[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
February 20, 2008
Hilton Garden Inn Hotel
815 14th Street, NW
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
TABLE OF CONTENTS
- Call to Order, Welcome and Introductions
- Review of Agenda – Simon Cohn, M.D., M.P.H.
- Highlights From Executive Subcommittee Strategy Session – Dr. Carr, Mr. Reynolds
- Privacy Letter on Sensitive Information in the Electronic Health Record, Action February 21 – Mr. Rothstein
- Department Update — Data Council – Mr. James Scanlon, ASPE
- CMS Update (on Health Insurance Portability and Accountability Act of 1996) – Karen Trudel
- ONC Update – Dr. John Loonsk
P R O C E E D I N G S (9:10 a.m.)
Agenda Item: Call to Order, Welcome and Introductions
DR. COHN: Well, welcome everyone. Good morning.
I want to call this meeting to order. This is the first day of two days of
meetings of the National Committee on Vital and Health Statistics.
The National Committee is the statutory public advisory committee to the
U.S. Department of Health and Human Services on national health information
I am Simon Cohn. I’m 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 to
our first meeting of 2008.
I also want to welcome those listening in on the internet and it sounds
like those just calling in, members, I think, at a distance who will be
participating in the meeting today.
And, of course, remind everyone to speak clearly and into the microphone.
Let’s now have introductions around the table and then around the room.
For those on the National Committee, as always, I would ask if you have any
conflicts of interest related to any of the issues coming before us today,
would you so please indicate during your introductions.
Now, what we’ll do is to ask people around the table to introduce
yourselves, people present in the room, and then we’ll ask those who have just
called in to also introduce yourselves.
MS. GREENBERG: Good morning. I’m Marjorie Greenberg from the National
Center for Health Statistics, CDC and Executive Secretary to the committee.
MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation. Member of the committee
and I don’t have any conflicts that I’m aware of.
DR. STEINDEL: Steve Steindel. Centers for Disease Control and Prevention.
Liaison to the committee.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center. Member
of the committee. I have no conflicts.
MS. MC CALL: Carol McCall. Humana. Member of the committee and no known
DR. GREEN: Larry Green. Member of the committee. University of Colorado. No
DR. OVERHAGE: Marc Overhage. Regenstrief Institute and Indiana Health
Information Exchange. Member of the committee and no conflicts.
DR. FERRER: Jorge Ferrer, Veterans Health Administration. Liaison to the
MS. TRUDEL: Karen Trudel. Centers for Medicare, Medicaid Services. Liaison
to the committee.
DR. LEPKOWSKI: Jim Lepkowski. University of Michigan. I’m liaison to the
NCHS Board of Scientific Counselors.
DR. W. SCANLON: Bill Scanlon. Health Policy R&D. Member of the
committee. No conflicts.
DR. FRANCIS: Leslie Francis. Law and philosophy at the University of Utah.
I’m a member of the committee, and no conflicts.
DR. CARR: Justine Carr. Beth Israel Deaconess Medical Center. Member of the
committee and no conflicts.
MR. REYNOLDS: Harry Reynolds. Blue Cross and Blue Shield of North Carolina.
A member of the committee and no conflicts.
MR. ROTHSTEIN: Mark Rothstein. University of Louisville School of Medicine.
Member of the committee. No conflicts.
(Introductions around the room.)
DR. COHN: Would those members who have called in please introduce
yourselves and identify whether you have any conflicts of interest?
DR. WARREN: This is Judy Warren, University of Kansas, School of Nursing.
Member of the committee. No conflicts.
DR. COHN: I thought we heard a couple of other beeps there. I guess it was
people connecting and disconnecting.
Well, Judy, welcome, and we’re sorry that you can’t join us today in
DR. WARREN: I know, but Secretary Leavitt’s here in Kansas City. So I’m
meeting with him this afternoon.
DR. COHN: Well, good luck with your meetings, and, obviously, we’re glad
that you’re able at least to call in for the sessions and we appreciate your
DR. WARREN: Thank you.
DR. COHN: Okay. Now, before we move into agenda review, let me make a
couple of opening comments.
Now, first of all, I want to welcome Jim Lepkowski, our new liaison from
the Board of Scientific Counselors.
Jim, thanks for joining us today.
Jim was also present at our Executive Subcommittee retreat.
Without being real mindful of your CV, Jim is with the University of
Michigan and is a professor, I believe —
DR. LEPKOWSKI: Professor of Biostatistics, yes.
DR. COHN: Okay. And we’re obviously very pleased to have you joining us.
His alternate is Michael Grady, who, maybe you’ll remember, is a former
Assistant Secretary of the Office of Planning and Evaluation for HHS, and we’re
obviously pleased to have him also serving as an alternate, though he’s not
So thank you for joining us. We’ll look forward to obviously close and
cordial collaboration with the Board of Scientific Counselors.
Oh, Don, welcome. Would you also like to introduce yourself and indicate
whether you have any conflicts of interest?
DR. STEINWACHS: Don Steinwachs. Johns Hopkins University. No conflicts of
DR. COHN: With that, first of all, I want to begin by congratulating
everyone on what’s been a very positive and productive 2007.
Obviously, we talked last time about the many things that we did in 2007,
but I want to observe that even since our last meeting after Thanksgiving,
there have been a number of things that have happened.
First of all, we have finalized and published the report on so-called
secondary uses of health data.
We have also finalized and published the report on quality measurement and
data reporting from the quality workgroup that we had discussed and
balloted(ph) earlier last year.
There have been hearings from Standards and Security on both HIPAA and
e-prescribing issues, and I know some planning from their point looking into
2008 and beyond.
There have also been conference calls from both Populations, Privacy and
Confidentiality and Quality on sort of planning for 2008.
And, finally — and we’ll talk about this a little later on this morning —
there was an Executive Subcommittee retreat that we’ll sort of talk about some
of our musing and thoughts about sort of after the introductions and before our
So as we begin in 2008, I just want to thank you all for your hard work,
dedication and leadership.
Certainly, as I’ve looked at this — and I think we all know that the NCVHS
is known within the federal space as one of the most hardest working and
dedicated subcommittees. Certainly, our perspective and our sort of position is
to be providing sound, practical advice for the department in really being a
And, really, we’ve had wide influence on a lot of the activities over the
last 10 to 15 years in the sphere of health information policy beyond HIPAA,
e-prescribing, Medicare Modernization Act, issues around privacy, population,
as well as quality measures issues.
And I think we’re also providing thought leadership on many of the issues
relating to the developing national health information infrastructure, be it
the overall broad vision, be it privacy and confidentiality in the NHIN, be it
secondary uses of data, NHIN functional requirements, future health and vital
statistics, which we’ll talk about.
But, obviously, you know, the view is to provide useful data now, but also
provide a vision to help the department move forward.
Having said that, of course, our impact is not just felt within the
administrative branch. We make regular reports to Congress. We are asked on a
regular basis to brief congressional committees on work of the committee, as
well as important initiatives, be they privacy, standards or otherwise.
And what one would observe over the last several years, even though we
haven’t seen any new HIT legislation recently, but, at least on the ones being
proposed, our name is frequently mentioned as a player in this whole activity.
So, basically, NCVHS members, key staff surrounding us, I really want to
thank you. Obviously, this reputation, this national impact is because of your
commitment and vision.
And, of course, I want to especially acknowledge Marjorie for her help in
all of this.
I keep acknowledging Jim Scanlon, but he’s never here to be acknowledged in
But we do appreciate both of their leadership, and, of course, the
leadership and support from all of the skilled and dedicated staff to our
committee, subcommittees and workgroups.
DR. COHN: So let’s move into agenda review and talk about the new modified
agenda that is on your desk today that many of you probably have not seen
We’ve been switching things around a little bit because of people’s
Now, we’ve been adding things, but it’s more changing the order.
This morning, we begin with a review of the executive subcommittee retreat,
as I commented.
The main focus of the retreat was on transition planning as well as a
review of committee priorities, function and structure.
There’s a sort of PowerPoint in Tab 4 that Justine Carr and Harry Reynolds
will lead us through in just a second, sort of talking about, I think, some of
the recommendations and perspectives that came out of the executive
Now, after the break — and after that, we will be looking at Version — is
it 17 or 45? — of the privacy letter.
PARTICIPANT: Excuse me, that’s the final —
DR. COHN: Final version, yes.
Now, this is being brought forward for action at this meeting, and we’ll be
reviewing it this morning. It’s in Tab 3.
As always, given that this is 12 pages long, we obviously gratefully accept
wordsmithing, but unless it’s wordsmithing that specifically deals with
content, let’s take it off line and we can sort of deal with it in the final
version of the letter.
Certainly, if there’s any wordsmithing that deals with content or impacts
content, this is certainly the time we need to be talking about it — an
agreeable that process discussion.
Now, after lunch, we’re having Jim Scanlon in attendance, and we’ll be
having an update from the department as well as from Karen Trudel really to
what’s going on in CMS.
At two o’clock, we’re having John Loonsk joining us to spend a little
longer time than we had last meeting talking about what’s going on in the
Office of the National Coordinator.
I also want to direct you to Tab 6, which is a report from the National
Academies of Science looking at the function of the Office of the National
Coordinator, not an explicit topic for conversation, but something that I think
is useful as you sort of think about the functions and role of the Office of
the National Coordinator going forward.
At three o’clock, we will break into subcommittees. At that point, we will
talk about sort of the next day’s agenda and how that’s going to play out, but
we obviously have Subcommittee Population in this meeting. Privacy and
Confidentiality will be meeting.
And then after that is the Quality Workgroup, and all members are invited
to sort of that discussion, given how crosscutting quality is.
Now, tonight, we have dinner at — and I think we need to get a show of
hands. It’s about two blocks away, I believe, and dinner will be at six. So
pretty much immediately following all of our meetings and workgroup sessions.
I think we just probably need a show of hands for those who are planning on
coming and joining for tonight.
DR. COHN: OK. Look forward to seeing you.
Now, I do want to remind everybody before I hand it off to Justine and
Harry, meeting starts tomorrow morning at 8:30, and we think we’ll be
adjourning by one o’clock.
OK. Well, with that, I want to turn it over to Justine and Harry to sort of
take us through the discussion from the executive subcommittee retreat.
Agenda Item: Highlights From Executive Subcommittee
DR. CARR: Thank you, Simon.
I think that Harry and I put these thoughts together to just take a moment
in time for the committee to think about, as I’ve outlined here, where have we
been, where should we be going and how should we best organize ourselves to get
So we’ve split this up a little bit, and I’ll start with a little bit of
So, as you know, we’re coming up on our sixtieth anniversary, and I wanted
— I took the occasion to go back and read the charter and also some of the
history from the fiftieth anniversary. And I’m going to highlight for you the
things that jumped out to me.
But just looking at our charter and our areas of focus, it reminded me that
our focus is data needs assessment, emerging data issues, data collection
strategies, particularly multipurpose, integrated, shared, multiple uses of
data collected once.
We also strive to achieve data standards consensus on uniform data
standards, health terminology, definitions and classifications. Also focus on
information system, network design, interoperability, privacy, security, and,
of course, HIPAA.
So I point that out just because sometimes I think that we — there are
many dimensions of the topics we issue, but it just — for me, especially in
quality, we want to stay grounded in the piece that we are charged to do having
to do with data.
On the next slide, again, reading through the history, I just took a look
at – Okay. Let’s see. There we are — at selected history, and what struck
me as I looked back through is that from time to time there is a major event
that changes — that has significant downstream impact.
So if we look back to 1949 where we were focused on mortality, morbidity
and reportable diseases, our data sources were more or less raw statistics, and
the benefit of those raw statistics was increasing national awareness on these
mortality, morbidity and reportable diseases.
Fast forwarding to the 1980s, a major thing happened in that we developed
care delivery site data sets. So the hospital data set, ambulatory and
long-term care with that ICD-9 codes.
And the result of that was that we improved our understanding of diseases
and particularly disparities. Minority, indigent, mental health, disability,
long-term care, race and ethnicity issues came to the fore.
Obviously, 1996 brought HIPAA and all the issues about privacy and
security. We began looking at electronic transaction standards, and, with this,
we had increased opportunity for aggregation of claims data, better
understanding of disease management and resource utilization.
And then, of course, in 2002, NHII, NHIN, e-prescribing. We had more
information now about clinical data, lab, medications and the potential to
define and assess longitudinal episodes of care and person-centric focus.
This, in no way, is an exhaustive review, but it just struck me that every
couple of years, something major happens that fosters many significant
developments. So this is just my mini-perspective.
Again, reading back on the review in the 50-year history, I was struck by
the fact that 1986 the committee developed characteristics for assessing
emerging issues. And it was noted that the work moved away from technical work
to conceptual, consultative, looking at analyzing problems, reviewing research,
talking with experts and those affected by the issues and recommending
approaches and urging further study.
And that the function, again, had moved away from the technical analysis
more toward drawing attention to issues, providing a forum for legitimizing and
reenforcing new ideas and facilitating dialogue.
And, again — and I raise this just as we think about what role we play
So on the next slide, this was me counting all of the — and I realize I
made an error. So we may need Mark’s letter to get us to the 100 point. I think
I counted a response as a letter. So no pressure. No pressure.
But I think looking at the production of the committee in this way tells
several things. I mean, across the top for those listening in, columns are
privacy, standards and security, populations, NHII quality and other, and year
over year from ‘97 to 2008.
So, clearly, most of the production comes out of standards and security,
and that includes all the annual HIPAA reports to Congress. So a little bit
padded there, Harry.
And then I think privacy certainly has been an ongoing issue, but you can
see that around the time of the privacy — HIPAA, you know, certainly in 2004,
seven letters and reports coming out at that time.
Populations has been steady, although, as you see, more standards and
security than populations in recent years. And I think this is telling a bit of
the story about the fact that we’re 18 people and we have to focus year over
year on different things.
And, of course, we had a lot of work on NHII, NHIN. And quality, you know,
I put that up there for myself to see what — the reports that have come out of
So later today, I’m hoping as many folks as possible can join in on quality
workgroup, because I’ve taken the opportunity to review the report from
‘04 — 2004 to say what’s happened, and a lot’s happened since that report
was written, but, also, what’s the right direction with all the rest that’s
going on in quality.
And then under column other, I have the uses of data. I think we should get
double credit for that because it was 60 pages.
MR. REYNOLDS: We’re going to get to 100 today somehow.
DR. CARR: So it just — it shows how productive — to Simon’s point earlier
— how productive this group has been through the years, and continues to be,
and how the focus shifts, because we can’t do everything all the time, and as
we think about going forward, I think this is a helpful landscape.
So, for now, I wanted to just go to the next slide, you know, where should
we be going? And I’m going to just summarize two things. One is the core values
identified in shaping statistics for the 21st Century, and, then,
also, the guiding principles.
So next slide.
With the core values — and there are four — these would be, one,
maintaining confidentiality, and, then, secondly, maximizing the scientific
integrity of all aspects of health statistics while acknowledging the specific
ways in which political, cultural, business contacts may affect data
collection, analysis and interpretation.
The third core value is optimizing the enterprise’s accountability to its
users to ensure the availability of information that’s needed for improving the
And, fourth, ensuring the enterprise’s accountability to its data suppliers
to minimize their burden and provide them with timely feedback.
And, then, finally, I’ll just summarize the guiding principles of shaping
statistics for the 21st Century, and, again, not reading all of it,
but going through, one, enterprise-wide planning and coordination. Two, broad
collaboration. Three, rigorous policies and procedures for protecting privacy.
Four, flexibility to identify emerging health issues. Five, use of data
standards to facilitate sharing and comparability. Six, sufficient detail at
different levels of aggregation to support decision making. Seven, integrated
streamlined data collection for multiple purposes. Eight, timely production of
valid and reliable health statistics. Nine, appropriate access to and ease of
use of health statistics. Ten, continuous evaluation of the completeness,
accuracy and timeliness of health statistics and of the ability of
health-statistics enterprise to support their production.
So I hand it off to Harry now.
MR. REYNOLDS: This is the third time we’ve done this, and every time it
starts getting closer to a debate than a collaborative presentation, but in the
spirit of the political environment, our record stands and will be attacked by
So moving forward to Slide 11, balancing the portfolio, as we take a look
at who we are, what we are and what we’re going to be doing, all of you are
aware that a number of people — up to seven — could be moving off of the
committee. So that changes the landscape quite a bit. It changes some of the
leadership of the committees.
And so the executive subcommittee wanted to take a look at it while a lot
of people that have been here a while were in place to take a look at the types
of things to put on the table for discussion by everyone else as to how we
ought to approach going forward.
So, you know, we always have an ongoing oversight. Whether it’s the
privacy, whether it’s the regular population’s quality or standards, we have to
do some base things that we have to keep an eye on.
We’re collaborating, obviously. We’ve done some work with ONC and others to
get some things done. Emerging issues. We always have to keep in mind that we
can get stuck in the current, but we always gotta keep pulling ourselves to
emerging issues and envisioning the future.
So this really needs to be the kind of portfolio we look at in each
committee, because sometimes it’s easy to get pulled into today and it’s easy
to get pulled into what somebody says they want us to do, but going back
through the history and listening to Justine and Marjorie and the others that
have been around a while, you know, we’ve really been about making a difference
in multiple levels. And I think these four are examples of that, not the only
examples that you could use, but we have to keep that in mind as we go forward.
And speaking of a changing landscape, as you look at the electronic health
records, the whole idea of the NHIN, the AHIC — the change in the structure of
AHIC, where it’s moving to a private organization. The whole quality agenda,
which you heard earlier. Legislation. Be a lot more — continued focus on
whether there’ll be continued legislation in this environment.
Population strategy to ensure, again, that processes and data enhance its
success, because a lot of what we’ve done in populations has been to talk about
populations at the end of the process. Maybe we ought to make sure we get
populations more to the beginning of the process as more and more data is
getting collected, so that we make sure that it enhances the ability to use it
once it’s there. So just how that works or doesn’t work is something to
And then the key drivers of standards, as you see here, and then data, as
we all know, the uses of data that we did, the whole idea of stewardship
quality and then the support of future needs.
So those were just some examples of the changing landscape, not to be every
example, but some ideas of the things that need to be considered as we go
So going to the next one, so how should we organize ourselves to get there?
You know, we’ve got standing committees right now, and those committees are
made up in certain ways.
Under configuration, which is Slide 14, you can see across the top how
we’re organized. And, then, most recently, we’ve had a couple of ad hoc — NHIN
and uses of data, and we’ve tended to build the ad hoc because the subject went
horizontally more than vertically. And many of our standing committees have
tended to have to deal vertically, you know, within a subject matter and drill
down, but, more and more, we’ve got this horizontal flare going on because we
are the ones that can look across at — in its entire breadth as we do things.
And then if you look at the future, if you take the list that we put on
Slide 12, most issues need representation from all areas, whether it be privacy
standards, quality, et cetera, as opposed to being addressed by a single
committee, you know, so a lot of these things over here, whether you’re talking
about electronic health record, NHIN, these other things, it’s not — it
doesn’t just come to your mind that belongs there or that belongs there.
And then some areas — for example, standards — will have ongoing issues.
So as we said earlier, back in the balanced portfolio, standards is required,
for example, to deal with HIPAA as part of legislation and report to Congress
and so on.
So there’s some things in place that we all have to do, but, realistically,
these subjects may not fit quite as nicely as we have aligned ourselves.
So moving next to this idea of the — Slide 15 — the ad-hoc workgroup
model, you know, the benefits that we’ve seen from our participant expertise
alignment ensuring a fundamental knowledge base so you — you know — kind of
pick people that were interested.
And then the other thing that I thought was excellent was we also had
people that identified themselves as reviewers. So even though they couldn’t be
in the day to day, they, in fact, could stay with us, you know, in a parallel
track, not that they were on another committee and it didn’t matter ‘til
we got their full committee. That was very helpful.
It really broadened the experience — I know it did for me — of being with
people that tended to be in other spaces than the committees I’ve been on. And
it allowed, again, each of us to grow, because the more we grow on the subject,
the better we get.
Active working partnership with staff. They’ve been very helpful in that.
And then broad perspectives incorporated.
But the challenges, as most of us know that we’re involved in that, the
timeliness, the workload and the generation of new topics spawned by the
So once we do this, every time, whether it be in the privacy letter that
we’re going to talk about or whether it be in the uses-of-data letter, we say,
“And, oh, by the way, these X things need more work. And, oh, by the way,
we’d be happy to do it.”
But as it spawns out, does it fall nicely into one of our nice little
structures that we have that says that committee should take that and that
committee should take the other one? And that’s a struggle that we continue —
So that’s — Slide 16 kind of depicts that.
So out of uses of health data, we have a whole discussion on de-identified
data, which, if you think about it, really has a stream across numbers of
things. Whether it be quality reporting, whether it be privacy and whether it
be standards, what does it mean? Those alone would all be involved.
Data stewardship is a subject, not a committee, and that subject spans
everything that we talk about or touch or do related to anything that we’re
And then this whole quality and research boundary has many tentacles that
we need to make sure that we deal with.
So let’s go to 17. So how do we balance and manage requests for our
service? Because, more and more, depending upon how other things shake out as
far as what’s happening, we do have a lot of what we would call customers
and/or sources of requests.
So how do we make a difference by staying at the right level of
consideration, so that we don’t just become the adjudicators at a certain
level, we literally play across the entire spectrum that we listed earlier?
We have multiple sources of requests, and you can see some of the examples
that we have here. All really good efforts and all things that we should do and
we were excited to do, but we have to continue to have our own list, too.
And, then, topic selections, reactive versus proactive. Where do we want to
Broaden topics beyond HIPAA in the NHIN and ensure availability of
necessary data to support the healthcare reform.
And that was one of the topics that came up the other day is there’s a
whole lot — you say uses of health data and then you put it in that kind of a
sentence, again, it takes it to a different discussion, you know, it doesn’t
just keep it as always a byproduct of care. It now becomes how will data really
transform the health environment. So that, again, takes us to another level of
So you can actually take the same subject across our four levels and
actually move the same subject across all four levels, possibly at the same
time, which gets kind of interesting. You know, so data, if you put it over
there, would play almost in every one of our portfolio items as we look at it.
So looking at our structure, should we reconsider the role of standing
committees, rename or organize standing committees and workgroups?
So, for example, relocate security, possibly to make it privacy and
security. Refocus quality to data usage, rather than quality. Don’t know, but
it’s — again, we’re putting these things on the table as considerations.
And, then, for example, we had the group NHII that put out the excellent
document, but hasn’t kind of reinvigorated itself, but a lot of that, if you
look at it, maybe that is a standing ad-hoc committee, philosophically.
No, no, I mean, because if you staff it with a broad knowledge, rather than
maybe just privacy or standards or something else, you staff it horizontally,
maybe that becomes one of the places that you do it, if that’s the way it’s
done. But, again, this is all for discussion. Nobody’s making decisions and so
So — and then reconfigure around ad-hoc groups, and then designate across
committee representation for each subject versus ad-hoc self-selection.
So if the privacy committee was going to have a subject and it needed and
it was going to have a flair for some other piece, possibly adding somebody to
that committee during that time to make sure that that got adjudicated in a low
— way, then when it gets to the full committee, and then all these things that
you wish you could have handled or you wish you could have talked to people
about or somebody would have brought up because that’s their space would have
been done in that committee. So looking at it that way.
So, with that, next thing is member participation. You know, what are the
expectations? More and more — you know — it’s hard not to want to be aligned
with your expertise versus cross fertilization. You know, people want to be
involved in what they know and what they do and what their day job is, many
Attendance and participation. Making sure that we get everybody to play at
the right level as we’re moving along, because as these subjects become more
and more horizontal, settling it at the end in the full committee and trying to
catch everybody up to the whole subject — not the individual task or the
individual piece, but the whole subject — is becoming more difficult.
Distribution of work within the committee. What should staff be doing? What
should members be doing? What should consultants be doing?
And many of us in the ad hocs and others have seen it done all three ways,
as to exactly how it gets done, and we can show examples of that.
And then how to cultivate leadership to preserve continuity. So, you know,
some kind of a philosophical succession plan, especially within the individual
committees. Committee vice chairs. You know, it had been recommended earlier,
but not completely implemented in all cases.
I know that on the ad hocs we were on it took Simon, as the chair, and
Justine and I, as the vice chairs, all three of us, split the work up and
labeled it you know, did not have somebody just buried with all the
responsibility, but doing that as a purposeful thing in everything we do, so
that we share the load, rather than just on one person.
And then this whole idea of if you think of all these subjects that we put
up there and the things that we have going forward, educating new members. I
know I came on four years ago, and the subjects now are dramatically different,
and they are much more extensive and intense as we start moving towards these
things. So how do we actually educate new members? And we had some discussion
Last slide that I’ll touch is writers, consultants and staff. Who writes
the letter report? You know, has to do with content and editorial polish and so
on, dealing with that.
Balancing discussion between staff and members, how we make sure that we
have all voices at the right time for the right reason.
And then consistent look and feel to the documents and the website. So, for
example, we’re more and more putting out significant documents, and, as the
subjects get larger, all of us that are in the subject are writing it or having
somebody write it, but we didn’t necessarily step back and look at it from an
editorial standpoint and from a public-viewing standpoint.
We knew the subject. We wrote down the subject and we tried to masterfully
explain the subject, but we didn’t, but we may not be quite the writers — For
example, if a Susan Kanaan looked at some of these things, she would see it
differently than some of us did, even though it reads fine and we all approved
it, but it may have the same look and feel if we did it that way.
So, with that, those were the things that — and then we — as we say,
other issues, we had significant discussion at the executive subcommittee about
these, but it was requested to bring it here for discussion because you
couldn’t have a lot of votes there because most people are — a lot of people
there are actually scheduled to roll off. It would have been a bit of a hollow
vote. “Yes, you all have a good time. You all think that’s good,
But I think the point is that these are the kind of things that we wanted
to bring forward for discussion, take a look at and then make sure that we
build this going forward in the right way for the right reasons.
So, with that, Simon, we’ll turn it back over to you and open the
DR. COHN: Well, it’s not so much turning it back over to me, but it really
is opening the conversation, and I’d look for — you know, obviously, Harry was
talking about a wide variety of issues. I think sort of pick your punch is what
I would sort of say in terms of commenting, but we’re looking to sort of a
wider view of all of this as well as ideas about how we should best move
John and then Leslie.
MR. HOUSTON: Yes, I have some specific comments and some general comments.
I’ve been advocating for a while that I think privacy and security need to
merge, and I think that you touched on that in one of the slides, so I’m going
to raise my hand and say, boy, I think that’s a really good idea, one that I
think is past due.
I have some other general concepts. You know, I think that one of the
things that we also need to be mindful of is that part of our charter is
looking at emerging issues.
Frankly, I think part of our charter is to decide what are emerging issues
before they emerge. I mean, I think that back 10 years ago, or whenever, we
decided to — we provided the recommendation on the NHIN or NHII — which is
even before my time, arguably — that that really sort of set the direction of
a lot of people’s thinking as what needed to be done, and so we got out in
front of that even before it emerged, in some respects, I think.
So I think part of this committee also needs to decide — part of this
committee needs to be tasked with deciding what are the next topics before they
start to emerge or to try to — does that make sense?
And then I think also another concept or another concern that I have is
being very intimately involved in privacy.
I think that — I’m a little concerned with the way that I’ve seen some of
the letters go through the privacy committee, and I think it can — it’s
actually, I think — I think Mark would agree with me — Whereas, a lot of the
other committees, if you have expertise on those committees, you participate,
and rarely do non-subcommittee members really get involved in some of the
substantive discussion about those topics, because, frankly, I don’t know
anything about standards and I’m not going to start jumping up and down about
an 837 or a whatever, because I don’t know. I may look at the letters and
decide that maybe something needs to be worded a little bit differently, but I
don’t get substantively involved in the discussions because it’s a fairly
The problem with privacy, though, is that everybody has an opinion, and we
can talk ‘til the cows come home about privacy. And I think what happens
is that these letters we work really long and hard on in the privacy
subcommittee, and, unfortunately, when they come to the committee, there’s
still an enormous amount of difference in opinion from the general committee.
And I think what it ends up doing is it causes these letters to slow down to a
pace that I think makes — potentially causes them not to be relevant, because
they’ve been in committee too long.
And I think we need to have a framework in which we can try to adjudicate
some of these letters in a more timely manner, because I just — You know,
again, everybody’s got an opinion about privacy, and sometimes I think it just
simply causes these letters to — the pace of getting these letters through to
go to such a — to such a slow pace that they just — it becomes problematic.
DR. COHN: Is this time for rebuttal?
Yes, I think, Mark, you wanted to comment on this, and then Leslie.
MR. ROTHSTEIN: I just want to say, John, I agree with everything you said,
and the point also is one that I tried to make at the executive subcommittee
meeting when this issue was discussed.
And it’s just too long a process. There’s no reason that the letter we’re
talking about today should have taken 15 months or however long it took.
And I do appreciate the wide variety of opinions as well as the vigor with
which those views are expressed by the members, but we’re going to just play
ourselves into a state of irrelevance if we don’t get the stuff out in a timely
DR. FRANCIS: I’m fascinated by the selected history, the slide that Justine
put up. And part of why it fascinates me is the shift in focus — I’m thinking
substance here — from, on the one hand, what are patterns of disease and how
is care dealing with it, what’s happening to, for example, disadvantaged
populations. That’s really what’s going on up through the end of the ‘80s.
And, then, after that, the shift is all about the management of the
information, not so much about what’s the information telling us, but how are
we getting it, how are we protecting it and so on, which is a fascinating shift
to me, if I look at your slide.
Now, that said, I think both of those are interesting, and I — and both of
those are crucial, and we shouldn’t be losing one for the other.
So as I think about how to structure, we’ve got substance questions, which
is what are we about, and then we’ve got process questions, which is how are we
going to do what we’re about, and I guess part of it is it seems to me really
important to decide what the substance questions are, because, in a way,
they’re going to drive how we want to organize ourselves process-wise, which is
why I made that substance observation.
I would just say one other thing which is that there are advantages and
disadvantages of having a subject-matter committee, like, say, privacy.
The disadvantage, of course, is what Mark and John have just been talking
about. The disadvantage of splitting it up and having one privacy person on
each committee is the risk that things get diluted, and that could happen
whether it’s one populations person on each committee, whether it’s one quality
person, whatever it is, and I think we need to think about that when we think
DR. SCANLON: I’d like to come back to John’s point, which I guess I’m
wondering if part of this is an issue of evidence versus values. Whereas, some
of the privacy discussions may — actually, people are expressing values as
opposed to sort of pointing out that the evidence shows that this is going to
be the impact of A versus B.
And it raises a bigger question about evidence here, because we rely
heavily on testimony in terms of gathering information.
And testimonial evidence, in some respects is one of the weaker forms of
evidence, because you say from — what you say, in part is a function of where
you sit. And there’s a question of sort of getting sort of opposing viewpoints.
And, then, also, it’s sort of extrapolating to the rest of the world, sort of
being able to put weights on the kinds of testimony you have. Even if you have
all the viewpoints, there’s a question of which one is the most important or
which set of them are the most important.
And there’s an issue for us, in terms of the limited resources that we
have, of how do you reach a conclusion when you have this kind of fragmented
evidence and you don’t sort of — and you don’t have the ability to kind of go
and to do the more extensive sort of information-gathering that would allow you
to weigh things, allow you to sort of verify things, et cetera.
I think we do a very sort of good job with what we have, but there is that
tension that we’re always going to have to face.
And then there’s a question of when we come to something where values may
be playing a role, how do we introduce values sort of into this discussion?
And I think it’s not — I mean, my view of a committee like this is it’s
not that sort of the American people have designated these 17 people to decide
what the values should be about something, but we should be raising the issues
about values, you know, and raising them to the level of the Secretary and let
the Secretary decide — make the Secretary sensitive to what the value issues
are with respect to a point, not necessarily try and reach a consensus here and
say, “That’s what the Secretary should necessarily do.”
That may have an impact in terms of trying to make things easier to put
forward or it may not. I don’t know. I mean, it’s kind of like — It would be
interesting to do an autopsy on some of these letters in terms of why did it
take sort of — you know — this many sort of iterations, kind of what were the
diseases that were involved before we —
DR. COHN: Bill, let me just sort of ask, and I’ll let Carol sort of comment
also, is your observation, then, that a lot of the issues — getting into
values conversations may be where things sort of start getting into a very long
and involved process? Is that what you’re —
DR. SCANLON: Well, No, it’s not that. I mean, I can’t say that I’ve made
that sort of correlation sort of over the time on the committee, but I think
the privacy is right for values.
It’s kind of like when you say it’s very important to protect this
information because people are sensitive to it. Well, you’ve already introduced
sort of values into that statement. People are sensitive to it. It’s sort of
how people regard this.
And then, in terms of a policy, it becomes a question, in some respects, of
sort of what are the impacts, and then how important is it to protect even sort
of the very small minorities of people. I mean, and that’s value.
You know, it’s like the whole social sort of impact of something could be
sort of very minor, but that’s not the important thing. It’s if it’s in terms
of some individuals being protected, my values may be that I regard that as
very important, and I’m willing to do that.
And so it’s — I mean, this is — privacy is just — I think, is laden with
this value issue, and so it’s tough for a committee necessarily to come to sort
of a conclusion about it.
And the question I guess I’m partly raising is what’s our role in terms of
coming to a conclusion about it?
MR. HOUSTON: Or what’s our process?
Because I think part of the problem is, I think, it’s fair to say everybody
has a value and an opinion and that we need to respect that as well as the
people that we ask for testimony on, but once we try to get all that
information together and distill it down into a letter or recommendations, how
do we move that forward in an expeditious manner?
I think that is really probably the most frustrating thing that I feel is
that, boy, you know, part of the problem, too, with this letter was — is that,
then, all of a sudden, midway through the process, we got new members involved,
and then you started to re-vet issues that we had before.
And there’s nothing — I’m not saying that’s wrong, but it dragged out so
long that then it caused its own — we caused our own set of delays just
because of bringing members up to speed and things like that.
So I think there’s a process side of this that really is troubling.
DR. COHN: Okay. We have Carol and then Marjorie and then Mark.
DR. TANG: Simon, can I get on the queue also?
DR. COHN: Is it Paul?
DR. TANG: Yes.
DR. COHN: Paul, would you like to introduce yourself and tell us whether
you have any conflicts of interest?
DR. TANG: I did that. I think my headphone was not working, but, yes, Paul
Tang, Palo Alto Medical Foundation. Member of the committee. No conflicts. And
I’ve been here from the start.
DR. COHN: Thank you. Okay. We’ll put you in after.
MS. MC CALL: First some just kind of reactions, and the observation,
mostly, on just kind of the old versus the more recent is fascinating in terms
of subject versus process.
I guess one of the thoughts I had while you were talking is that it’s
become so overwhelming, you know, in terms of being that subject-matter expert,
that I think that those days are probably gone for this committee — right? —
just in terms of the quantity and things like that.
So I think my reaction would be that to think that we are going to be
subject-matter experts on morbidity, mortality, whatever, you know, to kind of
The second, it’s a fascinating thing about evidence versus — and
testimony, and how good testimony is as a way of gathering versus things that
are more emerging.
So if we think about that and those become some of the tradeoffs in the
topics that we pick, the subjects that we pick, I think that there are some
consequences to that.
One is that I think where there’s evidence and where our subject-matter
expertise lends itself, we’re going to — process will be faster, you know,
because we’ve worn a path and so we know how to do it.
And I think testimony probably can help, but if we’re looking at emerging
issues, if, in fact, we’re saying our role is to look at emerging issues, I
think they’re always going to be more cross-cutting.
I think we will have issues around values — Is that our role? — and it’s
going to be slow. All right? And then we have to look at how we go about
finding evidence, because, otherwise, we’re just looking where the light’s
So when we think about that, I think there are process implications for us.
I think there are capacity issues for us that we need to talk about.
And, then, I have a question for the group and also for you, Simon, which
is where has our value been most greatly appreciated? Is it in more
evidence-based subject matter — we can tell you consequence, so recommend
this, not that — or is it in emerging? Because we can talk about putting
ourselves on the path of emerging issues, and yet if that value isn’t going to
be able to be realized, then that’s probably not a good use of all our time.
DR. COHN: Carol, thank you. Let me at least try to answer your last
question, and then I will give it to Marjorie.
But I think what Harry and Justine and I think others have proposed is what
we’ve described as a balanced portfolio, because I think what we’ve seen is
value appearing in multiple different places.
I mean, part of what Leslie is commenting on is actually really the
re-chartering of the NCVHS in 1996, where, really, the focus — the Congress,
the Administration asked us to change — sort of lead division of health
information technology, which changed substantively. And rather than just
talking about core data sets, we suddenly started realizing, well, geez, if you
have standards, out of that is generated interoperability in standardized data
and sort of this realization.
But, at the same time as I say that, I think that’s been very helpful, but,
also, the NHII vision has been extremely valuable, I think, to the country and
the 21st Century vision of health statistics.
So it’s sort of this issue of trying to meet — you know, there’s not one
customer. There’s a variety of customers.
Anyway, that’s my comment.
MS. GREENBERG: Well, just wanted to make a few comments.
As I pointed out at the Executive Subcommittee meeting, not only have I
kind of been around a while, so — I really appreciated Justine taking on this
sort of current role as committee historian, because I — obviously, I think
that’s important, and so, you know, he who forgets the past is doomed to repeat
it or whatever.
But, also, as I pointed out, whereas, members come and members go, but the
staff kind of stay often, and so I appreciated —
I appreciated also the opportunity to reflect on the past number of years
and the future, and I thought that Justine and Harry did a great job with these
slides. They really stimulated a lot of discussion at the executive
subcommittee meeting, and I hear some very good discussion here as well. So I
just wanted to tip my hat to them.
As you’ll be hearing later, I mean, one of the things we do plan to do is
to update the history, the 50-year history that we did for the 50th
anniversary, for the 60th, and I think what Justine has done will be
a great contribution to the work that Susan Canon will take on in that regard.
Now, in reaction to a few of the things that have been said this morning,
you know, on the privacy issues, and particularly this letter which is going to
become our hundredth product, I don’t think you should be too hard on
There is a group sort of — you know — up on the Hill that hasn’t really
been able to deal with this issue from the point of view of legislation now for
a number of years and sort of bounces it back to the department and to the
committee. And so, obviously, it’s a very difficult — there are a lot of
difficult issues, and, as Bill said, values, et cetera. So 15 months would
probably look good to people who’ve been trying to get legislation on the Hill
for all these years.
And maybe that’s not the best way to go with legislation either, because of
the fluidity — sort of the more flexibility allowed without that.
But we did have an interesting discussion when we talked about this issue
of length of time that it takes, and particularly with the privacy letter, as
to whether — how the members who were at the executive subcommittee meeting
felt about the need for consensus versus just allowing some minority opinions.
And, certainly, our processes do allow for minority opinions, and we have
had a few instances where there have been minority letters or minority
statements, but there seemed to be — at least in the executive subcommittee
discussion — a pretty strong feeling that they really valued the consensus,
that it makes it harder and takes longer, but they really felt that what comes
out is of greater value to the department and to the broader constituencies. So
that might be an interesting thing to hear how those who weren’t at the
executive subcommittee feel about that.
The other thing, Leslie, I think, really nabbed it with the thing about
substance versus sort of, in a sense, process or technical versus — I mean,
you could say technical versus broader or substance versus more — you know —
sort of how you do things, which is — and I have to admit that that was a
great frustration to me when — in 1996 with that change because I really
valued the work that the committee had done with the data sets and with more
substantive recommendations related to data elements, et cetera. It was helpful
in many ways. But, at the same time, I think the vision work that the committee
has done since then has been very valuable.
So I would, again, support the idea of this balanced portfolio. I think,
you know, where you’ve talked about functional status or race and ethnicity
data or some of the other areas, I think that continues. You can really make a
difference in those areas, but, clearly, as has been stated, you can’t be an
expert in everything. So I think you need to balance both.
MR. ROTHSTEIN: Yes. I wanted to pick up on something that Bill said and
also that Carol spoke to, and that is what should be the evidence base on which
our letters are written? And, in my view, I mean, we have a very sort of
unusual basis on which to support our letters. I mean, these are not IOM
reports. They’re not academic reports. They don’t rely on references. They
don’t rely on independent literature reviews. They are based on a combination
of the testimony that we have, written as well as oral, and our own personal
And so, given that, I mean, you have to keep in mind what our charge is as
a committee and what our resources are.
I mean, we don’t have a staff of full-time researchers to do the research
on the issues. So what we’re basically trying to do is to serve as a liaison
between the public, broadly defined, and the Secretary, and translating the
thoughts, concerns, opinions of a very broad range of constituents and
individuals and try, from that, based on our own expertise, to formulate some
sound policy recommendations, to the extent that we can formulate them.
But, I mean, it’s a very difficult balancing act, because, since I’ve been
on the committee, we’ve always been charged don’t go beyond the testimony to
make statements, and we’ve never had independent research analysis, so I think
— and I’m not speaking specifically about the privacy subcommittee. I’m
speaking about all the work of the committee — I think we’ve done a very good
job of that, given our limited role.
But I think sometimes, maybe internally as well as externally, people
expect too much of us, given what we have to work with.
DR. COHN: Paul.
DR. TANG: Thank you, Simon.
First, I want to thank Justine and Harry for, really, an excellent teeing
up of this discussion, because I thought both the history and somewhat the
philosophy — was very helpful to bring into the discussion.
I don’t know exactly what — whether they were posing specific questions,
but I think the two kinds of ways we’ve been working — the standing committees
and the ad-hoc committees — are very complimentary and I think are actually
both necessary to move forward.
Leslie mentioned sort of her take on the history, which was — I think what
she said was the initial point was to see how to use data.
And then we’ve been focusing more recently on how to acquire and manage
data. And I wonder if we need to go back to the future and go back to as if we
were to get data how would we make effective use to improve the health of
individuals and populations. So I wonder if that’s actually calling us to step
it up a notch.
Having said that, I think — and I think this is what Harry and Justine are
proposing — that we really need to continue to make judicious use of both of
our mechanisms, not by excluding some other ideas, but there’s certain work we
have to crank out, sort of ongoing work, and standing committees are maybe the
way to do that, and probably in particular — standard subcommittee.
But the ad-hoc committee, I think has functioned very well to deal with the
emerging issues and populate it with people with cross-cutting expertise, and,
typically, certainly this last one, we turned up the heat on the timeliness,
and I think that’s — it’s a lot of work, but it actually makes our product
come out in a more economy(ph) manner.
And possibly that may be one of the answers to some of these privacy
questions. Maybe it needs to go through an ad-hoc committee, but I think we’ve
been using both of them — we’ve certainly evolved in having two main tracks —
way to get work done, and I don’t think we should give up one or the other,
because they’re both necessary, but I think other people have said that as
But so the parting words are sort of to come back to the roots of making
sure we make effective use of the data, and that means we have to find ways to
capture it efficiently, but also effectively in the sense of preserving its
meaning, and then make sure that the aggregate value, the knowledge that comes
out of it, gets back out to the deployed folks in taking care of patients in
the front line.
That seems like a tall order, but I think that we’ve been working up to
that point, and I think we should continue in that direction.
DR. COHN: Paul, those are very useful comments.
Now, we have Larry Green and John Paul.
And then I’m going to try to wrap this up, not that we have an answer, and,
obviously, the purpose of this conversation was not to have people vote at the
end, ad hoc versus standing committees or this or that, but I think we want to
begin to get some input.
And, obviously, this will be taken by the executive subcommittee and I
think sort of further massaged. Probably we’ll see it again in May, especially
as the transition progresses in terms of thoughts about how to move forward
from here, but I’m — It’s useful, I think, that at least the executive
subcommittee framework has turned out to be somewhat helpful in terms of, I
think, really crystallizing the issues.
Now, Larry, you’re next. John Paul, you’ll have the last comment, and then
we’ll get a break.
DR. GREEN: Well, Simon, I want to build on Paul’s comments, both the thank
you he gave Harry and Justine — I share that thanks — and, then, I want to go
back to this word, data.
The way I’ve been provoked to think about this by the materials sent before
the meeting, and now that I feel like I’ve just about completed my orientation
to the committee, this committee, it seems to me, is fundamentally about data.
It’s a data committee.
Data are the granular substrate out of which grows information that’s
critical to the seasonal issues of the day.
And as I read the statutory charge of the committee — and I went back and
looked at it again — and I particularly found that 50-year history booklet
very, very helpful — it seems to me we would do well to center and anchor our
thinking about what we’re going to do and how we’re going to do it around the
issue of data and how data are moved into information that can be used for
Data have to do with classifications and ordering principles. They have to
do with vocabularies and terminologies. They have to do with standards and
conventions, and they have to do with units of analysis.
It seems to me that this committee is charged and positioned to do that
sort of work on behalf of the nation, and that that sort of work is timeless
and captured — there are nets that go by that attract data that have to do
with values and political issues.
At the moment, the establishment of the National Health Information Network
is probably the strange attractor for data from a complexity science, one of
you, and it seems to me that we would do well to organize ourselves not so much
to comport with what I would call the seasonal issues of patient centeredness,
but whatever privacy — whatever those are — those will come and go, but it
seems to me that our charge and our duty from our statutory obligation is help
the nation have the data that can be organized in information so that we know
about the health of individuals and the health of populations.
If we did that, then it seems to me we can discuss further how we
accomplish what seems to me to be the only two options we have. So far, all
I’ve seen us do is we assess things and we write letters. So it’s assess and
recommend. Assess and recommend. Assess and recommend. It seems to me that’s
our common pathway.
So I’m trying to get my arms and head around this. I think in two-by-two
tables. It’s a curse, but data go to information. Information goes to policy,
and it seems to me that my question will be is, as we think about May and what
we want to talk about, I’d like for us to answer the question is how does this
committee get itself organized to be sure that the nation has the data it needs
to develop the information it must have in order to get value out of the
healthcare system and produce a healthier population.
DR. COHN: Larry, thank you. Well said.
John Paul, I think you have the last comment here.
MR. HOUSTON: Thank you.
Being involved in the AHIC a little bit, one of the committees, it’s
interesting that their pace at generating recommendations is much, much quicker
than ours. And I think they’re probably more driven on setting deadlines and
internal expectations about how quickly things need to get done.
And there might be some value, when we start to entertain certain topics,
like the secondary-uses letter, that we put together maybe not necessarily
deadlines, per se, but expectations on when we want to have things delivered
and when things will be available for review and what the expectations are in
terms of review and when you need to get comments back, things like that, so
that we can try to maintain the pace on some of these letters, I think, that
are — that I think are dragging.
That’s the one comment I want to make, and the other comment I wanted to
make goes back to something I was thinking about before and it was where do we
troll — what waters do we troll in?
And I think one of the areas that I think might be of interest is, as
NHIN’s coming together and people are starting to adopt electronic record
systems, is does it have value for this committee to be involved in assessing
the advances or the improvements in healthcare based upon the adoption of
electronic information systems and regional, as well as, potentially, the
national system of interchange?
So — and I know we’ve talked a little bit about that before, but I don’t
— in some respect — but I think it might be a topic where this committee
maybe needs to spend more time.
DR. COHN: Marjorie wants to make a comment, and then I’m going to wrap up
and give everybody a well-deserved 10-minute break. So Marjorie.
MS. GREENBERG: Well, I don’t want to misquote Mark, but he made an
interesting observation — and it may be related to the amount of time it takes
or whatever to get some of these things done — but about how this committee
was different from other committees he had served on in that the members really
are — the members aren’t just reacting to recommendations and documents that
have been developed by staff, which I think is more the way the AHIC has
worked, and I know, certainly, a number of other groups do as well.
Do you want to — and I just thought it was an interesting observation,
because it is true that is a different way that this committee works.
MR. ROTHSTEIN: Yes, at the executive subcommittee retreat, I mentioned that
I thought the NCVHS, in its operations, was different from many of the other
federal advisory or comparable committees on which I have served, in the regard
that it really is member driven. Our agenda, the substantive output is member
driven. The role of the staff — and the staff has been great to me over many
years — is to support us, to help us. It’s not to frame the issues for us, to
tell us, “This is where we’re going. Don’t you approve?” sort of
thing, and it really is driven by the members. And that presents some other
challenges to us, but we should be aware that this is quite a different thing.
And, frankly, it’s one of the leading things that makes service on this
committee so rewarding, because we do have the opportunity to shape our agenda
and our work products, and that’s a source, personally, of frustration in other
DR. COHN: Well, as I commented, without trying to solve the issues, I’m
glad at least we did have a chance to talk about them. We’ll have the executive
subcommittee sort of reflect on this one. I think we’ll be coming back with
Obviously, as the chair, I get to make some final comments that don’t get a
rebuttal, at least immediately, but I am always fascinated — And you all have
to realize, of course, I’m an emergency physician. So time is of some meaning
to me, but I find myself in an environment where the lawyers are being
impatient and the emergency physicians actually not really terribly upset with
the time frame. So I find myself in a very unusual circumstance, one that is
almost against nature, I think.
But having said that, I do want to observe that — and, John Paul, you
actually began to touch on this a little bit — that one of the things that
we’ve tried to do over the last couple of years — and, obviously, it’s once
again that question of balancing portfolios and what we do, but we’ve tried to
— much more than ever before — make sure we have customers for the work that
And one of the things about having customers is that it does drive time
lines and urgency and everything else. And I would just reflect on it that it
— I mean, one of the ways we can handle that — because not everything is
going to immediately have a customer, but, in those cases, we need to be
diligent and self-impose time lines or other things to make sure that things
remain relevant and timely.
But, certainly, in a whole variety of other areas, we sort of look at —
you know — we need to know. We need to do this by this time and then we
develop the work plan to meet that.
So, I mean, once again, it’s just sort of an observation of how — of how
sometimes we do things differently on a committee.
DR. TANG: Can I —
DR. COHN: Oh, please, Paul. Sure.
DR. TANG: The thing is I observed that the — what was called the Secondary
Use Ad Hoc Workgroup was able to deal with very much the same substantive
issues dealing with privacy and were able to make a deadline and produce a —
and I think a good product. There must be — there’s probably something to look
at there, too.
MR. HOUSTON: We set the deadlines up front on that letter. It was very
clear what the time lines were. So it was a different model.
DR. TANG: Well, I think it was run differently, too. So, I mean, I think we
need to just look at all the things that went into making that product good and
delivered on time and see if there’s lessons to be learned there.
DR. COHN: Well, Paul, thank you, and I think you’re the final comment
before we give everybody a 10-minute break.
We will get back together at 10:35, and then we’ll start off on one of our
hopefully more successful letters, even though it’s —
PARTICIPANT: Centennial letter.
DR. COHN: Centennial letter here. OK.
Agenda Item: Privacy Letter on Sensitive Information
in the Electronic Health Record, Action February 21
DR. COHN: Okay. We’re going to get started again here.
Now, as discussed, this part of the discussion is really reviewing the
letter on individual control of sensitive health information, accessible via an
NHIN. This is Version 17-A or -C or whatever, at this point.
We’re asking Mark Rothstein and Maya Bernstein to sort of go through it
with us, not word by word, but more section by section, just to address any
changes, especially substantive changes, to the document, which, hopefully, we
can be able to do literally on the screen as we’re sort of talking about it and
see what sort of changes.
At the end of that, obviously, we’ll sort of see where we are, whether it
needs to go back to subcommittee for final adjudication, whether the changes
all have sort of come together, at which point — you know — we can choose to
act today or tomorrow or whatever.
So we will sort of hold that as a sort of a decision to be made after we’ve
looked at sort of where we are now versus the additional changes and comments
that have come in.
So, Mark, I will turn it over to you.
MR. ROTHSTEIN: Thank you, Simon.
As you know, this is the letter that we discussed at our November meeting.
It’s been substantially rewritten since that time. You all should have received
a separate document electronically dealing with our comments in response to the
discussion at our November meeting that explains to you why we did what we did.
Since the letter was circulated in your briefing books, I have received
comments from a few people, either directly or indirectly.
PARTICIPANT: (Off mike).
MR. ROTHSTEIN: Well, comments made to Maya were relayed to me or comments
made to someone else were relayed to me.
So I have comments from Larry, Simon, Paul and Justine as well as a few
other minor typos that I’ve corrected in the document, but I think everyone has
had a chance to review it on several occasions and like to see if I could go
through it with you and just point out the general thrust of the letter and
note for you the suggested revisions that have been sent in that would affect
the version that you have.
The first page, of course, just presents the background, and we have one
suggested change. It’s in the first sentence, the second line, to change the
word “defined” to “limited.”
MS. BERNSTEIN: I think we’ve changed that back and forth several times,
MR. ROTHSTEIN: Well, yes. We’ve gone back and forth on that, and the change
would make it consistent with the language that’s used on page 2. So, unless
anyone has an objection, we’ll make that one change.
Anybody have any other comments on the first section of the letter, which,
as we say, is just background. It goes through the top of page 2?
The next section is on the importance of individual control. This is the
section of the letter in which the committee makes the case for why individual
control is important. It follows up on the June 2006 letter, and also sets a
framework for what goes to follow.
I do not have — well, let’s put it this way: I have not received any
suggested changes on this section.
DR. OVERHAGE: Sorry. Marc Overhage.
As we talked briefly this morning, I have a fundamental problem with it. I
think this is the heart of my problem with the letter, and that is I don’t know
that we have yet — as we said in our 2006 letter — have a decision about
whether individuals should have this right, based on an open transparent and
public process, and this paragraph presumes that has happened.
And while, certainly, deliberations of this committee are open, public and
transparent, I don’t know that that’s a sufficient discussion about the
desirability for us to make a recommendation.
MR. ROTHSTEIN: So let me see if I understand you — and we did have this
discussion earlier — that I think it’s your view that no recommendation or
letter of this sort would be appropriate until such time as there were
developed an evidence base of either individual preference in the country among
users or some evidence base of problems without affording that. Is that fair?
DR. OVERHAGE: I think that’s fair, and I think it builds on some of the
discussion we had earlier this morning about how strong we have to be.
But we’re making recommendations in this letter that will cost hundreds of
millions of dollars to implement. And I don’t think we should do that lightly.
I think — because there are many other things that we probably can and should
be doing in our healthcare system and with our data and with privacy. And I’m
not sure this is the most important one. Matter of fact, I’m quite sure it’s
MR. ROTHSTEIN: Okay. Other comments from subcommittee members or full
So, basically, I’m just trying to see if there is some way of accommodating
— basically, your position would be that the whole letter ought to be
scrapped, because it’s premature?
DR. OVERHAGE: No, I have a more positive response — suggestion than that.
MR. ROTHSTEIN: Oh, okay.
DR. OVERHAGE: Paul might suggest that, but I have a more positive — and
that is that it seems to me that we should focus on determining the
desirability, rather than proposing a solution to a presumed problem.
MS. BERNSTEIN: Well, patients have — may I?
MR. ROTHSTEIN: Please.
MS. BERNSTEIN: Patients have many of these controls in the current system
that we have —
DR. OVERHAGE: Could you say that more slowly? Maya, sometimes you speak —
MS. BERNSTEIN: Sorry.
DR. OVERHAGE: Slow down a little.
MS. BERNSTEIN: Get more to the New Mexico and less to the New York.
Patients have the ability to sequester one way or another a lot of the
information now, under the current system on paper. It’s partly because the
system is fragmented.
But I think what you’re saying is when we go to a nationwide health
information network we will be removing basically the rights that patients have
now from them, because we are not —
DR. OVERHAGE: Disagree with that assumption.
MS. BERNSTEIN: Well, but — OK. So —
DR. OVERHAGE: We’re not changing any patient’s rights.
MS. BERNSTEIN: Well, okay. They’re not rights in law, but they’re de facto
in practice the way that the world works. And what we’re — we would be saying
— I think what you’re saying is when we go to a nationwide health information
network, it’s not clear whether we should have those same abilities or not. Is
that a better statement?
DR. OVERHAGE: I think the assertion that we built this letter on is that
HHS should assess the desirability of allowing individuals to control access to
specific content of their health records via the net.
MS. BERNSTEIN: OK. You’re reading from somewhere.
DR. OVERHAGE: Right. From Recommendation No. 6 in our June 2006 letter.
MS. BERNSTEIN: OK. Where are you reading?
DR. OVERHAGE: Hasn’t been done, as far as I know. And I don’t — I would
assert we haven’t yet done that in this committee.
MR. ROTHSTEIN: I think it’s the view of the subcommittee that HHS not
having done that, we — and this is why we took up this letter, frankly — we
felt that it was important to get a policy recommendation out on sensitive
information, because the failure to recommend anything would, in effect, be the
default position of recommending no action.
In other words, as we have talked many times in the past, the private
sector and the developers of electronic health records and networks are moving
ahead at a very rapid pace. And if we do not take the position that there
should be sensitive information controls built into the system, then we — and
waiting until there’s an evidence base, it seems that we are, in effect, saying
let’s go ahead, and if there’s a problem, then we’ll step in and try to do
something about it.
And so that, I think, is — that’s not an answer to your question on the
merits. That’s an attempt to answer why the subcommittee felt that it was
appropriate to take up this issue as a follow up to our June 2006 letter in the
absence of HHS doing something. OK?
MS. BERNSTEIN: Well, and I think the other reason is that — which is what
Mark raises — is the cost of it, that if you work changes into the system as
we’re developing it, they’re much, much less expensive than if you try to
retrofit a system into it later.
MR. ROTHSTEIN: OK. Leslie had her hand up and then Larry.
DR. FRANCIS: Yes, I mean, we’re not going to have the evidence base about a
system before the system is implemented, right?
DR. OVERHAGE: I don’t think we need an evidence-based system. We need an
evidence base about desirability.
DR. FRANCIS: Well, what — I mean, what we’re saying, I think — As I read
this letter, what we’re saying is, right now, we’re in a situation in which
there are clear benefits of sharing information, and there are potential risks,
and so — but things are going along so quickly that if we just let them go
along and essentially not paying attention to a particular risk, we are in a
situation in which that risk goes unexplored, may materialize at a point at
which it is enormously expensive, then, to go back and revamp the system.
And so I don’t — I mean, I don’t know how to deal with that conundrum
other than to say that, as I read this letter, what we’re doing is we’re asking
that NHIN design to take these issues into account at the get-go.
Now, it may turn out that part of what the NHIN design would do is get some
much more — you know, get some evidence.
I mean, part of what — you know, we, as a committee, don’t have the
ability to do that kind of research, but I think part of what ought to be on
the table is getting more evidence about what the privacy attitudes of people
would be and what would be the most sensitive.
I mean, we’re not writing in stone a particular set of categories of
sensitive information, but unless that’s on the table, we don’t have anything.
MR. ROTHSTEIN: I’ve got Larry and then Simon. Oh, Jeff. I’m sorry, Jeff.
MR. BLAIR: Thank you.
MR. ROTHSTEIN: Jeff, then Simon. Sorry, Jeff. So Larry, then Jeff.
DR. GREEN: I think Mark makes two good points. One is the context of the
letter and the other is the ignoring of any financial implications of the
And I’m wondering if Leslie didn’t basically just speak, but would address
both of those if it were incorporated up front.
My simplistic notion of this is the letter recommends that a design feature
of the national — information network be — the option for individuals to
sequester by category personal health information, and that the reason this
letter is coming when it does is because Recommendation No. 6 from the 2006
letter has not progressed. But the NHIN is progressing and we have this sense
of urgency that this design feature needs to have attention called to it now.
And then, perhaps, there’s some way in the recommendations to say all those
recommendations — about study this, research that, evaluate the other,
evaluating the need and operational characteristics of this could be
I’m looking for a way forward that does not ignore Marc’s concern.
MR. BLAIR: Number one, I wanted to start off by once again saying how
beautifully written this was. It’s so complex and so sensitive, yet, it’s
something where it could be read and understood, and that’s not a minor
achievement. So I don’t care how many versions of it you might have gone
through, I think that is worthy of mention.
The other piece is I have been a little bit torn between some of Marc’s
concerns and those of privacy advocates. With the experience that we’ve had in
New Mexico, there’s legislation that we were part of crafting to try to see if
we could come to accommodation in terms of legislation that would protect the
privacy of individuals when their healthcare information is in electronic form
and the NHIN and HIEs. And it has sensitized me to the tremendous concerns that
significant portions of our population have about protecting their privacy of
their health information.
So I — on the one hand, I think that the basic proposal of this letter I
On the other hand, I’d like us to recognize two of the points. I think that
Marc really made two points, because when I was reading through this, an
individual I just happen to work with was reading this, and while it was my
view in reading this that we were moving forward and doing things to protect
rights, there are individuals who automatically assume that these rights
already exist and they don’t know that they don’t.
And I think it would help us, number one, to point out that these — a
number of the elements that are proposed here don’t exist in federal statute as
rights today. I think we should clearly say that.
And the second thing is that we are proposing policy here. We’re proposing
And then the third thing is that we’re making a proposal that is a major
step forward and neither the technology nor the finances for this have been
fully explored yet and that we’re recommending that that be done.
So I would like to see all of those elements in there. I think that that
would help us to maybe broaden the acceptance of both the folks that have
extreme concerns about privacy, on the one hand, and I think it would also
maybe address the very valid concerns that the finances and technologies of
this proposal haven’t been examined yet.
DR. COHN: I’ll be speaking as actually a member of the subcommittee, as
opposed to necessarily my role as chair.
I did, obviously, want to just reference to Jeff that, at least from my
view, the research, development and implementation section, which is at the
end, really is meant to sort of recognize that, I think, the view of this
letter is it is intended to be more directional, rather than saying doing this
tomorrow, because I think there’s a recognition that technologies and whatever
really don’t exist well to do all this in the current world. And, therefore,
we’re saying this is a promising direction that needs to occur, but unless we
start now with research, development and otherwise, we’re not going to be able
to be implementing this. And if we don’t architect it in, it’s — there’s not
going to be an opportunity.
So, I mean, it doesn’t explicitly mention finances, but I think it’s — the
view is is that HHS investment needs to occur.
Now, I actually wanted, however, to go back to — I’m hearing from Marc a
very fundamental question, and I just want to — and we’re been sort of talking
around it. And I’m just trying to figure out whether — I’m not hearing
wordsmithing recommendations to deal with concerns. What I’m hearing is a very
fundamental question — and maybe I’m mistaken about this one — which says,
“Geez, you don’t believe that at the basis that NCVHS, through its
process, assess the desirability of — this going forward.”
And I guess — and I think that’s what I’m hearing you say, and I guess I’d
have to look to the subcommittee to recommend — Normally, in the subcommittee
processes, part of the hearings are to assess the desirability.
Now, I think what I’m hearing you is saying — and I’m just not sure where
— I mean, is your view that the NCVHS process was not sufficient to assess the
desirability or that more needs to be done or someone else needs to do it? Just
so that I can understand a little better.
DR. OVERHAGE: I think that I wanted us to ask ourselves the question: Have
we — because we’re making use of this was directional, and, yet, when I look
at the recommendations, they are far beyond directional and are rather
When a healthcare provider accesses health information with one or more
categories sequestered, a notation will appear. I mean, that’s a very explicit
policy recommendation not directional in any sense, I don’t think. And I think
you could make similar points about many of the others.
I would challenge — at least for me, I am challenged to stand up and say,
“We have determined desirability based on what I have seen,” and
that’s partly a process question.
I understand we have limitations on our resources, but, then, we shouldn’t
make recommendations beyond our ability to do it appropriately. You know,
making a decision based on poor information is never a good idea.
Second, I think that if we, indeed, are trying to address the question, we
think we have thought through desirability and we can come back to this, but
the next section is entirely missing, which is what are the costs and risks to
the individual and society of autonomous choice and the individual’s limited
ability to limit access? And what are the implications of educating an
And if something like this were going to go forward, I would really
strongly like to see the individual have to be, much as you might do with an
abortion decision or something, the individual counseled with written decisions
about the implications of this decision for them, because the thing is they
have no idea what they are deciding about.
For example, if they choose to sequester their reproductive health
information — and that includes birth control pills — they may well get
pregnant, because they’re going to come in and see a doctor, think there’s
absolutely no relevance, and they’re going to get an antibiotic that inhibits
it, and that’s going to happen.
And you can’t — that is a very long, deep discussion to have on each of
these topics that are proposed.
So I think that we have not adequately, my view, in the letter — and I’m
not sure we have in our discussions — addressed the implications and cost to
the individual, to healthcare providers and to our healthcare system. Nor have
we asked the question: Is this so important as to be worthy of the Secretary’s
attention and the cost associated?
MR. ROTHSTEIN: May I use the prerogative of the chair just to explain the
This letter really does follow on the hearings that we held before our June
2006 letter. We held five hearings across the country in which we heard from
literally dozens of individuals and groups representing all the major medical
societies, all the other major providers of healthcare. We heard from the
nurses. We heard from chiropractors and et cetera, et cetera. We heard from
patient groups. We heard from all sorts of people around the country.
At that time, we did not have as directive, if you will, a recommendation
in our 2006 letter. So our discussion on this letter and our recommendation is
much more granular and more assertive, if you will, than the 2006 letter.
For this letter, when we were contemplating deciding whether to recommend
additional steps for sensitive information, we did have a hearing in April of
2007 in which we invited to present before the committee representatives of
organizations and providers who deal with sensitive information, the
mental-health and substance-abuse community, ACOG, et cetera.
And it was on the basis of their testimony and the individual testimony as
well as the older — earlier testimony that we reached our conclusion that this
was an appropriate topic to do.
So I just wanted to just deal with a process issue before the substance.
So can I — you’ll get another chance. I just want to make sure everybody
gets heard. We have Carol, Steve and then Harry.
MS. MC CALL: OK. It seems to me that, Simon, you captured what started out
to be the question, and I believe the question was originally whether or not to
accept the premise that individual control is important and that you were
suggesting that we put a question mark at the end of that, as opposed to a
statement. And, honestly, that’s not something that I could support.
I agree this is policy. There are a lot of places where we talk later about
things to be determined, technology not necessarily ready.
But I believe that this isn’t about money. This is about the why, not the
how. And what I believe is happening is this: There’s very specific testimony
around privacy, and in a world of ambient informatics, where information flows,
unless you stop it — unlike today in a fractured system where it does not flow
unless you push it, and I mean push it hard, and, even then, it doesn’t — to
maintain privacy, which is understood in all hearings that we have to be of
paramount importance, one must design in specific control.
And as a policy decision, I think it’s also right to call out, Jeff, as you
pointed out, that this is not in law today, but it is an idea whose time has
come. And if there were anything to be added, it would be that, and because
that becomes a policy issue of paramount importance that this is unprecedented
stuff in a world of ambient informatics.
So I do believe that we have established it. I think we hear about it all
the time. I think that you have captured it here when you talk about other
countries, when you talk about the testimony you specifically call out and you
quote people by name.
And so I believe that we have established this as a statement, that it is
important, and I think that — so I would recommend that we keep that in there
and add whatever we must in order to enhance some of the things that Jeff had
DR. STEINDEL: I’d like to comment just from a — basically what happened
this weekend at another meeting I was at.
In 2006, when we made the statements that we made in R-6 and R-7, it was
actually somewhat of a far-reaching statement. It was the summary of a lot of
views that we had heard over the years, testimony presented to NCVHS, our own
knowledge from other sources and a condensation that people wanted control of
the individual electronic records, and we didn’t state there really what the
control was. It’s just that we wanted control.
In this letter, we’re being a little bit more specific. We’re saying,
“OK. We said there we wanted control. These are some areas that we have
found that are sensitive issues that people have raised. These are the
recommendations we’re making on how to control it,” and, as Mark points
out, we’re specific in some of those recommendations.
And then we go on at the end and we say, “We don’t realize the real
impact of these recommendations. So we want you to go out, install them, start
them and investigate them.” That’s from an NCVHS point of view.
But since 2006, the world has evolved. ONC is now making these same
statements that we made in 2006. They’re saying that we should have some level
of individual control over the records. They are charging the NHIN cooperative
in some of its studies to actually implement individual control and start to
show the impact of that. It doesn’t reach as far as this letter, or it may. It
depends on what they design. But ONC is starting to look in this area. So this
has been accepted, you know, from a department level.
And what I want to point to, just from this weekend point of view, I just
happened to go out to an American College of Medical Informatics annual
symposium, which is kind of a high level discussion session, and there were
questions and comments and discussions raised by that group on the very topics
that we are raising in this letter, and nothing to point to as to references to
say, “OK. What does some authoritative body or what’s the groups that have
looked at it?” So this, first of all, will put a stake in the sand.
And, then, we had an interesting discussion on forming some recommendations
for the meeting, when I was actually sitting next to Rob Kolodner, and Rob was
actually saying, “This should be the most important thing that we talk
about,” you know, the very topics here about individual control.
And, surprisingly enough, I actually said, “No, I don’t think this is
the most important thing that ACME should be talking about,” and I was
very specific. I said, “This is because of the nature of the group that
we’re in. You know, if I was in another group, I would feel identical to what
you’re saying. It’s just I feel ACME has another place to put stakes in the
sand.” But it was very interesting that Rob took these positions.
So I really think that this letter needs to go forward. It needs to go
forward from the point of view that NCVHS has a very good job of doing and
that’s putting something out there that the public can discuss.
Our role, obviously, is to recommend to the Secretary, but we have to
realize there’s a secondary nature of our letters. They come out there and they
serve as a focal point for moving public discussion forward.
MR. REYNOLDS: Going back through some of the slides we had this morning and
thinking about value, this is — we’re in a value discussion right here.
But cost also has — part of the value of cost is timing and where does it
get — does it get in the front of the process or does it get in the — halfway
through the process or does it get after the process?
Having sat through every one of these hearings, when we did the 2006 letter
and so on, and not being a privacy lawyer and not being a doctor, I have had
the opportunity to be comfortable that we have debated emotionally,
passionately, structurally. We have had people that came in that took us far
further afield than this and people that wanted to do nothing.
The NHIN is still a ghost. It’s a philosophy. It’s still a ghost. But, for
example, health information exchanges have already failed in the United States,
and where’s that data and what is that data and how is that data and so on? So
there are things that have gone on that are electronic.
So as we — and having just come off our stint of uses of data, that ought
to scare — I mean, that got all of our attention significantly.
And, again, this letter looks like a small subset, but it’s really part of
a journey. And I’m telling you, it’s been a long one and it’s been a tough one
and it’s been one where no voice has been withheld and no — and meetings have
been very visible and the discussions have been visible. And it’s probably been
as contentious a subject in the four years that I’ve been on the committee,
because of the fact of the values, and the values really come in. And we have
had to adjudicate those values, and, many times, each of us have had to step
back and be very independent in looking at this. You know, you can debate each
side. You can debate each value. We did.
Our process is imprecise, as we discussed it. We don’t have endless staff.
We don’t have endless time. We did do it in a public forum. We did allow for —
We did receive in one case, 1,100 emails about it, which would mean that maybe
people think it should go stronger than this. So we have had more than enough
visibility to do this.
The other thing is, as we’ve heard about the impreciseness of
opt-in/opt-out, and any of us around the table who have read any of the
documents that are out from lesser esteemed environments than maybe, Mark, you
or others, some of those documents do not give the person any idea where their
data is or what it is or what it means. And I have personally had an
opportunity to challenge a few.
And so I think what we are saying is we think of emerging issues. Everybody
— I don’t think — the NHIN is not here yet. It is an emerging issue. It is an
emerging issue, and the issues may be a capital loss, because we just don’t
know what it looks like.
I could vote dramatically differently if somebody told me what the NHIN
was. If they told me exactly how it was going to work and what it would look
like and where it would reside and who would own it and who would drive the
data and where did this connect and where did that connect and what did it do,
then I may recommend different things.
We had an interesting statement made at the executive subcommittee, where
somebody made the statement that they had spoken to the person — one of the
key executives at Visa and said that they used opt-in for use of credit cards
over the internet and look how many people, and everybody — We said, “How
many people in the room would use a credit card over the internet?” And it
was pretty much most of us. OK. We had the opt-in. And so the point is but the
industry right now is running towards opt-out in a lot of cases.
And so all we’re trying to say here is if there’s not some stake in the
ground to say, “Your attention, please. This is an issue” —
And as an implementer, cost is foremost in my thinking. And so I’ve heard
enough all the way around, sitting there a little more — maybe a little more
independently than somebody who had a dog in the fight on this particular one.
I’m proud of what this committee has done. I’m proud of what Mark has led
us through in difficult times. I think we’ve been very open.
If you give me two more pieces of data, I’ll change the letter. If you give
me — if you tell me a month from now exactly what it’s going to look like, I
might recommend changing the letter. But we are dealing with such an imprecise
discussion right now, and nobody is taking up the stance that the person —
that there are individual — We heard enough of them. There are individuals who
truly worry about their data and how it would be used and secondary — other
uses, reminded us of that over and over again. Just the difference between
quality and research and just some of the things that are still on the table,
So I’m not — this is not — it’s not a lecture or — I’m telling you, we
have sat through this and through this and through this, and we could sit
through it for another year. All we’d know is more about where it is, then, and
we might change it. But, right now, this sets a tone. This is a little bit
like, “Your attention, please.” This isn’t going away. “Your
Tell me everybody’s going to opt-in and maybe I’ll pull most of this out,
because maybe people won’t want to get in, because they would understand what
it was. That’s all I’m saying.
I’m not saying right or wrong, but — So that would be why I am in support
of this, even though I could equally go through and if you gave me two more
pieces of data take pieces of it apart one at a time. But that’s not where we
are, and it’s imprecise, and some people are good at the NHIN and good at HIEs
and good at — and others aren’t. And others don’t even know what it is yet.
So thank you.
DR. STEINDEL: Harry, if I could comment very quickly. The person who made
that opt-in comment at the executive subcommittee meeting was Rob Kolodner.
MR. HOUSTON: Yes, to expand on both Steve and what Harry said, the first
thing is is that just having participated in an AHIC confidentiality, privacy
and security workgroup meeting, this topic did come up, and I counseled that
group that, “Hey, we’re getting done with this letter. You don’t need to
investigate it yourself.”
And there was a lot of interest in what’s the timing on this, because it is
clearly a matter of great interest for that group as they were planning on what
they wanted to do next. So I think this is extremely timely, based upon what
they think is important.
Secondly, I think some of the things we heard regarding cost and the
financial issues and the like related to this type of recommendation was almost
— this is such a fundamental component that is necessary for the NHIN to even
succeed that the cost associated with this may almost be a secondary issue in
some people’s minds.
“If you don’t have this, I don’t know how we can support you having an
NHIN.” I’ve heard that from a lot of privacy advocates. “You don’t
give me this capability, I don’t want to participate, and I’ll do everything I
can to stop it.” I’ve heard that, and there’s very clearly a sentiment in
that regard out there. So I think it is absolutely important that we make these
types of recommendations.
MR. ROTHSTEIN: Thank you, John.
I have Larry and Leslie on the list, but I just want to pick up one thing
that you said. I was at a meeting a week ago of the National Governors
Association and their task force dealing with electronic health records, and
specifically privacy issues, and they are just getting around to take up the
issue of sensitive information. So it’s an area that is of great interest, and
somebody’s got to tackle this, whether it’s us — If it’s not us, it’s going to
be somebody else.
We’ve got Larry and then Leslie on my list.
DR. GREEN: Mark, I have a question basically for you.
I’ve heard Leslie and then Carol and Jeff and Harry and now John provide
quite articulate and cogent context for this letter. And I’m wondering what
your opinion is about adding a — something akin to a preamble paragraph or an
introductory paragraph that incorporates the scope that I’ve just heard here in
The conversation that’s gone on in the last 20 minutes positions this
letter into the national dialogue in 2008 when it’s being rendered. I’m
wondering what your opinion is about the possibilities of adding such a
MR. ROTHSTEIN: I think certainly it’s doable.
The question that I have is a very practical one. This is draft number 17,
and it’s taken a long time to get here. The letter is not perfect. It’s not —
it doesn’t represent 100 percent of the views of any of the subcommittee
members, I’m sure.
And I’m afraid that if we decided, as a committee of the whole, to direct
the subcommittee to come up with new language that does various things, some of
which, I think, were very good suggestions — Now, I don’t know whether we can
do this and still get an approval at this meeting, and it would be very
unfortunate if we had to bump the letter back to May. So that’s a practical —
DR. GREEN: Well, I’d like to register support for moving the letter at this
My own view is that I would hope that you and the subcommittee might be
able to write a three- or four-sentence paragraph that we could look at and
that it would be our intention for it to not be perfect, but for it to be good
DR. FRANCIS: Larry, where we tried to capture that is actually, I think,
the second sentence of the letter, the critical considerations, both, on the
one hand, protecting concerns about privacy and confidentiality, and, on the
other, encouraging participation in an evolving NHIN to improve patient care
and so on.
And those are the concerns that are on everybody’s mind as the discussions
go on at, for example, National Governors meetings and so on. So that’s where
we try to do that.
I wanted to say to Marc that — I mean, obviously questions like what
informed consent would look like, those are all really important questions, but
I don’t know how you answer them, at this point, until you get the design
questions out on the table. And what this letter is doing is saying get the
design questions out on the table.
I mean, we don’t want to blow by those issues. I mean, I think an important
question about the quality of patient care would be some of those kinds of
But if they don’t — if this doesn’t get to first base, your questions are
like third base, it seems to me. We won’t get there. And my worry is that
unless we get a letter like this getting us to first base, many of the
advantages of electronic records are actually going to be lost, because, you
know, people were talking about the opt-in strategy about credit cards. There
are a lot of people who don’t buy things, say, off of eBay for exactly all
those little email messages that you get about your Pay Pal account and what it
MR. ROTHSTEIN: Thank you.
Simon, then Marc and Marjorie.
DR. COHN: Yes, I’m going to trade spaces with Marjorie and let her go —
MS. GREENBERG: Gee, thanks.
MR. ROTHSTEIN: Because he wants to rebut whatever it is you say.
MS. GREENBERG: Probably. Probably.
OK. I think this has been a good discussion.
My bottom line is what Marc — I think he underestimated the risk of
deferring this to May, because you have to realize that we may actually have
new committee members in May. We could have as many as seven. Nomination
package is going through the process now, but we have put the meeting back to
May just because we know that seven members’ terms end June 1st, and
with no wiggle room. And so in case we don’t have those new members by then, at
least we knew we could have a meeting.
But you cannot leave this to a bunch of new members. I mean, you’re just
starting then. That would be ridiculous. I mean, you can’t have the majority —
almost the majority be all new members. I mean, it wouldn’t be fair and you
couldn’t expect them to deal with this. So I would say it is now or if not
never, now or not for another few years.
I’m not trying to be an alarmist. I mean, I think that is just really
realistic. The timing of those members being named is completely in the hands
of the Secretary.
But, frankly, as we put — I mean, it’s only responsible for us to be
putting through a nomination package and our hope would be act on it sooner
rather than later.
So I think it’s now or never. I mean, if not now, never — not never — you
know, take another few years.
Last, at the November meeting, many of these issues came up and the
committee and the subcommittee had quite a lot of discussion. And the bottom
line was that the committee told the subcommittee to go forward with this. The
possibility of just ending it, you know, pulling it off the table was there,
but the decision, at that time, was made, no, the committee — subcommittee —
this is not a letter that should be withdrawn. It is one that needs some work.
There’s been — I can tell you because I’ve sat in on most of the
conference calls — it has been an enormous amount of work, not just
wordsmithing, but really thoughtful discussion that has gone on in the past
several months, which has been open to any of the members if they wanted to
participate. And I think there’s been quite a lot of — there was give and take
and quite a lot of good discussion that went on. And that was — the committee
was — the subcommittee was encouraged to do that.
There is a document from the subcommittee that describes how every single
comment — We’ve never seen this in my history of working with the committee,
which you know has been 60 years. I started I was just a little older than my
grandson, but, in any event, I’ve never seen this where every single comment
made by the committee has been, if not rebutted, at least responded to in some
So having said all that, I guess you can see where I’m going, but I do
think there are a few things that maybe could be added, if they could be added
without — but I can tell you that every word that is changed has taken a lot
of time to agree to. So just like writing three or four sentences, you have to
have participated in this process, Larry, to know that is not as easy as it may
But I don’t see anything here in the letter that actually says — it refers
to the one hearing — but says what often we do say is that there have been
like 15 months of deliberation. I don’t think that’s said anywhere, and I think
that kind of would emphasize — That’s just a factual piece of information, but
it would emphasize that there really has been a lot of thoughtful deliberation,
not just this one hearing on April 17th.
MS. BERNSTEIN: I thought I’d just leave the caption at the top that says,
“Draft 17 — “
MS. GREENBERG: The other thing is I do think there are quite a few escape
valves in here, even though some of the recommendations are quite specific,
because all the calling for pilots and for research and for assessment of, you
know, the impact, I think is certainly an escape valve for someone who feels
that they’re not ready to embrace everything that is suggested here.
You might want to, in Recommendation 5, add the issue of costs, because it
only refers to liability and human factors, and I think costs — you know —
could be added there. Probably everyone would agree to that.
And there is — As I mentioned in our previous discussion before the break,
there is always the possibility for any member who feels so strongly about not
wanting to sign on to this to do a minority letter or of course to abstain or
to vote against it, but, also, then, to document why he or she did that. And I
think despite the committee’s desire always to have a consensus, that is always
an option. So that’s what I wanted to say.
MR. ROTHSTEIN: Thank you.
We’ll go to Marc, and, then, Simon will have the last word. Then we’ll try
to wrap —
DR. OVERHAGE: And I guess what I’d like to say, rather than trying to go
through and address issues like Steve’s comment that ONC supports this one —
In fact, ONC’s recommendations that came out of the prototypes explicitly
restrict their comments about patient control to PHRs, for example. They may
talk about a lot of things, but their documents do not reflect that.
So there’s a lot of specific things I could cover here, but I guess the
thing I’m struggling with, and I’m still not comfortable, and I’ll shut up and
go on, is that I heard Simon describe this as directional. I heard people talk
about raising this as an area of great interest, which I agree it is. I think
it is of great importance to get a recommendation out.
I just feel like we’ve gone way too far in specificity of a set of actions
that we can’t — I think it’s very hard to support.
MR. ROTHSTEIN: Well, let me just say what our overall approach was that we
tried to have in this letter and that was we are making, I think, a statement
about the importance of individual control of sensitive information and saying
there are lots of ways to do it. We think the most promising way is
sequestration and to — I think that’s the — sort of the minimum level of
directiveness, because we didn’t say which of those we preferred. That wouldn’t
really advance the ball very much.
So we’re saying that this is the option that we prefer for the following
reasons. We recognize that there are all these issues. We don’t recommend
categories. We say you need to decide on categories. You have to decide on
inclusion, exclusion criteria. You have to have pilot programs to see if it
would work and so on. And it may affect the physician-patient relationship and
we need to be cognizant of that. And it may affect liability and you need to be
understanding of that and so on and so forth.
I think to do less would really not be of value. If we didn’t select one of
the methods of limiting disclosure or giving individuals the right to do that,
I think it really wouldn’t be a valuable letter, and we tried not to go any
farther than we did in terms of recognizing all the things that it would
And you remember November we had the discussion of, well, what about
break-the-glass features and all that sort of stuff.
So we put a minimum amount of things that had to be in there because we
wanted to display the fact that we do appreciate these issues. We raised the
issue of clinical decision support, but are non-prescriptive at all in terms of
clinical decision support. We say this is an issue that needs to be studied.
On the notice, we couldn’t agree in the subcommittee about what the notice
should say, whether it should identify the categories that were sequestered or
just a general notice. So we said, “Well, you probably ought to be
notified as a provider, but we’re not saying what, when or how.”
So it’s a philosophy and I think it’s balanced. We certainly worked very
hard to do that.
DR. COHN: OK. Well, in the interest of subcommittee time and process, I
actually want to sort of move beyond this particular conversation.
I think this has been very valuable — begins to get everybody’s views,
values, opinions out on the table.
I do have to agree with Marjorie that — I mean, even though I think we
strive towards consensus, that isn’t in our charter. It isn’t absolutely
required. And, certainly, at the end of the day, there may be honest
differences of opinions, there may be needs for certain people to either
abstain or actually vote no. And I think we have to confront that after we’ve
reviewed the letter and had a chance to reflect on it.
Certainly, Marc, just — and I’m very respectful of your views on all this
stuff — if, as we — you know, I would just observe that the comments, at this
point, are a high enough level that it’s sort of hard to know necessarily what
to do with some of them in terms of the context of the letter.
So it may be that as we move from section to section there may be places by
changing a word, changing the strength of a recommendation that you may want to
propose that might be something that you want to bring up for the full
committee to discuss, and I think that’s a very appropriate role the full
committee and full committee members to do.
I obviously — you know, the issues you’ve brought up are much more
fundamental than the issues of a paragraph or whatever. It gets to be really at
that level of do you actually support even a letter going out, and, once again,
you know, committee members can certainly decide to vote no. The letter could
actually go down because a majority decides not to support it.
So I think — having said that, I think we — we’ve heard a couple of
things. I’m hearing, for example, other suggestions for wordsmithing. I think
whatever it is we pass — assuming we do pass something — could certainly be
further wordsmithed by the executive subcommittee, including, if we can’t get a
couple of sentences at the beginning that are appropriately strategic, you
know, that could be something that is done if the executive subcommittee —
actually, the privacy subcommittee doesn’t have a whole lot of time to do that.
But, with that, I’m going to suggest, Mark, that we move on into some of
the other areas, assuming that everybody’s comfortable with that as a process
Marc, are you OK? OK. And thank you for bringing up the issues.
MR. ROTHSTEIN: So thank you all for your comments. It reminded me of one of
our conference calls.
So let’s move to the next section, which begins on the middle of page 3 and
continues through to basically the — well, we’ll stop at the end of page 4.
This is our discussion of why it is that we are recommending sequestering,
what the advantages are, what the disadvantages are, what some concerns are.
And this was a section that, according to my records, I did not have any
specific comments on.
OK. No one has any additional comments.
The last part of that section is on page 5, where we have the example
categories, and we just need to do a couple of minor things.
One is there’s a typo in the mental-health information. Second line should
be “diagnoses of mental illness or therapies.”
The major thing that we might want to consider is, in the paragraph after
substance abuse, where we talk about liability issues, and Justine called to my
attention the fact that — well, do you want to make your point, and then I’ll
say what we’re going to try to do?
DR. CARR: So in that last paragraph we talk about legitimate concerns
raised about how sequestering categories of health information would affect
medical malpractice liability.
And it says, “Liability could potentially be affected in at least
three ways.” The sequestration of critical information might do the
following: One, cause providers to give less than optimal advice or treatment.
We understand that.
The second sentence says, “On the other hand, without sequestration or
other limits on the scope of health records, the potential for liability could
increase because a provider might be held responsible to know and take into
account every detail of a patient’s health history” via NHIN. And I think
they are two separate issues.
Whether you sequester today’s — you know — special category is separate
from whether, with the NHIN, you are accountable for reading every note in the
history. And, actually, that’s true with paper records anyway. I don’t know
that we ever resolved that.
So it just — I think we just need to separate out that limits on the scope
of health records is an issue unto itself, and sequestration of a particular
episode, whether it be today or 10 years ago, is what the focus of this letter
is. So I just felt that that was inappropriate.
MR. ROTHSTEIN: So let me see if I can respond to that. I think Justine is
right that this paragraph is not parallel, and rather than hashing out in the
full committee the wording of how to correct that problem, what I would suggest
is that — actually, I drafted new language to take your concerns into account.
What I would suggest is that we can take that — either take that up with
the subcommittee this afternoon or if you need a vote — We gonna vote
DR. COHN: Well, probably, I think.
MR. ROTHSTEIN: OK. So if there’s no objection, we will try to make that
fix-it that Justine suggested.
DR. SCANLON: My fix is to drop the sentence.
PARTICIPANT: Yes —
DR. COHN: Yes, I was going to say that’s my —
MR. ROTHSTEIN: So which sentence are you talking about?
DR. SCANLON: “On the other hand, without sequestration — “
DR. COHN: Yes.
PARTICIPANT: Yes —
DR. COHN: Yes, I think that’s a very simple fix.
DR. SCANLON: This involves issues of liability and sort of practice that
goes way beyond sort of what we’re talking about here.
DR. COHN: Yes.
PARTICIPANT: I agree.
DR. COHN: Yes.
DR. SCANLON: So I think we need to be there.
DR. COHN: Bill, interestingly, that was my comment to Mark also that if we
just get rid of that sentence it doesn’t hurt anything.
DR. FRANCIS: Just change it to say, “Liability could potentially be
affected in several ways. The sequestration liability might also be implicated
as a result of violations of confidentiality,” and drop the middle
sentence. Because that’s a general question about the NHIN.
MR. ROTHSTEIN: I spent a half an hour working on this paragraph.
DR. OVERHAGE: Mark, two thoughts about the example categories.
One is I would suggest that we drop signs and symptoms from the
mental-health example. I think it sets a very risky precedent, because it’s
impossible to distinguish signs and symptoms and attribute them appropriately
to the condition. So it implies a level of ability to distinguish things that
simply doesn’t exist.
MR. ROTHSTEIN: So — excuse me — so your suggestion would be that it read,
“about diagnoses of mental illness or therapies.” Is that correct?
DR. OVERHAGE: Yes.
DR. COHN: Did we come to a conclusion about that other paragraph? I think
DR. OVERHAGE: Oh, I’m sorry. I’m sorry. I apologize —
MR. ROTHSTEIN: So the suggestion is, on page 5, under “Mental health
information,” that it should now read, “This category might include
information about diagnoses of mental illness or therapies.” OK?
PARTICIPANT: Therapies to treat mental —
MR. ROTHSTEIN: Therapies to treat mental illness or treatment —
PARTICIPANT: Or treatment.
MR. ROTHSTEIN: Diagnoses of mental illness or treatment?
PARTICIPANT: Therapies is —
MR. ROTHSTEIN: Therapies is preferred? OK.
DR. OVERHAGE: And that really relates to the second — which is there were
edits made to the last paragraph on the end of page 4 to address the specific
issue about information that sort of spills over, medications being a good
MS. BERNSTEIN: Where are you, Marc?
DR. OVERHAGE: I am under Example Categories and the subcommittees responses
to the comments you suggested — you changed some of the wording to say give
due consideration to existing state and federal laws.
I would like to strengthen that a little bit by adding into the examples
and explicitly saying that information such as medications and diagnoses are
not in these categories.
PARTICIPANT: I don’t understand.
MR. ROTHSTEIN: I’m sorry, could you tell us exactly where you are?
DR. OVERHAGE: Sure. I am — well, it’s a suggestion for an additional
addition under Example Categories to include counter examples.
MS. BERNSTEIN: Where would you put that?
DR. OVERHAGE: I would put it after “Substance abuse” would be my
But the reason I think that’s so important is that — the wording is very
tough, because “Mental health information,” we say, “and
therapies.” Well, what are the therapies? Well, many of them are
medications, you know. Yet, we sort of — we’re talking out of both sides of
In one case, we’re saying the example is exclude medications, but then
we’re saying, but we’re not going to exclude medications or implying that. And
I don’t think we go far enough in implying that in the last paragraph of page 4
in response to the comments from last meeting.
MR. ROTHSTEIN: First of all, does everyone understand what Marc is
(A chorus of no’s).
PARTICIPANT: Where does it say to exclude medications?
DR. OVERHAGE: It does not say that now. I think it must.
DR. STEINDEL: And I think that’s impossible.
MS. BERNSTEIN: I think — yes, in addition to — He’s talking about this —
if I could highlight it here on the screen. I’ll read it. It’s — there’s a
sentence above the list of categories that says that the process of developing
the list “must be open and transparent and give due consideration to
existing state and federal laws, as well as professional and accreditation
And I think — if I remember the conversation at the last meeting, Justine
raised the issue of what the joint commission has been doing, and if I remember
Justine right, you raised the issue of the fact that they want to — at the end
of each encounter —
DR. CARR: They are, not they want to. This is today, every EHR has a
medication reconciliation tab and every provider must enter every medicine
every time from all categories. So, I mean, that’s — I still have that.
I noticed that you’ve mentioned it under clinical decision support on —
MS. BERNSTEIN: So it’s —
DR. CARR: — make reference to how that would work, but, as of today, this
is kind of an irreconcilable issue.
DR. OVERHAGE: It is. And I think that’s why it’s so important to explicitly
say, because the casual reader reading this kind of says, “Oh, mental
health — OK.” You know, but you can’t.
MS. BERNSTEIN(?): It doesn’t say drugs, though, right?
DR. STEINDEL: Marc, I think there’s a specific statement in this section
that says, “These are examples,” and then there follows a very
specific statement that the actual details of what would be sequestered needs
to be worked out because it’s a very touchy subject.
And because of what’s just been raised with regard to medications, which I
totally agree with. It’s an extremely complex subject, in a letter like this,
we cannot make a statement one way or the other about it. It needs to be
handled at a much more detailed level by other groups.
DR. OVERHAGE: Then I’m okay with that, but then let’s take the explicit
example out that is here.
MR. ROTHSTEIN: What explicit example are you talking about?
DR. STEINDEL: — example?
DR. OVERHAGE: “Or therapies.”
DR. STEINDEL: Therapies can be anything. We have another in reproductive
health where we’re talking about sexually-transmitted diseases which is treated
DR. OVERHAGE: But therapies, how many therapies do we have? We have
surgeries. We have drugs. We have psychotherapy. It’s one of the major
DR. STEINDEL: Well, so are drugs for STDs.
DR. OVERHAGE: I agree.
DR. FRANCIS: Could I try something —
MR. ROTHSTEIN: Please. Try anything.
DR. FRANCIS: Instead of playing around with what’s in the example
categories, where Mark started us was the paragraph, “We have listed below
some categories.” OK? The sentence that, “The process of developing
such a list must be open and transparent and give due consideration to existing
state and federal laws, as well as professional and accreditation
Is there a way to, for example, reference JCAHCO standards, such as JCAHCO
standards about medication?
DR. OVERHAGE: All I’m saying is our examples should be consistent with our
DR. FRANCIS: Right. Well, they are consistent —
DR. OVERHAGE: No.
DR. SCANLON: Well, to support Marc’s point, mental health is the only one
that has therapies. The rest are all conditions — information about
MS. GREENBERG(?): Abuse of illicit or licit drug obviously has to do with
DR. FRANCIS: Well, interventions to deal with the —
MS. BERNSTEIN(?): Interventions to deal with —
MR. ROTHSTEIN: Look, I have a suggestion. How about we put simply,
“This category might include information about mental illness.”
PARTICIPANT: Yes. Yes.
PARTICIPANT: It’s not might. It would.
PARTICIPANT: How could it be anything else?
PARTICIPANT: Well, there’s also in the substance-abuse example —
PARTICIPANT: Exactly. And under genetics.
PARTICIPANT: — it says, “treatment for such a condition,” which
is a therapy. So it doesn’t use that specific word. So —
PARTICIPANT: And genetic, it says, “interventions” need to deal
with genetic disorders.
MR. ROTHSTEIN: This is —
MS. MC CALL(?): I’ll confess to being confused on what is the specific
point with which you are taking exception, Marc?
DR. OVERHAGE: That we, on the one hand, are saying we must allow and
exclude from these sensitive categories information which is required by state,
federal laws or professional accreditation agencies, and then we turn around
and give explicitly in our examples things that are required by those laws.
MR. ROTHSTEIN: No, actually, we’re not saying that. I think we’re saying,
given due consideration for it. And so it may well be — I mean, we’re not here
to decide that issue now. It may well be that the people who are deciding that
issue are saying federal law needs to change in some way or another.
DR. FRANCIS: Or it might be that the definition of mental-health
information would have a specific exclusion.
MR. ROTHSTEIN: Right.
DR. FRANCIS: I mean, that’s all open. That’s the point. I mean, that’s why
it says, “might include.” And, of course, it might include
information about therapies, but some of those might be included and some of
those might not be. That’s the whole idea here.
DR. CARR: Well, I think Marc Overhage and I are both concerned about the
I think if we just say “mental-health information,” we’re not
setting up this conflict of, on the one hand —
I mean, in today’s world, you have to have all the medications. So rather
than introducing the concept of the medications in the excluded categories,
could we not be more general in the categories?
And, Marc Overhage, would that help, if we just — if we had, as we said,
mental-health information in this category would include information about
mental-health illness — mental illness, and not say and therapies?
MS. MC CALL: But it doesn’t really solve the problem because somebody would
then — with that being broader still go, “Well, does that include
therapies — “
DR. CARR: Well, but that’s for — I mean, that needs to be adjudicated,
right? If it — right? Today, you could not accomplish this — you know —
DR. STEINWACHS: Let me just ask — it may be a very small point — if I
could just interject, we are constructing the electronic health record as the
only source of information now. And so I would assume you with a patient, would
say, “This is in your record,” if you can see all that information.
“Are you taking that medication now?”
We don’t know the things that are prescribed are actually filled, many
times, and if they’re filled, we don’t know whether they’re being taken.
And so I was less concerned about this because I think you have to talk to
the patient, still, in that drug-reconciliation process.
And to think that the record’s going to carry everything is —
DR. CARR: But that is the goal of electronic health records. That is a
JCAHCO safety priority, and, I mean, we’ve just spent an intensive six months
of creating something that every provider participates in. It says, “Are
you taking — “ and we are getting from e-prescribing the fill record. So
DR. STEINWACHS: Do you still talk to the patient?
DR. CARR: You do, but you don’t — but the patient says, “Sometimes I
take the blue one and occasionally I take two of the pink ones. I can’t
remember which,” you know.
So, I mean, the point is medication reconciliation in the interest of
safety. So —
MS. MC CALL: I have a specific recommendation.
MR. ROTHSTEIN: We had Marjorie and then we’ll get that.
MS. MC CALL: Oh, I’m sorry.
MR. ROTHSTEIN: OK. Thank you. Marjorie and then Carol.
MS. GREENBERG: First of all, it is my understanding that this is about —
not about what should be in the electronic health record, but whether people
can sequester information as it moves across the NHIN. Is that correct?
MS. GREENBERG: OK. So I don’t think anyone’s questioning whether it should
be in the electronic — what should be in the electronic health record, only
what’s, then, moved across the NHIN.
PARTICIPANT: That’s correct.
MS. GREENBERG: I mean, I do think that’s a distinction here, isn’t it?
MS. GREENBERG: OK. The other thing is that you’ve got, in any of these —
of course, genetic is genetic — but is a history of some of these things
versus or current.
So 20 years ago, it might be someone had an anti-psychotic drug or
something. They haven’t — you know, had anything like that has been given to
them in 20 years. So that’s a different story than what your current
medications are, which could create problems.
So I think by eliminating — you can eliminate therapies here, but I don’t
think we’re just talking, in any of these things, about current health issues.
We’re also talking about history of health conditions, treatments, et cetera,
which, I mean, now, a person just doesn’t have to — you know, going forward,
those histories could be in the record. Whereas, now, they probably aren’t.
But — and if you wanted to have something here under mental-health
information, rather than just an obvious statement like this is about mental
health or mental illness, because all the others do have some little
MR. ROTHSTEIN: Might be about —
MS. GREENBERG: Yes. Could be possibly. You could say, “This could
include information about history of mental illness or current mental
illness,” or something like that, because I think — you know, these are
two different topics, two different — I mean, conditions.
MS. MC CALL: One recommendation would be to add — to modify a sentence
modestly to actually bring in the conflict — talking about, which is,
“The process of developing such a law must be open and transparent and
give due consideration to existing state and federal laws, as well as
professional and accreditation standards and requirements.” OK?
Because what I hear you saying is that there are some requirements by law
that would come into conflict with the examples which are merely examples as
written. OK? It is not intended to say that these examples are specific enough.
They are examples. We use the word “might,” and only to call out that
there will be requirements. So that would be one.
We could further — second or kind of 1-B suggestion would be to enhance it
by saying, “Some of whose requirements will need to be reconciled as the
existing law — some existing laws and standards conflict.”
MR. ROTHSTEIN: OK. Maya, it would go after the word, “attention.”
No, no, no, after the word “standards.”
MS. BERNSTEIN: She’s talking about standards over here —
MS. MC CALL: And requirements.
MR. ROTHSTEIN: And requirements.
MS. BERNSTEIN: What I was pointing out was —
MS. MC CALL: And requirements.
MS. BERNSTEIN: — just that the previous sentence says, “We recognize
that selecting a list of categories and defining the categories will need
considerable attention.” Right? And —
PARTICIPANT: He’s just calling out.
DR. FRANCIS: Just go to standards and requirements after standards.
MS. BERNSTEIN: Are accreditation standards different than requirements?
MS. BERNSTEIN: OK.
MR. REYNOLDS: Why wouldn’t we take Carol’s recommendation? Why don’t we put
it up and look at it?
MR. ROTHSTEIN: Yes, we’re doing that. It’s up there.
MS. MC CALL: That’s what I understood you to say — talking about. On the
one hand, we’re saying, “Don’t do it,” and, on the other hand, there
are laws on the books that say you must.
DR. CARR: And my — I like Carol’s recommendation, and my recommendation on
example categories would be to simply use the words in italics and not
If we’re saying — if we’re making a directional document of things to be
explored, I think we’re only inviting controversy by being prescriptive.
And, also, is the word “licit” a real word —
MR. ROTHSTEIN: Sure.
PARTICIPANT: What word?
MR. ROTHSTEIN: “Licit.”
So what do you want to put in —
DR. CARR: My recommendation is to simply have, for example, categories,
genetic information, mental-health information, reproductive health, domestic
violence and substance abuse.
PARTICIPANT: Without —
DR. CARR: Take out the descriptive categories.
I think it’s self explanatory. Most people would have a good idea of what
those categories represent, but we don’t — by being prescriptive about
therapies, medications and so on, we open the door to exactly what Marc O was
saying, that we’re going farther than directional, and there are some real —
the medication thing is a major, major challenge, and I think we just stay
within the directional recommendations.
MS. BERNSTEIN: OK. So my only hesitation about that is that the preceding
paragraph and the one that follows are designed to explain that that
description is only an example and not —
So, now, we would need to change the previous paragraph and what follows,
so that it’s not — you know, we did a lot of work, actually on this paragraph
DR. CARR: I understand that, but I think —
MS. BERNSTEIN: — try to soften the example and make sure that it was not
considered to be prescriptive. And there’s lots of language in this paragraph
that does that. If we take out all the description, then that paragraph sort of
doesn’t make so much sense anymore.
DR. CARR: Why don’t we take that out, too?
I mean, I’m getting back to where we were coming from is we’re trying to
build consensus and we agree that this is an evolving asynchronous process and
we’re trying to be directional and raise things up without taking it too far
into detail. I feel that that would be a way of bringing us closer to our
MS. BERNSTEIN: So I’m just asking if this paragraph makes sense —
MR. ROTHSTEIN: Well, let’s see first whether people like the suggestion.
MR. ROTHSTEIN: And then we’ll worry about the words later.
MS. MC CALL: I like the suggestion if we could enhance it by doing one
thing. In addition to kind of a bullet-pointed list, say, “While the
details within each of these categories will differ, they might include
information, such as — “
And these are generic terms, right? About the condition or about the
diagnoses or whatever it is, so that they — there’s enough specificity that
says, “What was the intent of putting these here? What are the kinds of
information that you would expect to be discussed and decided when considering
DR. FRANCIS: How about if we took it — to follow up on Carol’s suggestion,
how about if we took all the specifics out and then, indented at the end, had a
sentence that said, “Defining — you know, while the information included
under each category might — or under the respective categories might differ,
issues to be taken into account in defining these categories include whether to
include tests,” et cetera.
DR. STEINDEL: In all the iterations of this letter, the examples in this
list is one thing that I’ve bounced back and forth with mentally, about whether
we include specifics or not.
And I personally find that the specifics are very helpful in saying what
our thoughts are are included in a lot of the areas.
Like I may not think of some of the things that have been listed, because
I’m not a practitioner in that area. I’m not familiar, but looking at the scope
of some of it helps me in framing, “OK. This is what they’re talking
I may or may not agree with that in that list, but that’s an example. It’s
something to discuss, but I do have some information here to seed the
I think the only one of these that we’ve actually had some controversy on
is mental-health information, and my personal feeling is we can just solve the
whole thing by just, in that particular one, just eliminating the list there.
DR. OVERHAGE: Do you want to do each?
DR. STEINDEL: It’s self- —
DR. OVERHAGE: We can do that. I mean, that has all the same issues.
PARTICIPANT: Yes, we’ve pointed out that there are drugs in substance abuse
and in genetics —
DR. STEINDEL: No, there’s drugs in all of them. No, I agree with that.
PARTICIPANT: — drugs either.
DR. STEINDEL: No, I agree.
PARTICIPANT: We did a lot of this discussion —
DR. FRANCIS: How about another way of trying to do it? Leave the language
exactly the same as it is here and change the header to “Examples of
Possible Categories and Information.” Would that do it? Just change the
MR. ROTHSTEIN: Well, what about the people who are uncomfortable, would
that raise your comfort level at all, Justine and Marc?
DR. CARR: No, not for me.
I think where you’ve been, I haven’t been on the subcommittee, but for the
input that I’ve given and discussion I’ve heard.
There is a whole host of changes that would be obligated by sequestering
information. How you write a history — how you write today’s problem — you
know, getting to the question we had earlier — do you blank out certain words
or do you have categories?
There is so much that needs to be adjudicated in this that I feel that we
should not pretend to know more than we know. We already know medication
reconciliation is an issue.
You know, whether you have a history of today’s problem and you’re allowed
to refer to any of these things, it’s so complex that I think less is more.
I go back to what we said initially, that we are trying to be directional.
We are trying to identify that these are areas that are very, very concerning
for privacy, but we’re not in a position to resolve these, and I think that we
contribute without distracting by naming them, and then identifying that it
needs to be further modeled in different —
DR. FRANCIS: I have a suggestion on that, though, because I think — I
mean, I think Steve is right that there’s information here that people might
not have thought of that I don’t want to lose.
On the other hand, I don’t want to say how any of these particular
categories should be defined. That’s — or even whether all of them should be
included. That’s the directional problem.
What I want to do is have this on the table for consideration.
So that’s why I’m thinking about maybe changing the header to say,
“Examples of Categories and Information for Consideration.”
If we put it that way, what we’re saying is this is what needs to be
thought about, not the conclusion. That’s why I’m thinking the header would
respond to your concerns.
MS. GREENBERG: Well, I understand why some of — you know — some of these
examples are here and I can also report from having sat in on these calls that
they were certainly discussed and changed and things were dropped out and, you
know, et cetera.
But, as a matter of fact, I don’t think you lose that much by just having
the italicized things.
We have versions, 16 and before, as part of the record. As the executive
Secretary, I must save all of these versions, and I can’t delete them, and
you’ve offered as a committee to continue this work.
So either the department will ignore this entirely or it will ignore
portions of it or will actually ask you to pursue some of these, and you’ll
have another chance to get your favorite examples in there, and they’ll
certainly be in the history of having written the letter.
But it sounds to me like there might be a greater comfort level among some
of the members if those examples were removed, and I don’t think you lose
anything by doing so.
MS. BERNSTEIN: I kind of agree with Steve that there are things in here
that even the subcommittee, when we discussed them, it was helpful to the
subcommittee that they didn’t consider, for example, that domestic violence
information should include your address or that information that identifies you
as a substance abuser, having nothing to do with your medical condition, is
part of that information, that, you know, when it was raised to our attention
by experts in that area we all went, “Uh, that’s interesting.” We
didn’t really —
So I was going to make a suggestion that goes in a different direction,
instead of being less explicit to be more explicit about exactly the problem
that Justine and Marc are raising to say there is this problem of medication
Here’s an example of one of the issues that is a real problem that’s
difficult to deal with. We have, on the one hand, the movement in the joint
commission to do this, and, on the other hand, the desire to give patients
If we make some of those issues as examples of where there’s the tension,
would that help the discussion, to add a sentence that says, “Here’s an
explicit example of where there’s the kind of thing we should be talking
MR. ROTHSTEIN: OK. Maya, I think Marc is saying that that was only —
MS. BERNSTEIN: One example. OK.
MR. ROTHSTEIN: — issue number one of several —
MS. BERNSTEIN: I haven’t heard the others, and so —
MR. ROTHSTEIN: Is that correct, Marc?
DR. OVERHAGE: Well, I think that in this way it gets difficult. There are
so many very specific issues they get problematic. I mean, another example —
MR. ROTHSTEIN: OK. So the answer to that is yes.
DR. OVERHAGE: Right.
MR. ROTHSTEIN: OK. So, Harry and then Bill.
MR. REYNOLDS: I’d agree with the people that want to take the words out.
I’ve been on the committee and — every word after every one of them, but I
think the point is it does not move us forward anymore. We need to get the
subject on the table. We need to talk about the issues of the subject, and
every one of those will be adjudicated by — over and over, maybe, by
individual hearings for each of us.
So I’m not sure that it builds us anything other than to say — because
we’re scared that — we were scared of the categories to even put any. So as
soon as you put a word, you just took yourself to a whole other level.
So let’s stay within our own comfort zone, which — things should be
considered, and back off of specifics.
DR. SCANLON: Well, with Harry’s comment, I can compress mine to ditto.
MR. ROTHSTEIN: OK. So is there anyone who has objection to changing this
category of the example to just bullets of the titles?
OK. So we’ll do that, and we’ll, then, just — is it okay also if we go
back to the original heading of Example Categories?
MS. BERNSTEIN: I was going to say we turn this into a sentence, because
they can just be a list now, instead of having a separate bulleted list, which
you don’t need, if all you have is a list.
MR. ROTHSTEIN: No, I’d like to have a bulleted list, because they’ll stand
out more than in a sentence.
OK. Moving along, picking up speed perhaps, on the bottom of page 5, we
have this section on Notations of Missing Data for Health Care Providers.
And just to explain, we framed what the issue was without taking any
particular position on this.
DR. CARR: We took the position that you should have a —
MR. ROTHSTEIN: We took a position that there should be a notation, but we
didn’t say exactly how specific it ought to be, yes. Thank you for that
OK. Let’s move, then, to Emergency Access, and I have a couple of, I think,
relatively minor revisions that were suggested by Larry, and he can correct me
if I mess this up.
In Emergency Access, in the first sentence, we would make it —
PARTICIPANT: Hang on.
MR. ROTHSTEIN: OK. You with me?
PARTICIPANT: I am now.
MR. ROTHSTEIN: OK. “In an emergency where a patient is unable to give
or refuse consent to access sequestered health information, such as when an
unconscious or delirious patient — “ So just to add those two words,
“or delirious.” And is that —
PARTICIPANT: How do you spell “delirious”?
There was another example —
DR. GREEN: Well, that’s correct. My key point is is that I think most
people reading this, when they see the heading, “Emergency Access,”
they’ll be thinking that this is an issue that is focused on emergency
departments. It should be broadened to make sure everyone recognizes that this
is a big issue.
There are many instances in which people cannot consent or refuse consent.
Delirium is another one. An insurmountable language barrier is another one. A
teenager in the office absent a parent is another one.
I mean, there are multiple reasons, and the scope of this emergency access
thing needs to be understood to incorporate basically every physician’s office,
every location of care that there is, not just the emergency department.
MR. ROTHSTEIN: Well, what we’re talking about — just to clarify, this is
emergency access to sequestered information, not emergency access —
DR. GREEN: Exactly what I’m talking about, emergency access to sequestered
information. It could be a pediatrician’s problem in a small town in Vermont
when a delirious 14-year-old comes in having been drinking or eating or
sniffing or something some substance.
MR. ROTHSTEIN: Right.
MS. MC CALL: You may want to remove the words, “in an emergency
MR. ROTHSTEIN: Well, see, what this is an example, the whole clause is,
“such as when.”
MS. MC CALL: Oh, OK. Got it. Such as when.
DR. GREEN: It’s not a wordsmithing issue. It is attempting to give explicit
substance to the scope of the problem —
MR. ROTHSTEIN: OK. So Maya has put up there, “unconscious, delirious
or otherwise incompetent patient.” Right?
MS. BERNSTEIN: I think like a lawyer. “Incompetent” is a legal
term, in this case. You’re not competent if you’re a minor. You’re not
competent if you’re unable to make decisions for — either because you’re
underage or delirious, you’re not conscious or there’s a variety of things.
DR. GREEN: And could we add, “in an emergency department, a
physician’s office or other healthcare setting”?
MS. BERNSTEIN: Yes, this is just an example —
PARTICIPANT: It changes it from an example —
MS. BERNSTEIN: Yes —
MR. ROTHSTEIN: See, it was supposed to be an example.
DR. FRANCIS: You could give another example or when —
MR. ROTHSTEIN: OK — if Larry wants more detail, we could take out,
“such as when,” and make it, “including.”
MR. ROTHSTEIN: Right? Would that be okay?
DR. GREEN(?): Yes.
MR. ROTHSTEIN: OK. So that is the —
MS. BERNSTEIN: Larry, say again, emergency department or —
PARTICIPANT: Physician’s office.
MS. BERNSTEIN: Physician’s office or — there was a third —
MR. ROTHSTEIN: Other healthcare setting.
OK. So let me just read it for the folks who are listening in.
“In an emergency where a patient is unable to give or refuse consent
to access sequestered health information, including when an unconscious,
delirious or otherwise incompetent patient is treated in an emergency
department, physician’s office or other healthcare setting, it may be”
blah, blah, blah, blah, blah.
MS. BERNSTEIN: “ … it may be essential to have the individual’s
complete health information.”
MR. ROTHSTEIN: “ … it may be essential to have the individual’s
complete health information.”
DR. SCANLON: In this sentence, I got hung up on the word
“essential,” because the letter is really about tradeoff, and my sort
of suggestion was that it may be extremely beneficial to have — I mean,
because it’s not — you know, today, people go into the emergency room
unconscious, and we don’t have any source of information. So we’re talking
about an improvement. We’re not talking about something that is absolutely
black or white.
MR. ROTHSTEIN: OK. That’s accepted by the subcommittee. I think everyone
else is okay with that? All right. Thank you, Bill.
So that is the only change in the first paragraph under Emergency Access.
Now, Larry had another issue in the second paragraph, and I want to see if
I can — it’s in the first sentence where — that currently says, “If this
feature is used, an audit trail should record the specifics of the incident,
and it should automatically trigger a review by health privacy officials at the
health care facility.”
And his point — and he can make if I don’t do it well enough — is that
this views the world as — only in terms of hospitals, and we need to recognize
self-providers and small groups in other settings.
So here is —
PARTICIPANT: (Off mike).
MR. ROTHSTEIN: Well, what — see, there’s a technical problem because every
covered entity is supposed to have a designated health privacy officer. So the
way I attempted to deal with that is, “to trigger a review by health
privacy officials at the health care facility or by a responsible party at a
facility without a privacy office.” That may be too many words —
PARTICIPANT: Just the relevant privacy officer.
MS. BERNSTEIN: Yes, isn’t there — under the law, someone has to be
assigned to be the officer —
MR. ROTHSTEIN: Well, there is somebody who’s supposed to be —
MS. BERNSTEIN: — even though they have multiple roles, right?
MR. ROTHSTEIN: Yes.
PARTICIPANT: Relevant, yes, that’s pretty good.
MS. BERNSTEIN: Then you have issues of — you know — conflicts of interest
and so forth if the person who is the privacy official is the person who —
PARTICIPANT: Just being directional here.
MS. BERNSTEIN: Yes. No, no, no, right. I’m —
MR. ROTHSTEIN: OK. So —
MS. BERNSTEIN: OK. So it’s supposed to say what? The designated —
PARTICIPANT: The relevant privacy officer.
MR. ROTHSTEIN: Yes, and then we can just put a —
MS. BERNSTEIN: I’m working on it.
MR. ROTHSTEIN: — period after that, right?
MR. ROTHSTEIN: OK. Is that okay with you, Larry?
Thank you for the comments.
OK. The section on re-sequestration, I did not receive any comments on
I have a couple of minor typos that I’ll spare you in the recommendations.
The only one of substance is in 1e, and this is from Simon, and the
suggestion would be to change 1e to, “The design of the NHIN should
contain — “ and that would make it parallel with 1d. OK?
MS. BERNSTEIN: Here?
MR. ROTHSTEIN: Yes, “The design of the NHIN.”
So any problems with Recommendations 1a through 1h, noting that there are a
couple of typos we’ll fix up?
OK. Other — Oh, I’m sorry. Marc.
MS. BERNSTEIN: Marc.
DR. OVERHAGE: A very brief one on — it’s 1c, I believe it is. Seemed to be
— in terms of sort of parallelism of level of where we could have been — for
example, 1d said, “The design of the NHIN should — “ But, in 1c, we
say, “When a health care provider accesses — “ and it seems like we
ought to try to say there — a long sentence, but within the — “The NHIN
should be designed so that when a health care provider accesses health
information — ”
MR. ROTHSTEIN: OK. We can do that.
DR. OVERHAGE: And on 1 —
MR. ROTHSTEIN: Excuse me. Maya, you have that? Just to make that —
MS. BERNSTEIN: I’ll work on it.
DR. OVERHAGE: And on 1e is EHRs the word we want to use there?
MR. ROTHSTEIN: No, we just changed that.
DR. OVERHAGE: Oh, I’m sorry.
MR. ROTHSTEIN: It now begins, “The design of the NHIN.”
DR. OVERHAGE: Sorry. Sorry.
MR. ROTHSTEIN: OK?
DR. OVERHAGE: Yes.
MR. ROTHSTEIN: OK. So, Maya, you’ll figure out 1a.
MS. BERNSTEIN: Do you want all of them to be that way? f, g, h.
DR. OVERHAGE: I guess I was suggesting that since we’re saying this is
directional and about design and putting this on the table, but rather than
being proscriptive and saying this should happen —
MR. ROTHSTEIN: Well, it can’t be —
MS. BERNSTEIN: It’s all recommendations.
MR. ROTHSTEIN: It can’t be for all of them, because 1b is different because
that’s directed to HHS.
MS. BERNSTEIN: Right.
MR. ROTHSTEIN: So let me — other than parallelism, was there some other
reason why 1c was troubling as is?
DR. OVERHAGE: Yes, and that’s the — you know, for example, in the way that
— Sorry. Go back again. The way that 1a is worded, it keeps us focused — the
recommendation focused on the design and conceptualization, as opposed to
recommending policy and —
MR. ROTHSTEIN: OK. So we can make 1f, g and h in that style as well.
DR. OVERHAGE: Maybe there’s just something ahead of it that says —
MR. ROTHSTEIN: That should not be a problem.
DR. OVERHAGE: Yes.
MR. ROTHSTEIN: OK. Everyone all right with that?
MR. ROTHSTEIN: OK. Other Options We Considered is not something that has
been a source of too much controversy in the past, unless someone wants to
DR. OVERHAGE: Instead of Health Information Exchange there, should that be
MR. ROTHSTEIN: Can you tell us where you are?
DR. OVERHAGE: “One possibility would be for a HIE — “ and
shouldn’t we be saying NHIN?
MS. BERNSTEIN: Where are you, Marc?
MR. ROTHSTEIN: The very first one under No Sharing Restrictions.
DR. OVERHAGE: We’re under Other Options We Considered —
MR. ROTHSTEIN: We can do that, yes.
OK. We’ll get Maya back to us in a second, but is everyone okay with that?
MR. ROTHSTEIN: All right. So under No Sharing Restrictions, the first
sentence would be, “One possibility for the NHIN not to restrict — “
PARTICIPANT: Would be for the NHIN not to restrict.
DR. OVERHAGE: And, similarly, in the same paragraph, we say RHIO or —
Where is it? Where’d it go? Seeing it here on the paper.
In the same paragraph — oh, “difficult in light of — “ rather
than “RHIO’s capabilities,” in the next row down, that, I think,
should also be NHIN’s capabilities.
MR. ROTHSTEIN: No, no, no.
(Several participants at once).
MS. BERNSTEIN(?): You’re talking about you. We’re talking about you there.
DR. STEINDEL: I have a problem with the no sharing that we just discussed
because changing from HIE, which is an entity, to the NHIN, which is an
DR. OVERHAGE(?): Yes, that’s kind of where I’m struggling.
DR. STEINDEL: And, you know, we’re specifically saying that the entity, not
to restrict the disclosure of information, and by changing it to the NHIN,
we’re saying that the abstract body, and, you know, I don’t know which way you
want to go.
DR. OVERHAGE(?): The HIE’s no more an entity than the NHIN.
DR. STEINDEL: No, an HIE is — it’s a physical construct.
MR. ROTHSTEIN: Well, we can do away with that issue by just taking it all
out and have it, “One possibility would be not to restrict the disclosure
of information,” and leave that —
DR. STEINDEL: Which is fine. Yes.
MR. ROTHSTEIN: Is that all right?
DR. STEINDEL: Yes. I mean, it gets rid of the dichotomy that’s actually
bothered me from the beginning as well.
MS. BERNSTEIN(?): There?
MR. ROTHSTEIN: Um-hum. Yes.
Marjorie, did you —
MS. GREENBERG: Yes, that’s fine.
MR. ROTHSTEIN: OK. All right. So any other comments on the other options?
PARTICIPANT: Yes, that’s fine.
MR. ROTHSTEIN: OK. The next section is on Clinical Decision Support,
including Recommendation 2.
And, here, this is our vaguest recommendation.
Then we have Research, Development and Implementation. And let me make a
suggestion based on things that we discussed earlier in Recommendation No. 5.
We could add, “HHS should support the ongoing study of the consequences of
sequestration of sensitive health information, including cost issues, potential
liability issues and the human factors necessary for successful
DR. FRANCIS: Why not also include issues of informed consent?
MS. BERNSTEIN(?): Of what?
DR. FRANCIS: Informed consent. That was Marc’s point.
MR. ROTHSTEIN: I have no problem with that. I mean, they’re going to have
to look at —
PARTICIPANT: But that’s not a consequences sequestration. Informed consent.
DR. CARR: You’re saying — Marc was saying understanding the consequences
of sequestration. Is that what you meant, Marc? Informing the patient of the
consequences of sequestration?
DR. OVERHAGE: Yes.
PARTICIPANT: Oh, I see what you’re saying. It’s a thing in the actual
MR. ROTHSTEIN: Well, wouldn’t that belong in 4?
PARTICIPANT: I think so.
PARTICIPANT: 4 would be more — yes.
MR. ROTHSTEIN: So we could put, “HHS should support research,
development and pilot testing of public and professional education programs
including informed consent needed to implement.” Would that be okay?
DR. FRANCIS: Yes — It’s an important issue and I think it should go
MR. ROTHSTEIN: OK. So if we add that there and add the cost issue — OK.
Maya, number 5, we’re going to add, after, “sensitive health
information,” “including cost issues, potential liability.” With
MS. BERNSTEIN: Yes, not my position to have issues with the cost issue, but
I have issues with adding it only because that’s something that like when AHIC
contracts out — I mean, it’s something that the private sector will obviously
have to consider, how to do these kinds of things most efficiently.
It’s not — I’m not sure it’s HHS’s — you know — purpose to figure out
how the private sector should implement something in the most efficient way
possible. That’s what profit-making organizations or even not-for-profits do is
they — you know, they figure out the cost of things and how they can do them
most efficiently. This is —
DR. SCANLON: There’s actually a requirement that when you issue a reg that
you have to do a cost-benefit analysis.
MS. BERNSTEIN: We’re not talking about regulations.
DR. SCANLON: That’s what we’re talking about here. No, that’s what we’re
talking about here.
MR. ROTHSTEIN: I don’t think it hurts to add that to this.
DR. STEINDEL: I have no objection to adding it. I just don’t like using the
word “cost” — something like “economic impact” or
something like that.
MR. ROTHSTEIN: OK. Fine. It’s okay with me. Is it okay with the people who
raised that? OK.
MS. BERNSTEIN: Where did I go?
DR. OVERHAGE(?): Are we a different topic, OK?
MS. BERNSTEIN: Wait a second.
MR. ROTHSTEIN: Unless someone wants to say anything else on this one. OK.
MS. BERNSTEIN: Is that the only thing we’re adding to 5 is the economic
MR. ROTHSTEIN: Correct.
MS. BERNSTEIN: Does that work?
MR. ROTHSTEIN: OK. Marc.
DR. OVERHAGE: In this section, the Research, Development and
Implementation, the second paragraph, we say, “NCVHS also recognizes that
the sequestration of sensitive health information by category in EHRs
represents a new model — “ I think we should remove “in EHRs.”
That’s probably not the only system impacted. So pharmacy systems at CVS,
laboratory systems at —
MR. ROTHSTEIN: OK. We’ll do it unless there is objection. OK?
MS. BERNSTEIN: What did we just do? I’m sorry —
(Several participants at once).
MR. ROTHSTEIN: That’s it. Done.
OK. And, now, we have one last paragraph left that sort of ties things
together, we hope, that begins, “Individual control.”
Anybody have any comments on that?
OK. Simon, we’ve gone through it. Now, what do you suggest?
MR. HOUSTON: Can we actually move to adopt the letter? Are we allowed to do
MS. BERNSTEIN: No, we can’t, if we’re going to fix the three sentences in
the first — that Larry asked us to do — in the first paragraph.
DR. CARR: We could ask the executive subcommittee to add those three
sentences, because I think they represent the consensus. I don’t know that
they’d be controversial, and then we could —
MR. HOUSTON: I would propose that —
(Several participants at once).
MR. ROTHSTEIN: Can we have — I would like, to be comfortable before we get
to your motion, a little more guidance about what we’ve agreed those sentences
are going to contain, because I don’t want to come back with something that
people say, “Where’d that come from?” Would that be okay?
MR. HOUSTON: I’m just trying to move it all forward.
MR. ROTHSTEIN: No, I agree, but can we revisit, for just a minute, before
the vote, the issue of what we’re supposed to do to make everybody happy with
our — agreeable on this letter?
So, Larry, do you want to start?
DR. GREEN: I’ll take a shot at it.
Again, Leslie — well, several of you, Jeff and John — provided fairly
eloquent explanations for how this letter came into being and the context in
which it is being delivered.
And the only guidance I’m interested in is, rather than the letter opening
up, this letter recommends that you adopt a policy, that there be some sort of
preamble that leads into that.
Marjorie also made the point that it would be nice to add, after 15 months
of deliberation and multiple hearings just factual statements we would do this.
I believe the letter stands a better chance of being better received and
achieving what we’re trying to achieve if it’s just positioned at the
And I don’t think it’s necessary for it to be three sentences. It might
just be one. It might be two. It’s not the number of sentences that matters.
What matters is contextualize the letter, so that a reader can see the date in
2008 and know that — where it was in time and space.
MR. ROTHSTEIN: Well, there was another thought that — I don’t know how we
put this into these sentences, but it was Jeff’s point that — or someone’s
point that the recommendations that we are putting forward here are not
currently — exist in federal or state law anywhere. Now, I mean, this is
I think we’re trying, in this letter, to justify it by the fact that we’re
having these new networks emerge and that justifies —
MS. BERNSTEIN(?): Well, there are examples —
MR. ROTHSTEIN: Yes.
MR. HOUSTON: But the but to that, then, needs to be it’s not in federal or
state law today, but that this is a topic of great interest —
MR. ROTHSTEIN: Right.
MR. HOUSTON: — or a reoccurring theme or something that says that this is
something that is generating a lot of dialogue.
MR. ROTHSTEIN: Right.
(Several participants at once).
DR. CARR: — on page 2 — health care providers may obtain information
without permission from the individual because of HIPAA privacy disclosures for
treatment do not require authorization.
MR. ROTHSTEIN: So maybe we can add that point there.
MS. BERNSTEIN: OK. Let’s not lose that before we move on. Can you tell me
where it is you want that?
MR. ROTHSTEIN: OK. We want Steven and Leslie.
DR. STEINDEL: It sounds to me, just based on this discussion, that there’s
enough deviation in those three sentences that the committee might want to
think that it’s premature to adopt the letter until tomorrow morning.
I think there’s no controversy beyond those three sentences.
DR. FRANCIS: I actually have a draft.
DR. COHN: You have a draft, Leslie? Why don’t we hear your draft?
DR. FRANCIS: So how about a sentence that begins —
MS. BERNSTEIN: Are you at the beginning of the letter?
DR. FRANCIS: Yes, right at the beginning of the letter.
MR. ROTHSTEIN: In the beginning?
DR. FRANCIS: Yes. Right at the beginning.
“Individual control of sensitive health information accessible via the
NHIN for treatment purposes is a matter of concern to — “ and we should
put in where it’s been raised as a matter of concern “ — and is not
currently addressed in federal law.
“NCVHS has held 15 months of discussion concerning this issue.
“This letter recommends that — “ and we go on from there.
MR. BLAIR: Can I just add something there?
I think — I feel comfortable with what you have written so far.
The only other pieces that I thought would be helpful to add — and I’m
going to have to speak in terms of concepts here, rather than specific wording
— was that the intent of this letter is to set forth policy direction or
direction on policy and that it is understood that before these policies can be
adopted or supporting regulation enacted that liability issues, technical
issues, economic issues and competing rights between different stakeholders.
Forgive me if you’ve said this somewhere, but we’re trying to protect the
rights of consumers and patients, but they have to be balanced with the rights
PARTICIPANT: (Off mike).
MR. BLAIR: OK. You do. OK. Then I’ll stop here.
MR. ROTHSTEIN: OK. Simon.
DR. COHN: Yes, you know, I was actually — Leslie, thank you for being a
member of the committee. I actually like your first sentence. I actually think
that actually it means that we actually don’t need the second sentence.
MS. BERNSTEIN: Sixteen months of discussion?
DR. FRANCIS(?): No, but that’s —
MR. ROTHSTEIN: No, no, this letter is —
DR. COHN: OK. This letter recommends that you adopt a policy, duh, duh,
duh, duh. It seems sort of — I mean, we can take that offline to the executive
subcommittee for wordsmithing, but I —
MS. BERNSTEIN: Well, that states what’s coming in the letter. I mean, it
tells the Secretary —
DR. COHN: Well, but there’s a way up on the top that says what’s coming.
MS. BERNSTEIN: Well, but —
MR. ROTHSTEIN: Says the topic, not the —
MS. BERNSTEIN: That’s the topic.
DR. COHN: Well, that’s — I take that —
MR. ROTHSTEIN: OK. We’ve got Marjorie, then Bill.
MS. GREENBERG: Well, I have a little problem about — I have a problem
about in the very first sentence mentioning federal law because I really don’t
think you’re talking about — I mean, it would indicate to me that what you’re
making is some recommendations related to future federal law or something. I
don’t think that’s — that’s not the essence of it.
But I was going to recommend something slightly different. I think, on the
other hand, I could also recommend — I’ll tell you what that is, but, then, we
could have a little group work on this during the lunch hour, which — and then
bring it back right after that.
But I was — to kind of give the flavor of, I think, what Larry was kind of
wanting and what I was mentioning about the — you know, without showing him
all the blood, tears and sweat that have gone on in trying to get to this
letter, but sort of that the National Committee on Vital and Health Statistics,
you know, brings this letter to you or presents this letter to the department
or something like that after 15 months of holding hearings and intense
discussion, deliberation regarding individual control of sensitive health
information accessible via the NHIN for treatment purposes or something.
This is a matter of concern to — you know, you can say that, if you want,
but, blah, blah, blah, blah. And you could say, then, and is not addressed
comprehensively in law or current policy — in current law or policy.
But something about, in that very first sentence saying we are bringing you
this letter — we’re presenting you with this letter after — you know — a
serious period of hearings deliberation, et cetera, over 15 months.
So that, right away, that kind of frames in somebody’s mind, OK. This was
not just something that they came up with.
MR. ROTHSTEIN: OK. Is it time to recognize John?
DR. COHN: Well, okay. Well, I guess I’d ask — I’m sitting here beginning
two or three different first sentences. I guess Mark was asking direction about
what the first sentence should be.
MR. ROTHSTEIN: Right.
DR. COHN: I think, right now, we’re getting down to the wordsmithing of the
first sentence, whatever.
MR. ROTHSTEIN: I’m comfortable now that I know what people want, and we can
work it out.
MS. BERNSTEIN: Larry’s nodding. Are you nodding?
MR. ROTHSTEIN: So is recognizing a motion in order, Simon?
MR. HOUSTON: I make a motion.
MR. ROTHSTEIN: Oh, I’m sorry.
DR. SCANLON: I mean, I’d like to revisit Recommendation 5. I think economic
impact is too polite. The point that Marc raised at the very beginning was the
issue of cost, and I think we need to tell people there are — we need to be
thinking about the tradeoffs here. OK? What are we gaining? What is this going
to cost us?
This is not a stimulus package. This is something that’s going to have
benefits, but it’s also — have costs. So —
DR. STEINDEL: Bill, I would also be equally happy with cost-benefit
DR. COHN: Recommendation 5 —
DR. STEINDEL: I just didn’t like the specific word “cost.”
DR. COHN: Yes.
Maya, Recommendation 5.
(Several participants at once).
MS. GREENBERG: I thought you were not supposed to do cost-benefit analysis
when it comes to privacy. Isn’t there something about that? But —
MS. BERNSTEIN(?): Actually, that’s —
DR. STEINDEL: No, this is —
MS. BERNSTEIN(?): Benefit-cost analysis because, you know, costs are always
something, but benefits are —
(Several participants at once).
MS. BERNSTEIN(?): Former OMB geek.
PARTICIPANT: Is there a reason why technical feasibility is not part of
this? Because I — you know, this has never been done before —
(Several participants at once).
DR. COHN: So, Bill, are you talking about financial, though, rather than
DR. SCANLON: Well, no, it’s not impact. It’s cost.
PARTICIPANT: Cost. Yes.
DR. SCANLON: You know, including potential benefits and costs. I would put
benefits and costs. That’s fine.
DR. STEINDEL: Yes. That’s fine with me. I just didn’t want the isolated
DR. COHN: OK. So there has been a motion to pass this —
MR. HOUSTON: (Off mike).
DR. COHN: OK. Please.
MR. HOUSTON: My motion is we pass this letter subject to Mark and the
executive committee wordsmithing the sentences at the beginning of the letter
as per our collective discussion as of a few minutes ago.
MS. BERNSTEIN: The executive committee or the subcommittee, which is
meeting this afternoon anyway?
MR. HOUSTON: Well, the subcommittee is going to work with Mark, but,
ultimately, I want to leave it up to Mark, the final decision of the
subcommittee or to Mark in executive committee, I’m assuming.
MS. GREENBERG: Well, to the executive committee on which Mark belongs.
MR. HOUSTON: Right. For final approval.
DR. COHN: Larry, was that a second?
DR. GREEN: Yes, sir.
DR. COHN: OK. Is there discussion?
DR. FRANCIS: Third —
DR. COHN: OK. Leslie third. OK.
All in favor —
(A chorus of ayes).
DR. WARREN: Aye. This is Judy.
DR. COHN: OK. Opposed?
MR. ROTHSTEIN: Thank you. You broke the tie, Judy.
DR. COHN: Opposed?
OK. Any abstentions?
OK. So this has been passed by the majority. There is one against and one
MR. ROTHSTEIN: Who abstained?
DR. COHN: There’s no abstention. I’m sorry. No abstention.
And, Marc, I think this is the practice, obviously, if you want to include
a statement at the end of the letter to be included as a dissenting —
attachment as a dissenting member, that is certainly your right.
MS. BERNSTEIN: And I can help you put that together if you want, to make it
go with the package.
DR. COHN: OK. Well, with that, I’m going to thank everyone. I guess this is
number 100, and the — actually, the second letter in my tenure that has
actually — not in my — in my membership on the committee that has not
actually had unanimous consent. The other being, actually, interestingly
enough, the initial privacy recommendations to the Secretary related to HIPAA.
PARTICIPANT: Shocked. Shocked that it had to do with —
DR. COHN: Just to remind you.
Having said that, I want to thank everyone —
MR. ROTHSTEIN: Let me have a word —
DR. COHN: Oh, Mark, gets a final — I’ll let Mark have a final word, and
then I’ll give everybody a —
MR. ROTHSTEIN: Yes, I want to thank you all for hanging together with us,
and I want to express my thanks to Maya and the subcommittee members for
keeping to task on a very difficult —
MS. BERNSTEIN: And the other staff, who have been very helpful throughout
the whole process.
MR. ROTHSTEIN: Exactly.
MS. BERNSTEIN: Their input’s really been helpful.
MR. ROTHSTEIN: So thank you.
DR. GREEN: I can comment that I’m going to stop my — now.
MS. GREENBERG(?): What’d he say?
PARTICIPANT: He’s going to stop his medications.
(Several participants at once).
DR. COHN: I think we were conferring and let’s reconvene at 1:40, which
will be a couple of minutes —
PARTICIPANT: That’s fine. It’s fine.
DR. COHN: OK. Why don’t we try to get back at 1:30 and we convene then.
A F T E R N O O N S E S S I O N (1:46 p.m.)
DR. COHN: As mentioned this morning, we moved the agenda around a little
bit, and we’re now leading off with Jim Scanlon to talk about, as a department
update, and that will be followed by Karen Trudel talking about CMS activities
A little later this afternoon, we will be having, obviously, a
presentation. We’re expecting John Loonsk from the Office of the National
Coordinator to be having further conversations with us.
Agenda Item: Department Update — Data Council
DR. COHN: With that, Jim, thank you very much for coming and turn it over
MR. SCANLON: My pleasure. Good afternoon, everyone.
Let’s see, since we met in December, a couple — a number of things have
happened in data policy, not to mention we actually have a budget at this
PARTICIPANT: Oh, hear, hear.
MR. SCANLON: — which always helps matters.
MR. SCANLON: But not so fast. We have — there’s a freeze. No, no.
So I’m going to talk a little bit today — I’m passing out to you just a
one-pager on the budget, but I’m going to talk a little bit about it as we go
But I’ve also passed out to you the Secretary’s nine priority areas. They
have been revised, though I think we talked about this at our December meeting,
but I think you’ll recognize all of them.
And then our strategic plan. There are four goals in the HHS strategic plan
and a number of sub-objectives. And, again, I think you’ll see that many of the
Secretary’s priority areas, as well as the major goals and objectives in the
strategic plan — really either directly involve health IT, privacy and
electronic health records and so on or rely heavily on that kind of support. So
the work that the committee does is really directly relevant to a lot of the
priority areas here.
Let me talk a little bit about the budget. When we met in December, I don’t
think we had a budget at that point. Most of the federal agencies were on the
continuing resolution, but we now do have a budget for fiscal year ‘08,
and, in general, they are fairly flat budgets for most domestic agencies that
are non-security agencies, but we had a couple of good developments in the HHS
budget. Let me tell you about that.
On the population data side for the fiscal year ‘08 budget, we’re
actually not only holding steady, which is a major accomplishment for most of
our major data-collection activities, but we actually were able to get an
increase for the National Center for Health Statistics of about $7 million,
which I think was — (applause).
So, for example, MEPS would be funded at its regular amount, which is about
$55 million a year.
The Medicare Current Beneficiary Survey at CMS — that’s pretty much the
major survey they rely on — is still being funded at its current level, and
most of our other sort of major statistical activities are at least — they’re
being protected. No major increases, except in CHS, but at least that’s a major
— that was a major accomplishment.
So I don’t know what Ed will say, but at least that’s $7 million this year.
And, that, I think, is directly attributable to the department and the Data
Council sort of singling us out as a major area, and I think other agencies
were willing to support it.
It’s unusual that you’ll see other agencies supporting a sister agency, but
I think this was seen kind of as a common resource for all of us. And it also
supports efficiency, so that we rely on one family of surveys, rather than
having a number of others as well.
On the IT side — again, this is for fiscal year ‘08 — the picture is
pretty much level in terms of budget trends.
The ONC budget for this fiscal year is $61 million. Now, that’s much less
than the President requested, almost a doubling, but it’s about what their
budget was — a little more than it was for ‘07.
And, then, let me switch now to the ‘09 budget. The President
submitted the fiscal year 2009 budget. Now, that’s what Congress will
deliberate on for the coming months.
By the way, the HHS budget is $737 billion. I think we would probably be —
if we were listed among the Fortune 500, we would be in the Fortune 10. I think
we would be one, actually.
PARTICIPANT: You’d be number one.
MR. SCANLON: We would be number one. But we’re not for profit, of course,
But only 10 percent of that budget is discretionary. So 90 percent of our
budget is Medicare, Medicaid and those are programs where they’re entitlement
or otherwise mandatory costs.
So, really, it’s about $73 billion that funds all of our discretionary
programs from NIH to FDA to CDC to part of CMS and so on.
And, again, here, we have good news on the population data side. NCHS would
get another increase of $11 million. It’s probably the only — one of the few
agencies where we were actually able to protect and secure an increase in the
That would get them up to about $125 million, which, at least in prior
years, we thought was the level that it shouldn’t fall below. And so, again,
we’ll have to see how this transpires this fiscal year, but at least the
ingredients are there to give some help to the population data programs.
And for the other surveys, such as MEPS, MEPS would be funded at the full
level, as it is now. Medicare Current Beneficiary Survey is protected again.
Even though the research budget at CMS went down considerably, MEPS would still
be protected and funded at its normal level.
Now, for ‘09, as I said, the ONC budget — and I think Rob or John
will talk about this later — a slight increase was requested for $66 million.
So that would be an increase of about $5 million for that office.
And, then, on the health IT side, AHRQ would continue with about a
This is a focus on quality and patient safety in ambulatory settings
through health IT. So these are the grant programs at AHRQ.
My own office, ASPE, we’re proposed for $3-1/2 million to continue our
independent evaluations, policy research and economics research relating to
adoption and other issues relating to health IT.
The Indian Health Service, for all of their direct care sites — remember,
some of the program was contracted — they’re funds so that — for EHRs for
their direct sites as well.
On the — again, on the health IT side, the fiscal year ‘09 budget
includes $3.8 million for the second year of the CMS ambulatory care EHR demo,
which we’ve talked about a little bit here before.
This is the proposal the Secretary made a while back to recruit about 1,200
small to medium-sized physicians’ offices to participate in the five-year demo
of electronic health records. So this would be for the second year.
And, again, there’s — didn’t have exactly the amount, but AHRQ has
increased funding for their network of clinical research centers that do
comparative effectiveness research. Some of that would include some IT
So, basically, on the population health side, mostly holding steady
protecting most of the major statistical systems.
And for NCHS, at least a two-year increase, now, that gets them up to $125
Again, I don’t know — the Data Council has scheduled for our next meeting
a look at what the impact is on our major data systems, and I think we will be
relying on NCHS to give us more detail about what they say — how they see this
playing out, but at least it’s — it’s definitely heading in the right
direction for NCHS.
A couple of words about legislative developments. You’ll remember in the
last session of Congress several health IT bills were introduced. In the
Senate, it was the Wired for Health Care Act, and there were a number of
provisions that would have codified ONC, would have codified the AHIC or a
similar arrangement, and it would have created a partnership — public-private
partnership for health IT, and it would have established grant and loan
programs, and, again, there were privacy concerns that actually slowed all of
In this session of Congress, health IT, again, is expected to be a
priority, but, again, it’s hard to predict what will happen.
I read yesterday about a bill being introduced in the House that was called
a Trust Bill, and it looked like it was — there was interest in — I had a
write-up here I can make it available to you, but it was introduced by — let’s
see — Representative Rahm Emanuel and Ed Markey, and it’s called the
Technologies for Restoring Users’ Security and Trust Act. It focuses on health
It would establish a standard-setting process. It would provide grants to
foster nationwide health information exchange.
And I can make this available to you, otherwise. But there’s some privacy
provisions there as well.
There would be mandatory notification if there were any privacy breeches in
health IT systems, among other things.
So — and, apparently, it’s supported by some of the privacy folks.
But, again, just an example, I think. We may see more interest, but, again,
in the year before a presidential election, it’s hard to predict what, if
anything, will happen in terms of —
MR. HOUSTON: You say the first word in that is “Restoring.”
MR. SCANLON: Technologies for Restoring User Security and Trust in Health
Information. It’s a long —
A couple of quick words about some projects my own office is undertaking. I
think I gave you a preview of some of these previously. But my office has
started a couple of things in the fall.
One is on the emergency-preparedness side. We’re repeating and expanding a
survey on emergency preparedness, emergency departments, and preparedness
measures in emergency departments across the country.
We sponsored an earlier survey back in — about four years ago, and
everyone thinks that the preparedness capabilities have increased since then.
So we’ll take a look at that.
And we’re also looking at pandemic preparedness as well, which has come
about since then. So we’ll try to get some good national measures there.
I think I mentioned to you that we were partnering with CMS on an
evaluation of the electronic PHR demo for the fee-for-service program, and AHRQ
is partnering for the managed-care program.
So we’ve got those projects underway, and we’ll begin to see — these are
demos among Medicare beneficiaries or for PHRs. We’ll be looking at
functionality, what are the features that folks use, what kind of consumer
satisfaction, what kind of physician satisfaction, and we’ll get some
statistics as well. So we’ll hope to get some systematic information there.
We’re also looking at an assessment of health IT — EHRs and information
exchange in community health centers.
This is, again, a study we did an earlier version of four years ago, and,
now, everyone believes that there has been more penetration, more capability.
So we have a study underway there.
I think I mentioned to you as well that we recently completed a study of
the health IT workforce. We were looking at what are the needs projected. If
much of these capabilities were to come about, what does the supply look like?
What does the pipeline look like? What are the kinds of skills and how do you
address those skills?
We have some new projects under consideration, but we haven’t really gone
forward with these yet.
We’ve been asked to work with CMS, with Karen — on the evaluation of the
Medicare ambulatory HR demo program. So we’ll be thinking about an evaluation
design for that.
We’ve also been looking at, growing out of the workshop, which the — and
our office sponsored at NCHS last year, we were looking at the capabilities of
current EHRs for public health statistics and public health data.
We had a good two-day session there, and while at the — the assessment was
that the — based on the survey is the actual penetration of the HR — was
still relatively small — whatever it was, 10 to 14 percent — so you couldn’t
really rely on it as a main pillar for surveys.
There clearly were areas of — where there were deep, deep expertise. So
for pilot studies, for — and for research there were opportunities there. And
we agreed that we would probably move this concept to the next step and try
some actual demos from current EHR systems and look at the extent to which we
could obtain the data for health statistics.
And, now, we’re going to be looking at data for drug safety as well.
So to what extent might EHR systems currently in existence be able to
provide analyses or data related to drug — after approval — drug safety
issues or —
So those are the kind of projects we’ll be moving forward with.
And let me stop there.
DR. COHN: Questions?
DR. STEINWACHS: I didn’t want Jim to go without a question — so I was very
impressed by — additional resources for population and health, even though you
and I know that they’re probably more needed, just as you were describing in
the NCHS terms.
You were mentioning redoing the survey on the ERs. I understood that.
There was another survey you were talking about in terms of pandemic
preparedness. I was just wondering what the sampling unit of the pandemic
preparedness, is that at a government level, counties and so on or is that
institutional and organizational?
MR. SCANLON: This is still hospital emergency department. That would be the
focus. It’s the same survey. It’s the same survey. So what we did was updated
questions relating to preparedness in general as it was relayed to a hospital
— emergency department, particularly.
But we do ask about other hospital policies. We ask about whether they have
regional, mutual support and agreements and that sort of thing.
And, then, in pandemic, there are certain measures that folks look for for
pandemic as well, and it’s number of respirators and other containment
facilities and so on. And so we added that whole range of questions relating to
pandemic preparedness as well.
But it’s emergency department focused. Hospital focused.
MS. GREENBERG: I did have a question and perhaps — you know, in the
document you gave us a handout —
MR. SCANLON: Yes. Um-hum.
MS. GREENBERG: And there’s — the second page are the priorities, which
we’ve seen before.
But, now, in the new strategic plan that has a full four goals, at least in
my attempts to — I don’t find it anywhere, this priority related to electronic
health records and information technology.
I wonder — this actually created a problem for me as I was trying to align
certain things in my own work. And I wondered if there’s an explanation for
that or if I’m missing something.
MR. SCANLON: Yes, there’s — I’ve given you just the goals and the
objectives for the strategic plan. I think it’s the second page you have. And
there’s more information under each of these. We actually had to — you raise a
good question, Marjorie. In fact, we had to prepare a crosswalk between the
Secretary’s priorities and where they fit into the plan.
But the health IT priority, for example, would fit under — this is the way
to crosswalk — it would be under Objective 1.2 and 1.3 — quality, safety,
cost — So it’s listed as one of the —
MS. GREENBERG: But it relates to public health also.
MR. SCANLON: Yes. Yes. Yes.
MS. GREENBERG: OK. So that’s where you had crosswalked it.
MR. SCANLON: That’s where the crosswalk places it, yes.
And I actually should probably make a crosswalk available to you as well.
But you raise a good question. It was how do these all relate.
DR. COHN: Well, why don’t we move on and ask Karen to talk about CMS?
And, in the meantime, John has now joined us, John Loonsk, one of the
Directors of the Office of the National Coordinator.
John, thanks for joining us. Hopefully you’re feeling okay.
DR. LOONSK: Thank you.
DR. COHN: Karen, would you like to talk about CMS?
MS. TRUDEL: Sure.
DR. COHN: Thank you.
Agenda Item: CMS Update (on Health Insurance Portability
and Accountability Act of 1996)
MS. TRUDEL: OK. Thank you.
I’ll start out with an update on e-prescribing. You may recall that in
November of 2007, November 15th, we published a proposed rule
recommending a second set of standards for e-prescribing, most specifically,
standards for medication history and formulary and benefit information.
The comment period closed on January 15th, and the final rule is
now nearing the end of the HHS review processes, which is something of a land
speed world record.
We do believe that we will be able to publish the final rule fairly
Moving along from there, though, we have the three proposed standards that
we did not adopt, RX Norm, the structured and codified sig and prior
authorization. And we’re beginning to have discussions with other HHS
components, including AHRQ and ASPE, to move forward with a second round of
pilot testing to begin to move the standards along.
Update on the DEA and issues that relate to e-prescribing for controlled
substances, there was a hearing in December on the Senate side to discuss
issues related to e-prescribing for controlled substances. CMS testified for
the department. DEA testified as well. And Congress made it clear that they
were looking to see some real progress there.
The DEA has developed a proposed rule that does discuss e-prescribing for
controlled substances, and it is on its way through the review process at the
Department of Justice.
Update on the National Provider Identifier. We’re moving quickly towards
the compliance date, the final compliance date of May 23rd.
Medicare fee-for-service began requiring NPIs on all institutional claims
— that’s all claims processed by fiscal intermediaries — as of January
The compliance rate is near 100 percent and our reject rates are running
very steady and fairly low. So we think that one was pretty much of a success.
There will be a similar requirement put in place for professional claims or
anything processed by a Medicare carrier as of March 1st, and we’ll
need several weeks after that to be able to assess what the impact is. However,
the percentage of NPIs on claims is running fairly high.
We’re hearing anecdotal information that people still are not going to be
ready. We’ve heard information that some plans are receiving what they consider
to be alarmingly low percentages of incoming NPIs on claims, and we are
continuing to reach out and talk to Blue Cross Blue Shield Association and
others to get their input, but the May 23rd date is looming, and if
Medicare fee-for-service is any indication, we are making significant progress
With respect to HIPAA regulations, we are working on the proposed rule that
would move forward a proposal to adopt the new HIPAA versions 50-10, D.0 for
the pharmacy and the proposed Medicaid subrogation standard, according to the
recommendations that were sent forward earlier by NCVHS.
That proposed rule is moving into the clearance process, and, as well, is a
link to the successful ultimate implementation of ICD-10.
We don’t have a reg publication schedule that I can communicate to you now,
but there is a great deal of discussion going on at the department about
ICD-10, and even though we have not proposed a rule or proposed an
implementation date, CMS feels that it needs to begin looking at the impact of
implementation now, whether there’s a proposed date or not.
We did let a contract to AHIMA to come in and help us look at our own
internal operations, and we’ve begun that process with internal interviews. And
we hope that this will give us a better idea where we need to target our
planning, where we need to identify key issues that need to be resolved, so
that we can come up with an implementation plan that, should a regulation go
into place, we could make work, because, after all, the implementation period
for this is extremely long. It’s very complicated.
With respect to HIPAA security, we have conducted our first compliance
review using our contractor, PricewaterhouseCoopers.
We have additional reviews that will be scheduled throughout this fiscal
year. We’re thinking a total of between 10 and 14, and we’re selecting
candidates for review from the universe of covered entities against whom
complaints have been filed. We’re not selecting entities at random.
We’re looking to develop best practices and outreach materials from our
findings to assist covered entities in assessing and enhancing their own
And, to that end, I can tell you that, today, we posted on our website the
checklist that — is using as it goes in and begins to do these audits, and we
post this simply as a piece of educational material and outreach for covered
entities. So that is on the CMS website as of today.
Jim talked about personal health records. We are getting ready to roll out
our fee-for-service PHR project, which will be in South Carolina. It’s a pilot
that will go live. We’re targeting before the end of March.
We have a team of Health Trio, which is the PHR, Palmetto, which is one of
our contractors that will be supplying the Medicare data to roll into the PHR,
and a contractor called QSSI.
We will be providing a PHR with Medicare data populated to up to 100,000
Medicare beneficiaries in South Carolina who elect to have one. And, as Jim
mentioned, we’ll be specifically studying aspects of usability and outreach.
Be happy to take any questions.
MR. HOUSTON: Where on the website is the —
MS. TRUDEL: I’ll give you the URL.
MR. HOUSTON: OK. That would be great.
MR. REYNOLDS: So, Karen, would it be considered a payer-based PHR, using
MS. TRUDEL: Yes.
MR. REYNOLDS: OK. Thank you.
MS. TRUDEL: Yes, there will be the ability of the beneficiary to add data
MR. REYNOLDS: OK. Thank you.
DR. COHN: Any questions? Larry.
DR. GREEN: What’s the question for the PHR in the South Carolina
MS. TRUDEL: I’m sorry. What — The question that we’re looking at?
DR. GREEN: Yes.
MS. TRUDEL: Is, essentially, how Medicare beneficiaries utilize personal
health records, what parts of personal health records do they find useful, how
do they use them in their care and how well does it work for them to have
Medicare data embedded in this PHR, so that they don’t have to —
The other thing we’ll be looking at very specifically is outreach
mechanisms. So if PHRs are determined to be a good thing and beneficial to
beneficiaries what is the way to get the word out to beneficiaries, explain
what PHRs are and convey what they can do?
Jim, do you want to add anything?
MR. SCANLON: — and possibly areas where consumers would like to see
improvements and —
MS. TRUDEL: Right. Specifically functionality, what’s there and what’s
useful and what’s not there that they would have liked to see.
DR. STEINWACHS: I was just wondering on the PHRs, I assume they’re areas
that Medicare beneficiaries could put in their own information, right?
MS. TRUDEL: Yes.
DR. STEINWACHS: And so you’d also be looking at how they use those areas or
what they put in.
MS. TRUDEL: Sure.
DR. FERRER: Are you looking at PHRs also in relation to EHRs? For example,
like the VA where they have both My Healthy Vet and the EHR coexisting together
or you’re not going to look at any PHRs that are actually coexisting with other
MS. TRUDEL: This particular pilot is a limited non- — disconnected PHR
using pair data.
We also have another pilot that we’re doing, that Jim also alluded to, that
we’re doing in partnership with some of our Medicare Advantage Plans where
we’re simply looking at the functionality that they already provide to their
Some of those, I don’t know, but they might be tethered to an EHR. I just
don’t know, and AHRQ is working on the evaluation for that pilot.
DR. COHN: Yes, I guess I should just disclose, being with Kaiser
Permanente, we are in a Medicare Advantage Plan that has been involved in that
pilot. So there should be things that look sort of like the VA functionality.
MS. TRUDEL: Thank you.
DR. COHN: John, thank you for joining us again, and we’re sorry we’re
running a couple of minutes late, but the good news is that we’re not under the
same time pressure as we were back in November. So we actually have about 45
minutes or so that we can sort of talk through sort of what’s going on with the
Office of the National Coordinator, as well as, I think, citing new
demonstration projects that you have underway.
So thank you for joining us.
DR. LOONSK: Thank you, Simon, and thank you to the committee for the
opportunity to talk to you.
It is always a challenge to figure out what to talk about. There are a
number of — many things going on. The last time I was here, we had a rather
whirlwind tour of some of them.
So what I sort of thought would be appropriate would be to lay out what’s
in front of you is to talk a little bit about standards and the national health
IT agenda — there have been a number of things that have happened since then,
actually, in that regard — make reference to certification as a core
capability here and how it fits into this picture, and, then, perhaps, spend a
little more time than we had a chance for last time on the nationwide health
information network and talk about where we are with that and what’s going on,
because there is a lot of activity there and we’ll have enough time to go into
that, and then make note of AHIC 2.
I would welcome interruptions, comments, and anything that doesn’t come
close to throwing something across the room would be appreciated.
So in terms of standards in the health IT agenda, this slide is my latest
version. I’m trying to encapsulate what is somewhat of an involved process.
Priorities expressed by the American health information community are
turned into use cases, are provided to the Healthcare Information Technology
Standards Panel, who produces interoperability specifications.
Those specifications are delivered to the American health information
community, who then recommends them or not to the Secretary.
The Secretary accepts them, and then signifies that there’ll be a year
waiting period between acceptance and when they will be recognized.
And, then, they are fed — once recognized — into a number of different
activities for consideration.
So one is that we use them in the Nationwide Health Information Network,
and I’ll talk a little bit more about that later.
Another is that Executive Order 13410 says that all recognized
interoperability standards need to be included in federal health IT systems and
contracts that are new health IT systems and contracts and upgrades to them.
And so this is part of the teeth of getting the federal sector to
participate in this, to walk the talk of the use of these recognized
The other piece here is that certification will embody these standards. So
the Stark and anti-kickback work, the relaxation of Stark and anti-kickback is
predicated on the fact that hospitals can donate to referring EHRs if those
referring providers have interoperable EHRs and since they are not locked into
the hospital for purposes of referral. The interoperability being central to
What we’ve used these standards for is to help define that
interoperability. So one can either assert that the system is inoperable and
the hospital then has to establish the fact that it’s interoperable or they can
use certification as the deeming, so to speak, for the fact that it’s
All certification processes that do this need to implement these standards.
So there is specific language in all recognized certification bodies that says
they need to use the interoperability standards in their certification process.
The reason I said this is that, in fact, in January, Secretary Leavitt
recognized the first round of the HITSP work that was based on the first three
use cases that went through this process.
These now interoperability standards include both high-level name standards
as well as specific constructs that define how those standards need to be used
to try to accomplish interoperability in the systems that involve them.
There are a couple of exceptions. The HL-7 lab implementation guide was
something that was still being balloted. That will be recognized in June.
There’s a have(ph) standard about hospital utilization that is also still being
balloted that would be recognized thereafter.
But there is now an expectation that all, as of this official event of the
secretarial recognition, that all new and upgraded federal health IT systems
will use these standards and that new federal contracts and agreements will
also insist that these standards are used as they are advanced.
I mentioned the fact that there’s also an expectation for use in all
recognized certification processes, CCHIT is the one certification process that
is currently recognized, and so CCHIT will have to implement these standards in
the course of its process as well, and that’s part of the setting for the Stark
and anti-kickback release.
Also, in January, the Secretary has accepted the second round of standards.
This was on the next round of priorities that came from the AHIC, and he has
indicated that in January of 2009 — He accepted them in 2008. He will
recognize them in January of 2009 before the end of his term.
And so the one priority area that did not make it under that line was the
medication management priority area, but the rest of them will follow this
process as well.
So just from a numeric standpoint, I mentioned that these include name
standards and specifications or constructs.
In 2006, there were roughly 30 name standards that were identified. In
2007, there were 31. The number of specifications in 2006 was 22; 2007, 29.
There is some overlap between those. So the total of interoperability
standards that we’re talking about is represented on the bottom line there.
A substantial amount of standards just by gross calculation, numerically,
but, importantly, between these standards and the other standards that are in
the pipeline — so the next round of priorities from the AHIC includes six use
cases that are going forward now — there is a substantial amount of specified
standards and implementation guidance as to how to use them to advance clinical
health IT systems.
And I think that what we see here now is really the fact that we’re moving
beyond the issue of the availability of harmonized standards for this activity
moving forward to the issue of how fast can they be taken up in systems, since
they are available, and implemented to meet these objectives and goals.
On the certification front — I’d be happy to pause if there were any
questions about standards or anything that I just referenced.
Certification is another core component of what the national agenda is
moving forward. And I mentioned the fact that Stark and anti-kickback is
predicated on the fact that this donated systems, indeed, are certified or are
Anecdotally, that seems to be working. We’re seeing a good number of people
who — and hospitals who are indicating that they are making donations on the
basis of this and that it is helping to increase the amount of EHRs that are
available to referring physicians, and so that’s encouraging news.
And I don’t know when the last time you have had an update from Mike
Leavitt or from certification in general, but the certification process is
going great guns. They have — are in, now, their second round of ambulatory
EHR certification. It’s pretty clear from a number of standpoints that, like
other processes, it takes more than one round for this to mature and to really
I think, from the standpoint of the philosophy of this certification
process moving forward, wherein the hope was to have a bar that many vendors
could meet and then to incrementally advance the bar to get to
interoperability, for example, that this, too, is a reason to look very
strongly at the second and third years of the process in terms of their impact
And so ambulatory is in its second year. There’s a first round of inpatient
EHR certification that’s now going in a particular focused area of inpatient,
and the network process is starting up, and we anticipate that the network
process would have its — initiate its first round in an October time frame,
which would coincide with the NHIN work as well.
ONC asked the Certification Commission to look at specialty and special
settings as well, and they are — in addition to doing some initial work in
some of the domains listed, they are developing a roadmap for further progress.
And they’ve really basically reorganized their approach to certification to
have basic certification criteria that can be applied in a number of different
settings as well as specific criteria that can apply in a special setting or
specialty EHR as well.
DR. CARR: John, certification has implications for vendors, but what about
proprietary homegrown systems that are already in existence, how do they
interface with this or do they need to?
DR. LOONSK: They are also viable as certification targets, and a number of
the larger hospital systems have looked at the — and have put forward their
ambulatory-care systems for certification.
So it doesn’t have to just be a shrinkwrap, commercial product, and there
are examples of those that have already come forward and been certified for
systems they’ve developed as well.
DR. CARR: But what is the incentive — I mean, why would they do it? Are
they required to or —
DR. LOONSK: The issue of why certify is one that has import in all the
different areas I just have talked about.
In the ambulatory care setting, certainly, if you’re going to be donating
EHRs to referring physicians, you need to have it be certified or attest to its
interoperability to qualify for the Stark and anti-kickback relief.
So one of the reasons that they’re doing it is because, frankly, they want
to donate it to referring physicians, and to do that, they need to make sure
that it’s interoperable, and certification is the easiest way to do that —
clearest, easiest way to do that.
So as we talk about things like network certification, the value
proposition for becoming certified — and you’ll see this in the NHIN
consideration — is very much of a chicken-and-egg situation. That’s difficult
to break that cycle.
If you want networks to work with each other, to use standards and to be
able to be certified to show that they can use those standards in working with
each other, it’s hard to get that cycle going.
Some of the health information exchanges want to know what the value
equation is for them to be certified, as an example, in the network domain, and
it’s a reasonable question as one is getting started.
So it’s a complicated question. I think that there’s — certification is a
tool for ensuring functionality, security and interoperability is an important
We also asked the certification commission to look at PHR certification.
And this was an area where the American health information community had a lot
of discussion. Was it too early for the market or was it appropriate?
Certainly, the case could be made that certifying security in PHRs was
something that could have tremendous value. But there weren’t many PHRs either,
and so that has been slow to come forward.
I think, now, with the number of announcements of PHRs, some of the major
industry participants who are talking about advancing personal health records
— or some of them call that personal health record infrastructure, because
they’re developing a platform on which personal health records could be built
— that it is a maturing market, and so the certification commission is going
to pay attention to that.
But when you’re getting the certification started, particularly, the
question of having a self-sustaining certification process that actually
provides value to a developing market is a challenge.
DR. STEINDEL: John, do we have any information on how many of the
ambulatory EHR vendors that were certified in the first round are coming back
with new versions of their product to be certified or — you know — to be
certified against the increased number of criteria?
DR. LOONSK: There are numbers for that. We’re still in mid-process —
DR. STEINDEL: I know.
DR. LOONSK: — in that regard. So it’s hard. It’s really — I don’t have
those numbers with me. It’s certainly something I can get back —
DR. STEINDEL: But they are coming back.
DR. LOONSK: They are coming back. Not all of them are coming back. I think
that’s one — you know, when the certification of ambulatory care EHRs started,
estimates were there were 400 products on the market. Not that many came for
the first round of certification.
There are additional challenges in the next round. It is — if you were to
balance functionality, security, interoperability, I think the interoperability
piece, partly because the HITSP standards weren’t there yet, was the part that
was not as well developed. That is developing.
And so, clearly, there is work to be done to make them meet the
interoperability criteria, but we are seeing them coming back. There’s still
The time in which they come back may relate as much to them trying to get
as long a duration out of their existing certification as possible. There are
all kinds of dynamics that could be considered, but be happy to share those
DR. OVERHAGE: One of my favorite topics, Dr. Loonsk. Thank you.
DR. LOONSK: Dr. Loonsk or —
DR. OVERHAGE: Both. Both.
Can you say a little bit about — One of the things I struggle with is —
Certification is one thing, but the implementation of these systems you talked
about, for example, ensuring that they’re interoperable, and we see frequently
certified systems — and I know we’re still in the process from the
interoperability certification process, but just because a system is certified
and potentially interoperable doesn’t mean that the implementation is
And so I worry a little bit that — actually, I worry quite a bit — that
— it feels a little bit like a smoke screen.
In other words, we’re making the argument that, well, it’s okay and we’re
safe, in terms of Stark and anti-kickback and those sorts of things, when we
know that the machine on the other end is interoperable or the software on the
other end is interoperable, when, in fact, the interfaces and so on that could
be built may be highly non-interoperable and the physicians be very locked in.
So it feels a little like we’re putting a little lipstick on the pig and
calling it beautiful.
DR. LOONSK: Yes, sure. Right.
I think you’re bringing up a very important point that is relevant to not
just interoperability. It is particularly relevant to security as well, and
So I actually have a slide later on when I talk about the NHIN that I’d
like to get to to address some of it, but we do try, and I know this
certification commission makes every effort to try to communicate what
certification is and what it’s not, and it’s just hard, you know.
And I think if — does having a certification seal indicate that the
company that’s supporting that product is never going to go out of business,
you know, as another example? No, of course, it can’t, and, yet, there are some
who would expect that that is what it is, and it’s not.
In this case, particularly, take the example of security. If you’re
certifying an EHR product — a shrink-wrapped, ambulatory EHR — how that EHR
is implemented is at least if not more important from a security perspective
than it is — than the attributes of the product per se.
Do they have a firewall? What are their practices? Do they paste the
password on the side of the screen? You can go on and on about implementation
issues, many of which are not about the product, per se, but about the
attributes of that network, of that environment and that are critical.
So I’m going to talk a little bit more about that, but I think your point
is well taken. Part of it is a communication issue in trying to say that we’re
constantly struggling to try to say what certification is and what it isn’t and
try to be clear about it and not overstate it.
But it’s not a substitute for doing other things relative to security in
those environments, and I would also suggest in terms of testing.
Now, I think the certification commission would be among the first to say
that the interoperability component of certification has been the part that’s
been least developed.
ONC has been funding the NIST to help develop certification — well, help
develop testing infrastructure, testing infrastructure that can help to
automate the process for ways in which systems can be tested, because those
who’ve been in the trenches and doing this know that it’s not just a question
of getting the system to work. It’s also a question of how does the system
handle bad data and errors when it gets it, and this gets very complicated.
It will only get more complicated as we get into a more complete health IT
world where different business processes bring to bear multiple systems that
could have an impact on that.
We agree it’s an area for development. We’re trying to work on ways in
which we can help advance tools for the automated testing, so that people can
go on line, and, essentially, what you need to have is you need to have very
tight testing software. You need to basically be able to simulate the
healthcare environment behind that, so that you can put forth all the different
permutations of data and errors that it could face, but, you know, this is
going to be an incremental process.
DR. STEINDEL: John, this conversation that you just had with Marc raised a
question in my mind.
When we look at certification, we’re saying that a body, the certification
commission for health IT, has developed some criteria. It’s taken a look at
EHRs, and it said, you know, “Based on our tests, this EHR can do
And, then, really, what you and Marc were just talking about is more how
that EHR is substantiated in the area.
Is there a need for accreditation, that second step in this process, and
should we start thinking about that?
DR. LOONSK: I think — the simple answer is — I think is yes. I think
that’s what you’re going to see on one of my slides. I think that there’s a
series of things we need to consider.
But let me tease out, at least two pieces of that question, because one of
them is about how it’s installed on site, and that’s very important, and it’s a
big issue, and that goes to security. It goes to interoperability.
But another is to actually have — the certification process, as it exists
now, is really what we would call inspection testing, and inspection testing is
You have a pool of jurors who look at the product. Does it do this? You try
to have it be non-biased, and I think that CCHIT has done a wonderful job of
building a very strong juror-based inspection process.
And you can do some surrogates for interoperability testing there. You can
give them data — and you know some of this, Steve — but you can give them —
DR. STEINDEL: Unfortunately, all too well.
DR. LOONSK: Yes, you can give them data, and, then, as part of that
inspection test and then see if it actually gets into the EHR.
So — but what we need to get to is conformance testing, and conformance
testing is something that CCHIT has started to do a project on around the CCD,
and it’s something that — as I said before — we’ve been working with NIST to
try to advance general infrastructure for. We’re doing a lot in regard to the
NHIN for that that you’ll hear about later, but that’s the other side of this,
and doing inspection testing for interoperability will never meet every need in
MR. REYNOLDS: John, certification — my understanding with certification is
that it’s a moment in time. So once you get it, you don’t have to recertify.
You don’t have to attest each year that you stayed certified. So one system one
year, another system the next year, and the third system can all be certified,
but the — at three different levels, possibly.
DR. LOONSK: The certification seal is a three-year duration. The Stark and
anti-kickback relief actually asks for them to be certified within a year.
So the certification is three years. Stark and anti-kickback requires one
year to have been certified if you’re going to make a donation within a year.
And if you bring new software to the table, that would have to be
recertified. So if you’re bringing the same version of the software back, there
is an update process, but, largely, as the software advances, you do have to
You know, it’s one of the reasons that — and this is another communication
issue. It’s very valuable for people, in making purchases of software, not only
to say that they need to use — you need to use certified software, but to also
put it into the contract that they have to get recertified and that they have
to maintain the certification of that process over time, particularly in the
context of what I’ve talked about that this is a maturing process, that
interoperability is still going to be a developing activity.
You don’t want to just — even though they would have to get recertified,
you don’t want to base your contract on the fact that it was certified at one
point in time and then had built nothing in there about getting recertified and
doing software updates.
So some of that’s on the basis of who’s purchasing the software and
ensuring that they, in fact, demand that the software be recertified.
So to the NHIN, much of what we talk about when we talk about the national
health IT agenda is about mobilizing health information and using it for a
number of different purposes.
P> We obviously know that it can produce cost savings, can potentially
decrease duplication, that it can make inroads in quality, that we need
clinical data to get to really strong quality measurement and quality reporting
and quality improvement, not just claims data.
We think it can help with transparency on healthcare, and we obviously
think it can help with public health and emergency preparedness and activities
in that domain as well.
These are the vision statements for the NHIN and for moving forward.
There’s a lot of different models, though, that are out there for health
information exchange, and this is one way of articulating them.
You could think about health information exchange that occurs in an
organizational context, think of an integrated delivery system, where they’re
exchanging information internally.
You know, the benefits of that are that that integrated delivery system has
a very strong alignment of that information exchange with their business
objectives and business goals.
The challenge is that extra organizational exchange is not as well
supported, and, clearly, when you’re thinking about that in the context of
non-proprietary exchange or exchange with other organizations, that’s a huge
We have the category of geographic health information exchanges, and the
language around this has been changed and rechanged and et cetera. We had the
RHIOs and — Regional Health Information Organizations.
We have been trying to use the term “health information exchange”
to define a broader target, which would be potentially inclusive of all these
rows here. I’m not sure that’s caught on in the industry, but that’s the
language we’ve been using.
So let me just say that a geographic health information exchange and a RHIO
might be very similar, where you have a multi-stakeholder organization who is
trying to support non-proprietary exchange. They’re largely in it because they
think that that can improve healthcare in their jurisdiction, accomplish many
of the benefits here.
The issue is that the business model for that activity has been a
challenge. There have been some successful exchanges. There have been some who
aren’t successful. There have been a lot of discussion in the literature about
whether that’s a viable model moving forward.
I think one could say — I mentioned 400 EHRs before as a starting point
for EHR certification. I’m not sure 400 health information exchanges is a
viable way of moving this industry forward either, and so, as we see some that
are closing down, you know, it’s hard to say right now, to be honest, whether
that’s a natural part of moving forward or whether that’s, indeed, a sign that
just cutting it and making this a sustainable activity is going to be more of a
challenge than some can achieve.
We are also now seeing a number of groups coming into the market in the
personally-controlled space, and I’m loath to try to contribute another acronym
to this space, but we’re trying to talk about this category of a personally
controlled health record.
You know, they don’t like to necessarily be called health data banks,
because some of them don’t like the bank analogy.
The PHR is inclusive of a number of different models for how that’s
supported and how people can or cannot access — control their information. So
just naming it as a personally-controlled health record or support organization
— and there are a number of examples there. They offer some promise, in terms
of the consumer’s involvement, and, potentially, the consumer’s ability to get
their data and to collect their data and to manage their data, either directly,
as an individual, or, I think, more realistically, with surrogates who would do
it for them, but, whereby, those surrogates would be trusted and could
accumulate their information and make sure that it was accessible when needed
in support of their healthcare.
Some of the models for this actually go to point-to-point exchanges, where
some of these organizations are trying to reach out to a particular provider
organization, say, “We’ll exchange with you. You’ll exchange with
us.” You know, that’s a huge challenge if you think about all the
different connections that would have to be manifested in that regard.
So what are we trying to do in ONC to try to accelerate the appropriate
exchange of data?
Obviously, there’s a whole variety of things being done on the privacy,
security front, but, clearly, we need to have common standards and
specifications. That’s part of what we’re doing in the NHIN.
Right now, we have nine health information exchanges that are interested in
the non-proprietary exchange of health information. We have the federal sector
participating in this, and they are working on those specifications, based on
standards, to manifest that exchange.
Clearly, we also need agreements that can define the relationship between
these different exchanges, so that they can work together, they can have trust
relationships as well, and I’ll talk more about that.
And we also feel that we need to encourage the demand for using standards
If the NHIN is about using common standards for connecting, having common
policies for how to connect, we want to make sure that people are compelled,
organizations are compelled to join that club, and that this, too, is a
chicken-and-egg situation, because the more participants we have, the more
compelling it will be, the more desirable it will be for people to participate,
the more desirable it will be for them to be certified and/or credited and/or
meet the standards and do the work of health information exchange. So getting
to that threshold is an important consideration.
So the NHIN approach is based on this. What we’re trying to do is identify
a minimum set of exchange standards to support cooperative health information
We are trying to embrace different models of participation. All three of
the models I previously referred to are viable models for health information
We’re not trying to suggest that it has to be a dedicated organization that
does it. We think those organizations that are out there struggling to do this
are doing admirable work and that we are trying to be as encouraging as we can
be, given resources that are available for them to consider how they can be
sustainable, how can they facilitate health information exchange in their
communities, how they can bring multiple partners to the table.
But there are other models as well, be that an integrated delivery system
that’s also participating or be that a personally-controlled health record.
There are several different ways that this exchange can go forward, and we
think that all of these models are viable and attractive to have participate
using the same standards and adopting the same policies for health information
We’re trying to do this in a way that encourages market competition. So we
want these minimal standards, but we know that what will be in a few years is
not what is now, and we’re trying to advance those common capabilities, but
recognize that, indeed, if this is done in consideration for confidentiality
and security, that there can be tremendous benefits that build on top of this,
just like the internet, but to accomplish goals that we can’t even completely
anticipate right now.
So we’re trying to build demand. We’re trying to support the processes
necessary to get to this point.
The process we’re using is prototype. We did that. Specify and test. That’s
where we are now with the trial implementations.
And, then, what we hope to do is, by the end of this calendar year, have
eliminated all the obstacles to go into production, and we hope, by the end of
this calendar year or the beginning of the next calendar year, to, not in a
big-bang way, but in an incremental way, begin to bring up NHIN services,
production NHIN capabilities, if you will, to start this path toward this
So the NHIN trial implementations are an important intermediate step in the
middle of that. We’re asking them to demonstrate, in place, these capabilities.
So we’re walking a fine line here. We, for a number of reasons, are not
asking them to use live data for these purposes. What we’re asking them to do
is to use test data that is statistically appropriate, to use systems that
indicate that they have the capability to actually go to production immediately
after this year and to work through the agreements that actually would allow
for them to have what we would call a DURSA, or a Data Use and Reciprocal
Support Agreement, in place — a live agreement in place, available at the end
of this year, so that, indeed, we can convert to production.
We are having them focus on four principal things: delivering data — the
summary record plays an important role in that — supporting cross-organization
look-up and retrieval, exchanging consumer access permissions and supporting
the delivery of data for population uses. Four core functions.
And then we’re asking them to also implement use cases. So two of each —
each participant has signed up for two use cases of the first seven that came
out of the American health information community, and they will be helping to
develop the specifications for those use cases and then demonstrating that
use-case functionality on top of this process as well.
MR. ROTHSTEIN: John, could you say something more about the summary?
DR. LOONSK: The summary record.
MR. ROTHSTEIN: Yes.
DR. LOONSK: From the start of this, in both conjunction with the Healthcare
Information Technology Standards Panel, or HITSP, we have seen the fact that a
summary record could be a very important component of a developing electronic
We know that putting an entire record on line is going to be a challenge in
most all circumstances. We know that, for many purposes, you don’t necessarily
need the entirety of the record to carry out a number of different
It was compelling with Katrina that if — when we had all these displaced
individuals — if a generalized summary record of that patient was available in
the context of the care that — where they were receiving emergency care, that
would have significantly advanced the ability of the clinicians on site to do
We also know that this has been one of the most contentious areas in the
standards domain for a few years. There have been issues of conflict between
something — the continuity-of-care record that was articulated by ASTM and
Very clear business case. Very — stated. “Here’s a summary record.
And I think that it had great traction with clinicians because it was tangible.
You could say, “That’s what this is,” and you could understand the
context of that.
On the other hand, we have a huge amount of work that’s gone on in HL-7 to
develop a broader architecture for how health information can be shared, for
the terminologies and the context for those terminologies and the messaging for
some of that that’s been going on all along.
So one of the significant accomplishments of HITSP, I think, was to help
advance the harmonization of the CCR and the CDA from HL-7 into the CCD.
And what we’re focusing on in the NHIN, what certification is focusing on
for their testing of certification is the CCD as the summary record to do that.
It is something that — for the purposes of the NHIN work, there’s a ground
floor that’s being described. The ground floor is to say, “If I’m an
emergency physician and I’m getting a patient that I’ve never seen before —
“ this is the biggest scenario in the emergency-responder use-case
priority that came out of the AHIC “ — what general summary record
information could I have that would allow me to treat that patient in that
So it’s not about an emergency-room physician sending information back to
the hospital. It’s about treating a displaced patient when you don’t know
exactly what information you need. It’s about saying, “I need a
generalized summary record, so that I can treat — help treat this
That’s the floor, but in the context of what I’ve just laid out for you
also, the use cases will have additional demands on that, and some of them will
add data elements moving forward.
The opportunity here is that the summary record can actually accommodate a
great amount of data and a great amount of other possibilities. And I think
this, too, will be an incremental thing, but what we’re doing with the NHIN is
saying we’re going to use the HITSP standards, but we’re going to try to also
make sure that that’s a generalized summary record that can be used in a number
of different contexts, and we’re going to test it against the use cases as well
as it moves forward.
MR. ROTHSTEIN: So the question I have, when you do your evaluation of the
plans, I assume that you’re going to consider not just the ability to transfer
the data electronically, but the effect that that data set has on clinical
DR. LOONSK: I think it’s a highly-relevant question. I’m not sure that the
NHIN contracts and the participants in the NHIN are necessarily the right group
to do that evaluation.
If you think about it, a lot of this is coming from the technical side,
from the health-information exchange side. I think that is going to be an
inevitable component of looking at the summary record as a viable clinical
tool, but I’m not sure that’s really in the scope, considering it’s — the
specific demands it would have on clinical analysis of the NHIN contracts.
MR. ROTHSTEIN: I mean, but it seems to me that it’s equally important as
the ability to transfer the information is to consider whether the users of the
information regard it as adequate and accurate and sufficient to do what they
need to do with the information.
And there obviously would be a lot of push-back if that were being
developed as a standard when people are uncomfortable using it, and so the
empirical data from these pilots on whether it, in fact, is good enough would
be, from my way of thinking, extremely important.
DR. LOONSK: Let me add a couple of things here, because none of it is quite
as cut and dried as I’ve just laid it out for you.
So what we’re doing with these is to have a summary record to be able to
push that in association with certain needs.
The summary record will, definitionally, have a certain level of semantic
interoperability that some other electronic data won’t, but we are also
advancing the capability to do a lookup and to identify where other data on
that patient exists and then to have a retrieval where those data that are
subsequently retrieved, obviously, would have to be in the electronic form to
be retrieved, but would not necessarily have to be in the format of the summary
record or in a — necessarily a standardized format for them to be pulled
across. They could be visualized, so to speak.
And so from the context of the work we’re doing in the NHIN, both those
capabilities are in play, and so I think to drill down into this issue — and
it is an interesting issue, and your points are quite valid — from the
standpoint of the NHIN, we’re not just talking the summary record. We’re also
talking about this ability to do a more generalized lookup and a more
generalized retrieval as well, but, nevertheless, this token of exchange of a
summary record, I think, could be conceived of as a starting point that may
initiate some of that as well.
DR. COHN: John, I just want to do a time check with you. Are you okay for
another 10-15 minutes?
DR. LOONSK: Yes.
DR. COHN: Okay. And before we — people getting into this particular topic,
how much more do you have —
DR. LOONSK: I have one more slide.
DR. COHN: Oh. Would you like to do the last slide and then we’ll continue
with the questions?
DR. LOONSK: Sure. Because I think this might inspire other discussion, too.
DR. COHN: Oh, sure. Go for it, John.
DR. LOONSK: So in the NHIN, we’re developing specifications. We’re trying
to coordinate this with HITSP. So we have this multi- — you know, HITSP now
has over 300 different organizations. We have these multiple NHIN contractors.
We’re doing this multi-body collision of trying to make sure that the work
going forward from the NHIN is thoughtful in the context of the standards
coming forward from HITSP, that HITSP can also give additional input where
As an example, we also have liaison to CCHIT as they move forward in the
certification process as well.
And the NHIN has already made some requests of HITSP where it said,
“We don’t see the standard in this particular area. Can you help us to
figure out what we should do?”
But the final thing I wanted to name, I said that we’re working with nine
geographic HIEs and the federal participants, and, as of yesterday, there was
— at grants.gov, we have put up a new grant opportunity, and this is — these
are very small amounts. This is — mini-grants was a term used. Micro-grants
was a term used. I was sort of settling on micro-mini-grants. These are not
long-skirt grants. These are —
But the point is that there has been an expression from a number of
different organizations in the categories that I’ve walked through that they
would like to participate in the testing and demonstration as well. And so this
is an opportunity to do that.
It’s not huge sums of money. It’s up to $100,000, but we think that there’s
a substantial interest. We’d like to have some of the personally-controlled
health-record industry start to get on this same bandwagon, because we think
that there’s a real synergy between these things.
We think there are other geographic HIEs that might participate. We think
that there are integrated delivery systems that would be interested in
participating and that that’s helping to flesh out this broader picture of the
NHIN. We also think that there may be some specialty networks that can offer
What we’re trying to do is to bring others to the party that can offer
value to those who are connected, using the standards and participating.
And we wish we could offer more funds to help support this, but we’re doing
what we can, and we think that this is an opportunity to help continue to grow
this pool of participants using the standards and participating in the NHIN
MR. BLAIR: Would those mini-grants be available to any of the HIE networks
that want to use that for an additional-use case if they have entities that are
interested in that?
DR. LOONSK: The way that this is structured, this is bringing new people to
the table, not new specific functionality to build on top, but, indeed, new
participants at the core services level, and that’s what’s articulated in these
DR. STEINDEL: I think we had Lisa(ph) and Larry asking.
DR. LOONSK: OK. I’m sorry.
DR. STEINDEL: And then I have a geeky question that’s probably going to
pick up on theirs.
DR. FRANCIS: I had a question a couple of slides back, where there was
mention of trust.
DR. LOONSK: Yes.
DR. FRANCIS: And I’m interested in what specific questions have come up
with respect to generating the kinds of assurances that are needed for trust
when networks share.
DR. LOONSK: I’ll use that as an opportunity to do this slide, which I never
actually talked about.
DR. FRANCIS: I mean, part of that is, of course, whether protection of
privacy and so on —
DR. LOONSK: It’s very relevant. Good.
So the way we’re thinking about this is that there are several components
to building trust and implementing policies for this kind of network of
networks, and that obviously there’s state and federal laws and regulations.
Those are there.
We talked about certification and there’s things it does. There are things
it doesn’t do.
We feel that there’s probably a need for an accreditation-like process that
would have more of an onsite component, more of a policy component than
certification currently does.
We think that there may be a need for ongoing governance as well, and so
one of the candidates for this is the AHIC 2. And I did say I might talk about
that a little bit, but the AHIC 2 is a possibility for this where the AHIC 2
might actually play a role in an ongoing governance relationship, because none
of this can be completely static. It has to move forward.
And then we see there to be a role for data use and reciprocal support, and
there’s an opportunity here in conjunction with governance to say, “These
are the things we agree to, to participate in, to make sure that there’s a
chain of trust and trust relationships for how this worked together.”
If you think about this, much data sharing right now is either done point
to point or it’s done at least maybe with one intermediary who has a regulated
role in that particular function.
What we’re talking about here could have several steps and where you have
to ensure that trust is manifest in a chain across those different steps.
And so what we’ve been working on as part of the NHIN is to develop the
kind of agreement that these health information exchange organizations could
all agree to, so they would not be doing point to point, and that would help
establish this chain of trust that would allow for the way the information
would be treated and the way in which they would support each other in the
different complicated activities that need to be carried forth.
This is a somewhat complicated picture, but we think a number, if not all
of these, at least most of these things need to be coming into place to
actually advance this activity going forward.
MR. REYNOLDS: John, this morning, we finished up a privacy letter talking
about people being able to possibly control the use of their data across these
types of things.
The list there seems to — at least in initial reading — seems to really
address trust amongst entities and certification processes, not really the
individual and whether or not — and it doesn’t mention anything like — as
we’re all talked about before, the privacy notices are hard to understand now.
Opt in and opt out is in the eye of each beholder.
And, then, this idea of whether you — you parse data out or you do some
other things like we talked about this morning.
So could you give us a little more on those three? Because, as we’ve said
today, this is moving fast, and to quote you, too. So as it moves fast, how is
the other staying up with it as we go along?
DR. LOONSK: These are tools. What those tools implement is — the kinds of
activities you’re talking about are easily potentially in scope for the right
tool in the right context.
So one of the things that we in ONC have found valuable is that we’ve been
able to use the NHIN contract mechanism to say, “Well, this is the bar
we’re trying to set, you know, we’re trying to set for this activity.”
We have referenced the work of this body in terms of saying that this is
part of that bar. This is part of establishing that bar for what needs to move
The use of a contract in that regard is helpful, not to conflict with state
or local laws or to conflict with HIPAA, but to potentially supplement and to
potentially move forward in ways that are important.
We see data use and reciprocal support as a — kind of tool, that there is
an ability to potentially implement in there some capabilities that will allow
for moving that bar forward.
We do have — In the NHIN, we’re trying to work on technical infrastructure
that allows for the consumer to express their choice, but, realistically, here,
too, the data that are flowing now and the activities that go on inside of most
provider organizations are, at times, far from that implementation, and this is
not biting off all of that. This is talking about the network and trying to
start to endow the network with capabilities that can ensure not only that care
can be carried out, but that the consumer can have a certain amount of say in
where their data are and how they’re being used.
MR. REYNOLDS: Thank you.
DR. GREEN: John, thank you again for coming in the time and — and good
luck with this.
We have in our preparatory materials for this meeting the letter report
from the IOM that you asked for at the — and I think I understand the letter
report a whole lot better now than I did an hour ago.
So I have two recommendations. One was that ONC should develop a strategic
plan providing a roadmap with specific objectives, milestones and metrics for
the national health information and technology agenda.
And the other was to clarify and include the ONC’s processes for advancing
the IT agenda, specifically processes for decision making, workload
coordination and feedback.
My question really is is what’s your plan for responding to the report?
DR. LOONSK: So to set the context for this for everyone, the Office of the
National Coordinator commissioned the Institute of Medicine to look at the
question of whether standards were being advanced in health IT too slowly, too
fast or just right.
So the context for this was to try to get from them an educated view on
In the context of their response, they came forward with the
recommendations that you relayed to me, indicating that it was hard for them to
resolve the question that was asked of them without particularly the first
piece of information.
ONC has been working on a strategic plan. I anticipate that a strategic
plan will be available in a short period of time that will — The process of
going through a plan in government is an interesting one involving many twists
and turns. There had certainly been hope that it would be available sooner, but
I don’t think it’s going to be long now.
Will that answer all the questions? You know, will that give the
information that’s necessary to adjudicate the issue that we asked of them? I’m
The issue of feedback and input is an interesting one. I sat through the
IOM activities. I think there was — I found there to be one area of complete
agreement among those who testified, and then areas where there were a lot of
The area of complete agreement was that none of them liked all the
priorities that were set forth.
The area of non-agreement was that none of them could agree which were the
wrong priorities. And I say that in a somewhat flippant fashion, but it really
There was sort of a parade of different people who had different interests,
who had different perspectives on what was important. Was it the medical home
or was it a personal health record or was it — you know, all the same issues
that you all see, and they came forward.
And so I think that’s both healthy and not necessarily completely helpful
in terms of coming forward with an alternate set of priorities. So that has
been one of the biggest challenge.
What the AHIC has been used for is to try to set priorities. What should be
worked on first? The way that input has been given to that, it’s a FACA. You
know some of the challenges with FACAs. The AHIC developed a bunch of working
groups that were also acting like FACAs and contributing priorities.
Was it perfect? No. Did it manifest all the priorities? No. Did it
necessarily come forward with them in the right order? I don’t know, but I do
know that it was critically important to have a group that was prioritizing,
and the AHIC did that job.
I have to commend Secretary Leavitt for him leading that. It was highly
contentious, but we had priorities. We moved use cases through. We’ve
accomplished what could be called now a backlog or harmonized standards that
can help to feed this activity and further activities going forward.
And, now, it’s a time to relook at that and to see if there are some gaps.
I think the next round of AHIC priorities is going to be around gaps.
And then the AHIC 2, I think is a tremendous opportunity to see if, in a
broader way, how can things be better represented and how can that organization
take a more permanent positioning.
One of the critical aspects of the AHIC 2 is how are states and regions
hooked into that? This is not — cannot occur at the federal level exclusively,
and there’s been relatively a disconnect between state-level activities and
federal-level activities in this regard.
So I think there will be a strategic plan shortly, and I think that the
process of the AHIC 2 offers a wonderful opportunity to try to work on methods
of input to the process and look at them again and learn from what has been
done well and what hasn’t worked optimally going forward.
DR. COHN: I think we’ll finish up now. Is there — Steve, you have a –
please, go ahead. Last question and then we’ll wrap up.
DR. STEINDEL: John, I appreciate your comments, and I appreciate the
comment that the IOM letter report didn’t exactly address what it was charged
But the IOM letter report has some extremely critical comments about the
process in the ONC office. Is anything being done to address that?
DR. LOONSK: Steve, those were your words, not mine. So let that go on the
DR. STEINDEL: I stand by them.
DR. LOONSK: You know —
PARTICIPANT: That’s what it said.
DR. STEINDEL: It’s actually in the report, those words.
DR. LOONSK: Well, no, the first part of your statement were your words, not
DR. STEINDEL: Oh, OK. The first part.
DR. LOONSK: You know, I read the report. I sat through the proceedings. I
actually believe, and I think that there probably is some harmony with this in
terms of the kinds of testimony that you get at times, that this is one of the
most challenging areas that is being engineered right now.
There was a study that came out this week that listed the 13 top
engineering challenges, and one of them was reverse engineering the brain.
Another was carbon sequestration. And another one was electronic health
I am very proud of the way that the different participants in a small
office in the Office of the National Coordinator have helped move this agenda
And I guess I would say, too, that if there was another common theme that
came forward in the IOM study it was that almost universally every testifier
said that there’s been more progress in the last few years than there has been
in the last few decades.
So I choose to look at it as a cup that’s half full, and I think that we’ve
made a tremendous amount of progress.
DR. COHN: With that, John, I do want to thank you.
I think you guys have made — I agree with you. I think there’s been
tremendous progress, I mean, really, over the last 10 years.
Obviously, the fact that the Secretary has been completely behind things
over the last several years has, I think, made all the difference in the world.
And I think — you know, obviously, look forward to obviously further
evolutions as well as how things are going to evolve over the next year or two
with the new administration and Congress. So it’ll be, certainly, an
interesting time for us all.
But I think, certainly, there’s been a lot of progress. You have much to be
proud of. So I want to thank you for taking the time.
(Whereupon, the Full Committee adjourned at 3:25 p.m.)