robert
Tennant, Lorraine Doo, Leslie, Diane O\'Brien. Are there other
volunteers?

\>\> CHARLIE: Nancy, this is Charlie. I\'m happy to be on the committee.

\>\> NANCY: Thank you. Charlie Safran has also agreed. And I think we
volunteered Sue and her staff earlier in the call. Kelly and Jodi, do
you think you have a robust group there, or do you need us to continue
to get additional volunteers?

\>\> KELLY: I think it would be helpful if we could at least run
whatever we\'re thinking \-- RxHub and SureScripts, because they have
already thought what their current businesses are doing in the context
of HIPAA. So I think they might have some real-world private sector
experience to add to the analysis.

\>\> NANCY: That\'s fine. And that was SureScripts, and who was the
other entity?

\>\> KELLY: RxHub.

\>\> NANCY: Okay, that\'s great. And are there any other volunteers, or
we have completed that one?

\>\> I would also mention, I know there\'s someone who is chairing the
Privacy and Security Workgroup under HIMS that was \-- expressed
interest in testifying at our next meeting, so we might want to \--

\>\> NANCY: That would be \--

\>\> \-- collaborate with that person to get more of the PHR vendor
perspective as well.

\>\> NANCY: That\'s very good, and we\'ll reach out to them as well.

Moving away from that bucket, I\'ve lost my buckets in trying to get
back to my page, but know we do need to deal with the interoperability,
which we know is going to be handled by \-- we\'ve looked for a great
deal of time at a number of the issues that we agreed, when David Lansky
was reviewing them, that all of them involve interoperability and that
we need to have some comments \-- we need to have some comments made to
the interoperable issues. Myrl participated in that discussion a great
deal. And I don\'t know that we ever identified any individuals that
would be attacking \-- trying to develop recommendations around \--
under the sample required functions, Bullet 1, Bullet 2, Bullet 4,
Bullet 6, and Bullet 9. Do we have volunteers that would be willing to
deal with the recommendations around authentication and identify
individuals uniquely to the satisfaction of all data suppliers, provide
security downloads of registration or medication data and to consumer
facing application, enable consumers to record adverse events associated
with their medication? Do we have volunteers on the phone that would be
willing to deal with that?

\>\> CHARLIE: I\'m happy to be on that.

\>\> NANCY: I\'m sorry, who was that? Was that Charlie again? Charlie,
yeah.

\>\> KATE: And Kat Mahan

\>\> NANCY: So Kate, you\'re willing to be that. And was that Charlie?
Rick?

\>\> MATT: Please open Lorraine Doo\'s line.

\>\> LORRAINE: Yeah, I think it would probably make sense for me to help
on that as well. It\'s related to the authentication and identity
management.

\>\> NANCY: And that\'s Lorraine.

\>\> LORRAINE: Uh-huh.

\>\> NANCY: Okay. So that\'s going to be \-- and any other volunteers?
David Lansky, did you want to be in that one? \[Laughter\] Just because
you don\'t have a thing to do, we just thought we\'d give you a couple
of other things.

\>\> MATT: Please open J.P. Little\'s line.

\>\> NANCY: Okay.

\>\> J.P.: Hi, this is J.P. Little.

\>\> NANCY: Hi, J.P.

\>\> J.P.: Certainly, RxHub would be willing to be involved in the
identification of patients, and one thing I want to say to the whole
group: when you\'re looking at the matrix and you\'re looking at the
percentage coverage we have for all the various areas, that coverage is
\-- represents the patient mix, obviously. But our experience around
that has been solely around providing medication history to providers.
It hasn\'t been to provide information to consumers. So you know, Kate
mentioned earlier that we could certainly go back and poll all of the
technology companies that we\'re working with to see if they have a
consumer angle, and we will go do that. I just don\'t know that it\'s
been used \-- that information has been used in that context to date.
But I\'d certainly be willing to participate in this group.

\>\> NANCY: Thank you, J.P.

\>\> JUSTINE: Justine Handelman.

\>\> NANCY: I\'m sorry, was there someone else there?

\>\> JUSTINE: Yes, Nancy, it\'s Justine Handelman about Blue Cross Blue
Shield.

\>\> NANCY: Justine, you\'d be glad to help. Thank you.

And Myrl, did you want to work in that interoperability working group?

\>\> MYRL: I have other areas I\'d be more interested in and have a lot
more expertise.

\>\> NANCY: Okay. That\'s great.

So now, moving ahead to the education bucket, do we have volunteers who
would work with us in the education bucket that would be helping to
shape recommendations that we would make to the Secretary concerning the
education component, being sensitive to use of these materials by many
different ethnicity and with many different language learning needs?

\>\> MYRL: This is Myrl, and I would be happy to do that.

\>\> KELLY: And certainly Jodi and I would be more than happy to do
that.

\>\> MATT: Please open Robert Tennant\'s line.

\>\> ROB: Yeah, I\'d be happy to help on that committee as well.

\>\> NANCY: Good; thank you, Robert. And others on the call that would
like to participate? And looking at the issue of demos and pilots of
special populations, I think we actually have those folks that are going
to be working.

\>\> MATT: Ross Martin, I think, was trying to jump in on that last
point, Nancy.

\>\> NANCY: Okay, the education \-- okay, Ross?

\>\> ROSS: Actually, the interoperability bucket: you can stick me in
that group.

\>\> NANCY: So Ross, you want to be in the interoperability. Thank you.

And in terms of the bucket that is going to be dealing with demos and
pilots of special populations, Kelly and Jodi, do \-- we already have, I
think, the folks that we said would be participating in trying to get
initial information on that, Myrl\'s recommendation of care and David\'s
recommendation of some of the survey work that\'s already out there.
Helen recommended perhaps a CAP survey and information we could get from
there. Linda at VA had a recommendation in that regard. And Kat Mahan
had a recommendation. So I don\'t think we need additional people there.

In terms of the timeline of when we are going to have initial documents
ready for us to present, we all know that the final date of presentation
is on May the 6th. And so I\'d like to open the floor now for discussion
about dates for initial materials to be available for review. And Kelly
and Jodi, I\'d love for the two of you, since you have to do so much
work in the coordination of this \-- for you to jump in. If you have an
ideal timeline that you\'d like us to consider for the next 6 weeks,
week by week, we\'re happy to listen to that.

\>\> KELLY: Well, I\'ve worked in the last few days talking to different
workgroups chairs and the staff that\'s doing a lot of work in trying to
figure out sort of a general timeline, but this may not work, given what
our conversation has been today.

But we were originally thinking that if we could draft some high-level
recommendations where there\'s consensus and enough information to go on
by April 14, that would allow for another couple of weeks to really sort
of highlight the areas where there\'s \-- there needs to be a lot more
deliberation and public input, further public testimony, more fact
finding, and then have it detailed set of recommendations drafted in a
letter form the week of either April 17 or April 24, but they really
need to be finalized that first week in May, given that \-- the fact
that we\'ll have a lot of \-- a lot more fact finding going on, a lot of
work at sort of a subgroup level, and we\'ll need to report back and
have a much longer discussion about all of the work that we\'re doing
offline. And in addition to trying to get some additional testimony that
we talked about today, as a part of another meeting, I would think we
probably need to agree on a time to meet again and have public workgroup
meeting either the end of the week of the 17th or the week of the 24th,
so that we then can turn around right after that and start drafting a
detailed letter with recommendations.

So that way, we spend probably more time over the next 3 weeks focusing
on working at a subgroup-level fact finding \-- find the experts to come
in for public testimony, pulling that together for another probably
4-hour workgroup meeting, and then have a date where maybe another core
group of us is interested and willing to actually start drafting a
letter. And then once we have something in draft form, we could
circulate it, hopefully by \-- if not the last week in April, by May 5
to get more group input on that draft letter.

\>\> NANCY: Your recommendation was that we try to have another meeting
on April the 17th or sometime the week of the 17th in.

\>\> KELLY: Yeah, it\'s right around the holidays.

\>\> NANCY: It is, and I don\'t know if that could be problematic for
some folks that may not be available that week.

\>\> KELLY: We were thinking maybe the 20th or the 21st toward the end
of the week might be better than right around Easter or Passover. But I
think the end of that week is still the end of Passover.

\>\> Yeah, it is.

\>\> 14th?

\>\> Yeah.

\>\> I think the week of April 10 is going to be much like the last week
in August: nobody will be around. We may want to look at real early
recommendations not unless letter form as early as the 7th.

\>\> Our process isn\'t going to allow for it, though, is the problem.

\>\> Okay. I assume you can poll us all by e-mail. Even if it\'s the end
of the week, the 20th or 21st, I would think \[indiscernible\] people
with other obligations. I think just because it\'s Easter week, they
wouldn\'t use everybody \--

\>\> Yeah. I mean, how many people couldn\'t make a meeting on the 20th
or the 21st?

\>\> I know I would not be here, Kelly. And I don\'t know whether Gail
will be or not.

\>\> Okay.

\>\> But I would certainly see if she could cover that day.

\>\> Okay. And then would the 24th work for \-- you\'re gone that whole
week? You\'re out, too? Oh, you are, okay.

\>\> Okay, well, \--

\>\> I don\'t know if others on this call might be more available if you
tried to have a call on Monday, April the 10th. Does that give you time
to get some of your work completed, or do you need to really wait until
it\'s later?

\>\> Well, I think that given we have three subgroups going and some of
them are going to require probably a significant amount of iteration and
back and forth, we probably would be better off with a workgroup meeting
on the 24th. And that would at least allow that whole week, the week of
the 24th, to get some subsequent work done.

\>\> Okay, so you will circulate the next date of that meeting?

\>\> Yeah. I mean, I think \-- the 24th appears to work for most people,
although it doesn\'t work for Marilyn, unfortunately; then maybe we
should go ahead and agree on that date. And then we could set up
immediately after that a \-- what do you \--

\>\> We will try to meet again on April the 24th, is the recommendation
at this time?

\>\> Yeah, and why don\'t we follow up immediately after this meeting
and figure out which \-- out of the 20th or 24th which works for the
most \-- the majority, and then we\'ll go with that.

\>\> DAN: This is Dan Greene, the 24th right now \--

\>\> Volunteers for each of these \--

\>\> Policy council \--

\>\> \-- working groups to make certain that there are opportunities for
them to visit with you as they do their work or to set their meeting. We
have a number of volunteers for each of these groups, and we did not
identify a chairperson for each those groups.

\>\> Okay.

\>\> NANCY: So will you and Kelly be coordinating with them to see
whether their group is going to be meeting? And I know you usually like
to have a representative in those meetings or attending those meetings.
And we will work with your office to know what the date of each of the
groups will be having their calls and their meeting to get materials to
you.

\>\> JODI: Yeah. I mean, I think it\'s relatively informal. I mean, I
think ONC will make sure that, you know, we\'re organized and we have a
meeting date set and we passed around the right background materials.
But I think \-- you know, I think there\'s sort of consensus in this
room there doesn\'t need to be a definitive chair for these subgroups
and also to remind everybody, according to FACA \-- I think it\'s okay
that we work offline and we do this fact finding and work together. We
just need to make sure that we all come back in a public forum to
discuss whatever we come up with as subgroups., and that we all, as a
larger sort of FACA subcommittee, agree to whatever we come up would
then go to the full committee. So just a process check there.

\>\> NANCY: Great.

\>\> MATT: Nancy, J.P. Little is waiting to make a comment. And just a
note: as we head toward 5:00, we need to reserve a little bit of time
for public comment at the end of all this.

\>\> NANCY: Okay. J.P.?

\>\> MATT: Please open J.P. Little\'s line.

\>\> J.P.: Ever so briefly. I'd like to throw another hat in the ring to
the education workgroup. Shelly Woolly from our \--

\>\> NANCY: Which organization is Shelly with?

\>\> J.P.: RxHub.

\>\> NANCY: Thank you so much.

\>\> J.P.: You bet.

\>\> NANCY: And Matt, we\'ll open the phone for public comment now.

\>\> MATT: If there\'s a member of the public on the phone right now who
wishes to make a comment, you need to press star-1. For those following
along on the Web, we\'ll put up a slide that has the call-in and
commenting procedure.

\>\> DAN: Nancy, while we\'re waiting for comments, this is Dan Greene.
I noticed on the calendar that Jodi Daniel is tentatively holding a
Federal policy IT meeting on the 21st \-- 24th; I\'m sorry.

\>\> MATT: Yes, that\'s correct. If that turns out to be the best date,
then we may decide to either change that time or cancel the meeting.
We\'ll see what people come back with. And if we need to cancel that or
change it, we will.

\>\> DAN: Fine.

\>\> NANCY: Thank you, Matt.

\>\> MATT: We actually are scheduled for the 1st.

\>\> NANCY: Matt, do we have any public comment?

\>\> MATT: Nobody yet. Operator, is anybody calling in for a public
comment?

\>\> OPERATOR: There\'s no one calling in at this time.

\>\> Nancy, I have one more just process comment.

\>\> NANCY: Sure.

\>\> If we do in fact move this meeting to the 20th or the 24th, then we
would be relieved a meeting of first week in May and use that time to
finalize our letter of recommendation to the community.

\>\> I think that\'s \--

\>\> NANCY: That\'s excellent.

\>\> I think that was what we would tentatively \-- were talking about.
That seems like a good process.

\>\> NANCY: Yeah, absolutely. And I think we just need to know which day
is going to work best for Jodi and for Kelly moving forward.

\>\> Right.

\>\> Okay.

\>\> MATT: It doesn\'t look like we have any public comment, so we\'ll
leave the e-mail address up on the Web for those members of the public
who do wish to send something in, and we\'ll circulate it to the chairs
of the workgroup. But nobody is calling in right now.

\>\> NANCY: All right. And Matt, I would like to take the opportunity to
say thank you to Jodi and to Kelly for your time with us today and for
your leadership in this call and your preparation in getting all of us
ready for this call.

I would like to thank every member who has been so generous in donating
time to work on these groups between now and our meeting in May. Thank
you sincerely. And I thank you each for contributions that you\'ve made
this afternoon in helping us to stay focused and to move this initiative
to the next platform.

And Dan, are there closing comments that you would like to make?

\>\> DAN: I just want to echo your comments and thanks everyone. But
especially, Nancy, I\'d like to thank you for chairing this meeting and
moving us through the process.

\>\> NANCY: Thank you, Dan. Thank you, Matt. Thank you, all that were on
the call.

\>\> Goodbye.