[This Transcript is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
Full Committee Meeting — Plenary Session
June 21, 2007
National Institutes of Health
CASET Associates, Ltd.
10201 Lee Highway, Suite 180
Fairfax, Virginia 22030
- Ms. Karen Trudel
- Dr. Justine Carr
- Dr. Paul Tang
- Ms. Carol McCall
- Dr. Leslie Francis
- Dr. Marc Overhage
- Dr. Seven Steindel
- Ms. Marjorie Greenberg
- Dr. Simon Cohn
- Mr. John Houston
- Dr. Judith Warren
- Mr. Harry Reynolds
- Dr. Larry Green
- Dr. Donald Steinwachs
- Dr. William Scanlon
- Mr. Garland Land
- Dr. Kevin Vigilante
- Dr. Eugene Seurle
- Ms. Susan McAndrew
- Mr. James Scanlon
- Call to Order – Dr. Cohn
- Update from the Department Data Council – James Scanlon, ASPE
- Committee Actions – Dr. Cohn
- Uncovered Entities
- NPI Letter
- HIPAA Streamlining
- Data Linkages
- Booz Allen Presentation
- Fatima Rias
- John Loonsk, MD, ONC
- International Health Terminology Standards Development Organization (HTSDO) – Betsy Humphreys NLM
- International Classifications and Related Activities – Follow-up – Ms. Greenberg and Dr. Steindel
- Data Stewardship, Quality RFI – P. Jon White, MD, AHRQ
- Secondary Uses of Health Information – Dr. Cohn
- Concluding remarks/meeting reflections – Dr. Cohn
P R O C E E D I N G S 8:50 AM
DR. COHN: Good morning. Will everyone please be seated? I want to call this
meeting to order. This is the second day of meetings of the National Committee
on Vital and Health Statistics.
The National Committee is a statutory public advisory committee to the US
Department of Health and Human Services on National Health Information Policy.
I am Simon Cohn. I am the Associate Executive Director for Health
Information Policy for Kaiser Permanente and Chair of the Committee.
I want to welcome Committee members, HHS staff and others here in person
and also welcome those listening in on the Internet, and I think I want to give
everybody a special reminder to make sure to speak clearly and into the
microphone. We actually had one comment yesterday that people were having
difficulty understanding and hearing the conversation yesterday.
So, once again it isn’t just our sense of it. Sometimes really the reality
that in the heat of the conversation things do get garbled. If you can think of
it it would also be useful if when we talk potentially we make sure that we
identify who we are when we are speaking as much as we can keep in mind to do.
Anyway with that I wanted to also thank the National Institutes of Health
for hosting us at the Natcher Center this morning and I think it has been very
pleasant and helpful accommodations.
With that let us have introductions around the table and then around the
room. For those on the National Committee I would ask if you have any conflicts
of interest coming before us today would you please so publicly indicate during
your introduction. I want to begin by observing that I have no conflicts of
MR. SCANLON: Good morning, everyone. This is Jim Scanlon. I am the
Executive Staff Director for the full Committee, and I am the Deputy Assistant
Secretary for Planning and Evaluation at HHS.
MR. HOUSTON: John Houston. I am with the University of Pittsburgh Medical
Center and a member of the Committee. I have no conflicts.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the Committee. I have no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina,
member of the Committee and no conflicts.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, no conflicts.
DR. SCANLON: Bill Scanlon from Health Policy R&D, member of the
Committee, no conflicts.
MR. LAND: Garland Land, member of the Committee, no conflicts.
DR. CARR: Justice Carr, Beth-Israel Deaconess Medical Center, member of the
Committee, no conflicts
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the Committee,
MS. MC CALL: Carol McCall, Human Health Plans, member of the Committee, no
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
liaison to the Committee.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC and Executive Secretary to the Committee.
DR. VIGILANTE: Kevin Vigilante, Booz, Allen, no conflicts.
MS. JONES: Catherine Jones, CDC, National Center for Health Statistics and
staff to the Committee.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC,
MS. BICKFORD: Carol Bickford, American Nurses Association.
MS. FERRIS: Nancy Ferris, Government Health IT.
MS. CANUN: Susan Canun, writer for the Committee.
MS. JEANSAN: Hi, good morning. I am Angela Jeansan and I am with the
American Osteopathic Association.
MS. WILLIAMSON: Michele Williamson, CDC, NCHS.
MS. VILLAR: Allison Villar, American Health Information Management
MR. KYLE: Frank Kyle, American Dental Association.
DR. COHN: I want to welcome everyone in attendance as well as listening in
on the Internet. As mentioned yesterday the agenda has been somewhat modified
and actually will continue to be modified as probably we go on during the day
today. I think as you all observed we are starting a little bit early. The
intent was an eight-thirty start which we didn’t quite make, but we are also
not doing too badly.
This morning what we are going to do and once again this is a little
different even than announced yesterday is we are going to start with Jim
Scanlon with an update from the Department and especially information on the
Data Council and secretarial priorities.
From there what we will do is to begin to deal with remaining action items
from yesterday and we have two letters and we will try to take care of those
after Jim’s presentation and before the next presenter but we will also if we
don’t we will do some action items then and some a little later on in the day.
This will be followed by an update from the Office of the National
Coordinator. Rob Colodner unfortunately has a conflict but in his place we will
be pleased to welcome Karen Bell who is a Director with the Office of the
National Coordinator to present an ONC update and we look forward to that
Now, as mentioned yesterday since our last meeting we have formed a new ad
hoc work group on secondary uses of health information. This work is at the
request of the Department in particular ONC.
I will be leaving the work group. I am actually delighted that Harry
Reynolds and Justice Carr are going to be the Co-Vice Chairs. Maybe we will
talk about this a little later because I also want to introduce Margaret A, but
she is not in attendance at this point.
Suffice it to say after the morning break we begin with the first briefing
on the issue of secondary uses of health information in the world of the
nationwide health information network and this will obviously be with an
emphasis on quality reporting and improvement.
Now, this will start about ten-thirty. The first part of that briefing will
be led by Fatima Rias and Kristine Anderson. Fatima will probably be leading
From there we go to conversations and actually Kristine Martin Anderson
will be hopefully on the phone with her. Then we will be pleased to welcome
John Loonsk, a Director from the Office of the National Coordinator to do the
second part of that morning briefing which will function on NHIN core services
and the quality use case.
At 1 p.m., which will be after lunch hopefully we will be pleased to
welcome Betsy Humphreys for the start of a conversation related to
international affairs. She will be talking about the formation of the
International Health Terminology Standards Development Organization which is
sort of a mouthful. We typically call it the SNOMED SDO.
I should comment that even though I don’t know that it is quite a
disclosure that I am an alternate to the International Governing Board for that
activity but obviously this is not a paid position, but I do just want to
publicly disclose that.
This will be followed by a presentation and discussion by Marjorie
Greenberg and Steve Steindel on their perspective on international activities
related to codes, classifications, standards and the work that they have been
For those of you who have been on the Committee you will recognize this as
a continuation of a conversation we started two meeting ago, but I have asked
them to sort of retrace some of the conversation because since then we have
obviously had new members and so it will be useful for people to be reminded of
the conversation and then we will sort of go on to talk about that.
Now, at 2 o’clock we have a presentation from John White, the Health IT
Director from AHRQ on the AHRQ RFI on data stewardship which is really once
again sort of a second briefing that relates to secondary uses and hopefully
from there we will have a chance to talk about that as well as the general
issue of secondary uses and the intended work of the ad hoc work group before
we adjourn at about 3 p.m. today.
At between three-fifteen and three-thirty we will start with the ad hoc
work group which will meet from approximately three-fifteen or three-thirty
until five and then again tomorrow morning from nine to twelve.
With that, Jim, why don’t I turn it over to you for the departmental update
and as I said then we will begin to handle some action items as soon as we are
finished with that first presentation.
MR. SCANLON: Thank you, Simon and good morning, everyone. Let me just give
some sort of overall framework for relating to HHS priorities and strategic
planning just for the Committee’s general framework.
You have at your place an updated version of the Secretary’s top nine
priorities, and they are changed since the last time we discussed this.
Let me just indicate what the changes are and again remember these are the
activities that the Secretary is willing to focus his own time on and some
resources in the belief that changes at this level on these issues will bring
about changes at additional levels as well.
So, the first one here is affordable choices. This was not on the list that
I discussed last time. This is an update.
Basically this relates to the proposals to make health insurance more
affordable and accessible to everyone in the US and the specific proposal here
relates to the President’s proposal for tax credits.
So, this is basically a Treasury proposal. So, the idea is that you would
be able to deduct. There are some other intricacies but you would be able to
deduct as a deduction part of the price of health insurance premiums that you
paid and the belief here is that this would stimulate the market to offer more
individual health insurance policies.
That is coupled with some state reform efforts that would actually help to
link those individuals without health insurance with the providers, with the
payers in that state.
So, you have examples in Pennsylvania, Massachusetts, California and other
places where they refer to this concept of a health insurance connector so that
if you are not in a group health insurance plan you are basically on your own.
You are going to pay a lot more for health insurance. With the connector there
is an attempt to kind of link up individuals in the individual health insurance
market with the health insurance plans and there is usually in these plans some
sort of a standard insurance plan as well.
Sometimes it is more or less catastrophic coverage. Other times it is a
combination of prevention and catastrophic as well, but the idea here is to try
to get that moving.
On the Hill there is interest in tax credits rather than deductions but we
will have to see where that ultimately goes. That will need a statutory
Secondly, in its own right the priority here is insurance for children in
need. So, this priority relates to a series, several programs that provide
health insurance coverage to children. The SCHIP program, Medicaid program and
so on, the SCHIP program is up for reauthorization this year. So, particularly
getting that authorized at appropriate levels is the focus here and then the
remainder of these are priorities that we talked about earlier.
Value-driven health care really refers to the idea of providing consumers
and others with information about quality and about price and supported through
health IT so that consumers and others can make informed choices about health
Information technology, we are all familiar with the effort there.
Personalized health care, again is kind of appropriate to be here at NIH. The
goal here is to link up the fruits of research and discovery and technology
through the development process and to bring it into everyday practice in
I think some estimates are it takes 17 years for innovation to make its way
from the research side to everyday medical practice and genomic discovery
technology is prominent in this area as well.
Health diplomacy refers to a number of efforts, for example aid to Africa
and other developing countries for TB, HIV and malaria, prevention and
treatment and so on. There are some Central American developments there as
The other three I think we have talked about before, general prevention. I
think the focus here is specifically on physical activity, possibly leading to
guidelines for Americans just as we do for dietary guidelines.
Louisiana health care system, this is trying to restore Louisiana and the
New Orleans area to restore the health system there but not so much on the
hospital emergency room based system that existed previously more of a primary
care unit which is a real challenge and then a variety of activities relating
to pandemic preparedness and emergency preparedness generally.
So, those are the activities that again at the very highest level of the
Department probably in budget planning and other planning those are the
I have also given to you, there is an update of the HHS strategic plan. It
is the second page I have given to you.
We renew and revise the strategic plan about every 3 years or 4 years or 5
years. This one is currently out for public comment. There are four goals you
will see relating to safety, quality, affordability and accessibility of health
care. A second goal relates to prevention. A third goal relates to the whole
economic well-being side of the society and the fourth goal relates to
scientific and biomedical research and development.
I won’t go through the specific objectives but you will see these again.
These will be part of the HHS strategic plan.
Just a couple of other things quickly, on the legislative side 110th
Congress we are beginning to see the outlines of some rough bills on health IT
developing. I think the estimates are that we probably won’t see any, well, we
will probably see more attention in the fall.
Nevertheless, there are some draft bills floating around, one in the
Senate. Basically it is similar to last year’s.
It would codify the Office of the National Coordinator. It would codify the
AHIC. It would create some other sort of a partnership for health care
improvement, public, private partnership and it would create a number of grant
and loan programs that we saw in various bills last year.
So, again it is anyone’s guess how these will go. I think we expect to see
some other bills as well. There are also privacy provisions that are just a
small provision there relating to privacy and some privacy rights for
Let me see, quickly just to report on the overall budget shortly after we
met in February the President sent his Fiscal Year 2008 budget up to Congress.
That is now under development in Congress. On the health IT side there were a
number of investments.
You will remember that funding for the Office of the National Coordinator
was about $118 million. AHRQ had about $45 million request for health IT mostly
in the ambulatory care setting and my own office, ASPE had about $2 million
basically for evaluations, overall evaluations of health IT and activities and
for evaluations of the economic side of all this.
So, we will see how this works out.
Included in the funding was a fund. I think it was about $5 million for HHS
wide sort of a pool for data standards and terminology efforts because
otherwise we had to do this with whatever funding we could pull together in a
So, we have been working on that and if it actually works out that would be
very helpful in HHS, and for personalized health care as I describe it there
was a $15 million initiative as well.
We now have a budget for Fiscal Year 2007. We are almost in the fourth
quarter of course and there is a couple of projects that my own office, the
Data Council are working on. There are three of them.
Let me mention them to you quickly because of their relevance to the
Committee and we will probably be asking for your help. First of all we had a
very nice under the auspices of the Data Council and several members of the
full Committee here, we had a workshop over at the National Center for Health
Statistics looking at the potential of electronic health records and health
information exchange as a resource for our national health provider surveys and
several of you were on the program and helped think this through as well.
Given the penetration of electronic health records in ambulatory care now
this is more of a promise than a reality in terms of national surveys. Clearly
there were examples where electronic health records are available for research.
Those I think provide opportunities for us to look at in terms of pilot
studies. How would surveys work in a world where these were more prevalent and
I think we actually followed up with NLM and I think NLM is willing to try to
offer some of those to NCHS for some pilot studies.
Again, I think while some of those electronic health record systems clearly
are at the stage where they support research I think the general thinking and
several of you were there, we are not at the point now where you could have a
probability sample where you have to take the good and the bad and the advanced
and the initiates into your sample, but at any rate I think it was very useful,
a good discussion and we will keep looking at that.
We are starting as well, the Medicare folks have asked ASPE to help with an
evaluation of a couple of pilots, personalized health record pilots. Medicare,
and Karen might have announced this yesterday has I guess the proposals were
out for fee for service electronic personal health records, pilots and I think
CMS will be making the selection shortly.
ASPE, my office and others will be working on the evaluation of those fee
for service pilots and let me just report on an update. We initiated a study in
my office under the Data Council looking at, this is on the population health
statistics side of the utility and the quality of the data that is collected on
income and assets. Again, this is often a very important variable for health
planning in our major federal surveys.
So, we have probably got sort of half a dozen or so major federal surveys
and the evaluation is well under way and we will probably want to make a
briefing to the full Committee here when we are a little farther along.
One other project in its early stages but apropos of the population
committee and emergency preparedness, my office is probably going to be funding
at the National Center for Health Statistics an update of a survey of emergency
departments that was conducted in 2004, again asking about questions and
measures relating to preparedness. Different from the 2004 survey we now have a
whole set of activities focusing on pandemic preparedness as well.
So, we will have to add questions and I think we are asking the National
Center for Health Statistics to start with the questionnaire that was used in
2004, but we have to update it and expand it. So, we will probably be asking
some of you to take a look at some of these measures as well, and let me stop
DR. COHN: Before I open it up for questions there has been a number of
members who have arrived that I would like to give them the opportunity to
introduce themselves as well as publicly indicate whether there is any
conflicts of interest.
Gene, do you want to start?
DR. STEUERLE: I am Eugene Steuerle from the Urban Institute and I have no
conflicts of interest.
DR. FRANCIS: Leslie Francis, and I am from the University of Utah and I
have no conflicts.
DR. COHN: With that any questions for Jim?
DR. SCANLON: Bill Scanlon. I am just asking about the IT bill. Who has
introduced it and how much support does it have at this point in terms of
MR. SCANLON: An unauthored draft I guess has been circulated not just to
federal agencies but to others as well. So, it is in the Senate but I think it
is a serious bill.
DR. SCANLON: Someone wrote it.
MR. SCANLON: It is anonymous.
DR. COHN: Steve Steindel?
DR. STEINDEL: Yes, I have heard somebody has seen a draft of Patrick
Kennedy’s bill reappear in the House also as a draft version.
MR. SCANLON: I think the expectation is we will see a number of other bills
throughout the summer and probably more serious activity in the fall.
At the moment obviously in Congress there are a number of other activities
including the budget. In HHS for example, we have major activity relating to
the whole reauthorization of the FDA. So, clearly in both the House and the
Senate there are a lot of other priorities but I think the expectation is
perhaps in the fall but there clearly are drafts beginning to be developed.
DR. COHN: Any other questions?
Okay, Jim, thank you very much. I appreciate the update. Now, what we are
going to do is spend the next probably 20 to 25 minutes beginning to work on
some of the remaining action items from yesterday.
Don, can we go through your letter? I guess we will look at the changes to
this letter and I think we need our headline maker to sort of assist us with
some of the headlines here. We may be having some problems but please go
DR. STEINWACHS: We will start with the headlines because we know that is
the most important part here. This is up there on the screen now. We have gone
paperless in the population subcommittee and no longer have to worry about
paper. That is mainly because I can’t master the technology of getting it out
of the computer to a xerox machine or whatever that copier is.
So, this is the letter you saw yesterday with edits put in to address the
suggestions and we had multiple suggestions for the running title but as you
have already said, Simon, it is probably still a work in progress. So, I am
happy to take suggestions on that.
Paul, do you want to think about that and we will move on and then we can
DR. COHN: Could I make a proposal for an alternative? I actually think that
this is really more increasing the value of federal health data sets while
protecting confidentiality and security but that would be my proposal.
DR. STEINWACHS: It is sounding better. I am going to move over there so I
can actually type it in. This is a full purpose subchair here or otherwise I
can type it on my own screen and that doesn’t help it up there.
DR. COHN: No, certainly someone should go up there and do it.
DR. STEINWACHS: I can see that Marjorie has no faith in my typing skills.
So, increasing value —
DR. COHN: Of federal health data sets. Is it federal data sets or federal
health data sets?
MS. GREENBERG: Federal health data sets.
DR. STEINWACHS: Potentially they are not just health.
DR. FRANCIS: And they are linked. You need to keep the linked because that
is the crucial issue.
DR. STEINWACHS: I actually think in the title I am not sure that is the
critical issue. At least that is my personal view on this.
MS. GREENBERG: Yesterday I was arguing for linked because that is really
what it is about but I think that your title actually works.
DR. SCANLON: Since our recommendations do center on these access to the
data centers, the access to the data centers does not just involve linked data
but it can involve a single data set that has to be protected for privacy
purposes. So maybe not having linked in the lead is fine.
DR. VIGILANTE: It is not clear to me that you know linked is juxtaposed to
this notion of protecting confidentiality because linking poses a threat to
confidentiality and it is a major part of the first paragraph.
So, if we are going just to say value I don’t understand the imperative to
underscore. I mean it is not clear that increasing value is a threat to
confidentiality and why those would be juxtaposed in a way and that if we are
going to talk about linking in the first paragraph trying to obscure it in the
re: line doesn’t make sense to me.
DR. COHN: Other suggestions Steve?
DR. STEINDEL: I have a problem with the word “value.” I actually
liked the original title better because the way this reads, increasing the
value of federal data sets it is saying that the federal data sets aren’t
valuable now. I would rather stick to what we were talking about originally
which is increasing the use of linked data sets while protecting
confidentiality and security. That is what this letter focuses on.
DR. VIGILANTE: I think the point of having a re: line is to give a heads up
to an executive that what you are about to read is about this. These are the
bottom line issues. Otherwise it doesn’t help an executive. It makes it vague
and ambiguous and it doesn’t really help the executive know what is coming.
DR. COHN: John?
MR. HOUSTON: To split the difference between value and use could we use a
word like “utility” or we could say value and utility or value and
MR. SCANLON: Headlines should be short and I think the detail is in the
paragraph. So, I think I would say something like enhancing the utility.
Enhancing means it is good but could be better and utility I think everyone
understands what that means and enhancing the utility of federal health data
sets, something like that and otherwise I would keep it short
DR. STEINDEL: Do you think we are at consensus now?
DR. COHN: I was going to let Gene make a comment.
DR. STEUERLE: It is unfair because I missed the debate yesterday but I have
always felt that somewhere in that topic sentence and in the first paragraph we
really need to make it more compelling that the goal is to increase the
well-being of the population. Otherwise it sounds like a bunch of researchers
wanting something and then the caveat about confidentiality always says,
“Oh, by the way, there is a bunch of researchers out here who want
something, but there is a big confidentiality issue that is going to pose a
political risk on you.”
I think unless you get in there increasing something like the nation’s
health or improving the nation’s health by making better use of linked data
sets or something like that you have missed the whole message of why you are
doing this. That gets rid of value just by improving the use of or something
but I think improving the nation’s, that is not what you are, you are not
trying to increase the value of the set. You are trying to increase the
public’s well-being somehow, increasing the nation’s health, something like
DR. COHN: Think about what word smithing you would propose.
MS. MC CALL: I, too, like Gene was not here yesterday for the debate. So, I
would suggest something like harnessing the power of linked data sets to
improve the nation’s health.
I think it is more than use. It is about other things as well and what we
are trying to do I think I would leave the word “linked” in, linked
data sets because that is essentially the topic that is most vital and it is
not about whether they are used or not. It is not about whether it is enhancing
or they are bad but it is about whatever needs to be done to harness the power
that I think we all believe is there. That would be my suggestion.
DR. TANG: It is just a minor improvement on Carol’s. It is just leveraging
federal data sets to improve the nation’s health.
MS. GREENBERG: You dropped linked.
DR. TANG: I did drop linked.
DR. COHN: I guess we ar trying to put both of them up there to see what —
DR. VIGILANTE: Can we vote on linked versus missing link?
DR. COHN: Marjorie, do you have a tie breaker there?
MS. GREENBERG: I am not so sure about a tie breaker. I really like Carol’s
a lot harnessing the power of either federal data sets or linked federal data
sets to improve population health or the health of the population.
I think we can go either way on this. That one deletes the while protecting
confidentiality and security. I am okay with that although I have to admit that
too often the idea of protecting confidentiality and security is an
afterthought but somehow when it is included in this little headline it kind of
sounds like an afterthought, too.
So, obviously I think it is very much included in the content of the
letter. So, I don’t think you really need it in the headline.
I think leveraging again is a little too much of an in term, kind of tacky
in a way. So, I would say harnessing the power of either linked or not linked
federal data sets to improve the health of the population or to improve
population health is good and then I would agree with Kevin that you all should
vote on the linked versus not linked.
I mean as we mentioned yesterday data centers are used for non-linked as
well whenever the data are such that you really can’t release them because of
the risk of identifying individuals and of course linking only increases that
So, a lot of this is about data centers which goes beyond just concern
about linkage but you know you could go either way on it.
DR. STEINWACHS: Okay, do you think we are near a resolution here.
DR. COHN: I guess what I am hearing, I mean the one question I have is
still the linkage versus none but my general sense is that this is more than
just about linked data. That is my general view but I actually think that if
something like harnessing the power of federal data sets to improve the health
of the population while protecting the nation’s, well, to improve the nation’s
health while protecting confidentiality and security.
MS. GREENBERG: You want to keep that?
DR. COHN: I sort of like, I mean if Mark was here he would be advocating
for that pretty strongly and I guess that would be my proposal but we will see
what others thing.
MR. HOUSTON: My understanding of the purpose of the letter was to make the
case for improvements that needed to be made in order to improve the utility
and my fear is that without using words like what did we use originally,
utility, we are missing the whole purpose of the letter which is sort of a call
to action whereas this isn’t as strong. Harnessing the power sort of implies
that you could take that to mean that everything is already in place and
nothing needs to be done and I thought the purpose of the letter was to say
that there were some opportunities to improve the use of these data sets.
MS. MC CALL: You could have a preamble that said, “Actions needed to
harness the power.” It basically says that you have it to do.
MR. HOUSTON: But my point is the subject matter, the re: is important just
simply to make someone want to read the letter and I think when you say that
something needs to be done that I think you provoke people to want to read the
letter rather than the way this is being worded now.
DR. VIGILANTE: I guess we have to be clear on what the purpose of the re:
line is. If the re: line is to entice people to read something it is one thing.
If it is to signal to an executive this is a pithy statement of what you are
about to read here so you can set your mind appropriately to consume it then it
is two different things and I was thinking it is the second. It is going to the
Secretary. We are trying to pack as much information in the re: line as
possible to be concise.
I do think it is about stating the benefit. I think you do need to state
the benefit and while the letter is about a lot of different things relative to
data centers linkage was at the core of the intervention and the obstacles
about which this letter is relevant and I think that was the topic of most of
the testimony and I think not signaling that and then talking about it in the
first paragraph is unnecessary obfuscation.
DR. STEINDEL: So, Simon, we are looking for the Solomon approach here.
DR. COHN: I will retract my comments. I think probably the harnessing the
power of federal linked data sets to improve the nation’s health while
protecting confidentiality and privacy is that a, can we agree and move on?
Paul, what do you think?
DR. TANG: I was going to try to find a way around this. Of the things that
did come through clearly in the letter one is the linkage to harness the full
power and the other is how we need to streamline the process so that they can
get it faster than 18 months.
So, by just talking about the value I am not sure we have come across the
second thing and so one way to try to talk about harnessing the full power
without linking it is to use that phrase and so I will try one more. Improving
access to the full power of federal data sets to improve the nation’s health
and the full power refers to the — no, I have already got a grimace. So, I
will retract that offer.
DR. STEINDEL: We could conduct an experiment here and we could send the
Secretary two or three versions of this and see which one we get a reaction to.
DR. COHN: Don, I guess what I am going to suggest is let us go forward with
the first. We can I think all reflect on it during the day and before we finish
off the meeting we can go back and revisit it. I think we ought to not hold the
whole letter hostage to the title. So, let us continue on with whatever changes
are to the body of the letter.
DR. STEINWACHS: Okay, that sounds good. So, if you would scan on down,
Debbie to where red text begins there are some editing things that were picked
up, little reds. So, keep going.
Okay, we had talked about taking the second recommendation splitting it in
two and then providing some intros to those pieces.
So, the first recommendation is NCVHS recommends that NCHS should
streamline the project approval process, add staff as needed to minimize access
delays for data users and then says, “Similar to NCHS other agencies
within the Department operate data centers including AHRQ, SAMHSA and CMS.
NCVHS also recommends agencies within the Department in addition to NCHS that
sponsor research data centers should review their data access policies and
procedures to develop greater and more effective use. I will stop with that for
MR. HOUSTON: Is it use or integration of data or linkage of data or —
MR. SCANLON: The data centers themselves it would just be the idea of use
because the linkages are going on outside of the data centers within the
Department. The data centers are for access for outside the Department or
outside of government users.
DR. STEINWACHS: Any other comments on this? Then we split off from that —
Gene, I am sorry?
DR. STEUERLE: One question. I don’t know whether we would have to word
smith to do this but here and in other places is it possible to have a
requirement to report back on a regular basis on their success? I mean you know
you get a command going out to people to look at something and okay, I looked
at it. Now, I am done. It seems to me you need some process that requires some
reporting back and accountability. So, is it possible to put in some words like
“and report back on a regular basis”? There may be other places that
it comes up but I am just wondering if the Committee would be willing to add
MS. GREENBERG: At the end of the letter since there are several
recommendations and this will go to the Data Council and I mean I defer to Jim
but I assume this would be discussed at the Data Council because particularly
something like this and the Data Council has been looking at this issue. So,
you could ask for a report back from the Data Council in 6 months or something
DR. STEUERLE: I guess I don’t want a report from the Data Council. I want a
report from people responsible for the centers and other places. The problem is
you know like if we had to report back then it is again the reviewer reporting
back as opposed, I am trying to put a little accountability into the system.
So, in fact the people responsible for the data should have some
responsibility for reporting back on their success at getting other people
access to it. I am not sure a committee, I just worry about a committee
reporting back but maybe we don’t need to get into that. I am just saying that
somehow or other we should have a reporting back. It is extremely important.
MS. GREENBERG: With several agencies and they all participate in the Data
Council there is a coordination value there but you want to get reports back
from each of the agencies and you have got the users on the Data Council. You
have got the —
MR. SCANLON: Again, I think your job is to raise the issue. I don’t think
you need to be specific about the mechanism.
DR. STEINWACHS: So, Jim sort of put something in there at the end of the
letter. So, we will put in something near the end about that we are monitoring
this and would appreciate periodic reports on progress toward these objectives.
Let me take you to the other change which was to split out the second half
of that recommendation as a separate recommendation with some introductory
material that says that traditional use of data centers has required the
researcher or policy analyst to relocate to the site of the data center and
submit in-person data requests and obtain statistical outputs.
The Center staff review data requests and statistical outputs to ensure
protection of confidentiality. Progress has been made in developing remote
access systems as exemplified by NCHS. Remote access is essential to increase
access to health data sets when it is not possible to provide public use data
sets without compromising privacy.
NCVHS recommends agencies that sponsor data centers should take full
advantage of remote access technologies that support electronic submission of
data requests and return of statistical outputs.
Comments, suggestions, Leslie?
DR. FRANCIS: I would just change privacy to confidentiality at the end of
that without compromising. It is about who gets the information not about the
original acquisition of it
DR. STEINWACHS: Debbie, why don’t we do that, change that to — yes, okay.
MR. HOUSTON: It seems like that last sentence in the unbolded paragraph
starting with remote access almost seems like it is a run on because when you
look at without compromising privacy I am not sure what that is intended to
modify. The way you read it it almost sounds like it modifies — I know what
the intent is but it just doesn’t read correctly. You want to ensure that you
don’t compromise confidentiality through the process of providing remote
DR. STEINWACHS: Maybe an idea just to simplify this is I think the data
centers are essential and you cannot provide public use data sets and maybe
just to end that sentence at that point and say that essentially increase
access to health data sets when it is not possible to provide public use data
sets and then just leave it at that and we will assume that people understand
that there are two options here.
John, would that do it?
MR. HOUSTON: Yes, that would be fine. Either way if you want to still talk
about confidentiality considerations that is fine. The way it was structured
DR. FRANCIS: You could just change that and say that when it is not
possible to provide public use data sets in a manner that does not compromise
DR. STEINWACHS: Debbie, I think we have a solution. In engineering school
we skipped over English. I think there was another language. So, John, thank
MR. HOUSTON: My undergraduate degree is in computer science. So, I am
DR. STEINWACHS: Okay, other suggestions on this? Why don’t we go to the end
here and just quickly construct a sentence about reporting and feedback to the
Committee and so I can make sure I get Jim’s input on this, too and Gene’s.
So, in the last paragraph and let us see if that is where we try to make
the case that Gene was pointing out before of the importance of the information
for this and so the last sentence talks about the Committee will continue to
identify ways to improve the utility and benefits. Maybe before that sentence
we might put in a sentence and, Jim you had sort of said, could I get you to
say something again that we might insert there about the Committee desiring to
monitor this and wishing for it?
MR. SCANLON: Maybe down to the next paragraph, the Committee will let me
see, we could say something like the Committee will monitor progress in these
areas and how did I say that previously, and would appreciate periodic progress
reports, something like that. That is a little short. The Committee will
request periodic progress reports from the Department on this issue and then
the Committee will monitor progress in the areas and request periodic progress
reports from the Department and then periodic progress reports from the
Department and I think the last sentence is fine.
DR. STEINWACHS: Any other suggestions? We went through now all the changes
that have been made based on the conversation that we had yesterday.
DR. COHN: So, we have a letter at this point but we are still arguing about
the title. Actually I have one question and I guess is this, are you presuming
that this letter is clean at this point or is it still subject to further word
DR. STEINDEL: Don was happy but that is not sufficient for this process.
DR. COHN: I had one question and I apologize. We were trying to deal with
things and then we had to figure out what to do with this now and then move on
to our presenter who we are running a little late on here but I think this was
a sentence that I think John Houston brought up as an issue and if you would
put it actually onto the screen so I could see it here, it is in the red lined
area. Keep going. Okay, stop. It says, “Remote access is essential to
increase access to health data sets when it is not possible to provide public
use data sets in a manner that does not compromise confidentiality.”
I guess I am wondering about that sentence actually only because I —
DR. STEINDEL: It has too many accesses in it but other than that —
MR. SCANLON: And it is not essential since people could go to the center.
So, maybe remote access can greatly facilitate use of health data sets when it
is not possible. So, we get rid of the second access and say, “Greatly
MR. HOUSTON: You could change access to use, the second —
MR. SCANLON: Yes, change access to use and instead of saying, “Is
essential,” say, “Greatly facilitate use of. Remote access greatly
facilitates use of health data sets when it is not possible.
DR. COHN: So, we are getting rid of essential, right?
MR. SCANLON: Right.
DR. STEINDEL: Remote access can greatly facilitate use and cross out, yes,
and you can cross out is essential to increase and we have got an extra use in
there. You can cross out to increase, also, facilitate use of instead of to,
get rid of the to, of health data sets when it is not possible to provide
public use data in a manner that does not compromise confidentiality.
MR. HOUSTON: I am looking at this again and I am still confused. It is like
when it is not possible to provide public use data sets in a manner that does
not compromise confidentiality you can provide remote access which is not what
you intend but I think it is the way you could read it. I am almost thinking
back to your original thought which is just take out in a manner that does not
compromise confidentiality for fear that you misinterpret that.
DR. SCANLON: I think we are talking about remote access though to the data
center and we have identified sort of that the data center puts restrictions on
the way something is used. So, we are though that still protecting.
MR. HOUSTON: My point is you could also read this sentence and I am going
to reword it just to tell you why. You could say that when it is not possible
to provide public use data sets in a manner that does not compromise
confidentiality remote access can greatly facilitate use of health data which
is not what you intend but the point being that somebody could interpret this
to say that you are going to provide remote access if direct access would
DR. SCANLON: I agree we could drop this but I think the other part would be
to say that remote access to a data center because we have already implied that
the data center has a lot of restrictions built into it. So, it is not saying
that you can come and get all the data. It is you can come and get the data
under controlled circumstances.
MR. HOUSTON: Can we say, “Remote access on a confidential basis can
DR. STEUERLE: I don’t think anybody supports — does anybody think we need
the clause? You propose just dropping the last clause. Doesn’t that solve all
MR. HOUSTON: That is what Don originally proposed.
DR. STEINDEL: Okay, why don’t we go back and drop then and have it as
remote access can greatly facilitate use of health data sets when it is not
possible to provide public use data sets, period and then just delete all that.
Then it goes NCVHS recommends.
MS. GREENBERG: Remote access to data centers.
DR. STEINDEL: Okay, remote access to data centers.
DR. COHN: Don, let me suggest this? I think we are almost there. What I
would love to see is actually have people get a copy of this marked-up version
so they can read it and hopefully maybe we can vote on this either right before
lunch or right after lunch.
Will that work for everybody? That will give everybody a chance to look at
the title or title options as it relates to the body of the text.
DR. STEUERLE: Could I suggest on the title I think we know what the two or
three issues are and we could just go yea or nay and I think one issue is
whether we say, “Link” or we don’t and we just vote on it and one was
whether we add this confidentiality phrase or we don’t, and we could just vote
yea or nay. I don’t know whether we need to discuss all those again.
DR. COHN: That is well said. I just think we need to look at this and make
sure it is clean. So, Debbie, we can make copies or we may not be able to.
DR. STEINWACHS: There are technology challenges in every area, right? Why
don’t we try to do that and then bring it back about lunchtime.
DR. COHN: Okay. With that I want to turn to our next presenter and I want
to welcome Karen Bell who is a Director with the Office of the National
Garland, did you have a comment while we ask Karen to come u and join us?
MR. LAND: Yes, I have always wondered about when we write these letters do
we get feedback, and I know we worked on this letter to get feedback on this
particular letter but I am wondering what is the typical protocol when we write
letters. Do we come back a year later and ask the Department to give us
feedback as to what happened or should we be putting this type of clause in
every one of our letters so that we are sure that we are getting feedback?
DR. COHN: Garland, why don’t we hold this conversation until later in the
day only because Karen I think has to leave by 10:05 a.m. and so we are really
appreciative to have you there hold the thought and we will discuss it before
the end of the day but let us not get into that conversation right this moment.
Anyway, Karen we are very pleased to have you joining us and presenting an
update on the many activities of the Office of the National Coordinator.
DR. BELL: Thank you so much. It really is a privilege to be here with all
of you this morning. I really do wish I could stay though I have been
sandwiched in between because Rob is off today, between the Secretary’s
meetings this morning and the Hill after I leave here. So, I do apologize for
truncating my visit with you, but you can invite me back anytime.
What I would like to share with you this morning is basically some updates
on three of the things that are hopefully as near and dear to your interests as
they are too ours and those are in the areas of privacy and security, what is
going to happen with the American Health Information Community as it moves into
the successor phase and then lastly a little bit about our strategic plan and
how we are going about moving forward in that direction.
I will dive right into what I think is probably one of the most important
areas that we have with respect to moving forward the agenda of HIT and it is
not technological problems. It is really around privacy and security.
The approach that ONC is taking is really three parts. The first is to
recognize that we have an existing body of laws and regs and policies,
everything from the federal and sometimes I can’t even get all of this right,
the Federal Information Security Management Act through HIPAA, through OMB
policies and to a lot of the guidance that comes out of NIST that it codifies
at least some aspects of privacy and security or confidentiality and security.
We recognize, however, that in the current environment and in the
ever-burgeoning environment as health information technology grows that these
may need to be revisited, to be added to or perhaps and I say this, sometimes
we have to break them. Sometimes we have to make them and sometimes we have to
So, we really do need to go back and look at the whole entire federal
structure of laws and regulations.
The second piece of work that we are doing in this particular area has to
do with what is happening in various states. As many of you may be aware we
have had a contract that we share with AHRQ that is looking at variation in
state-based policies with respect to privacy and security.
The good news is that there has been a tremendous amount of work that has
been done and that we expect to have by the end of next week the first of three
reports that will be coming from the folks doing that work, that contractor
with the other two to be following immediately within the next week also.
So, by the end of June or early part of July we will have those reports and
they will be presented to the Secretary and be made public to all of you
through the AHIC very, very shortly. Aside from looking at what can be done in
this regulatory arena or the legal arena we are also very dependent on what is
happening in the rest of the environment and leveraging all of the wonderful
work that the various experts frankly around the globe have been doing.
Clearly you all are a primary source and for that I just want to extend on
behalf of our entire office a strong vote of gratitude for the work that you
are doing here and will continue too do.
Just as an example I just wanted to underline for everyone that the report
that you produced not that long ago with respect to privacy and security in the
NHIN, the National Health Information Network is an integral part of the
contract that has actually not gone out but has gone out in the RFP phase and
that all of the recipients will be expected to take all of those
recommendations and incorporate them in their work.
A second area that we are going to rely very heavily for you on and also
the work of AMIA(?) is in the area of secondary uses of data.
As you know, the American Health Information Community is informed by a
series of work groups. At least three of those work groups have made
recommendations and have expressed concerns about secondary uses of data.
So, the need to really come forward with really substantive actionable
recommendations and policy with respect to secondary uses of data is a very
important piece of our progress and again I want to thank you for that. I know
that work is starting this afternoon.
A third piece that we are leveraging has to do with the framework that we
are building around privacy and security and the first step is to develop a set
Now, a lot of organizations have been in this area as you all know. I could
mention Markle(?). The Office of Economic Cooperation and Development in Europe
is another. There are many folks who have been working in the principles arena.
We are attempting and I think any of you who were at the June 12, AHIC heard
about this, to harmonize all of these principles in a way that they can be used
across the board widely without necessarily being associated with any one
Now, the first step of that harmonization process is being done with a
small group. However, once that happens clearly it will go through a very
important public-private vetting. So, you can certainly be expected to and we
certainly hope that you will provide a tremendous amount of input into that as
So, the issue of leverage and I know you were just debating this a little
bit is absolutely critical for us. We are very dependent on work being done
The third area of privacy and security falls in the realm of what the
American Health Information Community is doing primarily through its work
groups as well. There is the confidentiality, privacy and security work group
and thank you, John, for being on that and I am sure you can share what is
happening there with the group but it will be coming forward with more
recommendations to the Secretary through the American Health Information
Community on actions that the Federal Government needs to take in order to
assure that privacy and security is protected in such a way that we don’t
compromise public health and other important uses of data as well.
So, the AHIC then becomes a way where new work can be accomplished and also
where the security piece is emphasized because as many of you know technical
standards for security are being developed by the Health Information Technology
Standards Panel. Those are being fed to the Certification Commission for HIT so
that they will continue to be incorporated in their security criteria so that
all ambulatory , all impatient and soon to be all health information exchanges
adopt those particular standards, technical standards to maintain security.
So, those are the three different ways that we are moving forward with the
security agenda and again very dependent on all of you and very grateful for
I mentioned the AHIC. So, let me just dive right into what we are calling
the AHIC successor organization right now. It will be a very quick not very
deep dive because we have not yet fleshed out everything we need to before we
can really move forward. However, I would like to emphasize that this is an
attempt to move a public-private partnership into the private sector where it
is out of the influence f the political environment that exists in Washington.
So, it will continue to have very intense Federal Government influence. It will
be heavily, again, populated by stakeholders from multiple different areas and
the intent is to really make it a decision-making body.
Right now as you all know it is a FACA, a Federal Advisory Committee Act
committee. So, its recommendations go to the Secretary and then the Secretary
determines how to fill them out, how to move forward with them or if even to
move forward with them, but the new American Health Information Community
whatever that is going to be would be hopefully a decision-making body on its
If you have any questions I would be happy to answer them after I just
finish this last little piece of the update and that is that we are continuing
to move forward with a strategic plan. It is not just for ONC. It is not just
for HHS. It hopefully will be a strategic plan that will really move the nation
forward. It is built on the original strategic framework that David Brailor and
company set forth in July 2004. That has been augmented by a series of goals
objectives and strategies that was presented to the AHIC last May as a matter
of fact of 2005. There has been a lot more work that has been done with those
goals, objectives and strategies. There is a lot more work that has to be done
with those goals, objectives and strategies but probably most important is the
fact that one can have all of these pieces and I will go back to the fact that
my father was a carpenter, and he used to collect all of these wonderful things
for me to play with when I was a kid and I could never quite understand how
they all turned into an absolutely gorgeous home because they just lay around
on the concrete for weeks at a time and in many ways that is what it feels like
a little bit right now. We have all of these pieces. We have all the building
blocks. We have all of the wood. We have the nails, but we haven’t really
thought through how to put together what you need to build first and so the
most important piece of our strategy frankly is to take all of these pieces and
to really think through what do we have to do first; what do we need for the
foundation? What do we need for the framework? What do we need for the walls so
that we can actually build the strategy in a way that we will meet everyone’s
goal of effective access and use to electronic health information in the most
effective and efficient way possible?
So, those in a nutshell are the three things you probably have not heard
about in the previous update or heard very much about. If you like I can talk
ad nauseam about any of our ongoing work from the work groups, from our
contracts but I know that you have probably heard about a lot that before. So,
I will leave it up to you in terms of any questions you may have and any other
information you would like to share.
DR. COHN: Thank you very much for coming and we realize that this is not
quite as easy as just walking across the street to the HHS Building. With that
why don’t we open it up for questions and sort of wee where people have issues
Harry Reynolds and then Leslie Francis.
MR. REYNOLDS: Dr. Bell, thank you. You made a comment about HITSP and you
used a word that they are developing standards. Are they selecting and
packaging or actually developing new standards?
DR. BELL: Thank you for catching me on my slip. The reality is that they do
not do any development. We rely on standard development organizations to do
that work and then they do determine which ones which actually be set forward
and will be made public and available to everyone.
DR. FRANCIS: When you commented on the synthesis of privacy and privacy
principles from various documents and sources that was discussed in the meeting
recently, we were talking in the Privacy Subcommittee yesterday or day before
yesterday actually what your timetable is in terms of the question of when it
makes sense for our contributions to come into play on that.
At the moment we still have a little bit more work to do on the process. We
would most likely share the document internally with you all, with others in
the Federal Government before we go out into the private sector with it.
So, I would expect that certainly by the summer you should be able to see
the document and then provide your input and any type of guidance you think is
MR. SCANLON: In addition, as Karen is aware the small group working in
Karen’s office on this framework we have shared the NCVHS earlier principles
and recommendations relating to privacy in the health information exchange
network. So, hopefully that will be, and I think we have offered Maya Bernstein
who also staffs the Privacy Committee to help on the work group. So, as the
framework and matrix kind of gets pulled together a little bit more it will be
more reflective of all of the work being done.
DR. BELL: Thank you, Jim.
DR. COHN: Other questions or comments?
I guess I should just generally express our appreciation. I mean I think we
are very pleased to see obviously work being done in ONC on the whole issue of
additional work being done on privacy and confidentiality and I am very pleased
to see sort of the multi-pronged approach given that it is a large piece and a
I wanted to sort of express for the Committee that we are pleased to help
in any way that we can on all of this stuff. We do feel that the NHIN privacy
and confidentiality document was a very useful document, and I think we would
consider that to be principles as well as practice.
So, we are obviously very pleased that it is part of the ONC RFPs that have
just come out and hopefully that will become part of the actual analysis work
in your department as you try to develop the overall framework for this.
DR. BELL: Absolutely and again I can’t underline enough how important it is
for us to take the work that you have already done and incorporate that. We are
not interested in creating new things if we don’t have to.
DR. COHN: I think if Rob were he would comment that he is the coordinator
and obviously the intent is to coordinate all of this going on. So, we do
Any final comments or questions?
Okay, I think we have gotten you out with a couple of minutes to spare. So,
we thank you.
DR. BELL: You are all wonderful. Thank you so much.
DR. COHN: Now, let me just ask the Committee, we have about 15 minutes to
our break. We tried one letter. Are we going to be able to get copies of that?
DR. STEINWACHS: The work is in progress. I think that before lunch you will
have a copy of that. Do you want a clean copy or just, I was doing an edited
DR. COHN: I think an edited copy so we can sort of look it over and make
sure we are all comfortable with the title, with the changes and I guess I
would ask is the NPI letter?
MR. REYNOLDS: We are having the same print problem as them. We can put it
up on the screen.
DR. COHN: Are people comfortable taking a look at it over the next 15
minutes and seeing if we can either accept the changes or see if we can find
someplace to print it?
MR. REYNOLDS: If you remember you had asked us to take a look at the
letter, take out some of the history and really drill it down into what we were
actually trying to deal with. So what we have up here is our edited version. We
can look at the regarding again to start there and we don’t want linkage in
ours. What we have right now is a need for continued UPN enumeration and access
throughout the NPI contingency period. That is pretty much the bottom line of
what we are looking for. Any comments or questions on that?
Okay, now if we start down through the letter if you notice when we get to
the second paragraph there we took out all of the previous discussions and as
others mentioned some of the things that had gone on since the last time.
So, if we go down to the bottom paragraph there on May 1, is when we really
started getting further updated testimony and based on that testimony which is
next and I will actually make sure we read the next paragraph based on this
expert testimony at the subcommittee hearings and our own private deliberations
we have the following observation: Some health plans currently use the UPIN as
a legacy number for claim adjudication and payment. Providers who bill those
plans but will not migrate to business operation, use of NPIs until sometime
after May 23, 2007 will need the ability to acquire UPIN numbers for new
DR. COHN: Harry, I think what the document says is our own public
deliberations but you said, “Private.” I think you mean public.
MR. REYNOLDS: No, it is public. I am sorry. Yes, it was public. After
hearing that testimony we are convinced that CMS should maintain business as
usual by continuing to issue and make available UPIN numbers until the end of
the NPI contingency guidance period (May 23, 2008).
NCVHS also recommends that CMS make the subscription UPN database and UPN
online registry capability available through the full contingency period versus
the proposed June 30, 2007, cutoff date. That concludes our letter and
hopefully meets what I thought were excellent requests from the Committee to
MS. MC CALL: I think it is a great paragraph. I have two specific
recommendations. Where the sentence begins providers who build those plans and
I would then at that point —
MR. REYNOLDS: Which paragraph are we in?
MS. MC CALL: The one that you have —
MR. REYNOLDS: Yes, thank you.
MS. MC CALL: Providers who build those plans, comma and who will not
migrate to business operation use until after. I would change but to and, and I
would remove the word “sometime.” It is not adding any information.
Other than that I think it is very clear.
MR. REYNOLDS: Okay, so, we are recommending to remove sometime, Karen, in
the next sentence or in the next line. I am sorry.
Are there any other changes or comments from the Committee?
DR. FRANCIS: Harry, just word smithing but in the second to the last line
NCVHS also recommends that and CMS make the subscription UPIN database
available through the full contingency period, I would just say instead of as
opposed to versus.
MR. REYNOLDS: Okay.
DR. FRANCIS: This is another simple word smith but it would read better to
me if instead of right at the end of that paragraph before the recommendation
if it read, “Will continue to need the ability.”
MR. REYNOLDS: Okay, John?
MR. HOUSTON: A question about the providers who build the plans but will
not migrate the NPI, why is that not occurring?
MR. REYNOLDS: Sometimes if the vendor of their system has not converted
their business they are needing to continue to use, in other words let me give
you an example. If your institution hired a new doctor and your institution has
not converted its systems yet and you are using UPIN numbers to bill people or
do other things philosophically you will have no way of enumerating that person
into the system.
MR. HOUSTON: Should we then change the words, “Who will not
migrate” to something like who cannot or are unable to migrate?
MS. MC CALL: It is not about willingness or ability.
MR. HOUSTON: Excuse me?
MS. MC CALL: Doesn’t that mean that you are trying to distinguish between
ability or desire? For whatever reason, regardless of reason they won’t be
MR. HOUSTON: I guess when I read this it sounds like somebody has made the
conscious decision that they are just simply not going to migrate and therefore
it would be helpful for either some clarification or worded in a way that says
that there is some issue that prevents them from migrating.
DR. CARR: Who will not be able to migrate until after that date?
MR. HOUSTON: Yes, because when I read that my reaction is okay, fine, they
have decided not to. Well, the heck with them. I mean it is —
MR. REYNOLDS: I think that is a good point.
MR. HOUSTON: So, some other choice of words that in some way indicate that
there is an issue with migration.
MR. REYNOLDS: Why don’t you select what that would be right now? Why don’t
you give us an idea? I am serious. I would like to finish this.
MR. HOUSTON: Who will not be able to migrate or are unable to migrate I
think is all. Justine, is that what you said? Who are unable to migrate.
MR. REYNOLDS: Unable is fine. I like that.
Anything else from the Committee?
Simon, do you want to see a written copy or I would actually ask for a
DR. COHN: I guess the motion I would suggest is a motion potentially to
approve with further word smithing as determined by the Chair of the
Subcommittee and the Executive Committee if that is comfortable everyone?
DR. STEINDEL: So moved.
DR. COHN: Is there a second?
DR. WARREN: Second.
DR. COHN: Any discussion?
All in favor?
(There was a chorus of ayes.)
DR. COHN: Opposed?
DR. COHN: Abstentions?
DR. COHN: Okay, the motion passes.
MR. REYNOLDS: Thank you very much for the recommendations. I think it makes
the letter much better.
DR. COHN: Okay, so, I think what we will do is to break here in just a
second but it sounds like we are endeavoring to try to figure a way to print
out a copy of the letter. Oh, we actually have done it. Okay. Technology is on
our side today.
So, what we will do then is to take a 20-minute, actually a 15-minute
break. We will start again at ten-twenty-five. I guess it depends on what clock
we are looking at. I am looking at the computer clock here. So, I guess these
are a little different but we will start at ten-twenty-five and we will start
with our second session and have briefings on secondary uses of data. So, thank
you all very much.
DR. COHN: We are actually testing out the mikes for the next session.
Hopefully these will all work. As I mentioned during our introductions to the
day this really is the beginning of our, what I described as our first briefing
on secondary uses of health information in the world of the NHIN and with an
emphasis on quality reporting measurement and quality improvement.
The first part of this briefing is meant to provide background on the
quality work group activity from AHIC and I think we are very pleased to have
Fatima Rias presenting and I think you will be primarily presenting from Booz
Allen and Hamilton in terms of some perspective on that and then of course we
are delighted to have John Loonsk joining us. John is Director for the Office
of the National Coordinator and I think John is going to hopefully provide
additional context setting in terms of talking about the NHIN core services
concept and how that is envisioned to play out as well as how the quality use
case applies in all of this.
This afternoon we will have a second briefing from Jon White talking about
data stewardship issues from AHRQ or RFI. These are all meant to be sort of
context setting as we begin to sort of move into this work that we have been
asked to do related to secondary uses of data in the context of the evolving
and developing nationwide health information network but I should also add with
an emphasis on the quality use case and quality measurement, quality
performance, quality reporting.
Now, yesterday and this morning I sort of indicated and once again thanked
the various members of the Committee who are going to be spending their summer
with me here on various hearings. Anyway I really wanted to thank the members
who are participating and obviously I will be chairing the activity.
Once again I want to thank Harry Reynolds and Justine Carr for being
willing to be the co-vice-chairs of the activity and Paul Tang, Bill Scanlon,
Marc Overhage, Mark Rothstein and Kevin Vigilante for joining us on this and as
I commented as the agendas for the hearings get better fleshed out there may be
other members who want to participate in select areas and certainly many of you
are going to be reviewers.
Now, the one thing I did not get a chance to do though was to introduce
Margaret A. who is our lead consultant on the effort and, Margaret we are very
pleased to have you again joining us on an NCVHS activity. You will remember
she was our lead consultant on e-prescribing, also, played an instrumental role
in our work on functional requirements for the NHIN.
So, Margaret, thank you for once again being involved with us.
DR. AMATAYAKUL: It is my pleasure.
DR. COHN: I, also, want to mention that we obviously have many liaisons
that are going to be involved with this and also our lead staff which is Debbie
Jacksons, and, Debbie, thank you very much for taking on that activity. I don’t
know that you actually raised your hand, but we are still very pleased to have
you in that role.
Okay, with that, Fatima, why don’t I let you lead off and thank you.
MR. RIAS: Thank you very much. As Dr. Cohn mentioned, I am here presenting
on behalf of Kelly Cronin and the Office of the National Coordinator. Booz
Allen is supporting their efforts related to the American Health Information
Community Quality Work Group, and I am here to give an overview on the work
group’s activities, their vision and their steps moving forward.
To start off with in August 2006, as many of you know the Quality Work
Group was formed to address how HIT can be used for the development and use of
They developed both a broad and a specific charge to guide their
activities. Their broad charge was primarily focused on four areas how HIT can
provide data to help with the development of quality measures, how it could
help automate measurement reporting of quality measures, accelerate the use of
clinical decision support and how performance measures could align better with
the capabilities and limitations of HIT.
Their specific charge then was to look at HIT should capture, aggregate,
report on a course of ambulatory and outpatient or inpatient measures, rather.
To help frame and guide the activities of the Quality Work Group the
Quality Work Group produced a vision document to articulate what the future of
quality measurement and reporting should look like.
This slide contains an number of high-level bullets that sort of exemplify
what that future state should look like and I am not going to go through all of
these but a few of the key ones to point out are that in the future we are
envisioning that stakeholders will have transparent reporting information
available to them to help inform their decision making, that the national
agenda will be in alignment with state, regional health care reform policies,
that performance and quality improvement will be accelerated because
information systems will be able to increase the ability to make optimal care
decisions and that results will demonstrate significant progress on the
nation’s quality goals reinforced by public reporting on metrics and payment
frameworks that align expectations and resources among providers and players,
public and private payers and consumers.
So, the vision of the AHIC Quality Work Group is really based on both
building blocks and characteristics of the national quality enterprise that
they are hoping to move towards.
The characteristics of that enterprise include the ability to disseminate
information to help consumers make choices about their care, information
sharing to help providers manage their care, population health management, care
coordination, quality improvement, quality measurement reporting, aligning
payment with quality and the building blocks that are needed in order to do
that are the development of consensus-based or harmonized quality metrics, EHR
adoption, EHR products that enable quality measurement, data stewardship, data
aggregation, population reporting and feedback, health information exchange and
of course privacy and security.
So, this next slide then presents a case study of that future vision. The
top part of the slide shows a scenario of a patient seeking care and shows the
patients’ perspective of their interactions with the health care system.
The bottom then shows how source of data would input and then receive
output from each point in that process. So, starting from the left a patient
who was admitted for care in the ER would have, there would be an EHR attend
form, the information that the providers receive about the patient’s history.
The next box over shows the provider assessing the patient again being
informed by the EHR and being supported by clinical decision support.
I think important to note here is that in that future vision what we are
seeing or what we would like to see is that health information exchange enables
the sharing of information across institutions.
Next we see CDS supporting the physician’s ability to make clinical
treatment decisions and then HIE enabling the sharing the information across
institutions in this case enabling the electronic ordering of a prescription
and then informing the patient’s PHR.
Moving on this next slide actually depicts what happens after the
encounter. A patient is able to use the PHR to track the procedures, test
results and prescriptions. They can go online or to another data source to
select another physician based off of the public information that is available
regarding either the physician’s performance or cost information.
The new physician is able to develop a care management plan based off of
his review of the patient’s electronic health record, across providers over
time and then clinical decision support not only helps in making treatment
decisions but also helps in enabling prevention activities to take place.
So, after this vision was developed AHIC then moved on to develop their
first set of recommendations and the set of recommendations was focused on
improving information flow during the health care encounter to both ensure
delivery of quality of care and enable automated quality measurement.
So, the first recommendation was the automation of data capture and
reporting from electronic health records to support a core set of AQA clinician
focused and HQA quality measures.
I will point out that there are a number of more specific
subrecommendations under each of these areas.
The next recommendation was to establish a unified framework and enhanced
collaborations for gathering key data from care processes and delivering key
information to providers to help improve outcomes.
Next, is being able to enable data aggregation for public reporting for
quality-based metrics on data that pool both provider and payer data and also
merge other data sources while maintaining privacy and then last the alignment
of quality measurement with the capabilities and limitations of HIT.
This next slide depicts the quality enterprise at a very high level. It
shows the flow information booth into the health care encounter and out of the
health care encounter to inform care delivery and to inform quality improvement
The circles depict where each of the recommendations is envisioned to
impact both the flow the information and improve that exchange.
So, the remainder of my slides really talk about where the Quality Work
Group is headed. They have developed this first set of recommendations and they
are now in the beginning stages of embarking on an environmental scan and what
they are doing is using longitudinal measurement as their framework for this
environmental scan. The vision document recognizes that quality measurement
from a longitudinal perspective is the future. We would like to be able to look
across care settings, look over time and be able to get a full 360 view of the
patient and be able to provide care management from that perspective.
There is an example here of diabetes care but given that most of you are
physicians I am not going to walk through it because I think most of you are
familiar with how care management ought to occur for diabetes patients.
One of the things that we are hoping that longitudinal measurement will be
enable or this focus on longitudinal measurement is looking at the integration
of multiple sources of information to inform measures.
The Quality Work Group hopes to define a path from predominantly sole
source measurement and in this current state it is primarily claims data to
multi-source measurement eventually incorporating and probably predominantly
relying on EHRs and other network clinical data.
So, right now we are at the point where the Quality Work Group has
published a Federal Register notice outlining a number of key questions related
to several areas involved with longitudinal measurement and the collection of
information to support it. We are holding our next Quality Work Group meeting
actually tomorrow afternoon to collect additional testimony around longitudinal
data management strategies and eventually we are going to be conducting I
believe anywhere from five to nine under OMB clearance stakeholder interviews
to gather more additional information, and so the types of questions or the
types of areas that we are interested in obviously overlap with areas that
NCVHS is looking at and that we hope that the ad hoc work group will be looking
at as well.
They include business and financial drivers for your data management
strategies, collection and aggregation of data from multiple sources and across
multiple organizations, database storage hosting and ownership, data
availability and reliability, provider feedback and quality improvement, data
use and data sharing agreements and finally privacy and security.
I am sure the intersections here are clear but you know some of the ones
from reviewing the charge for the ad hoc work group that I pulled out were data
use, access and sharing, stewardship and ownership and of course privacy and
security and I think we all look forward to working with you in the upcoming
months to further develop recommendations around these areas.
That is it.
DR. COHN: Okay, Fatima, thank you very much. I guess maybe what we should
do is try to go through all the presentations and then we can have discussion.
Are we okay with that?
John, why don’t we turn it over to you then and thank you again for joining
DR. LOONSK: Thank you, Simon. Good morning. I appreciate the opportunity to
come and speak to NCVHS. I am here to make really two presentations.
One is on the NHIN core services and to bring NCVHS up to date on the
status of the NHIN activity and the other is to talk about their quality use
case and the specifics of how the work there has laid out some of the details
of and architecture or architectural needs to get to some of the vision that
the Quality Working Group has put forward.
So, in terms of talking about the NHIN I have spoken previously to NCVHS
about the plans for the trial implementations. The intent is to have a network
of networks built around health information exchanges. Health information
exchanges as you will see play a critical role in some of the conceptualization
of how quality use case and quality activities can be advanced as well, to
securely connect consumers, providers and others, to do it in a way that is not
based on a national data store or central systems at the national level to
create this network of networks, to not use a national patient identifier in
doing so and to build this really through shared architecture including
standards, services and requirements and developing processes and procedures
for how that will come about.
In the context of discussing that we have brought forward a couple of new
acronyms. There seemed to be a dearth. Health information exchange is the
general term we are using for the networks that will comprise the network of
networks and we have talked specifically about the fact in terms of the last
year’s prototype architectural works and the plans for moving forward that
there will be eventually a role for specialty networks, functionally specific
networks that play a role in this network of networks but for the time being we
are really intending to build it out of health information exchanges and to try
to define some core capabilities, core services for those health information
exchanges that would enable them to participate in this network of networks
that will be the NHIN.
So, this is really the focus of the next round of the trial implementations
is not to go to production with this but to indeed begin to flesh out with more
specificity these core services, the transactions that are involved and
actually get the next round of consortia led by health information exchanges to
connect up through the process of the contract, the time, the period of
performance of the activity and actually demonstrate connectivity at the end of
that time frame.
Building on our vast experience with acronyms we have decided not to call
the NHIN HIEs NHINHIEs. That was very astute and so we have opted for N-H-I-E’s
as a term to designate the health information exchanges that meet these
architectural requirements processes and procedures to be part of this network
We, also, and I think I mentioned here before have a term for a health
information service provider and what we are really differentiating in this
regard is the role that in some circumstances a governance and
multi-stakeholder at times loose knit organization that may be a health
information exchange that is focused on issues of participation and governance
in a region or in a state may have and a role that a provider of reliable,
secure technical and operational services may have in supporting that HIE.
In some circumstances that will be one organization. In some circumstances
we feel that indeed these will be two groups, one that is supporting the other
and the health information service provider in this case might be supporting
multiple different HIEs and providing these services but led by the governance
of the health information exchange for participation and buy in and trust
relationships in the jurisdiction being served.
That is an important concept moving forward and in terms of conceiving how
we can get to and develop this layer of health information exchange that is so
critical to so many of the different activities that have been put forth in the
We in terms of process have taken the products of the first year’s work on
the prototype architectures and a number of different related activities and
have built them into the request for proposals and since I have been here last
the request for proposals has been put out on the streets and in it you will
see references to a number of specific products that are listed on this slide
in front of you including I would note the functional requirements we worked on
with NCVHS last year as well as the NHIN privacy and confidentiality
recommendations which are in and referenced in the RFP as a requirement for
We are clearly using this vehicle, this contract vehicle that is the NHIN
to begin to develop some of the capabilities that we want to see in terms of
the eventual network of networks that is the NHIN.
As policy activities develop, as the specifics of implementation are
advanced the capabilities to support those activities are being developed
through this activity and we are using NHIN contract to establish a level of
functionality that I want to talk to you about a little bit today.
So, based on the prototype architectures, we had four of them, they each
had, were asked to look at core capabilities as well as the three use cases at
that time. That was the scope for the their activity but they were then asked
to produce a number of different products which we have been mining and
refining in a number of different settings to help move forward as guidance for
Each of the different prototypes had some in addition to covering some of
the common ground unique aspects to it that we have also mined and what the
process here looks like is the development through iterations of establishing
prototype architectures and capabilities coming forward with the common
capabilities as well as the features that can be pointed to as valuable in
moving forward and a number of these have been pointed out in the summary
report that was published on the HHS web site recently. It was done in
conjunction with Gartner which looked at these four prototype architectures and
helped to define some of the transactions that are necessary to support these
So, what I am going to talk to you about briefly and what are listed on
these slides are these core services that we are using as one part of defining
what an NHIE will be in this coming trial implementations period.
So, first there are data services and this is an obvious one but it is
about push and pull. It is about secure data delivery. It is about data look up
and data retrieval services and it is about the ability to match patients to
their data in the context of the kind of activities necessary supporting that
kind of health information exchange.
There is an expectation here that a summary record as specified by the
Health Information Technology Standards Panel will be the CCD standard for a
summary record, will be transactable(?) by all of these NHIEs.
There are issues in terms of data integrity and non-repudiation. There are
needs in terms of audit logging and error handling and there is a need for
supporting secondary use of clinical data that is relevant particularly to the
kinds of discussions that you will be having and that we will be talking about
Clearly there are capabilities here around anonymizing and
pseudo-anonymizing and de-identifying data in appropriate contexts that are
important for this activity as well.
The area of user and subject identity management, user for the purposes of
this activity is someone who is connected to a system, could be a provider,
could be a patient connected to a PHR. It could be a provider or patient who is
connected to a health information exchange or to an application or capability
that is in turn connected to that health information exchange and subject is
referencing the subject of a data transmission or data retrieval.
So, there is a need for the HIE to play a role in identity proofing,
authentication and authorization and of arbitrating identities between some of
these exchanges. If you think about it if you don’t have a national; l patient
identifier there are times at which one health information exchange has to
arbitrate an identity with another health information exchange or with a
connected provider organization and these kinds of capabilities are a critical
aspect of the endeavor.
There are some basic management services that need to be thought about in
this regard and some of these management services relate to the process for
handling issues that occur in health information exchange if a user has to be
disabled temporarily or permanently, some complicated issues there around when
you have multiple networks working together and the need for one organization,
one network to be responsive to another network’s needs or an issue that has
arisen in another context and these are some of the business practices that are
going to be worked through in the context of the trial implementation and the
ongoing work as well and also listed here are some issues related to emergency
access capabilities to support appropriate individual and population emergency
The final slide here is the one that I wanted to talk about principally
with you and spend a little more time on because it represents a raising of the
bar in terms of some of the consumer services that are being advanced through
So, I think as you go through your secondary use conversations and talk
about quality data and about the ways and needs of longitudinal data access as
well as multi-data source access it is important to keep in mind some of these
capabilities for health information exchange that are being advanced and we
have to get to a place where there is a reconciliation of some of these
capabilities moving forward.
So, first in terms of a consumer service we are identifying the fact that
consumers should be able to identify the locations for their storage of their
personal health records. The plural here is not intended to induce multiplicity
of records but to recognize the fact that at times there will be more than one
personal health record and it will be something that needs to be dealt with.
So, the consumer and this is very much in keeping with the first year’s use
case on registration data, I as a consumer should be able to say that this is
my personal health record, to be able to give out that address, to be able to
share that connection with those who I want to have access to that and this is
part of the need in that regard.
The second service listed here is to support consumer information location
requests and data routing to consumer identified personal health records.
So, a lot of the activity around health information exchange has at times
looked like how does a provider look up data and find it where it exists
somewhere else in another provider organization or another information store.
In this context we are talking about the consumer’s ability to indeed know
where data about them exist and to be able to retrieve that information and to
then also be able to have appropriate data routed to them to support the
population of their personal health records.
The third service here is about the management of consumer controlled
providers of care and access permissions. It is a very complicated area with
lots of issues but what we are articulating here and what has been teased out
in the context of the first year’s work of the prototype architectures is the
need to be able to have transactable(?) permissions, controls that can be
exchanged between PHRs and health information exchanges and other entities that
are participating in this network vision, that the consumer has to have the
ability to express who should be able to access, whether that be done on an
organizational level or at times a more granular level and the context for
their access to their personal health record and in this context to access to
that information via health information exchange.
Another service that is being articulated here is the management of
consumer choices to not participate in network services and the office feels
that it is an important statement to make that a consumer should be able to
express their desire to not participate in network services going forward. It
is at least a capability that needs to be developed in support of that
Consumer access to logging and disclosure information for PHR and HIE data
is another capability being advanced, so, not necessarily the detailed kinds of
audit logs that systems exchange or have accessible at times but something that
can be consumed by the consumer, an access log if you will as well as listing
of disclosures that can be provided to the consumer in a format that they can
digest them and finally the final service here is the routing of consumer
requests for data corrections. So, the basic technical capability is that these
NHIEs should be able to accept a request whether it is initiated in the PHR or
through another application when a consumer has identified the fact that they
feel data from a distal provider is incorrect that the NHIE should be able to
route that request for correction to the appropriate provider as part of the
services they support as well.
So, there is a lot of technical capabilities and technical complexity under
the covers of these services but these are the starting place for defining
these NHIEs, recognizing that there is refinement that will need to be done,
recognizing that there are going to be policies and procedures that need to be
worked out, that there are data exchange agreements and importantly reciprocal
support agreements that are going to be necessary to get to this concept of a
network of networks to advance this activity, and we are excited about the
prospects for this next round. We anticipate that this will start up in the
fall. The scope of the activity will be inclusive of seven use cases that are
now on the table having gone through the process of comment and description and
so quality will be one of the use cases that we expect the NHIN health
information exchanges to work on in the course of this next year’s work.
The general look of that is that we expect that the offers of those that
are successful in receiving one of these NHIN contracts will be expected to do
the core services that I have identified here, to be able to exchange a summary
record as I specified as per the standard identified and each one will work on
two of the use cases and our hope is through the negotiation around the
awarding of these contracts that we get to that level of two use cases per HIE
and there could be as many as 15 HIEs that are awarded, each of which doing two
use cases and covering the gamut of the seven with multiple HIEs, and part of
the next step will be the development of the NHIN cooperative with a good
amount of the work done over the course of the next year will take place.
So, I think that is an important context for you to consider in both as an
update relative to NHIN activities as well as it is relevant in intersection
with the quality endeavor and secondary uses.
So, I mentioned the fact and I am going to now go into the second
presentation unless there are any clarifications that need to be made. I
mentioned the fact that use cases play an important role in not only defining
some of the activities, the data that HITSP needs to standardize, the
considerations for certification criteria but also specifically for the
concrete activities of the NHIN defined both in terms of scope and specificity
by these use cases and the recently published quality use case was one that
received a great amount of attention in terms of the comments that were
received as it was being developed and the input for what it should look like
and so the process that has been used here is that the priorities from the AHIC
and the AHIC working groups were coordinated and brought together into clusters
around a variety of specific activities.
Quality was a new working group of the American Health Information
Community. It had a broad and specific charge and so the work of the use case
was relatively better defined than some of the others as a starting point but
it, too, has received input some of the other priorities from other working
groups of the American Health Community as well.
So, specifically the quality use case tried to address a number of
different priorities in the area around quality and as much as we try to make
each of these use cases stand on its own and be specific enough to be usable in
the context of the secondary use of them, it should also be considered in the
broader context of the other use cases and some of the capabilities there.
So, for example, one of the other use cases this round is consumer access
to clinical information which has relevance to a number of the different
activities in the health information exchange domain as well as does this one,
but from the standpoint of quality the goal was to use EHR data to support
quality measurement, to support feedback to clinicians and we certainly
received in the course of the some 1600 comments that we received overall on
the use cases a number of comments that expressed the importance of feeding
information back to the provider of care in the appropriate time context of
Clinical decision support as I think you know there is a work group focused
on clinical decision support issues that is spanning a number of the different
AHIC working groups. The feedback to clinicians alone has been identified as a
method of clinical decision support in this context.
I think the next round of use cases will further develop the clinical
decision support aspects of a number of these different use cases but as it now
stands there is some footprint of clinical decision support in this one, to
support quality measures based on non-claims-based clinical measures.
So, yes, claims are a possibility here but there is a lot of “to
be” expectation in this use case of identifying the use of EHR data and
using non-claims-based data and the necessary approaches that have to be taken
to get to that kind of capability, to support quality measures based on data
from multiple entities and multiple data sources and to support quality
measures based on longitudinal patient care.
So, as I said, there are a number of “to be” expectations and it
is one of the things that in the use cases overall there is a real tension
between “as is” and “to be” in terms of trying to define
the world as people would hope it will be with electronic health records versus
also incorporating the intermediate steps and considerations that need to
accommodate the world as it now stands and this one had a good amount of the
“to be” expectations around longitudinal data and multi-data source
data but it was also based to some extent as you heard earlier on AQA and HQA
considerations for measures.
So, the use case does break itself into a clinician-related scenario and a
hospital-related scenario and the distinction there is not intended to continue
to perpetuate differentiation in that regard as much as it is to recognize the
fact that this is a reality of the current world and that there are different
information flows that also need to occur in the context of clinician quality
measures right now and hospital quality measures.
The use cases or this use case defines multiple functional roles and
hopefully we can get the next graphic.
There we go. It defines multiple functional roles and you can see squarely
in the center of it is an important consideration for health information
exchange. As this use case was developed it started out in its initial
prototype incarnation having much less of an emphasis on health information
exchange, more of an emphasis on the current information flows and processes
for existing measures.
The comments and the input from the Quality Working Group and others were
convincing and substantial in suggesting the fact that health information
exchange needs to play a role in achieving the vision of the quality measures
that are done here and that was one of the changes and one of the refinements
as the use case went forward.
These are functional. As you look through the use case it is important to
consider these as functional columns. They are not intended to be
organizational. They at times can be supported by one or more than one
organization in terms of their implementation and I am not going to go through
the individual steps and activities here but an important point of
consideration for a number of the next steps is represented by the lines
between each of these different functions.
The overall approach that we are taking in the national agenda is to
concentrate on interorganizational standardization and information exchange
that indeed we are trying to ensure that the different internal organization
architectural approaches can be manifest wherever possible and you see that in
this context that most of those lines of information flow indeed although they
are drawn between functions are also representing some level of likely
interorganizational flow but there is a very delicate balance between these two
and if we are defining functions that can at time be supported by one
organization we can’t always obviously address just the clean distinction
between interorganizational flows.
Important in this context are a number of issues around data stewardship
and around data exchange, data linking and data reporting that you will grapple
with in the context of your work.
We have identified so you have both the flows, the use case is available to
you. I think it will, I hope it will also offer a very concrete foundation for
some of the considerations that you will be tackling as you move forward.
We have identified some of the things that have been teased out sort of in
the intersection between the Quality Working Group, the use case and the NHIN
that will be important aspects of the work you do moving forward.
I mentioned data stewardship authorization and access are important.
Critical in this context is achieving the goal of longitudinal multi-source
data, doing that in a context where there is not a national patient identifier
and hence the needs to be able to link patient data with other patient data in
the context of accomplishing that.
There are needs in terms of temporal stewardship. How do we support
provider feedback of these linked longitudinal multi-data source data to
providers that indeed may be operating in just one of the data providers for
that activity, and how do you put that information back to the provider in a
way that they have comfort that the measurements that relate to them can be
viewed by them before they are reported out?
How are these quality reporting needs and quality management needs mapped
against the consumer capabilities and services that I described to you earlier?
What are the levels of information and what are the appropriate levels of
granularity at the different levels of information in this complex patchwork of
data from different sources trying to construct a longitudinal view?
What is the relationship to the linking activity that I alluded to,
pseudo-anonymization as appropriate to support patient identity but also to
enable appropriate linking and what are the limits and appropriate business
rules necessary to support those activities?
So, it is a complicated activity. I hope that the use case lays out a
foundation that can help you work from in terms of taking the next steps in
your work and we in the Office of the National Coordinator very much appreciate
your willingness to tackle this critical activity for the national agenda.
DR. COHN: John, I obviously want to thank you. I, also, I guess should also
thank you for your willingness to be involved and provide counsel as we sort of
move on in some of these areas.
Obviously I think your conversation helps to provide context and
background. I think it is one thing to talk about secondary uses but I think
what we have all been trying to say is secondary uses in the context of the
developing NHIN. It isn’t just secondary uses and I think you provide some of
that vision of the future.
Yesterday when I was talking about the work that we are doing and then I
will obviously open it up for questions and comments, at least as I articulated
the scope of the work group activities and know some of them are things that
have been asked for by ONC and HHS, some are things that we think just need to
Hopefully with the work in context is a realization that I think there is a
need for an overall conceptual and policy framework that just relates to
We use that term a lot and exactly what does that mean in this context? It
includes things like taxonomy, definition of terms, not that
pseudo-anonymization begs for a definition but some might feel that way but I
think there is this overall context and the next is developing questions for
HHS for guidance for public education, potentially extensions to regulation,
and hopefully that will be the last piece if we can avoid that one but related
to the expanded uses of health data as you have been I think describing very
appropriately in the context of the NHIN but with obviously as we have
described an emphasis on this quality use case hoping to help ground the
conversation so the conversation just doesn’t go everywhere.
Obviously we will be refining the scope as we talk in the ad hoc work group
and all of these efforts are sort of iterative scope discussions but I think
this once again helps put that conversation in context.
So, I want to thank you.
With that let me ask if there are questions?
Harry, do you want to lead off?
MR. REYNOLDS: Yes, I do. Thanks to both of you, excellent overview,
especially as we start this. Thank you.
John, you mentioned the CCD and this doesn’t have to do with the Committee.
This is trying to think this through.
So, it would seem to me that if the CCD is selected by HITSP as kind of the
package and that is all the data that you would want to say about someone
pretty much, kind of the data that would be passed around the NHIN through HIEs
through others about someone, and then I would assume that obviously EHRs would
have to play off of that and use cases would have to play off of that and so
on. So, am I misreading that or is that kind of a step down that starts to
DR. LOONSK: I think we have great hope for a summary record in terms of the
role it can play in a number of these different activities, but the context
here is as a summary record and so is it an important transactable commodity?
Absolutely and you see it represented prominently in the NHIN RFP, but we also
are realistic in that it doesn’t represent all the data that need to flow or
all the needs for exchange either and so I think we haven’t yet really plumbed
the depths of the value of a summary record in terms of electronic health
information exchange but I think it is going to be very critical.
MR. REYNOLDS: And as it is built you would assume that whatever it is
whether it is CCD plus, whatever it is, those other pieces would be based on
some kind of a standard whether by HITSP or someone else.
So, when you have NHIEs talking to NHIEs everybody understands how that
data is supposed to work.
DR.LOONSK: I hope you understand the context of the CCD and I am going to
throw some acronyms at you but the context of the CCD has arisen as really an
important product of HITSP harmonization where ASTM was advancing the CCR which
was a really thoughtful business-oriented approach to what data are important
in the summary record and that has been harmonized with the CDA of HL7 which
represents the conceptualization of the clinical architecture, the kinds of
terminology necessary to support that summary in a much broader context as well
as to continue to refine the structure of the content that will be transacted.
So, the harmonization of the CCR and the CDA from ASTM and HL7 respectively
has produced the CCD which really is bringing with it some of the best aspects
of both and so I think it is a significant accomplishment.
It is a new accomplishment. It is something that is still relatively fresh
but it is an important step in supporting a variety of the different use cases
as Harry suggests.
DR. COHN: We have Marjorie, Paul and then Leslie.
MS. GREENBERG: Thank you, John. Just since you threw a few new acronyms at
us and I love acronyms and also I have committed to always updating a list of
acronyms for the Committee I just wanted to clarify a few things.
As I understand it HIE is not only an action but now it is an entity also.
Is that correct, and is for example I didn’t see the word “RHIO” at
all in your slides, is an RHIO a type of HIE?
And you can answer in letters if you want.
DR. LOONSK: We could perhaps just use flags or something. The concept of a
state regional health information organization didn’t make a lot of sense but
the definition of an HIE would certainly be inclusive of a RHIO in that
The intent is that it could as the NHIN RFP; so I am doing my best here
asks for, I couldn’t figure that one out, the, it could be a regional health
information exchange, a state health information exchange which might indeed be
a combination of other health information exchanges or a non-jurisdictional
health information exchange and some of this is still developmental.
Exactly what a non-jurisdictional health information exchange that would
have the kind of governance attributes that are specified in the request for
proposals would look like is still, will be interesting to see but yes, a RHIO
would be an HIE as would potentially a broader non-regional health information
MS. GREENBERG: Okay, and thank you. That was helpful, and then on your
slide about consumer access and I am not quite sure that was the title of it
DR. LOONSK: Consumer services?
MS. GREENBERG: Yes, consumer services, thank you. There were a number of
references to personal health records and was the intention there really to be
to personal health records as opposed to the health care record?
There were some things about I don’t know if it is easy to bring it up
again, if not, that is okay, but about consumer access and then but there was
something also about consumer correction which seemed to have more to do with
the health care provider’s record and also something about deciding who will
have access and authorizations and all that.
DR. LOONSK: The language there was specific. It was specific to PHR
although PHR is not currently a very specific definition right now, but the
specifics that are articulated in the consumer services suggest a step forward
in terms of advancing capabilities for PHRs.
What we are largely talking about in the NHIN context in terms of what the
request for proposals identifies is really what one might call at least I
started another acronym a personally controlled health record where not all
PHRs necessarily represent that right now but in terms of some of the
attributes and services that I described and that you made reference to for
example the consumer expressing access controls, that might be a way of
defining that as well.
I am not sure I want to start another acronym in that regard but I think
that is a little helpful in terms of the conceptualization of what the NHIN is
advancing. That being said, too, it does express some services and some
transactable permissions that could be applied in other contexts, and in terms
of the definition of an NHIE it is suggesting that some of those consumer
access preferences need to be supportable by an NHIE, and that is where we are.
DR. COHN: Next is Paul Tang and then Leslie Francis and then Carol McCall
and then Garland Land and then Larry.
DR. TANG: Thanks, John. In your latest RFP looking for more HIE contractors
you said that they all had to have demonstrated at least two use cases and you
also said at the beginning that they would be required to implement the
recommendations of the NCVHS’s recommendations on privacy.
Since just yesterday we approved a letter that is going to address
recommendation R12, since we spent so much time on that I am curious whether, I
just want to ask that question and R12 says that and also the CPS group in AHIC
said the same thing that all people, all entities that have access to personal
health information should be accountable and responsible much the way a covered
entity would be like, you know, would have to live up to in the HIPAA world. Is
it the intent then, does that mean that all of these contractors would have to
implement that kind of a responsibility and accountability?
DR. LOONSK: As a floor to the activity yes and so not necessarily as a
ceiling or a cap.
DR. FRANCIS: This is really a follow-up to Harry’s question. When we were
talking in the privacy subgroup we were looking, we were trying to think
through the question of what kinds of choices consumers might want to have and
that question gets seriously interrelated with the question of what is in the
summary patient record that is thought of as being interchanged. So, if for
example I mean one simplistic way to think about this is that certain kinds of
provider information ought to be subject to patient choice, say, if you see a
Another way to think about it is that certain kinds of information should
be labeled as especially sensitive and that that could be masked in some way
maybe with a break the glass feature or whatever but the question depending on
what goes into that summary record how one thinks about that set of questions
looks very, very different because if the primary care physician’s notes about
depression don’t go into the summary care record then you don’t have to worry
about mental health records being generated by primary care physicians and so
So, I wonder if you could comment on that monster?
DR. LOONSK: I have two comments. One is that some of the issues you are
identifying relative to a summary record also play out at a health information
exchange in terms of record look up and other capabilities there.
So, it is not just the summary record. So that is one issue. I think
another comment I would make is that there is no doubt I think that there is
tension between the practical aspects of user or consumer management of access
control to data and the provision of care and that this is a very complicated
issue that still needs more work in terms of in several respects, in terms of
the level of granularity that is actually practically achievable; does that
include segregation of certain data in a summary record or not? So, there is
work that needs to both occur at the policy level, at the standards and
technology level and at the practical level of implementation of some of the
practical aspects of that kind of access, and we recognize that.
That is one of the reasons we are in trial implementations not in
production but I will say that there is an expectation in DNHI services that
there will be controls, the ability for the consumer to express controls over
meta data not just data relative to for example, a consumer look up, so that if
information at a health information exchange specifies the location of data at
an institution that is sensitive that that is meta data which there should be
consumer capabilities for managing access and so hopefully that helps with the
question. Obviously there is still more work to be done.
DR. COHN: And, Leslie I think it points out the privacy subcommittee may
have to delve into standards and some of these other issues.
MS. MC CALL: Two questions. First is a follow on to Marjorie’s question. I
just wanted to clarify for my own purposes when you talk about a PHR and I will
put another acronym into the game, I didn’t know if you were, are you talking
about personally controlling something that is already there or are you also
talking about or instead more of an API, some sort of API to a personal health
record capability that was in your first bullet point where people may have
access to and storage of information that is flowing in there? So, in the
second scenario for example somebody may be putting information into it and so
there is actually input coming. So, that is question No. 1, and question No. 2
is actually following up Harry’s. The concept of the CCDs is relatively new to
me and if it is in fact a summary or an aggregation in some way is it the
intent for our secondary use conversations to consider just secondary use of
the summary or the components as well that went into it because there may be
times where as a consumer I may be comfortable with a secondary use of a
summary but not its component pieces?
DR. LOONSK: So, maybe tackling the second question first the
conceptualization of the CCD is a summary record. Now, the specific
implementations, the practical practices that go into what data are there and
what are not and how they are filled out there is still a lot of work to be
done in that regard, but it is not, I don’t think it is our expectation that
the work of this group would focus only on a summary record and I just wanted
to make that clear.
So, it is going to be an important component but it is also a new component
in the way people exchange health information and so I think there is a lot
still to be done in that regard. That is specifying it.
Relative to your first question as I said the definition of the PHR is one
that is still fraught with controversy and different interpretations.
In the conceptualization of what we are talking about in the context of the
NHIN a couple of important concepts. One is that indeed that we are talking
about a connected personal health record. So, just to be sure in the network
world and in the considerations of what people talk about as PHRs the value of
having data be able to flow to that PHR and not have it stand alone is a
critical component of the utility as many people believe but in terms of
whether the PHR is inclusive of the data store or not I think I am going to
have to direct you to the fact that the NHIN conceptualization of this is very
much about a PHR that also involves personal, some capabilities for personal
control which suggests influence over that data store; who has access to it and
who does not.
But I am not going to attempt to refine the definition of a PHR at this
time because there are obviously many different people in the industry who
articulate that in different ways but from the standpoint of the NHIN that is
what we are talking about right now.
DR. COHN: John, thank you and I fully agree that certainly the work that we
are describing goes I think significantly beyond any sort of summary record and
towards secondary use and as well as commenting that I think when the NCVHS
looked at this a couple of years ago obviously the area of PHRs I think is a
conceptualization is pretty clear as an instantiation and still wide
variability as I think you have described.
Garland Land, you are next.
MR. LAND: I am drawing you back to your public health roots. As you know,
public health requires a lot from providers in terms of data. My association is
vigorously working on electronic burst systems, electronic desk systems; other
programs require reporting for newborn hearing, communicable disease reporting,
cancer registry reporting, all sorts of surveillance systems that come from
either hospitals or clinicians and I am wondering to what extent public health
is part of this process in terms of determining how these networks are going to
meet their needs so that they don’t have these redundant systems that we have
right now that are impacting on the providers.
DR. LOONSK: Thanks for that question, Garland. I think one of the things
that I can point to in regard to the importance of public health playing a role
here is that we have been pleased to have been working collaboratively with the
CDC around the procurement that they have just put forward that also focuses on
health information exchanges in this context to work on the biosurveillance use
case as well as some peripheral issues around that and we all agree that
cultivating this level, this layer of health information exchanges is important
for a number of different purposes including public health in terms of
supporting public health needs and so the CDC now has a procurement that is
also open that borrows heavily from the concepts of the NHIN procurement. It is
going to be awarded to health information exchanges that will participate in
the NHIN cooperative so that we can try to make sure that these things stay
knitted together and that the public health needs are advanced in the context
of this as well.
So, we do perceive that to be a very important component of what health
information exchanges can help to support as well.
DR. COHN: Larry Green?
DR. GREEN: I want to keep building on Garland’s question just for a moment.
I think I almost got the answer. I want to be sure. You let up to 15 HIE awards
each addressing two use cases or more and the CDC has something in the works
about how all of this might help with public health reporting.
I really want to try to nail this down. What are we going to know when
these use case experiments are done and reported out about the ability that HI
E or a network of networks to provide this nation with vital and health
statistics and my concern about it would not surprise anyone but you know if I
heard you right there is no national identifier. We understand how the hell
that happened. There is no national identifier. Duplicate records are expected,
presumed to be there and there are options to not participating.
So, let us pretend that we are a bunch of people that care about numerators
and denominators and when I put all of that together I have a sense of urgency
of being sure in these demonstrations that we test the ability of the network
of networks to produce some valid vital and health statistics or is that going
DR. LOONTZ: Just to be a little more specific about the existing public
health or those things that are named specifically as public health that have
been in the use cases and part of the national agenda to this point in the fist
year we had the biosurveillance use case which focused on what could be called
the secondary use of EHR related data to support situational awareness and
biosurveillance purposes, not traditional public health reporting, not
traditional public health case reporting but an important area for
It, also, touched on utilization of hospital resources to support and
dynamic utilization information to support some response activities. That use
case is going to be one of the use cases that the NHIN group works on this
year. The trial implementations, that will be on the table as one of the use
cases that is expected to be covered in the NHIN. It is also the predominant
focus of the CDC procurement in terms of advancing that conceptualization and
those are going to be working together. So, we expect the CDC offers to be at
the NHIN cooperative and working on that.
In the next round of use cases, so we have the next round including
quality, consumer access to clinical information. We have the emergency
responder EHR use case which also has significant public health implications
and we have the medication management use case.
Those are finished and are being fed into the national agenda. There is
another presumed round which is coming forward. There are six use cases that
the American Health Information Community has cited as though they didn’t
prioritize them last time, they prioritized these four that I just mentioned.
They did say that they were important and they wanted us to work them up and
have them available by December of this coming year to feed into the next
We are going to go back to the AHIC in July and confirm their
prioritization but in that round there is public health case reporting and
other aspects of public and population health that are on deck so to speak.
To get more specifically to your question though and I think there are a
number of complicated issues in what you have asked and I am not sure we can do
full justice to them today but coming from a public health background as
Garland suggests and understanding the realities of public health reporting as
they now exist even with some of the challenges you referenced in terms of the
things that have been said I think the prospect of improved data to public
health through the NHIN and through the advancement of electronic health
records is going to be an overwhelming improvement too the public health
information access and reporting and I am not trying to minimize some of the
challenges we still have to reconcile that and consumer access and consumer
issues but when you look at the number of case reports that are actually
reported on reportable diseases in a practical setting and realize that they
are pretty low from a yield perspective I think the prospect here is very
DR. COHN: Kevin Vigilante?
DR. VIGILANTE: You know, I was just thinking about our task and what we are
going to be asked to do just maybe to get some specificity around how to think
about this. Very often we measure what we do because we can measure what we
happen to have and so that availability defines measurement which in turn often
defines what we can think of as being quality and what we measure today may not
be what we measure 10 years from now. Instead of measuring hemoglobin A1C’s we
may measure in the future risk adjusted diabetes outcomes among a network of
So, it may be a vascular surgeon, an ophthalmologist, a primary care doc
and say an endocrinologist.
So, as we think about these use cases I presume we should be thinking of
them in a sort of a measure agnostic way in terms of what the future might
bring in terms of yet to be defined measures and the elements that would
I guess I am trying to calibrate at what level of specificity we need to be
looking at the use cases and the measures we need to be envisioning.
DR. LOONTZ: I could answer that at two levels. At one level all the use
cases in the entire NHIN activity is intended to lay a floor for the kinds of
capabilities that can be advanced recognizing that like the Internet what the
world will look like relative to the medical, the health Internet in 10 years’
time is going to be very different. We can’t anticipate all of that and part of
our responsibility is to be minimally prescriptive and minimally restrictive
and only do that in the areas where it is absolutely important so that it can
develop and that we can take full advantage of it.
So, that is the general response. On a more specific response relative to
the quality measures I might turn to Paul who as I think most of you know has
been leading a working group. The quality use case specifically is sensitive to
measures but it s largely measure agnostic and the parallel activity has been
to identify a core set of measures that will be advanced in conjunction with
that and that work we very much have to thank Paul for in terms of and the
working group and their deliberations in moving forward but that is also an
important consideration for you all, that product.
DR. COHN: I will go to Justine but I think that maybe I would almost
comment also in terms of trying to answer Kevin’s comment that I would tend to
agree that we need to be agnostic. On the other hand, if what we are describing
doesn’t even meet the current needs we know we have done what we need to do and
indeed that helps to provide some foundation and reality to test against.
DR. CARR: Thank you. Maybe this is very, very fundamental but as we think
about a medical record today t here is a continuum of structured fields to
unstructured tax and we are hearing on Monday about the VA and how their
narrative is just that, a narrative that is not in structured fields.
So, as we are talking about what is getting exchanged, stored, aggregated
and also what represents the personal health record where is that what is today
a narrative, maybe a PDF or something like that? Where does that fit in all of
DR. LOONSK: We are absolutely in a progression moving from the very
unstructured to strategically identifying the places in which structured data
are critical to moving forward and there is this clearly a paradox to the
extent that highly structured data are sort of proportional to the challenge in
recording and managing them and we all know that as we are trying to move
toward greater adoption of the EHRs this is one of the challenges we face. So,
there is a titration here and I think as we move forward we have to be
strategic about it, identifying the places for structured data as we move
forward, trying to make sure we are harmonized around the structured data so
that we don’t have conflict in that regard.
The summary record really represents a step in that progression. It is
built on the clinical document architecture from HL7 as I specified before
which indeed is a step in that progression increasing the amount of structured
meta data if you will but still allowing for unstructured content to be
transacted and we think that is an important step for the NHIN and other
activities moving forward that we have to think about how text can be
transacted and how we can still have this vision of true semantic
interoperability and the data that are stored and managed in such a way that
they can be used for algorithmic processes to really improve quality of care.
That is still the vision but we have to take steps to get to it.
DR. COHN: Larry, you may ask a second question.
DR. GREEN: What is longitudinal data?
DR. LOONTZ: In the context that I used the term it refers to data about
multiple episodes of care around a patient or a consumer.
DR. GREEN: So, it assumes the ability to too define an episode?
DR. LOONTZ: I think it presumes that it is multiple episodes though they
may be defined differently in different circumstances. I am not sure we have to
get to you know, I don’t begrudge you your desire to get to specificity in that
regard but I am not sure you need it to define longitudinal data either except
that it is to be incorporating multiple episodes and to try to put together a
picture of the patient’s medical history that would span those.
DR. GREEN: So, it does presume that we have some mechanism at some level of
specificity to say that that is an episode because you have got to get the one
episode before you can put it with the next.
DR. COHN: I think this builds on encounters, doesn’t it?
DR. LOONTZ: It could build on encounters. My point was and maybe I wasn’t
clear was that we are defining longitudinal data as something that spans
multiple encounters, spans multiple episodes of care over time. So, whether we
have an exact definition of an episode of care I am not begrudging the desire
to get to something in that regard but I am not sure you need it to define
longitudinal. DR. COHN: Steve?
DR. STEINDEL: John, there has been I think a hidden presumption throughout
in the use of the word “longitudinal” and I think Justine actually
keyed in a little bit when she brought up the historical VA data and that is
longitudinal data is data going forward.
Is there any thought about legacy data and how it might impact on this
system and a lot of the secondary uses that we are talking about legacy data is
actually very important in defining the future system.
DR. LOONTZ: If you think about trying to be strategic about places for
standardization and think about interorganizational exchange for example as one
of the places one can be strategic and try to get to a tighter specification
another place clearly is what to do with all the data that are out there and
some of which is not manageable, some of which is manageable from an electronic
standpoint and will be mappable or transformable into the standards that are
being advanced for exchange and so I am not sure this answer is going to be
satisfactory to you but I think that we are going to have some sort of
compromise between where historical data that are accessible will be
retrievable. We are not identifying a massive effort here to reconstitute
historical data in electronic form to support these purposes. I mean the
practical realities of that obviously are very challenging in a number of
DR. COHN: Steve?
DR. STEINDEL: As a follow-up comment actually that answer is quite
DR. LOONTZ: Thank you. I finally did it for you, Steve.
DR. COHN: You know it is getting close to 12 noon and I know you have got
to be out of here in just a couple of minutes. I just want to thank both of you
for what has been I think a very useful background context setting conversation
around secondary uses. It will obviously not be our last one on this topic as
we will confirm and reconfirm scope and I think many of you were asking
questions that really indirectly relate to sort of scope, specificity issues as
we begin to do this work. I think it has been a very helpful conversation.
Now, I had talked about having the next letter first talking about it
before lunch. If it is okay, what I am going to suggest is given that you have
just had a chance to look at it why we don’t we take it up as the first
activity when we get back say at 10 minutes to 1 and we will at that point take
a look at it and see if we can deal with it in an expeditious fashion and we
will start a little bit early.
With that why don’t we adjourn the meeting for lunch and we will see you
back in an hour.
DR.LOONTZ Thank you.
DR. COHN: John, thanks.
(Thereupon, at 12 noon, a recess was taken for lunch until 1 p.m., the same
AFTERNOON SESSION 1:00 PM
DR. COHN: Welcome to the last session of the full Committee. I think as we
discussed this morning our first act after lunch was to review a letter being
brought by the Population Subcommittee and you have marked copies of this in
front of you and so I think we need to bring it back.
Don, I will give it to you and from there we will move into conversations
with Betsy Humphreys, Steve Steindel, Marjorie Greenberg on international
DR. STEINWACHS: Okay, you have in front of you a marvel of technology that
we were able to find some way to take a computer code and put it out on a xerox
machine and I want to thank staff for that.
This is a chance to give you to look at those things we just went through.
Let me just start off quickly. We have the re: line which now says,
“Harnessing the power of federal linked data sets to improve the nation’s
health while protecting confidentiality and security.”
So, are there any concerns about that? Is that okay? I look at Paul
immediately. I know have him type classified and we are going to get you a
little hat here that you are good at it.
Anything on that?
DR. STEUERLE: I don’t necessarily want to discuss it because we were
discussing it before but I would vote to remove the last clause, but I am just
wondering if we could have a yea or nay on whether people really think that
helps or hurts the message.
DR. STEINWACHS: Simon, do you want to hold the vote? You are the chair. So,
you have to hold the votes.
DR. COHN: I guess the question I would have is does anybody have any
objection to the way it is right now before we vote up or down?
Well, I guess per your request let us do a vote on it just to make sure.
Any conversation about this as it is right now?
DR. STEINWACHS: No, I think we sort of talked about the pros and cons
already. In part it is what you think this re: line is supposed to do and I
don’t think there is a consensus yet on that.
DR. COHN: Okay, so all in favor of leaving it as it is.
(There was a show of hands.)
DR. COHN: Whoever is in favor of striking it?
(There was a show of hands.)
DR. COHN: Okay, I think the consensus is, not consensus but the majority is
to leave it as it is.
DR. STEINWACHS: Okay, to take you down to the next part of the letter and
we had been working primarily on the paragraph in front of the third
recommendation which is on the top of the third page. That paragraph started
out traditional use of data centers has required the researcher and so on and
we were particularly I think trying to fiddle with a sentence there that says
that remote access to data centers can greatly facilitate use of health data
sets when it is not possible to provide public use data sets.
Simon and I had a quick conversation off line and it is like many things.
You are trying to anticipate who your audience is and what they know and they
don’t know and one idea was if that sentence is still troubling to people we
would like to drop that sentence and just end it before that and say that
progress was made in the developing access systems exemplifying NCHS and then
to go to NCVHS recommends that agencies that sponsor data centers should take
full advantage of remote access technologies that support electronic submission
of data requests and return of statistical outputs.
Any comments on eliminating the sentence or keeping the sentence and if
keeping the sentence does anyone want to change it?
MS. GREENBERG: What was the problem with it? You thought that people might
not know what public use data sets are or data tapes? I mean it does help
explain why remote —
PARTICIPANT: What part of the sentence are you speaking about?
DR. STEINWACHS: The sentence we are speaking about is the last one of the
paragraph where it says, “Remote access to data centers can greatly
facilitate use of health data sets when it is not possible to provide public
use data sets,” and I think part of the concern was that that implies that
you probably have a certain level of knowledge about the options for providing
data and what public use data sets are and so on and so I think in part when
Simon and I were talking about it we were saying that if you really want that
to be clear maybe you need to add another sentence or something and then the
other approach might be is if you think that doesn’t add to clarity as it is
then maybe just drop it out and just drive the point home.
DR. VIGILANTE: Can you get away with just saying, “Remote access to
data centers can greatly facilitate use of health data sets,” period, and
just end it there?
DR. STEINWACHS: That would be fine with me.
Any other comments on this? Do you want to go with the shortened sentence
that would be remote access to data centers can greatly facilitate use of
health data sets, I guess, period, and then just take out the — okay.
Then the only other addition, we made an addition at the end of the letter
that was to request that there be monitoring and feedback to us and as you see
there this now is a separate sentence line but it may very well either be put
into the paragraph before it or joined with the sentence right after it, but it
ought to be clumped into one of those.
It says, “The Committee will monitor progress in these areas and
request periodic progress reports from the Department.” I thought that was
a great idea.
Any comments on that?
Mr. Chairman, I think we may be ready for a motion and maybe a vote.
DR. COHN: Okay, is there a motion?
DR. STEUERLE: So moved.
DR. VIGILANTE: Second.
DR. COHN: Any further discussion on this letter?
All in favor say, “Aye.”
(There was a chorus of ayes.)
DR. COHN: Opposed, nay?
DR. COHN: Okay, abstentions?
DR. COHN: Okay, the motion is passed.
With that then let us move into our, and, Don, thank you and I really
appreciate the work of the Population Subcommittee on moving this letter
So, thank you.
Now, with that as I said we are going to spend the next oh, about an hour
talking about international activities and we are very pleased to have Betsy
Humphreys and most everyone is pretty much familiar with her. She is a
Associate Director of the National Library of Medicine and has also been one of
the driving forces between the I guess I had best describe as the SNOMED SDO,
and I am asking her to provide a briefing on that and then as I said we will
move into a conversation that also includes Steve Steindel and Marjorie
Greenberg about other international activities and, Betsy, I do want to start
by apologizing that you actually are Deputy Director. So, my apologies for the
mischaracterization of your title but thank you for joining us.
MS. HUMPHREYS: It is a pleasure. Okay, I think maybe all of this group
noticed when the International Health Data Standards Organization was formed
and publicly announced at the end of April, and it has as I believe you all
know acquired the intellectual property in SNOMED from the College of American
Pathologists and I am going to give you a little bit of background on the new
organization and what this means in terms of US membership, licensing and what
some of their current priorities are.
So, the new organization is a non-profit called association established in
the country of Denmark and if you want to know what this organization is, what
its purposes are and what is really inside it the document you read is
something called the Articles of the Association which is required by Danish
law when you are establishing an organization of this type and really has quite
a lot of detail about the purposes of the organization, the structure of the
organization, how it is going to operate and also because one of its chief
purposes is the ongoing update and dissemination of SNOMED the articles include
in it the licensing, describes the rights of the members, that is the
organizations that are representing countries in the organization and also the
licensing terms are actually all part of this one document.
So, as you can see there are nine countries where the initial charter
members, everyone in the world was invited to join and these were the nine that
agreed to join as charter members and each country is represented by a single
organization. NLM is the initial US member. The articles of the association
allow for the member to be changed.
So, for example, the way it would work out in the United States would be
that the Department of Health and Human Services could designate someone,
another organization to be the member.
A lot of the organizations that are members are straight government
agencies as NLM is but in the case of Australia and Canada as you may know they
have formed these separate organizations that are funded by various levels of
government but actually have sort of a separate status, NETA(?) in Australia
and I am forgetting what the Canadian name is at the moment.
So, they are the members for their countries. This has all happened very
recently. People walk up to me and they say, “Why hasn’t the SDO done X, Y
or Z yet?” and I always say, “Well, give them a few more weeks,”
because the organization was officially formed in Denmark on March 9. It was at
10 a.m., Copenhagen time. So, I had to participate too vote the organization
into being and it was a 4 a.m., call from my house, but the organization
completed the purchase of the IP from the College of American Pathologists only
on April 24, and then the public announcement occurred 2 days later on April
As you can see here the purchase price from the CAP was $7.8 million and
all of the charter members contributed to that except for the United States,
and the US did not contribute because we already had a perpetual license for
the use of SNOMED which we had purchased in 2003.
The way this works, the SDO has now contracted with the CAP for 3 years to
be the support organization that will actually maintain the terminology for
them and do some of the dissemination activity. This is not to be interpreted
as business as usual because the SDO is really setting the direction, the
priorities and overseeing this.
We had to conclude our contract with the CAP. It had 1 more year to go. We
closed it out and we are going to set up a new contract with the SDO which will
be put in place by the end of this month.
At the end of May there were a series of meetings that took place in
Evanston, Illinois between the management board and most of the general
assembly members and the interim officers of the SDO and the outgoing standards
board and working group members, and this was an exciting an interesting few
If you want the inside dope Judy was there from dawn to dusk. Steve was
there for a bit of it. I don’t know if anyone else in the room was there but I
think it was a very productive set of meetings.
So, these are the principles, also, spelled out in the articles of the SDO.
It is hard to argue with these and I think that the members have a real
commitment to going forward on this.
I think that they are very interested in collaborating with other standards
groups to facilitate interoperability and they are very interested in working
out arrangements so groups who want to make intellectual contributions to
SNOMED can do so and not lose the ability to make use of their own work.
So, we are dealing with member countries, sponsored countries and
non-member countries. That is what you divide the world up into under this.
Anyone can be a member country. Of course, we are hoping that many more will
join. The fees are based on World Bank indexed information about the wealth and
population of countries and they were pegged to the US fees.
So, as you know in all of those indices the US comes out at the top in
terms of the wealth and other measures that are used. So, our fee is the
largest and the others are graduated down from that.
As I mentioned before the other charter members contributed to the IP
payment and when new countries join they are going to pay a joining fee and
then they will pay annual fees as well. There is a concept of sponsored
countries and this for countries that are below a certain threshold, developing
countries, poorer countries they can make use of SNOMED through the payment of
a one-time fee which will then give them perpetual access and ability to use
updates of SNOMED without any additional fees.
Some of the annual fees for these countries are in the hundreds of dollars
or $1000 or whatever. So, the payment of this one-time fee for many of these
countries is not a big deal, and it can be paid. It obviously can’t be paid
without the knowledge of the health ministry or department or whatever in the
country, but it can be paid on behalf of a country by anybody. You know, we
could all sponsor a country if we wanted to and if in the future these
countries wanted to have full membership benefits in terms of voting and other
things then they could join and be members at that time but they wouldn’t have
to, and then in non-member countries there is a fee in most cases for, there is
a royalty fee assessed if you as a vendor or otherwise were to deploy a product
in a hospital in a country that was not a member. There would be an annual fee.
Those are also graduated.
Obviously the idea is to try to encourage as many countries to become
members as possible. So, the member rights are equal to or greater than the
rights the National Library of Medicine had based on the US-wide license
arrangement we had.
So. NLM is the member. When somebody talks about a member of the IHSDO they
are talking about the actual organization that is representing a country.
So, we can do all of these things that we want to. We can distribute it. We
have rights. We also have responsibilities. We have to distribute it but we
also have to distribute in native format as well as in any other format. So, we
are doing that, and we have the same survivor rights that we had under our
previous arrangement which is for whatever reason there was no longer a US
member then US, we could still continue to use the last version that was
delivered throughout the US.
There is a General Assembly which is the sort of basic group that has the
ultimate authority. One member per member country, I am the member at the
moment. Vivian is my alternate. The Management Board has up to 12 members. At
the moment there are nine, one per member country. The initial US member of the
Management Board is Andy Wiesenthal from Kaiser. Simon didn’t have enough
things to do. So, he is the alternate. We were worried that he had too much
time on his hands and the Chair of the Management Board, the initial Chair is
Martin Severs who is the one you know deserves to be called the sine qua non of
this arrangement. He was the one that really pushed to get this organization in
place and exhibited amazing creativity, patience and perseverance to overcome
all obstacles and even when people want to do it this is not an easy thing with
nine countries and different laws and lawyers and whatever. So, the guy
deserves a lot of credit and the deputy is Karen Gibson who is of NETA(?) in
Australia and she is not far behind him in terms of her level of commitment and
the huge numbers of hours and so forth put into this.
So, the structure has in addition to the Management Board and the General
Assembly executive officers. These people work for the SDO and the idea was to
make initial interim appointments to some of them and to move as quickly as
possible to recruit permanent officers. So, you can see we have an
international group as the initial interim appointments and Kent Sapckman is
the chief terminologist currently.
I think the goal is to get a permanent CEO as soon as possible. There will
be four standing committees. These are described. There can be ad hoc
committees of other types, too, but these are the ones that are described in
the articles, content, technical, quality assurance and research and innovation
and the chairs of these committees will be members of the Board, the Management
Board and it was felt that sometimes in the previous organization of SNOMED
there was somewhat of a disconnect between the layers at least on occasion so
that things that were being proposed and developed down here were not
necessarily on the same wavelength with whoever was actually managing the
organization so that sometimes people would spend time and effort on things
that wouldn’t move forward, and they are trying to avoid having that happen
which seems good.
Andy Wiesenthal will be the initial Chair of the Content Committee. Karen
Gibson is the initial Chair of the Technical Committee and the others have also
been picked but I just didn’t put them up here.
So, the General Assembly is meeting on June 30. The way this organization
is set up all meetings of the General Assembly and the Management Board and the
committees are, it is written into the articles that people do not have to be
in the same place to participate in these meetings, that is that
teleconferencing is an acceptable level of participation.
I really just realized right at this moment that I don’t know what time I
have to get up to participate in the General Assembly on June 30, but I am
going to participate and one of the things that we are going to do is the
Committee members are elected by the General Assembly and the first such
election will take place in June and the articles allow for whatever Committee
members are coming up for election to be elected in October but we are electing
them to get this thing going. So, the first set of people will actually even if
their initial appointment — the appointments are staggered. So, for those
people who have a 1-year appointment it will actually be a year and 3 months or
So, in order to handle this in the United States, it is being handled
differently in different countries, we sent out a solicitation for nominations
inviting people who were interested to submit their own names or the names of
We got a lot of excellent input. Forty-three were received and we will be
forwarding 12 of these on and the process that we set up to do this the first
time given the amount of time we had to do it which was virtually none was that
we set it up so that I am making the selection in consultation with Simon as
the Chair of the NCVHS, with John Hilampka as the Chair of HITSP and with Rob
Colodner as the head of ONC.
We, in the initial announcement I sent out, we said we were going to be
able, the US was going to be able to nominate two per Committee but that has
changed in the interim. So, we are going to be nominating three per Committee
and if you go to the articles right now you will read about the Committees and
the working groups and the participation in them will look more restrictive to
you than what I am describing here and this is because after meeting in the
transition meetings the Management Board and the General Assembly decided that
what was written in the articles about the number of people on Committees and
the way they were selected and the way working group members were to be
selected was too restrictive and would limit useful participation.
So, as a result on June 30, the first thing we are going to do is vote to
amend the articles in several places, just minor things that have come out and
we will amend the articles to allow this more open participation.
So, the working groups are going to be established by one or more
Committees. They will have a charge that is prepared by one or more of the
Committees with the Management Board approval and then participation is going
to be open to interested people who have a reasonable background for the work.
The affiliates forum is basically like a users’ group in the sense that
everyone who has a license is going to be able to join this and participate if
they care to do it.
These things are going to be set up over the next few months. We had to
move a little bit in seriatim and get the Committees established first.
The other thing that is important here is harmonization boards which are
also described, the notion that there will be such things and the purpose of
these is to actually have a formal mechanism for working with other standards
organizations or related groups to harmonize or align or synchronize
So, the initial priorities in setting these up are the World Health
Organization and you may hear about this from another angle in a few minutes
and LOINC. Those are the two that sort of rose to the top in terms in terms of
initial priorities and you will be hearing more about both of these groups set
up over the next few months as well.
So, I am not going to go through this. I will just highlight a few
interesting things. I love the fact that there is only one license. It is for
everybody and it is quite a good license. It gives you quite good terms and it
means that you could start off doing R&D and then decide that you had a
product that you wanted to market in the US and then decide that that wasn’t
good enough. You wanted to market it worldwide and the original license you had
would cover all of these activities and it would just be that when you started
marketing your product outside the countries of the members or the sponsored
countries you would have a royalty payment that would be due to the SDO but you
would not have to negotiate a different license to do it which I think is nice.
It is quite possible that, oh, it isn’t possible. It is going to happen
that some of the countries will have official national extensions to SNOMED for
particular purposes and you will have to go to the particular member country to
get those and find out what the terms are for using them.
So, the highest SDO priorities at the moment are obviously to really set
the shop up, recruit the permanent officers, you know, establish the
Committees, the working groups, etc., and documentation is a very high
There is not at the moment really wonderful documentation about the current
structure editing policies and procedures, release things, etc., for SNOMED and
many people feel that there are a lot of useful ideas for improving on this
situation going forward but the first requirement is for people to actually
understand what is happening now and have documents that they can refer to that
are accurate. So, that is a very high priority.
Related to that is the definition of what belongs in SNOMED. There are not
clear guidelines for people in terms of submission of new concepts nor for the
staff as to what is the desired scope of the terminology.
This is a tough nut to crack. One could say that being vague in this area
could be a useful marketing ploy because this is a topic on which educated and
well-meaning and good people who want to use SNOMED could disagree but on the
other hand it is very difficult to build specific aligned relationships with
other standards if you have no idea where one is supposed to end or the other
one begins and I mean I don’t mean to particularly pick out SNOMED for this
problem. We have this in more than one place but I mean if we don’t solve it
then it is going to be tough to have a nice interlocking set going forward.
The relationship between SNOMED and ICD and therefor the WHO thing, I am
sorry this SNOMED LOINC should be out on the margin as well. I don’t know what
happened with that. It was at one moment. The SNOMED ICD relationship is a high
priority. There are many countries that are interested in having a robust
mapping to ICD-10 and I of course can’t resist saying that the only country
that cares about mapping to ICD-9CM is us.
The medication terminology strategy is another high priority for the group.
The word that they received in the transition meetings from the people there of
the working groups and others interested that were there at the meeting was
that no one is at all satisfied with the medication portion of SNOMED and I
think that the SDO’s view is that they should look at the strategy of
medication terminology more broadly and look at what are the full range of
alternatives there are here which may not necessarily mean fixing up something
which actually it is hard to find anyone who is enthused about it at the
So, we will see what happens with that. So, just to tell you where you can
get more information about all of this and you can get to it from the ISDH web
site if you go to this NLM web site. There will be links off to all of these
things and there will be changes to the articles that after the June 30,
meeting which will line up the information about the Committees and the working
groups more with what I have presented here.
I guess you could say that the US role in all of this was that they
obviously couldn’t have done this without the US buying in because you know
they would need our payments that we have been making and I think that our
particular emphasis was on the licensing terms and I think we had a nice
positive impact on the fact that these licensing terms are really very, very
nice and better for the US than the previous ones.
I think that is what I have to say.
DR. COHN: Why don’t we open it up for questions for a couple of minutes and
then we will move to the next part.
DR. CARR: Thank you for your hard work and your great presentation. Five
years from today what do you imagine might be different because we have this
that we are now able to do?
MS. HUMPHREYS: I actually think that 5 years from today we will have, that
it is highly likely that we will have defined the boundaries in some sensible
fashion between SNOMED and LOINC.
I think we will have more focused development of SNOMED in areas that will
assist its implementation and I think we will see broader implementation in
terms of things like more clinically useful subsets that are available.
I think we will, I really believe we will see a lot more real bedrock
international collaboration on enhancement of content than what we have now and
it is my belief that we will have, that SNOMED will be much more in a format,
will have evolved to be much more useful in electronic health record systems.
DR. CARR: Just following up on what we heard t his morning from John, where
would this fit in if we have SNOMED and the quality use case? I mean is this
the language that we are going to be using? I am looking at Paul to say that
now that we have this great opportunity where will it appear?
MS. HUMPHREYS: I guess I wasn’t responding with the right question but,
DR. TANG: I think it is a bit of a chicken and egg situation right now.
Very few if almost any EHRs use SNOMED as the way to code diagnoses because
there is such a big driver for billing. Yet IC9 is the languishing code set.
So, that is a limitation and I think we all have to align the drivers in the
right way so that there is a premium placed on accurate useful coding of
diagnoses and leveraging that and we will see probably the start of the use of
SNOMED and then it will need its mapping over to ICD so we can continue to bill
presuming that is how we will continue to bill. What would you say, Betsy?
DR. HUMPHREYS: I wouldn’t disagree with that at all, and in the meantime
there is work that is going on at CDC that Steve could comment on which is
driving use of other parts of SNOMED in terms of organisms and tests and
surveillance. So, the desire there is that certain requirements for those you
need the tests, well, that is LOINC but you need the thing you are testing for
which is coming out of SNOMED.
So that is a use case, and I was at a very interesting meeting this morning
with a bunch of people from a variety of places about getting more accurate
results in tests and better exchange of data related to newborn screening and
there are pieces of that which are definitely on the SNOMED end of the thing,
and there are pieces that are on LOINC. So, I think that there are lots of
specific areas where SNOMED will definitely be more heavily used in 5 years and
I think that there will be some environments in which it is used for problems
and diagnoses but we will probably still have a long way to go.
DR. WARREN: I think the answer for this and it is one of the reasons why I
have been very involved in SNOMED is that we are finally getting down to a
terminology that describes clinically useful things instead of billing things
and so as Betsy said, if you are doing newborn screening you will have
terminology that you can put in there.
You will also have the terminology that can drive decision support so that
if you use various scales or other kind of clinical data to drive that with you
will have the terminology to do it.
Now, one of the things that hinges on that there have been some of us in
SNOMED that wanted to do and it was always put at the lower end which I was
glad to see was on Betsy’s high end priorities is the documentation of how to
use it. That I think is going to be one of the biggest challenges and
contributions to the SDO that I think they are uniquely situated to do.
The knowledge that is out there to enable the use of SNOMED is in the minds
of a lot of people who built and not out there for vendors’ use or hospital use
or things like that and so I think that is an area that the SDO can really move
the product forward as well as do some of the quality manipulations that need
to be done on SNOMED to make it a more robust terminology.
MS. HUMPHREYS: One of the other things that I have personally along with
many other people been looking for in all of these things in terms of providing
ongoing support and facilitating free dissemination of these standards within
the United States, the whole issue is we need to get these things more used in
real clinical systems so that we can then enhance them so that they are really
useful for this purpose.
We are going to find and that is something that I believe that this
international group is going to push forward because in fact there are several
countries in here. They have their own different paths of what they intend to
use SNOMED for but I pretty much guarantee that at the end of 5 years SNOMED
will have been used in more clinical situations and therefore we will have
gotten the feedback loop that we need in order to get it to the point where it
is more easily implementable and more readily available.
SNOMED is really an outstanding piece of work. It has very interesting
structure. We haven’t done all the testing and evaluation that needs to be done
to figure out whether everything in the structure is needed, will be used. I
mean are there things that are there that are difficult to maintain in a
consistent fashion, that are critical and we are going to have to figure out
how to do better? Are there things that are difficult to maintain in a
consistent fashion which are not actually going to turn out to be that useful
for people in clinical environments in which case we can have a more
streamlined approach? There is a lot to be learned here. I do think that this
is a sustainable model for the maintenance of the vocabulary as long as we move
forward and do that iterative testing and people see the value of it and as I
say I am certainly quite optimistic about it because I am uniformly impressed
with the level of the people and the commitment to all of this and I have been
on so many hundred hours of phone calls with these people over the last year
and one-half that I feel like I know them better than I know members of my
DR. COHN: And, Betsy we do want to thank you for your leadership on all
this. I guess I should comment just sort of repositioning sort of Paul Tang’s
comments that when I am not here being Chair of the NCVHS the organization that
I actually work for is a relatively large provider of health care in the United
States and takes care of about 4 percent of the total population of the country
and actually has made good use of SNOMED in its clinical information systems
which actually happen to be the same ones that Paul uses at his location but
obviously he is not using the SNOMED terminology in them.
Clearly I think we would all benefit significantly if we had industry
standard mappings to whatever administrative and financial code sets we happen
to be using at the moment because I think that that would obviously do a lot to
help but Betsy knows that. That is one that we have been having conversations
for a number of years about, but I just want to just frame it, just not as a
future potential but also remind and I think Judy similarly, Paul, uses SNOMED
at least to some extent in her organization and that there is actually current
use of the terminology.
MS. HUMPHREYS: You know obviously that was in designating the US member of
the Management Board no one at the National Library of Medicine can be a member
of the Management Board because our method of paying our annual fee is through
a contract and it just can’t look that way that you have a contract with
yourself if you are on the Management Board of the other organization and so
therefore I thought this was wonderful that I couldn’t be on the Management
Board. I was thrilled but I think that the other issue was and I consulted with
Rob Colodner and John Loonsk about this, I was really enthused about having
someone from the Kaiser serve on the Management Board because they are really
users of this thing and they are in the real health care environment and I
think that is a very good way for the US to be represented on the Management
DR. WARREN: I would just like to add because Simon is being very low level
on this Kaiser has had a long partnership with SNOMED to develop it. So, about
50 percent of what is in SNOMED has come from the modelers and the people at
Kaiser which I think has really helped to make it much more clinically useful
than it would have been without Kaiser’s work.
DR. COHN: Larry?
DR. GREEN: I am wondering what your opinion, Betsy or yours Simon or
Marjorie’s is about what are the future business items we as NCPHS members can
expect to emerge out of this international development that is pertinent to our
mission and our charge here.
MS. HUMPHREYS: I can imagine the NCVHS being asked for their advice or
being asked to consider in order to inform the US participants in the SDO some
of the key issues and so forth that are coming up if there are real differences
of opinion among countries about which way to go on things. I mean one of the
things is we are going to be part of an international organization. We are
going to have one vote. I think that everyone is in the same position that as
the SDO is constituted no one can vote to take away your survivor rights. If
they vote to do that you have N months to get out and still keep them. So, that
was built in. That was something that I also did to be sure we could never be
done out of our surviving rights if we left but the thing is that obviously
they aren’t going to want to see any countries leave this and they certainly
are not going to want to see the US leave because we have a big part to play.
On the other hand here are many items that I could imagine going forward before
this group where we would not in any way, shape or form find a uniform view
within the US of which way to go.
So, I would imagine that if there is a real difference of opinion within
members of the SDO about what to do about something with SNOMED or which
direction to take or what the priorities ought to be or whatever I will bet you
money that we will find some large groups of people in the US that agree with
each one of the different opinions of the other countries.
I could imagine that. I think that there is going to be this issue of
coordinating with other standards and obviously I think that is going to
potentially give a role for NCVHS and HITSP as well in terms of what makes
sense with coordination of these other standards and who should be represented
in discussions and also what is in the best interests in terms of trying to
maybe get some of the other standard developers who are here in the United
States to head in one direction or another to make this all come out better.
DR. COHN: Maybe I will jump in here just because just like I was a little
low key, obviously Betsy and the National Library of Medicine has been
instrumental and I think as that medication terminology strategy begins to be
discussed I think that will be a major piece that we will want to be involved
MS. HUMPHREYS: One of the things that has recently come to my attention is
that the International Conference on Harmonization which as I think many of you
know is the group that brought us MedDRA and FDA of course is the major
participant in that activity and apparently they were also thinking that up to
a certain level they needed to have an international medication terminology and
the first set of discussions that went on over there was with people within
this International Conference on Harmonization thinking that this was the next
thing where they needed to create a new one and we should all be very grateful
to our colleagues at FDA because I think they weighed in there pretty heavily
to say that this was not really a very good strategy and that they ought to
instead be looking at which of the existing systems could form the basis for
There probably are other people here who know more than I. So, as a result
of this the SDO for SNOMED is also aware of this and actually the International
Conference on Harmonization has recently had a joint meeting with some people
from ISO which is the venue that the ICH wants to use to help them select or
focus on which would be the best solution because the International Conference
on Harmonization has members outside obviously North America, the EU; Japan is
a big member. So, now as I understand it the ISO group is likely to take on
certain tasks or certain things that the ICH would like help on in terms of
selecting appropriate things for this and they are going to be meeting in
Australia when all these meetings are being held around MedInfo in August and I
believe now it is working out that the members of the SNOMED SDO who are
interested in this issue are going to see if they can actually go to some of
the same meetings and then consider what their options are based on that.
So, I think we are trying to get all these things together.
DR. COHN: I think I saw Carol and Paul and I want to wrap this particular
piece up because we actually have additional presentations on the international
MS. MC CALL: This is actually directed to the secondary uses group and it
is really more food for thought and I want to link it back to what we were
talking about now around the topic of pharmacovigilance and so when you start
thinking about secondary uses of data a question for you is is something like
that within the scope of the work and the definition that is being considered
for secondary use and if it were then is there a link when you start thinking
about medication terminology and the fact that many of the issues when you
launch a drug there are things that are just much more international about
that. They don’t necessarily go everywhere simultaneously but it is in fact
more international and that might be a nice thread to pull through. So, it is
something to consider in future conversations.
DR. COHN: Okay, Paul?
DR. TANG: Just as a way to add to the groundswell of initiatives trying to
drive towards the use of SNOMED one of the things that John Loonsk alluded to
was under contract to HHS NQF had an extra panel that was looking at quality
measures and one of the principal recommendations is to substitute billing
diagnosis that is so important in the quality measures of today and instead us
problem as diagnoses. So, obviously that is an opening for ditching the ICD-9
world and going to at least another code set that may include SNOMED. So, one
of the draft recommendations is to HITSP to say, “Help us decide what code
set should be used to encode problem as diagnose.”
So, that is one piece and another part of the draft recommendation is help
us identify a universal code set to code medications and medication allergies
and once again the AHRQ’s norm then has an opportunity to be recommended by
HITSP. So, these are all these inflection points to try to add to a groundswell
of let us find the right way to code the concepts needed to take care of
patients, report on quality, population, etc.
DR. COHN: Paul, point very well taken. Thank you. With this, Betsy, thank
you so much. I don’t know if you want to stick around for the next piece or
whether you have another activity but we wanted to turn to Steve Steindel and
Marjorie Greenberg to talk some about other international activities.
MS. GREENBERG: I want to thank Betsy, also, for being flexible about when
she came today and coming, etc.
You all have the hard copy of the slides that we presented in November and
Simon pointed out to me that a number of you were not on the Committee in
So, conveniently Steve had them with him, but we are not going to go
through all of them because there just isn’t time, but you do have a copy of
Okay, I see Steve sneaked on in there and then since we gave this
presentation in November actually a number of activities have taken place
including the one you just heard about that we knew that was coming or we
thought it was coming but it has obviously changed the landscape on
classifications and terminologies fairly significantly.
So, I will try to integrate that into our discussion. Now, let me see is
DR. STEINDEL: That is mine.
MS. GREENBERG: That is yours. Okay, since I am up here right now maybe we
should start with mine. I see myself in Steve’s but we won’t go there right
Okay, so back in November we just tried to give a bit of a primer as it
were on what is the WHO family of international classifications and how the
classifications are maintained and updated and the priorities of the WHO-FiC
network and how this all relates to terminologies and other standards
development, and I will briefly go through this with really skipping over all
the stuff about for the most part about the WHO-FIC network and you can see
that in your slides, however, and if you have any questions about it now or
later you can ask me about them, but the WHO family of international
classifications is a suite of classifications for international use covering
areas such as death, disease, disability and health as well as related health
systems parameters such as health interventions.
You will see it doesn’t say anything about billing. I know that many of you
think ICD is only a billing code. It really around the world is used for many
purposes other than billing and in fact not at all for billing probably in most
Certainly for coding mortality on death certificates around the world if we
didn’t have agreement on a standard for that we wouldn’t really be able to make
So, I see it much more as a health statistics tool. That does not mean it
is a clinical terminology tool. It isn’t though the goal is to align it much
more with clinical terminology and with SNOMED being the central partner.
So, I think we are on the road to hopefully some of that convergence but it
is not going to be quick, and it is not going to be easy but if you will just
allow me that little commercial.
Okay, so the family here is the ICD which all of you know and either love
or hate and another classification which most of you at least have heard of
here and that is the international classification of functioning disability and
health which captures sort of the consequences of diseases and injuries and
functional status and then under development potentially an international
classification of health interventions not to replace the ones in use in
countries that have established health intervention classification. We sort of
unfortunately have at least two but many countries have none, nothing up to
date and so we are trying to meet their needs plus come up with a kind of a
framework that we can do some comparisons since practice of medicine is
different around the world but human beings have basically the same organs and
all of that and so a lot of the same interventions are going on around the
world and it would be nice to be able to do some comparisons, outcomes, etc.
Now, those are the reference classifications principally now ICD and ICF
and then there are derived classifications and related classifications and that
is a growing list. There is a whole process for bringing classifications into
this family as it were and some of these you have heard of and others probably
not and that will really be discussion for another day, just to say that new
members can apply for related or derived status.
Derived you really are derived right from that reference classification.
Related can be different but working collaboratively with the reference
classification, but most importantly for this ICD and ICF are maintained and
promoted by an international network of WHO collaborating centers for the
family of international classifications or the WHO-FIC network and these
centers are established by language and geography.
This is actually outdated because I would say there are I think 12 fully
designated centers. We have just designated Italy and there is another one I
think missing here as well and then other centers that are sort of coming up
and coming along and our North American center which covers the US and Canada
was established in 1976 and since 1996, I have had the privilege and
responsibility of being the head of that center. It has always been housed at
the National Center for Health Statistics.
We partner with Statistics, Canada and the Canadian Institute for Health
Information and we are actually designated by the Pan American Health
Organization which is the regional office for WHO in the Americas.
So, the purpose of these collaborating centers is to develop, disseminate,
implement and update the classifications to improve their international
comparability of health data as I referenced and to assist in addressing what
we call the information paradox which kind is a way of describing the situation
where countries with the worst health outcomes and the greatest burden of
disease have the least information to address it.
All right, I am not going to go through this information about the
priorities of the network or what any of the committees are doing except to
mention that there is an update and revision committee which is responsible for
updating the ICD-10.
Up until ICD-10 the ICD did not change. The base ICD did not change from
one revision to the next and it was revised pretty much every 10 years. It has
now been more than 20, almost 25 years or maybe more since it was updated and
maybe 17 years since it was started to be implemented, ICD-10, and that was
partly made possible, in good part made possible because we have developed an
updating process which actually was modeled to some degree on the process that
we use for updating ICD-9CM and if I live long enough updating ICD-10CM in my
lifetime if I live long enough to see it.
Okay, we have a process. We get recommendations from the collaborating
centers in the countries, etc., and we have to balance a clinically current and
credible classification with one that has stability over time for comparative
purposes. So, in that way it is different from a terminology where of course
you do want continuity to some degree but you just can’t be adding things
constantly and have any international comparability on statistics, but every 3
years we do major changes and annually minor changes but we do need to
distinguish and update from a full revision.
We have a number of reference groups as well. Several of them are new. One
is the terminology reference group which Steve is a North American member of
and he can tell you a little bit about that. How to challenge the information
paradox as I mentioned we establish collaborating centers and we really see the
need to spread that net. We have made some progress but we are very much trying
now to establish collaborating centers in Southeast Asia, Africa, and the
Eastern Mediterranean. We potentially will have one in South Africa very soon.
We already have one in Japan and China. We may now have one in Korea, but we
need more in Africa and also we don’t have one for the Arabic language right
now even though it is one of the six WHO official languages.
We have to make the case internationally for the importance of health
information. I don’t have to make the case to this group but I will tell you it
is a hard sell to countries that think they can’t afford to have health
information and really the problem, the real truth is they can’t afford not to
because otherwise they have no idea where they should put their money and if it
is getting them anywhere, but when you have very limited resources that is a
We are trying to partner with the Health Metrics Network which is now
working out of WHO to really try to build health information systems in
countries where they don’t have them and starting with a real focus on
mortality data and cause of death information and we need to support vital
registration systems which really takes almost a generation to have a really
solid robust vital registration system but there are things we can do to move
We need to develop training tools and tool kits and the Education Committee
which I chair is working on that and we need to develop national committees
actually. This National Committee, the one you are all sitting on was
established in response to a recommendation by the World Health Organization in
1949, that countries should have national committees to support international
statistics and the international classifications, the ICD, and you have done
that over the years and I think other countries have national committees but
those that don’t would benefit from that as a way to bring together
stakeholders, do some of the things at least that I think this Committee has
effectively done over its long and distinguished lifetime.
Okay, so I just want to say a few words about revision of ICD-10. As I said
back in November there were plans to establish a revision steering committee.
The revision steering group it is actually called now was established with its
first meeting in April.
I am currently a member of that group because I am the Chair of the
Planning Committee for the WHO-FIC network. Whether I will stay on that group I
am not sure because it is a 2-year term that is actually coming to an end at
the end of October of my being the Chair of the Planning Committee but it
remains to be seen.
In any event the Chair is Chris Shute,
Dr. Chris Shute from Mayo Clinic, and we are working very closely with him
in that regard. He is working now on an initial, we had our first meeting. We
had a big roll out in Japan because frankly the only real money going into this
revision process now is coming, for the most part is coming from the Japan
Hospital Association which decided they preferred to focus. They couldn’t
really use ICD-10 for clinical purposes and instead of coming up with their own
clinical modification like some of the rest of us have they were convinced to
instead put their resources into launching the ICD-11 revision process. That is
the short of it.
So, we launched the whole thing there. We had press conferences. You may
have seen some outcomes of that. They are going to start by bringing together
the clinical modifications because we are the people who are really using the
ICD-10 for clinical purposed for better or for worse but have clinically
extended it. There is one in the US, one in Canada, one in Australia and one in
Germany. There are also some others in France, etc.
These will serve as input to the revision process to try to harmonize that.
You know how do we all treat, do we all treat diabetes the same or differently
when we try to clinically extend it, you know, and go on from there and I heard
a shocking statistic, I thought at the quality hearing. What percentage of it
was it that was going for just diabetes care alone of funds or heath care
dollars in the US? It was quite dramatic and so if we don’t even if all code it
the same way it is problematic in doing comparisons.
The commitment is that the alphanumeric structure of ICD-10 will be
maintained. We have to really try not to make too much discontinuity with
ICD-10 and ICD-11 because of the strong uses for international and national
statistics and mortality data and also because no one will certainly implement
ICD-11 if it is too different from ICD-10.
I said no firm time line had been established. Now with the official
launching of the process, the plan is to take ICD-11 to the World Health
Assembly for approval in 2015 but that is dependent upon adequate funding.
Right now there are several task groups or they are called technical advisory
groups, TAGs, mental health, oncology, external causes and injuries, rare
diseases. There is one in internal medicine and there are a few others being
developed and a number of NGOs are working with WHO on this and they basically
all have to be self-funded. So, there is no funding for this. WHO really
doesn’t have any additional funding other than what they got from the Japan
Hospital Association, a lot of volunteer efforts going in but it is dependent
upon resources and IT development.
Separate views are going to be created for mortality and morbidity. So,
there may actually be sort of an international clinical modification but I
would say that it is still likely that some countries will have to do their own
extension beyond that but will start with much more of a common base but if you
think of the fact that right now the Department is required by Congress to
consider at least updating ICD-9CM twice a year, we do it once a year and we
are prepared to do it in midyear if there is a real need particularly in the
So, you are never going to update ICD-11 twice a year or probably even once
year. It is going to have to be on a less frequent basis maybe 2 years, maybe 3
Interestingly enough a number of countries that have clinical modifications
don’t even update once a year. In Australia I think it is every 2 or 3 years,
the same in Canada, every 2 years, but you know it depends on the uses.
So, I would say even if it were approved in 2015 by the World Health
Assembly and even if it was all ready to go unlike ICD-10 where we didn’t even
have an alphabetic index for several years after it was approved, still it
would be I don’t know 2018, 2020 before we could probably implement it.
So, the message behind that is that ICD-10CM as I truly do believe is a
pathway to ICD-11. It is going to be the same structure. We are using it to
build ICD-11. We are working closely with Chris Shute on this and Mayo Clinic
on some of the underlying technology. A lot of stuff is going to change under
the hood and this is the idea of alignment with terminological standards.
That is the goal to actually align the terminology in ICD-11 with SNOMED,
CT and other terminologies and so the bottom line is that ICD-10CM is a pathway
to ICD-11 and ICD-9CM is a pathway to nowhere at this point.
Truth in advertising, my staff is responsible for ICD-9CM. We love it
dearly but also are responsible for ICD-10CM. So, clearly I am biased on this
but I mean I care about the data and I do think it is time to move on.
I should mention that part of what was announced in the press release was
that this is really going Internet and not only Internet but it is open to
everybody, this revision process. They are setting up something like a
Wikipedia and you might want to invite Chris Shute back sometime to really talk
about what is being planned, but the idea is that there already is an Internet
platform and it was the money from the Japan Hospital Association which helped
them build that and anybody, anyone in this room can go in and suggest an
update or revision to any part of ICD-10.
This is ICD-10, and put forward your evidence and then obviously some
voices will have and some evidence will have more credibility than others but
this is really totally unlike the past where it was just a group of experts in
a room, they will still be meeting but there will be real opportunity for input
which is going to make it very interesting and that is why I think the 2015
date also has to be taken with a bit of a grain of salt but if you go too the
WHO web site you will find that you can get into that platform.
Okay, so as I said we are inviting stakeholders in the revision to
participate through this international platform and a question that I want to
pose to you is what role does the National Committee on Vital and Health
Statistics want to have as we launch into this revision process.
Part of our thinking, I mean Chris and I have talked about this and staff
is that as new components of ICD-11 get kind of vetted by the clinical experts,
etc, we could move them into ICD-10CM. They could move them into ICD-10AM. What
would be ideal would be if it were almost a seamless transition because it is
not going to be seamless we know going from 9CM to 10CM, and we don’t want
another one of those. I mean it seems like we don’t since we have had so much
trouble even getting agreement to move to 10CM.
So, I would see this as kind of a way that we could start building a lot of
this new knowledge, aligning the oncology sections with the most current
version of ICDO which ICD-10 is currently not, a number of things where we
could really be working together to try to move this forward.
I should have mentioned and seeing Larry reminded me that in addition to a
mortality and a morbidity view there is a commitment at WHO to have a version
that is really usable in primary care which ICD-9, 10 are not and working with
WONCA(?) on that the World Organization of Primary Care Physicians and Michael
Klinkman is not on the revision group but he was at a meeting that we had after
that and we already are working with WONCA, the WHO-FIC network.
So, there is a real commitment that was a demand made during the ICD-10
development process but it didn’t happen.
So, I think there is much more of a commitment now to that. Also,
traditional medicine, we are looking how to bring that in. So, we are working
with the Asian countries that have very strong traditional medicine
classifications or terminologies.
So, really that is my final question to you and then I will ask Steve to
come over and provide his portion of this but for you to be thinking about what
role you want to have in this, and it is tricky in the US because we are still
using 9 but I think it is very important that we have a significant role in the
development of ICD-11 and that as I said we try to make a transition to it if
we are going to go to it eventually as seamlessly as possible from 10-CM.
Okay, oh, these must have been misnamed. Okay, that was the confusion.
DR. STEINDEL: I think our main intent of scheduling this session was to
receive questions, comments, discussion from the Committee regarding the
presentation that we gave in November because we have had abortive time and I
think to keep on the agenda you know it might be good to just move into a
My slides are very brief and mostly pertain to what Betsy talked about.
MS. GREENBERG: Except for this one.
DR. STEINDEL: Except for that one and the comment on that is would you buy
a classification from this person?
MS. GREENBERG: That was the day we went to see Mount Fuji and we walked
right up to it and couldn’t see it. Of course part of the problem was that I
had my eyes closed, but even those who had their eyes open couldn’t see it.
DR. STEINDEL: I think in light of the time it might be best to, the only
comment that I really want to make and Betsy alluded to this is I am part and
Marjorie just mentioned it, I am part of the WHO-FIC Terminology Reference
Group and one of the first tasks —
DR. COHN: Steve, I am sorry would you spell out what WHO-FIC stands for?
DR. STEINDEL: WHO International Family of Classifications Terminology
Reference Group and one of their first tasks is going to be to meet with the
IHTSDO and figure out how we are going to do mapping between the international
family of classifications and SNOMED and once we decide on principles, methods,
testing, results, etc., then we may proceed to do the mapping. That hasn’t
really been fully decided but we first want to organize principles and we hope
to have those principles organized by the early part of 2008, but I think we
should just have discussion and questions from the Committee.
DR. COHN: I am delighted to hear you are working on the mapping pieces.
Obviously you have had lots of experience at least with things that have almost
worked in terms of all of this.
Comments, Larry Green?
DR. GREEN: I have two questions, Steve and Marjorie. One is can you teach
us a little more about the payoff for doing all that mapping? That mapping
sounds a little intimidating to me. I mean that looks like a serious piece of
work and can you help us understand better why it is going to be worth it? When
I get mapped what is the payoff? That is my first question and then I have a
DR. STEINDEL: I think I may give a strange answer to that question because
we are not sure and that is why we are taking the first step of trying to
figure out the principles and how to do and how to test the maps because all
the efforts that have been done in this area at this time have proven to be
very expensive, time consuming and not well used and one reason they are not
well used is they are for highly specific use cases and what we see is like for
instance there has been a development of an ICD-9CM to SNOMED map for a very
specific use case in billing that is not widely used because it doesn’t apply
to all the billing situations and this is one reason why you heard mentioned
that one of the efforts in creating ICD-11 is to create a structure within the
classifications so that they will better align with structure in the clinical
terminologies and one of the tasks that the IHTSDO is going to look at is how
do we better align the structures within the clinical terminologies so they
match the classification systems.
Now, Betsy didn’t mention this but this has been an underlying principle
that is slightly different from the CAP organization is the IHTSDO was thinking
about medical terminologies as being a collection of federated terminologies
and they fully recognize and understand the need for classification systems and
that WHO is the holder of classification systems in the world today.
So, we want to work out synergistically how the clinical terminologies
which we hope will be in the domain of the IHTSDO will then merge with the
classification systems of WHO.
When we get that alignment then we may be able to talk about mapping
between the two that is clean and not so use case dependent.
So, when we are discussing it today it is fuzzy and I understand your
question fully and I don’t have a good answer except the one that I just gave
but in the future we are hoping that we can align the two of them, and your
MS. GREENBERG: I thought that was a terrific answer. I might just say that
I think there is a recognition now, a growing recognition that this is a
continuum sort of. It may not be totally linear but between terminologies and
classifications it is not you need one and you don’t need the other which used
to be said, and so there just has to be a way that they work together and you
could, one option would be just to throw out all the current classifications
and just build all your classifications on SNOMED but I don’t think, I mean
that is certainly not going to work for the whole world and I don’t think at
this point anyone is really suggesting that. So, you are going to have to have
them work together and one thing that happens quickly when you do do mapping is
you find out what is missing and what works well and what doesn’t, but I think
really good mapping or good alignment will only happen if we build this
terminological basis into the ICD which I think will actually inform the
development of SNOMED CT as well.
DR. GREEN: My second question, and, Paul I wish you would help me out with
this, too, if you don’t mind, but just bear with me. It is a sort of a naive
intuitive sort of thing going on in my head here as I listen to this and try to
understand what you are talking to us about.
I have got some sort of grasp about the importance of this creating an
interoperable electronic health record for helping to take care of people of
the United States, and I have got an idea about needing to have health
statistics to guide policy and decision making and clinical decision making and
all of this is sort of just hanging together in my head pretty well, and then
the idea of globalization suddenly hits, and I realize that you just showed us
a picture of Marjorie not seeing Mount Fuji and globalization is in my view now
a done deal and we were talking about 2015 and 2020 for when this sort of stuff
comes out that we should be thinking about a world in which health information
needs to be able to zip around the planet instantaneously because it is the way
people will be living their lives.
So, I have an intuitive belief that what you have just presented to us is
extraordinarily important but it may not be. Paul, you may say that the
interoperability thing and globalization, this is a waste of time. It is going
to happen in other ways. You know, just go for the ride. Don’t worry about it.
What do you think?
DR. TANG: I am not sure I totally understand but I mean this is relevant no
matter where you practice or get sick. So, it is nice to see this happening at
the international level but it certainly impacts us anywhere and it is
important anywhere. Did I get that question?
DR. STEINDEL: Larry, if I can address that from a global point of view this
is something that CDC thinks about a lot when I put on my day job hat because
we recognize today that our biggest threats to the public health of this
country right now probably are coming from outside our borders and pandemic flu
is probably the prime example, and to do that, to be aware of what is going on
with pandemic flu, to be aware of how it might start, how it might spread we
have to be able to exchange data with our international partners and right now
we are doing it on the microbiological level and we definitely want to start
doing it on the clinical level.
DR. GREEN: I like that answer. I suggest that be your answer next time.
DR. TANG: So, the headline is there is no such thing as domestic health
care. Steve, did you mention a time line for the mapping between SNOMED and
ICD-10, let us say?
DR. STEINDEL: No.
DR. TANG: So, just like we were building the case and the groundswell for
the use of SNOMED on first principles this would be a rate-limiting step on the
getting it adopted in practical terms?
DR. STEINDEL: What I did mention, Paul, was a time line for us and us being
WHO and the IHTSDO to agree on methods and principles for creating the maps and
testing the maps and once we decide that then we are going to take a look at
that and see what it would actually take to build the maps and at that point we
may be able to answer your question and some of that has to do with
prioritization within both organizations.
You heard Betsy talk about there is a lot of work to do in the IHTSDO. They
realize that finding out what they need to do to do a map is very high
priority. When they see that they may realize that doing the map is going to
take this much time, this much money and really needs to fall down here on
their list of priorities. I can’t answer your second question.
DR. TANG: But it is rate limiting for its use.
DR. COHN: Paul, I think even the lack of a map for ICD-9 is rate limiting
in its use.
DR. STEINDEL: And the map will go to 10.
DR. TANG: The utility of going from SNOMED to the ICD-9 —
DR. COHN: Okay, I mean I think we are talking about a variety of things
that are being rate limiting.
MS. GREENBERG: On the international scene obviously there is no interest in
9, but that doesn’t mean we aren’t interested here, but work has been done.
There is a map that the UK has developed between ICD-10 and SNOMED. There is at
least one map that has been developed with 9CM. So, it is not like they are
going to have to start from scratch, but as Steve said, at least at this point
it is going to probably have to be use case oriented and we all have different
use cases but it is a very high priority as I understand it for the IHTSDO and
it is pretty high priority for WHO, too but you are not talking about heavily
resourced organizations. So, that is part of the problem.
DR. STEINDEL: Just a comment on time and everything, the UK developed a map
between ICD-10 and SNOMED. The Danes wanted a map between ICD-10 and SNOMED and
asked to see the UK map. They decided the map wasn’t any good and did their own
map. So, this is the whole problem in mapping and why we want to establish
basic principles so people can agree that the map that is done is usable in all
MS. GREENBERG: There is a subtext there, too. The Danes happen to actually
speak Danish although nobody else does, and they speak English, too, but this
to really work in a global way this has to be multilingual and terms tend to be
language specific. Classifications can be more, you know, used at the — so, I
don’t know. I heard some phenomenal number of hours, days, years, man years,
person years that the Danes put into translation or developing their own Danish
version of SNOMED-CT. So, this is really non-trivial and non-English
DR. COHN: I see Carol there. We are down to one last question. Carol
Bickford, you have the last question. and thank you for being up there and then
we will wrap this part up and then we will talk about sort of the time for the
remainder of the meeting.
DR. BICKFORD: Carol Bickford, American Nurses Association. When you were
describing the fact that WHO and STO are going to be working on a mapping
initiative Betsy indicated one of the key activities is the documentation of
how we are doing sorts of things. So, the lessons learned and the pieces of
decision making that you guys are doing inform that IHTSDO process. Are you
going to be doing your stuff over here and then they are going to be struggling
with how are they going to be doing some of those concepts related to mapping
and how you do development sorts of pieces? Are the things that you are going
to be doing internationally collaboratively going to help inform the
documentation for IHTSDO? Am I making sense?
DR. STEINDEL: I think that the principles of mapping and the use of mapping
can be done in part without the type of documentation that Betsy was talking
about which is the maintenance and continuation of the underlying terminology
itself and so the principles of mapping we think are somewhat independent of
that but one of the things that is holding back the effort a little bit is the
lack of documentation we have from SNOMED on the work that they have done with
mapping. So, we are trying to recreate that as well.
DR. COHN: We are just mulling about next steps and all that. Thank you,
Marjorie, for I think a very useful presentation.
I wanted to say sort of at least to me a very obvious next step is to
probably get Chris Shute to come and talk about the work and, Marjorie I agree
with you completely about inviting him. Now, we will talk later on today about
what September is going to look like and my preference would be to have him in
September. If the schedule doesn’t accommodate it we will obviously put him
into the November schedule.
MS. GREENBERG: He is doing a lot of work August and September on this. So,
he may have more to say actually in November.
DR. COHN: Yes, but I do think we want to follow this along as a Committee
for the moment and then we will sort of figure out what appropriate next steps
there are after that assuming that makes sense.
I think this is an issue of general interest and I have seen general
interest from everybody. So, rather than just referring it off to a
subcommittee for work I think we want to keep it at the Committee level for a
Now, having said all of that, we are not at two-thirty. In the remaining X
number of minutes we obviously want to hear from Jon White and we are actually
very pleased that he is here to join us. We, also, have to do some sort of
ending of the actual meeting.
Now, the agenda calls for a 3 o’clock adjournment. I want to do a time
check with everybody because it looks to me like we are more on like a
three-fifteen to three-twenty glide path.
What I am going to suggest is let us take a 5-minute stretch break right
now to enable us to go to say about three-twenty and then we will do a formal
adjournment. Does that work for everyone?
Okay, so, we will take a 5-minute stretch break and then come back.
DR. COHN: Okay, welcome back. As I said this is our last session and we are
delighted to have Jon White joining us. Jon is the Director of Health
Information Technology for AHRZ and he offered and we have been very delighted
to accept his offer to give us a briefing in context around data stewardship
and in particular the work that AHRQ is doing developing and publishing a
request for information on this.
I think we heard this morning that stewardship was really one of the issues
and exactly how we do that, what sort of recommendations we have obviously
hopefully informed by the work that AHRQ is leading will I think be critical as
we move to the secondary uses of data discussion, and so, Jon, we want to thank
you for coming and giving us a bit of a briefing and context setting as we
begin to think about the secondary use issues.
DR. WHITE: Thank you very much, Simon. You may not be so happy after I am
done, but thank you nonetheless for having me here.
I want to thank you very much for being tolerant of my scheduling issues. I
was supposed to speak by twelve-thirty on Capitol Hill and I followed one
Kennedy and two senators. So, you can appreciate why I am here an hour late.
This is sort of like dying in the Great Johnstown Flood in Pennsylvania,
getting to heaven and being asked to speak at a seminar on floods and finding
out that you are after Noah, but we made do. We did okay.
Thank you very much for asking me to come talk to you about stewardship. My
day job is as Simon said, the health IT director at the Agency for Health Care
Research and Quality. Many of you probably know we have a large portfolio of
grants and contracts. We use those vehicles to develop the evidence on health
IT and how health IT improves the quality of health care in our country being
the mission of the agency where I work and what I truly believe in actually.
Many of the primary uses to which health IT is put in improving the quality
is making sure that the data is at the right place at the right time. My former
day job was as a practicing family doctor before I got to AHRQ. I actually had
the pleasure of having Larry Green come speak to us up in Lancaster,
Pennsylvania not too long ago before I came here where I came to have a great
appreciation for how information systems can be used to really improve the care
that we deliver at the point of care.
So, there are great primary uses and then there are secondary uses and
these are really if you think about how we intend to improve the quality of
care in this country, the secondary uses of health data loom quite large. You
generate clinical data for the purposes of direct care of a patient and then
you want to step back and look at that data and say, “How am I doing in
taking care of my diabetics or more broadly how are we doing in our practice or
how are we doing across the state?”
There is great interest every year when AHRQ publishes its national health
care quality report in saying, “How did my state do?” We have had
angst and wrung our hands over the quality of health care in this country and
we have really said that we need to improve this and to improve the quality we
need to measure what we do. We need to provide decision support for how we make
our decisions in health care and we can do that based on guidelines but we
would also like to do that based on the evidence and what is happening out
there right now.
We talked about these real-time learning networks, rapid learning networks.
That is based on large databases of information. I could go on. I won’t.
So, you all have an appreciation for the power of what information systems
can do when the information is structured and can be looked at in the various
ways that we can do.
I am also a great believer in the adage that with great power comes great
responsibility. We are also equally aware of some of the pitfalls that go along
with having data brought together in large pools. It feels like almost every
day you hear about a laptop that has been stolen out of a car that had your
Social Security Number on it or had your health care information on it and
maybe your financial information on it but maybe other information as well and
that is really just the first step.
As we get further down this path you are going to have your patients if you
are a doctor say, “Who got to look at my data, and how did they get to
look at it, and how do I know it is secure?” and all these other great
questions that are very legitimate questions and should come up.
With this great power to improve the quality of care through information
systems comes great responsibility to make sure that we take responsibility and
wisely use the information that we have.
There is a definition of stewardship that I love on Wikipedia which is the
responsibility to take care of something which is not one’s own and that is
what I typically default to when we talk about stewardship.
Now, that brings up the issue of ownership of health data. People get a
little touchy when you talk about who owns the data, you know. Doctors stand up
and say, “I made the record. I own the data.” Patients say,
“That is about me. I own the data,” and the payer says, “I paid
for that. I own the data,” and so on.
Those of you who are in the research field have a good sense for how
sensitive you are about who owns whose data.
I would offer this thought to you. When data is digital and you have a copy
of the data, you own the data. So, lots of you could own the same data, okay?
Now, so then we get to the issue of well, once you own the data what can you do
with it or what can’t you do with it or what shouldn’t you do with it and this
is the whole issue of stewardship and this is a very rich discussion. I am not
going to belabor you with all the thoughts and I am sure you all have taken
some good consideration to it, but like all good stories I will start in the
middle and in particular I am here to talk to you about a request for
information that we published not too long ago.
Let us talk a little bit about how that request for information came about.
Two and one-half years ago approximately the AQA which started as the
Ambulatory Care Quality Association or Alliance, but has since become the AQA
gathered and they gathered for the purpose of measuring physician-level
performance and there were three work groups that were formed. The first was
the group to select the measures by which physicians would be measured or
judged. The second group was the sharing and aggregation work group and that is
where I have been engaged largely and the third was the reporting group, how do
you report out this information. The sharing and aggregation group focused on
two things. They focused first on well, how can we pool this information
together and at the time we were really talking about claims data. There were a
number of large insurers around the table, ACPE, AAFP, AHRQ and eventually CMS
and everybody agreed that we ought to start with claims data because that was
what we had and that was what we had digitally.
So, we began to look at how we pooled that information together and how do
we actually start to make that real and corporeal and as a result last year we
got the AQA pilots which became CMS’s better quality, BQI, better quality
improvement initiative, let us call it that which has led to subsequent
discussion of things like value exchanges and value-driven health care which I
am sure you all have heard a great deal about.
So, that was one stream of discussion. The other stream of discussion we
had was well, how do we know that we are being responsible with all this data.
You are talking about for the purposes of measuring Jon White and how Jon White
does and how he cares for his patients. We are pulling together information
from United and Aetna and CMS and Blue Cross Blue Shield; how do we know that
we are being responsible with that?
So, we have had very robust discussion over about 2 years about the concept
of data stewardship and in that context talked about the fact that they thought
that AQA needed some sort of an entity to help them oversee what they were
doing with that data. So, hence was born this concept of national health data
All the information on all of the discussions at the AQA is on the AQA web
site. I am not going to exhaustively go through those, but I think it would
suffice to say that there are some key points to those documents that are
included in the RFI. I will talk about them in a minute but we came to a point
towards the end of last year where we said, “Look we have advanced this
quite far and we also realize that there is a number of other initiatives out
there talking about secondary uses of health data, AMIA(?) had a conference.
They just had the second round of it this year, but they had had also in April
of lats year, 2006, which was very exciting, good people around the table. We
heard several news announcements from, for example, Blue Cross Blue Shield
talking about a large database that was being created that was going to be used
to look at how to improve outcomes and how to improve the quality of care that
was delivered and that is a great concept.
Not too long ago NCVHS itself was asked to grapple with the concept of
secondary uses of health data. So, it became clear to us that this was a fairly
It was also clear to us that while we all liked ourselves and thought there
were great people around the table that perhaps we didn’t have all the answers
and perhaps the issues that we were dealing with might stretch beyond just the
purpose of quality measurement for physicians. So, we came to the conclusion
that we need to get better information and asked for broad input.
So, hence the concept of an RFI was born and as it has evolved it has
coincided with a lot of other things, your work in particular being one of
those things. So, it took a while but June 4, we published a request for
information in the Federal Register. It was published through AHRQ but it was
largely developed through the AQA and subsequently through a second round of
input from a lot of other individuals. Phone calls were all open. Anybody could
join if they wanted to. So, we took a lot of different inputs.
I don’t have copies of the RFI here with me today for you. I apologize. It
is in the Federal Register. It was published June 4.
DR. COHN: We actually have it.
DR. WHITE: The gods must be crazy, excellent. So, the RFI is in there for
you and I will just point out a couple of things to you. There is a brief
discussion of why there is a need. There is material from the AQA and in
particular there is a proposed mission, proposed precepts, a proposed scope of
work and proposed characteristics.
Now, some of these are very much like the scout motto, you know, should be
objective, independent, knowledgeable, responsive, trustworthy, adaptable,
transparent, timely. You get the idea, many good principles that go behind it.
The scope of work again was developed in that context of the AQA in the
context of pulling together different streams of initially claims data but also
could incorporate other sorts of types of data for the purposes of quality
So, that is the context in which all those things got developed, but I
thought the mission was brief enough and interesting enough to read it to you.
The public-private entity will set uniform operating rules and standards
for sharing and aggregating public and private sector data on quality and
efficiency, offer guidance on implementation of such national operating rules
and standards and provide a framework for collecting, aggregating and analyzing
data to afford means of more effective oversight of health care data analyses
and reporting in the United States which gets into a lot of people’s nests. You
know we stopped and thought oh this goes a little bit beyond just quality
measurement. This goes into a lot of other places.
So, given this background and those materials we asked for responses to a
number of different topics. There are 25 of them listed out there, ranging from
is there a need for such an entity to what role should different institutions
play in that entity, to how would such an entity be funded and do its work and
how it would relate to other initiatives that are ongoing. They are all listed
out here for you. I don’t want to again get into it too extensively.
I do want to call your attention to potential responders. The list if
fairly extensive and includes pretty much the range of stakeholders in health
care in this country and we really would like to get input from as broad a
range as possible in the interests of being as comprehensive in the information
gathering as possible.
It is important to know that No. 1, there is not a specific intent to issue
an RFP or subsequent solicitation or proposed legislation or what have you out
of this other than to No. 1 take that information back to the AQA, given that
is where this discussion started and help them in their deliberations and No. 2
make that information broadly publicly available, okay, to help better inform
everybody’s discussion as they move forward.
I mean we all appreciate that there is a lot of different efforts around
this happening. It is our stated intent that every response will be scanned
into a PDF and made available on the AHRQ web site and that there will be a
summary of responses, a qualitative, not necessarily a quantitative, but a
qualitative summary and not analysis by the way, not looking to analyze this
information yet but a summation of the responses and that will also be made
So, there you have it. That is what we are about and that is the intent of
the RFI. I am really looking forward to your efforts as you look at secondary
uses of health data and participating with those as you move forward with that
and I would really love to hear discussions or thoughts that you all have about
this at this time.
DR. COHN: Jon, thank you and I think we appreciate you putting it back in
our court but I will think about that one for a while. We are obviously
delighted that Jon is going to be participating with us on the secondary uses
activities. So, we want to thank you for that also.
Are there questions or comments?
MR. SCANLON: Jon, the way the RFI is worded it sounds like there is one
entity and in fact there could be many entities. I think you are
conceptualizing an entity that would meet certain criteria and openness and
transparency. So, if I am understanding it this is not one entity monopoly.
This is more how this could be one or many or any combination.
DR. WHITE: The short answer is yes. The longer answer is it was originally
conceived of as one entity that would help guide the AQA but came to a good
appreciation of the fact that there are a lot of different folks that either do
play these roles presently or can play these roles and that we wanted to have a
robust discussion for that and my hope is that we allowed for that in the way
we worded what we asked for feedback on.
You know we talked about is there or is there not a need for an entity who
could play that role out there; what roles would they play? So, there could be
Now, we have a complicated health care system as it is. It would behoove us
to be thoughtful about how we do that and make sure that all the parts of the
MR. HOUSTON: The proposed mission speaks to you talk about offering rules
and standards regarding quality and efficiency related data specifically and I
think of data stewardship as being a much broader concept and data is sort of
the core and then uses of data, I would think that quality in public, I am
sorry, I am getting this all mixed up. Quality data is just one aspect of it or
using it for quality purposes. How are you planning on dealing with the other
types of uses of data and data stewardship or is that really not part of what
you are trying to do?
DR. WHITE: It was sort of a judgment call. It was sort of guided by OGC,
but it was also sort of a judgment call. You could boil the ocean with this. I
mean the uses of data extend, you alluded to all the different places it could
go to. It is my hope that folks will, that respondents will as they see issues
that are relevant to this like that they will bring those up in their
I don’t want to pre-judge responses or precondition responses before they
come back. I think in order to keep the responses relatively focused I think we
said, quality in there. Again, given the background and given what we hope to
do with it and given the agency’s focus, too, really given that we are the
Agency for Health Care Research and Quality but I think you are right. I think
the different uses go far beyond quality and I think there is going to need to
be some thoughtful consideration given to this.
MR. REYNOLDS: Jon, as you think about this if you use a model right now
that is kind of out there of HITSP and then CCHIT and some of those where HITSP
is kind of picking what it is and then if somebody want to get certified they
may go through CCHIT; is that a model that might — I am not recommending it. I
am just asking a question. In other words, back to Jim’s point of is there an
entity that does all of this and then are people going to have to certify that
in other words if somebody else wants, as you said there may be a lot of other
people that want to be data stewards. So, okay, what do they do?
DR. WHITE: There are a lot of people who want to be data stewards.
MR. REYNOLDS: I was being conservative. I wanted to be sure you said that,
not me but just because at some point whomever wants to be is going to either
have to become an entity or they are going to have to go to an entity to get
kind of certified which is kind of what is going on with some of the other
So, it is not that it would be just like those but that is a concept that
is on the street now.
DR. WHITE: Did you want to respond?
MR. HOUSTON: I just wanted to follow up. I mean I always think of data
steward as being sort of a monolithic role. I mean it is an organization or an
individual who is responsible for a set of data, and I never thought of it as
having a purpose overlaid on top of it and that there would be a data steward
for this type of use and there would be a data steward for that type of use,
and I guess it is sort of troubling to me that you could have a whole bunch of
data stewards sort of many chefs and the fear is that we lose sight of all the
different uses of data because you have all these data stewards who are
supposedly overseeing the use of data.
DR. WHITE: I think it would be useful to clarify that there are many
potential secondary users of health data, okay. The concept of many different
health data stewards is one potential given that you have a lot of different
sectors of the health care market now. You wouldn’t want one steward addressing
the same, multiple stewards addressing the same individuals but that is the
point. The point is to have the discussion because it could get complicated.
MR. HOUSTON: It could also happen. You could go forum shopping or data
steward shopping depending on whom said, “Yes or no,” or what you
wanted to try to do.
DR. WHITE: Absolutely, and my gut tells me that is not in anybody’s best
interests, not in the general common good, but again that is my gut. I don’t
know which is why you ask.
There are issues with a monolithic single health data steward. It is a
really complicated issue and to have one person deal with that might prove
I would just real quickly say that Harry mentioned are HITSP and CCHIT a
model that might be usable. It is definitely one model and there are strengths
to that model and there are weaknesses to it of course just like there are with
a lot of different ones and I think a good understanding of the merits of it
would be really helpful before anybody starts going down that sort of a path.
DR. COHN: I guess I would maybe ask a question that I was sort of mulling
over which is and hopefully not to upset John Houston but in some ways isn’t an
IRB yet another model for data stewardship? So, obviously there are multiple
ways of doing all of this and this is obviously in the research sphere but it
speaks of multiple secondary uses of data. It is just another model for us to
MR. HOUSTON: By the way IRBs, people do go forum shopping for IRBs and so
there is that potential for abuse and multiple IRBs can actually provide
permission over the same set of research potentially.
DR. COHN: Justine, maybe we will give you the last question or comment
DR. CARR: I am trying to integrate the many threads that have gone through
the last couple of days but in some ways it is like the oversight of ICDs and
ICD9’s and DRGs and what they go together and how they are weighted and things
There is one place that you go with regular updates. I don’t know. I am
just following up on Marjorie’s talk but there is a lot of coding clinics that
relate to when you use this code or that code and what maps to what DRG. It is
just my world. Never mind.
DR. COHN: I think I know that area but I may have to get a tutorial from
you to understand how that all interrelates.
DR. CARR: I am just saying that there is a way that as you tell the story
about an admission oh, you don’t live in the ICD-9. You live in SNOMED but as
you put together —
DR. COHN: We all live in the world of ICD-9.
DR. CARR: But as you put together a story of a DRG and what ICD-9 is mapped
to there is a coherent set of rules that you can go back to.
Not everybody agrees to them but they are traceable, they are documented
and they are consistent and it is why we can use administrative data year over
year because those rules have been set.
DR. COHN: I think that is one model. I think what I am hearing from you is
your comment that I think we are talking about entities but it also may be
rules or functions.
Marjorie, I will let you have the last comment on this one and then we need
to wrap this one up.
MS. GREENBERG: Obviously this is an area that the Committee has worked in
and will certainly be working in within the upcoming project.
I see that the comments from the RFI are due July 27, no later than July
27. Is there any intention of the Committee, I mean obviously individuals can
submit comments. Is there any intention or feasibility or interest in the
Committee in –
DR. COHN: No, I think the only interest the Committee has would be as
whether ore not it is a topic that we would get testimony on.
Now, that was an easy answer to that question. Now, Jon, I want to thank
you. I mean obviously we are going to be transitioning to secondary data
conversations more over the next couple of minutes. So, if you just want to
stay put in all of that, please?
The next piece we wanted to do and once again we are down to about the last
20, 25 minutes of this meeting, I want to hand over to Harry and Justine to
talk a little bit about secondary uses, just once again additional context
setting for the full Committee and then what I am going to do is take about 10
minutes at the end to sort of try to not put together the secondary uses
conversation but really to try to close the full Committee meeting as well as
talk about some of the next steps, action items, open issues that we have as we
sort of move forward into September.
We will then adjourn this meeting and relatively rapidly after that we will
reconvene the ad hoc work group and with that Harry and Justine, please?
MR. REYNOLDS: Yes, Justine is going to kick it off first with a discussion
of the overall scope and then I am going to touch base on some of the way we
are going to ask each of the testifiers too work with us and then we will give
you a quick update on the numbers of hearings we are going to have that we
already have scheduled and just briefly mention some of the types of people
that will talk to us and then we will let you go home and we will remain until
DR. CARR: I think everybody has these handouts at their place but we have
been working by conference calls trying to weave together the various themes
and come up with a scope of work that will focus on the summer.
So, I will just take you through where we are with it. It is a work in
progress. So, we invite your comments now as well as on your ride home or next
So, two premises that we have outlined, one is that HIT should serve
quality well because it enables more complete and accurate data capture and
analysis and actually I would add exchange to that, too, and the second is for
HIT to serve quality there must be adherence to standards, appropriate privacy
and confidentiality protections.
So, we have outlined three tasks. First is develop a framework that
addresses uses of electronically transmissible health data and elaborates upon
types of uses of data including health related from individual to population,
payer related, research related and other.
The second is include in the framework a taxonomy and it says here,
“That defines,” but I am almost wondering that clarifies terminology,
e.g., anonymization, deidentification, aggregation.
I suppose we need to add pseudo-anonymization to the other stakeholders and
the third is develop recommendations for HHS where there is a need for policy,
guidance, regulation and/or public education on expanded uses of health data
and data linkage with emphasis on how data for quality measurement reporting
and improvement is authorized for use temporarily and permanently, so,
authorized for use, stored, transmitted and processed for use in various forms.
How does that sound, Carol?
MS. MC CALL: I guess some of the questions that I have as I listen to you
are to understand your thinking about the things that you deliberately left out
of scope, some of the trade-offs that you thought that you were making and for
example in the third task there is an emphasis on quality remeasurement
reporting and improvement and I am wondering if that was a deliberate reduction
in scope and what you left out.
DR. CARR: Right, as we heard this morning from John Loonsk this began with
the immediate need of the AHIC quality work group use case where issues related
to the secondary use of data arose.
So, while we are trying to address things at a higher level it will focus
down on the quality use case but understanding that those as we develop this
that we will be thinking about other areas as well.
Harry, did you want to say anything?
MR. REYNOLDS: Yes, it is an aspect that we will use to maybe stay a little
closer. You can talk at a high level but drill down on this because that is
what they really want.
They want to start that. They want to make sure that we have identified
some of the things but we will continue to bounce it against the greater good
to make sure that we don’t get too astray just by picking one.
MS. MC CALL: One only added comment and then I will release the mike. One
is a fact that add me to the review list.
I will in fact become a reviewer and as a reviewer one of the things that I
would ask is that while I applaud the need to be specific that anything that we
create include recommendations wherever it is that we believe that specificity
has left the overall discussion.
MR. REYNOLDS: Yes.
MS. MC CALL: Limit it, that we just highlight that to say that we will be
DR. COHN: Thank you. Did I see a hand from Jon?
DR. WHITE: In taking a look at your first two tasks and looking at my notes
from last week’s AMIA meeting around secondary use of data have you had a
chance to talk t them? There is a shortfall up to now. Have you had a chance to
talk with them yet?
DR. CARR: We were there.
MR. REYNOLDS: We are leveraging data wherever possible.
DR. CARR: And I think that we will be talking about this this afternoon,
but their scale of transparency, appropriateness, all of that, we found very
helpful, consent in terms of looking at different areas to say, well, let me
just say that that scale we found helpful.
I think we will have some discussion about whether their definition of
secondary use is the one that we would go with. They say, well, that was an
area that we wanted to discuss further.
MR. REYNOLDS: They have a taxonomy of secondary uses which we don’t use.
DR. CARR: Yes, what constitutes secondary use. We want to review a little
bit. Harry, do you want to —
MR. REYNOLDS: Yes, put the next slide up real quickly, please?
As we have decided trying to put this framework together and again we are
going to spend tomorrow morning reworking to make sure we have got everything
that we want to do.
The chart is what I am looking for. We have put together kind of a chart to
aid our thinking and it also serves as the types of questions that we are going
to ask all testifiers because we are going to have a broad range of people
coming in and talking to us and we tried to put some normalization down as to
how we want to talk about them.
So, just quickly, you know we are going to talk about what sources of data
they deal with, what are the uses of the data. Privacy and security obviously
is a key point in this as we deal with it.
What is the actual quality use of data that they have, and then as a side
note back to the idea of thinking of the whole other are there data standards
or other things that ought to at least be considered.
So, we are going to flesh this out more tomorrow and as you are on your
trip home if you think or there are things in any of these boxes that you think
would be helpful for us to make sure we use as other filters we would be happy
to do that but we just wanted to have something we could work from so that the
testifiers are on some similar string. Otherwise this thing can turn into a bit
of a free for all if we are not careful. So, that is what we have tried to do
with this as we are going through it.
We, also, have a very long list of testifiers that we are going to be
hearing from. We broke them into different categories and I just put it in the
wrong place but we had some people —
DR. FRANCIS: Harry, I think we have got that for the work group meeting
because it has changed.
MR. REYNOLDS: Yes, I wasn’t going to, yes, okay. So, we have got a long
list. We will make sure you see a copy of that and if there is anybody else you
can think of and some of you we have already tapped you on the shoulder and
said, “Hey, we are looking in this area. Do you know someone?”
So, I think that is good. The other thing I wanted to mention is that we
are using the as we said earlier we are going to try to think about other
secondary uses kind of using the AMIA taxonomy that they had, at least the
high-level categories not drilling down all the way down that they were.
The last thing we wanted to cover today, Simon before we close this out is
in your handout you will see that most of us won’t see home after today.
We are meeting tomorrow until noon and then we meet July 17, 18 and 19,
August 1, 2, 3, August 23, 24, a full conference call on September 6 or 7.
We meet as part of the next full Committee meeting with you and then
October 4 and 5, with the goal of having something that is a worthwhile output
product at that point.
So, we are being aggressive with this. So, if you want to come along with
us please stay engaged, and we will try to keep you updated as we do along the
way because you can imagine with the subject we had when a letter comes in to
you and that is why we wanted to get help to do the primary today. For all of
you when the letter does come in it will have distilled an awful lot of
information about the subject.
So, as each of you watch us along the way and you have questions please
submit them to us so that we can help you somewhat stay with us as we are going
through this in what has been accelerated obviously a very accelerated time
frame to take this subject to market.
So, with that, Simon, oh, Leslie, you had a question?
MS. MC CALL: Yes, I just had a question for those of us who are not full
participants but are reviewers if we have a particular area of either expertise
or interest, for example, I am particularly interested in relationship between
QI and research and the question of research data, is there a way for us too
come to a particular part of a hearing or a particular hearing so that we are
more up to speed on what is going on on the ground for that particular area?
Does that even make sense?
MR. REYNOLDS: The one option that is really easy is for you to dial in. I
am not sure, I don’t exactly but in other words if you are just looking for a
specific time or you look at the testifiers and I think what we will do is,
Simon, probably send the minutes and the next agenda out to the whole Committee
because a lot of people have shown an interest in staying close to us. Then as
you pick that you could in fact call in. That would probably be the easiest.
DR. FRANCIS: That would be great.
MR. REYNOLDS: Call in and actually participate and even question in that
piece of it without having to come clear out.
MS. MC CALL: I think that is a great idea. I would in order to facilitate
that if there are materials, if you and I for example are on the phone and
think that we might be able to contribute that it has been very valuable for
example over these last few days to have the material physically in front so
that you are not taking notes as much as you are jotting down the thoughts that
accompany just the actual content.
DR. COHN: Similarly as we will be talking obviously tomorrow and towards
the end of the day about testifiers and so if there are areas that you see,
topics that you feel we should be investigating as well as testifiers that you
think could help illuminate the topics that would be something we need the ad
hoc work group but we really need the full Committee’s input.
We don’t want to be in September saying, “Gosh, if only you had heard
from X you would have really understood this area or you would have come to a
So I think that would be the one thing I would ask as a responsibility for
all Committee members be they members of the ad hoc work group, reviewers or
others on that.
Now, I do want to comment just in terms of this location is always
important even though phone, you know, Internet and all this stuff but the
meeting on July 17, 18 and 19, will be up at NCHS in Hyattsville as I
understand and w will be meeting downtown in Washington I believe at the Cohen
Building. I guess that is being determined.
These are obviously various sites around Washington. We will give you more
information as these things become more confirmed but I think it is pretty
clear that the NCHS meeting will be there.
Now, having said all of that I do want to make a couple of comments. We are
finishing up and I apologize we are running about 15 minutes late which I try
to avoid but we obviously had a lot of things added today and we didn’t get
started quite as early as we had hoped.
Obviously there is a lot of action items coming out of this meeting of
course some of which I can’t find right now. I have written them down very
carefully I want you to know.
I think that we are going to be seeing a variety of letters and comments
coming for next meeting and then hearing the HIPAA streamlining letter will
likely come to the full Committee next time as opposed to you know hopefully we
will have taken your input and hopefully be able to bring something back.
I think there may also be something on the 5010 depending on how the
testimony goes in July for standards and security. We, also have a letter
coming from privacy that we anticipate having coming forward and we are
obviously hoping that at some point you will have a chance to do further
investigation around the CCD and how it all plays into all of this.
I am hoping that maybe we will see a letter from quality coming forward
from your hearings on June 19. Obviously what I am I think beginning to
describe is that we may have another day’s worth of, and of course we will have
secondary uses coming forward. So, this will be a lot of reports and products
coming out of the Committee which of course is what we want to see and
encourage because as good as it is for us to talk really the value that we show
to America and to the Department are really in the work products we develop and
So, I think it is an exciting piece on that.
MS. MC CALL: I have a quick question about dates. You are talking about
secondary uses having something at the meeting on the twenty-fifth and
DR. COHN: Of September, yes.
MS. MC CALL: As a final product because there was something scheduled after
that. Would it be an internal product?
DR. COHN: I think that we will see. I think the view is that we will be
bringing something to the twenty-fifth and twenty-sixth.
MS. MC CALL: But it may not be final?
DR. COHN: It may not be final. We may be getting input from you having a
meeting on October 4 and 5, and we may need to have a conference call to
finally fully adjudicate the whole thing. I am just leaving that open as a
possibility. Our preference obviously would be to have it all done September
24, 25, but this may require a little conversation. It is aspirational.
Now, we also talked about the international discussions and I think
everybody was pretty engaged on that and we will try to get Chris Shute which
we talked about potentially coming though once again looking at that agenda
whether it will be September or November let us just sort of see how the
agendas come together around all of that.
Now, you also see in terms of your agenda that there are additional
hearings of subcommittees and work groups. We have obviously got an aggressive
schedule there. We have got standards and security coming forward. We know
there are conference calls on privacy. I am sure populations will have
conference calls also.
So, once again it will be a busy summer and all of that. Now, have I missed
MS. GREENBERG: Yes, there is 2005, 2006, NCVHS annual report.
DR. COHN: I knew I had forgotten something. Yes, just in case you lack for
reading this summer we will be having that coming forward also.
MS. GREENBERG: Let me just ask, Debbie, did we forget anything?
DR. COHN: Okay, good.
Now, I think we are at a point where I really just want to, I think it has
been sort of an interesting meeting. I mean it is full of work products and I
think the conversations have been useful but as always as the meeting begins to
wind down I really just want to open it up to ask sort of the fundamental
questions, you know, what worked at this meeting? What didn’t? Do you have
suggestions for improvement as we begin to plan future meetings? I just want to
ask people for your thoughts.
Oh, don’t be shy, come on.
Carol, do you have a comment?
MS. MC CALL: I have never seen a group so shy. That is my comment. Actually
I think and I get to say this not having been able to attend the first day, but
the comments that I heard are that everybody felt like there was a lot of
progress, that a restructuring of certain things to the front part better
informed dialogues going on later parts so the ability to connect was greatly
enhanced by that.
So, I think that that is a plus and just the observation that man there is
a lot of work coming through and its relevancy will prove I think wonderful.
DR. COHN: Justine?
DR. CARR: I think I have said this before but where our work crosses so
much of the work of the subcommittees and work groups that having the
opportunity to vet it together and leverage the expertise of everyone I think
just adds great richness and I thought this was a great meeting that had timely
presentations that were immediately relevant to the work that we were doing and
I think it was beautifully orchestrated and thank you.
DR. COHN: Other comments?
DR. FRANCIS: I will make a neophyte comment. I found the meeting enormously
helpful and I was very sorry that I had left behind my copy of Marjorie’s
acronym list from the last meeting but it would be wonderful to have it in the
next briefing book.
DR. WHITE: Didn’t you read the FAQ?
DR. COHN: Leslie, thank you for coming. We will continue to update that but
I want to tell you that your first meeting you are a neophyte. Now, you are a
seasoned member. This is your second meeting, no longer any excuses.
Okay, with that I want to thank you all. I, personally, think this was a
very valuable meeting. I think we got a lot out of it and certainly I was very
So, I want to thank you for participating. We will adjourn this meeting and
we will take about a 15-minute break and then we will reconvene this as the ad
hoc work group on secondary uses.
I do want to tell people that tomorrow for those of you sticking around for
the work group the meetings will be in Rooms F1 to F2. So, we need to be nimble
on that one and that meeting will be going from nine to twelve as currently
scheduled in this building.
So, again, thank you.
The meeting is adjourned.
(Thereupon, at 3:30 p.m., the meeting was adjourned.)