American Health Information Community

Personalized Healthcare Workgroup Meeting #4

Tuesday, April 17, 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 HHS; nor does mention of
trade names, commercial practices, or organizations imply endorsement by
the U.S. Government.*

**[\>\>\
]{.underline}**Okay, Judy, we\'re ready to get started.\
\
**[\>\> Judy Sparrow:\
]{.underline}**Thank you, and welcome everybody to the fifth meeting of
the Personalized Healthcare Workgroup. Just a reminder that this
Workgroup is designed to meet the requirements of FACA. It\'s being
conducted in the public domain. The meeting is being broadcast over the
Internet and the summary will be available within the next week. Also,
at the conclusion of the meeting there will be opportunity for the
public to make comments. And a reminder for Workgroup members to speak
clearly and distinctly and please identify yourself as you speak.
Let\'s, Jennifer, if you could introduce members on the telephone and
then we'll go around the room and introduce those of us here at ONC.\
\
**[\>\> Jennifer Macellaro:\
]{.underline}**Sure. On the phone we have one of your co-chairs Doug
Henley, from the American Academy of Family Physicians. Michele Puryear
from HRSA. John Loonsk from the ONC. Beryl Crossley from Quest
Diagnostics. Armando Oliva from FDA. Deven McGraw from the National
Partnership for Women and Families. Janet Warrington of Affymetrix.
Steve Teutsch from Merck. The other co-chair, John Glaser, from Partners
HealthCare. Betsy Humphreys, NIH. And Lisa Rovin, FDA. Did I miss
anyone? Okay, and Judy, just so you know, we\'re having a little trouble
with the slides but we should fix that soon.\
\
**[\>\> Judy Sparrow:\
]{.underline}**Okay. Thank you, and here in the room we have.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**Alan Guttmacher from NIH.\
\
**[\>\> Paul Cusenza:\
]{.underline}**Paul Cusenza.\
\
**[\>\> Mary Beth Bigley:\
]{.underline}**Mary Beth Bigley from the Office of the Surgeon General.\
\
**[\>\> Kristin Brinner:\
]{.underline}**Kristin Brinner, Office of the Secretary.\
\
**[\>\> Greg Downing:\
]{.underline}**Greg Downing, Office of the Secretary.\
\
**[\>\> Judy Sparrow:\
]{.underline}**Okay, with that let\'s just turn it over to Dr. Glaser
and Dr. Henley.\
\
**[\>\> Doug Henley:\
]{.underline}**Thanks, Judy. Welcome, everybody. John and I would like
to welcome everyone, as Judy did earlier, to this particular call. As
you know, we have got a three-hour time segment to complete our
business, and we certainly will not go over that. And perhaps with some
efficiency we might even do better than that. Again, I would just remind
everybody to try to keep your phones muted if you can, if you aren\'t
speaking, but let us know when you do have something to say and as noted
earlier, please introduce yourself each time that you speak. Everyone
should have gotten the agenda materials by e-mail, earlier this week,
from Kristin and Greg. The first item \-- John, any comments you have?\
\
**[\>\> John Glaser:\
]{.underline}**No, Doug, just fine.\
\
**[\>\> Doug Henley:\
]{.underline}**The first order of business, we forgot a bit of
housekeeping last time in terms of approval of the summary from the
February 21st meeting, as well as the March 12th meeting today. So I
would ask first, are there any potential additions, corrections,
deletions, to the February 21 meeting summary from the Workgroup? All
right, hearing none, without objection, we will approve those.

Next we\'ll go to the March 12th meeting that we had face-to-face in
D.C, for most of us. And again, would ask for any corrections,
additions, or deletions. And hearing none there again, absent objection,
we will consider those approved as well. Thanks for that.

The first item of business gets into, you recall at our March 12 meeting
we had a review of the charges of the Workgroup, both the broad and
specific charge, and during our conversations came up with some
potential suggested changes which we tried to capture in the second
document, or I guess the third document that was sent to you with the
agenda materials, and this is the one that shows the current charges and
then the suggested changes through strike-through and the addition of
new language.

So first let\'s focus on the broad charge and the suggested changes that
were discussed at the last meeting are reflected there in both the third
and the fourth line of the broad charge. Any comments, suggestions from
the Workgroup? All right. Hearing none, I\'ll take that as a sign of
general agreement, so is there any objection to accepting the suggested
changes to the broad charge? Hearing none, we\'ll consider that
approved.

And then under the specific charge, again you can see in the third line
the suggested addition, change and addition. John and I did have a
comment here for the group to consider. We did not feel it was necessary
to have both genetic test and genomic test and that perhaps it\'s best
just to consider one of those phrases versus both of them. And I think
both of us were inclined to say genomic test and family history, but
certainly would be open to using genetic test versus genomic test, but
would like to hear conversation from the Workgroup.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan Guttmacher. I agree with you that only one
term would suffice. To keep it parallel with the previous paragraph
where we say genetic information, I might opt for genetic test in this
paragraph as well.\
\
**[\>\> Doug Henley:\
]{.underline}**Thanks, Alan.\
\
**[\>\>\
]{.underline}**I would concur.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay. So hearing \--\
\
**[\>\> Betsy Humphreys:\
]{.underline}**Doug, this is Betsy.\
\
**[\>\> Doug Henley:\
]{.underline}**Go ahead, Betsy.\
\
**[\>\> Betsy Humphreys:\
]{.underline}**I just, I don\'t really have a strong objection to this,
and I certainly will defer to Alan, but it just seems to me that very
often in people\'s minds, genetic tests means the ones that are really
routinely done or frequently done now and genomic test means, or genomic
information means perhaps the complete individual patient genomic
(inaudible). So somehow genetic test seems narrower to me.\
\
**[\>\> Doug Henley:\
]{.underline}**Comment from the group on that?\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan \-- (inaudible).\
\
**[\>\> Doug Henley:\
]{.underline}**We\'re having some feedback.\
\
**[\>\> Betsy Humphreys:\
]{.underline}**What did you say, Alan?\
\
**[\>\> Alan Guttmacher:\
]{.underline}**I\'ll try again. I would agree with Betsy\'s point. This
is the problem with inprecision. I personally think the term genomic
should never have been invented. It would make life much easier. Because
both terms exist, to some people genomic does imply the entire genome,
and therefore microarray and other kinds of tests fall more neatly under
that. However, the common usage seems to be to encapsulate all of that
under the genetic test.\
\
**[\>\> Betsy Humphreys:\
]{.underline}**And in most historic textbooks genomics was also captured
underneath genetics.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**In most historic textbooks genomics didn\'t exist \--\
\
**[\>\> Janet Warrington:\
]{.underline}**Well, we also have \-- this is Janet Warrington at
Affymetrix \-- we also have definitions from the FDA in their guidance
documents where they make a distinction between pharmacogenetics and
pharmacogenomics. And so I mean, I think as long as we come to some
agreement on what it means, make sure that it\'s broad enough, and we
define it somewhere in the document, I think we\'re okay. I think if we
restrict our use of the terminology and that gets misinterpreted in some
way as being restrictive, then I think we\'re going to have some
problems.\
\
**[\>\> Doug Henley:\
]{.underline}**Let me ask \-- these are great comments. Let me ask our
great staff. If we go with the word, or the phrase genetic test as
suggested by many, can we create some sort of a definition that
references what we\'re speaking about including genome and so forth?\
\
**[\>\> Greg Downing:\
]{.underline}**Yes, traditionally, and I think we actually used this in
the September 12th presentation to AHIC, so the National Human Genome
Research Institute's Web-based definition of genetics captures a large
sweep of everything, proteomics, metabalomics, epigenomics, and it\'s a
very broad definition. That\'s the one when we\'re pressed on it and
respond to questions, that\'s the reference that we use. I don\'t want
to really footnote the charges because that\'s (inaudible) but I think
we can certainly make available the interpretation of what genetics
means and use one of the definitions that\'s government-sanctioned, if
you will.\
\
**[\>\> Doug Henley\
]{.underline}**All right, with that information, how do Workgroup
members feel about that? Using genetic test with that definition being
there in the background but visible when we need it to be visible.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan Guttmacher again. That would certainly be
fine. Another option, I think we need to use the same, whatever the
usage is I think we need to have the same for both the broad charge and
the specific charge. Another option would be simply to put genetic slash
genomic information or test, depending upon the paragraph and therefore
include both clearly.\
\
**[\>\> Doug Henley:\
]{.underline}**All right. Wishes of the group to do both with a slash?\
\
**[\>\>\
]{.underline}**Well, I tend to prefer that simply because I feel that if
people see a particular sentence or paragraph or charge by itself
without reference to broader documents where our definition is included,
they may get the impression that we\'re not concerned about an aspect of
the issue or problem that we really are focused on.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay. So I think what we\'re probably referencing now is
both in the broad charge on line four, we would add genetic slash
genomic information and in the specific charge we would, on the third
line, we would do genetic slash genomic test and family medical history.
How do people feel in general about that suggested change?\
\
**[\>\>\
]{.underline}**Fine.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay. Looks like we\'ve reached some consensus on that.
Is there objection to moving in that direction?\
\
**[\>\>\
]{.underline}**I \-- (inaudible).\
\
**[\>\> Doug Henley:\
]{.underline}**We\'ll make those suggested changes and thanks for that
helpful conversation. I think that will be helpful to better explain
those issues both to AHIC and to other groups that we need to make
comment to. At this time let me turn things over to John.\
\
**[\>\> John Glaser:]{.underline}**\
Thank you, Doug, and apologize, I\'m on the tail end of a cold here, so
I may sound hoarse. If I start squeaking, you'll understand. We have two
major pieces of writing in front of us. One is the vision summary and
the second is the proposed priorities for the Workgroup. I\'m not able
to get to the Website. That may have been mentioned earlier here, so I
don\'t quite know, those of you who have, I don\'t know what you are
seeing at this point. Why don\'t we start with the vision summary, which
I hope you have in front of you. We did receive comments from some of
you but not necessarily all of you. And just a couple of overall
thoughts on this. One is, obviously very interested in your feedback and
reactions to this. I think as a general statement some of the prose
could be tighter than it is now. And as part of a , related to that, we
are interested in comments in areas where we need to alter the writing,
but I\'d like to see if we could avoid sort of sentence-by-sentence
crafting of specific language although if we have to go there to clarify
certain things, that would be fine. So why don\'t I open it up to folks,
and anywhere you'd like to start on this document, if there are comments
or points or things we missed or things where we're unclear or things
that ought to be removed, getting folks\' reaction to this.\
\
**[\>\> Greg Downing:\
]{.underline}**Yes, John, beforehand \-- this is Greg. I just wanted to
let the other members know that we have taken all of the comments that
we\'ve received, including those yesterday, and made those available to
the chairs in an updated document so that they have to work from, but we
didn\'t think that was going to be a useful thing for everyone to see
today. So we would encourage those who have submitted comments to bring
them up in the discussions, but it was getting rather complicated to
incorporate all of the comments for everyone\'s discussion. So we
encourage those who have provided us with comments to go ahead and
discuss them in the meeting today.\
\
**[\>\> Michele Puryear:\
]{.underline}**This is Michele. One general comment is, on the view of
the changing, not changing but the clarification or the words with the
changing in wording with the charge. You should go through the document
I guess and also use genetics, genomics, with a slash, I guess.\
\
**[\>\> John Glaser:\
]{.underline}**No, I think that\'s fair. But we\'ll see whether there
are specific lines where that doesn\'t quite work. I think as a general
statement that would be appropriate.\
\
**[\>\> Michele Puryear:\
]{.underline}**Then I have, I\'m not, I didn\'t feel like \-- and I was
trying to figure out where to put it, that a case wasn\'t necessarily
made for the importance of health information technology, and
understanding phenotype-genotype relationships, how, how you were going
to sort of build the evidence how health information technology as an
infrastructure would help you build that information base you would
need. And I know it\'s implied but it\'s not necessarily said
explicitly. That\'s what I felt like. Under current status I would have
thought a case would have been made very clearly there about that, and
if not there, under researchers\' perspective. You do talk about
gathering the evidence but you don\'t, it\'s, it could be clearer, I
thought. But if no one else thinks that, then \--\
\
**[\>\> John Glaser:\
]{.underline}**Michele, I think that\'s fair and I don\'t think this
document has to carry the necessarily the full burden of defending that.
But nonetheless I could see as part of the first paragraph because the,
it leverages across all of it. Obviously the integration of those two
classes of data has value for research. But it also has value for
decision support and has value for patients trying to figure out their
own health issues and how to respond here. So I think we could probably
add something on the order of a paragraph up front that would pound home
how the, not just the two arenas, the EHR and the data it produces or
the understanding of the genome and its relationship to disease, but how
the integration of the two has a level of power and importance that is
only beginning to be understood.\
\
**[\>\> Doug Henley:\
]{.underline}**Another place where that might, a comment could be made
in that regard also is like on Page 5 of the vision summary under health
information exchange. There may be an opportunity there as well.\
\
**[\>\> John Glaser:\
]{.underline}**That\'s fair. Other comments, reactions?\
\
**[\>\> Greg Downing:\
]{.underline}**I think we have some here in the room.\
\
**[\>\> Paul Cusenza:\
]{.underline}**This is Paul Cusenza. In the first paragraph, second
sentence from the end there, it says understand the relationship between
disease and genetics. My only comment is that I think we also need to
incorporate treatment in genetics as well, and so \--\
\
**[\>\> John Glaser:\
]{.underline}**That\'s fair. Good point. Good point. Other comments?

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

I think within that same sentence \-- this is Alan Guttmacher \-- we
might want to reference health.\
\
**[\>\>\
]{.underline}**Actually, that\'s a point, and maybe it\'s just my point
again, but we talk about disease prevention, and usually we talk about
health promotion, disease prevention, and they\'re different to me.
Because you often can\'t necessarily prevent the disease, especially
with genetics, but you can promote health in terms of lifestyle changes,
et cetera. And so I think that health promotion emphasis is important.
But \--\
\
**[\>\> John Glaser:\
]{.underline}**Well, no, I think that\'s fair. I can guide you to, it
certainly helps for an individual to stress certain behaviors and
lifestyle choices being more essential than perhaps other folks. And I
could see places both in the consumer and in the provider sections of
this thing, or provider perspective where we could incorporate that.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan Guttmacher. While we\'re talking about
lifestyle choices et cetera, I think as exemplified in the third step of
the first paragraph, we make the mistake here of defining personalized
healthcare as really being about one's genetic makeup alone. And that of
course we wouldn\'t want to say. That it\'s really a combination of
genetic makeup and environment and, depending on how one defines
environment, other cultural, behavioral factors, et cetera, et cetera.
And I think we need to be clear about that in the document.\
\
**[\>\> John Glaser:\
]{.underline}**I think that\'s fair. The genetics is an important
contributor of personalization but not the only thing.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**The research might refer to the genome.\
\
**[\>\> Grant Wood:\
]{.underline}**This is Grant Wood. I\'m representing Marc Williams. He
did include in his document in that sentence adding a variety of factors
including culture, personal behaviors, preferences, family history.\
\
**[\>\> Doug Henley:\
]{.underline}**And their unique genetic makeup, right?\
\
**[\>\> Grant Wood:\
]{.underline}**Right.

**[\>\> Deven McGraw:\
]{.underline}**This is Deven McGraw, with the National Partnership for
Women and Families. Along those same lines, it almost looked, I know
this is supposed to be a visionary document and we\'re talking about an
idealized future, but without sort of incorporating room for consumer
behavior incalcitrance, I think we end up sounding a little bit
unrealistic. That consumers will all experience fewer side effects and
better efficacy. That would be desirable but I think we need to build in
a little bit of reality, that even if we give people the right
information doesn\'t mean they\'ll act on it.\
\
**[\>\> John Glaser:\
]{.underline}**That would be appropriate. We can put that in the
consumer perspective, is that is a, we ought not to be pollyannaish
about this.\
\
**[\>\>\
]{.underline}**Maybe the point about education being important.\
\
**[\>\> John Glaser:\
]{.underline}**Right, right.\
\
**[\>\> Kathy Hudson:\
]{.underline}**This is Kathy Hudson, I want to support Michelle\'s
comments about the gap in the document between basic research findings
and then their implementation. And I think in the section on Page 4
there\'s room there to address that issue as well as (inaudible) I think
that evidence gap has been really eloquently spoken to by Alan's work,
and others, so I think that language sort of exists and could be plopped
in.

My second comment is that on Page 4, there\'s a focus on, there's sort
of an assumption that the information to support clinical decision tools
exists. And they really don\'t. And so I think we need to at least
mention the need for the development of robust guidelines for genetic
testing and practice. That we\'re going to drive the decision tools that
we be integrated presumably into the electronic health record. In fact,
on Page 5, in the confidentiality and privacy section, the first
paragraph, it really focuses on the technology for security, sort of the
technology fixes rather than the policy fixes.\
\
**[\>\> John Glaser:\
]{.underline}**Good point.\
\
**[\>\> Kathy Hudson:\
]{.underline}**And in the last sentence of the first paragraph, likewise
innovation and new security and privacy methods and policy \--\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\> Kathy Hudson:\
]{.underline}**\-- would help address that. I think the document,
supplementary document on confidentiality really emphasizes both the
technology and the policy.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah.\
\
**[\>\> Kathy Hudson:\
]{.underline}**And then also on Page 5 in the second paragraph, I don\'t
have a recommended fix but want to point out that the last sentence is a
little bit troubling where it talks about an individual's genetic
information only being used to guide treatment and decision-making and
then not being used in law enforcement. I think it is used in law
enforcement and there are allowances for subpoena, et cetera, in
existing health privacy rules and I think we need to be more
circumspect.\
\
**[\>\>\
]{.underline}**Well, indiscriminate modifies law enforcement \--\
\
**[\>\> Kathy Hudson:\
]{.underline}**Yeah, I know. What does it mean?\
\
**[\>\>\
]{.underline}**Needs to be made clear.\
\
**[\>\> Betsy Humphreys:\
]{.underline}**This is Betsy. I didn\'t like the use of the word
indiscriminate in front of marketing because it sounded to me that there
was such a thing as discriminating marketing, and its okay to use
everybody\'s genetic information for that, whatever it might be.\
\
**[\>\>\
]{.underline}**Right.\
\
**[\>\> Greg Downing:\
]{.underline}**This is Greg. We could use a little technical help here
on, we bantered about using unauthorized but that has a different
connotation also. So we would like some options if someone could work on
that sentence and help us with that.\
\
**[\>\> John Glaser:]{.underline}**

I think they\'re all fair points. Those are good.\
\
**[\>\> Greg Downing:\
]{.underline}**I think the challenge we have, John, is that trying to
keep this concise and yet provide enough detail to make the specifics of
this come through is a daunting challenge for us in terms of space and
clarity.\
\
**[\>\> John Glaser:\
]{.underline}**No, I think, Greg, I think that\'s fair, and I think
given the feedback we\'ve gotten today both prior to this call and
during this call \-- (audio description). What Doug and I can do is work
with you and staff to iterate and incorporate as much of this as we can
without turning this into a dissertation. Nonetheless, I agree with you.
We\'ll take a good shot at it and see if we can get as much as possible
without making it too lengthy.\
\
**[\>\>\
]{.underline}**I guess I was one of the ones that think that you have a
few extra words in this there already, so \--\
\
**[\>\> John Glaser:\
]{.underline}**I think there\'s some room to create room.\
\
**[\>\>\
]{.underline}**On page 4, in the first line, the researcher\'s
perspective, I actually wasn\'t quite sure what was meant here by
genetic technologies.\
\
**[\>\>\
]{.underline}**I think we were just trying to broadly capture the
different types of genetic testing there is available. Maybe it would be
more succinct to say development evaluation of something like analytical
technologies that use genetic information. I know that\'s getting
longer.\
\
**[\>\>\
I]{.underline}**f we\'re talking about analysis and testing, then maybe
we should just say testing, because \--\
\
**[\>\>\
]{.underline}**Okay.\
\
**[\>\> Greg Downing:\
]{.underline}**There was \--\
\
**[\>\>\
]{.underline}**I\'m wondering whether we were talking about genetic
therapies or what here.\
\
**[\>\> Greg Downing:]{.underline}**

Yeah, we, your comment was hit home on, that that we weren\'t looking at
intervention. Purely for analysis.\
\
**[\>\>\
]{.underline}**Then we had multiple comments sent out in advance by
people, Andy and Marc, on the business about the, on Page 3, on the
business where it says, where it says consistent privacy protections,
the ability to view and correct information. And reading both Andy\'s
and Marc\'s comments, I wondered if we increase the specificity a little
bit in that area, whether we might be able to agree, so I had suggested
some language for doing that. Because it does seem to me if we\'re
talking about records to which the consumers have, I mean patients have
made contributions, or where there are, you know, bad data that is
preventing them from getting services because their ZIP code is wrong or
whatever, that this is a different issue from being able to alter rather
than just amend or annotate, and information that might have been used
as the basis for care, and it does seem to me that if you always have,
if you have to retain a history of all the changes, then maybe that
takes care of both points of view.\
\
**[\>\>\
]{.underline}**No, I thought, Betsy, your suggested clause, the ability
to view, annotate, and, in appropriate circumstances, correct
information, was a good substitute for this. Other comments and
thoughts?\
\
**[\>\> Charles Kennedy:\
]{.underline}**This is Charles Kennedy from WellPoint. I noticed that
there wasn\'t much reference to potential impacts to health plans and
employer groups. And I recognize the sensitivity around confidentiality
and all that. But I was just wondering if, what the thinking was around
that and whether we should call the potential impacts out there more
specifically.\
\
**[\>\> Andrew Wiesenthal:\
]{.underline}**Hello, this is Andy Wiesenthal. I\'m sorry I just missed
the last section because the operator chose the time when I wanted to
come in and interrupt to tell me there was something wrong on my line.
Can you all hear me okay?\
\
**[\>\>\
]{.underline}**Yes.\
\
**[\>\> Andrew Wiesenthal:\
]{.underline}**Okay. Because you were talking about the part where I
submitted a comment related to correction, and I still feel that using
this seemingly innocuous the ZIP code is wrong, the fact of it being
wrong could have precipitated some thing or other, a decision or action
on the part of a clinician, and if you remove the evidence that it was
ever there from the record, then you can\'t understand why the doctor
did what they did. So I\'m not suggesting that we can\'t amend it, say
as of such and such a date, correcting my ZIP code, but if the
(inaudible) presence altogether from the record seems to me to be asking
for trouble.\
\
**[\>\> John Glaser:\
]{.underline}**Andy, I think maybe what we might do is given Betsy\'s
suggestion, which I don\'t know whether you heard.\
\
**[\>\> Andrew Wiesenthal:]{.underline}**

No, I didn't. He cut me off.\
\
**[\>\> John Glaser:\
]{.underline}**Okay, the ability to view, annotate and in appropriate
circumstances correct information, I think if we replace correct with
amend, that might \-- I know that we have a lot, we have restrictions
here and (inaudible) about the ability to expunge stuff and you can\'t,
is how restrictive it is. I don\'t know whether that would cover out the
need to point out a factual error but the need to preserve the audit
trail.\
\
**[\>\> Andrew Wiesenthal:\
]{.underline}**I think that's correct, and as long as expunge, the
ability to expunge is clear, then it\'s fine.\
\
**[\>\> John Glaaser:\
]{.underline}**Let me go back, I think the point on the purchaser\'s
perspective, I\'m inclined to include something along those lines
because there is a, and certainly in our discussions with our plans with
the area, they have great interest in understanding how this can help
them be more effective at, you know, fulfilling their obligations to
take care of folks and in guiding them in terms of what ought to be
reimbursed versus not reimbursed, et cetera. So we don\'t have something
here. I\'d like to get something here, if that makes sense to the rest
of the folks on this call.\
\
**[\>\> Doug Henley:\
]{.underline}**John, this is Doug. And this would be under the consumer
perspective, or where?\
\
**[\>\> John Glaser:\
]{.underline}**I think, Doug, I might have a separate perspective. You
know, where we put it and maybe it follows the providers\'s perspective
but it's the perspective of the purchaser of care.\
\
**[\>\>\
]{.underline}**Are you looking at the payers? The payers, the employers,
the insurers, the government?\
\
**[\>\> John Glaser:\
]{.underline}**Anybody writing the check for the care at the end of the
day. I mean, e-Health initiative uses purchasee to cover all that,
whether that\'s the right term or not. But sometimes the plan is
obviously the administrator but not the purchaser.\
\
**[\>\> Doug Henley:\
]{.underline}**Payer may be the better term.\
\
**[\>\> John Glaser:\
]{.underline}**Fair enough. Does that make sense to folks, that we add a
perspective along those lines?\
\
**[\>\>\
]{.underline}**Fine with me.\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\> Greg Downing:\
]{.underline}**Can we just quickly talk about the major elements that
would go into that? We had some discussions around that at the visioning
session, but maybe Charles wants to weigh in, or someone else?\
\
**[\>\> John Glaser:\
]{.underline}**How about you give us three or four bullets that we ought
to incorporate that, and the staff can deal with the prose.\
\
**[\>\> Charles Kennedy:\
]{.underline}**Well, this is Charles. Do you want me to weigh in on
that?\
\
**[\>\> Greg Downing:\
]{.underline}**Yeah.\
\
**[\>\> Charles Kennedy:\
]{.underline}**Sure. I think one area that immediately comes to mind is
medical policy and technology. You know, assessing what is, quote,
unquote, community standard and what is experimental I think the payer
will have huge impacts to that, and needs to be well understood and well
thought through so that it works out effectively. A second area that
comes to mind is it may actually impact how you do benefit design. You
know, if a member chooses to share certain genetic information, you may
develop disease management programs, or benefit plans that are in some
way genetically impacted. So those are the two that come to mind right
off the bat. You know, disease management programs and other things
would certainly be \--\
\
**[\>\> Paul Cusenza:\
]{.underline}**This is Paul Cusenza. I should add something on the issue
of prevention and early detection hopefully reducing overall payer
cost.\
\
**[\>\>\
]{.underline}**Yeah.\
\
**[\>\> John Glaser:\
]{.underline}**Greg, does that help?\
\
**[\>\> Greg Downing:\
]{.underline}**Thank you very much. That\'s great.

**[\>\> John Glaser:\
]{.underline}**Other comments and suggestions on the vision statement?\
\
**[\>\>\
]{.underline}**This is (inaudible). On the vision statement and a couple
other places, where it's, the fourth or fifth line down it says in which
physicians and other healthcare providers. It seems like throughout all
the documents providers is used generically, can we search and find and
substitute physicians for healthcare providers where appropriate?\
\
**[\>\> Doug Henley:\
]{.underline}**This is Doug I think I suggested to Kristin in some of my
edits in some areas it may very well be appropriate to put physicians or
physicians and other healthcare providers or at times clinicians.\
\
**[\>\> Greg Downing:\
]{.underline}**Does the group have a preferred terminology? We\'ll try
be uniform through here. We\'ve had different versions with different
terms.\
\
**[\>\> Doug Henley:\
]{.underline}**I think you may be stuck, Greg, with having to kind of go
with both phrases to make it read good, because sometimes clinician just
doesn\'t work well.\
\
**[\>\> Greg Downing:\
]{.underline}**Right.\
\
**[\>\> Doug Henley:\
]{.underline}**But a lot of times it does, and other situations you can
put physicians and other healthcare providers.\
\
**[\>\> Greg Downing:\
]{.underline}**Okay.\
\
**[\>\>\
]{.underline}**Isn\'t a physician a healthcare provider?\
\
**[\>\> Greg Downing:\
]{.underline}**But they\'re not reciprocal.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, I suspect we\'re either using healthcare providers
or physicians, depending upon the circumstance, one of those two.\
\
**[\>\> Greg Downing:\
]{.underline}**Nurse practitioners.\
\
**[\>\>\
]{.underline}**They\'re healthcare providers just like physicians. I\'m
pushing the issue just because of a recent law case in New Jersey where
the physicians decided that nurse anesthesiologists could not do their
jobs and it was all is based on the word physician. Physicians are
healthcare providers and I don\'t know why they have to be separated
out.

**[\>\> John Glaser:\
]{.underline}**Yeah, without having gone through it, I think in certain
test ordering or drug dosing that might be the case. But why don\'t we
go through and make sure we generally use the term, and again I\'m easy
on whether it\'s health care provider or clinician, there may be some
particular phrases where it really is the physician who is the target of
the sentence or the paragraph.\
\
**[\>\> Greg Downing:\
]{.underline}**Okay.\
\
**[\>\> John Glaser:\
]{.underline}**Other thoughts, comments?\
\
**[\>\> Becky Fisher\
]{.underline}**This is Becky Fisher, and I have a comment about the
provider\'s perspective. I don\'t really understand what the CDS tools
are thought to be. They don\'t really exist in reality. Can someone give
me an idea of what those are right now?\
\
**[\>\> John Glaser:\
]{.underline}**Well, I\'ll give you some examples of some of the CDS
tools, early stages where I am. Some are still, we still have some
exploration to determine how useful they are. One is tools regarding
dosing. And you're your genetic makeup may have a large impact on where
we start with dosing or your relative tolerance to a normal dose.
Another area is that if you\'re going to begin a chemotherapeutic regime
which is going ot be effective, where there\'s a presence of some genes
but not others, and you order the chemotherapeutic regime, we will ask
you have you performed the genetic test if we have find no evidence that
you have done so. So we may interrupt your ordering to make sure the
genetic test results match the ordering that you are carrying out here.
So those are two example areas where we will guide the order based on
the presence or absence of a genetic test and again I think it may be,
there's still a lot to be learned here about how much of a influence
your genetic makeup has on our ability to dose more effectively.\
\
**[\>\> Kathy Hudson:\
]{.underline}**Can I add to that? Respond that?\
\
**[\>\> John Glaser:\
]{.underline}**Sure.\
\
**[\>\> Kathy Hudson:\
]{.underline}**This is Kathy Hudson. There\'s also a small, and
hopefully growing, number of guidelines, for example the American
College of Obstetricians and Gynecologists has a guideline that's been
out there for now six years about offering CF carrier testing to couples
of a reproductive age. There's ata to show that the adoption of those
guidelines has not been particularly robust. So in theory, an electronic
medical record could help that a lot of when you\'re seeing couples of a
reproductive age it would trigger you, this is the time to be offering.
Don\'t wait until they\'re pregnant. But my point was there\'s very few
of those

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

And that\'s a point well taken. The reason I asked is actually when I
was reading over one of the documents prior to the meeting, I responded
that I think some kind of collaborative space would be good to build
into the electronic health record because, I mean, just beyond
algorithmic logic you could build in with a software program, I think
it\'s really important that physicians are encouraged to teach each
other about these things, and if there\'s no room in the record for
doing that, then I think that we\'re missing something important.\
\
**[\>\>John Glaser:\
]{.underline}**Yeah, I think that\'s fair. Usually for us the
collaborative element occurs outside of the record and groups of people
discussing advances and what they\'ve learned, and that could translate
into clinical decision support. It\'s a fair idea to have using sort of
new generation of collaborative tools to share knowledge not only on
this topic but a wide range of others.\
\
**[\>\>\
]{.underline}**I think that you\'re going to move away from the
patriarchal model of medicine. You almost need to do that, because
that\'s where we\'re going as a culture.\
\
**[\>\> John Glaser:\
]{.underline}**No, I think that\'s, and there's somewhere, I\'m not
quite sure where we would target it, on the mechanisms to disseminate
knowledge in this area, one of which, an important one, would be
collaborative tools, there are other ways, but nonetheless it is the
handling the knowledge explosion on the part of the very busy
clinician.\
**[\
]{.underline}**Other comments, thoughts? Well, if \-- Greg and Kristin,
again, nice work. We have some work to do still, but nice job. Do you
have a timetable on which you guys would like to suggest that any
further comments be sent to you all?\
\
**[\>\> Greg Downing:\
]{.underline}**I think we should \-- well, let\'s see how we\'re doing
with the priority areas. That may help us and we can develop a plan from
that, after that section.\
\
**[\>\> John Glaser:\
]{.underline}**Okay. Well, it may that be we get \-- you guys may have a
little bit more time to send in further comments. Doug and I will work
with Greg and Kristin and others to get the next version of this put
together. I\'m not exactly sure when in our subsequent meetings we\'ll
come back to this but nonetheless we will certainly share the result
with you all and make sure that we got closer to the mark and
incorporated as much as we can of all the terrific ideas you have put
forward here.

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

John, this is Doug. Let me just make a schedule crunch here. For Kristin
and Greg, I think we were going to try to present this document next
week to AHIC, were we not?\
\
**[\>\> Greg Downing:\
]{.underline}**I think that what we would like to do is to present, like
to see how we do on the priority areas, but we can certainly present
draft ideas and we don\'t have to circulate the whole piece. It seems to
me that we\'re going to want to review this one more time in final form
perhaps at the May 15th meeting. But in terms of keeping in sequence
with the workflows, we felt it was important to give AHIC an update on
our vision and priorities and directions that we\'re going with the
anticipation that we would have recommendations on two areas at the July
31st meeting. So the purpose in the April 24th meeting was really to
provide updates to them on our vision and priority areas, and we could
work this a couple different ways in terms of getting a revision done in
the next day or two and circulate that to everyone and have something to
provide them in a draft form. But let\'s just see, our recommendation
would be to you is let\'s see how we do with the priority areas and then
make a plan.\
\
**[\>\> John Glaser:\
]{.underline}**Fair enough. Reasonable segue into the priority areas. I
hope and presume all of have you a copy of the draft that was sent out,
and again I thank those of you who did send in some comments here. Greg,
why don\'t I ask you, just take an interlude here to explain the
priority areas and the context relative to AHIC, and you had mentioned a
couple things about by July what we would like to have put together but
why don\'t you help frame this document and its importance in the scheme
of what we\'re trying to do here?\
\
**[\>\> Greg Downing:\
]{.underline}**Thanks, John, and Doug. What we had taken was, from the
visioning session and the discussions from prior meetings, to try to
frame and use this document and there\'s an accompanying graphic that
shows what we would propose as areas of work that with the anticipation
of fitting \-- and again the charge that AHIC gave us back in October.
This is really flushing out some of the details behind the areas that
they had suggested we work on. In the first two areas that we\'ve
discussed and had testimony on to this point are in the areas of the
incorporation of medical genomic/genetic tests into electronic health
records, and a lot of discussion at the prior meetings on incorporation
of family medical history. So those are the two areas that we think we
would suggest or recommend to you that we work to develop
recommendations for the July 31st meeting, and perhaps we can go to that
graphic in a few minutes to review the timeframe for that.

Additional to that were some critical areas that have been identified
not only by this Workgroup but by AHIC itself to be addressed are the
areas of clinical decision support and confidentiality, privacy, and
security. I think we\'ll talk more about that in detail but these are
efforts that I think are meant to contribute to other AHIC working group
activities of which a number of other people in this room are already
participating in. So the idea here, and we\'ll go through this in some
detail is to begin to flesh out for both clinical decision support and
CPS, the issues that are focused on genomic tests or genetic information
as they relate to personalized healthcare. So I don\'t know if you want
to go through any details here, but in order for us to be in synch with
other AHIC activities, we felt that recommendations for at least some of
the work of this committee beyond the genetic test and family history
would encompass these two areas. And so that\'s why these are sort of
fleshed out in some detail. But we would recommend that the work of the
committee over the next two meetings be to help frame our
recommendations for this genetic test information area and family
medical history. Does that help?\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, I think and to be redundant, the intent would be in
the July 31st AHIC meeting, is that we present priority areas and I
guess initial recommendations for approval and concurrence to move
forward in use case development and things like that. Given that there
are broad initiatives on privacy and security and another broad
initiative on decision support, I think it\'s also worth making sure
that we leverage the talent and knowledge of folks who are part of this
Workgroup and feed into those particular areas here. So we would intend
to use the next two meetings that we have, May and June, to really focus
on this document in front of you. It doesn\'t preclude other items but
it really becomes the focus of the work that we do. So that\'s a little
bit \-- and I guess we\'ll get to the work plan in a couple minutes
here, but let me stop and see if there are any questions on this
document and its role?\
\
**[\>\> Greg Downing:\
]{.underline}**I may add, John \-- this is Greg again \-- that he
priority areas documents has helped other Workgroups to other
communities be beyond just beyond the working group, whether it\'s AHIC
or other organizations or people that are interested in this, to serve
as a guide post to say what are we going to be working on over the next
year, year and a half, for example, and what areas can they expect to be
developed? And so this is meant to be some milestones or guard rails, if
you will, on the kinds of things that will be coming up for discussions
here. That doesn\'t mean other things can\'t be added or addressed as
we\'re going along but it\'s meant to provide some context to what the
discussions will be about and the recommendations we\'ll aim towards.\
\
**[\>\> John Glaser:\
]{.underline}**Let me see if there are any comments or questions on \--
or maybe we\'ll start at a little higher altitude and then we'll drop a
little bit. On the four areas of testing, family medical history,
decision support, and confidentiality, privacy, and security is one. Are
there an area that\'s missing here?

Fair enough. Hearing silence means there\'s concurrence. Either that or
you all went on mute and can\'t get back on. Comments or reactions to
the specifics of the document? Either perhaps in some of the text, on
the paragraphs or the sub-bullet under each of the areas?\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan Guttmacher. I would make the same point in
the introductory sentence as we did in the last document, that
personalized healthcare is more than just genetic makeup. So we should
also mention environmental exposures or whatever. We want to be
consistent between the two documents.\
\
**[\>\> John Glaser:\
]{.underline}**That would be appropriate.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**It\'s a little trickier here because we\'re not going to
then, I think in the bullets below, since nobody said anything, develop
customized treatment management plans for individuals based on their
environmental exposure as well as genetic makeup. Eventually that\'s
certainly what we want to do, but we don\'t outline in this document how
to do that.\
\
**[\>\> John Glaser:\
]{.underline}**Right.\
\
**[\>\> Greg Downing:\
]{.underline}**I think the one emphasis that's in here is on the
near-term, and the near-term relative to the next two years in our
visioning exercise.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**I personally think it\'s fair to do that but we should
still \--\
\
**[\>\> Betsy Humphreys:\
]{.underline}**And if we \-- this is Betsy. If we add genomic to genetic
here, the slash business, then that solves my problem with this
document, where I started to interpret it too narrowly.\
\
**[\>\> Greg Downing:\
]{.underline}**Thank you.\
\
**[\>\> John Glaser:\
]{.underline}**Other comments, questions on any aspect of this
document?\
\
**[\>\> Armando Oliva:\
]{.underline}**This is Armando Oliva from FDA. This is a comment that I
think we already sent previously, but just wanted clarification on the
bullet, the sub-bullet, the second to last sub-bullet under genetic test
where it talks about \-- I\'m sorry, third from the last bullet, where
it says examine clinical validity and utility of genetic tests through a
multi-stakeholder process. You know, the FDA does clinical validity
assessment as part of its pre-market review of genetic tests and was
wondering how this differed from what we already do.\
\
**[\>\> Kathy Hudson:\
]{.underline}**This is Kathy Hudson, I\'ll respond to that, and I have a
comment about the bullet. If my understanding is correct, the goal of
the EHR is to include the results of laboratory-performed tests that
fall outside of the scope of FDA\'s current purview, so the number of
genetic tests that have gone through FDA\'s process is something around
a dozen, and there\'s over a thousand tests out there, most of which are
performed as laboratory-developed tests that do not require, at least
presently, any evidence (inaudible) oversight for clinical validity.\
\
**[\>\> Armando Oliva:\
]{.underline}**I see. Okay.\
\
**[\>\> Kathy Hudson:\
]{.underline}**I think that\'s the goal. On that same bullet, I would
recommend that we add analytical validity in addition to clinical
validity and utility to that bullet. And then just raise the question of
whether examine is sort of sufficient for the activity that we have in
mind here. I think there\'s been a number of governmental groups that
have examined, I\'m just not clear what examine means really.\
\
**[\>\> John Glaser:\
]{.underline}**Kathy, do you have a suggestion of a proper verb?\
\
**[\>\> Greg Downing:\
]{.underline}**Actually, the other, to keep it in parallel structure,
the other ones don\'t use verbs.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, fair enough, Greg, although there\'s a verb in
there somewhere, implied or otherwise. My thought is that, in a way,
I\'m not sure this Workgroup will go and figure out how to do to deal
with the thousand tests that the FDA doesn\'t oversee or have an opinion
on at this point, but we need to help the doctor who is trying to
interpret this stuff understand the validity, so there\'s some set of
fields, I\'m not quite sure what they are, frankly, that might indicate
whether this has gone through a high degree of analytical and clinical
validity or not.\
\
**[\>\>\
]{.underline}**Uh-huh.\
\
**[\>\> John Glaser:\
]{.underline}**So we\'re not going to go after all thousand tests but we
have to have some way of helping guide the provider.\
\
**[\>\> Greg Downing:\
]{.underline}**It seems to me where we\'re trying to get to here is
providing \-- you get a test result and we\'re trying to provide
supplemental information about the qualifications of that test result
and how the test was performed. And somehow it\'s the characterization
of what the laboratory test data mean relative to the evidence behind
its performance. So we can work with some other options for this, I
guess. But I think the terminology that we\'re trying to, that is
crucial to this interpretation are the words analytical, clinical,
validity, and utility. Those are the major descriptors that we\'re
talking about.\
\
**[\>\>\
]{.underline}**I think the end game of being able to clue in the
provider at the end who is receiving these test results back of how much
confidence to have.\
\
**[\>\> John Glaser:\
]{.underline}**Right.\
\
**[\>\>\
]{.underline}**How to interpret them. I think that\'s exactly the right
end point.\
\
**[\>\> Armando Oliva:\
]{.underline}**This is Armando again. Just \-- sorry if I\'m being very
concrete but if I were a clinician viewing a genetic test result in
someone\'s electronic health record I would possibly, there would be a
link from that test name or test result to some other site or location
where I would have more detailed information about the performance of
the test itself? Is that, is that what we envision?\
\
**[\>\> Greg Downing:\
]{.underline}**This is Greg. That\'s one way of doing, it I guess. There
may be others.\
\
**[\>\> John Glaser:\
]{.underline}**That\'s possible. I don\'t know that we know yet. I mean,
for example, in just basic laboratory tests where the assay methods are
different we give the normal range. So in a way we mask the assay
approach, just say pay attention to the normal range here. So I don\'t
know what we would do here, and this may be part what have we have to
figure out, is \-- and I think if we start asking the doctor to go
somewhere else to check it out, we\'ll lose them. Are there ways that in
a field, so to speak, in a transaction, one could score validity and
utility? So I don\'t know what the options are of helping guide a
clinician.\
\
**[\>\> Armando Oliva:\
]{.underline}**And who would actually do the scoring?\
\
**[\>\> John Glaser:\
]{.underline}**That\'s a fair question. I don\'t know.\
\
**[\>\>\
]{.underline}**What if this also talked about a process, through a
multi-stakeholder process, as opposed to what we\'re trying to achieve,
which is provide that information to the user.\
\
**[\>\> John Glaser:\
]{.underline}**I frankly think, and you guys may disagree, we could
probably drop the multi-stakeholder process. All this stuff has to be,
to some degree, a multi-stakeholder process.\
\
**[\>\>\
]{.underline}**Uh-huh.\
\
**[\>\>]{.underline}**

On another bullet in that same section, and maybe Michele can respond to
this, I was unclear why in the bullet on newborn screening \--\
\
**[\>\>\
]{.underline}**You mean harmonization?\
\
**[\>\>\
]{.underline}**Harmonization \-- I understand the intention of
harmonization, but I was wondering, it\'s limited to metabolic screens.\
\
**[\>\>\
]{.underline}**Yeah, it shouldn\'t be. It should be \-- because it\'s
more than metabolic. There\'s hemoglobin, I mean I would do \-- and
it\'s not really \-- they\'re not all genetic either.\
\
**[\>\>\
]{.underline}**Get rid of the word. Newborn screen.

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

Newborn screen.

**[\>\> John Glaser:\
]{.underline}**Okay. Other thoughts, comments?\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan Guttmacher. I have a couple bullets to
suggest adding under the family medical history.\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**Logically after the first one that we have I might add
two more. The first would be inclusion of structured family history
data, in electronic health records or EHRs and PHR, however one wants to
put it, but the idea that the, no matter who enters it, the fact we
would have structured family history data would be helpful.\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\> Alan Guttmacher:\
]{.underline}**And then a third bullet would be
development/harmonization of family history standards for EHRs and
PHRs.\
\
**[\>\> Greg Downing:\
]{.underline}**This is Greg, can I ask a question?\
\
**[\>\>\
]{.underline}**Absolutely.\
\
**[\>\> Greg Downing:\
]{.underline}**This is to a point that Betsy raised earlier about
comprehensive levels by broad audiences of this. Will structured family
medical history, will that be understood as what structured means for
most audiences?\
\
**[\>\>\
]{.underline}**No, you\'re right. Maybe we need another term that\'s a
little more, standardized, something.\
\
**[\>\>\
]{.underline}**I\'m sure staff can come up with the right word.\
\
**[\>\> John Glaser:\
]{.underline}**I do, too. I think the staff is brilliant.\
\
**[\>\>\
]{.underline}**Does coded data work?\
\
**[\>\> Greg Downing:\
]{.underline}**I just want to probe here a little bit so I understand
the intention or what is your concern as to why to modify family medical
history. Is it that \-- are we addressing interoperability
capabilities?\
\
**[\>\>\
]{.underline}**Analyzability, too.\
\
**[\>\>\
]{.underline}**I think particularly interoperability.\
\
**[\>\> Kristin Brinner:\
]{.underline}**This is Kristin Brinner. I\'m just going to speak for
Marc Williams for a second. He has suggested standardization of family
relationship nomenclature and other critical issues relating to family
history and then in parentheses, e.g., age of onset, bilateral or
current disease. Is that kind of the type of information you\'re trying
to capture?\
\
**[\>\>\
]{.underline}**Yes.\
\
**[\>\> Kristin Brinner:\
]{.underline}**So I think he's made the same point.\
\
**[\>\>\
]{.underline}**Happy to play along and figure that out.\
\
**[\>\> Greg Downing:\
]{.underline}**Thank you.\
\
**[\>\>\
]{.underline}**Kristin, should we mention that last bullet that Marc
suggested about \--\
\
**[\>\>\
]{.underline}**Go ahead.\
\
**[\>\>\
]{.underline}**Yeah, he, the last bullet he suggested was studies to
assess validity and utility of family history of disease to prioritize
the information that is most important to capture.\
\
**[\>\> Greg Downing:\
]{.underline}**Was his intention, I mean I think it\'s not the purview
of this committee necessarily, working group to do the studies, but to
utilize information from studies? I\'m not quite sure I understand what
that was meant there.\
\
**[\>\>\
]{.underline}**Yeah, it\'s probably not the purview of the group to
perform the study but maybe this group could suggest that the studies
are important.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, the only concern I have about that is you could
take any one of these four areas and have lots of studies that would be
important. I think one could make that as a broad statement across all
of these priority areas. I\'m not sure I would just have it specifically
as a bullet under family medical history because you could make the same
for genetic test and decision support, et cetera.\
\
**[\>\> Greg Feero:\
]{.underline}**Hi. This is Greg Feero. Under family medical history, you
call up physically entering data into a personal health record, is that
a necessary step and an intentional step? There are some EHRs that have
interfaces that allow patients to add data. Do you want to be
particularly driving \-- I mean, the comment sort of drives the use of a
PHR which is sort of an entirely different or additional kettle of fish
to bring in. Do you want a more genetic statement regarding electronic
health records in general rather than personalized health record?\
\
**[\>\> John Glaser:\
]{.underline}**I think that\'s a fair point. My gut is to keep the PHR
reference but also note that that on occasion and as appropriate can be
in the electronic health record directly.\
\
**[\>\>\
]{.underline}**I think about a more general audience, we should
someplace in here make a clear distinction what we mean by each of those
terms, I think.\
\
**[\>\> John Glaser:\
]{.underline}**I suspect there\'s some distinction language floating
around these various Workgroups.\
\
**[\>\> Greg Downing:\
]{.underline}**Yeah, I think ONC can help us with proper designations.
Thank you.\
\
**[\>\> John Glaser:\
]{.underline}**Other comments, suggestions?

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

This is Charles. On the clinical decision support section. We talk about
providing to consumers evidence and accompanying information but we
don\'t actually talk about providing them a tool. And is that \-- I
guess the first question is, was that a conscious decision, or should we
call out consumers as potentially laymen consumers of this information
as well? And the second point is also on that same section, introducing
a concept of usability. Meaning for clinical decision support you can
have something that\'s clinically valid and good, but does it work for
the physician\'s workflow? And so should we be making something
statement about workflow sensitivity for deploying these tools?\
\
**[\>\> John Glaser:\
]{.underline}**I think that would be appropriate up in the body of
decision support, and perhaps not in a bullet but up in the body there
because it would cut across all these. Did you have particular tools in
mind, or thoughts?

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

I don\'t think we know at this point, but just the availability of
having them as a designated audience for the tool.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, that\'s fair. Other comments, suggestions?\
\
**[\>\> Alan Guttmacher:\
]{.underline}**This is Alan Guttmacher again. Also on clinical decision
support, the first bullet I think it would be useful to expand it. As it
reads now it\'s just about selection of genetic tests, and I would
suggest we might expand to education, information to guide provider, use
of genetic information, in personalized healthcare including use of
family medical history and genetic tests.\
\
**[\>\> John Glaser:\
]{.underline}**Okay. That\'s good.\
\
**[\>\> Amy McGuire:\
]{.underline}**This is Amy McGuire. I have kind of a general comment
that I think spans all of these topical areas, which is thinking about
how to deal with genetic information that may be generated not from
genetic tests ordered through physicians, but maybe either commercially
generated genetic information that individuals want to store in their
personal health record or information generated from research
participation that may get stored or returned to them in some capacity
and I think it raises issues for sort of clinical decision support, also
confidentiality issues and kind of probably spans all of these. I don\'t
know how best to kind of incorporate that, but I just wanted to raise it
as an issue.\
\
**[\>\> John Glaser:\
]{.underline}**Well, now, it\'s an issue. We do for example, here,
screening at your request that we do not incorporate into the EMR,
unless you tell us you want to do that. I don\'t know \-- that\'s a good
point. I don\'t know whether that\'s up in the genetic test section or
quite where to put that but that\'s a fair point.\
\
**[\>\> Amy McGuire:\
]{.underline}**I think it will come up mostly when people enter that, or
somehow store that information in their own \-- if we don\'t put it in
the electronic health record, if they\'re putting in their own personal
health records and we\'re getting other information from that source,
like family medical history information, there\'s going to have to be
some knowledge about how to use that information or what to do with it
or how to educate physicians and patients about all of these issues with
regard to that information.\
\
**[\>\> John Glaser:\
]{.underline}**And also the burden of privacy then falls on the consumer
directly.\
\
**[\>\> Amy McGuire:\
]{.underline}**Right.\
\
**[\>\> Greg Downing:\
]{.underline}**John, this is Greg. If it\'s under clinical genetic
genomic test then we probably need to modify \-- I guess I\'m arguing
not to put it there and that clinical generally applies to that it\'s
part of the medical decision-making piece. So where would it go? Or we
could drop the word clinical and use genetic/genomic tests and then we
could make that a broader category for incorporating those things that
are attaining information from outside the healthcare delivery system.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, I think that\'s fair. Maybe both on some of the
labels, and that the decision support may be solely confined or a
particular rule to a PHR, that the test data is there. Other comments,
questions? Suggestions?\
\
**[\>\>\
]{.underline}**Did we resolve what we\'re going to do in the suggestion?
Right? It\'s a tough issue because in this case here, if someone gets
for example a genetic test and it\'s done with some commercial entity
but doesn\'t have all of the \-- it shouldn\'t be used, for example, for
this kind of a medical purpose, right? Could have been done for example
for heredity or other sorts of things, looking at your heritage and
ancestry and stuff. And so therefore, what do you do with that kind of a
genetic test and how does it then play into this if it\'s not intended
for medical purposes? So I think it\'s confusing if we start to make
comments about what do you do with tests about, say, ancestry, but it\'s
genetic information and do you say put into a personal health record?
And the consumer standpoint.\
\
**[\>\> Amy McGuire:\
]{.underline}**Maybe there just needs to be \-- this is Amy again, I\'m
sorry \-- It seems to come up primarily in the clinical decision support
arena with regard to education. I guess both the providers in their use
of this information for medical purposes or, you know, treatment or
diagnostic purposes, but also patient education and then maybe \-- so
maybe add a bullet or modify one of the bullets there and then also the
confidentiality and privacy and security, I think that\'s going to have
to be dealt with in that section as well.\
\
**[\>\> John Glaser:\
]{.underline}**It will have touch points in family medical history. It
will have touch points up in the genetic test portion where we just
presume it\'s the EHR when in fact it might be only the PHR that goes
involved here and that on the decision support broadly, part of what
we\'re talking about is how do you inform consumers about what these
tests mean and what tests are available. That would be an aspect of
decision support. And then there are aspects of privacy, the fact that
you might have done it on yourself, you have to be mindful of the fact
that result can tell a lot about your siblings and kids. And here the
burden of privacy falls on you because you\'re outside the healthcare
system.\
\
**[\>\> Paul Cusenza:\
]{.underline}**Maybe then the solution \-- let me know if this works for
you. This is Paul Cusenza again. On Page 2, the top bullet, where it
says education and information to guide provider selection of genetic
tests. How about if we change that to be provider and consumer of
genetic tests? Similarly a suggestion the confidentiality section had
something that talks about consumer education about their risks and what
they may be getting into if they do direct consumer genetic tests.\
\
**[\>\>\
]{.underline}**I think that\'s good. One other sort of nuance to throw
in is sometimes I think more in the coming up soon, this data may be
generated in the context of research, which is slightly different
because \-- and it may be given to participants under certain
circumstances. I think we\'re starting to do that on a very limited
basis right now, and there\'s discussion about doing more of that. And
if that\'s the case, it\'s slightly different because it\'s not a
consumer relationship where they\'re generating the information but
it\'s also not within the physician-patient relationship.\
\
**[\>\>\
]{.underline}**That sort of goes back to the annotation of the test and
its quality score or assessment or validation. Some information back to
the provider and to the patient about how do you weigh this.\
\
**[\>\> Greg Downing:\
]{.underline}**John and Doug, this is Greg. I think it would help us as
staff, to you know, get a sense from the Workgroup as to whether a more
intentioned consumer focus and perspective on this, we were looking at
this in sort of the near-term and perhaps we\'ve underestimated the
relative degree of consumer-based healthcare seeking in this area at
this point. And you know, it\'s a tough walk because most of our
familiarity is with what\'s going on in medical systems and medical care
capacities right now, and sort of framing this near-term agenda. But if
there\'s a consensus among the group to take a more consumer-slanting
approach to, for example, not using the word clinical genetic test,
implying that a physician or a healthcare provider has ordered it and
start building it to a more consumer-based approach to this, we can
certainly do that. I\'d like to try to get a better sense of the
temperature on that from the group.\
\
**[\>\>\
]{.underline}**You know, the other aspect here is that consumers can
access not just genetic tests directly without going through their
healthcare provider, but a whole array of laboratory tests. And so it
may be an issue that needs to be addressed more broadly than just in
this Workgroup. What do you do, what does a consumer do with the results
from laboratory acts that they got regarding a whole panoply of things,
some of which are genetic, and what does the healthcare provider do, how
does the EHR handle that kind of information? So it may be a little
broader than just genetics.\
\
**[\>\> Greg Downing:\
]{.underline}**I think this is going to be important relative to trying
to get to the recommendations for this, but we should try to settle in
on some perspective of this. There is a consumer's, consumer working
group in AHIC and we can confer with them about how they\'ve been
addressing other testing issues. But I think there\'s probably been more
sensitivity to this in our discussions than there has overall at the
others. John, or Doug, can you help guide us through this \--\
\
**[\>\> John Glaser:\
]{.underline}**Well, being all wise, all seeing, and powerful, I\'ll
give you a shot.\
\
**[\>\>\
]{.underline}**And modest.\
\
**[\>\> John Glaser:\
]{.underline}**That\'s right. Only when I close the door do I dream
about doing these things. When I walk out the door, I\'m none of the
above. I think, Greg, what we might want to do is, one is in the first
paragraph up here, is that right now it\'s very focused on the EHR and
you know, we, while we include the term consumer and clinician, you
know, it\'s very centered or implied on the provider side of the house
here. I think what we might want to do, point out here in another
sentence or two is that we also see the incorporation of this testing
where the testing is done by the consumer, outside of the healthcare
system, for incorporation into their PHR. And so acknowledging the fact
that there\'s a whole separate realm here and that could be either for
screening purposes or where they get it as a result of research purposes
but there will be a lot of genetic testing done, an unknowable amount
perhaps at this point. Some decision support in all these areas will
ripple through in a thread that is really purely consumer controlled, so
to speak, here. What we might do when we get to the point later on in
this conversation about asking folks to start working on some
recommendations, is to say, well, we think perhaps we ought to focus in
on the provider as being the sort of core of this, nonetheless we\'re
going to ask you in the course of your recommendations is to consider
and have some recommendations which are directed to the consumer, both
the consumer in conjunction with the provider but also the consumer
outside of the healthcare system. I don\'t know if that made sense at
all..\
\
**[\>\> Greg Downing:]{.underline}**

I think that\'s probably the right area in which to embellish this. One
aspect of this really with regard to the work that ONC and AHIC does,
and, you know, I think our sense here, incentivized here to focus on
what\'s doable in the near-term, given the realities that the
recommendations that we\'ve been sort of plowing through in terms of the
readiness aspects, you know, have been dealing mostly with health
messaging and standards development activities that are principally been
supported to date as far as I can see geared towards the traditional
medical practice community world. This isn\'t meant to avoid or stop
dealing with these emerging consumer-based approaches. I\'m just not as
keen and maybe others are, on what standards activities have been really
developing for that particular marketplace, for the lack of a better
word. So in mind we\'re really focused on the mechanics of feeding
aspects into the AHIC process that ultimately will help facilitate areas
here, but we are not limited or bounded by that. We can certainly
develop recommendations that are going beyond the HITSP process and
CCHIT, and perhaps this is an area where we can make recommendations
that deal with the consumer-based world. We just don\'t know enough to
be able to work and develop background materials that support the
working group\'s activities in these areas. So I think what we\'ll try
to do is work on the front end of this to deal with that broader concept
of the emerging consumer-based world and realm where these tests are
going to be employed.\
\
**[\>\> Doug Henley:\
]{.underline}**John, this is Doug. Some comments as well. Again, I think
this is where going back to our specific charge and our broad charge,
but especially the specific charge can be helpful in giving us
direction, consistent with what you have said and what I think Greg just
implied. We can\'t slay all dragons at one time. So I personally think
that the priority areas that we\'re focusing on are very a propos in the
short-term, particularly as it relates to genetic tests and family
medical history. When we get into clinical decision support on Page 2,
that\'s a larger part of the broader charge, the first two areas relate
more to the specific charge, and clearly comments today, but comments at
our previous meetings about confidentiality, privacy, and security have
all the world to do with consumer focus and things of that nature. So I
think adding some of John\'s thoughts, Greg, in the introductory
paragraph to this two-page document relative to PHR and the consumer, I
think is good, but I\'m not sure we need to fret much more about it
beyond that at this point in time.\
\
**[\>\> Charles Kennedy:\
]{.underline}**This is Charles. I could give you a couple of real world
data points that, granted this is a personal health record based on
claim data, but we do include clinical lab results and what you
generally see are low single digit utilization rates by the community
it\'s offered to. You know, 3, 5, 7 percent something like that. So
consumers do use it and I can only imagine that information that's order
of magnitude more specific to their circumstances would drive that
number up significantly. So I do think there will be a fair number of
people who will use it.\
\
**[\>\> Betsy Humphreys:\
]{.underline}**This is Betsy. I also feel that it would \-- it\'s
certainly a terrific concept that the standards that we promulgate and
develop for the EHR would actually be used to record the PHR data, I
mean data in PHRs. I hope we don\'t have two sets of standards for the
reporting of the actual test results.\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, I think, Betsy, a couple things. One is I think
above and beyond the addition of stuff up in the first paragraph, is a
lot of the standards we\'re talking about in a way, not in a way \--
should be the same whether you\'re getting it directly from a screening
test for your only personal consumption or whether it's part of a
relationship you have with your physician and nurses, et cetera. So the
standards ought to be equivalent. Some of the privacy issues might be
different. And obviously there\'s overlap in education about what does
this test mean, what do I do with it? And that information ought to be
the same information regardless of whether you had this done for
personal reasons or whether you had it done for care reasons.\
\
**[\>\> Andrew Wiesenthal:\
]{.underline}**Yeah, this is Andy, I mean I wonder if this is \-- if
we\'re worrying a little bit too much here. Because the fact is that I
would hope that all clinical laboratories are going to migrate toward
LOINC. If they don\'t, they\'re going to be in trouble. And the ones
that perform the genetic testing, a few will be isolated and only do
that. But most will be larger laboratory complexes that have systems \--
they won't be able to afford a dual system, one where they report with
HL7 messages using LOINC standards to one set of users and don't' report
using LOINC to another. So that\'s one thing.

The second is if any of you have been to the pharmacy to pick up a drug
lately, you know, you all get the handouts stuffed in paper bags, they
come from the routine data source. And I think the laboratory, the
laboratory providers will migrate towards some routine provision of
explanatory material about tests. And it will all come from the
functional (inaudible) or something like that. They\'re not going to
start making this stuff up on their own. It\'s too expensive and too
complicated. You know, I believe we should encourage, it but I don\'t
know that we\'re going to have to really take tremendous action to
ensure it because it will happen as a matter of course.\
\
**[\>\>\
]{.underline}**I think there\'s a difference, though, is that the
information being provided about pharmaceuticals is governed \-- what
claims are made and what statements of fact are made is actually
overseen by somebody. It\'s not just an inherent good will of the
companies. There\'s actually somebody minding the store and that\'s not
the case in the testing arena. If we take care of the fundamental
problem, I think you\'re right. But the fundamental problem being that
tests aren\'t governed for their \--\
\
**[\>\> Andrew Wiesenthal:\
]{.underline}**I agree with you, but I can\'t see the large providers
who are going to want to dominate in laboratories, who are going to want
to dominate the market here having anything about (inaudible) of the
meaning of laboratory tests that are beyond reproach because the lawyers
won\'t let them do otherwise. They\'ll set the standard for the
marketplace.\
\
**[\>\> John Glaser:\
]{.underline}**I think if we \-- we\'ll ask the folks who work on
recommendations for each of these four areas to focus on the clinician
and the EHR, but I think any one of those conversations would be remiss
if it didn\'t point out some observations or recommendations that is
didn\'t deal, you know, specifically with the consumer side or again
particularly that case where the consumer is taking on this area outside
of the healthcare system. Other questions or comments?\
\
**[\>\>\
]{.underline}**I have a question on the clinical decision support that
mirrors the comment that I made in the vision document, which is that
while the bullets talk about, emphasize development of information,
materials, guidelines, the paragraph that precede this really doesn\'t.
So I would recommend we include in the first sentence, development and
dissemination of up to date information.\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\>\
]{.underline}**In the first sentence. And then in the second sentence,
as a consequence, important clinical guidelines often take years to \--
insert develop and incorporate. Because both of those are very
time-consuming, slow processes.\
\
**[\>\> John Glaser:\
]{.underline}**Those are fair. Other thoughts?\
\
**[\>\> Steve Teutsch:\
]{.underline}**This is Steve Teutsch. Just to emphasize that. And it
should be evidence-based practice information. What we need to do has to
have a firm grounding.\
\
**[\>\> John Glaser:\
]{.underline}**Fair enough. Other comments?\
\
**[\>\> Kathy Hudson:\
]{.underline}**This is Kathy again. I have one more that echoes Betsy\'s
comment in the vision document, under confidentiality, privacy and
security ,the second sentence talks about concerns about unknown aspects
of new technologies associated with genetic information. Which I think
has are that same sort of meaning problem, that Betsy pointed out. The
same fix, whatever it was, would work here.\
\
**[\>\>\
]{.underline}**Change it to genetic/genomic test.\
\
**[\>\> Kathy Hudson:\
]{.underline}**Yeah.\
\
**[\>\> John Glaser:\
]{.underline}**Okay. Other comments? These have been terrific. I want to
thank you all, both those who sent them in and who contributed during
the course of this conversation. I think maybe what I\'ll, do Kristin,
Greg, if it\'s okay with you, sort of talk a little bit about the
recommendations and then go back to the work plan.\
\
**[\>\> Greg Downing:\
]{.underline}**Sure.\
\
**[\>\> John Glaser:\
]{.underline}**Greg and Kristin, let me know if I wander off the game
plan. What we would like to do is in our May and June meeting is discuss
specific recommendations that would occur in particularly the first two
areas, genetic testing and family medical history, but also the other
two. But focusing on the first two. And the first two will be the core
of the conversation with AHIC in July. The other two we'll have to both
develop recommendations but also feed them into, as mentioned before,
overarching discussions about clinical decision support and
confidentiality, privacy and security. So we\'d like to use the next two
meetings to focus in on the specifics of recommendations and what we\'d
like to do is invite you all to be part of a, break yourself into teams,
so to speak, and to be part of specific groups and discussions. It
doesn\'t preclude you from being in more than one but some folks will
have more of a natural interest in one of these four areas than in other
four areas. So I don\'t know, Greg, Kristin, whether we want to do that
now, get volunteers, or whether we want to follow-up with e-mail
subsequent to that to get folks who would be willing to spend some phone
time and some reading time and some comment time between now and the
next couple meetings to put together some specific recommendations.\
\
**[\>\> Greg Downing:\
]{.underline}**This is Greg, John. I think it\'s fine to \-- either way.
I would like to point out we are going to be, we think, based on the
guidance and discussions today, asking several members for their input
on CPS, and clinical decision \-- or decision support activities. I just
want to reiterate the timeframe that we\'re trying to fit these into are
to provide contributions from this Workgroup to both of those trans-AHIC
working group activities, and we think this is an appropriate time to
try to bring those two additional Workgroups into play. So in the
background of having individuals from this Workgroup developing
recommendations for the family medical history and genetic/genomic
tests, there are individuals that we think would also be able to
contribute to these others. So that\'s just a cautionary note that
we\'ll be asking people to volunteer for probably four different kinds
of activities here, and we\'ll leave it up to you to determine how much
time and effort you can contribute to one or more of these.\
\
**[\>\> John Glaser:\
]{.underline}**Do you want to let folks know what names you have in
mind?

\[laughter\]

Open the door, buddy.

\[laughter\]\
\
I think, why don\'t we do that, Greg, and if people want to think about
that and get back to you or are concerned about that, why don\'t we go
ahead and do that?

**[\>\> Greg Downing:\
]{.underline}**And again, I think John Loonsk is on the call or has been
earlier, and has been working double time with the rest of the ONC
activities to enable our use case development process to be in synch. So
my apprehension is not to \-- is to try to contribute to the broader
AHIC activities and that means commensurate with our suggestions for the
CPS and CDS activities. But not to sort of get behind, if you will, on
developing the recommendations that are necessary to feed into the use
case development and the timeframe this fall. If John's on the call yet,
he may want to contribute as to what that is. But we see the specific
recommendations for these two priority areas as being important to have
ready for the July 31st meeting. So I\'d like to get a sense from you as
chairs and the committee, the Workgroup, to first of all to say you\'re
in agreement with that approach. And we\'re not trying to \-- we\'re
trying our best to utilize your time in the best ways that will work
with the AHIC process. So as long as everyone is agreeing with that,
then we\'re here to help guide the work and your time can be done,
utilized most efficiently. So first of all, I just want to make sure
we\'re on the same page, and I\'m looking around here and seeing heads
nod up and down, but there may be some objections to our timeframe in
taking that into place.\
\
**[\>\> John Glaser:\
]{.underline}**Greg, the only piece of advice I have for you is that
when the heads \-- some heads are going one way, and others are going
the other, that\'s when you\'re in trouble. Presumably they\'re all in
same direction. Folks have any comments on that, or reactions?\
\
**[\>\>\
]{.underline}**I have to say that it would be very helpful to me to get
some sort of an e-mail that would categorize all of these different
activities for which Greg would like us to provide assistance.\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\>\
]{.underline}**Because he sort of mentioned them all but I\'ve lost
track.\
\
**[\>\> Greg Downing:\
]{.underline}**I think we were sort of now moving to the section on the
agenda, John, that\'s really developing the high level Workgroup plan,
that\'s tab 6, so maybe you want to take a moment to jump to that.\
\
**[\>\> John Glaser:\
]{.underline}**That\'s fine.

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

I think one of our only color-coded tools that we have \-- we don\'t
have color printers here, so this is a challenge. So if you could go to
tab 6, Kristin \-- either one of us can guide us through here. But on
the top line, it\'s really identifying what meetings we have to work
with, and that is kind of gauging what work we have to get done and the
timeframe we have to use your conference calls and the convening power
of the public meetings that we need to have. So we\'ve again addressed
the genetic, genomic test and the family history activities as the areas
where we felt that the ability to develop recommendations and the use
case development process on the back end that would need to take place
is really dependent on having recommendations made to AHIC at the July
31st meeting. And this would enable John\'s group and the standards
development processes to be under way within their timeframe to develop
the use cases and get that into the turning of the crank, if you will,
of AHIC use. So the other sort of parallel activities that we think are
going to be substantially longer in terms of developing input for our,
relative to these two areas in which there\'s cost-cutting involvement
with other Workgroups, and those are the CPS, or confidentiality,
privacy, and security areas and the clinical decision support
activities. And again, these were areas initially identified by AHIC as
ones that should be in the field of play. We have identified members of
this working group that we feel have expressed interest in the past in
participating in these latter two, but we\'re certainly willing to take
on other members, if you will, and I can identify those. but the most
immediate deed I think coming out of this meeting today would be to
identify individuals to work on family history and genetic test
recommendations. Betsy, does that help clarify the timeframe and the
work activities?\
\
**[\>\> Betsy Humphreys:\
]{.underline}**I guess.

\[laughter\]\
\
**[\>\> Doug Henley:\
]{.underline}**Greg, this is Doug. When you speak of the genetic test
part of this, I assume that you\'re speaking to the necessary IT
standards for those tests relative to HIT issues and eventually what
HITSP will do, et cetera.\
\
**[\>\> Greg Downing:\
]{.underline}**That\'s correct. We would be providing a broad
recommendation and probably sub-recommendations for, for example, the
harmonizing the standards that are developing for both the nomenclature,
the electronic messaging, and laboratory data reporting standards. So it
brings together the standard development organizations that have been
working and as we\'ve talked about in the past, HL7, for example, has a
balloting activity undergoing for family history information for
electronic health record now. So it will be developing the
recommendations that would help the use case development that would feed
into the overall AHIC process.\
\
**[\>\> Doug Henley:\
]{.underline}**For both family history and medical genetic tests?\
\
**[\>\> Greg Downing:\
]{.underline}**That\'s correct.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay, thanks.\
\
**[\>\> John Glaser:\
]{.underline}**Other questions for Greg? Greg, do you want to go ahead
and take some volunteers at this point?\
\
**[\>\> Greg Downing:\
]{.underline}**Sure. Well, why don\'t we ask for volunteers for both the
family history and genetic testing areas right now?\
\
**[\>\> John Glaser:\
]{.underline}**Yeah, we\'ll do the others later.\
\
**[\>\> Greg Downing:\
]{.underline}**I don't know how you want to do this. Shout out your
name.\
\
**[\>\> John Glaser:\
]{.underline}**That will work.\
\
**[\>\> Greg Downing:\
]{.underline}**We will also recommend an appointment of a sub \--
workgroup subcommittee chair for each of these so we\'re able to
optimize the decision-making aspects for moving these forward.\
\
**[\>\> Grant Wood:\
]{.underline}**This is Grant Wood speaking for Marc Williams. I think
it\'s obvious that we would like to volunteer for the family history and
genetic tests.\
\
**[\>\> John Glaser:\
]{.underline}**Terrific.\
\
**[\>\>\
]{.underline}**Is that two different groups or one?\
\
**[\>\>\
]{.underline}**Two different groups, isn\'t it?

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

You can be on more than one group if you want. We need two groups. One
is family history and one is genetic tests.\
\
**[\>\> Grant Wood:\
]{.underline}**Can we volunteer for both?\
\
**[\>\>\
]{.underline}**Because Marc needs to be on more committees.\
\
**[\>\>\
]{.underline}**Yes.\
\
**[\>\> Grant Wood:\
]{.underline}**I\'ll let Marc know what I just did when he gets back.

\[laughter\]\
\
**[\>\> John Glaser:\
]{.underline}**It\'s been nice knowing you, I\'m glad you were able to
join us for this call.\
\
**[\>\> Greg Feero:\
]{.underline}**I\'d be happy, can you use Greg Feero too? How about one
of us will do family history and one will do genetic tests and we\'ll
have a mano a mano to figure out who does which.\
\
**[\>\> Michele Puryear:\
]{.underline}**This is Michele Puryear. I\'d like to volunteer for the
family history.\
\
**[\>\> Betsy Humphreys:\
]{.underline}**This is Betsy, I\'ll volunteer for the genetic tests.\
\
**[\>\> Beryl Crossley:\
]{.underline}**This is Beryl Crossley and I would like volunteer for the
genetic tests also.\
\
**[\>\> John Glaser:\
]{.underline}**Others?\
\
**[\>\> Lisa Rovin\
]{.underline}**This is Lisa Rovin. I think FDA will probably want
someone to work on the genetic testing as well but I\'m not sure who has
time right now, so I'll have to get back to you.\
\
**[\>\> John Glaser:\
]{.underline}**Okay.\
\
**[\>\> Greg Downing\
]{.underline}**Janet, are you on the call? We had nominated Janet
Warrington as another person. Everybody else was sort of self-nominated
that was on our list. All right. Family history. Are there any other
late takers for that one?\
\
**[\>\> John Glaser:]{.underline}**

I think, Greg, if you all could reach out to folks who were not able to
join us today who you suspect might have an interest, we might be able
to add a couple folks.\
\
**[\>\> Greg Downing:\
]{.underline}**I think we\'ll discuss deliverables after we get through
this part. But we\'ll bundle a chart with the names and let people
review it and make sure they\'ve \--\
\
**[\>\>\
]{.underline}**Greg, can you add me to genetic test?\
\
**[\>\> Greg Downing:\
]{.underline}**Okay.

**[\>\> John Glaser:\
]{.underline}**Thank you all for volunteering. I appreciate that.\
\
**[\>\> Greg Downing:\
I]{.underline}**f we could move on to the CPS, what we\'ve been doing
and (inaudible) I think there are activities aligning themselves with
the CPS working group, and an ad hoc steering committee to address
clinical decision support areas. I think on the last one this is going
to be a complex area that\'s going to take some time, and we would like
to, both John and Doug, and on this, designee, Marc Williams and Steve
Teutsch as alternates, participate in a steering group that will try to
address broad AHIC multi-Workgroup kinds of CDS-related issues. And what
we\'ll ultimately do is bring back to this Workgroup specific areas that
are being developed there and as we see the opportunities unfolding for
more in-depth work on the genetic tests or medical history areas, pull
the trigger and ask you to pull together more of a subcommittee
involving more members. And we\'ll certainly be bringing back to the
Workgroup what this ad hoc steering group will be addressing. We think
this is complex and requires some broader ONC and AHIC strategies to be
engaged before we try to develop a subcommittee in that. Both of these
look like longer-term Workgroup activities but we need to be engaged in
them at this point is our opinion.\
\
**[\>\> Kristin Brinner:\
]{.underline}**This is Kristin. I\'m going to jump in here. I believe
for the March 12th meeting, I sent out a document that was a clinical
decision road map and that is maybe going to be used as a tool by this
ad hoc working group to plan its activities. I\'d be happy to send that
out again to anyone that would be interested in seeing what the initial
thoughts are. This document was developed over the last year by members
of ONC and other people. So probably useful tool for that workgroup as
well.\
\
**[\>\> Charles Kennedy:\
]{.underline}**This is Charles Kennedy. I\'d like to see it.\
\
**[\>\> Kristin Brinner:\
]{.underline}**Okay.\
\
**[\>\> Greg Downing:\
]{.underline}**We\'ll redistribute the CDS road map document. It\'s
relatively hefty and maybe we\'ll give you a quiz at the end. All right.
And then on the CPS, the Confidentiality, Privacy and Security group, as
a subcommittee of our Workgroup, we\'ve identified, and there\'s been a
subcommittee that initially met in a conference call back in December
and Kristin, if you want to review the people that have already
identified themselves to deal with these issues. In your packet today
there was one or two-pager that sort of identified what the visioning
session identified are five major areas, and two categories of potential
solutions that came out of the visioning session. And so we think that
there\'s probably a good opportunity now for this subgroup to start its
work and in parallel with the CPS working group recommendations that are
being developed. There\'s an overall attempt in AHIC to develop a CPS
sort of road map, if you will, that addresses many of these areas. And
the piece of this Workgroup is to really address that which is unique to
genetic tests and family medical history information. So we\'ve
identified Becky Fisher and Deven McGraw, Amy McGuire, Mark Rothstein,
and Kathy Hudson as the subcommittee for that and we would certainly
encourage any other members to participate. I\'d like to have a chair
nominated for that, if that\'s feasible.\
\
**[\>\> Kristin Brinner:\
]{.underline}**And this is Kristin again. Just to clarify in terms of
the activities of this working group. it\'s confusing because there\'s a
CPS working group and then there\'s our subgroup that we\'re forming
that is also dealing with these issues. And we think the most useful way
for these two groups interact is that our CPS subgroup of the PHC
working group will be longer-term activities and it can start either
drafting priorities or recommendations, whatever they feel is
appropriate. And then these can be then further presented to our working
group. And then we will use the CPS working group of AHIC to kind of
work with them in addition for setting these recommendations or whatever
documents that come up with to the AHIC. So this working group will deal
with the more specific issues we\'ve identified in terms of being
relevant to personalized healthcare and then we\'ll work with the
broader CPS working group of AHIC to present those.\
\
**[\>\>\
]{.underline}**Kristin, can I make an observation about the subgroup of
this group that is working on confidentiality, which is that it doesn\'t
have any representation from the private sector nor from people who
understand sort of the technology underlying security. Because I think
the group would be benefited by both of those perspectives \--\
\
**[\>\> Greg Downing:]{.underline}**

Yes, thanks. A number of people \-- and we have talked to Steve
Matteson, and he was not going to be able to join us today. But your
comments are consistent with others and I think we do need \-- that\'s
our perspective also.\
\
**[\>\> Paul Cusenza:\
]{.underline}**This is Paul Cusenza, I'd like to join.\
\
**[\>\> Greg Downing:\
]{.underline}**Okay. John and Doug, I guess we can turn it back to you
now that we have members identified.\
\
**[\>\> John Glaser:\
]{.underline}**Again, I appreciate that, Kristin, Greg, for laying that
out. So in the next presumably next several weeks we will get these
various working groups or sub-working groups together and get folks on
the way of developing specific recommendations and contribution. I
don\'t know, unless Doug, Greg or Kristin, we have other things we need
to cover on this agenda item on PHC recommendations at this point.\
\
**[\>\> Doug Henley:\
]{.underline}**I think you\'ve done it, sir.\
\
**[\>\> John Glaser:\
]{.underline}**It\'s a pleasure, sir.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay. Well, let\'s go then on to the agenda item about
action items for the May meeting. I think just by the discussions over
the past 15 or 20 minutes we\'ve pretty well touched on those but let me
try to summarize. First, along with John, let me thank everybody for
your great feedback today about the vision statement as well as the
priority document. That\'s been very helpful and, as Greg and Kristin
have said, we\'ll be working on that quickly and get those revised
documents back to you. As you\'ve heard, we\'re trying to shoot for the
AHIC meeting on July the 31st, this summer, in terms of making some
initial recommendations to AHIC. The AHIC meeting next week, we may
simply present some more high-level aspects of what our Workgroup is
about, and our areas of focus that we\'ve spoken about. But July 31st
hopefully will be some more specific recommendations. So backtracking
from that, what we hope to accomplish at our next two meetings,
certainly at this May meeting, and perhaps at our June meeting of the
Personalized Healthcare workgroup are to formulate a series of more
specific recommendations that relate to the issues that we just
discussed. Specifically, what are the necessary HIT standards that we
need to be thinking about and recommending to AHIC to then go on to the
HIT Standards Panel, relative to clinical genetic tests and family
medical history.

And then perhaps in a bit broader way, relative to these two new
workgroups, let me backtrack, then obviously we\'ve got members of this
Workgroup that will be working on those two areas that we\'ve talked
about. IT standards for clinical genetic tests and family medical
history. Then there will be the two subcommittees dealing with
confidentiality, privacy and security. That\'s one subcommittee. That
will discuss and consider those types of recommendations as it relates
to our area of genomics and genetics that come to the PHC Workgroup and
then probably will be laterally referred over to the broader AHIC
Workgroup called clinical Confidentiality, Privacy and Security and thus
eventual recommendations to AHIC either jointly with us or coming simply
from that group.

And then of course there\'s the representatives from our Workgroup that
will participate in this larger group about clinical decision support.
So hopefully by the May meeting, and certainly no later than June, we
need to have some specific recommendations for AHIC about HIT standards
relative to genetic testing and family medical history, and perhaps some
other recommendations that relate to those broader categories of
confidentiality, privacy and security, and/or clinical decision support,
yet to be determined in those two lateral groups. So I think we\'ve got
our agenda laid out for us pretty well as it relates to the May meeting
for sure, and probably the June meeting as well. So let me ask John and
Greg and Kristin if I\'ve missed anything. And then see if there are any
comments from the Workgroup.

**[\>\> Greg Downing:\
]{.underline}**I think from the staff\'s perspective, you\'ve got it.\
\
**[\>\> Kristin Brinner:\
]{.underline}**This is Kristin. One thing that I\'m just going to add is
that we are, in terms of the timeframe for presenting at the AHIC
meeting in a week, we obviously need to have those documents done
relatively quickly. So we will try and very quickly turn around all the
suggestions that you\'ve made about the vision and the priorities
documents and get those back to you, and if you could be as rapid as
possible. I believe the kind of drop-dead date for those documents is
either Thursday or Friday of this week. So we will get them to you, if
possible, this evening and hope you can get back your comments quickly.
We\'ll have to see what the nature of the comments in terms of how we
proceed with them. But just wanted to kind of reiterate that the
timeframe is short.\
\
**[\>\> Doug Henley:\
]{.underline}**Thanks, Kristin. And I\'d also add that the following the
July 31st meeting of AHIC, whatever is adopted there, hopefully will
then help guide us in the use case development process late summer,
early fall, that then is the use cases that ultimately get referred to
the HIT Standards Panel for their consideration and their pronouncement,
if you will, back to AHIC regarding the standards. Any other comments
from the Workgroup about that, kind of that outline and road map? Okay.
Greg and Kristin, are we ready now for public comment?\
\
**[\>\> Judy Sparrow:\
]{.underline}**Yeah, we can bring in the public, Jennifer, if you\'d do
that.\
\
**[\>\> Jennifer Macellaro:\
]{.underline}**I just put a slide up. You should see it in a second.
There\'s a phone number there for people to call in who are not dialed
in already. If you have already dialed in, just go ahead and press star
1 to alert the operator. There is an e-mail address if anyone would like
to write in after the meeting. And I\'ll check back in with you in a
minute or two.\
\
**[\>\> Kristin Brinner:\
]{.underline}**This is Kristin, while we\'re waiting for public comment,
we actually are going to be having a call at 4:30 today to discuss
family history issues related to the DOD\'s AHLTA system and the Surgeon
General\'s family history tool. If anyone is interested in that, drop me
an e-mail and I can send you the conference call information for that as
well.\
\
**[\>\>\
]{.underline}**Thanks, Kristin.\
\
**[\>\> Doug Henley:\
]{.underline}**Are we on yet for public comment?\
\
**[\>\> Judy Sparrow:\
]{.underline}**I don\'t think we\'ve had any response. Let\'s wait a few
more minutes.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay.\
\
**[\>\> Judy Sparrow:\
]{.underline}**Or a few more seconds.\
\
**[\>\> Doug Henley:\
]{.underline}**I see the slide on the computer.\
\
**[\>\> Jennifer Macellaro:\
]{.underline}**This is Jennifer. It doesn\'t look like we do have anyone
calling in today.\
\
**[\>\> Doug Henley:\
]{.underline}**Okay, thanks Jennifer. Great. Thanks, kudos to everyone.
You\'ve done your work in about an hour and 45 minutes. That\'s a lot
better than three hours for all of us, I suspect, and so we\'ve found
about an hour and 15 minutes, some time that all of us can get caught up
on whatever we need to get caught up on. So my thanks to John, to you
for your excellent work getting us through most of this agenda today but
also to the Workgroup members for your great input. And obviously as
always, to our superb staff back at ONC and elsewhere at HHS, to get us
through this. John, any further comments?\
\
**[\>\> John Glaser:\
]{.underline}**Doug, nicely said and my thanks to all for all the hard
work and look forward to conversations in the weeks ahead.\
\
**[\>\>\
]{.underline}**All righty.\
\
**[\>\>\
]{.underline}**Thanks, everybody.\
\
**[\>\>\
]{.underline}**Bye-bye.\
\
**[\>\>\
]{.underline}**Bye.