American Health Information Community

Personalized Healthcare Workgroup Meeting #3

Monday, March 12, 2007

**Disclaimer**

*The views expressed in written conference materials or publications and
by speakers and moderators at HHS-sponsored conferences do not
necessarily reflect the official policies of the HHS; nor does mention
of trade names, commercial practices, or organizations imply endorsement
by the U.S. Government.*

[**\>\>** **Jennifer Macellaro**:]{.underline}\
Okay. It does look like we\'re ready to get started now. This is
Jennifer. I\'ll just go ahead and run down the list of who\'s on the
phone, and then you can introduce who is in the room there before we get
started?

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

Okay.

[**\>\>** **Jennifer Macellaro**:]{.underline}\
Okay. On the phone it looks like we have Jean Slutsky from AHRQ, Jim
Rollins from CMS, Carolyn Clancy from AHRQ, Marc Williams from
Intermountain, Campbell Gardette from HHS. And it looks like that\'s all
the Workgroup members on the phone. I will just remind everybody that
it\'s a Federal Advisory Committee Act proceeding today so we are being
broadcast over the Internet, transcribed, and recorded. If everybody
will introduce themselves before they speak and speak clearly and
distinctly, and keep their phones on mute when they are not talking,
that will help. And there will be an opportunity for public comment at
the end of the meeting. So if you want to introduce everybody in the
room there, we can go ahead and get started.

[**\>\>** **Greg Downing**:]{.underline}\
Okay. I think we will do introductions in just a few minutes. Thank
you.\
\
I wanted to thank all of you for making the effort to come here today. I
realize the changes with the AHIC meeting tomorrow to the West Chas
created some challenges for a number of you and I appreciate flexibility
in accommodating our changes in plans here as well. The discussions that
have taken place in the phone calls and in the meetings prior to here
have been very, very productive, and our efforts today are really about
establishing a vision for this working group\'s activities.

And I want to really compliment the chairs, Drs. Glaser and Henley, on
their efforts to try to pull this together, a very complex area. And I
think all of us here in HHS agree that the progress made to this date
has been really helpful in refining, particularly with regard to
electronic health record components for genetic tests and family
history. And I think one of the enduring things for us as the staff has
been the degree of engagement that the members have had on this working
group, and we hope to capitalize on that today.

I would like to just acknowledge our facilitator today is Mike Cowan,
and Mike will tell you a little bit in a moment about his activities and
roles here. But he has participated in a similar session that was had
with the HHS agency chairs about a year ago on personalized healthcare.
And those efforts, I think, led to the framework for which the Secretary
has embraced this initiative. So Mike will be handling the facilitation
today with the chairs. And we will talk a little bit later about the
products out of this.

But first I would like to introduce Sheila Walcoff who is a counselor to
the Secretary. And she has been the leading AHRQ interfaces with the
Secretary\'s initiatives, of which she\'ll tell you a little bit about.
But I would like Sheila to open the meeting and provide some
perspectives on the Secretary\'s view of the initiative overall.

**[\>\> Sheila Walcoff:\
]{.underline}**Thank you, Greg. And please excuse my voice this morning.
I honestly don\'t usually sound like this.

On behalf of the Secretary, I wanted to reiterate Greg\'s welcome and
thank you all for participating today in the first face‑to‑face meeting
of our Personalized Healthcare working group. At the outset I would also
like to acknowledge the leadership of our chairs, John Glaser and Doug
Henley, for your participation and your work on an issue that\'s very
important and has made it into the top 10 of the Secretary\'s
priorities. I listened to the deliberations that you all have had on the
phone; and I have to say for such a new and complex issue, I think that
you have made a lot of progress in the last three months. It is
important that so many of you have committed your time and effort to
this. I know it is a volunteer effort, and I wanted to let you know on
behalf of the Department that we very much appreciate that.

I think you will get more out of this session here in person today for
those of you that were able to make it in person, and I look forward
listening to the deliberations here today. We have been working on the
issue of personalized healthcare at the Secretarial level for over a
year, and your work will add considerable value and direction as the
Secretary continues to lead initiatives that will shape opportunities
and solutions in personalized healthcare.

I would like to say a few words also about where Secretary Leavitt is on
the issue of personalized healthcare. In September he endorsed a project
plan for areas on which he can devote significant personal leadership to
advance his personalized healthcare. The work of this group, in its
advisory capacity to the AHIC, will help shape the future of the
interface, the electronic health record, and health IT. He is also
addressing important policy issues, including endorsing and providing
technical assistance for federal legislation to prohibit genetic
discrimination in employment and insurance, pay an appropriate oversight
to the genetic tests themselves and also to harmonize access to
federally‑funded genomic databases. Secretary Leavitt is also keenly
aware that the work of this group contributes to the other priorities
he\'s undertaken in the Department. This includes work on value-driven
healthcare and harnessing initiatives across government to try to
advance more personalized, predictive, and preemptive healthcare.

Most importantly I think the Secretary is focused on a role of the
consumer and the consumer\'s perspective, how we benefit from the
advances in basic science and information technology, and can we make
sure that genomic information supports new knowledge in managing
healthcare, our healthcare needs and costs without causing harm.

We have a number of important events coming up in the next couple of
weeks, and I\'m sure that the points you discuss here today will play a
significant role in assisting the Secretary as he seeks to develop
policies that support the convergence of genomic science and health IT
to drive the future of personalized healthcare. I will be here for part
of the meeting today and I\'d be happy to answer any questions that you
might have now or as the work of this working group progresses. And I
look forward to hearing the deliberations. Thank you.

[**\>\>** **Greg Downing**:\
]{.underline}Thanks, Sheila. If there are not any questions we will move
along with the agenda, and I will ask the co‑chairs for their guidance
and wisdom at the outset of this meeting. And then we will go through
introductions and ground rules and then introduce our leader in our
facilitation of the visioning process. So John and Doug.

[**\>\>** **Doug Henley**:\
]{.underline}Good morning, everyone. It is nice to finally put some
faces to the names over the telephone. I must admit that being a family
doctor from rural North Carolina, to be in the Secretary\'s top 10 is
pretty heavy stuff. So good for us.

[**\>\>** **Sheila Walcoff**:\
]{.underline}From my perspective it is the top two, because I\'m in
charge of two.

[**\>\>** **Doug Henley**:\
]{.underline}Even better. So we obviously have our work cut out for us,
as we knew when we began to engage in this adventure. But it is
important, both to the future of healthcare and, more importantly, the
future of patients and consumers in this country.

I think today\'s session focused predominantly on our visioning for the
coming months so that we can meet both our short‑term and broad work
plan, as we have identified it, and as approved by the AHIC, is a very
important first step in moving towards those goals and getting some
eventual recommendations and use cases back to AHIC for implementation
as we've discussed in our previous phone calls. So I certainly look
forward to our discussions today. John?

**\
[\>\> John Glaser]{.underline}**[:\
]{.underline}I don\'t have anything to add other than to welcome all of
you, and your willingness to devote a big chunk today. I know most of
you came from the West Coast, which means there was even a larger chunk
of time coming out here. Express appreciation for your willingness.

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

Okay. Thank you, both. I\'d like to just kind of go through the agenda
for the day and what our ambitions at least from the HHS perspective are
in how to use this session. And I would like to just first of all say
that the, again, for the other participants that aren't on the phone,
make sure you are speaking into the microphone. We do transcribe this to
develop a report as an official document for this. And our goal is
really to have everyone in the room and online engaged in this
discussion, and so this is relatively open process. As you will hear
from Mike, he used to have a lot to do with the Navy in the past. But we
run a little bit of a loose ship in terms of, we expect people can come
and go as they please. We\'ve negotiated this in advance. We are not
going to be taking orders and following protocol that closely. But the
efforts are here. We do realize some people will be coming in and
leaving as they go, and we will try to accommodate those issues.

We talked a lot with the AHIC leadership, that other working group
efforts have really utilized a session in the early stages of their
working group activities to help crystallize the directions in which
they feel their efforts are really aimed. And the topics to this point
have really predominantly been focused on the readiness and the AHIC
process of developing standards for electronic health records. And I
think that some of the early sort of kernels that came to play into
this, and necessarily supporting the function or the utility of this,
really came up with regard to the family history efforts. And at the
September and October meetings of AHIC this notion of really defining
clinical decision support or the evidence necessary to help make
consumer-focused decisions, whether it\'s from a provider\'s perspective
or from a policy perspective or the consumer, that that family history
as coupled with the genetic test was really a critical piece. And I
think that was one of our first steps that we took, to acknowledging
that connecting test information with other pieces of the family health
records and other elements of medical information is really critical to
that ultimately being something that the, is of utility in making
decisions.

We have been shaping a longer term perspective internally and came up
with this notion of what we have described as the Grand Canyon. And that
basically, the longer term objectives of being able to have at your
fingertips all of the information that you need to really encompass the
genetic basis of disease and the clinical manifestation that ultimately
guides theraputic decision-making and prevention and opens new doors of
managing disease is, we realize, a vision that\'s probably quite a ways
off yet.

And in the short‑term we have recognized, and we can come back to this,
but our specific charge was really focused around utilizing this
Workgroup to help structure the readiness for the electronic health
records. So we have got some firm milestones, relatively firm, in the
early days of this journey and the longer-range vision, and what we have
described in the middle is what we have sort of characterized as the
Grand Canyon, somewhat meant as a metaphor to characterize the space,
the magnitude of that space, and sometimes the daunting task of trying
to be the first ones across that chasm is kind of what this effort is
about, is trying to envision what that world may be and some of the
opportunities necessary to, for us to engage new technologies and new
ideas of information management to support that journey.

So in the course of the discussions today we will talk a little bit
about that longer-term vision and what we see as some of the barriers
and obstacles and opportunities. And we are going to be doing this from
a framework of the consumer\'s perspective, the healthcare provider\'s
perspective, and then other stakeholders that we will describe. And Mike
will go through that framework in a few minutes.

Just on a logistics side we will be taking breaks throughout the morning
and the afternoon session. We have structured this so that we could, and
this is really with the chair\'s direction, is to put the visioning
session in today\'s meeting up front and that we will spend several
hours this morning and maybe regroup in the afternoon for the early part
of that session to look at a framework, if you will. And this is not
meant to be proscriptive in any way, but we are going to come out of
this with a, from today\'s meeting as a copyedited version as what
everybody views as the vision. But what we want to do is get all of the
ideas out on the table and have an interactive forum in which we can
frame the next steps that the working group will undertake. We have
talked in prior meetings about the aspects of HITSP standards, the
certification process, the integration with NHIN. And now I think we are
really ready to embark on what\'s the value aspects of the information
that we are talking about that has impact in clinical healthcare.

We heard, I think many of you heard about Aetna\'s programs that are
being announced this week on the personalized health record and how the
healthcare systems are starting to embrace the ability to manage this
information. I was struck by the full-page ads in the *Times* yesterday
about the impact of even identifying family history information in that
was important. So there is clearly a lot going on in the transition
times through most of our times here, just in the last year has
witnessed a great deal of change on technology and information
management. And I think one of the aspects that we have to grapple with
is what\'s that pace that we are dealing with and how do we gauge the
readiness of certain activities that we want to embark on.

So just again to take a moment, the afternoon session will have two
presentations. One is focused on a presentation by Maren Scheuner who is
going to be here to present some perspectives on what a RAND study is
doing and looking as what was being defined as the electronic health
record for the ecosystems that incorporate genetic and family history.
And her report is going to be defining many aspects of what vendors are
looking at, and we thought was a unique opportunity to hear at a
relatively early stage what the commercial sectors are doing in
preparing for these types of information.

And then the DOD\'s AHLTA system has been something we have talked about
in prior sessions here and the functionality that, which the Tricare and
other aspects of DOD have been utilizing this certainly been a focus of
the AHIC discussions as well, but we are going to be dropping down into
that another level looking at the family history and medical record
aspects of how genetic test information will be incorporated.

So we may end up early today or we may just continue and decide on
certain areas that we want to park for future meetings. But this is
meant to be your meeting to really focus on the issues that you think
are most important to getting to that future of personalized health
records. We will talk a little bit about some boundaries in few minutes.
But we will be taking a break. The lunch today will be, go upstairs to
the cafeteria. Government rules apply here. You can get your lunch and
bring it back down. We can have discussion during lunch, but we\'ll see
how the day is going as to how much time you want to take for that. And
we\'ll take some breaks here in the morning. There is coffee on the
side. If people feel like we are not making progress where we need to go
and you want to redirect the meeting, we will certainly be able to do
that with the facilitator. So I\'m going to stop there and see if there
are any questions about the plan for the day. And certainly be willing
to open this up for any discussions with Mike as to how you want to
progress through the visioning process today. So are there any questions
before we begin?

If not, let me introduce Mike Cowan. And Mike is working for one of the
consultants that has been supporting the Secretary\'s initiatives, and
it\'s BearingPoint. And he has a very interesting background to present,
I think, to help guide us through this process. Certainly a lot of
issues in military healthcare have come to pass in the AHIC
presentations and certainly in the front pages of the news in many
contexts today. And he, I think, has seen this initiative evolve over
the last year in terms of its direction and the specific projects we
have undertaken here. And I think we will utilize his services today to
help not so much direct the flow of information but to try to put it in
a framework in which we can use it as working group activities continue.
So I\'m going to turn it over to Mike for a few minutes to sort of
explain our context for the meeting today.

[**\>\>** **Mike Cowan**:\
]{.underline}Thanks. I\'m Mike Cowan. I retired from the Navy in the
summer of \'04, and I now work at BearingPoint as the Chief Medical
Officer. At the time of my retirement from the Navy I was the Navy
Surgeon General. Over the course of the years I\'ve missed that from
time to time. But with the series of articles in the *Washington Post*,
I have not missed it nearly as much lately as I used to.

I\'m going to ‑‑ what we are going to do is try to envision a future. We
will be actually accomplishing several things. We will do some level
setting within the committee. We will create a shared vision, probably
create some sub‑visions as people diverge on things. At the end of the
day, at the end of this process, we will be creating a roadmap that will
guide success of this Workgroup going forward on personal healthcare.
The product from today, we will collect your thoughts and keep them as
organized as we can. And then that will go to the co‑chairs and the
thought leaders in this group, who will put together a more refined
document that will be presented again to this group in September, is
that correct, as a draft, and then become final in October. And in a
minute I will stand up to the board here and talk about how we will go
through it.

Rules first. There is not many. First rule is no hitting.

\[laughter\]

We are going to try to do a consensus brainstorming. We are not going to
try to decide or debate on particular ideas. We want to get things up
and in the open, and then the function of the group will be to do that
downstream. So this is trying to populate the, this is trying to create
the population of things that this group will be working with.

Greg mentioned about lunch. We will break before noon. I\'ve been in
this building many times. And if you try to go have lunch at noon, you
spend a whole lot more time in line. So we will get you up there so we
can have a nice lunch and sit down and relax and chat.

If you would please turn your cell phones off or put them on stun, it
will make the meeting go slicker. Please feel free to come and go as you
need to. If you need to make a phone call or need to make a comfort stop
or anything at all, just go ahead and don\'t feel constrained. We will
have a break. But when you are in here, please stay engaged. Let\'s
really put our souls into this and make the best use of our time.

We will not be tyrannical about time. If something seems to be taking
longer but it's worthwhile, we will simply go on with it. We have three
hours allotted. If it doesn\'t take three hours, we will stop, and go on
to the rest of the meeting.

As we begin in a moment we will talk about more content. I think you
want to talk about more content, too. I see this step, I recently ‑‑ the
historians are starting to talk about the Manhattan Project. There have
been several books come out about it. When historians ask the people who
did the Manhattan Project, how did you create a whole new school of
physics and how did you create the weapons and then, how did you do that
in just a few years? They said it was the dialog. An issue would come
up, a problem. We wouldn\'t know what to do about it. We would talk
about it. And pretty soon the answer would be there, and nobody ever
really knew quite who came up with the answer. I think this process is a
little bit like that Manhattan Project conversation. And the power of
this group to carry it forward, I think, will be very prominent in the
nation. So this is going to be a very worthwhile event.

You want me to talk about the assumptions, or do you want to hit that?

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

I will take care of those.

[**\>\>** **Mike Cowan**:\
]{.underline}Okay. Any question on our process? We will capture your
notes here. We will put them up on the wall so we can follow the
discussion as it goes on. This is the kind of thing that low tech lends
itself to so we are going to stay very low tech. All right?

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

Thank you, Mike. Next up I would like to do is go through, for those in
the room that are members of the working group, is introductions. I know
you have all met on the phone. But particularly how, mention, I would
think, your role in the communities that you represent and then what
your ambitions would be for this meeting today. And then I would like to
start setting the stage in terms of some of the things we have been
working on here in terms of the, a matrix for this visioning process. So
let\'s start on this side with Betsy. If you could just introduce
yourself, where you are, and the organizations that you represent and
ambitions for this meeting.

[**\>\>** **Betsy Humphreys**:\
]{.underline}I\'m Betsy Humphreys. I\'m the deputy director of the
National Library of Medicine. In connection with this activity perhaps
I\'m, my background that\'s most relevant is that I\'ve been involved in
federal support for, and trying to rationalize federal support and make
more generally available certain clinical data standards, including,
mostly terminologies, including SNOMED, LOINC, and RxNorm, and to make
these available in a sort of standardized format through the Unified
Medical Language System Metathesaurus.\
\
I guess my objective for this meeting is, I would really like to have us
focus on, or what would be helpful to me, would be to focus on what are
the specific aspects of this that we need to deal with, without
re‑inventing what people have already done in terms of the electronic
health record and the quality vision, and what have you. Because I
really see this activity of focusing on how we can use genetic
information to personalize healthcare as really being a subset, with its
own issues and problems, of these other issues.\
\
I read the thing, the quality vision. We could say the same thing. I
mean, this fits right into it. Then it just seems we have the specifics.
I\'m not so sure that spending the, all the same time to invent the
vision of the quality of healthcare, which obviously the only reason we
care about this is because of prevention and the quality of healthcare.
I just think we should try to focus on our piece.

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

I think that\'s been something the chairs have brought up, too. I don\'t
want to interrupt the flow here, but I think that is becoming fairly
clear to us. And the activities of the quality group, I know Carolyn is
on the phone here, is that we have, even in their use case that was
developed, see opportunities to build off from just inserting a
paragraph, for example, and utilizing some of the work other groups have
done, and we will talk about that today, I think. So Felix we can jump
back here.

[**\>\>** **Felix Frueh**:\
]{.underline}Yes, I\'m Felix Frueh. My last name is German. It means
early.

\[laughter\]

It is environmental. It is not genetics, I guess. I apologize for being
late. I\'m the associate director for genomics in the Center For Drugs
at the FDA. We deal a lot with standard development and formats for,
well, new types of genomic submissions that we receive under INDs, NBAs,
and what we call voluntary genomic data submission program. And over the
last two years or so we gained significant experience on what works and
what doesn\'t work. And I\'m here mainly because I believe that we have
some experience that we can bring into this group. And I hope that we
develop standards that are as useful for electronic health record at the
patient end as they are in the pharmaceutical industry for developing
the data in the first place and then submitting it to the FDA for
approval processes.

There are two kinds of data I think that we need to keep in mind. It is
the data, the type of raw data that genetics and genomics is producing
using experimental systems. And then it is the data that actually deals
with a patient\'s genetic makeup. And these are the two very important
aspects that, from a regulatory perspective, we need to look at at the
FDA.

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

Beryl.

[**\>\>** **Beryl Crossley**:\
]{.underline}I\'m Beryl Crossley. I work for Quest Diagnostics in
Southern California. And as you know Quest Diagnostics is the, probably
the largest diagnostic company in the U.S. And my particular field of
reference is I work for genetics R and D and have spent a number of
years at Quest in data management, and particularly data management
within the laboratory. One of the greatest challenges that we have at
Quest is the manipulation of data, the storing of that data,
standardization of the way that data is stored, long‑term storage of
data, and the ability to correlate the history of a patient when tests
may be conducted in several of our different business units. So I\'m
particularly interested within this group in being able to define such
and being able to also standardize on data management and the way that
data is sent from business unit to business unit and organization to
organization. And also ways in which we can correlate the clinical
history of the patient with the laboratory genetic data information we
receive. Thank you.

[**\>\>** **Amy McGuire**:\
]{.underline}Hi, I\'m Amy McGuire. I\'m with the Center for Medical
Ethics and Health Policy at Baylor College of Medicine. And I primarily
do research on issues of privacy and confidentiality with regard to
genetic information, so that\'s my particular interest in today\'s
session. And I guess if I had to say what my goal for today was, it
would be to try to get us to think about the privacy issues associated
with what we are doing. I would challenge us to do it at two levels, I
suppose. I think there is the minimum standards level where we try
to think about what are we going to prevent people from doing and how
are we going to regulate it and how are we going to ensure compliance
and issues such as that. But I\'d also challenge us to think more
broadly about the global issues of how are we going to balance issues of
privacy and concerns about privacy and confidentiality with the
enthusiasm that I think everybody shares for moving this forward and
having sort of an electronic health record that everybody can have all
their information in and everybody can access to. So to try to temper
that with some of the concerns about privacy and make, achieve an
appropriate balance at a global level, I suppose.

[**\>\>** **Mark Rothstein**:\
]{.underline}Good morning. My name is Mark Rothstein. I\'m the chair of
the subcommittee on privacy and confidentiality of the National
Committee on Vital and Health Statistics, which is a Federal Advisory
Committee to the Secretary on health information policy.

My day job is director of the Institute for Bioethics, Health Policy,
and Law at the University of Louisville. After hearing Amy\'s agenda,
I\'m proud to say that she\'s one of my former students.\
\
\[laughter\]

**\
**And my goal for the day is rather a sweeping one. I want to see if I
can persuade the members of the working group to totally change the
direction and totally change the focus of what we are setting out to do.
I will spare you the specifics until a more appropriate time, but
basically my concern is that there are a series of very essential,
fundamental principals that we have not yet even addressed, and that
will influence any use of genetic information in electronic
health records and beyond. And unless and until we have some
understanding and, hopefully, consensus on what those principals are,
then I think it is really putting the cart before the horse to go to the
level of granularity that is implied by some of the documents that I\'ve
read. So that\'s my modest goal for today.

[**\>\>** **Steve Teutsch**:\
]{.underline}Morning. I\'m Steve Teutsch. I\'m a physician,
epidemiologist, and head the Outcomes Research group at Merck. But I
really don\'t think I\'m here for that reason. I\'m retired from CDC,
where I was involved with coordinating the national surveillance systems
and then developing the evidence-based public health agenda. I serve on
the Secretary\'s advisory committee for genomics and health, and have
been on a variety of evidence‑based panels, including the group at CDC
that is developing the evidence‑based genomic applications, I've been on
the U.S. preventative services task force and on the community health
preventative services task force. But I think I come at this primarily
because of interest in the translation of evidence into practice and the
critical role of information systems in facilitating that process, and
the need to provide the kind of decision support so that we actually end
up delivering the kind of services that provide real value to both the
population and individuals.

[**\>\>** **Allan Guttmacher**:\
]{.underline}I\'m Allan Guttmacher. I'm a pediatrician and medical
geneticist by background. I\'m the deputy director of the National Human
Genome Research Institute and also director of the office of policy,
communication, and education. I\'ve been particularly interested in the
last few years about sort of, I mean, why am I coming to work at NIH?
The idea that you have got all the sequence, what does it really matter
in terms of health and healthcare? And I guess my goal for the day is a
continuation of that, that we come up with an ambitious but realistic
kind of vision that really does move forward in terms of integrating
genomics into healthcare in a way that helps the lives of both providers
and particularly patients that really does something that will work.

[**\>\>** **John Glaser**:\
]{.underline}I\'m John Glaser. I'm the chief information officer for
Harvard Partners healthcare, which is a large delivery system in Boston.
We were founded by the Brigham and Women\'s hospital and Mass General
about 13 years ago. And we have been making rather substantial
investments over the last three to four years in this realm, centering
on the electronic health record, leveraging that data to support
research into the genomic base of disease and, over the course of last
year, altering our EHR to both store genetic data but also to
incorporate genetics decision support, so this is in front of us,
although still very early stages.

I hope that the conversation today will be freewheeling and informative,
et cetera. And largely, at least for me anyway, into a relatively
comprehensive framework, for lack of better. We\'re not going to get
into the wordsmithing. At least I hope not. I would take one of those
voluntary absences while we fight over adjectives. But I really would
like to understand the range of futures. And so whether it is
pharmocovigilance or dosing that might be done or patients treating
themselves, et cetera, and how a wide range of stakeholders will engage
in a wide range of activities in the future. So make sure that we get a
fairly broad understanding of the terrain and what's likely to be there.
We can then flesh that out in subsequent discussions. I think the
conversation is very important in setting the stage for use cases, which
will drive or confirm standards process. May very well be, Betsy, that
the vision material is an addendum to other visions rather than a
supplanting of that. Clearly it will frame how we think about privacy
and a number of other social issues that go with this. And if at the end
of the day we imagine a good chunk of this will be in the hands of Doug
and his colleagues, people taking care of people, how we set that up so
they are in a good position to deliver extraordinary care.

[**\>\>** **Doug Henley**:\
]{.underline}Doug Henley. Executive vice‑president, CEO, the American
Academy of Family Physicians, based in Kansas City. First an admission,
and then my hope for outcome of our efforts, both today and in the
future. The admission is, while I was a clinician in private practice
for 20 years, I don\'t have a background in medical genomics or
proteomics or protomics and so forth. But I do have a connection. I know
Allan.

And I was a classmate in residency with Francis Collins, in medical
school and residency. That\'s about my only connection with this topic.
However, I\'m very passionate about it because, as John just said, and
Steve said earlier, if you look at the environment in which medical care
occurs in this country today, and it\'s not likely to change
significantly in the future other than how care is rendered, it will
become less and less face‑to‑face and hopefully more
electronically‑based and so forth. Thirty percent of the physicians in
this country, the primary care docs, family physicians, general
internists, and general pediatricians provide 60 percent of the
ambulatory based visits in this country. And of the other 40 that are
not ambulatory based in primary care, half of those occur because they
were referred from a primary care base.

So it is critical, I believe, that as we engage in this important
discussion that we are going to embark upon today and in our future
meetings, that we make sure that it does translate into the clinical
environment and so that it does improve patient care in a very real and
serious way. And that clinical decision support can be there,
particularly for the large body of primary care visits that will occur
in the future so that it becomes real and tangible for the benefit of
our patients.

[**\>\>** **Janet Warrington**:\
]{.underline}I\'m Janet Warrington. And I\'m leading two initiatives
that are basically grassroots initiatives from the genomics community to
develop standards for the use of genomic technologies and to accelerate
their adoption in the clinical environment. I\'m also the leader of a
department at Affymetrix. It is an R and D department. My background is
in molecular genetics and biochemistry.

My goal for today really is to try to help develop consensus. This is a
very ambitious project we have got going here. And my mantra is embrace
the complexity, really trying to identify those areas where there might
be gaps in this proposed vision.

I come to this from a developer\'s perspective. And I do understand and
appreciate the value of having standards in place at the very beginning
of a development process. It is more efficient and more cost‑effective
if you know what your specification is at the beginning rather than
trying to guess at what the community will need and require.

So you guys have done a great job pulling together a variety of
expertise today, and I\'m looking forward working with you today, to try
to identify those places where, as a developer, we can contribute to
this process.

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

Hi, I\'m Michele Puryear. I\'m a pediatrician. I\'m here representing
the Health Resources and Services Administration. I\'m also the
executive secretary of the advisory committee on heritable disorders and
genetic diseases in newborn and children. That being said, I want to
make sure that pediatrics is part of the picture, and also that the
underserved are part of the picture and part of the consideration. They
are a large part of our constituency within our programs at HRSA. Public
health is also, needs to be considered a partner in this perspective,
too, and the work that we are doing. As we go forward and want to look
at ways to conduct surveillance, and then base our health promotion and
prevention activities on that analysis of surveillance, they need to be
part of whatever effort that goes forward.

[**\>\>** **Mary Beth Bigley**:\
]{.underline}Hi, I\'m Mary Beth Bigley. I\'m a senior health fellow with
the Office of the Surgeon General. And when I came on board, one of my
primary projects was with the Surgeon General tool, family history tool.
Since that time I\'ve been interested in family history and primary
care. I\'m a nurse practitioner. And I agree that in primary care as
well as public health, there is so much that a provider can do when we
see patients for the 20, 10 minutes that you have. So to be able to make
the family history part of a patient\'s responsibility so they
understand, too, how important it is to their health. That aspect of
patient, family, and population is what I hope to bring to the table
here.

[**\>\>** **Deven McGraw**:\
]{.underline}Deven McGraw, with the National Partnership for Women and
Families. We are a non‑profit, non‑partisan, advocacy organization here
in DC. The two program areas that are most relevant to the topics that
we work on, in this Workgroup, are improving access to quality
healthcare and increasing the accountability of the healthcare system,
and also preventing discrimination based on health status or genetic
make‑up is something that we are actually currently working on. I\'m
also a member of the Confidentiality, Privacy and Security Workgroup of
the American Health Information Community. And so we are grappling with
a lot of privacy issues, but I can say at the outset that we presently
are treating all healthcare information as somewhat equally sensitive.
And so what I would like to see us focus on a bit in this Workgroup is
whether there need to be some heightened considerations for personalized
healthcare information, whether that\'s family history or genetic
information.

[**\>\>** **Paul Cusenza**:\
]{.underline}I\'m Paul Cusenza. I\'m currently a senior adviser and
board member of 23andME, which is a company I co‑founded in 2006 to
allow consumers to have direct access to personal genetic information,
and presumably have a product out sometime in the coming year. And prior
to that I was with Perlegen Sciences where I was the senior
vice‑president, and we did extensive homogenous associations to
determine the genetic basis of disease or differential response to
drugs. We\'re very involved with a number of public efforts, such as
HapMap effort and others.

My goal is to participate as part of this group to hopefully define an
appropriate vision of the future that can guide public policy and that
includes looking at where technology is going and how to leverage that
and information systems while considering the bio‑ethical and privacy
issues, so that we have a good vision that can guide us to where we need
to go because it is obviously a very complex situation.

[**\>\>** **Steve Matteson**:\
]{.underline}Hi, my name is Steve Matteson. I\'m more of a technologist.
I spent the past 20 years working both in public health and in the
pharmaceutical industry developing applications that enable the
scientific community. I can kind of second Janet's comments about the
benefits and the needs for standardization. I would love, I\'m so happy
to be part of this, to look at coming up with standardizations relating
to medical, electronic medical records and genetic information that can
also benefit not only the discovery of new drugs but also how we treat
disease. So I\'m very proud to be part of this group. Thank you.

[**\>\>** **Kathy Hudson**:\
]{.underline}My name is Kathy Hudson. I\'m the director of the Genetics
and Public Policy Center at Johns Hopkins University. I\'m interested in
how this Workgroup can help enable quality genetics research and quality
genetic medicine. I\'m involved right now in a project looking at how
the public would view large population studies on genes and environment,
and so we\'ve been talking to America and racking up frequent flyer
miles as we travel around the country.\
\
I share two of Secretary Leavitt\'s policy priorities, first to enact an
anti‑discrimination legislation, an area I\'ve worked in for many years,
and secondly to make a coherent framework for the oversight of genetic
tests. I think that has direct relevance to the work of this group,
because if we don\'t have quality test information going into the
record, we can\'t possibly expect to have quality healthcare coming out
the other end.

I\'m interested to hear more about Mark\'s re‑shifting of all of our
intentions here. I guess my aspiration for the day is that we come out
with, I feel like I lack in this Workgroup a clear understanding of the
specific work products and the timetable for those. And so I would like
a clearer focus on our specific tasks and timetables as we come out of
this visioning process.

[**\>\>** **Sheila Walcoff**:]{.underline}\
I\'m Sheila Walcoff. As I noted earlier, I\'m counselor to Secretary
Leavitt for science and public health policy. My background is in law
and policy and in addition to representing the Secretary here I also
share your passion for advancing genomic science and health IT in an
appropriately balanced way. Thank you.

[**\>\>** **Becky Fisher**:\
]{.underline}And I\'m Becky Fisher. I am a medical librarian by
training. I currently work for the CIA in the Center for the Study of
Intelligence. That\'s why there is nothing after my name. I\'m also a
wife and a mother of three. My oldest daughter graduated last year from
Duke and worked for Dr. Guttmacher at NHGRI one summer. So I also know
Allan. I\'ve been working for several years in the area of genetic
discrimination, privacy, as a patient advocate. My family is afflicted
with the genetic mutation BRCA1, and it has really taken its toll on us.
So as a patient participating in this group, I am interested in genetic
information privacy and also in issues of informed, fully informed,
consent.

As a librarian who has worked as a practitioner of evidence-based
medicine, I\'m interested in getting genetic information into the
medical curriculum, and also in translational issues. And I know that\'s
a big ticket, but it would be wonderful if we could educate patients to
know at least as much, maybe even more than what their family doctor
knows about their predisposition to disease. And I think that\'s where a
lot of us are right now, and it\'s a very strange place to be. So I
guess I\'m here as a listener more than anything, and when I feel you
bump up against me too roughly, I will let you know. But I\'m limited in
my medical expertise and technical expertise, but I am a patient.
That\'s why I\'m here. Thank you.

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

Thank you. I think there are a number of Workgroup members on the phone.
I will test you out here to see if you are there. And I have no way of
knowing whether you can hear us, but maybe you can signal us. Is Carolyn
Clancy on the phone?

[**\>\> Carolyn Clancy**:\
]{.underline}I am indeed.

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

Good morning.

[**\>\>** **Carolyn Clancy**:\
]{.underline}Good morning. So I\'m Carolyn Clancy, and I\'m a director
of the Agency for Healthcare Research and Quality. And perhaps my
interesting singular distinction is I\'m actually part of and chairing
one, I\'m part of three AHIC Workgroups and chairing one of them. So I
guess I could be an in‑house expert on how these Workgroups work, in
addition to folks who are on. The nice thing about going near the end is
you can kind of say what they said. As Steve Teutsch very nicely
articulated, our focus is really on the translation of this work into
practice. So I liked Allan Guttmacher\'s vision for what we could
accomplish through our work. And I would only add to that a little
emphasis on realistic timeframes. I think if you will recall, the first
presentation to the full AHIC meeting, there was a lot of excitement
when Doug Henley first spoke about clinical utility.

We have also had the privilege of working very closely with Greg and
Sheila and Kristin Brenner on the Secretary\'s initiative in
personalized healthcare and will, budget processes willing, and so
forth, be working very hard on new initiative, what we are calling a
network of networks, in shorthand, to try to work very closely in a
public/private partnership with existing healthcare systems that have
made big investments in health information technology and electronic
health records already so that we can begin to figure out a platform for
doing some of the research on genomics and other breakthroughs in
personalized healthcare and also evaluating the impact. So this is not
just about learning more stuff, but also it is about making sure that
that\'s linked with the delivery side of these healthcare systems so
that that information gets translated into practice. I know Jean Slutsky
is on the phone. Jean, do you want to add anything to that?

[**\>\>** **Jean Slutsky**:\
]{.underline}No, I think you said it very well, Carolyn. Thank you.

[**\>\>** **Carolyn Clancy**:\
]{.underline}Okay.

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

To the extent that, Carolyn, that you can inform us about the utility of
the other Workgroup activities as they relate to this, particularly on
the Quality group, that would be very helpful.

Andrea Ferriera‑Gonzalez.

[**\>\>** **Andrea Ferriera-Gonzalez**:\
]{.underline}Yes, good morning. My name is Andrea Ferriera‑Gonzalez. I
am a professor of pathology of Virginia Commonwealth University, in
addition to director of the molecular diagnosis laboratory. I\'ve been
involved in genetic testing for the last 15 years. And during these last
15 years seeing an increased change in the acceptance of these testing
by healthcare providers and the public, and actually seeing a huge
amount of new technology being incorporated into everyday testing. That
includes laboratory information system and how we actually cope with the
amount of information we produce, and then how we translate that
information to our healthcare providers to actually make use of that
information. I\'m also a member of the Secretary's Advisory Committee on
Genetics, Health, and Society. So my interests are looking at quality
and oversight of genetic testing. In addition, one of the goals I have
for working on this committee is to see how we are going to help
standardize some of the vocabulary we need to develop to really transfer
the information that we generate in the laboratory to the medical
records. And as we move that information, we also have to be very
careful that we incorporate some of the information necessary for
appropriate interpretation of technology and the information that we
provide. In addition I think it is very important, the security of the
data that we actually produce to make sure it is not misused and then
fully informed consent of the information that we are going to gather
and how we are going to transmit that.

[**\>\>** **Carolyn Clancy**:\
]{.underline}This is Carolyn. We are getting a terrible echo here on the
phone. I don\'t know what that\'s about, but if there is any way to fix
it, it would be great.

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

Yes, Carolyn. Thank you. I think that at least one of the participants
is on a cell phone, and we may need to have someone phone back in. We
can't tell from here where the interference is from.

Marc Williams.

[**\>\>** **Marc Williams**:\
]{.underline}Marc Williams. I\'m the director of the Clinical Genetics
Institute at Intermountain Healthcare. Our job within Intermountain, a
large integrated healthcare delivery system, is to take this knowledge
related to family history, genetics, and genomics, and translate that
into improved care for patients. We have a lot of experience here in
quality improvement and informatics, and so we have been exploring how
we can utilize those tools around these areas.

My particular interest right now relates to family history, given that
there is an enormous amount of family history information that is
already in our medical records but is being virtually unutilized because
it is in a free text format that really cannot be manipulated at all. So
we are looking at ways to not only enter currently described family
history, that is, no identification, just identification of relatedness
in a coded way so that we can perform risk stratification and ultimately
develop clinical decision support messages to providers to personalize
care. And then ultimately, as more comes down the road in terms of
genetics and genomics, to overlay that information into the context of
the family history and hopefully be even smarter. So my interest today
is to really kind of get a sense from all the participants about where
they think things are going, from a broad perspective. I\'ve been very
interested in use cases around family history and how we could
incorporate that in different scenarios and have actually been charged
to work on developing use case for this Personalized Healthcare group.
I\'m also a member of the Secretary\'s Advisory Committee on Genetics,
Health and Society.

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

Thank you. Are there any other members of the working group that are on
the phone that we have not identified? If not, I think that completes
our introductions this morning. I would like to suggest that we talk a
little bit about ‑‑ I don\'t know if you can pull this up ‑‑ the broad
and specific charges that were in draft form we have been working on
from prior discussions, just to reorient ourselves. And I think I will
try to address the timeline issues that Kathy brought up a few minutes
ago. Can we pull that slide up? Thank you.

I\'m going to focus on the specific charge. Again, these are draft and
have been discussed previously and not modified to accommodate some of
the things we have talked about in the past, but this is sort of the
starting point at which we agreed to when the working group was formed.
And the specific charge was, again this is all about developing a
framework in which recommendations are made to AHIC. And the specific
charge was to make recommendations to them to consider means to
establish standards for reporting and incorporation of common medical
genetic testing data. We have been putting into brackets here, and
family history, medical history information, into electronic health
records and provide incentives for the adoption across the country,
including federal government agencies.

And this really follows in the pathway of what the AHIC has been working
on in the past and a framework in which, when ready, as we have been
discussing previously, the mechanisms by which the committee\'s work can
be engaged into broader capabilities of adoption of specific
information. And many of you have contributed to an environmental scan,
if you will, of the readiness of various aspects of genetic tests and
what other standards development organizations are currently doing on
the framework for establishing the capability to exchange information
electronically in these efforts. And we will hear this afternoon about
more of those technical capabilities and the readiness aspects. And in
our discussions with ONC, and I think we would like some guidance around
this today, we have already sort of been through the HITSP process in
terms of what\'s necessary for that and making developing
recommendations to AHIC as our, sort of our next goal, if you will.

And in the context of the broader charge, this relates I think to this
activity today. I would like the chairs to weigh in on how we structure
this meeting to be in a meaningful tool. There is a vision document
ultimately setting the expectations for this meeting, how we utilize
this information going forward.

Our broad charge is making recommendations to AHIC and to, for s process
to foster broad community based approach to establish a common pathway
based on common data standards that encourages the incorporation of
interoperable, clinically useful, genetic laboratory test data and
analytical tools into the electronic health records to support clinical
decision support for making the healthcare provider and patient.

So I think that, you know, we would, I think we should spent a few
minutes talking a little bit about this to make sure we are on the same
page and then using this as a framework for the visioning process. But
let me digress here for a moment, to the chairs to see if you need to
focus on that aspect of it first or if you are comfortable working in
this framework of these charges as we have defined them.

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

Pretty well ‑‑ \[inaudible\]. Second, it\'s a little fuzzy to me still
\[inaudible\] take what we will comment on it, and \[inaudible\]
privacy ‑‑ range of considerations go on in that regard. Fourth is the
adoption ‑‑ \[inaudible\] four areas that went on \[inaudible\] ‑‑ the
visioning exercise per se, it seems to me there is two things, one is
there is a group gets together to talk about, get the ideas out on the
table, reasonably consistent understanding what the future might look
like, what ‑‑ \[inaudible\] so lack of a better word, the ‑‑
\[inaudible\].

The second is, that it does give a framework of if we believe that the
future ought to behave this way, whether it is five years out or 10
years out, that really ought to guide our use cases, ought to frame how
we think about privacy, ought to frame how we think about vision
support.

So in a way it provides the framework and the roadmap at a level about,
from there, some altitude one drops down, however far we have to drop
down to form the true work product in these fours areas. But this
conversation, as we get through the preliminaries, is to really get
people\'s ideas out on the table and start traversing this territory and
getting as much consensus as we possibly can about what the world ought
to look like.

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

I'll concur with John\'s comments there, as it relates to the specific
charge, I think our capturing reference to family history in addition to
genomic test data has been an important addendum that we have added to
the specific charge.

As it relates to the broad charge, again, all open for continuing
discussion, particularly as we get into the visioning process. In
previous phone calls, you may recall that we have discussed perhaps two
bookends of the broad charge. One is the privacy and security issues
John just mentioned. And the thought prospect being that there is
another Workgroup of AHIC that\'s working on privacy and security in
particular. But to the extent that we have comments to make to that
Workgroup, let\'s have that conversation, and perhaps there are simply
recommendations to the other Workgroup rather than something that has to
be incorporated into our broad charge.

And on the other end, at which both Kathy spoke to and Sheila mentioned
in her remarks, is the whole large issue of how do you validate that the
test, instrument, or process or whatever, is a good one so that you
actually get a good result. And the Secretary obviously is paying
attention to that in terms of how that might occur, whether it be
through FDA or whatever. But again, at least here to date we have not
seen that as part of our charge but rather a process that does need to
be in place to assure that the test data is in fact accurate and
therefore dependable.

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

Thank you. I think first I want to comment on some of the documents that
we have provided to you. We are obligated to put this in a framework,
the information that we are sharing with you in a format that can be
shared with the public and, therefore, the presentation formats of this
are a little bit awkward. As a matrix we felt that it was a reasonable
place to start. And we are not going to go through these in a formal
way, but it was hopefully a way for us to describe, sort of in a current
state, the landscape of what sort of infrastructure, what\'s happening
across the country in terms of setting the stage for the future. And we
have been sort of describing infrastructure from the capabilities of
research programs, policy setting bodies and activities. There\'s this
whole emergence of issues relative to risk and benefit balances, whether
you are the patient or the consumer, and the healthcare systems overall.
The commercial development of the platforms, which I would like to
comment on in a little bit more detail. What\'s the timing of getting
all the systems developed and operating in a way in which the hand‑offs
are not going to be fumbled? And we have sort of been working on some of
this, as we have seen it, but we don\'t know whether that resonates with
how the communities here are engaged. And this touches on everything
from public health practices to, you know, treatment decisions, to early
detection capabilities. And centered in the middle of this is how we can
think about the use of electronic means in which to share information
and ways in which we need to think about protecting it in certain
scenarios.

We have been dealing internally with a lot of ways in which to
communicate these complex issues. And we have used many case summaries
or scenarios in which healthcare decisions are made, whether it is in
the selection through pharmacogenomic approaches, utilizing genomic
tests to select for the more effective therapies in some cases or to
avoid those that may cause adverse events and related to potential
side‑effects that we can predict in some ways related to genetic
predispositions.

We understand and note this notion that, Albert reminded us about the
dangers and hazards of genetic exceptionalism. We put that on one side
of the ledger. And then we also look at some of the complex issues for
which we don\'t have sufficient protections in some capacities about how
that information can be used, not only to facilitate use in healthcare
decision making but perhaps limiting or restricting access in some cases
to those who may benefit from this most. So those are both public health
domains, public health issues as well as individual treatment issues.
And then we have seen this whole spectrum of, emerge in which the
consumer themselves are the focal point of these messages. And given the
issues of health literacy in this country, how do we make messaging of
the utility of genetic tests and the electronic health records and
family medical history, approach all these populations in a way that is
going to be of great utility to the most people. And these are very tall
tasks in which we, you know, have our obligations to try to accomplish
over time.

The focus that I think we have looked at in the current state has been
set up in ways which we would like to use as a framework for our
discussion today. And that is in the consumer-based approach, the
healthcare provider approach and then other, what we have referred to as
other stakeholders: research development, R and D, population health
applications, clinical laboratories. We can, I\'m going to rely upon you
to bring each of these perspectives up as we are going through some of
these issues. We can use this framework as a guide for our discussions
today and talk about some of the specific things that are in place today
in terms of evaluation of technologies, the research databases that are
emerging that will have a lot of genomic data on well‑characterized
populations coming into the fore in the next couple of years. So how do
we set the stage for the integration of these capabilities and apply
them towards a clinical setting?

As an end state we sort of picked, from an AHIC perspective, the
President\'s plan for health IT was an integration component over the
next 10 years from the timeframe in which he focused on this, would be
targeted as 2014. We think in terms of the concepts of being able to
integrate large amounts of data in a predictive way, to enable complex
analyses to be developed, that to accomplish that in the next six or
eight years would be a mighty, mighty challenge. So we have not put any
specific dates, and you will notice a question mark of 10‑years out,
kind of perspective in time is very loosely framed. What we are trying
to do is envision a world in which there are ‑‑ we are going to try to
make some assumptions about that today. And given those assumptions,
recognizing that they\'re not in place at this moment, I think will help
facilitate a lot of dialog about the things that inhibit us from doing
them at this moment.

And so some of those capabilities are really the technological pace at
which genomic information is going to be developed. And one assumption I
would like to put on the table is that we do see the capabilities of
doing large scale human genome sequencing in the next several years at
the order of 1,000 dollars. That\'s been one of the targets from an R
and D perspective, and we are going to make an assumption today, we
think, that that will be achievable in the next few years to 10 years,
that the capability of doing, generating large amounts of data at an
individual level will be technically feasible. There are a number of
challenge projects that are evolving out there now, and we think that
that\'s a reasonable safe thing to do.

From a perspective of human subjects and oversight and protections, I
think it is worthwhile at least imagining ‑‑ we can discuss a lot of the
specifics of this today since it is a very important issue \-- that some
form of protection about limiting the ways in which genomic information
can discriminate access to care and the provisions of care should be in
place in this timeframe. So that in the end state that should not be
something that we have to continue to wrestle with, but that doesn\'t
undermine the importance of putting those protections in place today.

Other assumptions we can make is that the capabilities of linking and
associating data from large numbers of data sets from disparate sources,
whether they are from the healthcare setting or others, that those
capabilities also exist and that a framework will need to be developed
to develop an analytical system in which the consumer and provider
interfaces can be developed to provide information that is, perhaps not
real‑time, but in a framework in which a patient is presenting with a
new issue or is, in terms of the routine health maintenance programs,
are being offered provisions and options of care that are really
developed around the personalized approach based on either their history
or the genetic information, and that that has some reference points to
evidentiary data that we have from a lot of different sources.

So we have talked a lot about the clinical decision support needs along
this way. And our discussions along the last several months, in looking
at how some of the other working groups have used these visioning
sessions to start setting the stage, we have identified some potential
areas in which we can see some barriers, that existing infrastructure
and capacities for analyzing information or integrating it from a lot of
different sources don\'t yet exist. What are some key ingredients for
that, and what are some key concerns that we may have about how we
develop the use rights to access different data sets and what becomes of
that information from secondary applications, for example. So these are
some of the examples of ways in which I think we can use this session
today to sort of articulate, if you will, a vision and some of the
obstacles that will come up in shaping that as we go forward.

We anticipate that there will be continued, as Dr. Clancy mentioned,
continued efforts at trying to develop evidence along this pathway. At
the same time, we don\'t want to stifle innovation in terms of the
capabilities of addressing new science and new capabilities and new
medical practices that come along. And for example, we don\'t have in
this country an analogous pathway to clinical trials of evaluating new
therapeutic approaches for diagnostic tests and other kinds of
preventive methods. The whole reimbursement models that exist today may
not be suitable in the future for considering preventative capabilities
for looking at a future state in which we can avoid later occurrences of
disease and pre‑empt them, how do we integrate the capabilities of
testing with therapeutic management.

So there is a broad landscape of issues out there. I think what we are
going to try to do is touch on those important ones and then develop
areas in which we think this community can start making recommendations
or advice to AHIC and then ultimately some specific recommendations that
we think in the early days can set the stage for the future.

I think back to when the Secretary sort of described the journey that he
asked us to embark on, it was along the lines of define for me the
destination and the characteristics of that, and then set out on a path
in which you can start describing some of the things that you are going
to encounter, and then how as a community we develop ways in which we
can apply what we have today, and then start identifying the things we
need for tomorrow to bring along. So that may be an infrastructure to
develop clinical validity for a large number of genomic tests ongoing,
the adoption of technologies and the ways in which these are integrated
into the healthcare system, recognizing we don\'t have a way to develop
the full evidence necessary at this point, how do we go about gathering
that information and recognizing that it is probably not the
responsibility of just one organization or one body, but through
public/private partnerships, for example, and other frameworks in which
a new regulatory considerations come to the bare, are borne out. And
these are, and the reality is, that a number of communities are working
on these at this point in time. But whether the full vision of that has
been captured yet, we are uncertain.

So the enablement of information to support our improvement and quality
of health is our ultimate goal, we believe. What we are talking about
today is trying to find a way in which we can capture that vision in a
structure that enables us to go through certain issues and then
identifying areas where recommendations to AHIC can be useful to many
communities beyond just this one, and hopefully ways in which we can
capture the efforts that your groups are participating in already. So
I\'m going to stop there and turn this back over to Mike and the chairs.
But that\'s kind of the snapshot of where I think we are today, and
before going on, see if there are any questions about how we want to
embrace each other today or not.

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

I just have a ‑‑ go ahead ‑‑ question about the charge. The group seems
to be making a distinction between genetic information and genomic
information, or genomic test data versus genetic test data. I want to
know if that\'s purposeful or ‑‑

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

I\'m not sure I understand the distinction. What are you ‑‑

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

Well, but you do say that. So I want to make sure. Is there a
distinction between genomic test data and genetic test data, and a
genetic test versus a genomic test?

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

No, it is not intended to be a distinction. We are using the
definition ‑‑

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

And there is consensus about that here?

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

It is a definition we have been using, the National Human Genomes
definitions of genomics is the reference point. But we can debate that.

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

It doesn\'t have to be a big debate. I just want to know if genetics
\[inaudible\] ‑‑

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

The ‑‑

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

‑‑ are genetic tests excluded from this or ‑‑

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

My sense is we are, from a lay (inaudible). Fundamentally genetics is
movement of genes through time. And population genomics is what do you
have, what do I have and part of that is family history, et cetera. I
think we are treating this question, if you have DNA and I do and we
test that, what then happens and what are all the issues that come
through that. Now, there is another concentric circle like family
history surrounding that and the protein expression, I think ‑‑

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

Genetic test ‑‑ \[inaudible\].

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

We will have to tighten up the vocabulary at some point, but (inaudible)
there are others equivalent.

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

I\'m going to turn this over to Mike to facilitate, at this point, so I
would like to be able ‑‑

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

We need to clear the questions and make sure we are on the same page and
then we will get started.

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

As far as some of the other things that were said here that were broader
population health perspective. Most of what\'s on there is clinical, it
looked like. Yet I\'ve heard you, Greg, and others talk much more
broadly about population health-oriented issues. Is there or is there
not a disconnect between the charge and that, or are we talking about
population health within the charge, or is that out of scope?

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

Well, I think that, I don\'t think it is out of scope. I think that ‑‑ I
don\'t quite see how, this has come up from a couple others. At least
with the specific charge, you know, it is intended to really apply to a
broad array of population health areas as well. I cannot ‑‑ from the
specific charge I\'m not sure how I see how that limits this to
treatment scenarios, for example.

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

I think by setting the frames how we are going to operationalize this, I
think it will answer your question. Ask it again. Let\'s do that right
now.

Here is our approach. The first thing that you will do as a ‑‑ oh, I\'m
sorry.

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

Thank you. I just had one concern about the charge. And it\'s only a
word, but it is an important word. In the broad charge it says that, to
make recommendations that, in the, at the end of the fourth line,
encourages incorporation of interoperable, blah, blah, blah. And also in
the fifth line of the specific charge, provide incentives for adoption.

And I would, I don\'t know whether it is within our scope to change
words. But the word \"encourage\" is rather directive. And I think in
the world of genetic counseling we wouldn\'t want to be in the position
of encouraging people against their wishes to record genetic information
in their health records.

So I would suggest that we just, either mentally or in writing, change
the word \"encourages\" to \"facilitates\". Because we want to make that
information readily available in standardized format, et cetera, for
those people who want it. But I don\'t think we want to be seen as sort
of pushing people into that. So I would like us to agree on the idea
that we are going to facilitate this, both in the broad charge and in
the specific charge where it says provide incentives for adoption, and
just put \"facilitate adoption\". So that would be my suggestion.

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

\[Inaudible\] ‑‑ my general sense, and I\'m not as bright as the rest of
you guys. There really are two questions. One that has massive
ramifications and one that has discrimination concerns and things like
that. If someone is predisposed to something, you have to be really,
really careful about that. The other is, we do some of these today,
genetic tests to set a dose, or determine why there is hearing loss. In
some ways no different than any other phenotypic finding, so I think
facilitation ‑‑ you might not want to ‑‑ clearly we don't want to
encourage the former. Very, very careful where you want to facilitate
the latter to a degree. So I think it is a fair word change, assuming
the rest of the folks are comfortable with that.

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

Would enables have the same kind of context? That was another suggestion
we had, too, but ‑‑ okay.

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

Steven?

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

Only comment to that is that, what is our future expectations for this
information? If the future goal is that within five or ten years that
individual, personalized information about their medical condition or
health is something that we can look across, you know, a wide
population, do we want to not encourage that, you know, is our
expectations that the future that we will have some level of
standardization. I understand a lot of people\'s concerns regarding
privacy and confidentiality. But if we don\'t achieve that level of
standardization, will we be able to leverage the benefits that you're
looking for, I think, as physicians?

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

I think it's fair, Steve, and I don\'t mean to harm the conversation
here, but I think we are going to get into these scenarios, talk a
little more thoughtfully about what we'd like to see happen, and both
the good side of that and also the spectre that it raises or challenge.
The other thing is that a spectre out there, is that a test that has
sort of clinical, immediate clinical guidance today may turn out five
years out to have actually some other baggage that it brings with it. So
the stuff that is, it can move over time. And so we will have to sort of
think about, or think our way through something that is ‑‑ under the
second case, but all of a sudden becomes quite clear smack dab in the
middle of the first case there. I hear what you are saying and ‑‑ sure.

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

Mark, just a point of clarification. I think whether we use the word
facilitates or enables in the broad charge is a good point you make.
Relative to the specific charge, you know, the provision of incentives
in that second half of the specific charge really refers to the
standards that we are trying to create that enable EHRs to do thus and
such. So it does not relate to the information itself but rather to the
standards that will be imbedded in the ‑‑

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

Could we put, facilitate, provide incentives for adoption of standards
or something like that?

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

Of these standards. We can refer back to the earlier part of the
paragraph.

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

Yes. That would satisfy it. Just you could read it the other way.

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

Right. Right.

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

Okay. Thank you.

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

All right. Let\'s operationalize this. Step one will be for us to
brainstorm into an ideal future state of the personal health record. And
we will break that down by brainstorming three different ways. We will
try to see it through the eyes of the consumer first, then we will try
to see it through the eyes of healthcare providers, and then other
communities of interest. And these will be everything from research to
clinical laboratories to community health to ‑‑ everything that is not
related to an individual patient that attaches to the personal health
record.

We thought initially, as we planned this out, we would then brainstorm
what we have today. But actually that is going to be pretty much
inferred by what we think an ideal future will be, and we don\'t have
that yet. So we will skip that as a perhaps unnecessary step. And then
after lunch what we will be talking about mostly is the intermediate
states and the things that we would need to do to get to the idealized
state. The way we would approach data, the way we would approach data
mining, the way we would handle personal health record, all of the
things that would carry us towards the goal of the ideal state that we
would like.

Now, it clearly ‑‑ something that would be an ideal state would be maybe
ideal for every community. I think it is still worthwhile thinking about
those aspects that most particularly pertain to consumers and then the
providers, and then to others is still worthwhile. This makes sense?
Everybody okay with this?

All right. We are going to do an experiment then. We are going to have
what\'s called a working break. We are going to take 10 minutes. And
when ‑‑ and during this break please sit down, and without ‑‑ and give
me five things that you think would be characteristics of an ideal state
for a personal health record for consumers in the future.

And then we will have a structured brainstorming. We will go around and
give everyone a chance to make comments. Put their comments up. And then
we will go to some unstructured brainstorming around consumer. And then
we will shift immediately to provider, do exactly the same thing. All
right? So help yourself, but five items of an ideal future state.

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

About personalized healthcare specifically or about electronic health
records in general.

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

This is personalized healthcare.

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

Okay.

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

Personalized health record.

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

Talking about personalized PHR or personalized EHR?

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

Greg, could you give us that clarification?

[**\>\>** **Greg Downing**:\
]{.underline}We are ‑‑ okay. And I would allow, I think we can allow you
to provide recommendations for both. We are looking at more of an
umbrella personalized healthcare. What\'s that interaction going to be
like? And without ‑‑ your recommendations can be specific to either of
those, but I think the context we are looking at is more a broader
umbrella of information management and the interface with healthcare and
care delivery.

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

Public health, is it under community? Is that what ‑‑ public health, is
under community. The public health professionals under community.

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

Yes.

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

Okay.

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

We may need to take a third call and break it into other pieces
but we\'ll ‑‑

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

Yes, we expect that that\'s, that\'s been our experience on some of the
calls leading up to this. But the third column probably relates to
subsets. And we are happy to do that.

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

All right. This is Marc Williams on the phone. How do you want us that
are virtually participating to send you our five?

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

We will go around the table, and you will be part of the table. We will
simply call on you.

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

Okay.

\[break\]

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

All right. Everybody is back. We can still be writing down, but we can
also go ahead and get started and start moving around the room. Let\'s
start where we started. Felix.

[**\>\>** **Felix Frueh**:\
]{.underline}Okay. Would you like to jot down a whole bunch of key
words?

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

You get one.

[**\>\>** **Felix Frueh**:\
]{.underline}One?

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

You get one, and we go around. And then obviously if somebody else steps
on one of yours, you scratch it off. And we will go until we start to
wind down.

[**\>\>** **Felix Frueh**:\
]{.underline}Okay. I think the key point to me is access everywhere. So
wherever you go, you want to be able to access it.

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

Ubiquitous access.

[**\>\>** **Felix Frueh**:\
]{.underline}Yes. Access in real‑time.

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

Great.

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

I ‑‑ in the ideal future, I think we would have consumers who understood
both the difficulty of keeping and the potential danger of certain types
of family secrets. Like whether children are adopted or not, you know,
indeterminate paternity, et cetera. It seems to me that this always
comes up in any kind of testing.

And I think in some ways people have to understand that if the real
family history is not known by the people who are trying to act upon it,
that ‑‑ and obviously this can have all kinds of potential negative
ramifications in the family. But it seems like everybody should know
that it\'s hard enough to keep these secrets. They come out anyway. But
they don\'t have to come out as much as they can come out in the
scenario. And I think people don\'t actually understand that they may
not be helping a child, for example, in some very serious way by, in
essence, hiding from that child certain facts about their family
history.

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

Yes. In a nutshell, balance clinical usefulness with privacy? Is that ‑‑
how would you capsulize this?

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

I don\'t really think it is a balance. I think in this environment
people have to understand what are some of the potential risks ‑‑

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

Okay.

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

‑‑ of essentially suppressing information that they may have very strong
reasons to suppress otherwise.

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

All right. Very good. Thanks. Beryl?

[**\>\>** **Beryl Crossley**:]{.underline}\
Okay. I think the consumers would like to have access to established and
validated algorithms for personalized therapeutic management. For
example, in cardiovascular risk or thromboembolic risk, to make the
consumer aware that they are part of the diagnostic and therapeutic
process, and to allow that partnership between the consumer and the
provider.

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

So decision support algorithms for consumers?

[**\>\>** **Beryl Crossley**:\
]{.underline}Yes. And validated by an appropriate authority.

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

Validated.

[**\>\>** **Beryl Crossley**:]{.underline}\
Right.

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

Got it.

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

The same ones that are available to the clinicians.

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

Yes.

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

Or close. Amy?

[**\>\>** **Amy McGuire**:\
]{.underline}I guess I have a lofty goal or ideal, which would be ‑‑ and
it might require some culture change ‑‑ but a high level of trust among
the population. And that might require, I think it requires several
things. One would be strong security measures in place. Another would be
sort of what I was talking about before, regulation and standards. And
then also, I guess the lofty part of it would be professional integrity
and, I guess, an emphasis on those ‑‑

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

Okay. That\'s good. And when we come to, when we come to the next step,
building our ramp to get there, then we will get more specific about
what supports it.

Mark, are you going to throw the big one here now?

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

I will play by the rules. One at a time. But to play by the rules I will
preface what I was going to say anyhow by saying, in the future, should
genetic information be stored separately or treated differently, and
does genetic exceptionalism increase stigma.

I cannot say what the ideal will be because it is based on assumptions.
It depends on the assumption. So it is more of a question than a
statement of the ideal. And the question is, should genetic information,
broadly defined, be treated separately and isolated in medical records
and have a different legal status than other kinds of health
information?

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

Okay. Steve.

[**\>\> Steve:**\
]{.underline}And it was about access to meaningful information,
interpretal information about risks, for instance, about environmental
or other kind of exposures and preventative strategies that would be
individualized so that they can avoid disease and help outcomes.

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

I think I got that. Could you say it again?

[**\>\> Steve:**\
]{.underline}Well, to access meaningful information, not just data.

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

Right.

[**\>\> Steve:**\
]{.underline}But meaningful information that will allow them to assess
their risks regarding various exposures to the environment, socially,
and develop preventive, develop appropriate preventive strategies.

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

Actionable information for decision-making, and that is not only genetic
but environmental.

[**\>\> Steve:**\
]{.underline}Incorporate that.

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

Yes, incorporating genetic and environmental information. Allan.

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

Control over who has access including having access one\'s self. I can
get two in for the price of one.

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

That if my doctor were to tell me I might have a disease or I\'m going
to be treated, that I would know which genetic test, if any, should be
run and what they would tell me. So I would just like to know what those
are.

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

Okay. So how would you say that in a nutshell?

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

\[Inaudible\].

\[laughter\]

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

Well, I mean, just so we don\'t ‑‑

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

If you go to WebMD and put in a disease, what tests should they be
running, some of which will be genetic, some of which will not. But if
they\'re genetic tests, what is it looking for, what are some of the
answers and ‑‑ genetic part of informing a patient about treatments and
treatment options and diseases and what they ‑‑

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

Full disclosure on genetic tests.

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

Of all of the above.

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

Okay.

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

So this test has got variable quality, this test is rock solid.

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

Got it.

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

So it is the genetic equivalent of consumer health information.

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

All right.

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

Well, again, looking from the consumer perspective, that my personal
health record will be truly interoperable with the electronic health
record in whatever part of the system I need to connect to.

To have it continue conversations with my personal physician or others
about, this is my family history. What does that mean? What genetic
testing does that perhaps indicate I should be thinking about and have
access to? And what are the risks of that? And once the testing is done,
what does it mean? And what are the next actionable steps that I, as the
consumer, in concert with my physician need to take to get the, go to
the next step.

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

Okay. So full interoperability with the electronic health record, plus I
think that\'s back to algorithms for decision support.

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

Right.

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

The term access is really interesting. And it can mean different things
to different people. But one of the things that I put in here, not only
does everyone have access but everyone can afford to act on the
information. So I don\'t know if access is broad enough to include that
there is healthcare \-- there is actionable ‑‑ I mean, the information
is actionable. People need to be able to afford to get what they need,
whether it is genetic counseling or a new test or treatment. So for me
it came down to not only access to the information but being able to
afford to act on it.

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

Okay. Access and being able to afford to act. Good. Michele.

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

And I would want to make sure that the programs operate under what\'s
been termed community-based participatory research principles.

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

Okay.

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

Does everybody know what that is?

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

No.

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

That the consumer, the patient, the family, the individual is an equal
partner in these endeavors, is part of the decision-making process. I
think it encompasses a lot of the principles that you are talking about,
but they get to decide how they are going to participate, the limits or
parameters of their participation. And they're consulted along the way.

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

That\'s, for the scribe\'s ‑‑

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

It is known as ‑‑ there is a whole thing, body of knowledge called
community‑based participatory research. That is ‑‑

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

Okay. Community‑based participatory research.

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

Along the same lines, I think, of health literacy, and as we put
together products for the consumer so they can act upon them and make
changes, you need to go into the research realm to make sure that what
you are providing to them is material they need, they understand, and
will act on and change behaviors. So ‑‑

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

So promote health literacy?

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

It is also making sure that it is an intrinsic part of every component,
that education, health literacy component I ‑‑

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

Okay. All right.

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

Going on WebMD is great for a certain segment of the population. But
that\'s a small segment that would look at, you know, I went to my
physician\'s office. They told me I need this genetic test. There
is really a lower level that needs to be looked at.

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

Yes. This business of algorithms and clinical decision support, health
literacy, promotion, I think, is already coming out as a very dominant
theme in this. Deven.

[**\>\>** **Deven McGraw**:\
]{.underline}I actually wrote down three things in somewhat simplistic
terminology. I think they\'ve been touched on in various ways by some of
the things that folks brought up but I\'m just going to read them out
anyway. So you don\'t have to write them down, Kristin, if you think
they've already been covered. From a clinical individual patient
perspective, I think personalized, sort of a consumer ideal,
personalized healthcare information that is clinically relevant for my
care. And this touches on some issues that Kathy, I think, has raised
about the quality of the information going in. It is available to my
healthcare providers in real‑time. That touches on the EHR perspective.
This information is also available to me in a format and in language
that I can understand so that I have the tools to better manage the care
for myself and for my family. And the third thing, the information is
protected against inappropriate use or disclosure. And this means that
it is not accessible, even within a healthcare institution, to
providers, even, for whom it is not clinically relevant, and then of
course for folks who are not treating me in a clinical capacity. And
then even out ‑‑ and then of course we are talking about outside the
doors of the institution.

And then from a population standpoint, that the information is available
in a de-identified format for purposes of, you know, for advancing
public health and improving the quality of care.

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

Be sure to get that last one. De-identified information for population
use. And ‑‑

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

And I guess I want to add, I like the terminology about consumer
role‑based control the information, so they can decide who has access
and how they have access. And, you know, coupled with that, I guess, is
this concept of the data format being interoperable to move among
different entities because you may have a situation in the future where,
for example, the government may provide for those who need it, through
CMS, other mechanisms, support for a basic minimum personalized health
record. But beyond that you may have commercial entities that then you
could also, because the data is portable and in the same format, be able
to translate to them to provide the more, as they may view it, enhanced
decision support systems to help the individual. But it all starts with
of course the individual having control to say who do they want to have
access to or not of the record.

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

Okay. And I think the key there is that the individual could have
multiple levels of control. Is that ‑‑

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

Correct. Correct. So for example, they could make it available for
research purposes on an anonymous basis. If I chose to allow someone, to
get a second opinion, to get the data, even though they may not be
directly involved with my healthcare, I have the right to do that. If I
choose, on a bioethics basis, to say I don\'t want to have anything to
do with this, then that should be my prerogative too. It is a freedom of
choice of the individual. But hopefully we provide enough education so
that the basic public would understand that there is extensive value to
actually participate in having this information collected so better
decisions can be made about them, and accurate decisions so that even
though there is family secrets, they get the accurate information and
they understand what is their real relationship.

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

Great.

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

I don\'t ‑‑ do you want a, sort of a different kind of informed consent,
shared decision-making process? Is that what, than what we currently
have? Is that what you are saying?

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

I think that we have to, as we evolve forward, have an appropriate
informed consent process that matches a goal that does give the consumer
that degree of control. So let\'s say I\'m going to do a genetic test.
It would be clearly defined as to what they can and cannot in that
informed consent, as it goes into that database. And then the
personalized health record, as I view it, is, I mean, our genomes are
three billion plus bases long. As you may do tests in the near‑term,
maybe they are a few million steps or something. But you can keep
sticking it against that map, if you will, of the genome. Eventually we
will get to the point where you just do all three billion bases. In the
meantime, though, you may have filled in a lot of it. Rather than keep
repeating genetic tests, you have one place to put it. Now if there is
individuals though that decide, I don\'t want that information in there,
that\'s their right. But those that want to put it in there, at least
have a mechanism to do it. Because I personally believe that\'s the
right direction, is to use the data.

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

That gets back to the initial question about the distinction between
genetic and genomic information ‑‑

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

It does.

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

‑‑ and the quality of the information‑‑

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

Right.

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

‑‑ and the potential for incidental information coming out of that that
may not be very high quality or high confidence.

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

Let\'s capture distinguish genetic and genomic. Certainly we are going
to have to come back to that ‑‑

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

Yes. So it\'s an interesting situation ‑‑

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

‑‑ and the quality of data.

**[\>\>\
]{.underline}**‑‑ complexities there in terms of the testing. Because we
all know that in any genetic test, whatever you may have, one of the
thousand of the data points that may be misread, right? But you may read
them multiple times. If you can have in this database with your
personalized health report, not only where you put the data in but
you\'ve also got different reads, right? So if, for example, I did one
scan that just sequenced a gene because I was worried about it, and then
later I did the whole chromosome or the whole genome, I may look at
differences and disparities in that data. And that may tell me that,
hey, here is a point of lack of confidence, whereas if they match for
it, it increases my confidence. And this is all about probabilities and
risk management, which of course is the toughest issue about educating
the populous, is that these are not black and white decisions. They are
gray. And it\'s probability and how do you convince them about the
probability of something happening or not happening and have them
understand that when, you know, how much do basic high school graduates
understand fully about statistics and how that work? So we have a
mission in front of us there too.

**[\>\>\
]{.underline}**Stand in.

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

**[\>\> Steven:\
]{.underline}**Thanks, Paul. I mean, I have the same thoughts around
access and security that everyone else has mentioned. But as someone
thinking about almost the implementation on this, I was kind of leaning
towards technologies of having a common vocabulary that the information
I would capture is machine consumable so it can actually be retrieved in
a way that can make sense in the future.

And I think, getting to your point, Paul, is that, can it be ‑‑ how can
it be centrally managed, whether it is virtual or physical? All of this
information, if it really is going to have the potential of future value
to the scientific and medical communities, how do they, how can they
plod through 300 million population that we have today and make those
types of decisions?

**[\>\> Mike Cowan:\
]{.underline}**All right. Good. Kathy.

**[\>\> Kathy Hudson]{.underline}**:\
I would echo the priority on access and affordability that have been
mentioned by others and would just add to the security and privacy issue
that I think in the future we'll need consistent privacy protections,
irrespective of who holds a piece of medical information. So if it, that
it be sort of grounded in what the information is rather than who has it
and for what purposes they are using it. And so I can be confident that
wherever my medical information is, it has certain safeguards around it.

**[\>\> Mike Cowan:\
]{.underline}**Okay.

**[\>\>\
]{.underline}**I\'ve heard quite a few things that I would concur with.
One word I wanted to mention was organized, in terms of organized data.
And I think that goes to how consumers understand the data that they are
able to access. And also enabling consumers to know not only what is
known but also what is not known. And I think that as we progress in
time, there is always going to be medical information or medical
opportunities that are not known and there are not opportunities to take
action on a perceived health problem, so I think that it is important
for consumers to be aware of that as well, as medicine evolves.

**[\>\>\
]{.underline}**And since I\'m the token consumer.

**[\>\>\
]{.underline}**You ‑‑ \[inaudible\].

**[\>\>\
]{.underline}**I was thinking that as we were going around, which is why
not one of my points going to be new. But I do have four things. First
thing I want to know is what\'s wrong with me. So I want my record to
contain the information on my mutation. And I don\'t want it to just be
haphazard. My family went through years of testing, inconclusive testing
because they were using MRNA instead of genomic DNA. That ended up
becoming a problem for us, so that is in terms of two sisters,
non‑mutation bearing, who hae prophylactic surgeries. So a huge thing.
And that speaks to Kathy\'s issue of quality.

The second thing I want to know is why. Why is it happening to me? What
does the mutation do? I want, like someone down the line, Deven, I
think, said, give me this information in a usable way. Let me know what
it actually means. What ways will it affect me? What ways will it affect
me in the future? Not just now, but also what about my kids, what about
my grandkids? So second word would be implications.

The fourth and ‑‑ the third and fourth things that I have are both under
the category of interventions. What can I do about it? I know right now
surveillance is the most often response. So I would want to be told by
my physician what surveillance options were available to me. But I would
also want to know about actual interventions that exist. So right now
the medical literature about the (inaudible) is just replete with things
that are all disparate. These are pieces of information that are
discrete units of information that, unless you have the skills to pull
them up out of a database of 17 million citations, you are never going
to see them. So my point there would be, you know, have people aware
that these mutations have a whole list, long list of implications for
the patient. The patient can begin to do things about it.

And then my fourth question is, what can you do about it? My third was,
what can I do about it? Fourth is, what can you do about it? What is the
information going to tell you about me? And on that note, I would say
the word \"integrability\" would be a really strong, important point.
And this is in a really ideal end state. It is nowhere near happening
now. The best example I can give of this would be on online Mendelian
inheritance in man, which if you look up genetic mutation connects you
to BLAST, LocusLink, PubMed, it has got all kinds of tentacles. The
problem being, people don\'t know how to use it. So over‑arching the
whole enterprise would have to be a strong incentive to the patient.
Mary Beth and Janet have mentioned this. Patient responsibility,
absolutely essential to get rid of the paternalistic model of healthcare
that is in place. It is unfair to both parties. It is unfair to the
patient, but it is unfair to the physician as well. So that\'s it for
me.

**[\>\> Mike Cowan:\
]{.underline}**Thanks. Greg.

[**\>\> Greg Downing**:\
]{.underline}I think that this combination of the electronic world we
live in and just the whole notion of organizing science in new ways
around genomics presents a unique opportunity for this being a community
project or community endeavor that provides equities ‑‑ define that term
a little bit \-- to everyone. And it enables, and not disables, those on
the basis of the information it provides. That we have the ability or
the capability of providing the same amounts of information, or the
capabilities of informing healthcare. And it has the opportunity, I
think if done right over the next generation, to be one of the great
equalizers across society on a health basis rather than who can afford
it, who has a computer, who knows how to use it. As we improve the
literacy capabilities and understandings of all this, that it can be a
great equalizer as a community endeavor. So behind that there is a
notion it\'s not just driving a commercial development or private
development, but that it has a societal value that is really something
special that we, as a great society, be able to utilize science and
technology in new ways to improve the quality of life.

**[\>\> Mike Cowan:\
]{.underline}**Great. We will go to Maren and then to the telephones.

**[\>\> Maren Scheuner:\
]{.underline}**Hi. I\'m Maren Scheuner, I\'m from the RAND Corporation.
Nice to meet you all. I think the only thing I might comment, I agree
with everyone\'s comments. What I was thinking about was related to
affordability. And that even if I have health insurance, that how will
this predictive, pre‑emptive healthcare be viewed by my insurer? Will
this be a medical benefit, preventive benefit? Will I have only 500
dollars a year for these types of services if it\'s a preventive
benefit? So just to have access there, too, even if I am insured.

**[\>\> Mike Cowan:\
]{.underline}**Marc Williams.

[**\>\>** **Marc Williams**:]{.underline}\
I had two things. I\'m not going to say the first one because I think it
is just a crystallization of other comments that have been made. But I
will say that I must admit I\'m a bit less optimistic that this ‑‑ I
think this information is going to be quite challenging to package for
anyone, whether they be provider, consumer, and of course we are all in
some sense both. So I think there is going to have to be a ‑‑ the
quality of the information really, or I should say the quality of what
we do with the information that\'s represented is really going to be a
critical piece, so that there is a level of trust across providers and
consumers that the recommendations that are coming out are robust.

But the comment that I'm going to contribute that I have not heard is
that the consumer will have the opportunity to view and revise
information contributed to the electronic health record necessary for
best care in a user‑friendly interface that supports all levels of
sophistication.

**[\>\> Mike Cowan:\
]{.underline}**That\'s well said. Carolyn Clancy.

[**\>\> Carolyn Clancy**:\
]{.underline}Yes, I would only reemphasize the points that a couple of
folks have made that the information needs to be actionable, and I guess
I would say accessible or understandable. I really like Sheila\'s point
a lot about being clear when we don\'t know the answer.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Andrea. She may have dropped off. There is some,
clearly there is some themes ‑‑

**[\>\> Charles Kennedy:\
]{.underline}**Hello?

**[\>\> Mike Cowan:\
]{.underline}**Yes.

**[\>\> Charles Kennedy:\
]{.underline}**Yes, hi. It\'s Charles Kennedy from WellPoint. I\'ve been
on the call a bit. I would like to emphasize as a payer, with a payer
perspective, that this kind of information has both, I guess, electric
third rail almost components from a privacy and security and payer
interface, but also has some potentially very compelling and
constructive and innovative components to it that could be used. So I\'m
going to emphasize the latter and say that under my control and at my
discretion, I am able to use this genomic data to pick a unique
consumer-directed health plan insurance product that delivers customized
healthcare services uniquely to me.

**[\>\> Mike Cowan:\
]{.underline}**All right. Yes.

**[\>\>\
]{.underline}**\[Inaudible\] I have not heard expressed yet, which is
that I hear everybody talking about sort of the patient. And I think in
an ideal future, that we need to be more family-centered because a lot
of this information has implications for family members as well, both in
our care and in our decision-making about access and issues such as
that.

**[\>\> Mike Cowan:\
]{.underline}**All right. So sort of family feature, family focus to the
PHR. That\'s ‑‑ we did structured. Let\'s do unstructured now. I think
we have hit major themes and sort of have a shape coming out of the
mist. So ‑‑

**[\>\>\
]{.underline}**I want to add to the family. I think the, going back to
the comment, sometimes you don\'t know who your family are. And I think
the whole idea of when we make the standards for this, there is
identifying numbers so that people can be aware that there are other
family members with genetic problems, even though they may not know that
they\'re their families, because it may be important. I know that goes
to the confidentiality issues. But if you don\'t know who these people
are, you can't gather the information. And it\'s, I think it is a huge
problem and probably understated. I know my father doesn\'t know who his
father is, and my husband doesn\'t know who his grandfather is. And I
think we have a very traditional family. So I imagine when you start
seeing the lines all over the place, how that\'s probably very
confusing, three generations.

**[\>\> Mike Cowan:\
]{.underline}**You had your hand \--

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

We operate under the principle that the entry point for this as a
newborn. I this that\'s important. We are not just thinking of adults.
We are thinking of infants.

**[\>\> Mike Cowan:\
]{.underline}**Good. Steve and then Mark, I think.

**[\>\> Steve:\
]{.underline}**I wanted to get to a little bit to quantifiability so
that people understand what the benefits and harms are associated with
whatever condition we are talking about, as well as the uncertainties
associated with them. And then each of the therapeutic or management
alternatives that they have so they can understand it.

The other thing that\'s inherent in all of this is manageability. There
is potentially an overwhelming amount of information here that\'s it\'s
going to be very hard for people ‑‑ it\'s easy enough when you think of
a specific gene that presumably you'll get to the point where you can
communicate effectively about a specific thing, when we are talking
about the potential complexity of all of this, there\'s got to be a way
to sort through it in a way that provides a distillation of the
important and separation out of the noise.

**[\>\> Mike Cowan:\
]{.underline}**And that speaks very strongly, I think, to Becky\'s
point. If it is not usable, then it doesn\'t matter. Mark.

**[\>\> Mark Rothstein:\
]{.underline}**Well, I was wary that this may be my last shot.

\[laughter\]

**[\
]{.underline}**I\'ve got several points that were either not touched on
or were only touched on slightly. First, in what ways would it be
feasible to compartmentalize genetic information such as through
blocking, sealing, masking, or other kinds of computer technology, or
the use of contextual access criteria for disclosure to third parties.

Next, are current, genetic, privacy and anti‑discrimination laws
adequate? Short answer, no.

**[\>\>\
]{.underline}**No. Absolutely.

**[\>\> Mark Rothstein:\
]{.underline}**And just to add a, sort of paragraph about that, I
testified before Congress in 1981 on the need for genetic
nondiscrimination legislation, and we are still working on it. And even
if the bill that\'s pending in Congress passed now, it would make very
little, if any, difference to genetic discrimination and the willingness
of individuals to undergo genetic testing. Because it is, I mean, I
nominally support the legislation because I can't not support it. But it
would have very little value. I\'m happy to tell you why later, if you
want.

What concerns are raised about the quality of genetic testing in
non-clinical settings? We talked about the absence of regulation of
clinical labs, but there is a whole cottage industry out there now that
wants to do my genotype and tell me what kind of shampoo I ought to use
and everything else under the sun. And these people are not regulated at
all, and consumers certainly need to be protected against that.

I want to pick up on a point that a few people made about access to care
based on genetic test results. And one of the concerns that I have is
that\'s likely to be, in the short run, a source of further tiering of
healthcare. And I see that coming mostly in the area of
pharmocogenomics. Because these new meds are in the pipe line that are
genotype-matched are going to be very expensive. We see it already with
several that are available. And it may not be on your formulary. If you
are, certainly, Medicaid or an HMO or some low payment system, you are
not going to have that. And that raises all sorts of questions that
perhaps we will get to for, when we get to the provider area.

Next is, are the frameworks that we are talking about today adequate to
contemplate the future world of genomics? I mean, we cannot have it
frozen in 2007, and there are many things in the pip line and Allan
talked about this with more expertise than I can, but there is going to
be a lot of other things that we will want to know other than getting
someone\'s sequence at birth. I mean, that will have some value of
course, if you wanted it, but it is not going to pick up somatic
mutations, it is not going to deal with epigenetics, it is not going to
deal with toxicogenomics. It is not going to deal with lots of other
things. So the question is, do we need to sort of think down the road in
terms of designing a system.

And then finally, having heard all these concerns that people have
raised, I\'m going to go back to a major, big one. And that is do the
benefits outweigh the risks of engaging in a sort of aggressive effort
to include today, or starting today, or starting shortly, more genetic
information in everybody\'s health record? And that relates to the, what
I see as the charge of the committee. I mean, we don\'t regulate genetic
tests. We don\'t regulate the non‑clinical use of genetic tests. We have
no genetic privacy law. We have no genetic non‑discrimination law. We do
not have equal access to genetic testing, the results of genetic
testing. We have don\'t have enough counselors, we don\'t have
physicians who are trained. And the list can go on and on and on. You
know that.

So in line with that, is it appropriate to recommend the, sort of this
full speed ahead movement toward inclusion of genetic information. And I
am certainly one of the big boosters of genetics research and ‑‑ but I
have got some serious questions about what we are all about here. And if
what we are, what we do is list, you know, 50 terrible things that can
happen. And then next we are going to trot out the five things we want
to start doing immediately, that doesn\'t make sense.

**[\>\>\
]{.underline}**Mark, my perspective on this, which is ‑‑ you brought
forward a number of issues. One way to think about this from my
perspective is if we can define a vision we all agree would be an ideal
state in the future and then say, okay, if that is the ideal state,
forgetting all the barriers and problems we have today, how do we then
move forward to achieve that stat, right? So some of these issues, like
the counselors and the education, and we don\'t have appropriate
legislation, et cetera, maybe if we sit there and say, let\'s define
what we think is the best thing for society as a vision, and then say,
but if we are going achieve that then we have to have appropriate
legislation to protect. We have to have more education of the public. We
have to have more genetic counselors trained, et cetera. These are
things that would allow us to achieve that vision.

**[\>\> Mark Rothstein:\
]{.underline}**That\'s exactly what I\'m saying. And what I would see
the most value of this working group is if we came out with two or five
or ten things that we need to do in broad terms, rather than coming up
with the specification standards for inclusion of family histories in
medical records, or some other use cases that can be waved around and
say, here is a great use of genetic information. Yeah, I ‑‑ we\'re not
in disagreement at all.

**[\>\> John Glaser:\
]{.underline}**I think in, certainly sitting in a provider organization,
we do genetic tests which as you know has a great bearing on how long
you live with lung cancer or not, and has a great bearing on a kid with
hearing loss about whether we do a hearing aid or surgery here. So there
is part of it where the horse is out of the barn, to a degree, where you
can have real gain on this kind of stuff. Nonetheless, I think there is
some terrain that, if we don\'t handle well, is going to create some
disasters in the years ahead.\
\
My general belief, and Doug and I have chatted about this, is while we
have specific things that we need to deliver, we do need to deliver some
use cases for standards, et cetera, I\'m reasonably comfortable, if you
all are, with having a broader purview of this topic. More than strictly
what is stated in here.Now obviously, you all have time and day jobs and
want to see how much we can get done in a period of time. But I think it
would be fair game, given the talent at the table and the importance of
this topic, is that we range reasonably broadly across this realm.\
\
I think Greg and Chris, probably one of the things we need to do is to,
given the number of issues raised here, which have been terrific, is to
touch base with other groups going on in HHS so the quality of the
testing, I know there is a group looking at that. I believe there is
someone looking at reimbursement activities, although interesting points
raised about whether, yes, a test might be paid for, but is the care
that follows covered, and to what degree does it lead to a specific
tailored, consumer‑directed health plan. Interesting questions here. So
we ought to tease out, above and beyond the vignettes, and the vision
here is triage these into a bunch of different areas that need further
pursuit and discussion, perhaps linkage in. For example, we\'ve got to
talk to the privacy group. I don\'t know where they are with this kind
of stuff and what we can add or not add to the work that they are
already doing, et cetera. I think there is a series of issues that we
will need to dock with other activities. And I think, Mark, to your
point is realizing it is moving, is how do you move it in a way that is
smart rather than a way that is haphazard, chaotic and makes a mess in
some areas where it is just not necessary we do that.

**[\>\>\
]{.underline}**I wanted to add something which sort of takes, is related
to these previous points but brings it perhaps down to a more technical
level. I think that my, one of my points which was not mentioned, or one
of the things I wrote down, was that the consumer should be in a
position to at least do some high-level validation of the data that has
been sent to them. I mean, assume, even within the 2017 timeframe, the
consumer is going to be getting data from all kinds of places. Most
people are. They are not going to have one pipe that\'s come from this
lab or this, whatever, or whatever. Maybe it is coming from, you know,
send in your thing and I will send you your genomic profile.

And it seems to me that in most kinds of data that are in the health
record, an educated person can look at the data or run some kinds of
algorithms and detect that they are dealing with totally bogus data, or
at least a suspicion of something where the last digits got dropped off
in that data feed or it was all corrupted or \-- these things happen. So
it seems to me there ought to be some methods that are available also to
consumers to detect whether they, there is at least a suspicion that
some of this information they have, you know, may be just wrong or
incomplete or awful.

**[\>\> Mike Cowan:\
]{.underline}**I\'ve got two more questions on the floor. And then I
think, unless there is something really burning, that we are beginning
to segue into solutions. And so we need to pull ourselves back, go
through the eyes of the provider and then figure out some way to handle
the community. And if we could get all that done before lunchtime, we
will be in really good shape.

\[laughter\]

Felix.

[**\>\>** **Felix Frueh**:]{.underline}\
I have two more points, that I\'m not sure they were mentioned, at least
I didn\'t capture it in that sense. The first point is about, and that
goes to what we have as a specific charge, talking about incentives. I
think one thing that we have not really touched on is how is this going
to look at the end. How is the information being delivered? How is it
going to be used in a primary care situation? If I go to my physician
today, I mean, everything is on paper. If I go from one place to another
place, it\'s all on paper but ‑‑ and I did ask the doctor, why aren\'t
you using a computer? Paper is pretty good. It works for me. You know, I
write it down while I talk to you, and next time you are coming I\'m
taking it out of the folder. So what\'s the incentive to change that?

I was told that, you know, there are three main components. Does it save
me time? Can I see two more patients a day or three? Does it save me
money? And can I serve my patient better? I think these three components
need to be addressed by this.

The second point I wanted to make is about, and it\'s been touched a
little bit about pharmocogenetics and pharmocogenomics. I think one
really important consideration is, if we are able to capture the
information about the drugs being used for individual patients, we
really have the means that so far we do not have to identify issues such
as adverse events. And you\'re going to be able to do research with that
with on a completely de-identified basis. So having access to that
information in that kind of setting, I think, could make a tremendous
difference in how we practice pharmocogenetics.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Greg.

**[\>\> Greg Downing:\
]{.underline}**This, I think, probably spans more than just the
consumer\'s perspective but managing expectations, I think, has been
very difficult for us in having these dialogs about what are the
potentials and ways this information can be used. And often you\'re, you
know, in a position of defining the specific applications without being
able to cast the more specific information about longer range use of the
information that you provide today. And that may have some influences on
the decision you make about what the information you yield to someone
else and how it is used. And some of this, the term that has come to
mind most recently is that a decision about certain aspects of
relinquishing information is that it is immutable in the future. Meaning
that once it is, decisions are made and information is relinquished,
there is in most cases no way to get it back. So that\'s an element that
I think is unique in some ways about genetic information relative to
other biological data, that it has a standard in time that prevails.
Other laboratory tests may vary over time, but much of what we are
dealing with has additional meaning beyond just the intended application
at the moment.

**[\>\> Mike Cowan:\
]{.underline}**If there is anything that has to come up we will do it
here, otherwise we will segue into the next. Michele, did you have ‑‑

**[\>\> Michele Puryear:\
]{.underline}**This may segue into providers ‑‑

**[\>\> Mike Cowan:\
]{.underline}**All right.

**[\>\> Michele Puryear:\
]{.underline}**‑‑ but it is also individual pet peeve of mine within the
genetic testing world, that in the future ‑‑ I don\'t know how to solve
this, but in the future that ‑‑ certainly consumers don\'t recognize
state boundaries, but our healthcare system seems to be firmly rooted in
state boundaries such that there are barriers around reimbursements,
barriers around treatment options, barriers around access to the kind of
subspecialists you need. So I think ‑‑ I don\'t know if that will be an
issue more broadly within common complex diseases. But I think as we
move toward the future, I would like to see the doing away of state,
having a license to practice medicine, one license across the country
instead of a state license.

\[laughter\]

But that\'s the future. That\'s the ideal future, but ‑‑

**[\>\>\
]{.underline}**Want to settle (inaudible) ‑‑

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

**[\>\> Mike Cowan:\
]{.underline}**That was one of the advantages of being in the military.
My license was worldwide. Okay. Yes.

**[\>\> Marc Williams:\
]{.underline}**This is Marc Williams. Can I make a reaction to the
comment that the other Mark made?

**[\>\> Mike Cowan:\
]{.underline}**Sure. Go ahead, Marc.

[**\>\>** **Marc Williams**:\
]{.underline}I certainly resonate with a lot of the issues and agree
with a lot of the points, but I have been a proponent of one place that
we can actually move forward is on the issue of family history which has
been collected in the medical record for, you know, at least 100 years,
depending on how far back you want to go and is a recognized and
essential part and element of a history. And the issue is, we are
collecting the information. Everybody collects it. Everybody gives it.
But we are not using that information particularly well. And I think,
you know, a first step is to, if we can actually get that information
into a usable format where we can actually do something with it and we
actually have some validated algorithms that could be used, we would not
in any way, shape, or form be bringing up new issues in terms of we are
not talking about constructing genealogies or identifying other family
members. We are basically saying here is what the patient is telling us
about their family. Here is how we know how to use using this
information. We are now entering this information, you know, every
single encounter the patient comes in, somebody asks them about it so it
is overrepresented in the thing. That's something that we could work on
where I don\'t think we are really bringing up any new issues in terms
of some of these very important things. So we wouldn\'t have to
necessarily stop dead and just be thoughtful, which a lot of groups are
already trying to do.

**[\>\> Mike Cowan:\
]{.underline}**Got it. All right. We are getting good at this. For this
next round, as you think through the eyes of a healthcare provider, if
there is something that has already been put into this personal health
record on behalf of the consumer that would also be good for the
provider we have no need to repeat that. So we have captured that
already. But if, wherever there are unique things that would uniquely be
ideal for the provider, that\'s the kind of thing we are looking at now.
We will do the same process. Take a few minutes. Write down some notes.
And we will do a round of structured thinking and then open it up for
discussion.

\[break\]

**[\>\> Greg Downing:\
]{.underline}**Is there someone on the line? Did someone just join?

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

No, I've been on.

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

All rightee then. I think we are about ready to gear up again. Felix,
are you going to start us off again, please?

[**\>\> Felix Frueh**:\
]{.underline}Okay. I have one bullet to identify the optimal healthcare
options that, I think, might be within a provider\'s portfolio. And with
this, to get into the benefit risk analysis for an individual based on
the information that the healthcare provider has, given the vast
datasets that they have available. So it is essentially benefiting the
individual based on the information that the provider has access to once
all that data becomes accessible through a vast database.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Betsy.

[**\>\>** **Betsy Humphreys**:\
]{.underline}Other than that, the ability to ‑‑ well, I could not
actually, even that, I could not think of anything I wanted the provider
to be able to do with the data that the consumer should not also be able
to do.

**[\>\> Mike Cowan:\
]{.underline}**Okay. That\'s fair enough. Good. Beryl.

[**\>\>** **Beryl Crossley**:\
]{.underline}Just wanted to reemphasize the importance of
standardization in data entry and as much automation as possible, both
for the provider and for the consumer when entering data to both
minimize the necessity for re‑entry of data and also, and Steven and
Felix have touched on before the need for machine-consumable data for
data that\'s in a format that can be subsequently data-mined ‑‑

**[\>\> Mike Cowan:\
]{.underline}**Okay.

**[\>\> Beryl Crossley:\
]{.underline}**‑‑ and the need for user‑friendly interfaces that are
standardized between organizations, between all providers, that we know
that the data that\'s entered is consistent in a consistent and standard
format.

**[\>\> Mike Cowan:\
]{.underline}**And along that line, the full interoperability between
the EHR and PHR of course. Yes. Okay. Amy.

[**\>\>** **Amy McGuire**:]{.underline}\
I think a lot of this was from the provider\'s perspective of what they
would want has been touched on, of access to information, both about the
clinical relevance about the tests and information, accurate information
about the patients.

I guess I will take the opportunity to say here that I\'m a little bit
concerned because I think from the provider\'s perspective, the more
standardization the better, because they want to know what to do and how
to do it in a very standardized way. And I guess my concern is that if
we are too standardized in our approach, that we will sort of kill the
art of medicine in some respects ‑‑

**[\>\> Mike Cowan:\
]{.underline}**Yes.

**[\>\> Amy McGuire:\
]{.underline}**‑‑ and people will become just, physicians will become
technicians that enter data and get the output.

**[\>\> Mike Cowan:\
]{.underline}**To maintain the balance of science and heuristic
medicine.

**[\>\> Amy McGuire:\
]{.underline}**Yes.

**[\>\> Mike Cowan:\
]{.underline}**Good. Mark.

**[\>\> Mark Rothstein:\
]{.underline}**My initial point is, touches on some of the comments that
were made earlier in the consumer discussion where several people said
that consumers should have a wide range of control over amending the
content of their health records. My question is what degree, at what
degree of control given to consumers will clinicians feel that the
health record is unreliable and unusable? What we don\'t want to do is
give consumers so much control that they will turn EHRs into PHRs, and
the value of an electronic health system will be lost because physicians
will feel that they cannot trust the completeness of the file. They will
have to take a new history, have to repeat all the tests that were run
because they are afraid that their patient has taken it out of the
record. And so it is a very delicate balance between giving consumers
certain rights but if you give them too many rights, then things are
going to be, it seems to me, worse. So the question is what is the
balance to be struck in giving consumers control and still having
physicians be able to rely on the records?

**[\>\> Mike Cowan:\
]{.underline}**At a minimum, know what they don\'t know.

**[\>\> Mark Rothstein:\
]{.underline}**Yes.

**[\>\> Mike Cowan:\
]{.underline}**Yes. Steve.

[**\>\> Steve:**\
]{.underline}You just mentioned, I guess Amy talked about the art of
medicine. But the evidence gets us so far in terms of what the
evidence-based process should be. But the evidence-based decisions need
to take into consideration and allow the integration of lots of
additional information about acceptability, feasibility, preferences and
values, affordability, all of those sorts of things, so that they can be
brought to bear at the point of service so that and so intelligent
decisions can be made about the best management approach.

**[\>\> Mike Cowan:\
]{.underline}**But that they are still decisions and they\'re not just
directed by an algorithm.

**[\>\> Steve:\
]{.underline}**Well, that\'s right. Evidence ‑‑ I think of it, you have
got decisions to be made, and you have got evidence, and the evidence
that we mostly are talking about here has been the quantifiable sort of
evidence-based medicine things. But then you have all of the things that
relate to the system in which you are practicing, the resources you have
available, and of course then the patient and family and community
values and preferences and those sorts of things.

**[\>\> Mike Cowan:\
]{.underline}**Great. Allan.

**[\>\> Allan Guttmacher:\
]{.underline}**Both input and use of the information for the provider
should be payer-independent. Should not vary according to the payer.

**[\>\> Mike Cowan:\
]{.underline}**Okay.

**[\>\> John Glaser:\
]{.underline}**I think most of what the sort of key points discussed
under the patient, but there is a bit of a twist. They all want
comprehensive, clinical views of their patient. They want logic to guide
decisions. They want to know how to have conversations that have, you
know, probabilities in them and lots of confounding variables. They want
to know they are going to be reimbursed for running particular tests.
It\'s not clear to me how the notion of managing a panel changes. If you
have a panel of diabetics, et cetera, (inaudible) panel be willing
certain set of variances, et cetera. Nonetheless, I think at a vision
level, they are probably mirror images. Probably when you drop a couple
of thousand feet below altitude we start seeing some differences between
patients and providers.

**[\>\> Mike Cowan:\
]{.underline}**All right. Great. Doug.

[**\>\>** **Doug Henley**:\
]{.underline}I think mine reflects the, again this is, again, from the
clinician\'s viewpoint, but it reflects the broad charge that, you know,
how can I or anyone as a clinician get these data, family history,
genomic tests, whatever, as seamlessly, as interoperably, and as
securely as possible, supported by clinical decision support, that
allows a true partnership to exist between the individual and physician
in terms of managing this data and figuring out what the heck it means
and what to do with it.

Again, I resonate with Rebecca\'s earlier comments. It should not be
paternalistic from clinician to patient. It shouldn't just be the other
way around. It should be a partnership. Because this is complex. It can
be confusing and can create as many questions as it provides answers. So
there needs to be a dialog.

**[\>\> Mike Cowan:\
]{.underline}**Yes. We have hit this a number of times in a number of
different ways. It is a very important concept. You drown in data. You
don\'t really want data. You want information. What you really want is
information that supports decisions and advances your knowledge. And so,
you know, one of the things maybe we should think about is, using those
words differently, when we are talking about a personal and an
electronic health record. Maybe we should be saying information and
knowledge and not data, just to make that differentiation. Janet.

[**\>\> Janet Warrington**:\
]{.underline}I think this is similar, and that is that my, I know that
my patients are trained to understand probability and confidence, and
that I\'ve been trained to understand the probability and confidence
that\'s associated with the information we are evaluating.

**[\>\> Mike Cowan:\
]{.underline}**Okay.

**[\>\>\
]{.underline}**I would want a EHR system of course that\'s
interoperable. Everybody has said that. But I would also want, when the
information is brought up, or entered, that red flags appear that direct
you towards possible research protocols, possible treatment protocols.
Because this all may not be a done deal, that you have what we call
action sheets, act sheets, where you, give you more understanding about
what it is, the predictability, the risk of, or how to interpret that
genetic test, what the clinical validity and utility are surrounding
that genetic test. More delivered within the EHR that\'s coming up on
your screen so that you can use it. Where to go for resources, where to
go to the National Library of Medicine for papers so you can sort of
weigh the evidence.

**[\>\> Mike Cowan:\
]{.underline}**More down the line of knowledge management guidance.
Okay.

**[\>\>\
]{.underline}**I am with Betsy. Whatever points I raised in the consumer
ideal, I think are equally as, apply in the provider context.

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

Good. Paul.

**[\>\> Paul Cusenza:\
]{.underline}**I would guess I would add that, from a provider\'s
perspective, there's still the art of medicine element. The PHR is one
input to that process, but it helps to make better decisions as an input
but ultimately it is still their decision-making choice based on that
information and what they also obtain.

In regards to the EHR, to me, the content of that is created by a
medical professional, and that is not editable by the consumer because
it is the record of what happened in that particular situation, and they
control that content. Albeit the control over the whole personal health
record and whose got access and other information about the individual
besides the EHR-specific elements of treatment, they would have control
over and be able to put input and information to it.

I guess the other thought I have on the provider perspective, it seems
to me it would be awfully nice if as part of the system ‑‑ and again,
this is complex in an anonymous situation. But if I\'m treating a
patient and I\'ve got the PHR and I\'m trying to use this whole art of
trying to decide what\'s best for this individual, it seems that if
there were others I had access to in the database that had similar
situations, if I could speak to those healthcare providers and get some,
have a discussion about what may be the best thing to do in this
situation, it would be nice to do that. That of course means being able
to have access back to that provider, maybe not the patient, but at
least the provider. And that\'s, obviously a lot of issues trying to
implement that, but it seems like it would be a good idea.

**[\>\>\
]{.underline}**So think many of you brought up the point that, to be
able to come up with triggers like you've just mentioned, Michele. There
is so much information out there today. If you just go into Medline and
look at the amount of literature that\'s generated on a daily basis, not
a single human being can consume all that. But if you had this
information electronically and we did have built in the algorithms to be
able to assess specific criteria to provide the physician triggers so
they could at least focus, bring down their focus from hundreds of
thousands of literature and research going on to something that\'s
consumable, I think that\'s really one of the key benefits of this. It
is not good to change the way that you would actually treat your
patient, but to give you that information in a way that you could not do
that personally, on an individual basis.

**[\>\> Mike Cowan:\
]{.underline}**Kathy.

[**\>\>** **Kathy Hudson**:\
]{.underline}I think this sort of follows earlier comments. As a
physician, I want to have ready access to quality outcomes information.
So I want to have, I want to know what it means. And that probably means
that I want to have access to professional guidelines. And I want to
have access to some rewards for adopting those professional guidelines
within my practice. And, Felix, I want a meaningful drug label.

**[\>\> Felix Frueh:\
]{.underline}**We'll work on it.

\[laughter\]

**[\>\> Mike Cowan:\
]{.underline}**Becky.

**[\>\>\
]{.underline}**Could you work on that, Felix, please?

**[\>\>\
]{.underline}**Just to get back, that would presuppose, I think, that
this database, as I think one person called it, would need to be
centrally managed, in the last session, somehow. It would presuppose an
ongoing relationship with, say, NIH to plug in the latest research
protocols instead of getting a letter in the mail from NIH about a
particular study. You would ‑‑ NIH would be able to put that medicine,
that information into electronic databases. National Library of Medicine
would be constantly updating their information so you would have a
central source of literature available to you. Same with FDA would be
updating their information about the test itself, which would be
changing over time. There is ‑‑ 

**[\>\> Mike Cowan:\
]{.underline}**That could apply to \--

**[\>\>\
]{.underline}**So, I mean, you would have to envision that, right? That
you would have, somehow the back door would be open to government
agencies or professional organizations to supply. They would not have
access to the individual, but they would have access to ‑‑ those
resources could be brought by the federal agencies or professional
organizations.

[**\>\>** **Carolyn Clancy**:\
]{.underline}Yes, this is Carolyn. I actually think that those are some
very good points, Michele. The clarification I would make is that it is
very easy, and I think actually very pragmatic to envision that there
would be a knowledge repository of some sort, but that databases with
patient data would not need to be centralized. And in fact there are
many, many reasons why not would not be desirable. So I just want to
draw that distinction, that we are not in the process of creating some
huge, megarepository with patient data. A knowledge repository that can
be linked to all kinds of systems, whether that's healthcare, electronic
health records, and so forth is a different concept than actually a
database with people\'s records and information in it.

**[\>\> Mike Cowan:\
]{.underline}**Becky.

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

From the provider standpoint, before I begin I would like to say, the
National Library of Medicine has done an incredible job making all sorts
of information available. It is just remarkable. So, Betsy, hats off to
you guys.

From a provider standpoint, I think I would want to step out of that
two‑dimensional model a little and understand that when mutation
information and genetic genomic information is given to a patient,
oftentimes it is not sufficient to hand them a piece of paper that tells
them what to expect or what to look for. Sometimes they are going to
need additional help. In my family that has involved psychological
counseling for some of us. So I would want to have, I would want to have
the ability to note where psychological counseling was necessary, and at
the very least, clinical genetic counselor services need improved
foundational support for their activities, including reimbursement.
ICD‑9 coding and things that don\'t yet exist homogenously for them.\
\
And the other thing I would want to do is, I would want to know easily,
quickly and easily what kind of surveillance algorithms were available
for my patient. And I would want them to be modifiable so that there was
an accountability piece built into it such that, if you look at an OMIM
entry, the last person who updated it, Victor McKusick, or whoever, his
name is going to be on it and the date that he messed with it is going
to be on it so there is a tie‑back to who put it there. Questions about
the information can be directed back to that person. So my two things
are other helpers and other decision support.

**[\>\> Mike Cowan:\
]{.underline}**We have a real‑world time issue. I would like to make a
suggestion, see how you feel about it. It is a quarter to 12:00. It
would really be a good idea to break at this point for lunch. And what I
would like to suggest, this is going very well, a break until 12:15, and
then we will pick up right here at 12:15 and continue on with the
process that we have got going. And that would mean bring lunch back.
Eat ‑‑ we can eat lunch while we do this. We can think and chew at the
same time.

**[\>\> Greg Downing:\
]{.underline}**For those ‑‑

**[\>\> Mike Cowan:\
]{.underline}**Is that all right?

**[\>\>\
]{.underline}**That\'s ‑‑\
\
\[multiple speakers\]

**[\>\> Mike Cowan:\
]{.underline}**All right. Back at 12:15.

**[\>\> Greg Downing:\
]{.underline}**For those ‑‑ for those who have not been ‑‑ for those who
have not been in this building before, the cafeteria is directly above
us. You can either take the elevator or the stairs just outside the
doors. And it\'s right across on that side of the building. The south
side. Those of you on the phone can find your way to wherever you can
have lunch.

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

Should we stay on the line, or just call back in?

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

That would be fine.

\[lunch break\]

**[\>\> Mike Cowan:\
]{.underline}**Okay, it\'s 12:15. Please feel free to continue eating.
We have a few stragglers not back yet, but I think we can go ahead and
get started. Are we back on the phone bridge?

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

I never disconnected it.

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

Oh, okay. Okay, so we are just finishing up our round of structured
brainstorming on providers before we broke Becky was the last one to
speak. So Greg, it\'s over to you.

**[\>\> Greg Downing:\
]{.underline}**I have just three brief areas. One is for the information
that\'s going to be provided to me, and I\'ll utilize in the future, is
it going to be meaningful with the next generation of information that
comes along, particularly in the genomics area. And so are there \-- is
it upgradeable and do I have to go back and reinterpret information from
prior versions and discussions?

The second, I think, is that we\'ve had lots of discussions around this
table today we haven\'t heard before in terms of the changing roles of
the provider and the consumer relationships. And so there may be new
definements of that and new opportunities for innovative ways the
provider is engaged with a consumer. So that tension comes up again
about the notion of the paternalistic aspects but one element that I
would embrace is that as you have many different providers out there
that there\'s ways to serve as a bit of a safety net or a guardian in
some capacity, not as the controller. But for example in the
establishing new ways in looking at sort of safety assessments of the
whole healthcare experience, that as new information comes along about
drug-drug interactions or new insights into whether a particular disease
condition or new medication, a medication a patient is already on is
provided out there, that these are often not just black and white
decisions. I think about the Vioxx experience where for some patients
there\'s still a lot of benefit to be achieved by that. Where does the
consumer go to to help make that more, the more arbitrary decisions,
meaningful?

And then I guess the third aspect of it is that in this concept of
trying to improve quality, capabilities that rate how am I doing with
this subset of patients. And right now it\'s more of a clinical
inference that selections or the treatment programs, the way that I
practice is more just by instincts or feedback from consumers. And that
\-- so that we enable a system in which there\'s a sort of continuing
renewal of my own experiences and enabling me to compare that to other
providers either in my group or in a broader experience. And that I have
some control over that information also. Saying that my patient
satisfaction rating based on this management strategy. You know, helping
me improve the quality of the care that I deliver. But that\'s not
something that\'s being necessarily viewed by the whole healthcare
delivery system. So that there\'s an individualistic aspect or a
provider-centric aspect to quality improvement that\'s, strives to
improve by their own personalized or customized delivery capabilities
that suit the patient population that\'s being treated. That\'s it.

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

Maren?

**[\>\> Maren Scheuner:\
]{.underline}**I think I have three comments, too, and I think one of
them is exactly what you just said. That is, when I practice
personalized medicine, or personalized healthcare, that I\'m recognized
for doing that. It\'s a quality issue so it relates back to pay for
performance measures, and I think that also means there has to be
metrics that measure that quality, which we simply don\'t have at all
today. And also related to that, that when I see patients and I\'m
practicing personalized medicine, that I\'m reimbursed for that effort,
that there are the appropriate CPT and ICD codes or whatever we\'re
going to have, so that I can bill and get paid for the time I spend
doing that. I\'m a clinical geneticist, by the way, that\'s been trying
to practice personalized medicine for almost 15 years and that\'s why I
have firsthand experience for some of these things, but it's hard to get
paid. And that, as let\'s say any health professional that I\'m trained
in clinical genetics, not just molecular biology, which is what they
teach in medical school today, but that I understand clinical genetics
and how to think genetically.

**[\>\> Mike Cowan:\
]{.underline}**Thanks. On the telephone, Marc Williams, are you there?

**[\>\> Marc Williams:\
]{.underline}**Yes, I am. It\'s been a bit gratifying to kind of hear
the comments, since I\'m fortunate enough to work in an environment
where we\'ve done most of the stuff that's been mentioned already, not
around genetic or genomic issues, but around common diseases like
diabetes, and processes like ventilator management, glucose control,
those sorts of things. So I\'m coming from a bit of a different
perspective and in terms of some of the concerns that have been raised,
I can tell that you from our physician and patient standpoints, that
we\'ve been able to do this type of decision support in an environment
that enhances provider satisfaction where they don\'t feel like they\'re
being, working off a prescribed cookbook, but it allows them to really
focus their efforts on those patients that don\'t fit as opposed to kind
of taking every patient and trying to do things from a de novo
perspective. It's also had a dramatic impact on quality of care and it
has absolutely no impact on patient satisfaction because satisfaction
operates completely independently from medical outcomes. And that\'s an
unfortunate characteristic of the healthcare system as it\'s currently
configured.

So with that as a preface, what I would say is that from a provider
perspective, we need to have validated decision support that is at point
of care and I envision a layered access to information regarding the
recommendations that come up. So that if a clinical support message
comes up that says you should consider doing this in this patient, that
I would be able to click right from that message to a first level which
would say this is based on guideline or this is based on best evidence.
This is the, the probability table or whatever the providers tell us
would be most important, but then they could continue to drill down into
resources or primary literature or even to the ultimate data if they so
desire, all at point of care. We really need this sort of just-in-time
system.

I would also note that people have brought up the idea of, that we need
to be collecting data and generating guidelines from a national
perspective and I think that\'s really important. However, I would also
note that in some cases some of these algorithms are going to have to be
developed locally, reflecting the individual patient mix at a given
location. An example of this would be cystic fibrosis in California,
their mutation panel they\'re testing for as part of the newborn
screening panel is significantly different than the nationally
recommended panel. And it\'s based on internal evidence that they have
developed that indicates the mutation frequency given their ethnic mix.

And I think the same thing goes for the data capture, that there will be
a responsibility on health systems to capture their own internal data
and I\'ve already seen examples where physicians, when they get a
decision support message, can choose to follow that message or not
follow it. And then that data is captured so that you can actually look
at patient outcomes in real-time to see what is the consequence of
following or not following that given instruction. And that\'s an
extremely important learning tool, because the reality is that as
thoughtful as you are on the front end, the algorithms, you can count on
them being wrong. And you have to be able to modify them going forward.
So those are the sorts of things that I think from a provider\'s
perspective ultimately is going to be needed.

**[\>\> Mike Cowan:\
]{.underline}**Great, thanks. Carolyn? Or Andrea? They may have fallen
off. Okay, open mic. Any comments? Yes, Betsy.

**[\>\> Betsy Humphreys:\
]{.underline}**Something that occurred to me and I think it came up
before, but I do think from the point of view of the provider, knowing
that there is information that is not being made available is probably
something that providers would really like to know. And I think that as
more information is available to the provider, you know, through
regional health information exchange, or potentially from other care
facilities, et cetera, they will \-- the potential downside would be
that as they see this information, and they know it\'s coming from all
these places, they would be more likely to think they had all the
information. And if in fact either facilities have chosen not to share
information or patients have chosen not to share information, I would
think it would become more important that they know that. Otherwise, I
think the assumption might be I have all the information or at least I
have it from this metropolitan area or this state or whatever the \-- I
was telling some people at lunch that I have the pleasure of being on
the technical advisory panel for the Memphis RHIO, in Tennessee, which
is an excellent project, doing very well. And they\'ve already observed
this. That people seeing certain kinds of information in the ED, start
to make the assumption that if information isn\'t there, then probably
the patient hasn\'t been seen or didn\'t have this information. And I
think that could be potentially dangerous, and become more dangerous as
people are more used to seeing the information and maybe thinking they
have a fuller picture than they actually have.

**[\>\> Mike Cowan:\
]{.underline}**So while a patient should have the right to withhold a
piece of information, the existence of that information should not be
withheld?

**[\>\> Betsy Humphreys:\
]{.underline}**Yeah, that\'s what I think, and I know a lot of people
can argue that both ways, but I do feel that as people become more
accustomed to having access to large amounts of information, then
they\'re going to be, start making assumptions, forgetting that
information could be missing. As opposed to the current state where they
have little information so they assume a lot of it is missing.

**[\>\> Mike Cowan:\
]{.underline}**Mark, you were next.

**[\>\> Mark Rothstein:\
]{.underline}**Yeah, two points. First one is that in the future, and
future now I\'m talking about is the near future, we\'re going to see a
continued shift away from genetic information in a few narrow specialty
fields to more primary care fields. And so it\'s not just going to be in
peds and oncology and whatever. It\'s going to be in primary care. And
that raises all sorts of education and continuing education challenges
for the medical profession. But there\'s a practical concern, and that
is a time constraint. Because as was suggested earlier, we need to worry
about getting reimbursed for those services and including genetic
counseling. But as the time of each clinical encounter is being
compressed in primary care, how are you possibly going to inform
patients of all their myriad risk factors and what to do in terms of
prevention and so forth? So I think that\'s a major factor.

The second point is the question about whether new ethical obligations
will be imposed on physicians who have more information, not only about
their individual patients about the relatives of their patients and do
they have a duty to inform them, do they have a duty to warn them,
suppose you learn genetic information about one patient and you also
just happen to be treating that patient\'s brother. Can you share it
with the brother without the consent of the other brother? I mean, there
are all these issues that are raised that we\'ve been dealing with in
genetic counseling and clinical genetics for decades. But the scope of
the number of providers that are going to have to be facing these issues
on a regular basis, is going to increase.

**[\>\> Marc Williams:\
]{.underline}**Marc, on the phone, please?

**[\>\> Mike Cowan:\
]{.underline}**Okay, Mark?

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

Yeah, this is Marc, on the phone. Yeah, again, a couple of reactions to
those comments. I think that those are very insightful. What I sort of
envision is that, and this has been raised by others, is that this risk
information really has to be context-specific, and that as much as we
need to know about the validation of the risk, we also need to
understand when is the optimal time to present that information. Some of
it will be relatively straightforward, like this patient is depressed,
and I need to use an antidepressant, therefore I will need access to the
pharmacogenomic information that is going to give me the best medicine
to use and the optimal dose. I also personally believe formularies will
be going away because this information will actually be robust enough
that they will no longer serve a purpose, but that\'s a side editorial
comment.

But you can also use other things like age, in other words if somebody
does not have an extraordinarily high cardiovascular risk, then you say
at the age 40 preventive medicine visit, this is where we address the
cardiovascular risk issues and we put some of the other things to the
side so that prostate doesn\'t get addressed until age 60 and colorectal
cancer doesn\'t get addressed until age 50, unless somebody would have,
in the parlance of a laboratory test, a critical value, meaning that
everybody in this family is dying of heart attacks in their 30s in which
case we have to do that. So I think that can be managed so that we do
not overwhelm providers with way too much information. Because that\'s
already a problem.

The second thing is again just getting back to the idea that we have to
change our paradigm of medical education. There\'s going to be a certain
amount that we can accomplish in medical school and residency and some
that we accomplish with CME meetings and but the reality is most of the
education has to be done at point of care, just in time, in the specific
context. And that\'s where the real learning is going to take place and
I think there\'s good literature to support that that\'s the direction
we have to go.

**[\>\> Charles Kennedy:\
]{.underline}**Hi, this is Charles Kennedy on the phone also. The
concept of reimbursement has been brought up quite a few times, and from
a payer perspective, one of the important gateways to getting a test
covered is the medical policy and technology area that many health plans
have. This is where a panel of community physicians go through and make
assessments about standard of care versus experimental status of various
interventions. And I would say one of the important points of feedback
that that area has given me is that they see plenty of information about
the technical and scientific validity of many of the emerging genomic
tests, but frequently don\'t see the type of comparative head-to-head
types of trials that compare these genetic tests versus best in class
treatments today. And that is an important enabler for expanding the
reimbursement of many of these genomic tests.

**[\>\>\
]{.underline}**I think we all understand the importance of the quality
of the individual data. But the other piece is the quality of the
algorithms coming out that will guide the decision support is important.
And obviously with the wealth of information that\'s going to emerge
it's going to be very difficult to keep that up on a timely basis,
particularly since it\'s likely to come from multiple sources, from an
individual institution or collectively. Something needs to be done to
make sure that the kinds of things we care about, the certainty of the
information that\'s emerging from those algorithms, the magnitude of
effect, if there, and the timeliness of it, so the providers know
they\'re actually dealing with the most current, most relevant, most
certain information is there at the same time, so they can apply it in a
useful way. It\'s easy to imagine that you\'re going to be dealing with
information that\'s 5 to 10 years old, just because it\'s so difficult
to keep it up. So where that\'s going to come from, how that\'s going to
be incorporated, seem to me to be important issues.

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

Greg.

**[\>\> Greg Downing:\
]{.underline}**Steve, I would like to follow up on that and if Carolyn
or Jean are still on the phone \-- this has been one of the areas that
we have been struggling with in terms of telescoping out to the future
how to develop that algorithm and whose responsibility it will need to
fall into the lap of it and the validation of that data and then testing
it for its quality. At least as far as we can see there are bits and
pieces of how that lands in different people\'s backyards, but how
that's integrated and the capabilities to develop valuable information
hasn\'t really emerged to us yet in looking through the inventories of
what, at least from the public health perspective, the government does.
And as we develop the technical capabilities for sharing that
information, I don\'t want to say governance, but the ability to say
it\'s being done in the proper way and it has meaningful results just
hasn\'t emerged. I think from a value perspective and leading to the
clinical decision support and the quality of care aspects of it, we,
we\'re really struggling a lot with seeing how that emerges. We have the
ability to develop large data sets and capabilities, but it\'s that
knowledge management components to it that we don\'t see the yellow
brick road yet.

**[\>\>\
]{.underline}**(inaudible) to say nothing of clinical utility, are major
problems for all of this and that information needs to be able to
whoever is going to use it, whether it's a health professional within a
clinical or even a public health setting, so they know what they\'re
dealing with and how to apply it in a meaningful way and then to rate
the quality of that information because as we get into more and more of
these conditions that are actually going to be fairly uncommon, we\'re
not going to have RCTs that even prove it. So we don\'t even have the
methodology in hand right now that would allow to us take the kind of
evidence-based approach, say, that the preventive task force does, and
apply it to what, to all of these different things. It\'s not practical.
So there\'s a whole methodology and rating and that certification or
other kind of process that will need to be there, and need some sort of
professional and perhaps governmental oversight and some common
providers. I just can\'t imagine this being done in, you know, 300
institutions across the country.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Amy?

**[\>\> Amy McGuire:\
]{.underline}**I think also sort of related to that is when we talk
about incorporating clinical useful information into the electronic
health record, is \-- and this comes back to what Mark said earlier
about thinking about the future because a lot of the information we\'re
getting from particularly genetics and genomics research right now may
not be clinically validated or useful today, but it may become
clinically validated or useful in a couple years and I think that raises
a lot of issues from the provider\'s perspective and also from the
consumer's perspective about how much of that information should be
stored in the electronic health record, or anywhere, for that matter.
How much should even be reported to the individual who it pertains to?
And what\'s going to be the obligation to follow up? Clearly that can
get, rise to the level of tremendous burden on physicians if they\'re
obligated to follow up five years from now, ten years or we did these
tests, or you were a part of this study ten years ago and now we know
this means X.or et cetera. So I think thinking about those issues is
also important from a provider\'s perspective.

**[\>\> Mike Cowan:\
]{.underline}**So as an umbrella, sort of moving knowledge into the
practice of medicine. Okay. Others?

**[\>\> Marc Williams:\
]{.underline}**This is Marc from InterMountain again. I think there was
a point that was made in the very last comment that we didn\'t capture
in terms of the provider, and that is what I would characterize as
avoidance of waste. In other words, with the genomic tests, we should
only have to do these once. And so that means establishing some way to
store the information in such a way as we\'re not ordering them multiple
times and we\'ve identified this as a problem within our own
organization. Because again we\'re then using valuable resources where
there is no value added and I think we wouldn\'t have to convene a large
council to agree that doing a genomic test more than once is not a good
thing. So I would just make sure we capture that as well.

**[\>\> Maren Scheuner:\
]{.underline}**Could I just add to that, Marc? This is Maren. Wouldn\'t
it also depend on, you\'d need to know the methodologies that were used
to evaluate that genomic test to make sure that there isn\'t something
new you might learn?

**[\>\> Marc Williams:\
]{.underline}**I think it kind of depends on the test. You know, if we
think about the sort of simplex testing like the Factor V Leiden or a
CFTR mutation analysis, then that probably doesn\'t need to be done more
than once.

But as has been referenced, we\'re going to be moving from that sort of
one-off to a multiplexing type of a situation where we\'re going to be
capturing larger amounts of information, let\'s just take as an example
somebody that would get a cytochrome P450 profile where basically all of
the cytochrome P450 genes would have the relevant polymorphisms
accumulated and you would pull from different ones depending upon the
medication context you were using. And there, there may well be
different information that would come up that would say you need to add
additional information or that this information doesn\'t mean what we
thought it meant. So there does need to be an ongoing data collection as
we start to look at more what I would characterize as multiplex genomic
assays.

**[\>\> Mike Cowan:\
]{.underline}**Okay. All right. In the interest of time, I think our
best bet now is to go into our third area and talk about the other
stakeholders. I don\'t think that we\'ll have enough time, it was
discussed earlier we might want to break these out and do them
separately. Probably don\'t have that time today.

But let\'s at least put up on the board who you all as a group think
those stakeholders are. And then as we have our brainstorming session,
then we\'ll know the range of the participants. So we\'ve got research.
One thing we didn\'t think through very carefully was having a physician
make notes that other people had to read.

**[\>\>\
]{.underline}**When you say research, researchers and subjects. I\'d see
that as two stakeholders.

**[\>\> Mike Cowan:\
]{.underline}**Separate or together?

**[\>\>\
]{.underline}**I think they\'re separate because they have different
things at stake.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Just go ahead and shout out what you\'ve got.

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

Industry.

**[\>\> Mike Cowan:\
]{.underline}**By industry you mean employers?

**[\>\>\
]{.underline}**Developers of tests and pharmaceuticals and even other
technologies. And then the employers is the other one.

**[\>\>\
]{.underline}**How about the EHR industry? The vendors.

**[\>\> Mike Cowan:\
]{.underline}**EHR vendors. Employers.

**[\>\>\
]{.underline}**Support group.

**[\>\> Mike Cowan:\
]{.underline}**Support groups?

**[\>\>\
]{.underline}**Insurers. I'm talking about life insurers, disability
insurers, long-term care insurers, et cetera.

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

Okay.

**[\>\>\
]{.underline}**Community-based groups.

**[\>\>\
]{.underline}**Can I ask a question as to how \-- don\'t we have them
already by their constituencies like a disease group, how are their
interests different than the consumers or patients that they represent?

**[\>\>\
]{.underline}**Groups who would, for instance, want to be able to mine
this data or use it some way to bring together people who have the
disorder but aren\'t otherwise linked to each other, or to offer through
it information and support to those folks who are identified as having
some condition who wouldn\'t have access to it otherwise.

**[\>\>\
]{.underline}**Law enforcement.

**[\>\>\
]{.underline}**Regulatory agencies.

**[\>\> Mike Cowan:\
]{.underline}**Okay.

**[\>\>\
]{.underline}**Family members.

**[\>\> Mike Cowan:\
]{.underline}**All right. I wrote too big.

**[\>\>\
]{.underline}**How about educators?

**[\>\> Mike Cowan:\
]{.underline}**So it\'s quite the list.

**[\>\>\
]{.underline}**Racial and ethnic groups. Population groups.

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

Is that enough? We don\'t need to be entirely comprehensive. Is that
enough to give us a sense that there\'s lots of stakeholders here? Okay.
So you guys know the rules. Give me \-- do quiet brainstorming, write
down some things and soon as \-- and you can respond to more than one
stakeholder, of course.

\[break\]

**[\>\> Mike Cowan:\
]{.underline}**Okay, most people are looking up. First, a reality check.
We've chatted with the chairs, any comments on this process, is this
going okay? Are we in a comfortable spot for getting through this third
phase before going on to how we\'re going to build interim states? Any
comments? I think the discussions have been very rich, and they\'ve
seemed very useful to me. So we all together? All right. Felix, you know
your job.

**[\>\> Felix Frueh:\
]{.underline}**It's an interesting position. Usually FDA comes last.

\[laughter\]

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

It's a new paradigm.

**[\>\> Felix Frueh:\
]{.underline}**Yeah, I'm getting used to it. I think much of it has to
do with of course access to data, informed consent and so forth. So I
think for me, an important aspect would be how all these stakeholders
can utilize the information, assuming that there is a reasonable way to
access it. So if we generate all this information, I think it would be
important to figure out how we can give something back to public health
or to the community that benefits at the level of the individual.
That\'s my first shot at it.

**[\>\> Mike Cowan:\
]{.underline}**Betsy?

**[\>\> Betsy Humphreys:\
]{.underline}**I guess I agree with what Felix said, and I would think
that as any of these secondary users of the data, what I would need is
some level of analysis or analysis tools that would actually help me
understand what kind of conclusions or inferences I\'m actually able to
draw from the data. I mean, how far are we off the denominator? I mean,
whether there\'s enough representation of certain kinds of people in the
data for there to be any statistical validity to anything I\'m looking
at at an aggregate level. And to what extent in order to protect privacy
down at the, you know, small cell level, the data has had to have been
fudged or abstracted or edited.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Berly?

**[\>\> Beryl Crossley:\
]{.underline}**I would just like to reiterate as a data advocate how
valuable it\'s been in our organization to have our data repositories. I
think when Marc Williams talked about the cystic fibrosis testing in
California, he may have been referring to our 12 or more years of
accumulated cystic fibrosis result data at Quest Diagnostics, and that
enables to us get a very strong appreciation of the mutation rates and
the different ethnicity results. We also have similar amounts of data
for fragile X testing, for a lot of our genetic testing also.

So as a very strong data advocate, I just see the value of this
de-identified data to be so very important and the need to keep that
data in a standardized format that\'s accessible to as many
organizations as possible. And we\'ve also talked about the algorithms
used for data analysis and how we must keep those algorithms
continuously updated and have access to the latest versions, continuous
access to the latest versions and also to be able to have feedback loops
that update the data and also update the algorithms as necessary.

**[\>\>\
]{.underline}**Yeah, I think I agree, I think that the big issue for
many of the stakeholders that are on the list is both access to the
information and the use of the information in a way that\'s going to,
from a very practical standpoint especially for industry, it\'s going to
make business sense for them but it\'s also not going to harm the other
interested parties.

**[\>\>\
]{.underline}**I want to focus on the users of the information who use
it not for the health benefit of the individual. There are numerous
entities that have a financial interest in learning about an
individual\'s predicted health in the future, life insurers, employers,
and so forth. It is very, very difficult to enact legislation that\'s
going to prevent them from doing that. And earlier we discussed the
principle that consumers should have control over all their information,
et cetera, et cetera.

That\'s not very easy to do, because each year in the United States
there are approximately 25 million compelled authorizations for
disclosure of health information. Which means that 25 million times a
year someone is asked, as a condition of employment, as a condition of
applying for a life insurance policy of a condition of applying for an
individual disability policy and so forth, to sign an authorization that
releases all their medical records.

And in order to prevent that from happening to the detriment of the
individual, two very important things have to happen. Number one, you
have to enact a law saying you can\'t do that as an employer, as an
insurer, so forth, when they may have legitimate reasons for wanting to
know whether someone\'s going to have a heart attack if they climb a
telephone pole. And number two, you have to have the capability of
limiting the disclosure of the relevant of the information and not
releasing the irrelevant information. So those things are
extraordinarily difficult to do, and that\'s why the current generation
of genetic nondiscrimination laws, those that have been enacted at the
state level, and those that are pending in the federal level, would have
no bearing on this. The problem of \-- in genetic discrimination is not
that there are hundreds of employers who are discriminating. I can count
on one hand the number of cases I know about. The problem is that people
who are at risk and might benefit from having a genetic test are
dissuaded from doing so because they\'re afraid of the consequences, if
their employer or an insurer got access to it. So what I\'m suggest
something is that to deal with all these issues that we\'ve listed there
is exceedingly difficult, complicated, and contentious, because if you
want to regulate any one of the industries that we\'re talking up there,
they\'re going to have issues with limiting the amount of data that
they\'re going to have access to. But if we\'re serious about protecting
health privacy in general, genetic privacy specifically, we have to take
that on. And nobody has been willing to do that yet.

**[\>\>\
]{.underline}**We have talked a lot about the users of this information.
But these are groups that also provide information back into the system.
For instance, employers and exposures. There are things about
communities and the environmental exposures that they have. All of which
are germane both at a decision-making for those groups, but also back
into the system that are germane to the clinician and the individual. So
there are \-- this is probably bidirectional.

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

Yes. Allan?

**[\>\> Allan Guttmacher:\
]{.underline}**Speaking of bidirectional, in terms of clinical research,
I would want to have a push-pull system where for those conducting such
research there would be an ability to let, inform people about the
availability of clinical research for certain disorders or whatever it
might be, but also for individuals and patient advocacy communities to
be able to access information about clinical trials as that becomes
appropriate to them or a question to them. These are the clinical trials
on a condition with which I've just been diagnosed.

**[\>\> John Glaser:\
]{.underline}**Yeah, I think, following up on Mark's comments, there may
it would be categories of secondary use. One in which there is no intent
nor is it necessary to go back and identify an individual. So
pharmacovigilance, looking for adverse events out of this stuff and
knowing it is more likely to occur within certain phenotypic or genetic
variables, without having to know exactly who this was, or in cases
where we do some (inaudible) part of anonymized collection of genetic
and phenotypic data get early hypotheses, see whether certain
correlations actually warrant further study or not. So there is a
category there where you can see for the life sciences, you can see for
the research community, looking for patterns and really that\'s the end
once you established or failed to establish the pattern. There is a
second area in which you intend to get to an individual. And whether
it's for underwriting for life insurance or in the research purposes
there\'s an IRB process for which you can go and consent on a variety of
things like that. That may help as we go through the vision statements
and see what we need to do in the different types of use cases.

**[\>\> Mike Cowan:\
]{.underline}**That\'s a great distinction. Doug?

**[\>\> Doug Henley:\
]{.underline}**I grabbed a hold of the perspective of the educator
partly because of the huge self-interest. Our organization is all about
educating a large body of the physician community out there, so what are
the challenges but also the opportunities and the methodologies that we
use to develop point of care learning and the associated standards and
so forth for that to support clinical support? I agree with Marc
Williams that traditional CME is not going to work here by and large,
and it\'s going to have be more focused on point of care learning and
clinical decision support tools at the point of care, just in time, et
cetera.

**[\>\> Mike Cowan:\
]{.underline}**I remember in medical school just having my head stuffed
with things that I had to memorize because I would have to make
decisions without the benefit of having a book. When information becomes
ubiquitously available I think it will completely change the way we
think about education. Janet?

**[\>\> Janet Warrington:\
]{.underline}**Well-defined mechanisms and protocols for evaluating data
quality and quality control. Because that in turn will feed back to the
people developing the diagnostics and the therapeutics when they put
together their product specification. So it's very important.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Got it.

**[\>\>\
]{.underline}**I\'m going to go first back to my first principle and
it's the one of community-based participatory research. I think however
the variety of users in the third category work within these projects, I
think they need to remain, or realize they're partners with individual
consumers or groups of consumers. Need to operate under that principle
that it\'s a partnership. And that consumers have to, both communities
have to be benefiting from this as much as the users or the researchers
have to be benefiting from it.

**[\>\> Mike Cowan:\
]{.underline}**Good, great. Beth?

**[\>\>\
]{.underline}**I\'m thinking along the lines of quality. But performance
indicators that can (inaudible) that there is coordination of care
across all these entities. And I know that\'s a very hard thing to do
and it could be satisfaction initially, but something so we can capture
are we doing what we hope to do in the end?

**[\>\>\
]{.underline}**This is a hard category for me because I can see
something that would be ideal for a vendor would in fact not be at all
ideal from a consumer point of view, but I\'ll speak to sort of what I
think, and I, recognizing that it\'s hard and I agree with Mark, I do
think that clear rules, clear sets of standards, clear codes of conduct,
and tools for enforcing those, would go a long way to sort of
facilitating this entire movement, but also benefiting a whole range of
stakeholders.

**[\>\> Mike Cowan:\
]{.underline}**Steve?

**[\>\> Steve:\
]{.underline}**So I\'ve been thinking about this as the nirvana of
having all of this information, and a standard way that it could be
accessible to researchers. Working with professionals in the public
health field where if nationally this information was available, the
benefits to public health, you know, whether it's isolating breakouts of
specific diseases, the avian flu concern, probably still, I imagine.
Plus prevalence of disease whether it\'s demographic or environmental. I
think it\'s just huge, huge potential in value. Working in the
pharmaceutical industry, I think coming up with standardizations in this
way is noncompetitive for our industry, and it benefits the, how we
actually conduct clinical trials in the future. There is no competitive
advantage in this area. I think it will also help in some of the areas
that we\'ve seen where safety profiles have been concerns based on once
the drug has been moved into large populations, if this is in a standard
form, the ability to monitor safety of our products would be greatly
improved and I think also in getting drugs approved through the
regulatory agencies. I think we could come up with tools and mechanisms
to make that even simpler. So I just think this is great potential in
the future.

**[\>\> Mike Cowan:\
]{.underline}**Kathy?

**[\>\> Kathy Hudson:\
]{.underline}**I think industry needs regulatory certainty and reward
for innovation, and in order to have that certainty I think the
regulatory agencies need both money and leadership because the task has
now gotten infinitely more complex than it used to be.

**[\>\>\
]{.underline}**I took as my subject the subject. As a subject, I am
actually very interested in what\'s going to happen to my blood after I
give it to you. And whether you\'re going to make money on my blood and
if you\'re going to patent what you find in my blood. And I think that
that opens up a whole host of issues, actually they\'re open now, I mean
I know that fully informed consent is not ubiquitous, and that some
companies are using residual blood specimens to discover and then patent
genes. So I think that\'s a problem ongoing.

**[\>\> Mike Cowan:\
]{.underline}**Anybody on the phone?

**[\>\> Marc Williams:\
]{.underline}**Marc here. To introduce the concept, and this crosses
several of the areas we were talking about in terms of research, public
health, those sorts of things, and that\'s the recognition that quality
improvement methodologies are going to be increasingly used in medical
care delivery and from a practical perspective that brings up the issue
of perfect versus good enough. And we've talked a lot about,
particularly from the algorithm perspective of how do we update things
and how do we make sure that the information is of high quality. And
that\'s all very important, but I think it\'s also important to
recognize that at any given point there\'s going to be information that
will be dramatic, that has the potential to dramatically improve care
and let me just give an example of this.

As an anesthesiologist, it would be potentially possible right now to
develop a chip that would identify, say, 50 to 60 percent of individuals
that are at risk for malignant hyperthermia which would be very
important for me to know in terms of avoidance of certain anesthetic
agents or, potentially, pre-treating. Now, I hear from one of my
anesthesiology colleagues who is interested in this that, from the
professional society perspective, they say if we don\'t have 100
percent, we don\'t want to do it. And so I think we have to make
decisions to say there are going to be times when we don\'t know it all
but we know enough to really initiate things that will have a dramatic
improvement in care and this is a real central paradigm to quality
improvement. And it also relates to what we currently have in drugs
where we spend a lot of money and do a lot of research, traditional
research, on drugs but we also know that from the post-market we learn
things that we never learn in the research. And this is going to be true
in this area as well. So I think we have to find a balance between what
we would consider traditional research, RCTs and the like, versus the
quality improvement-type of research modality where we basically capture
data going forward and learn on the fly, knowing that we\'re starting at
a point that\'s better than we currently have.

**[\>\> Charles Kennedy:\
]{.underline}**This is Charles. I would like to just follow up on that
comment because health plans, and the payers as a secondary user, health
plans increasingly are capturing significant amounts of clinically
relevant data, not just traditional administrative datasets, but now
moving into personal health records, potentially capturing family
history as a part of that. But the thing that would be needed, I think,
to make use of that information for clinical research, late phase safety
analysis, would be greater regulatory clarity around the potential roles
of health plans and the pharmaceutical industry and test manufacturers
in how to collaborate to ensure these tests which do offer a clinical
utility and improved patient outcomes can be introduced to the clinical
environment as quickly as possible.

**[\>\> Mike Cowan:\
]{.underline}**Well, I\'m certainly struck by how different this looks
depending upon whose eyes you\'re looking at it through, even though
there are certain common elements. Any further comments on this part?
Yes, Mark?

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

I want to follow up on the commercialization point that was made, very
well, earlier, and there\'s a commercialization issue specific to health
information technology that I think we ought to be aware of, and nobody
really knows what business model is going to emerge in terms of
electronic health record systems, and who is going to pay for them
long-term. And according to one estimate, 50 percent of the cost is
going to come from data mining and resale of the electronic health
record information. And when you get to genetic information, even if
it\'s de-identified, it may have a certain psychological or emotional
appeal, that people are reluctant to want to have this happen with their
information, even in a de-identified form. So I think we need to be
thinking about the commercialization aspects, not only from the biobank
side but also from the, from the data mining side of the clinical files.

**[\>\> Greg Downing:\
]{.underline}**I just would like to follow up with a question that this
is an issue that we\'ve been hearing a lot about. We didn\'t mention
this at the outset of the meeting, but back in October at the outset of
this working group we had a request for information that went out and
within a matter of days these will all be up on the Web. But many
aspects around this subject of security and privacy issues were at the
forefront of many of the organizations and individuals that submitted
this. One of the things that as we\'re trying to project forward and as
you pointed out systems and ways this is going to be used, the business
models, you know, there are so many different futures out there, that
it\'s very difficult to characterize the risk aspects of this in
coherent ways people can understand. It\'s been pointed out by many that
these applications of use of data from your purchasing or aspects of
lifestyles is ongoing today, and much of which we don\'t see every day,
but it may be coming to us in the forms of what we have in the mailbox
every day or the spam that you get on e-mail. And but people don\'t
necessarily see the connection with the information they\'ve provided
with how that is used and put back on them.

So one aspect of it is there\'s no transparency about all of this. The
second aspect is how is what\'s relative to your health information
different than other aspects that\'s ongoing in society and we don\'t
have a big conundrum about right now. And so whether it\'s this group or
others, one of the things we\'re struggling with in terms of
communicating these issues, is contrasting it from other aspects of life
that we don\'t seem to have so much struggle with that\'s ongoing today.

And the other elements of it is that characterizing that risk. How you
go about saying what are the ways in which this information can be used
to impede your life other than in jobs and in healthcare insurance
coverage. So that\'s sort of a reflection internally about how these
dialogues are going. We\'re having a difficult time suggesting about how
those can be barriers when right now we\'re not perceiving them as such.

**[\>\> Mike Cowan:\
]{.underline}**Steve?

**[\>\> Steve:\
]{.underline}**Another group is going to be working on this, but this
gets back to what do we really mean by de-identifiable? Intrinsically if
you have all of this, you can identify people. And so I\'m not sure
where this boundary really is, and at some point it becomes an
artificial distinction.

**[\>\> Greg Downing:\
]{.underline}**In the context now of a legal definition for which we\'ve
been using, this is related to HIPAA and I think everybody acknowledges
that that does not necessarily apply if you have sufficient amounts of
genomic information. We\'ve been very clear about that as a group, and
within the Department, that there are identifiability issues related to
information that we currently call de-identified. And I think that
certainly in the days in which the HIPAA privacy rules were being
developed, that context or that capability wasn\'t even thought to be a
practical problem at the time.

**[\>\>\
]{.underline}**Actually, it was.

\[laughter\]

**[\>\> Greg Downing:\
]{.underline}**Practical from the standpoint of saying it was going to
be here in a timeframe in which we would be necessarily grappling with
it today. And so now the issue is what comes and follows behind that and
how would you design structures to deal with that.

**[\>\>\
]{.underline}**I think you also raise an important larger question when
you\'re comparing sort of health information shared in the context of
this clinical relationship and other information that we give out when
we are consumers in the shopping mall or whatever. Which, and I guess it
raises one of the concerns that I have, but it may that be we\'re
shifting in the direction and there\'s no going back, which is sort of
de-professionlizing the profession of medicine and I think as we talk
about consumers in some respects I\'m like yeah, we\'re all consumers,
we're health consumers, we should be equal partners, we should be
empowered, but on the other hand I have this concern that we\'re sort of
de-professionalizing medicine and I think there\'s something different
in the context of that relationship that\'s different than when you go
to the shopping mall and give somebody your credit card or fill out
something, a form to get a new credit card or whatever. So we might
want, I think it\'s a bigger issue than we\'re here to address but I
think that raises \--

**[\>\> John Glaser:\
]{.underline}**I don\'t know how you get your hands on that one, Greg,
because it's a very intangible idea. I have to tell you, sitting in a
provider organization, you know, we\'ve had minor disclosures, should we
have our own sort of form of VA disclosure. There\'s a political and PR
fury which (inaudible). And so you just worry about that from a public
reaction, it's a different tone, of a different strength. Maybe it ought
to be. But not that TGX didn\'t get creamed for that release too.

The second, we live in fear that some number of patients stop talking to
us because they\'re afraid to. And that is about as insidious
undermining of the essence of a patient-provider relationship is that
it\'s not candid. Now, you\'ll never get your hands on that, to know
whether they are or they are not. But that is, and we sometimes talk
about of all the good we can do in IT, we can erode it in a nanosecond
if people are afraid to disclose stuff because of what can happen.

**[\>\> Mike Cowan:\
]{.underline}**Good point. All right. We have come to a turning point. I
think this has been, I think this has been perhaps the hardest of the
things that we want to accomplish today. But I think the conversation
has really been remarkable. And as that gets boiled down over time, very
clearly things will emerge that will be issues that this group will be
able to go forward with.

We have two more things to do. One is now to turn, now that we have said
this is nirvana, the next is to turn our faces to the steps we would
take between now and the time that we achieve nirvana. Instead of doing
the structured brainstorming, I think this is the world that every one
of you lives in for some facet or another of it. And so I think that
that it would be more useful for our time and it should be very
effective simply to turn this into a discussion. So, now many of these
steps have been spoken about earlier. We went back and forth between
actualizing things and what nirvana would be and those can get sorted
out later. But the kinds of recommendations that we\'re looking for now
are do verbs that say by sometime, we should do this, because it
achieves that. Are we, does that make sense, are we together? I see
knitted brows. Is that because I wasn't clear, or you're thinking of
things \--

**[\>\>\
]{.underline}**I have a question. A lot of the things that we\'ve raised
in this visioning exercise are things that are way out of our purview,
so I assume when you\'re talking about achievements by X and Y, are you
\-- I assume you\'re talking about things that we might be able to come
one recommendations to facilitate, as opposed to what should society at
large being taking on in some sort of temporal framework.

**[\>\> Mike Cowan:\
]{.underline}**I\'ll defer to Greg but I would suggest that it should be
everything. If, for example, policies we don\'t directly affect would be
a thing that really needs to be accomplished, then we ought to change
this policy to that to support this by, you know, and make that
recommendation. I think this shouldn\'t have walls on it at this point.

**[\>\> Greg Downing:\
]{.underline}**I\'ll ask the co-chairs to also weigh in on this, too.
There are going to be a lot of people with gray hair here, if we\'re
going to have to characterize all of the steps that go beyond. But I
think it is important to also be inclusive of saying, you know, and
reflecting upon what the Secretary\'s guidance has been on this all
along, is that if there are major things downstream, like the analytical
framework, things like that, that are nonexistent but are going to be
important for getting to the clinical decision support component to
that, that we don\'t need that right now but we need to start thinking
about an infrastructure that\'s capable of doing that. And that may not
be necessarily within the framework for this group, or the group can
make a recommendation saying somebody needs to be responsible for
planning this component of the future. So is that workable for you?

**[\>\> John Glaser:\
]{.underline}**I'll give my initial thoughts, and we may override all of
them. I think, just a thought here, when we get to actually constructing
the vision statement and comparing and contrasting that to the Quality.
One is I\'m not as convinced of the need for the intermediate state or a
statement. We can have now and then but the arm-wrestling over five
years from now what will happen. Talk about whether that\'s truly useful
exercise (inaudible)

The second, we may have two categories. Right now these are things built
into stakeholders, consumer, provider, all the way down here. One thing
we could consider doing is lumping provider and consumer together.
Different angles, but nonetheless there's different angles of education,
there's different angles having to deal with movement of data and
exposure to data, and obviously there's differences between. And the
second category is secondary uses, where obviously the life sciences
people are different from the purchasers of care and different from
public health. There\'s some broad cross-sectors between those two. And
that\'s more of a format stuff. Pointing out the similarities across the
other stakeholders and frankly no longer separating providers from
consumers but putting them together as part of a care team, they need to
consider a number of things. Anyway, that\'s a thought there.

I think my general suggestion is whether it\'s a do verb or something
that\'s got to be dealt with, is that we be pretty wide-ranging at this
point. At the end of the day, we don\'t have infinite time, either on
this assignment or your collective time. We're clearly going to have to
zero in on privacy, as we\'ve been asked to do, but in the decision
support which I think is now both provider and patient and broadly
education, it's not just algorithms, although that\'s a critical part of
it. There may be other thoughts that you all have and I think once
we\'re done with this today, what the (inaudible) in front of you, focus
on a couple and decide that some we may not get to or are being taken
care of by other groups in HHS. But I think let\'s be fairly
wide-ranging. I do think it\'s terribly important that we deal with the
broader privacy issues, and the stuff to do with that, and the broader
decision support aka education, in sort of its broader sense. I don\'t
know whether that makes sense or not.

**[\>\> Dough Henley:\
]{.underline}**I think it does. While I do think we need some specific
focus on the specific charge of the Workgroup, in the context of the
broad charge, as we said at the beginning of the day, as there are other
areas that while they may not be directly under our purview, they are
important to the overall process that some other Workgroup may deal with
or a yet undefined group. But somebody will need to deal with them, so
we ought to make some recommendations about those to the extent that we
can reach agreement as to what they are. Be it privacy and security or
be it the issue of validating the test before it becomes publicly
available, all those things.

**[\>\> Mike Cowan:\
]{.underline}**Okay. And one last thing to try to do as we do this, we
have two final steps. One is what are these stages? What are these
intermediate stages? And then the final will be what are the obstacles,
barriers, the difficulties we see? We want to try to have this round in:
here\'s what we should do. And then our last task of the day is
identifying the great big rocks and reefs and snags that we\'ll have to
navigate around.

**[\>\> Greg Downing:\
]{.underline}**One of the ways we\'ve been internally thinking about our
Grand Canyon, and at least on the information aspects of it, is that
we\'re sort of in the information organization, the ways in which we
collect information. And we see sort of the next wave of this as coming
our tools and capabilities of analyzing and developing knowledge from
it. And I don\'t know if that\'s an easy way to start thinking about it.
And ultimately another big phase of that interactive aspects of it and
then how we use the knowledge and the capabilities to improve sort of
the quality and the practices of medicine. So we\'ve sort of lumped into
three general phases of information, development, and applications
that\'s we\'re thinking about here, but there may be others. Few minutes
to think about it.

\[break\]

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

Okay. Any thoughts?

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

An invitation?

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

Yes. Mark?

**[\>\> Marc Williams:\
]{.underline}**Okay. I\'m just going to make one comment on current
state even though I know we sort fo said we\'re not going to cover that.
And that is, under the translation of basic research, there is a model
that was not on the list that I think covers a lot of the different
areas in terms of translating tests into clinical care, capturing
post-market data, and that\'s the CETT program, Collaboration,
Education, Translation of Tests that\'s run by CDC. And a lot of the
data elements that are listed under NIH programs are actually already
being collected by the National Center for Biotechnology Information.
And so I think they should be articulated under current state as well.

Now, in terms of my action statement, I would say that by 2010, family
history information that is currently being collected will be
represented in a standardized format that can be manipulated within an
information system to use what is currently known about family
history-determined risk and can be applied in a systematic way to
improve care and create new knowledge. So basically what I\'m saying is
we\'ve got all this information that we currently know, let\'s put it
into a format that we can actually use.

**[\>\> Mike Cowan:\
]{.underline}**Good. By 2010. Mark?

**[\>\> Mark Rothstein:\
]{.underline}**I have four items. And they come from the NCVHS report
and recommendations for the Secretary that were submitted June 22nd of
2006. And so I would couch them as by April 1st, 2007, number one, HHS
should investigate the feasibility of applying contextual access
criteria to EHRs and the NHIN, enabling personal information disclosed
beyond the healthcare setting on the basis of an authorization to be
limited to the information reasonably necessary to achieve the purpose
of the disclosure. So that means if you have a life insurance company
that requires you to sign an authorization, they get stuff that relates
to your mortality risk, but they don\'t get everything. They don\'t get
things that are 25 years old that have no basis. And we have no way of
isolating those data now. And the beauty of electronic health records
over paper records is that we could do it. We can\'t do it with paper.
We could do it electronically if we wanted to, but we need to take the
steps to integrate that technology.

Number two. HHS should work with other federal agencies and the Congress
to ensure that privacy and confidentiality rules apply to all
individuals and entities that create, compile, store, transmit, or use
personal health information in any form and in any setting, including
employers, insurers, financial institutions, et cetera, et cetera, et
cetera. And the reason for that is that the HIPAA privacy rule only
covers three classes of covered entities, and that\'s only a small
subset of healthcare providers. There are many other healthcare
providers that aren\'t even covered by the HIPAA privacy rule, not to
mention schools, employers, insurers, et cetera, and so we need
comprehensive health privacy legislation.

Number four \-- I\'m sorry. Number three on my list is actually
recommendation 22. HHS should support legislative or regulatory measures
to eliminate or reduce as much as possible the potential harmful
discriminatory effects of personal health information disclosure. So
that is the sort of substantive nondiscrimination in all of these
various categories. That are, were on some flip chart earlier.

And number 26, something that we didn\'t talk about earlier that I think
is very valuable, is that HHS should establish and support ongoing
research to assess the effectiveness and public confidence in the
privacy, confidentiality, and security of the NHIN, and its components.
We never study health privacy. If somebody asked us, does the HIPAA
privacy rule work? I don\'t know. Well, I have some ideas. But we don\'t
collect any data, we don\'t research it very well. And certainly as we
increase the scope and the interconnectedness of health records, people
should be engaged in an ongoing process of researching whether we\'re
increasing the level of privacy, whether the level of privacy is so much
that it interferes with research and public health, and so forth. And we
just don\'t have any idea at all. So those are four of our 26
recommendations that I think are especially relevant to our discussion
today.

**[\>\> Mike Cowan:\
]{.underline}**Great. John?

**[\>\> John Glaser:\
]{.underline}**I think we need to adopt these as being sort of a
five-year time frame. We ought to be in a position such that the initial
set of standards and the standard bodies in this field are set. So we
know where these are going to get set, who are the major bodies, the
types of transactions, semantics that they're going to be dealing with,
and realizing that this is a field that involve some core set has been
dealt with. Number one.

Number two, and combination of a variety of conversations one of which
you mentioned, Betsy. The model by which decision support is vetted. I
don\'t know exactly what that model ought to be and whether it ought to
lead to a knowledge service of some form that is summoned by all these
EHRs, that model should have initial forms nailed down so you get some
form of clinical seal of approval here.

The next four that I have, and then I\'m exhausted, really realize how
little we know about this realm. So I think there ought to be some
series of trials or experimentations about how to deliver genetic
information to patients, different ways to do this, in ways that are
easier to get, to more layman-esque. But the flip side of that is how to
deliver to doctors because they have no time and it was a long time ago
they went to medical school. Different ways to deliver this in the
context of the care and the context of the workflow and the context of
very harried people.

The other, I had two examples in the secondary uses because there are a
lot of theory with the value of secondary use and not a lot of practice
about the value of secondary use. I\'ve seen the 50 percent, I think
it\'s a hallucination on the part of 50 percent, but nonetheless, some
will go off and do this. The data is so crappy. It's unbelievable. At
least ours is, maybe yours isn\'t.

\[laughter\]

So I do think, and Becky, you pointed this out, there\'s an ability to
take discarded samples in an anonymized way, correlate genetic tests and
phenotypic data to see whether you get an initial sort of hypotheses
nailed down between genetic underpinnings without ever knowing who is
who on this stuff. But there ought to be demonstration to see how much
yield is there. Can you really, by two to three orders of magnitude,
short circuit that first process? You still have to go out and do the
trial, et cetera.

The second one is a lot of thought on pharmacovigilance. It's sort of
the Kaiser thing all over again, but to what degree could you really do
that at scale? A lot of both investigator initiated and mining of some
form discover other correlations between unhappy outcomes such as stroke
MIs, et cetera, and various patterns of phenotypic and genotypic data. I
think there\'s a whole lot of method issues and other stuff. But to
start investigating how real is this data and how good might the
existing phenotypic set coming out of the EHR, even in a quote
anonymized fashion, how good is that secondary use?

So part of these, I think there is some concrete things of standards,
there's some concrete things of privacy, and concrete things surrounding
initial processes for vetting all but there\'s an amazing amount of
experimentation and learning that\'s got to go on here. So I would spend
the next five years just learning about all the stuff. We have EHR
penetration so low that it will take a while for it to catch up at
anything resembling real scale.

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

Very good. Betsy? Then Becky.

**[\>\> Betsy Humphreys:\
]{.underline}**Building up a piece of what John said here. I agree with
him entirely and the other thing we don\'t know is whether we can
represent clinical knowledge or knowledge in any form that will be
reused from institution to institution in an effective, efficient way
for decision support. I think that I sort of believe that maybe you can
do, this but I\'m not sure we\'ve ever demonstrated it or I mean that
the level of effort is so much less at the second institution that
whatever standardized abstraction procedure that we went through was
actually worth it, I mean to export. I believe in the end we should be
able to do that, but I don\'t know that we have a lot of illustration
that we have done it in any effective way.

And I agree also entirely with this notion of how are we going to
explain this stuff and research and development around the best way to
communicate these concepts both to the patients or the potential
patients, and the providers. But I think that there\'s one thing that I
guess we know. And that is that in this new world we won\'t get anywhere
if we can\'t increase the base level of understanding of the population
of two things, genetics and probability. So I sort of feel that while
we\'re at this, we might go back down into the science curriculum of the
schools and the health curriculum of the schools, and translate these
concepts into something that actually is directly relevant to people,
which this does, for them. And start way down there and maybe the first
grade teachers will be the ones, or the third grade teachers will be the
ones that will tell the rest of us how to tell the doctors and patients
how to do it.

**[\>\>\
]{.underline}**(inaudible)

**[\>\>\
]{.underline}**I\'d like to add to what John said and to what Betsy
said. I think that the education piece is vitally important, having been
at Georgetown watching these young kids come in. They\'re as old as my
daughter, not understanding, overwhelmed, no easy way of learning about
this topic. In fact, I think at Georgetown the level of curriculum
commitment was like six hours during their course of study, which has
been increased since then, but so my first thing would be if we do spin
off, if you do spin off groups from this, the steering committee, that
you would form strong bonds with AAMC, they really do need to weigh in.
Increase funding for NCHPEG. And also bring people into the excitement.
This is exciting. This is engaging, this is enlisting all of our
imaginative faculties. And so it\'s not a linear, even though we\'re
trying to do linear work but really it\'s not linear at all. And who
said it recently, embracing complexity. Someone said she embraces
complexity and it just stuck in my head, so I\'m sharing it with you,
unattributed. And I think young people need to be part of this group.
Younger than us.

**[\>\>\
]{.underline}**Janet, your other quote was the truth is slippery.

**[\>\> Marc Williams:\
]{.underline}**This is Marc, on the phone. I think it was Becky that
made a comment about the demonstration of the ability to move
information across institutions. There is an extant example of that
within NIH, and that is research that Dr. Alan Morris here at
Intermountain is doing on glucose control in intensive care units. That
has been, that protocol has been exported both in a Web-based and a
PC-based environment to multiple institutions basically around the
world. And have demonstrated not only that the protocol will work in
situ, but also that you can collect data from all those sites to do the
post-market things. And NIH actually has recently put out, I think an
RFI, and it may even be closed, on studying this type of dissemination.
So there actually is a viable model out there that we can look at for
how to do this.

The second thing is just a stakeholder that hasn\'t been mentioned with
regard to probability education is if we really pull it off the lottery
system as we know it will collapse.

\[laughter\]

**[\>\>\
]{.underline}**I just want to say I\'m very familiar with Alan\'s work
so I could have said there\'s at least one good example.

**[\>\> Mike Cowan:\
]{.underline}**Felix?

**[\>\> Felix Frueh:\
]{.underline}**Yeah, I\'d like to continue on an earlier discussion. If
I look out one to, say, five years from now, I think that one thing that
I wish we had in five years is a good understanding of the risks
associated with certain types of genetic information. Because I think
there is a great difference between for example knowing a cytochrome
P450 genotype or your BRCA1 mutation. The former, I think, is something
that we can easily, well, generate, today, the information. It\'s a once
in a lifetime event that I think that is not that much a controversy
over whether it\'s useful or not. And if we start to be able to
implement these sort of first steps, we might be able to create a value
system that helps us to address some of the issues around privacy. And
leverage that to the level of public health record or personal health
records. Because one thing that I would like to be able to avoid is that
we start recreating a genetic exceptionalism in terms of creating
different standards for genetic health records and, than for others. I
mean, if somebody knows my cholesterol level, they certainly know more
about me than about, if they know my (inaudible) genotype. So I think we
need to keep the perspective to the clinic overall.

**[\>\> Mike Cowan:\
]{.underline}**Doug?

**[\>\> Doug Henley:\
]{.underline}**I agree with earlier comments about doing some important
research or demonstration projects in this area. My only plea would be
that while some of those may need to be, of necessity,
institutional-based, they have got to be based in the real world of
practice-based research networks. If we don\'t do the research there, it
just simply will not apply to the vast environment where most patients
are seen every day, or at least where they encounter the healthcare
system every day. So it has to be a very practical application of all
this in the world of practice-based research networks.

**[\>\> Mike Cowan:\
]{.underline}**Beth. Beth was next and then Allan.

**[\>\>\
]{.underline}**(inaudible) to, this is a perfect example of sort of
interprofessional education because you have the physicians, the MPs,
PAs, the genetic counselors, which actually is a group of people that I
don\'t know a whole lot about, that there has to be a shared
understanding of information being passed back and forth and to maybe
look at it as a bigger academic endeavor than just by profession.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Allan?

**[\>\> Allan Guttmacher:\
]{.underline}**So within five years we certainly ought to have
appropriate oversight of genetic tests, and despite Mark\'s concerns
that it won\'t do much, I would think genetic nondiscrimination
legislation should certainly be in place.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Paul, you were next.

**[\>\> Paul Cusenza:\
]{.underline}**We look at the personalized health records. They\'ll be
likely portable, in a sense, something that could be provided by either
payers or employers and as people migrate it has to move around and
could be government provided but also commercial provided. But
regardless, it seems to me that the government would have to have a
certified standard, that this is the data format and here\'s what is
sort of like the stamp of approval of a personalized health record that
then entities could adhere to, be they commercial entities or not. If
commercial entities then conform to that, then you\'d have one form of a
standard that would be used and they\'d have the stamp of approval that
would have to come from some body that\'s outside of the broader
commercial enterprises. If you did something like that and the metaphor
that may be interesting, how do you handle the underprivileged and how
do you provide it to them? The economics are very different but look at
electronically filing your taxes through this whole E-file mechanism.
The way the government works on that, if you want you to be a commercial
provider of that, you get a certification that says you\'re a certified
provider to do E-filing of taxes. And oh, by the way, for that then, if
you make over 50 grand or 55 grand a year, whatever it is, then you pay
for that service. But if you make less than that, it\'s free as part of
the reason that you can say you\'re part of the program. And so there
may be mechanisms of that nature that could be implemented as part of
how you make the healthcare records available. Similar to that.

**[\>\> Mike Cowan:\
]{.underline}**All right. I\'m going to have to take facilitator\'s
prerogative at this point. I know there are more ideas floating around
the table and I know there will be even more as you\'re driving or
flying home tonight you\'ll say I wish I would have said \-- Greg, what
would be a good mechanism for bringing those thoughts while they\'re
still fresh? E-mail to you or \--

**[\>\> Greg Downing:\
]{.underline}**We\'ll address that at the next juncture.

**[\>\> Mike Cowan:\
]{.underline}**Okay.

**[\>\> Greg Downing:\
]{.underline}**We have some business aspects.

**[\>\> Mike Cowan:\
]{.underline}**Good. So we\'ll set up a mechanism for bringing late
thoughts in.

The next step is \-- I collect old maps. Nautical maps, and on the old
maps they used to have pictures of dragons wherever the ocean had not
been explored, and the saying on the map was there be dragons here. That
just meant it had never been explored. So now we would like to shift our
minds. We were looking for the ways to positively do things. Now what we
want to do is try to get a sense of what you think the dragons and the
reefs and the dangers are. What things would this group or anyone trying
to push this entity along need to be aware of? One of them John said was
the loss of trust. I think that\'s a big dangerous reef. So what are the
obstacles, what are the barriers, what are the dangers that we may be
able to proactively avoid by understanding them? And working around
them? Michele?

**[\>\> Michele Puryear:\
]{.underline}**A significant lack of genetic literacy amongst healthcare
professionals and the general public.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Yes?

**[\>\>\
]{.underline}**A potential loss of community. Because we tend to get so
litigious and legal in our thinking that we lose sight of the fact that
we\'re all connected. Community.

**[\>\> Mike Cowan:\
]{.underline}**So excessive litigiousness. Mark?

**[\>\> Mark Rothstein:\
]{.underline}**I would say a real concern is delay. The private sector
is racing ahead to set up all these PHR systems and RHIOs and other
networks of their own, and they\'re not regulated at the moment. And
unless HHS gets its act together and gets moving, we\'ll be behind the
curve and then it\'s, and then we\'re going to have the problem of
trying to regulate people who already set up in business and telling
them they can\'t continue to do what they\'re already doing.

**[\>\> John Glaser:\
]{.underline}**I think there are all kinds of risks. One is that the
EHR/PHR, RHIO adoption is trivial. Sort of putters along and five years
from now maybe we\'re five points higher than today. But most of the
RHIOs will have imploded, PHR use is at two percent of the population,
so there\'s an assumption this IT infrastructure is going to catapult to
the sky. Maybe not. It might just sort of grind its way through here.

Another is we could discover, and I had an interesting sort of sidebar
with Steve here, in most cases, not all, this genetic stuff is too messy
and complicated to really be of much help to anybody. So there will be
some clear cases where it\'s compelling. Maybe cystic fibrosis. In other
cases it\'s a complicated mixture of variables and environmental
factors, so decision support and an empowered patient. It's you know,
too messy, and is really not all that helpful for most cases here. Part
of this is sort of grand vision of genomic-driven care and EHR, most of
them it may be less.

**[\>\> Mike Cowan:\
]{.underline}**I think Betsy you were next, and then Allan.

**[\>\> Betsy Humphreys:\
]{.underline}**It\'s sort of a variation on John\'s first thing. While
we may find that in fact we get broader adoptions of EHRs and PHRs, but
we don\'t get the level of specificity, rapid availability of new data,
that allows you to drive these things. I was recently looking at a study
where people wanted to provide a certain set of decision support to, in
the care of pregnant women. And lo and behold the system couldn\'t
capture fast enough the fact that the pregnancy was over. You know,
either the baby was delivered or, you know, or less desirable outcomes,
like miscarriage. So people were being counseled about what they should
do while pregnant, you know, two weeks after they had a miscarriage.
This was a disaster, obviously for the patient, provider, and they
basically had to stop that quickly because the downside risk in those
cases was just so awful. So I think that we may get it, but if we don\'t
get rapid, updated data available to people, not just a week later or
two weeks later but now, then we may have a similar impact. You can\'t
do the decision support because the data just isn't current enough to do
it.

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

Allan.

**[\>\> Allan Guttmacher:\
]{.underline}**We need to develop reimbursement models to allow this
incredibly time consuming, cerebral transfer of information, that covers
that and looks at innovative models for doing that because there are
parts that need to be one-on-one counseling, but to look at other ways
of doing it that would be more cost-effective than that traditional
model.

**[\>\> Mike Cowan:\
]{.underline}**Okay. Felix.

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

The dragon in my head and I\'m repeating what I\'ve been saying before,
that there\'s no uptake. I think we need to be able, all of us need to
be able, to formulate the business case for why this is beneficial to
consumer and to the primary care physician. Because these are the people
that will populate that information and if they don\'t buy in, if they
don't see a reason to do it, we might have a nice system but it won\'t
be used.

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

Marc Williams? Charles Kennedy, anyone else on the phone?

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

This is Marc. At the risk of painting a huge target on my back, my fear
is that we\'re going to cause real harm to patients by delaying
implementation of things we know work in this area because of concerns
about theoretic harm. An example is LabCorps presented a poster at the
American Society of Human Genetics last year where they asked the
question, would you be willing to take a test that would identify risks
for taking a certain medication? And then they asked the same question
and this was to consumers and physicians, saying would you take a
genetic test to avoid risk from a medication? So the same question but
genetic was inserted. And the response rate was 10 to 15 percent lower
when the word genetic was included as opposed to a test. And so I think
that we really have created a lot of fear around this. Some of it is
worth being thoughtful about. But I just am worried we\'ll paralyze
ourselves worrying about theoretic harm and basically not taking
advantage of things that would save people\'s lives today.

**[\>\>\
]{.underline}**I think that\'s absolutely right. When we look at our
experience with personal health records, we\'ve had one that\'s
pre-populated with the clinical aspects of claims data and made it
available to our members for a couple years now. And when you look at
the utilization rates, not just our experience but across the industry,
being low single digit, you know, it\'s really a sobering reminder of
the challenge before us. I think when you take Mark\'s comments into
view, the challenges get that much higher. So my greatest risk is that
it\'s five years from now and we may have some data standards, but our
utilization and engagement with the physician and the consumer remains
quite low.

**[\>\> Mike Cowan:\
]{.underline}**One last. Steve will be the last, and then I will wrap it
up and turn it back over to Greg.

**[\>\> Steve:\
]{.underline}**The whole coverage system when we get into this level of
specificity and have it adaptive, we won\'t be having sort of these one
size fits all coverage kind of systems, and we\'ll need to have some way
to manage it intelligently so we can continue to afford healthcare in
this country.

**[\>\> Mike Cowan:\
]{.underline}**All right. That wraps up this part. It was great fun. I
thank you, Greg, for asking me to come do this. It\'s been very pleasant
and very revealing.

**[\>\> Greg Downing:\
]{.underline}**I think that, first of all, I want to thank you, you\'ve
all been highly engaged in this. And I think some days we come into this
building thinking we\'ve heard every aspect of it, and we are proven
wrong every time. So I\'d like to sort of catch you up a little bit with
what we\'re doing here in the management of this working group, and then
I think we should engage in a discussion with the, led by the chairs,
about how we want to use this visioning information and what we\'ll put
together for you in helping frame the agendas for the working group and
what else to do with this, if that\'s okay with you.

We have been working hard to get the products of this group\'s efforts
developed into a Web-based format that will help with your information
management of what\'s going on here. And we\'ve added additional support
staff through ONC to help facilitate that. We\'ve been challenged a
little bit logistically on just the capabilities to support the
endeavor, and I think given the richness and the amount of intention
that you\'ve put forward to this, warrants that.

A companion Website to that which is found on the AHIC Website, is also
one that\'s on the Secretary\'s Website that is supporting the broader
initiative overall, and that houses the RFI information, for example.
And we\'ll make this easy. It is easy, now, to go from one Website to
the other in terms of facilitating how you want to use certain subsets
of that information. And what we'll be \-- we\'re happy to get input
from you about how the subcommittees from this or the subgroups from
this working group utilize a portal system that we\'ll be developing on
Secretary\'s Website for community engagement that allows to you work
together on certain aspects of what you choose to do. So those things
are currently ongoing in their development. And then as a framework for
working we think that the electronic tools can be done in a timely
fashion that allows documents to be upgraded and turned around and will
spare you a lot of unnecessary e-mails. And we apologize for the methods
in which we\'ve been doing this now, we\'re trying to catch up and keep
up with where the activities of the working group are going.

We\'ll be discussing in about two weeks with the co-chairs the findings
from our visioning exercise and have a draft for them to consider. And
our next Workgroup meeting is on April 17th which is about a month away.
We would think that we would have a draft from this ready for people to
start looking at and beginning to shape in terms of some aspects of
priorities of where you would want to go and I think we should have
that, some elements of that discussion today.

I wanted to point out that next Friday the Secretary will be speaking in
town here and reflecting upon his work in the last year on personalized
healthcare and how it connects with other initiatives and we\'ll
certainly keep you posted on some aspects of that.

One of the things that we\'ve been doing that might be a useful tool for
you in your deliberations is a characterization of what the related
activities within the Department are that are supporting the development
of not only the science but some of the other infrastructure
capabilities, the other advisory committees, and the work that they\'re
doing. There will be a number of participants here on the Secretary\'s
Advisory Committee on Genome, Health, and Society has a number of
reports that are coming due that I think that have components of this
element that what we don\'t want to do, as Betsy and others have pointed
out in this meeting, is replicate and do the work that others have been
doing.

I think that a number of questions have come up today in this discussion
about should this just be narrowly defined, in terms of the broad
agenda, to the electronic health record. We see, I think, that the
broader capabilities here really has to do with longer-range
applications of information utilization and the development of it. And I
think we\'d like to get some feel for you around the bigger global
issues that are show stoppers in terms of the direction of where we\'re
going with this for personalized healthcare and how recognizing limited
applications of what time you can commit to this and what we can
support, trying to develop some priorities, and I\'d like to hear some
reflections from this group today about how they want to use this body
going forward, recognizing we have some fairly good information now on
electronic health records themselves and family history in terms of the
status of these for standards. So we think that there are probably
opportunities to bring forward to AHIC in the next couple months,
probably, some thoughts about recommendations and a vision statement
overall.

But I\'d like to ask the chairs to engage in a discussion about some
aspects of how we\'re going to develop some priorities for the
Workgroup\'s activities and subgroups. We\'ve had one conference call
with the self-identified group of interested parties to share
information about where we are on confidentiality, privacy, and security
issues. And that has not gone forward in the context of we would like to
get additional input on how we want to formalize activities coming out
of this visioning process and moving forward. Then some discussions
about developing the clinical validity, clinical utility, and about how
information like this might have some focus of another kind of activity.
We think that the internal working groups that the Secretary has been
developing across the Department have been useful from the context of
bringing together those organizations and bodies that are responsible
for assessing and clarifying technical questions. It\'s doubtful these
will lead to, by themselves, as specific activities or changes in
directions without some formal activity engaged by a group like this
one.

What we\'ve been asked to do is to clarify various policy aspects of
current practices and the status of where current protections or
regulations apply. And that is in the context of the oversight of
genetic testing, for example and the same context of public protections
for genetic information. There are some aspects that the Secretary has
asked us to engage in in terms of how business is conducted within the
Department\'s agencies, particularly on the aspects of genomic
databases, for example. And we\'re happy to report on those to you as
Workgroups are ongoing. But I think we want to hear from this body today
just some initial impressions about how we see the products from this
vision statement going forward in terms of some prioritization of what
you believe to be the most important work that can be done here. There
may be recommendations that you have that are placed upon specific
agencies or organizations, and the context of this really should be in
the framework of advancing the capabilities of delivering personalized
healthcare in the broadest context of which AHIC has enabled us to work
as a group.

So that\'s kind of where we see things currently as we\'ve amassed a
fairly substantial amount of information and trying to provide clarity
on issues, whether they're policy related or on the status of current
aspects of projects. We think we\'ve developed a fairly comprehensive
compendium of activities ongoing in the department. There\'s so much, in
many ways so much happening that what we've served as a conduit for
connecting people and organizations as to where various activities are
taking place. We would like to be more of service to this group now in
terms of supporting specific subgroup activities or working group
activities overall. So I\'ll stop there and ask the chairs to chime in
and then perhaps facilitate a brief discussion of how we utilize the
products of the visioning session.

**[\>\> Doug Henley:\
]{.underline}**I\'ll take first stab and then let John jump. It seems to
me \-- I\'ll make two observations. In times of challenge with a
plethora of opportunities that are represented on those sheets of paper
on the wall, it\'s always helpful to come back to focus, i.e., the
specific and broad charge in terms of why we\'re here. And I also say
that in the context as a commissioner for the AHIC, certainly in getting
and keeping the Secretary\'s attention, and his constant reminder that
he has X number of days left in his tenure, that keeping some laser
focus on the specific charge and having some early recommendations that
get traction, I think then allows further progression into the broad
charge and the other opportunities that come from that.

Having said that, it seems to me that the next challenge, Greg, will be
to condense and summarize all this information from today and perhaps to
simplify, put it in two buckets. What are the near-term and nirvana
items that Mike has led us through today that relate to either the
specific or the broad charge in particular, and then the other bucket
that relates to important recommendations that may not necessarily be
germane to either charge, but yet are important for us to make comment
and statements about in terms of how that may relate to another AHIC
Workgroup or another part of the government or whomever that needs to
pay attention. Maybe Congress. And so forth. So that\'s my first initial
comments, Greg, in terms of that focus and see what John has to add.

**[\>\> John Glaser:\
]{.underline}**I think that\'s good, Dough. My general sense of timing
\-- it goes back to Kathy. What are we supposed to do by when? \-- is
probably between now and July we will get the vision statement out to
you all and that ought to lead to a couple of use cases that fall out of
that, that we can also provide off to the standards, the HITSP folks.
And my sense is you all have some timing in mind, that probably efore
summer gets too far along we ought to have use cases in the hands of the
HITSP folks to go off and do standards per the conversation we had with
them. But I think, frankly, between now and summer it will be really two
areas of focus, the vision statement, the use cases for the standards
folks. In the meantime, and in parallel with Doug, would take the other
issues that came through. It seems there are two that get a lot of
conversation, both the privacy aspect and the decision support, although
my understanding is decision support is broader. It talks about
educating consumers and providers, et cetera. Are the two big ones and
then collateral issues. We probably should lay out a timeframe through
the fall and through about this time next year by which we go after
those areas. I think it would be useful coming out of this discussion,
in both the two big ones, is four or five sub-bullets that say key
aspects of this. How do you help a patient find stuff on the Internet?
How do you sort of have a way of validating the knowledge base that
we\'re talking about? But there\'s four or five sub-bullets within that,
so just make sure we capture the key areas of conversation that need to
go on in those two, and then a list of other issues that would go
through. What I don\'t know is if we were to take from, I\'ll give you
guys an August break or something like that, as we go through September
through this time next year, what the rhythm, what it ought to be. If
you have day one on privacy, what do we talk about, what's the second
meeting and the third meeting. So how in the course of three to four
meetings we get closure, as much as we can, on a topic and how do you
interweave those and maybe we take the non-privacy, non-decision support
topics and sprinkle them along the way. Every now and then there\'s a
discussion dealing with warranting the clinical utility of the test. And
so, but I\'m not sure how to lay that out into a rhythm and a pattern
that gives us a structure and approach to dealing with these larger
ones.

But I think the next four months are reasonably clear and then we should
put together an outlines of a sequence and plan of a basic structure for
dealing with the two larger charter-specific issues and then perhaps
interweaving, rather than serializing them, some of the other issues.
That may be a little fuzzy but we can go I think in our meeting upcoming
we can walk through that kind of agenda and see what you guys think.

I do want to say, I thought the conversation today was terrific both in
terms of the breadth of perspectives and also everybody\'s willingness
to speak up and it was good. It was terrific. I look forward to more of
these things. Thank you all. And we\'ll have a chance to say that again,
just in case you forget it between now and an hour from now.

**[\>\> Greg Downing:\
]{.underline}**Thank you. I think that both of those comments I think
were really good, anticipatory guidance kinds of parameters and we do
owe you, I think, some soft, if you will, milestones of where we\'re
trying to get to. We\'ve been working very closely with the ONC staff
and perhaps the progression of trying to clarify with you the
intersections with, particularly on the privacy and security issues of
concern to us and that we don\'t want to hold things back in abeyance
when things may not be moving on track in some other areas. And I think
the same on the clinical decision support. There were a number of
conference calls and Carolyn\'s not on here now, I don't believe, but
with regard to a cross-section of other AHIC working groups, we feel
we\'ve been pushing this to some degree in terms of dealing with the
complex nature of the data that we have, we\'re not talking about simple
messaging necessarily, but longer-term visions of how to facilitate the
infrastructure development and characterizing some of that. There\'s a
little bit of a advantage to following behind in some people. As you can
see what ground they\'ve turned up, there\'s also, I think the
advantages of we\'re now trying to accelerate some aspects of trying to
get to some of these questions on clinical decision support, and I think
one of the documents that was distributed to you in advance was by a
Workgroup done last week, some of you \-- last summer \-- that some of
you may have participated in in some fashion. I know Betsy was involved
in the clinical decision support documents that have been published in
the past. I know we\'ll probably be doing a cross-cut of a number of
working groups in AHIC to address clinical decision support overall. So
we\'ll keep you appraised and updated on how that unfolds over the next
few months. And some of these are executive decisions within ONC
structure that will be presented to AHIC tomorrow and in upcoming
meetings. So I think that we\'ll do our best in terms of supporting
information flow in a bidirectional fashion with the other working
groups, as they're making progress, particularly in these two areas.

It\'s now at the top of the hour and I want to just see if there are any
other questions or comments about the visioning session we\'ve gone
through today. We have another full day\'s meeting, I think coming up in
September, if I'm not mistaken. I don\'t have the date with me, I
apologize. But this is hopefully a useful exercise for you and that will
give us insights how to make the next face-to-face meetings productive.
For those on the phone, or anyone here, do you have any comments about
this visioning exercise and what we can do in terms of a product from
this that will make it most useful for your work going forward? Any
thoughts?

Okay, if not, we\'d like to move on to the next session of this meeting,
in which we\'re really trying to heighten some of our experience and
knowledge base about what other organizations are doing and can you set
up \-- get the slides down? And for those of you that are online, you
should have the slide decks and we can pull those up. And maybe, I
don\'t have the information in front of me, but maybe Maren you can set
this up, I know you introduced yourself earlier, but some background
information of how you\'ve been gathering information and the reasons
that RAND is interested in this aspect of it?

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

I could just say that \-- I\'ve been at RAND for about a year and a
half. I trained \-- I\'m a physician \-- I initially trained as a
genetic counselor, then chose, went to medical school, chose internal
medicine as a specialty and then I also went on to additional training
in medical genetics and I practiced personalized healthcare, I think
that\'s what it was, genomic medicine for a number of years at Cedar
Sinai Medical Center in Los Angeles. I was the director of their adult
genetic risk assessment program. Mostly cancer genetics but also
cardiovascular, diabetes, other types of common disease genetics.

Then I went to the CDC for three years. I had a career development award
through the Association of Teachers of Preventive Medicine and helped
the CDC build their family history tool, family healthware, which then
morphed into the surgeon general\'s tool, at least the front end of it.
I\'ve been interested in family history for a very long time as a tool
to identify people at risk in the population, genetic risk but risk
overall as well.

At RAND I\'m interested in policy issues that relate to genetics. And
one of the topics that appeals to me is health information technology.
And they were kind enough to give me some funding to start looking into
this. So I\'ll talk a little about that today. Are the slides \--

**[\>\> Jennifer Macellaro:\
]{.underline}**This is Jennifer. When you want a slide, just go ahead
and say next slide. It does take a couple of seconds to refresh.

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

We need the slide deck loaded, please.

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

This is Jennifer. Can you hear me?

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

Yes.

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

The slides, I'm changing them, so when you need a new slide, just say
next slide. It does take a few seconds to refresh because of the
connection.

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

We don't have the deck loaded here.

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

Oh, you can't see it at all?

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

No.

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

Can you try hitting F5 on that screen?

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

(Inaudible)

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

Oh. So the question was about \-- RAND is a non-profit organization,
worldwide organization that does policy research in a number of areas,
objective analysis to help decision-makers, and there are a number of
different units related to defense, education, transportation, and I
work primarily in health. I think I\'m the only clinical geneticist. We
have other person who has a Ph.D. in human genetics but there are
hundreds of researchers and that\'s basically what RAND does. And RAND
stands for Research And Development. I learned that, too. Are we ready
yet? No, not yet.

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

We can project them here remotely, while we're showing them.

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

Jennifer? Hello?

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

Yes?

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

It\'s still not working.

**[\>\> Jennifer Macellaro:]{.underline}**\
It\'s going to be kind of hard for me to explain this. Are you sure that
you\'re logged in properly? It looks like maybe your connection dropped
off?

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

It shouldn\'t have.

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

It says we\'re successfully connected.

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

All I can suggest is that you try logging in again. I'm not sure. Is
anybody that's on the phone having any trouble seeing them or is it just
a problem in the room there?

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

We can actually hear the room echo.

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

The slides are fine, we can see the slides.

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

Well, we can\'t.

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

Are there print-outs of the slides in the room?

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

Why don\'t I get started while \-- okay, yes, okay, great. Put this on
slideshow mode. Okay. All right, the first \-- I just was going to talk
a little bit about why family history is the topic of discussion, but I
think that\'s been addressed actually. So we\'ll go quickly through
those slides and then I\'ll talk a little bit about familial risk
assessment and then the study that we just initiated in January at RAND
on genomics and HIT. This is the first slide for those of you not in the
room.

So why focus or discuss something as pedestrian as family history when
we have the human genome project and HapMap and all this nifty
technology? And one of the things I\'m just going to go over this,
family history is a very effective tool for helping us identify people
at risk for common chronic diseases. And it can also help in
facilitating diagnosis of rare genetic disorders. And for those rare
genetic conditions, single gene disorders, chromosomal disorders, family
history can reflect the genetic risk factors shared by affected family
members, and usually we can see this by observing specific patterns of
inheritance in the family. And then for the more common chronic
diseases, family history reflects that complex interaction of both
genetic and non-genetics risk factors that are shared by family members.
And typically we are not able to see a pattern of inheritance like
autosomal dominant, recessive, et cetera.

And the other, I think very helpful aspect about a family history tool
as a screening test is that you can assess a risk for multiple
conditions at relatively low cost. There is that time element. People
generally have easy access to their family history, and they believe
knowledge of their family history is important to their health. And this
was, that particular statement comes from a survey done by the CDC,
asking Americans if they thought that family history was important to
their health, and I think 96 percent of over 4,000 respondents to a
survey indicated that it was.

Most people are aware of many common chronic conditions in their family
members and accuracy of reports is generally high, but of course this
depends upon the specific disease and the age and education of the
person that\'s reporting. And family history serves as a primary
indication for predictive genetic testing, so we\'ve heard about BRAC 1
and 2, and that\'s how we identify people for whom this test might be
helpful is to look at their personal and family medical history. And in
addition, the context of family history is often necessary to interpret
results most, in an appropriate and most informative way. And then
finally, family history can influence disease management and prevention
for many common chronic conditions.

Now, and on this slide I\'ve listed not all, but many of the conditions
for which family history may influence or help diagnose or change
screening guidelines and/or management. And the level of evidence of
course for each of these may vary, some of it unfortunately may be what
you would call expert opinion. But others there is a rather high grade
of evidence suggesting that knowledge of family history might help
change the way you manage a patient, so not that one size fits all
approach.

Now, what do we need to really assess family history, to do this risk
stratification? And it\'s truly not enough just to say positive or
negative. This is not a binary type of information. And the worst is the
noncontributory. I don\'t understand that terminology, but, so what you
really ideally, and this is a list and there may be things list missing
here but what I could come up with is that ideally you\'d like to have
information about disease status in relatives. And of course a relative
can have more than one disease, so we need to be able to capture that,
age at diagnosis or age at onset of signs, symptoms, condition, very
important. Typically, people at younger ages have more of a genetic
risk. The type of relative is important to be able to identify.
Sometimes the sex of the affected relative. Lineage of effective
relative, especially if you want to pick out patterns of inheritance.
Mother and father ID. So if somebody reports about a niece, nephew, or
cousin being affected, it\'s very helpful to know whose parent was that
relative. Because that\'s the way again you can track through the family
history and understand what side of the family the disease may be
traveling on. Ancestry, or country of origin, because as we\'ve heard
with, for example, cystic fibrosis screening, it\'s helpful to
understand what people\'s background is to maybe know the right test to
order. And then it would be helpful to be able to capture genetic test
result information that would travel along with the family members
identified. And then additional information, but I don\'t know that
it\'s necessarily critical to risk assessment, is knowing whether that
relative is alive or dead. Knowing their current age or age at death.
And it certainly would be helpful to know if I reported schizophrenia or
breast cancer in my aunt, was that just my self-report or was I able to
obtain medical records to verify that diagnosis. I think that would be
very helpful information in the record. And then certain psychosocial
issues, maybe family dynamics that might help a clinician understand
maybe some of the limitations of the data that\'s reported.

And so on this slide I just wanted to go over really quickly that asking
the right question is extremely important. So the arrow was pointing at
the index (inaudible) pedigrees and I guess it\'s your upper far left,
basically is if we were just to ask about first degree relatives with
let\'s say breast cancer, if I was trying to understand risk for breast
cancer, then I have a mother with late onset and it\'s probably not too
much of a concern. But if I then expand that out and ask about second
degree relatives now I\'m capturing paternal relatives with early onset
disease, at least in that aunt. And if I also expand the questioning to
include other conditions that I know are related to breast cancer, like
ovarian and possibly prostate cancer, now I can see a pattern in this
family that\'s consistent with the very high hereditary risk. So asking
the right questions and capturing that is really important.

And then pattern recognition is important when there is genetic
heterogeneity. So again, breast cancer is an example. Not all strong
familial risk is due to the same (inaudible), and here we have three
different family histories, each consistent with a different form of
hereditary breast cancer. Maybe (inaudible) syndrome on the upper left.
BRCA 1 and 2 on the upper right, and (inaudible) on the bottom.

So in thinking about this when I was early on in my career, I came up
with some general rules for stratifying familial risk and they\'re
outlined on the slide. I went to the literature and my mentor wrote a
whole textbook on common chronic disease, she was an editor with some
other folks. And just basically tried to get a real sense of what are
the family history criteria that are associated with different levels of
risk. I won\'t go over the details of the slide. But there is a huge
amount of literature about this. And it will vary from disease to
disease but in general these are some of the basic characteristics.

Now, how are docs doing? You may have already had discussions about
this. There has been a lot written about what physicians are able to do,
what they don\'t know. A study done by Louise Acheson a while back now
looking at family history collected in family practice found that about
half of the time it\'s collected during new visits, and 22 percent of
the time during established visits, and I think that\'s good. It\'s not
terrible. One of the big problems, though, is given the limitation of
the time during those visits, family history is very minimal. Only two
and a half minutes. So that\'s a problem. And physicians overall just
don\'t feel prepared to deal with the family history data and often fail
to recognize high risk family histories.

So overcoming those obstacles, I think we\'ve had this conversation how
EHRs can help standardize the collection of family history and in a
structured way, organizing it in a usable form, and also incorporating
genetic tests ordering and results along with that. And that the
clinical decision support for familial risk assessment and pattern
recognition, and referral for consulting and testing when it seems to be
indicated. And also helping to interpret test results. So this is the
discussion this morning.

Now, I think what I\'ll do is, we\'re getting close to that because I
know we\'re running short on time, so given, this is the potential that
aid and diagnosis of rare genetic disease and assessing susceptibility
to common diseases, improving access to appropriate to diagnostic and
preventive genetic testing, increasing the accuracy and completeness of
family history, especially I think when a personal health record is
available, that can populate the EMR. Facilitating discussion about
health promotion and disease prevention between patients and providers
and family members, and improving disease management and prevention by
both patient, especially again with the permanent health record
self-management.

So the study at RAND, as I said, this is very early on, so I hope I have
a chance to tell you more when I have much more information to share.
But the aim was to begin an in-depth understanding of the state of the
art in EHR products regarding collection and organization of genetic or
genomic information, related clinical decision support, and stakeholder
needs and interests. The main data that we\'re collecting is coming from
the semi-structured interviews with representatives of stakeholder
groups, primarily I\'ve been focusing on the vendors of the EMR, and
PHRs, and the clinical decision support. The commercial vendors. Also,
genetics professionals and primary care providers. The data I have right
now is mostly related to what I\'ve learned from vendors. We\'re also
going to look at the literature carefully, search the Web, and going to
lots of conferences, meetings, to try and understand about the industry
as a whole. And analysis of qualitative descriptive work. We\'re going
to look at themes and contrast between stakeholder groups and policy
implications, hopefully identify barriers and potential mechanisms to
facilitate adoption of genomics or HIT. I\'m glad I used facilitate
instead of encourage.

Okay. So these are the questions we\'ve been asking. I've paraphrased
them a bit. So we\'re characterizing the people we\'re interviewing but
in addition we\'re asking this of pretty much everybody. How is family
history collected? If structured data is collected what elements are
included? How is data entered? How is data organized? Is there clinical
decision support for pedigree analysis and risk assessment? Are genetic
test results for family members captured? Is security and access
permission different for family history compared to other information?
And then with respect to genetic tests orders and results, is there any
special way of handling this in the EMR? What coding is used? Is
indication for the tests noted? Is there clinical decision support for
the tests, interpretation and again the security and access permission.

Some more big picture questions: what are the barriers, if any, to
including family history and genetic test information in EMR and PHRs?
How has the market reacted to the increasing discussion of
genetic/genomic medicine and has this translated to changes in data
input or other requirements? What is the impact of HIT on genomic
medicine and how do you see that changing in the next five to ten years?
And then the other question, what is the impact of genomic medicine on
HIT?

So this is what we\'ve learned so far. And a lot I learned just, I guess
it was the last week or week before at the HIMSS meeting, where I went
around, there were 900 exhibitors, it was huge, I couldn\'t believe the
extent of what was there in terms of the commercial vendors, and I went
to as many as I could, asking them to demonstrate their products. And
then I've interviewed about a dozen or so, more in-depth interviews
taking up to 60 minutes.

So I\'ve learned that family history is always part of the record, that
every vendor I\'ve talked to has a way of ascertaining this in a
structured way. But they also offer text format. And the vendors have
found that physicians generally prefer the text format. And again, I
think it\'s just a matter of time and docs prefer that. They don\'t see
a value of doing it in a different way, in the structured way.

That when I asked about specific data elements, basically the answer I
get back is that we can do anything you want. Just tell us what you
want. And when I see, when I looked at the off-the-shelf products at the
HIMSS meeting, when I saw what was, the structured data that was there,
it was interesting that some took the approach of first inquiring about
a disease, followed by the type of relative affected with that
condition. Others started with the, a relative and saying okay, what
disease or diseases does he or she have. I suppose you would be able to
get at the same information either way although, I don\'t know which way
is better or if they\'re both the same. And I think one of the problems
with the former is that a relative can only have one disease, and so
when you\'re trying to share family history data across applications,
you run into this problem of knowing, well, did I have four brothers
each having heart disease, one having stroke, one diabetes, one
hypertension, or did I have one brother that had all four. And I think
that could make a difference in the risk assessment, so this is a bit of
a problem. And age of diagnosis or age of onset was very rarely included
and when I mentioned that that could be helpful in risk assessment, the
people I spoke to were, this is news to them. But I can understand that.
The type of relative usually included, I saw sibs, parents, children,
and grandparents. I rarely saw aunts and uncles captured, nieces,
nephews, and cousins, never. Paternal and maternal usually was
delineated. And then current status, and current age or age of death
were sometimes included. These are those off-the-shelf products. So I
think if we were to, if you all were to suggest certain standards on
data elements, it would certainly help the industry in making sure stuff
was there that should be there.

What is not captured was this concept of have I verified that medical
history in that relative. You know, when I asked about how I could
capture that, they said fill it in in the text. So it couldn\'t be used
for clinical decision support. Same thing with laboratory results.
Ancestry, country of origin, twin status, if you\'re adopted,
step-relatives, et cetera. And none of the programs did a pedigree
drawing. Everything was presented in a graphical format which may be
just fine and certainly should be for clinical decision support.

Patient portals are available, however, without any standards for family
history, data elements that other useful for populating the EMR I really
couldn\'t see it. And clinical decision support for familial risk
assessment and pedigree analysis, no one even had thought about that,
really. And no special security or access rules for family history. But
again I was told this could be customized similar to what can be done
for psych or HIV status. And I found it interesting, I went to the IBM
booth where the NHIN\'s personal health record or whatever, I think it
was a prototype of some kind, and they had, I saw the way they collect
family history and asked about the relatives first and last name, date
of birth and then the disease that they had. And then when you can go
and say okay, I want this to go out to that network of networks, so it
can be used for research, it would de-identify my information, but it
wasn\'t clear that when I had entered my aunt Sally\'s first and last
name and date of birth, that that was de-identified, and that that was
stripped away. I asked why that was needed in the first place. It
wasn\'t clear to me.

Other things we\'ve learned, most handle, most EMR vendors handle
genetic test orders in a fashion similar to other lab tests. You know,
they just use whatever codes are available. One of the problems with the
results that I\'ve heard is that results are often received in text
format and so again clinical decision support is really impossible.
Indication for testing can be included, that\'s no biggie, they claim
using ICD 9, but of course those are not ideal for most genetic
conditions. Clinical decision support, again was lacking and no special
security or access in the off-the-shelf products.

So some of our early impressions with what we\'ve learned, barriers to
collection of structured family history data, the time to interview, and
input the data. So doctors will choose that text format of mother breast
cancer, rather than go and click in a structured way within the record.
That is the impression I\'m hearing at least and I still haven\'t talked
to the docs yet, so I need to do that. But this is what the vendors are
saying. So I think a PHR could actually be ideal in he remembers it of
collecting this information, but it has to be interoperable. And then
the other is this impression that family history information does not
provide actionable information. And so why should we really be focusing
on this or, because it\'s not really helping with clinical care. That\'s
sad. Lack of specific coding for genetic test results and receiving the
results in text format hinders clinical decision support, which I\'ve
mentioned. Genetics/genomics doesn\'t appear to be a current focus of
the market. But I think everybody is thinking about it in next five to
ten years. That was my impression.

So I think this is my last slide. Stakeholders, I think now we need to
inform them about the known value of family history and genetic testing.
That there are things that are actionable that we can do today. Data
standards, we\'ve talked about that. You guys are focusing on that. For
family history, for sure. And genetic testing. Clinical decision
support. Specific codes. More research for defining the validity and
utility of both family history and genetic test results. And standards
for the privacy confidentiality and security of family history and
genetic test results. That\'s it. Thanks.

**[\>\> Greg Downing:\
]{.underline}**Questions for Maren? Mark?

**[\>\> Mark Rothstein:\
]{.underline}**I just have a brief question. That is, whether you have
any research on the accuracy of patient reports that are included in
family histories. I mean, you ideally want to have a three-generation
family history. What percentage of patients are able to actually
construct that and are there studies on verifying through records, death
certificate checks, the accuracy of their recollections?

**[\>\> Maren Scheuner:\
]{.underline}**You know, I\'ve written a lot of book chapters and papers
and grants where this question comes up repeatedly, and so I\'ve had to
go to the literature, and it does exist for cancers and heart disease
and diabetes and stroke. We understand the analytic validity of those
self-reports of disease and usually first-degree relatives. When you get
beyond that people haven\'t been asking, except for the cancer. So it
depends upon the disease. But the literature is out there. So for breast
and colorectal cancer, the analytic validity is quite high. The same is
true for diabetes and coronary heart disease. Where it's not so good
would be things like ovarian and endometrial and cervical cancer, they
sometimes get all confused. But that type of work has been done for
decades. And I\'m not saying we\'re done doing it but people have
definitely researched that. And in building the CDC tool, that was one
of our criteria. We had eight criteria for which diseases should we
include in the CDC tool and we decided that, well, we want to have some
sense that what\'s reported has a reasonable level of accuracy. So we
won\'t include conditions where we know people don\'t do a good job of
reporting.

**[\>\> Mark Rothstein:\
]{.underline}**Is there any sense that over time it\'s improving?

**[\>\> Maren Scheuner:\
]{.underline}**I think that\'s one of the goals of this surgeon
general\'s initiative, the public health initiatives, is to make people
more aware of how important it is to know about their family history. So
that accuracy does improve. And I would think maybe one day \-- we
didn\'t really talk about this but if you\'re sharing your PHR with your
aunt and your cousin and it\'s basically their PHR and mine and it just
kind of merges so we\'re getting hopefully more accurate information
that way.

**[\>\> Greg Downing:\
]{.underline}**Maren, let me just ask, are there ways and public
activities that RAND will be engaged with that our working groups should
be aware of as this project goes forward and potentially how we can
incorporate some of the work that you\'re doing into as a resource for
this working group?

**[\>\> Maren Scheuner:\
]{.underline}**Well, aside from, you know, these are my little pet
projects at RAND, so I think that they\'re going to be thrilled that I
was able to speak to you today, and it\'s like a win-win for me because
I\'m able to share with you what we\'re thinking about, and when I go
back it\'s like, oh, I\'m glad, they\'re always glad to know that the
work that's being done might actually influence some decision-making.
So, but aside from my pet projects, I think the big project at RAND is
this personal identifier for RHIOs and how are we going to actually
share data that\'s de-identified but in a longitudinal way? So you have
to develop some type of personal identifier. And so there\'s a big group
of people at RAND working on developing algorithms for that. But, and
there\'s a lot of work on quality of care issues as well that relate to
all the work that you\'re doing.

**[\>\> Greg Downing:\
]{.underline}**Okay. Well, thank you. We\'re going to move on to our
next presentation. Jennifer, if could you load that for us, please. Let
us know when you\'re ready.

**[\>\> Jennifer Macellaro:\
]{.underline}**I\'m seeing. Are you guys seeing it there?

**[\>\>\
]{.underline}**We have it on our laptop here. So for those online,
we\'re moving to the next presentation as introduction to the DOD AHLTA
system. And we have a guest presenter today, Dr. Mark Hamra, who will do
a little background and introduction on what this presentation is about.

**[\>\> Mark Hamra:\
]{.underline}**My name is Mark Hamra, I work with the Department of
Defense. Dr. Do couldn\'t be here today. His wife had a baby, and so he
got a pass. One of the things that we\'re going to have a problem with
is my presentation is different than Dr. Do's and I found out yesterday
that I was going to be with you so I took two two-hour briefings and
turned them into hopefully a 25-minute briefing. The folks online are
going to miss out on the second half. We'll get them those slides later.

I am a family practice physician. I practice in the Air Force, and also
have a background in IT. And became involved in the AHLTA project and
have since left the Air Force, I practice medicine three days one week,
two the next, in a family practice clinic that uses an EHR. But I still
come to D.C. and I helped develop AHLTA.

So let\'s get into using the looking at the current program. I'm going
to give you some background on what we do. Most folks don\'t realize,
you think of the military, you think of guns and tents in the sand and
that\'s where healthcare is delivered. It\'s also taking care of
beneficiaries and I\'m not going it hit every point on these slides,
because we\'re short on time. The important thing is over half a million
outpatient encounters in a week, hospital visits, dental seatings,
prescriptions, labor and delivery. This is, we take care of
beneficiaries and it\'s a cross-section of any other population that you
would see. That that is still just military medicine.

We do have to consider theater so what we\'ve built is a platform that
is seamless around the world. You can accession someone into the
military, train them, get them ready for battle, they deploy. In
theater, if they\'re injured, we currently have handheld devices where
the care begins. These are beta-tested right now in Iraq. They\'re
called BMIST and it's a handheld device that people on the battle field
are documenting care through a point and click method. Very simple but
integrated into our theater version of AHLTA. This is a stand-alone
version, looks just like the version we use in the continental United
States or in garrison. So you fight as you train. However you\'re living
at home, it looks just like the EMR you use in the field at that point,
att battalion aid stations. So that data is transferred, it's
beta-tested, it's interesting, that data was being transferred by little
scancisk chips. They don\'t hold up so well in the sand, the contacts
tend to go back rather quickly. So now they're working with RIF, radio
frequency technology, in dog tags.

So you\'re deployed, injured, Medevaced home. The data is actually
beating the soldier home.Before they even get here, it\'s back to the
CDR, it\'s local, and can be accessed from anywhere in the world. So
it\'s seamless throughout their life cycle. We\'re working now in
sharing that data with the VA. The current VA/DOD projects have
successfully integrated allergies to medications and medications
themselves. Including outside PSD is a project with Eckerd and CVS. We
can actually pull in that data as well. So our medications are pretty
robust right now.

AHLTA is fully deployed, it's around the world. Really the interesting
part of this slide, the thing you need to look is the bottom number.
Went to the CDR, you know, three weeks ago and pulled four days worth of
data. We\'re getting over 100,000 encounters a day loaded into the CDR.
So the amount of data we\'re capturing is huge. And remember that, okay
that encounter is structured for us. And I\'m going to show you how that
works and we\'ll talk about some of those numbers as well. In theater,
three quarters of a million encounters are in the CDR. In December alone
we had 30,000 encounters logged from around the world.

I\'m going to show you how our structured documentation works. Again,
this data was pulled just at the end of last year. We went and queried
the CDR, and a million structured terms a day, and some 100,000 abnormal
findings were captured. So that data is obviously good for many things,
whenever you have it in a structured format. Most important, for us, is
switching from syndrome surveillance or tracking ICD codes, because when
you\'re busy and in a clinic, they can have fever, malaise, body aches,
and a cough, but you just put cold, when they have influenza. So to have
symptom surveillance to catch those things specifically, is what we were
looking for. We\'re tasked to avoid the next Gulf War. Or to be able to
track it. And understand it. Obviously bioterrorism surveillance,
disease management, population health. These are also very important.
This is not the department I work in. But you can imagine that
structured data can be used for any of those things, numerous others.

Okay, so usually here we do a live demo. I\'m going to show you some
static slides that I just threw together this weekend. This is the
actual application in the first part of the demo and then towards the
end I\'ll show you what\'s coming later this year. That is an overview
of what AHLTA looks like. It\'s a desktop view. You can see it\'s a
familiar format. The folder tree on the left looks like your Outlook
bar. It tells you how many consults you have, phone consults, what
tasks, how many tasks you have or need to address. You get down to the
patient\'s name \-- and let me mention this is a training system, all
this information is fictional. This is, none of it is real data. \-- so
Mr. Suarez here, we look at his chart, pay attention to the health
history. And specifically right underneath that problems, because I know
what you are talking about is family history so I want to address that a
little bit and how we capture that information. What we do well and
where we fall short, it\'s been very interesting listening to you, quite
informative. And I can tell you where we lack in a couple of areas.

We do use templated forms for some of our documentation and the template
you\'re looking at right now is just vital signs. In AHLTA, we tend to
build tools to satisfy a concept of need, instead of building a static
image. So instead of hard-coding things we tend to build tools to let
people build things. What I\'ll show next is a list of terms from our
structured documentation. You could put it in this format and have
little radio buttons and point and click through it. Those are an
alternate way of entering information.

Here you see that. Medcin is our clinical documentation tool. Several
hundred thousand individually or uniquely identified clinical concepts.
There\'s only one way to say substernal chest pain that radiated to the
left arm. Whereas with something like SNO-MED, which concatenates many
terms, you could say left arm pain that radiated from the substernum and
now it\'s different. So using this structured text we get structured
data and this is where everybody looks at it and goes oh, well, that\'s
where it breaks down. And we found that this is the hardest place to get
physicians to adopt, because you\'re changing natural language on them.
And you have to do, we found two things. One is there are certain areas
where it works better. Physical exam. All humans are kind of human-like.
You know, it\'s not veterinary medicine. So you can get a physical exam
and you can structure that. Family history, social history. These things
are templated and templated well. You start getting into symptoms and
history, HPI. We just tell them to type it. We give them voice
recognition, they can speak it. Use natural language there. Just trying
to get them on the right path. Because structured documentation works
well in some areas and it doesn\'t in others.

Templates are one of the keys for structured documentation. You have
several hundred thousand terms, nobody can sift through that list. So
what we\'ve learned, and people build massive amounts of templates. You
should see in my civilian clinic the amounts of templates our EMR has
developed. There are thousands of them and so they\'re not very useful,
you can\'t find what you need. What we found at the DOD, is encouraging
people to build a default template. One template that fits most of your
day and then teach them how to work around that with a mixture of free
text and dictation. We\'re getting a step towards the structured text.

The other thing we found is that primary care does use it. Despite all
the squealing that you hear from the field, we\'ve run analysis in some
68 percent of primary care, that's pediatrics, family medicine, internal
medicine, has nine or more structured terms in the SO, in the
symptomatology and physical findings. So they are using it. For
surveillance that\'s good, that\'s what we want. Great, the plastic
surgeon is not using structured text. Okay. You know, and so to make
these blanket terms everybody should use structured text. We've found
that that just doesn\'t work. You've got to let folks who can use it,
use it. And you'll find that a lot of them will adopt it.

For our structured family history, you can click on a parent concept,
and then right click on that concept \-- can you all see that okay?
Right click on that concept and then identify the individual
relationship to the patient, down to aunt and uncle. I don\'t think we
have cousins, do we? No cousins. And I\'m not sure about the last one.
Baby\'s father\'s history. I thought that was paternal. The baby\'s
father history. OB wanted it, they got it. We try to satisfy our users.
Reminds me of anything you want, we\'ll give you. Be careful what you
ask for. So through that right click functionality you can document
family history. Within an encounter that structured family history looks
like this. So this is within one encounter during a single outpatient
episode of care. That\'s okay, that\'s a good place to catch that but
that's not where it's useful. Where it\'s useful is longitudinally. What
you need is the whole family history. So here you see that and we\'ve
created two filters. One is sort by problems, here you can say here\'s
the diabetes and paternal grandmother had it, mother had it. The users
wanted to be able to group it by patient or family relationship or
member. Here\'s mom and all mom\'s problems. The nice thing about that
in our relational database, it means you compare them that way as well
whenever you\'re data mining. You can easily sort through that
information and get it any way you want.

The one thing we have been struggling with is that whole age of onset.
Since we\'re structured, we need to come up with the standard before we
deploy it and let people start to use it and our SMEs, and I sit in on
these meetings and running them actually and the SMEs are fighting. Some
want the actual age. The other side of the room says they can\'t
remember the age they got it, all we use is decade of life. One in the
corner says I don\'t even need that but I\'ll take it and I want to say
less than 50. I don\'t care if it was 30, 40. It depends upon the
disease. Now, so then you think, we'll give them all. Then you got a
list too long, won\'t fit in the dropdown. You got to figure out
compromises and so we\'re working on these things just like everybody
else.

This is future capability. This is coming in October. And this is the
thing, a tool set that\'s just going to be so useful in a clinical
setting, we hope. Excuse me, I\'m going to back up one second, and I
want to show you one other thing. I forgot to point this out. You see
the things in red, unverified patient reported data. We have on track
here on line, on TOL there are forms called hard and pre- and
post-deployment forms that can be filled out online and we\'ve
structured them using Medcin, just took the tools, built the form and
put on the Web, to allow people to fill them out. So the data's
structured, it gets imported, and we present it here or in other places,
so that you can right-click on it and if you\'re sitting with the
patient you can verify that information and it becomes part of the
permanent record. It changes the status over, it says patient reported,
verified. Found the same thing you all have. Nobody uses it. We\'re just
not getting much crossover. There\'s not much data coming in. So why
folks don\'t use, it I don\'t know, we're in the same boat. But we have
figured out how to implement it into the EMR.

The other thing we did is for the information that the patient is just
self-reporting, with like a blood pressure log or a blood sugar log. We
are creating currently, there\'s a project to create a personal health
journal. So the PHJ will be a module in this folder tree on tje left and
that data will be able to shared specific list, can share or not share,
so you can keep a journal and keep it private, or share it with the
electronic medical record and any military provider can then view that
data. Where we can structure it, we are going to, and you can
right-click it and import it into the EHR. But that\'s a project in the
works. So we split it out into a couple of different things. One is
questionnaires where you self-report, patient self-report. Another is a
journal type entry.

Now on to clinical practice guidelines. This is what we call automated
clinical practice guidelines. This tool, I mean I sat down on Sunday in
between weed-eating and Roundup, I built this CPG. Because this is not
in the field yet, but we do have a working model. And I just picked
diabetes. And if you look at the top, under protocol, this is where you
can decide what needs to be done and when. So monofilament foot exam
every year. Hemoglobin A1c every three months. Dilated eye exam, so on,
so forth. Those are modifiable at the patient level. If I\'m seeing a
patient \-- because in this first generation, it will do if, then, but
it won\'t do if, then, and \-- what it will do, if they\'re a diabetic,
it will give them these four things and set up the schedule for you. You
can right-click on any of those or go to the module and say this
patient's well controlled, they\'re at 6, their hemoglobin is at 6, I
want to do it every 6 months because that\'s what the guidelines
recommend. And you can modify that for that patient right there and
it\'s in the record and no matter what physician they see, it\'s set
that way.

Next, questionnaires. So if you have something that you would like the
patient to fill out on a visit when they show up, if a patient is placed
on the registry, that questionnaire pops up when they check in. And they
can fill it out at a kiosk, we've found those don't work too well.
We\'re currently working with some handheld devices. But those are
projects in the workings. None are deployed.

Templates. When I was talking to you about the templates that you can
have a certain family history, you can have symptoms, physical exam.
Questions that need to be asked. You know, (inaudible) whatever you want
to ask. Those could be put into an enterprise-level template. And when
the patient is registered to the CPG, the clinical practice guideline
for diabetes, that template automatically inserts itself into my list at
the top. It doesn\'t really get in my way, I can still work underneath
it. It\'s a standard of care right there. And I can click on it and it
presents me with overprint. A paper overprint, only it's electronic.
Order sets don\'t need to be explained. I tells you, it presents you,
and instead of you having to search for A1c, whatever labs you want, it
presents with you those labs, asks if you want to give them.

The interesting part about this registration, these are the things, and
this is the automated part. If I\'m seeing a patient and their A1c is
greater than 7, and that's what I\'ve said is a registration trigger,
they\'re put on the guideline and all of these flags are set, these
reminders are just turned on, and I can manually turn them off. But if
the enterprise determines that\'s a standard of care, that\'s what\'s
going to happen. If they\'re given, the diagnosis of diabetes, puts them
on the registry. If they bring me a piece of paper from outside, I can
click in file, I can put them on a registry, search through the list,
and place them. So it\'s automated and manual.

The next thing was to implement it into the workflow. You see the
reminders in the bottom left? We thought great, we\'ll put it there,
everybody will use, it it\'s right, there you can see it. They all
ignore it. No one touches it. In an effort to place it more in the
workflow, we\'ve decided to go with the dreaded pop-up. We all hate
pop-ups. I think they\'re evil, but we needed it here, and here\'s the
compromise, here\'s what we did that we think is smart and we think is
going to cause people to adopt instead of resist. This is a filtered
pop-up. If you\'re in the ER, and this CPG has been set for primary
care, it won\'t come up. You won\'t see it. If you\'re in orthopedics,
you won\'t see it. If you\'re in primary care, you\'re going to see it.
But you\'re not going to see the other, there's sexual tracking, sexual
abuse tracking registry, you won\'t see that. That will only be for
psych. They\'re the only ones who will see that registry. We\'ve tried
to implement it into the work flow. And you can turn this off. You can
turn it off if you want to use the reminders. This allows people to put
this into the workflow and have some customizability to it. Make it
available but not a nuisance. You don\'t, if someone is on three
different registries because they\'re very ill, you\'re going to get a
list here that\'s unmanageable. So we filter it. So you only get the
things pertinent to your clinic. We hope that's a step towards making it
more useful. Any questions about AHLTA? I gave you just the stuff I
thought would be pertinent to this group. Two hours of briefing we just
went through.

**[\>\> Greg Downing:\
]{.underline}**I think that\'s a good overview. Are there any questions
from AHRQ, or anyone on the phone? Marc?

**[\>\> Mark Hamra:\
]{.underline}**My apologies to anyone on the phones.

**[\>\> Greg Downing:\
I]{.underline}**f not, we should see if there\'s anyone \-- if there\'s
anyone on the phone bridge that has any questions or comments about
today\'s deliberations. Jennifer, are you there?

**[\>\> Jennifer Macellaro:\
]{.underline}**I just put a slide up with the number that people who are
just following along on the Web can call in. Anyone who has already
called in, should press star 1 to alert the operator. There\'s an e-mail
address if anybody would like to leave messages after the meeting today.
And I\'ll check back with you in a few minutes and let you know if
anyone has called in.

**[\>\> Greg Downing:\
]{.underline}**While we\'re doing that, I\'m going to turn to the chairs
for any closing remarks or comments or any of you that have closing
remarks that you would like to make.

Kristin\'s been the one distributing the input to you, in preparation
for this meeting. It\'s Kristin Brinner here to my left, if you haven\'t
met before. And we\'ll take comments or your feedback internally for the
visioning session, should go directly to Kristin. And for those of that
you are online and not here, it\'s kristin.brinner@hhs.gov.

**[\>\> Kristin Brinner:\
]{.underline}**You've probably gotten more e-mails from me than you want
to, so I'm sure you have my e-mail address.

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

Thank you. Doug and John?

**[\>\> Doug Henley:\
]{.underline}**Well, John and I when we got together first thing this
morning and looked at the agenda, we kind of laughed and said, this is
the co-chair\'s dream. We\'ve got great staff that has put this meeting
together. We had Mike to do the facilitation, all of you bright people
to do the hard work, and we get all the credit. So I want to thank you
for that. And recognize the good work of staff as well as Mike, he had
to leave early, and all of you again for your input. I share John\'s
observation and others that a lot of good discussion and brainstorming
today I think that will help us a great deal in the coming weeks and
months. Thank you for that. And look forward to continue working with
you in the future.

**[\>\> John Glaser:\
]{.underline}**Well said, I have nothing to add.

**[\>\> Greg Downing:\
]{.underline}**We look forward to hooking up with you again on the 17th.
We want to thank all of you for coming today. Hopefully the face-to-face
activities will help us work together as a team in developing actionable
items to come. I think all of you have made an impression upon us that
you really want to do something from this group. We think that those are
efforts that we can bring forward to AHIC and to ONC in helping us
facilitate the efforts behind this. And I know the Secretary is going to
be very interested to know what we\'ve learned from this and has the
impact on the overall initiative as well. So we\'ll be certainly
communicating the broad issues that you\'ve brought to to us, and to
him. And we\'ll do our best to make the work products from this useful
to you as a tool in defining the path forward. Thank you all for coming
and look forward to hearing back from you about this. Jennifer, I think
you can close now.

**[\>\>\
]{.underline}**Thank you.