[This Transcript is Unedited]

Department of Health and Human Services

The National Committee on Vital and Health Statistics

June 15, 2011

Double Tree Hotel
300 Army Navy Drive
Arlington, VA 22202

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402


P R O C E E D I N G S (9:00 a.m.)

Agenda Item: Welcome, Review of Agenda

DR. CARR: Welcome to this esteemed and expanded group of great thinkers and
generous contributors. This is the National Committee on Vital and Health
Statistics, and I’d like to call to order the full committee. What we do now is
we go around the room, and everybody at the table will go sequentially to say
who you are, if you’re a member of the committee and if you have any conflicts.

And you may have conflicts, but we’re only looking for ones that have to do
with the work of the Committee, so that will straighten it up a little bit. And
you may not even know whether you do or not, because we haven’t gotten into the
agenda, so you’ll have every opportunity to let us know. So I’m Justine Carr,
I’m from Steward Health Care in Massachusetts and I’m Chair of the Committee,
and I have no conflicts.

MR. SCANLON: Good morning everybody. Jim Scanlon, Deputy Assistant Secretary
for Planning and Evaluation at HHS. I am Executive Staff Director for the
Committee and I have no financial conflicts.

DR. FRANCIS: Leslie Francis, I am professor of Law and Philosophy at the
University of Utah. I am a member of the Full Committee, and co-chair of the
Privacy Confidentiality, Security Subcommittee.

DR. HORNBOOK: Mark Hornbrook from Kaiser Premanente, member of the Full
Committee, no conflicts.

DR. MIDDLETON: Blackford Middleton from Partners Healthcare Harvard Medical
School, member of the Full Committee and co-chair of the Quality Subcommittee,
member of the Population Subcommittee.

DR. BURKE: Jack Burke, new member from Boston, no known conflicts.

DR. FITZMAURICE: Michael Fitzmaurice, Senior Science Advisor for Information
Technology, Agency for Healthcare Research and Quality, liaison to the Full
Committee, staff to the Standard Subcommittee, and any other committee that is

No conflicts, except for time.

MR. SOONTHORNSIMA: I am Ob Soonthornsima, new member of the committee, and I
have no conflicts.

DR. NICHOLS: Len Nichols, new member of the committee, and I have no

DR. FRIEDMAN: I am Chuck Friedman, I am Chief Scientific Officer at the
Office of the National Coordinator for Health IT, I am liaison to the committee
and have no committee related conflicts.

MS. PRITTS: I am Joy Pritts, I am Chief Privacy Officer at ONC and I am
presenting this morning, and I have no conflicts.

MS. KLOSS: Linda Kloss, new member of the committee, and I have no

DR. COHEN: Bruce Cohen, new member of the committee, and I have no

DR. MAYS: Vickie Mays, University of California, Los Angeles, new member of
the committee, no conflicts.

DR. SCANLON: Bill Scanlon, National Health Policy Forum, member of the
committee, no conflicts.

MS. MILAM: Sallie Milam, West Virginia’s Chief Privacy Officer, West
Virginia Health Care Authority, member of the committee, co-chair of
Populations, member of Privacy, no conflicts.

DR. GREEN: Larry Green from the University of Colorado Denver, not from
Massachusetts, member of the committee and no conflicts.

DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the committee, co-chair of the Standards Subcommittee, no conflicts.

DR. SUAREZ: I am Walter Suarez with Kaiser Permanente, I actually wanted to
live in Boston, I am a member of the committee, and co-chair of Standards
Subcommittee, member of Populations, Privacy and Security, and I do not have
any conflicts.

MS. JACKSON: Debbie Jackson, committee staff, National Committee. I am
filling in for Marjorie Greenberg, Executive Secretary, who is on her way and
will be here momentarily.

DR. CARR: As I started to say, this is a time of new beginnings and a time
of goodbyes. And this evening at our dinner, we’ll have a chance to speak from
the heart to our departing members, which include Garland Land, Marc Overhage,
Don Steinwachs and John Houston. We welcome back Leslie Pickering Francis and
Larry Green. But I also want to pause for a moment and ask Larry to say a few
words about Barbara Starfield, former member of the Committee, whose untimely
death occurred last weekend. And I wonder if you might say a few words about
her contributions.

DR. GREEN: Sure, I wasn’t expecting that, but this is very easy to do. So
Barbara was doing something she really enjoyed. She was swimming at her
California pool last Friday and she died in that pool, and was found when she
didn’t show up to pick up her grandkids, as she was expected to do so. Word
spread all over the world, for example, the BMJ Primary Care Editorial Group
heard about this, and over the weekend, there was this outpouring of grief,
regret, praise, gratitude, from Poland to Portugal to Argentina to Costa Rica
to Mexico to everywhere.

So the world just seems smaller than it did this time last week. And Barbara
was a member of this Committee, and quite pleased with that. And as those of us
who worked with her know, well, I talked to Carl White about this also, another
former Chair of the Committee. I don’t mean to get her husband in any trouble
here, but he said, I can quote the following sentence, he was quite distressed
by this news, and after a long pause, he said, that woman darned the socks,
made all the meals, took care of all the kids, and did ten times as much work
as her husband.

DR. CARR: Just a few words about a couple of her major contributions in
primary care and so on, for those who may not have known her.

DR. GREEN: Well, I’m unaware of anyone that would dispute the fact that her
life work, which goes over about 40, 45 years, is not really the cornerstone
basis for the scientific evidence that supports primary care and its effects. I
mean, in a word, Barbara’s work, she summarized it in Cancun at the World
Organization of Family Physicians’ Annual Meeting last summer, as primary care
is medicine’s way of improving population health, relieving disparities while
containing costs. And the real kicker in it was the next slide, it said, and no
studies shows otherwise. I’m really going to miss her.

DR. CARR: So we will miss her and we will hold on to her incisive way of
viewing things, and her willingness to think ahead. Okay, with that, we’ll get
to update from the department. I’m just going to give a little heads-up. I need
to step out at 10:00, and Walter will be my able substitute, and I will be back
at 10:30 when we resume the agenda. So Jim, I’m going to turn it over to you.

Agenda Item: Updates from the Department

MR. SCANLON: Well, thank you, Justine, and it’s good to see our full
complement of committee members here. I don’t think we’ve had all 18 members,
all of the slots filled since probably the late ’90s, just after HIPAA was
enacted, so it’s very nice to see everyone. And I thank you again for agreeing
to serve.

So I’m going to give just a brief update of some of the activities at the
departmental level, and you’ll hear from other folks at HHS about specific
activities, HIPAA and Health IT and other developments, as well. We also have
an ASPE, we’ve established an initiative for multi-payer, multi-claims
databases, something that the department’s been asked to do for a long time.
You’ll be hearing about that later today, as well.

But let me start sort of at the top level. The HHS Strategic Plan, we
published it about two years ago. We’re probably going to be looking at it
again to update. But for the new members particularly, I think what I would
like to do, Justine, just go over the overall goals, but then we’ll make
available to you the goals and the objectives, and the website for the plan, as
well, just so you can see at that sort of 20,000 foot level, sort of how the
department represents itself, in terms of priorities. And none of these are
surprises, by the way, as you’ll see.

So the first goal is transforming health care, and this encompasses all of
the health reform, health systems change and all of the other health care
related activities that the department undertakes. A second goal is to advance
scientific knowledge and information. This encompasses the missions of the NIH
and CDC and FDA and so the science agencies.

Goal three has to do with prevention, advance the health safety and
well-being of the American people. There are a lot of program and activities
there. Then, so to focus inward, goal four is to increase efficiency
transparency and accountability of our own HHS policies and programs. And that
in data, particularly as data transparency is big, one of the sub-objectives
there, I’ll talk a little bit about it further.

And again, turning inward and turning to the workforce, goal five is to
strengthen the nation’s health and human services infrastructure and workforce.
So there are usually about six objectives under each of those, and I’ll make
those available to you. But again, I commend the strategic plan to you, just
sort of as an overview of the major activities within HHS.

The second thing I wanted to mention was obviously the Affordable Care Act.
The Department is undertaking a lot of activities to implement the provisions
of the act. We’re at work looking at what kind of data would we need to monitor
both the implementation and the outcomes of a health systems change. And we’ve
added, I’ll talk a little bit more about that, we’re looking at where would we
get the data to evaluate, implement and monitor.

But there is a specific section in the plan, of the Affordable Care Act, I
wanted to bring to the Committee’s attention, and it reviews with Data
Collection Standards, which we’ll be working on. So section 4302 of the
Affordable Care Act, requires the Secretary of HHS to adopt several, and
they’re named, data collection standards, mostly for demographic type items.
It’s basically sex, race, ethnicity, primary language and disability. So at any
rate, the Secretary is to adopt data collection standards for these items to be
included in a standardized way, in all of our major data collection systems
within in HHS.

Now, again, all of you are familiar with our systems. We have some standards
already in these areas, but the idea here was to be sure that this minimum set
of demographic and related items were included in all of our surveys. So we had
a work group under our data council, looking at these activities, and we
probably, within two weeks, will be publishing for comment what our proposed
standards are in these areas. And again, these are minimum standards, so
obviously for disability, they’re sort of an infinite variety of information
you might want. But this is a minimum set of information in all of our surveys
that we would want to have on persons with disabilities.

DR. MIDDLETON: Jim, I wonder actually, does it go beyond survey data
collection at all? Does it pertain at all to the clinical source of data?

MR. SCANLON: Yes, we’re proceeding in two steps here. And the other thing I
should mention is, this is self-identified data. So this is information that
the respondent has to be able to identify themselves. So this first set of
standards will apply to the surveys. We also have a parallel dimension that
we’re looking at how would we adopt standards that would apply to clinical
information. Administrative data is much harder, as you know, because you don’t
have a lot of room for additional items. But even there, we have something.

So we begin work, we need a little more consultation. We’re looking at what
the IOM recommended for quality measures for these areas, and so probably a
next step will be in our clinical, probably standards related to EHRs, if
possible, down the road. But it would hand deal with items related to these. I
have to say, we looked at all of our surveys, we looked at literature, we
looked at what the IOM has said about these issues. And we actually had a nice
foundation on build on.

DR. HORNBROOK: Jim, it’s Mark Hornbrook. What are they going to say about
having to ask the questions in the person’s native language? Are you going to
mandate certain languages?

MR. SCANLON: No, most of our surveys already have the capability. Right when
they visit the household or even when they first contact, they sort of get a
sense of what language, what sort of interviewer will be required. And in most
cases, it’s Hispanic, for most the cases, and then, arrangements are made if
there’s something else. So other than similar of an operational definition, you
have to be able to conduct a reasonably valid interview in whatever language.
So we provide that, that would be done, but the language standard that we’re
working on would be, and again, we sort of followed what the IOM was
recommending, particularly for clinical care and for research into medialogy,
as well.

Folks thought that the first thing was that the language proficiency, is
there English language proficiency, and then, specific language spoken in the
home, and so different measures to do this. We would be recommending a minimum
standard, and then for any setting or stage or community that wanted to add
more, a different array of standards, there’s the option to add additional

We would also be publishing probably, for each state, the ten most
frequently spoken languages from the census, so that everybody would know,
because it’s ten across the US. We could get the top ten, but there are some
states that it’s not the same top ten. So we thought what we would post on our
HHS website would be, for those requiring additional granularity, so the top
ten in your area.

Same thing for race ethnicity, we would be publishing. I can’t say yet what
the final will be, but we would be recommending additional granularity as a
basic standard for most HHS programs.

DR. SCANLON: Would this be something that the census bureau will be using,

MR. SCANLON: Yes, well, our authority applies to HHS surveys. But we took
care to look at what the census bureau and the ACS and the current population
survey of what we were doing. Because if surveys have already had experience
and we have some evidence that these questions work, those were the ones we
wanted to find first.

DR. MAYS: Can you say a little bit about what the process of a timeline will
be? So it’ll go out for comment; about when and how long, and then what are the
next steps?

MR. SCANLON: Yes, sure. So we will issue a federal registered notice that
says that the standards are now available for review. Again, this is planned,
so there might be variations. So we’ll post it probably on our minority health
website. And at least 30 days to comment, we’ll ask people to look at what
we’ve done, and if they have any other ideas or if they see problems, or if
there’s other things we should consider, so it’ll be at least 30 days. And
then, we’ll look at all the comments that come in, and in a deliberate process,
we’ll see what would we change.

Let’s assume there were no major changes, because again, we’re starting with
standards. For example, we have an OMB standard on race ethnicity, we can’t
really recreate that. We could expand it, but we can’t create something
entirely new. But let’s assume that everything went recently well, comments
were generally favorable or gave us ideas for future work. Then, probably
Secretary would adopt through a policy memorandum that we would post, and then
we would ask the agencies to implement these. The way we normally do this is
either with the creation of any new survey or with the major revision of a
current survey, things like that. And we would ask the agencies to give us a
timeline for when that would happen. So again, this is a projection. Anything
could come up or change.

The statute also gives the Secretary the authority to adopt additional
standards beyond those specified in the statute. So there are, as you can
imagine, a number of areas that people have proposed, but that will be in the
next round. Possibly, we will be asking the data council, the issue of social
economics standards comes up frequently, so we might be asking the data
council, and we’d like your ideas, as well.

I don’t think we’re looking at a SES index particularly, but we’re probably
looking at income and education, and the dimensions that make up. And there’s
some literature, I don’t think anyone does SES indexes anymore, but there’s
literature on this, and the Committee’s actually made recommendations there, as
well. So probably we’re looking at a couple of months before they’re finalized.
But everyone will see what they are.

DR. WARREN: Is this something that you want a formal response from this
committee on when it goes out for comment, or just individuals, should they
choose to?

MR. SCANLON: We can do it either way. We’d need the full committee meeting
probably. Why don’t I make sure that each of you get the email to look at, and
then you’ll see where we’re heading.

DR. CARR: What’s the timeline for comment?

MR. SCANLON: Well, once it publishes, let’s say at the end of June, let’s
say early July, 30 to 45 days, so that gives us a little over the summary. We
wouldn’t have a committee meeting until September, I guess. But I’d like you to
look at them, though, because I think you’ve all had experience.

DR. CARR: I think we would like to do that.

MR. SCANLON: I wanted to mention two more things quickly. We have created an
HHS, this is less so the population data, public health data, and more the data
for applications. But we created about 18 months ago, an HHS, what we’re
referring to now is a health data initiative. And it was done in connection
with our open government plan. All federal agencies were asked to look at ways
that they could make the operations of the agency more transparent and more
available to the public. And particularly, on the data side, were there ways
that we could open up access to our data with an HHS.

And again, most of you are, from research, you know we’ve made the data
available in the past. We’ve made it available in various ways, but you sort of
have to be an aficionado to know exactly where it is and where should you look
in. And then, we tried some other means, just to be able to focus more
generally on the data. So what we did was, first of all, the executive branch
created a website called data.gov, and the idea there was that federal agencies
should post data sets and tools, basically applications and analytic tools and
so on, that they had and that they thought would be available.

So we’ve posted already probably over 200 data sets and tools. It’s a little
tricky. You can’t exactly post 50,000 records from the household interview
survey there. You sort of have to go a different route to get that kind of
data. But we have other data that’s actually quite useful. We have indicator
data, we have data about our Head Start grantees, our community health center
grantees, all of the grantees. So this information is especially helpful in the
applications on your iPhone that deal with location. So you want to know the
grantees in your area, you want to know where the healthy food store is in your

So what we’ve learned is that, and this we owe really to our Chief
Technology Officer, Todd Park, who has testified before the Committee. But
basically, the idea here is to make the data available. Again, we don’t publish
identifiable data at all. Make it available through our health data indicator,
and also make it available through a sub part of data.gov, healthdata.gov. And
then, really get the data developers from HHS, and the web technology folks
innovators together, to see what they could do when you put these smart people
together, what kind of applications can you get.

And it’s actually quite interesting, because the applications usually are at
the local level. If you’re looking to move, you’re looking to move to a new
neighborhood and buy a new house, you start checking about what’s this
neighborhood like, what are the schools like. Well, we’ll probably get to the
point where you’ll be able to check this health set of your neighborhood, as
well. So we have had a couple, and again, this is less for the research side
and the public side. It’s really consumer related. I mean, the idea is really
to get the information into the hands of communities and consumers and
patients, and have the information available to them to make choices.

So we’ve had two very successful forums. A year ago, we had a Forum, it was
a joint effort of the IOM and HHS, where we first introduced these two
communities. And there were some nice applications that they demonstrated
there. And then, last week, and I think many committee members attended as
well, at the NIH, we had the second version a year later, where we had even
more applications and even more data sets to announce. So you could think, the
institutes of NIH are getting more interested, as well.

Cancer has always had a big outreach and communications effort in terms of
prevention and resources. And they announced some additional applications
there, as well. So again, we are pushing along these lines. If folks are aware
of data set that we have, that we haven’t published, you can let me know and
we’ll try to move them out. But the whole idea there is basically, I think our
Todd Park refers to this day of liberation, to kind of make it easier for
people to find this data.

I think researchers generally know what we have, but we could certainly make
that easier, as well. But this is for all those other developers to get this
into community, and into public health applications, as well. And one more
thing, just to update on the population data side, we are not in fiscal year
’11, and we’re in the third quarter of fiscal year ’11. Congress is working on
our 2012 budget. We don’t know what that would bring.

But for this year, at any rate, for basically our core health statistics
systems, and again, these are like the economic indicators. There’s only one of
these, and this is pretty much the source of data that we can see what’s
happening in the US with respect to health status, and everything from vital
statistics to surveys and administrative data.

In general, we were fortunate. Most other agencies and departments had
pretty significant reductions in their overall budgets. And HHS did, too, but
at least in this core statistical activities for this year, we’ve been able to
at least hold a level of current services, and in a couple of incidences, get
some additional information, additional resources. So we’ve used that to begin
to look at adding questions on some of our surveys that relate to health reform
or now things might be working and so on. So we’re looking at HIS and MEPS and
some of our other data, so what we could augment, both in terms of content and
in terms of geographic availability and detail, to be able to look at what the
impact of health reform is. So let me stop there and take questions.

DR. HORNBROOK: Is there any departmental effort to look at the folks who
lose their Medicaid eligibility because of state cutbacks, or is that something
we can’t deal with?

MR. SCANLON: No, we do try to measure. I’m trying to think of what the best
data source is. We’re always monitoring coverage, we’re monitoring
employer-based coverage, we are monitoring public coverage and what the changes
will be. And we’re monitoring uninsured status all together. And for Medicaid,
obviously it’s a state program and we do it state-by-stage. And so we have
administrative data, and then we have some of the survey data.

In fact, we’ll be announcing health insurance coverage figures in August, as
we normally do from CPS. So yeah, we monitor that very closely. There’s a lot
of concern about what might be happening dynamically, obviously with the
recession, states are in very dire straights, and there’s a worry about what
will happen with coverage, start strengthening eligibility for Medicaid and
other things like that. We’ll be monitoring that very carefully.

DR. MIDDLETON: The HIT measure space, of course, would be extremely
interesting for this committee to hear about, or at least one or two members,
maybe. And there is an OECD effort underway that might be useful to know, or
for those folks to know more about, too, so I just wanted to make you aware,
and help in anyway I could to connect the dots.

DR. GREEN: Jim, I’d like to ask for your opinion about, given the goals
related to population health, and measurably so, and this locality thing that
has erupted about community level data and its use and everything, have you
spotted what you judge to be a particular, timely and promising opportunity for
getting these data used at the community level, that you’d call to the
Committee’s attention, where we might want to focus some effort?

MR. SCANLON: Well, you saw today, I think through the addition of Larry,
some of these things are still unfolding. But part of that application, for all
3000 counties in the US, there’s a set of health indicators. I think you’re
familiar, Larry, with Wisconsin’s set of health indicators. So that’s often
included for each of the counties, so that’s sort of the basement for all 3000

You saw in the paper today, Chris Murray and his colleagues at the
University of Washington published a mortality analysis of mortality in all
3000 counties across the US, a life expectancy, basically, focus. And really,
it’s remarkable, the variation across counties in the US. The county we’re in
now, if it’s Fairfax, has the highest life expectancy for men. There are other
parts of Virginia that have probably, and other states, reached lower than
developing countries. So within and across counties, there’s a lot of

As we’ve always known, Chris has documented this now, but I think we, from
the National Surveys, as you all know, sort of run out of data the further down
we go. We have good national data, we have regional data, we can make estimates
for some of the states. And with census, we can make estimates at the state
level. But other than mortality data and vital statistics data and some of the
indicator data we’re putting together, we run out of steam. That’s the very
goal we’re trying to address, Larry. Can we put together other data, direct
measurement or sort of indirect measures, that we can help folks at the
community level, develop data for them to use in their own decision making.

But again, I think with the economy we’re seeing, and this is not new,
researchers have seen this over the years, when the economy goes sour as it is,
some of our surveys show, for example, folks are not taking medicine. They’re
not doing their doctor visits, they’re not getting the prescriptions they want.
We’ve measured this over time. Even in good times, this happens to a certain
percentage of population. But when the economy goes south, as it has, then more
and more folks go without. And we could clearly measure this, and it’s usually
age groups and income levels, but we can measure this in our surveys.

DR. FRANCIS: I just wanted to make an observation, which was that it was a
fascinating meeting. I would comment that more of the apps were either about
improving provider patient interaction or nifty little things for me to do to
live better, like record the amount of sleep I don’t get. And I was
disappointed in the numbers and interests of the ones involving communities. So
it might be worthwhile, keeping our finger on. The EHR vendors were there in
force, that’s where the money is. But the community public health folks were
not so much there.

So I’ll speak more about that later, because I think that what we want to do
today is go back to the retreat that we had last fall, what was the agenda set
for the new members? What’s been the history of the Committee, in terms of
looking to what is the next issue coming forward. And I think this is what
we’ve been talking about and I think it continues, that underscores the fact
that continued attention from this group is necessary. I’ll let Marjorie
introduce herself.

MS. GREENBERG: Good morning. I’ve spoken to many of you on the phone. I want
to welcome the new members. I’m Marjorie Greenberg. I’m from the National
Center for Health Statistics, CDC, an Executive Secretary of the Department. In
a moment of green devotion, I decided to take the Metro, and it was a mistake,
so I apologize that I was a little late.

I did want to, in seeing the donut rather than the hole, from last week’s
what Todd Park referred to as the health IT palooza, datapalooza. Anyway, first
I want to thank the members who did come, and also, we’ll hear more about that.
But a few things just in kind of this last little conversation. Ed Sondik,
Director of NCHS, did host or organize a session on the needs for information
at the community level, which we were there in force. And we did hand out a
summary of the two workshops that this committee has held.

Although, I must say, it seemed really low-tech to come in with a paper
document in that particular meeting. I wish that I could have had a blue button
somewhere in the room where you could’ve gotten the document from, but that’s
what I had with me. But that was an excellent session, it was a concurrent
session, but it was a really good session. And I think we can talk about what
we heard there later.

But the other thing that I think did tie in very much throughout, with our
community workshops, and more and more, and I was actually talking with Bruce
Cohen about this yesterday on the phone, is that going back to our 21st
division for health statistics in the 21st century, and that schema that we all
are so fond of, about the influences on populations’ health.

A lot of that came forward, all these apps to find out where the parks are,
where the grocery stores are. Many other things that aren’t health care, and
aren’t traditional health care, but as we know, have often a greater influence
on people’s health. And so, a lot of the apps did harness that kind of data. So
I think that there’s a lot of potential here.

DR. CARR: And again, I’ve pulled that, so that was part of our retreat, and
I think that’s exactly right to go back to that and look at the outer circles.
We have a couple of folks who have joined us at the table, who’d like to
introduce themselves.

DR. STEINWACHS: Don Steinwachs, Johns Hopkins, a departing member.

DR. KAPLAN: I am Bob Kaplan from the National Institutes of Health.

DR. CARR: Okay, at this point, another departing member, Chuck Friedman, who
has been a fantastic liaison for us with ONC, will be departing, but we look
forward to your insights, as always today. Chuck?

Agenda Item: ONC

DR. FRIEDMAN: While the slides are coming up, let me just say how much of a
pleasure it’s been to work with all of you. I have a new gig and will be
leaving the government on July 15, so I’m in that very funny nether or
transitional state, where I have announced that I am leaving. I have not yet
announced where I am going, but expect to be able to do so very soon. And I’m a
little bit unbalanced by that state I am in, and I hope that is not reflected
in the quality of my remarks.

So in my swan song to you all, I thought I would update you on the concept
of, and the progress that is now being made in relation to this very appealing
idea of a Learning Health System. I know many members of the Committee have an
enduring interest in this topic, and I’m hoping that I will be able to engage
the new members to the extent that they’re not already engaged in this topic by
virtue of these brief remarks that I’m going to give.

So first of all, this term is used in a wide variety of ways, and there are
probably many definitions. Maybe everyone has their own definition of what a
Learning Health System is. But let me give you the IOM’s definition, which is
probably as close a canonical definition as there is. And that is that a
Learning Health System is one in which progress in science, informatics and
care culture align to generate new knowledge as an ongoing, natural by-product
of the care experience, and seamlessly refine and deliver best practices for
continuous improvement in health and health care. You would think I would’ve
memorized that by now.

Being a bit of an amateur historian, I think it’s also important to point
out that actually what has grown to be known as a Learning Health System is
really the outgrowth of a progressive and continuous federal vision, that I
could take back earlier to the NHII report, and probably even further back than
that. But I will just point out that the 2004 Strategic Framework that was
issued when David Brailer became the first National Coordinator, the 2008 ONC
Strategic Plan, and now, as I will say a bit more about in a moment, the
forthcoming 2011 Health IT Strategic Plan that ONC is producing with assistance
from a large number of our friends all speak in various ways to this concept.
And the Learning Health System as a label on this concept is profoundly in
evidence in the 2011 strategic plan.

So just to bring that IOM definition down to earth a little bit, I think
most of you have seen these scenarios before. I’ve started using the tag line
in my talks about the Learning Health System, that we can take what now takes
17 years to bring new biomedical knowledge into routine use to something that
takes 17 months, or maybe in certain circumstances, even 17 weeks or 17 hours
by creating an integrated system supported by a digital infrastructure that is
capable of doing things with appropriate permissions and trust very, very

So two examples are seen here, how post market surveillance of drugs might
reveal serious problems, in this simple case, with a dosage based on a
personalized health algorithm. And the Learning Health System could detect this
very quickly, and equally quickly, create an intervention that would be
disseminated back out to practitioners who were part of organizations that are
part of this system, and indeed to the whole country, that would be implement a
decision-support rule in their EHRs to correct this problem. And similarly, the
Learning Health System could be used to track epidemics, but more over, and the
CDC is already experimenting with the pilot project that does this, actually
send alerts to physicians, EHRs or care practitioners, EHRs, basically saying
that the disease is headed your way and be on the lookout for the symptom
complex that is characteristic of the epidemic that is spreading.

I’m delighted that the Learning Health System is front and center as a
pillar of the forthcoming Health IT Strategic Plan, which has five goals,
actually four of which in various ways invoke the Learning Health System. But
the fifth and top most goal, specifically articulates achieving rapid learning
and technological advancement. So this strategic plan, which has gone through a
period of public comment and is now being revised for final clearance and
release, we hope very, very soon. It is a plan required by the HITECH Act,
which mandated a revision of the 2008 plan. And you will see in the plan, when
it is released, if you have not seen in the publicly released draft version,
this clear expression of the importance of the Learning Health System.

This is a very high level diagram, and I know some of you in the room have
seen this before, of what a Learning Health System might look like. This
diagram is not to be taken literally, it is a schematic. The idea of a cloud
does not necessarily imply that the Learning Health System will use cloud
computing technology, as we know it today. I think it’s very likely that it’ll
use something resembling that, but that is not intended as a literal statement.
But embraced in the cloud are the functions that a Learning Health System will
need in order to function. It will need governance, it will need public/patient

It will need above all trust, it will need technical functions, such as the
ability to aggregate and analyze data, whether by actually moving that data or
analyzing it while it still remains in place, and there are techniques
developing for that to be possible. And then, this outward flow, this afferent
flow of information out from the whatever entity or place converts data into
knowledge, back to the members, back to the periphery, back to the
practitioners, so that practice is, in fact, changed as a result of the new
knowledge that is generated.

Generating new knowledge by itself is not sufficient for the full
functioning and beneficial effects of this kind of National Learning Health
System. There needs to be the ability to move the new knowledge to the points
of care, to the points of research, to the points of decision, so that behavior
in the interest of improved quality, safety and effectiveness of care and
population health is realized.

ONC was delighted to work with the Institute of Medicine last year in the
holding of three workshops, which resulted in a report, a preliminary version
of which was released in record time in December. The workshops happened over
the summer, the preliminary report came out in December and the final report
was actually released on May 23. This report expands a lot on the diagram that
I showed you and how those functions in the cloud, through the creation of a
digital infrastructure, might actually be implemented. There are some very
important and creative ideas in that report, most notably the concept of the
Learning Health System as a so-called ultra large-scale system that would have
to function in much the same way that the internet functions today. You can
download the report from the IOM website at the URL noted on the bottom of the
slide, and I believe this report is extremely important, and I’m happy to call
it to your attention.

The Learning Health System is related to Meaningful Use, and I think it’s
safe to say that Meaningful Use is necessary, but not sufficient for achieving
a Learning Health System. One way to see that it is necessary, but not
sufficient, is to understand Meaningful Use as a status that is legally defined
and that is a status achieved individually by eligible professionals or

By contract, the Learning Health System tautologically, is a system that
includes these professionals and hospitals, but binds them together through
that systemization in a way that allows functioning to achieve goals that are
not achievable by the individual parts of the system, and allows function to be
carried about at the level of the system that is synergistic. And this just
repeats what the slide showed in the cloud, that these focus on systemness,
trust, data aggregation capability, analysis and dissemination are required
elements to make a Learning Health System a Learning Health System.

So one way to think about this is that Meaningful Use, plus some delta, is
what will be required to achieve a Learning Health System. That said, the
Learning Health System will inherit from the nationwide movement toward
Meaningful Use several very important, fundamental ingredients. Increasingly,
large amounts of digital, computable health data, substantial standardization
of that data, the capability to exchange that data. The Learning Health System
will require more sophisticated scenarios for health information exchange that
are currently contemplated for Meaningful Use, but those health information
exchange capabilities that are seen as required for Meaningful Use do an
important basis.

The governance of health information exchange that is being developed now.
The governance of the nationwide health information network through a formal
rule-making process was a requirement in high-tech, and that is being developed
now. And a number of privacy and security policies that will engender the trust
needed to support Meaningful Use will also be inherited by the Learning Health

So our grand strategy going forward is going to be one where we will need to
build toward national Meaningful Use, which of course is underway through a
large number of initiatives. We need to build that delta. But most important,
through coordinated planning, we need to do each one in a way that anticipates
the other, so that when both efforts mature, they will merge into something
fluid and synergistic.

So we have a few projects that are important, now getting underway to build
the delta. One is a federal Learning Health System coalition or working group
that has been formed. I want to emphasize that we are starting this effort in
the government for a number of reasons, but there is no intention that it’s
going to stay in the government. The next phase of this, that is contemplated,
would bring entities from the private sector into this effort.

We have engaged seven projects from four agencies, including the multi-payer
claims database that you’re going to hear about later in this meeting. And we
are basically undertaking an analytic exercise, engaging all seven of these
projects to explore the question of whether they could hypothetically join
forces to form an mini Learning Health System among themselves, using shared
technologies and policies, instead of having seven sets of technologies and
policies supporting these seven different projects, which is kind of the
pathway they are on now.

But I don’t believe, and I don’t think most people believe, that this is a
pathway that the nation can afford. We can’t afford N digital infrastructures
for N projects. We need many fewer digital infrastructures for a much larger
set of projects, and maybe eventually just one, which would be that Learning
Health System that I represented diagrammatically to you before.

We are also engaging the Institute of Medicine in a new study that I think
will be of great interest to this committee. I’ve called this somewhat
jocularly, the sushi great data study, where we’re going to look at what levels
of data quality are needed for different types of learning. As you all know,
there are proponents out there, a position that basically says use the data
that’s in the cloud. You can do Google searches and find out anything and
everything, as well as you could any place else.

And then, at the opposite end of the spectrum, there is a buoy that the only
real knowledge that is abiding and trustworthy is the knowledge generated
through prospective clinical trials, or studies that are equally,
quantitatively rigorous. The answer is that everybody’s right, each in their
own way, and this study is going to try to sort that out.

A third component of building the delta that will be rolling out soon will
be a kind of down payment on the most sophisticated kinds of health information
exchange, that the Learning Health System is going to require. This will be
coming out of our standards and inoperability framework in ONC, and it will be
a kind of lightweight initial approach to asking a question across a
distributed network.

So that is my introduction and conclusion of what I’m going to say to you
about the Learning Health System. This effort will go forward, because it’s a
component of our strategic plan, and for other reasons. And I’d be happy to
entertain questions, Walter, if we have time.

DR. SUAREZ: Yes, thank you, so much. So let’s open it for questions, Sallie?

MS. MILAM: Thank you, Chuck, great presentation. It was interesting to see
how the Learning Health System will inherit a lot from Meaningful Use. And as I
think about what sort of data Meaningful Use impacts, clinical data clearly
comes to mind. And a number of the domains, privacy and security, and I can see
how that fits together and how that is brought forward through Meaningful Use.

I’m thinking back to the workshops we held in February, then in May, and we
heard about the rich data stores and the state level, all-payer claims
databases that are emerging, and the hospital discharge data sets. And
obviously, those are administrative in nature. And we also heard of the
workshop that there’s great variety at the state level and the sorts of privacy
and security policies that are in place. There may be best practices out there,
but they have not been distilled or crystallized, and there’s obviously no
uniformity. So I’m wondering what role, if any, these administrative data sets
play in the Learning Health System, and what are they bringing to the table, is
there an impact by the lack of privacy and security uniformity, or is this an

DR. FRIEDMAN: I think it’s all an opportunity, Sallie. I did not mean to
imply when I said that the clinical data increasingly available in computable
form through Meaningful Use will be the only kind of data that the Learning
Health System would use. The kinds of databases that you’re talking about, as
represented by the multi-payer claims database project in ASPE, that’s part of
this work group, are certainly elements that will be part of the Learning
Health System. I think it’s completely open as far as what kinds of data,
including consumer-controlled data potentially could be used by the system to
promote the kind of rapid learning that we envision.

There are going to be enormous policy challenges, and you were eluding to
some of them to making this work. And the governance that is put in place is
going to have to be a medium for reconciling these state by state differences,
if indeed we’re going to have a national system. So you very accurately pointed
out some very challenging work that’s going to have to be done.

DR. FRANCIS: An observation about the chart and a question. All the arrows
in the chart went from peripheral entities to the cloud and back. None of them
went from peripheral entity to peripheral entity. That is, they were all
central. And the question is, is there any playing around with, and this comes
from the community data initiative kind of question, with leakages among the
various entities, for example, the local community and the local health care
system and the local payers, or is it all sort of one giant learning health
care system?

DR. FRIEDMAN: Leslie, that’s why I said don’t take that picture literally.
So the picture is an attempt to connote what kinds of entities might be members
of this thing, and the functions, however they’re carried out, that have to be
carried out. Nothing precludes member to member communication as an exchange,
and analytics as a legitimate mode of functioning of the system.

So I know if you take the diagram literally, that’s what it looks like is
being advocated here. I’ve tried 100 different diagrams. This is the one I’ve
sort of settled on, and I always make the disclaimer that the arrows don’t
necessarily imply the way the information will actually flow, with the
implication that other types of flows are excluded.

DR. MIDDLETON: Thank you, Chuck. Great to see the vision come to life, and I
appreciate your leadership in all the efforts. As you know well, and I’d like
to inform the Committee a little bit about, we’ve had a consortium funded by
the AHRQ, the CDS consortium, which has been looking at some of these very same
issues, of course, across a set of approximately 12 academic institutions, and
now 5 vendors, Siemens, GE, NextGen, Philips and the Air Force. And there are
just several thorny issues that I want to bring to the table, so we can ask for
your help in attending to them or consider them perhaps for future committee

One is that the learning system in our model basically, in a nutshell, what
we do is create a national portal for knowledge artifacts used in clinical
decision support, rules, alerts, templates, forms, guidelines and the like. We
create CDS services so that that efferent limb can deliver knowledge to remote
HIT, after a transaction has been received in the form of a CCD, so that CCD
for decision support transaction happens in real time, to remote EMRs. And
then, we do measurement, of course, of the CDS impact behavior change and
outcomes for the HIT and the CDS in place.

So that’s a nice vision after three years worth of work. We actually have
some of it working, actually all of it working, but here are the problems we’ve
encountered. There are significantly important data types missing from our
standard armamentarium of standard data. For example, the idea of an order
catalog has come up repeatedly. When you suggest to the remote provider, based
upon your patient assessment, here’s a rule which suggests you should do X, Y
or Z, we may have a standard terminology, but we don’t actually have a way to
link that to local order catalogs or code sets conveniently. So this idea of a
national order catalog has come up.

As you know, we’ve been doing a lot of work around the metadata,
representing the knowledge, and there are no standards to draw upon there.
Maybe the PCAST Report points to this idea of metadata, we’d like to make sure
that we recognize it needs to be applied, not only to data, but perhaps the
knowledge artifacts, as well.

I mentioned the CCD transaction. The CCD is a very convenient means by which
to do this transaction today. It’s a well-formed patient data object, more or
less. When you actually get down into the weeds and you implement it and you
have expectations for what you’re receiving in terms of standard codes in
terminology, there still is conformance which has to occur, even in a
well-formed C83, I think it is, CCD.

And we recognize also that to move towards more long-term decision support
in a stateless manner to really enable learning, we have to have a larger data
object than just the CCD. So somehow, we have to think about moving from CCD to
a larger patient data object, which can be conveniently transferred back and
forth in real time. The EMRs have been jumping through hoops to figure out how
to receive a decision support package with assessment, recommendation,
explanation and targeted end user, but they don’t have a standard way to do
that yet. It would be nice to have an as well developed standard for data
transaction in this realm of knowledge transaction, so that when GE receives
the message, they know exactly where to put it in the context of a standardized
workflow, in a way that makes sense, of course, for the end user. So this idea
of a standardized knowledge API for the HIT is important.

Completely out of my bailiwick has been work done to create the legal
framework to allow all this to happen. We’ve jumped through hoops to allow
remote sites to share data with a BAA or a HIPAA type agreement in place, to
share knowledge with indemnifications. So if I use Mayo’s knowledge, I’m not
going to be suing Mayo if something goes wrong, and then, this actual CDS
Services, which indemnifies the end user, the provider, from using a
knowledge-based tool.

This legal framework has been exceeding complex to develop. We now have a
signed relationship with the Regenstrief Institute, thanks to Mark’s help and
Bill Kearney and others. But this stuff is non-trivial. And as we think about a
learning system, we have to get this legal primary common place, so that
everybody can share data, share knowledge, in a way that goes beyond I think
what we’ve conceived HIPAA to be and to do so far.

Lastly, the major other big construct is this measures library, beyond the
knowledge artifacts and the metadata. We are drawing heavily upon NQF standard
measures to establish the logic, both on the CDS side and on the measurement
side. And I’d suggest that we have to think about CDS and measures in one
breath. They really are two sides of the very same coin, as you know well.

And I’d suggest that the idealized knowledge management repository or this
knowledge management portal would be a place where the user could go download
an artifact for decision support about diabetes care, and download an artifact
for measurement about their diabetes care in one fell swoop, and those need to
be connected. So it’s a beautiful vision to hear some of the things we’re
encountering in the trenches.

DR. FRIEDMAN: So Blackford, you just did a beautiful descant on this slide,
because you talked about things that Meaningful Use is going to do, you talked
about some things the delta is going to have to do, and then several of your
scenarios, you talked about how, if those two things are not done in a way that
anticipates the other, this whole effort could get painted into a corner. For
example, if the CCD is too limited, it’s not going to support the kinds of
decision support, capabilities and health information exchange to support
decision support that the Learning Health System needs. So that was brilliant
and thank you.

DR. SUAREZ: Thank you, Blackford. I think that set a core element that you
highlighted, constitute probably a wonderful set of elements for our next
meeting and NCVHS’ own next set of priorities in some of the areas that we’re
dealing with, so I took good notes about those. Thank you. I think we have two
more questions, and we’ll probably have to move on, Larry and then Mark.

DR. GREEN: Thank you, Blackford, that was terrific. I actually want to
direct a question toward Dr. Kaplan. Before I do, it’s a personal privilege for
a moment. I want to thank you, you’ve been a great teacher for me and I think
this committee, and I wish to express my appreciation to you for that, and I
want to wish you well, and I look forward to your announcement.

Dr. Kaplan, my question really is, what can you tell us about NHI’s response
to all of this?

DR. KAPLAN: Well, what a good question. So I’m still relatively new at the
NIH and I’m trying to find my way around. I will say that one of my personal
objectives is to expand what NIH is doing in these areas. I have a little
campaign that I’m working on, which actually includes the expansion of NIH
research activities and primary care, so we are working on this. As you
probably know, it has not had a lot of traction in the past because these sorts
of issues don’t clearly fit into any of the NIH institutes or centers. But
there is growing interest in this, and we are putting together a working group
that will be looking at these information issues, as well as primary care
research issues.

DR. GREEN: Where will that working group be located?

DR. KAPLAN: Not clear yet. So as you know, I’m in the Office of the
Director, and these sorts of activities that go across institutes and centers,
typically work out of the Office of the Director. But we’re hoping to do this
across these offices, and they’re four Associate Directors, like myself, that
are programmatic Associate Directors, one in the Office of Age Research, one in
the Office of Women’s Health and one in the office of Disease Prevention.

And so we are, as a group, starting to talk about these things. And I can’t
promise you that we’ll get traction, but I can promise you that we’re making
noise about it.

DR. FRIEDMAN: So I think that’s a great question, and Bob, I look forward to
talking to you about this. The Genome Institute held a meeting about six weeks
ago on genomics and the EHR, and I think that meeting was extremely successful
in a number of ways. And one of them being the ways it generated some things
that this committee should be concerned about, and that is the need to align
and harmonize the phenotyping standards that the research community either
based in NIH or funded by NIH, are creating, with other standards, many of them
standards to represent the same information, the same constructs, that are
being developed through other efforts, including the Meaningful Use agenda.

Does that failure to harmonize those is another way the national effort
could get painted into a corner that will be very difficult and expensive to
get out of. And I think the work to harmonize what the wonderful people at NIH
are doing, and everyone and others are doing around standards and inner
operability needs to begin immediately, if not sooner.

DR. KAPLAN: I think you probably know that with Russ Laskow, we held a
workshop about a month ago on developing standardized information that’s
psychosocial information in electronic medical records. We also are just
launching something, again, it’s in the very early stage, but we become
interested in the health services research of the future. So it seems to us
that the way we do health services research is going to change and change
fairly dramatically over the next decade. So the prospect of data collection,
although will never go away, will decline and that we’ll be doing many more
things with electronic medical record data.

The big problem is we don’t have the analytic techniques to deal with it, so
we’re starting to engage in the National Science Foundation to develop this
what we call a big data initiative to try to develop the analytic strategies
for the future.

DR. HORNBROOK: My comment is for the whole committee. The wonderful comments
from Chuck and Blackford have been very exciting and very insightful, but they
probably went over the heads of about 99.9 percent of the US population. And it
seems to me that we need to work on scenarios that the general public would
understand. I mean, Joplin, Missouri, disaster preparedness; would electronic
medical records for all those patients had made a difference in saving lives?

Travel out of the area, foreign travel, being away from my regular doctor,
would electronic medical records have saved or helped a number of people, lots
of people? Coordinating with all my pharmacies, if I bring pharmacies and my
doctor can see all those pharmacies, f I use 12 different doctors, if all of
them can talk to each other. If I want somebody to be able to see my chart,
that me, the patient, I want to grant the privilege for somebody to look at my
chart, how can I do that, and what’s the benefit of that. So somehow we’re
missing the currency among us, to be able to say we are really working in the
interest of the public, in ways that they understand themselves.

DR. SUAREZ: Great comment. I am sure that Justine would want to say a few
words, acknowledging Chuck’s work. And her message would be probably that we
really could have not been better served and could have not asked for someone
in a better position to serve as a liaison from the Office of the National
Coordinator. Personally, I think that the Office of the National Coordinator
works like 80 percent of the time on very detailed technical, focus on
standards and inner operability and Meaningful Use and all these details. And
we get the pleasure of working 20 percent of the time with the forward thinking
side. And so we really appreciate, Chuck, your involvement, your wisdom and
your knowledge in sharing that with us.

I think we’re going to move to our next presenter, Joy Pritts.

Agenda Item: Privacy

DR. PRITTS: Good morning. For those of you who are new, I’m going to give
just a little bit of background about my position, so you understand where I’m
coming from. I am the Chief Privacy Officer at ONC. My position was created in
the HITECH Act as a means of ensuring that privacy and security are treated
with a high priority, as we develop electronic health records and more to more
interoperable electronic system.

I am charged with, by the statute, with trying to coordinate all of this,
and to advise the Secretary and the National Coordinator on privacy and
security issues, as we’re developing a nationwide health information network.
So I work on what I would call the Big P policy issues that we face. I work
with some of our federal advisory committees. I would say that that’s one of
the primary roles that I serve, as they consider some of these issues and
provide us with recommendations.

I also work a lot with a lot of our programs. I will not be focusing on
those today. What I have traditionally done in this meeting is kind of give a
snapshot of where we are in some of these privacy and security developments.
There’s a lot on the table right now, so what I’m going to be talking to today
are just some of the things that’s going on. It’s not at all a complete
picture. Things are really kind of crazy right now. It would take me hours just
to discuss some of this stuff. But that’s what I do and it is a very
interesting job.

I do not do enforcement, that is for the Office for Civil Rights. ONC has
limited role making capabilities, so we focus on things like Meaningful Use and
ERH certification, so we are not the keeper of HIPAA or the writer of HIPAA.
Our privacy and security is broader based than that actually, because HIPAA
does not cover all health information. So with that, I’m hoping that you
understand a little bit of at least where I’m coming from.

And I’m going to jump right in, as Walter was saying to some of these real
detailed items that we work on. The Policy Committee has a privacy and security
work group called The Tiger Team, and it has been addressing a lot of very key
privacy and security issues on a fairly expedited basis. One of those is
recommendations on provider authentication. And the last time I was here, I
presented to this group what their recommendations were on what we call entity
level, organizational level authentication. And we believe that everybody
believed in health data exchange should be required to have a digital
certificate. And I’m going to go through the original recommendations fairly
quickly and you’ll see why in a minute.

They believed that they would be multi credential entities that would be
needed to support the issuance of that and that they should leverage the
existing processes, such as the federal bridge. They wanted ONC to establish an
accreditation program for these entities that would issue credentials. So I
know this is pretty in the weeds immediately, so what they’re talking about is
when organizations share information over the internet, they have a code
attached to their message that says, this is who I am, and there’s something
that stands behind that, someone who’s given them that code, who’s verified
they are indeed who they say they are.

And this is all designed to prevent phishing and scamming and things of that
nature. So it’s a very key component of security, and you want to make sure,
particularly when you’re dealing with the kind of information we’re dealing
with here, that the information is very secure and people are actually who they
say they are, because not only to protect the individual’s privacy, but you can
see where this plays a really important role in fraud prevention.

I won’t go into the details of how this happened, because that would be too
long of a story, but they ended up reconsidering, at the request of the
Standards Committee, what exactly it was that they were recommending. And so
their revised recommendations are a little different than they were originally,
but they base them on these following principles. That you need a high level of
assurance with respect to the organization identity, that there should be
multiple competitive sources and that the certificate should be acceptable to
federal agencies, given their frequent need for many providers to exchange
information with the federal health architecture. They also are focusing on
Meaningful Use, which will require some of this type of exchange.

They created a small work group on this, people who just focused on security
issues, and they identified what they thought were three potential options of
going forward. One is that ONC create an accreditation body, such as they had
originally recommended to supervise these organizations. The other was that
they should just choose certificate authorities that conform to these, what I
would call, other types of certification authorities, WebTrust or European
Communications Standard Institute, they’re accepted bodies that do issue these
kinds of certificates.

Or that the certificate authorities be cross-certified with the Federal
Bridge Certificate Authority. And what the Federal Bridge is, it is not the
federal government issuing certificates, per se. The Federal Bridge is the
federal certification authority. They say to other people, you can issue
certificates if you meet certain standards. So they were looking at this more
along the lines of that body fulfilling item number one, instead of creating a
new body.

And they concluded that they wanted to recommend that certificate
authorities be cross certified, or either directly be chained to the Federal
Bridge. They believe this was a high level of assurance, that there would be
multiple competitive sources for certificates. They were able to identify six
major ones that exist right now. They believe there’s a reasonable cost
associated with this, and that they were fairly firm in their belief that you
should only have to have one certificate to communicate both with private
bodies and with the federal agencies.

So the Policy Committee accepted this recommendation. Like everything we do
now, this in itself proved to be fairly controversial. When they first were
looking at this issue, they said, oh, this is a real technical issue, who’s
really going to care about it? The bottom line is, everybody cares about
everything very much right now. There’s a lot of money involved and there is a
lot of different players in the market. And you know, the rubber has really met
the road now, or is about to. And so, we can have these conversations in the
abstract for years, but now, it really matters.

The Standards Committee, which is related to this work on digital
certificates, they have recommended that digital certificates conform to this
standard. That is all I can possibly tell you about this. This has come over to
HHS for processing, and I’m way in the weeds above my head everywhere on this
one. But what I do understand, it is a very well-accepted standard, and this
one actually was not controversial.

There are a whole host of other areas where the Policy Committee is making
recommendations that are related to privacy and security. Another area that
they are looking at is how you build privacy and security into some of the
Meaningful Use related activities. And to pull this up to the big picture,
there are two fields of thoughts on this. One is that some parties believe that
Meaningful Use should be used to encourage the expansion of privacy and
security requirements.

And there is another camp which believes that the Meaningful Use
requirements are primarily to get people to adopt, that there are other means
and levers for getting privacy and security embedded in our system, and that
this necessarily is not necessarily the lever that the government should use to
move people forward in that arena. So it’s an interesting dynamic that’s going
on here.

In Stage 1, there was focus placed that everybody should be required to a
test, that they had done a security risk assessment, which is already required
under the HIPAA Privacy Rule, but which from surveys has been shown that most
people don’t do. And so, they’ve shone the spotlight on that one and said, this
is something that you need to really do in order to be able to qualify for
Meaningful Use.

In Stage 2, they recommended that this requirement be kept, but they also
want to focus more on encryption, in particular. Part of this is based on some
of the analysis that has been done on breach notification that has been
required under the High Tech Act. It’s clear that a lot of entities are not
encrypting their data at rest, including on mobile devices. And there are
rationales for people not encrypting their data at rest on large systems,
because if you have a Legacy system, it can be problematic, at least that is
the excuse that is given.

But on mobile devices, which are very modern devices, there is very little
excuse for not encrypting there, and they are one of the largest sources for
the loss of data. So they wanted to focus on this, as one of the recommendation
that this be included in Meaningful Use.

There has been question raised as to whether, again, this is appropriate,
given the limited scope of what Meaningful Use does. It is related to
electronic health records, and not all these devices would necessarily fall
within that category. They’re working on a host of other issues, but going
forward, one of the major items that the Tiger Team is going to be focusing on,
is looking at a more comprehensive security framework in light of evolving

So what they’ve been doing a little bit is looking at the HIPAA Privacy Rule
and trying to fill some of the gaps that they think may be showing up as we’re
moving and exchanging clinical health information. And the Security Rule also
was written well over ten years ago at this point, and it’s flexible, it’s
scaleable, but they’re not sure that it has everything, all the components that
you would have in a Security Rule, if you were looking at what is going on
today, so that’s an area that they’re going to be focusing on.

Patient information matching was a topic that we raised at the last meeting,
that the Tiger Team had been focusing on, and this now has shifted over to the
Standards Committee, and I believe Marc Overhage is Chairing this, that there’s
a Patient Matching Power Team to work on this issue over the summer. So this
shows a little bit of the interaction between the Policy Committee and the
Standards Committee. They identify the issue and then the Standards Committee
is actually doing a lot of work on this.

In addition to the Policy Committee update, I’m going to tell you a little
bit. We don’t do this work, but I just want to make you aware of it because you
don’t have OCR sitting here at the table with you. There are HITECH
modifications to the HIPAA Privacy Rule. There’s a large packet which is
scheduled to come out sometime late this summer or early fall, I believe. But
in addition to that, in late May, there was an NRPM issued on the Accounting of
Disclosures Rule, which was changed under HITECH. And OCR used its general rule
making authority, in addition to its HITECH delegation of authority, and it
actually expanded the accounting to include the right to obtain a list of who
has accessed your health information through an electronic health information

OCR took this approach, based on the information it gathered through an RFI,
where individuals indicated that they were also interested in knowing in
particular, who has looked at my record when I was in the hospital. You don’t
get that from an accounting of disclosures. So this was intended to kind of
fill a gap. There was also thought that since there is an audit requirement in
the Security Rule, that this type of information might, they may be able to do
this technologically now, without having to do a whole lot more technology
tinkering, in order to provide it.

There are also a lot of issues in the Affordable Care Act, and there are a
host of NPRMs, Notice of Proposed Rule Makings, Interim Final Rules, that are
all coming out to adjust these issues. A lot of them have privacy and security
issues. They are being taken very seriously by the department. There is an NRPM
out right now, for example, under which CMS will be sharing claims data with
qualified entities for performance measurement.

And the NPRM outlines the eligibility criteria, and it includes detailed
privacy and security requirements, including a governance structure. What’s
interesting to know here, and which I think you will see in the Learning Health
System and as we move forward, is that these qualified entities are not
considered business associates of CMS. And they are going to be required, under
the NRPM, at least, to sign a data use agreement. But we expect as the data is
shared more for a lot of these other purposes, we’re going to find other
instances of things that kind of fall between the cracks, from the current
HIPAA paradigm, because they aren’t acting on behalf of a covered entity.
They’re not acting on behalf of CMS when they’re doing this activity, and it’ll
be very interesting to see.

I often, at my session, give a little update on what’s going on, in the
broader scope of things. There’s a lot of activity right now up on Capitol
Hill, to get a bill passed that provides baseline federal information privacy
bill. Why is that important from the health perspective? It’s not clear yet how
that bill would interact with some of the sector-specific protections of
information, including in the health arena. And this does seem to have some
momentum there. A number of different pieces, a number of different bills have
been introduced, in both the Senate and in the House, and in both the Commerce
Department and the FDC have testified on this.

So that’s pretty much where we are right now. Like I said, it’s just a
snapshot, and there is a whole host of other activity that’s going on, that
we’ll save for another day.

DR. CARR: Thank you. I had the opportunity to review your slides earlier
this morning, so I appreciate the updates. I think we have time for one
question, if there is any, otherwise we are on our break. Are there folks on
the phone, Jim Walker, are you on the phone? When we resume, can we take a
12-minute break, and come back at quarter of 11:00?

DR. PRITTS: Justine, before you go, there’s one thing that I should have
mentioned that I forgot, and I think this committee, in particular, would like
to know this. So we have set up, I know there have been issues with NCVHS
issuing recommendations in the past, and then coming into HHS, and there hasn’t
been any activity on that sometimes. And so we have set up a process in HHS for
our federal advisory committees, at least the recommendations that come through
ONC. And it looks longer than it is, so the recommendations come into ONC,
they’re abetted by senior management at ONC. We have now an HHS interdivision
panel that is reviewing these to get their input.

And then, after we have that, we also take these recommendations to the
Federal Interagency HIT Task Force, in order to get them abetted by our federal
partners. And so, I wanted you to know that they are being considered.


Agenda Item: Recap from Orientation Part I, and review
NCVHS targets for Roadmap

DR. CARR: I’m going to use this time, the next couple of minutes, to remind
us where we were in the fall and where we are, because I think it’s important
for us to articulate our course, revisit it, assess or revise as needed, but I
just don’t want to lose the good thinking of the fall. So in September, just
six, seven, eight months ago, we met for a few days and identified a couple of

One, that we wanted to identify a focus and theme for the next 18 to 24
months, that will align with the NCVHS charter, the National Priorities and
Legislative Mandates, the emerging issues in health and health care, and the
resources and timeframes of committee members in meetings. Of course, now we
have eight teams, so take that one off, and invite feedback, as we heard today.
I thought what Joy mentioned was terrified in terms of getting feedback from
partner agencies.

So just to review our charter, the Committee shall assist and advise the
Secretary, through the Department of Health and Human Services Data Council on
health data, statistics, privacy, national health information policy and the
department’s strategy to best address these issues. The Committee also shall
assist in advice to department in the implementation of the Administrative
Simplification provisions of HIPAA, and shall inform decision making about data
policy by HHS, states, local governments and the private sector.

The strategic constructs Marjorie mentioned earlier, from 2002 a very kind
of landmark report coming out of NCVHS, shaping a health statistics vision for
the 21st century. And I put this in front of us, so that we can keep in mind,
as we develop our discussions for today. And as you can see, that the
population’s health is impacted by not just health care, but community
attributes, including the Built Environment Health Services, resources,
lifestyles, social attributes.

Secondly, context, including the natural environment, cultural context,
political context, and we heard some of that today in terms of the data that
HHS is looking to collect about cultural context and so on, and ultimately
place and time. This is the other important slide from that report that talks
about the different dimensions, the health care provider dimensions, the
personal health dimension and the population health dimension. And again, I
think as we’re thinking about, we talked today about, the community data
initiative, and also as we talk about the PCAST Report, we should be thinking
in all of these dimensions.

And what’s great about this committee is the balance between people who are
in the front lines, using EHRs everyday, people who are policy makers, people
who are standards developers, so that the richness of this committee is the
intersection of these experts. We don’t drill down and resolve immediate issues
in an EHR or how you use it, but we raise issues, we identify issues that we
come to together, bringing all these very rich perspectives together.

We put this together a while ago to just refresh our legislative mandates,
and also our letters and reports to the Secretary and to Congress. This is sort
of a subset, but I think the ones in red identify that legislation that had
specific assignments for NCVHS began in 1996 with HIPAA, and then in 2003, the
Medicare Modernization Act had assignments for us, E-Prescribing standards, and
most recently with the Affordable Care Act, as we’ll hear a lot about today,
from Judy and Walter, the very specific assignments we got about Administrative
Simplification and data exchange.

So current initiatives, Jim gave the kind of high level main categories of
strategies, but when we spoke last fall, we went through and identified some of
the more specific, strategic initiatives, and the ones with the stars, we felt
were relevant to NCVHS. Certainly the transformation of health care ongoing,
the implementation of the Recovery Act, just the population health, in terms of
healthy weight, and accelerating the process of scientific discovery to improve
patient care, were the ones that we focused on.

Coming out of that, we identified what are the specific initiatives that are
ongoing, that we do and that we have been doing. And then, we got back to the
charter and talked about what are the emerging data sources, and at that time,
we identified the community data initiative, the PCAST Report had not yet come
out at that time. And then, as Chuck alluded to, the IOM workgroup that focused
on digital health data from EHRs and Meaningful Use contributing to Rapid
Learning Health System.

So I’m moving quickly through this, but I think this was us going from the
macro, here’s our charter, here’s the strategy, this is who we are, this is
what we do, and this is what we have focused upon. So today, we want to make
sure that we are still working on these things, and I think you’ll see what
we’ll hear about the community data initiatives, we’re going to talk shortly
about the PCAST Report and then getting back to the Learning Health System that
Chuck mentioned. So when we had our retreat, we talked about three main points
that we addressed. One, I don’t want to lose sight of, it’s still on there,
that HHS wants a dashboard of progress, and Jim you were still talking about
that today, about outcomes and process. And we didn’t have an action item about
what we might do, but I think it’s still important to keep in front of us.

Second is can we look at communities that have used their data in dashboards
and achieved improvements in health and health care, and the questions here.
And so, when we have time later today to talk about the two hearings that we
had, you’ll see that we learned a tremendous amount. And so, I think our
assignment today is to review what we learned from those hearings, and now what
do we do about it? What do we want to recommend and move forward?

And then, the third was, can we drive governance driving principles for
these data systems, so that was the second hearing, in particular, focused on
that. I couldn’t help but steal this slide from Chuck, I hope you don’t mind.
But it’s really an excellent way, and I think very shaping and framing, and
actually to me, align with the themes that we’ll be talking about in the PCAST
Report, the governance, patient engagement trust, analysis, and dissemination.
And I think the focus on dissemination is just so important that we continue to
think about as we’re talking about data, it’s not just data for data’s sake.
What do we do with it?

So then this is just a summary of the IOM report, and the areas that
priority action targets. We highlighted governance and coordination as an area
that aligned with NCVHS and I want to come back to that throughout the day.
Just to remind you, and Walter will tell you more about it, with the Affordable
Care Act, we had some very specific assignments with regard to operating rules
for eligibility and health plan that need to be adopted by July, implemented in
January of 2013. We also asked to look at operating rules for electronic funds
transferring, had a hearing last December, and that’s slated for adoption in
July 2012. And finally, operating rules for health claims or equivalent
encounter information, enrollment or disenrollment, et cetera, and we’ll hear
more about that from Walter, but these were written right into the law.

We were also asked several things, the NCVHS was asked to advise the
Secretary in five main areas, whether or not a non-profit entity meets the
requirements above to develop a single set of operating rules, advise the
Secretary on review of the operating rules, advise on whether the operating
rules represent a consensus of stakeholders and do not conflict with existing
standards, advise whether the operating rules are consistent with electronic
standards adopted for health and information technology, and finally
recommendations on whether the Secretary should not be operating rules proposed
by the non-profit entity responsible for developing them.

So at this meeting, I tried to pull this together to say what is it that we
want to get out of today. And first, just taking that concept of data
information flow, value and privacy, these are themes that we’ll be talking
about, and just as we saw in that diagram from shaping health statistics, we
need to remember that we think about them in clinical care. But it doesn’t stop
there, it’s population health, and then also, Administrative Simplification
exchange of administrative data.

So those areas, the clinical care, the population health and the
Administrative Simplification, so it’s the data, the flow, the value of the
data that’s going and the protection of privacy of the individual. So many of
you will come to recognize that I usually would’ve made a grid to demonstrate
this, but I refrained. I restrained myself. But just to mention, it’s these
areas, care, population health and exchange, but with regard to how the data
moves, the value of the data that is moving and the privacy protections in it.

The second thing is, we’re going to have some education today. As we’ve
already heard from Jim, HHS updates, actually we didn’t hear from Karen from
CMS, she’s otherwise caught up.

MS. GREENBERG: That’s why I had asked who was on the phone because I thought
maybe Karen was on the phone.

DR. CARR: Maybe we can find out and get back to that. We’ll have the update
from Walter and Judy on the Standard Subcommittee on where we are with
standards across an array of areas, very critical. And then, tomorrow we’re
going to hear about the all-payer claims database. So again, as we talk about
data, we love to think about the very granular data that we’re developing in
electronic health records, and remembering that we’re still in the early stages
of Stage 1 of Meaningful Use, so that we’re beginning to get that data, but
it’s not rich.

And in fact, the old standby was claims data, and the payers have had it and
used it for a long time. Now, we see it at the state level. There’s more
sharing, so it’s not just one payer, but all the payers come together, where I
think we are now recognizing we need additional data, is Medicaid and Medicare,
especially as we move into the ACO pilots, where it becomes integral to use
these claims to be able to manage the population of patients in an ACO. So
that’s a very important presentation tomorrow.

Okay, so those are the educational opportunities here at NCVHS, but now,
here is the work of the Committee that we need to be focused on today and
tomorrow and going forward. The first is the letter to the Secretary on the
PCAST Report. That came out in December, and as we’ll discuss momentarily, had
a very bold, ambitious view of how do we just get quickly to be as seamless and
invisible as banking industry or Amazon.com or whatever. So we have some
comments about that, and I actually have some framing comments I’d like to make
about that.

Second, we’ll hear next steps on the hearings that we had on community, as a
Learning Health System using local data to improve community health. Susan
Kanaan, our writer who is not here at this meeting, but she did a beautiful job
summarizing both of those hearings. And I think with that, we can begin to say,
okay, what did we learn, what are the needs and how do we move that forward.

We’re also going to hear about the 10th HIPAA report to Congress. Usually,
we send a report every year, and it often focuses on what we, NCVHS, have done
with regard to the advancement of Administrative Simplification. This year
we’re going to try to take it a little bit differently. There’s a nice outline
there to sort of say, here’s the vision that we were supposed to achieve, we’re
one decade into it. How close are we to the vision and what does it take for us
to get there. And I think it’s been very helpful for us to walk through this
and learn it as a committee, but I think also, it’s important nationally to be
able to have a synthesis of this is what we were trying to achieve.

And then, finally, the subcommittees will be meeting today and focusing, you
know I’m just saying, emerging data sources and their uses, as sort of a
catch-all, for the new members of the Committee. Our four subcommittees are
quality, population health, privacy and standards. And you’re welcome to attend
all of them to get a flavor for what’s going on.

I will tell you that one of the richest experiences we’ve had in the last
year or so has been the mixing it up, so that when I, for example, because I’m
an internist physician and quality person, so I was on the Quality Committee,
it’s good, but it was much better for me when I went to the Standards Committee
and could bring a new perspective. I will tell you straight up, I didn’t
understand a lot of things, but that was actually helpful, because my role has
often been to say, I don’t understand this.

And so I think you should not hesitate in any way, or be intimidated about
joining another meeting and asking the fundamental questions. That is the
richness of all of the members here. And so I encourage you to try to sit in on
all of the subcommittees today, and then we can have further conversation
tomorrow afternoon about what works for you. Okay, so there’s that. Yes?

DR. MIDDLETON: Justine, thank you. I am sort of wrestling with sort of a
slippery slope problem. Given Chuck’s presentation and your outline of the
NCVHS work and our obligations, et cetera, I wonder when do we need to think
about the NCVHS fundamental charter applying itself, not only to information
and data, but to knowledge, as well. Obviously data analyzed becomes
information, information acted upon becomes knowledge, and if it’s acted upon
twice, it becomes wisdom. I think we’re at the verge of having to wrestle down
at a national level, given all the vision that’s going on and all the activity,
how do we really want to approach this Learning Health System and this critical
component of the knowledge management dimension?

DR. CARR: Brilliant. That’s the kind of thinking we need to do. As you could
hear from Chuck and Joy and the many presentations we have had from ONC, we
have content experts working on today’s work about getting it going. And our
role is to think ahead of the next big thing, and that’s a great example of
that. And I think hopefully, do you have that, as part of the Quality

But I think that’s right and I think it’s something that we all want to kind
of weave into the thread of the discussions today.

DR. BURKE: Since this is my first meeting, I hesitate to jump in before
lunch, but I just feel compelled. First of all, can I get your slides, can you
make those available?

DR. CARR: Yes, I will. I made them at six o’clock this morning.

DR. BURKE: Very nice overview. And second, as an economist, I’m looking for
the word cost and I haven’t found it yet.

DR. CARR: Value, did you see value?

DR. BURKE: I did see that. Are we precluded from it? What I’m particularly
focused on, the idea of communities, using information about cost where they
live, because that really is the motivation behind the all-payer data bases
bubbling up around the country. There are even some regions trying to do it
independent of the state. So are we allowed to think about that?

DR. CARR: Yes. It has come up. No, absolutely right, and that’s why you’re
here. Not just for cost, but I mean that perspective, because we often can get
caught up in our own perspective. Marjorie?

MS. GREENBERG: First of all, let me say that as I told a few of you that I
talked to on the phone, there are no rules against new members speaking at the
first meeting. In fact, we welcome that, so not a problem. Also, there are no
topics that can’t be discussed, so some of them are outside of our scope, but
certainly information about cost wouldn’t be.

But just when you mentioned education, I was sort of tying that with
educating the Committee and ourselves, which we always try to do as part of the
meeting. And I must say, this committee has been a learning system for me over
a lot of my career, and I think we all find out that we learn a lot from it.
But I was tying that in with Mark Hornbrook’s comment earlier, too, that we’ve
also struggled over the years with, and I just put this out as something since
we’ve got many new members and something to think about is what is the
Committee’s role in educating or providing educational resources to the
community at large?

We always hope that our reports will serve that purpose, and we’ve tried to
make them more user friendly over the years. We did put out a primer on data
stewardship, I’m not sure if you mentioned that, Justine, and we’ve talked
about developing other primers. But this whole idea of how do you communicate
within the industry, I think we’ve done a pretty good job with that.

But then, how do we at least support the department and others in
communicating more broadly with the public, is something that we kind of come
back to many times over the years, with the idea of communities and
patient-oriented health and consumer issues, etcetera, it’s something that I
think continues, that we dabble in a bit, but that hasn’t been perhaps
accomplished in the way that we might like to see it happen. So I just put that
out as another aspect of education, and sort of reinforcing what Mark said

DR. CARR: And I think that’s the perfect segue to the May 12th hearing,
where there was a very clear request, so that a key to building trust is
education, about what we’re doing, the benefits and so on. Mark Hornbrook?

DR. HORNBROOK: I just came from Academy Health before I came here, and one
of the presentations at the conference was a serious attempt by economists to
estimate the effects of the Affordable Care Act, as it rolls out improved
access for health insurance. And its subsidized, and it goes up to 400 percent
of poverty, it sounds great. But when you actually look at what the premiums
are expected to be, it is incrementalism. The marginal changes are relatively
small and it’s scary to me, because the opposition to the ACA is saying this is
tearing our health care system apart. This is no way coming close to it, except
for the basic non-truth telling.

Agenda Item: PCAST Letter Review for ACTION June

DR. CARR: This is a conversation we are going to continue throughout the
day. I’m just trying to frame it here and have us come back to it. What I’d
like to do is move into the PCAST Report, because I looked at that also with an
eye toward, what are we saying, who’s the audience, are we saying what we mean
to say? So I took the liberty of trying to pull this together.

We’ve done our work in different ways at different times. Sometimes we spend
a lot of time focusing on a letter and trying to make sure it says what it
needs to say. But from time to time, I find also that we need to step back and
say, what is it that we are saying, and if we’re clear on that, then is the
letter saying it the way we’re clear on it.

So from my reading, these are some of the things that I took away, and I’m
putting it out there. It doesn’t have to be in this order, but we really need a
yes-no. And also, in terms of new members speaking up, sometimes what we do is
just go around the room to make sure everybody has a chance to weigh in. And
you don’t have to say anything, but it’s very important that all of our voices
are heard.

So Theme Number 1, the Committee supports the compelling and bold vision of
an interoperable health information system, agree? Any disagreement?

DR. HORNBROOK: One of the things that’s important here is that there are
people who have interoperable health care system already, a microcosm. And
there are many people who don’t have it, so we want to make sure that we
understand the benefits and why we’re motivating the benefits that some people
already have and other people don’t have.

DR. CARR: Do we want to say that it’s a national, do we need a modifier

DR. HORNBROOK: Ideally, yes.

DR. CARR: So what’s bold about it is not interoperability, because many
people, even around this table, have interoperability, but that it is national
interoperability, nationwide.

DR. MAYS: Can you tell us where you are? We’re looking at the letter?

DR. CARR: This is me reading through and saying in different parts of the
letter, these things are said. And I want to make sure that, and maybe they all
need to be said up front, these are our observations now developed, here’s our
recommendations. But I found it hard to keep track of them. Mark?

DR. OVERHAGE: I wasn’t going to raise this because of our usual challenges,
but since you pulled them out, the compelling part troubles me. I’m not sure
that they made a compelling vision. It’s bold.

DR. HORNBROOK: If you can’t tell the compelling aspect of it, then we
haven’t done our job yet.

DR. OVERHAGE: No, that’s not our job. We’re commenting on the PCAST Report

DR. OVERHAGE: Thank you for the Committee’s views.

DR. CARR: So in other words, we feel the Committee supports the bold vision
of a nationwide interoperable health information system; are we good with that?

DR. SCANLON: Let me advocate for keeping compelling, because I guess the
question is, why do we support the bold vision if it’s not compelling. And the
reality is that I read that and read what they were saying is, to bring back
the issue of cost that Glen raised, we’re doomed if we don’t improve the
information systems that we have, and that’s pretty damn compelling.

DR. OVERHAGE: The question is that the vision that in the PCAST Report
itself, not the idea of a nationwide interoperable.

DR. SCANALON: That would be different.

DR. WARREN: So I think what we need to do is, when we say this word, are we
saying that we think it’s compelling, or are we responding to PCAST, because I
agree with Mark. The PCAST Report did not show me a compelling vision.

DR. CARR: I want to just get through the direction, and when we get back to
the language of the letter, we can get through this a little bit more. The
second thing is, the Committee applauds PCAST support for concepts that have
been priorities for NCVHS. That’s kind of what we’re saying, right? Things
we’ve said appear there, we’re happy about that, right?

The Committee recognizes the significant gap between the report vision and
the current state. The Committee advocates for an approach to interoperability
that can be achieved on an aggressive timeline, while using an incremental
approach, building on the progress to date, while at the same time, evaluating
innovative models in the related considerations regarding technology, clinical
value, privacy protection and attendance governance and policies. So that’s a
dense sentence, but I think this is what we’re saying, I just want to make

The Committee urges that we continue to build upon ongoing data standards
work. You can see that the verbs have meaning here. The Committee cautions that
the approach —

DR. MIDDLETON: I’m sorry, Justine, just to back up to that last one for a
second. I am not sure we actually mean to say we want to build upon ongoing
data standards work, because I think one of the main thrusts of the PCAST
Report is that the ongoing data standards work haven’t gotten us there. So I
think what we’re trying to say is something like leveraging ongoing data
standards work and recognizing the potential for paradigm shifts to new
approaches, whatever the right English is, is what we’re trying to say. We
don’t want to throw out the baby with the bath water, we want to build upon
that, though, and acknowledge this potentially different approach.

DR. HORNBROOK: What you said this morning was the metadata standards, the
bigger, higher, higher levels, which will go up, they have to standardized.

DR. CARR: Let’s come back to that, because I don’t have the right language
yet, but I get what you’re saying.

MS. GREENBERG: I guess I would just suggest that we not worry about
wordsmithing. When we get to the letter, we aren’t saying things clearly.

DR. WARREN: Wait a minute, I think that this may be where we have some
disagreement, because I do think we need to continue the ongoing data standards
work. Now, if we want to add to that some of the proposals that PCAST made of
looking at new, innovative strategies, now that, I think, is okay.

DR. CARR: So would you say urges that we continue ongoing data standards
work, while expanding?

DR. WARREN: All I’m saying is that at some point, we need to have a
discussion, because I think Blackford and I are coming at it from different
directions, and I want to be sure the Committee recognizes that. I want to stay
with the ongoing data standards work. You are wanting to get rid of the

DR. MIDDLETON: I’m sorry if I wasn’t clear. I think actually PCAST says
almost disregard the ongoing data standards work, here’s a new paradigm, here’s
a new approach, ultra large scale, metadata, etcetera. I think what we need to
say is that that’s not ongoing to work. We need to connect the dots between the
ongoing data standards work and potential new approaches.

DR. WARREN: Okay, that I agree with, so we want to keep the word ongoing in

DR. CARR: I don’t know how to undo it, but just remember that we want to do
that, new approaches as well, something like that?

The Committee cautions that the approach, I didn’t say this right, but
something caution about the approach metadata tagging with caution as there can
be unintended consequences for privacy. And I couldn’t quite get, in the
letter, it says unintended consequences, safety, privacy and so on. But I don’t
know exactly what we’re referring to, Chuck, I’m sorry.

DR. FRIEDMAN: Before you move on, Justine, my point actually relates to the
statement about data standards. And let me preface this for the record with
something I’ve said to Justine, that because during its deliberative stage of
the PCAST Committee’s work, I was actually their formal liaison. I feel like I
should stay out of the substance of these recommendations. But let me add a
process comment, which is I think we need to be clear about what we mean when
we say data standards, because there are lots of different kinds of standards.
And our disagreement in the room may be a disagreement about what the term,
data standards, means.

There are standards that are just the way the concepts are represented.
There are standards that refer to sort of the architecture of the package that
might be transmitted in a health information exchange scenario. There are lots
of different kinds of standards. We can talk about data representation
standards, we can talk about interoperability standards. They’re both standards
and we just need to be clear when we use the term, standards, what we’re

DR. SOONTHORNSIMA: I just want to also echo some concerns around being so
nationwide, that we lose sight of some of the local projects and activities.
How do we weave that into your statement, such a way that this is not a single
federal model, but one that is collaborative in nature and leveraging all those
other standards and projects and innovation that may exist at the local
communities, as well?

DR. CARR: Can I just ask, if somebody could take notes, because we won’t get
through all of this if I’m trying to type it. So I want to make sure we get
Chuck’s comment and also that we’re aiming for nationwide, building on current
work and current success.

DR. FRIEDMAN: And Justine, if I could just add to my thought. I think we
might be saying that it’s important to build on existing data standards work in
the sense of the standards used to represent concepts. But to the extent that
the PCAST Report really is talking about a different way of viewing the
package, which is a different kind of standard, that is available and mobile
for health information exchange. Maybe that should be addressed separately, as
that is where issue is being taken.

DR. WARREN: Chuck, I just want to clarify, when you say standards about
concepts, that means a very specific thing to me in the standards world. We
have transactions standards, which are all the HIPAA transactions, which are
not concept based. Are you saying throw those out?

DR. FRIEDMAN: No, I’m just saying —

DR. WARREN: So you’re including those in.

DR. FRIEDMAN: — acknowledge that they are different kinds of standards, and
be clear about which are being agreed with, in the context of agreeing with an
approach, as it relates to standards, what kind of standards are we agreeing
with and what kind are we taking issue with?

DR. CARR: Leslie, did you have a comment, and then Walter.

DR. FRANCIS: I had a general comment really, which is I am not quite sure of
what the function is of this. Are you really trying to have us draft what would
be the main talking points that would be at the front of the letter?

DR. CARR: My challenge in reading the letter multiple times was that there’s
a lot of cross referencing to, we believe in this, but it’s below, and we
believe in that, but we said it before. And I’m not sure there’s one place
where we’ve said, we believe in these five things and now we’ll elaborate.

DR. FRANCIS: So I can try to sort of summarize some of this, which is it
seems to me we’re trying to say three things. First of all, we think boldness
is cool. We like boldness, we think vision is a good thing and that’s a nice
thing that PCAST did. That’s one point we’re trying to make. I just made that
too colloquially, but you get the point.

The second point is that many of the themes in PCAST are themes that we’ve
sounded before and we want to bring those out in this letter. And the third
point we want to make is that we think that progress requires building on and
linking to what we have. And that would be the three basic themes, and not

DR. CARR: I’m going a little bit into details, and we come back because I
found a little confusion in the letter, and I’m hearing a little confusion now.
So we won’t belabor it, but I just want to make sure that we’re all on the same
page. So if you can bear with me for two more points.

It was unclear to me exactly the cautions that we were concerned about with
metadata tagging beyond privacy, and the next two points, Committee adds the
importance of ensuring the model builds in an infrastructure for patient
perspective and choice. I think that’s what we’re saying. And then finally, the
Committee supports revisiting the issue of patient identification. And if ever
there were a topic that we’re supposed to.

DR. SOONTHORNSIMA: Maybe you’ll be really bold by coming out and saying, the
vision shouldn’t be too prescriptive, because when you talked about metadata
tagging, I think there are some technicality issues, you get in the weeds very
quickly. So in the PCAST, I think the strategic intent is to create that bold
vision. Now, how we go about coming up with various solutions, and I think Dr.
Leslie really talked about those things.

DR. WARREN: And then just one thing, on the privacy, we were concerned, too,
about who would keep the metadata tag repository, because if your tags aren’t
the same, you still don’t have interoperability. So it’s the same issue with
all the other standards.

DR. CARR: We alluded to cautions about metadata, yeah, let’s see, Walter
wanted to say something and then Matt.

DR. SUAREZ: I am with Leslie. I read the letter several times myself, too,
and I find that it does go back and forth, referencing different things. But it
comes down to very concrete messages, which I agree, we could bring out the
front or out the back end. In summary, what we’re saying is this, or at the
beginning, highlight three or four or five points. I’m concerned that we’re
going down a path in which we’re going to begin to actually edit this type of
text and these sentences, and it becomes an issue of which letter are we
actually drafting and editing?

For example, concretely on the data standards part, and I talked it over
with Chuck, we do specifically point to the fact that we do not support the use
of metadata tagging for privacy purpose. However, if the concept of metadata
survives all this debate nationally, we need to create, and it is imperative to
first define tests and establish national standards that define the content
structure and terminology vocabulary to be used in this metadata tag.

So we’re actually pointing to the fact that this is an area where there
needs a lot of work to be done on the standard side. We do have a standard for
content and a standard for other things, but for standards about the data, not
the data itself, but about the data, we don’t have a lot of work done and
that’s what we are highlighting. But at the same time, we’re arguing, well,
even though we don’t agree with the foundational content of the report of using
metadata tags for privacy information.

MR. QUINN: So as somebody who’s worked on this, I really thank everybody. I
think this is exactly why this letter has made the progress that it has, the
enervative approach. And the power in the letter, in my opinion, comes that it
references past NCVHS hearings and work. So if you click on the link under each
of these recommendations, there’s rich, lots of thought that represents
hearings that we’ve held, etcetera.

The challenge here, and I think we’re balancing this, and we’ve toned down
some of the language, is that the risk here isn’t just privacy, it’s the
success of HITECH and the push for adoption and Meaningful Use. And so, the
real challenge here is, how do we build on the train that’s already moving,
imagine a train going down the track, and then all of a sudden, you say, we’re
going to change the gauge of the rails, and we’re going to do it a mile ahead
or two miles ahead.

And the question is, how do we maintain the current initiative and make sure
it succeeds, because there are huge implications to this. But also, how do we
get to that inflection point where the broader Health IT system that we have in
the future that is needed to support this, that inflection point, version 2.0,
not version wherever we are today. And so, that’s really the difficulty that we
want to communicate here, and I think that that’s in the past calls and
meetings that we’ve had about this, we’ve tried to communicate that message,
that the Health IT and the work that we’ve done, we definitely can’t throw it
out because we need to continue building on it for increment, and do it
aggressively. But at some point, parallel to this, there’s got to be a

DR. CARR: I don’t mean to say we’re going to start over on the letter, but I
do feel we’d get benefited from one or two framing sentences that foreshadows
what we’re saying, so that the reader is now tuned in, here is your point of
view. And while I think it’s there, it emerges over several pages, and I think
it’s better to have up front. We like, we urge, we hope, we caution, we

DR. KLOSS: I think one of the overarching goals in PCAST is some new
thinking to accelerate change. And I think maybe we could underscore that
notion that the Committee is really about finding those levers that move this
transformation faster. And in my reading of the letter, I didn’t see that there
were a couple of recommendations that we felt were most important to that
acceleration. For example, the discussion that we just had about metadata
standardization, there may be two or three of these that bubble up as being
most inline with their philosophy of trying to move this train a lot faster.

DR. CARR: I think you raised an interesting point. And so, if I try to tick
and tie that, maybe where we say can be achieved on an accelerated, not an
aggressive timeline, but an accelerated timeline, might be a better word. But
as I read the letter, having said all that, the letter is more about the
cautions. And that’s fine, because it ties to our previous work and so on. But
the letter is really about the cautions, don’t do this too quickly, don’t
forget about that, make sure you incorporate the patient perspective, and
that’s fine. So I like your use of the word accelerated.

DR. GREEN: Justine, at this level of summarization of the letter and
everything, I don’t hear Matt’s comments, or the comments about acceleration as
being contradictory at all. One way to unify them is that much of our letter,
take a policy perspective, everybody in Washington knows that, for most
policies, unintended consequences of what they become famous for. They were
supposed to do this, but what actually happened was that. And most of the
conversation for the last ten minutes, in my view, has been us around the
table, pointing, oh, we’ve got to watch out for an unintended consequence here.

And what happens is, is this bold idea that actually positions a great
acceleration of the Learning Health System and using data to get the
information, the knowledge, the wisdom, this is an exciting idea that can drive
that. However, you do this right now and you step down on the gas pedal, and
one mile down the road, the gauge changes and you’re going to have a train
wreck. And it’s not going to be pretty and it’s going to be your fault. And
this great idea is going to die an anonymous death prematurely, because no one
just had the good sense to continue to adjust and adapt.

This goes back to Chuck’s statement about the delta. This is about you got
to manage the delta on this thing. And if a full-throated, overloaded,
overwhelming endorsement of the PCAST Report for accelerated implementation in
the next two years, this Committee, I believe, is unanimous in believing that
would be a disaster. But we don’t want to say in the letter that we’re opposed
to this idea. We want to support the idea, and advise caution about the
unintended consequences, and then to go back to the acceleration comment, you
want to accelerate this? Go to work, night and day, on confidentiality and

DR. CARR: Or data standards.

DR. GREEN: We’ve got two or three of those, and the letter calls them out.
So I want to go back, at this level, and I’m doing my darndest to help our
Chair get us to the point where we have basic agreement about the concepts that
we’re trying to put forward in the letter, maybe we can have, up at this level
of the letter, whether it’s at the beginning or the end, coming back in and
say, while we support this, we have identified in much of our prior work, which
Matt has referenced here in the letter, there are some issues that you need to
work on very hard, very fast, very soon.

Now, at a different level of letter, while I’ve got the mike here just for a
second, I want to go back to being Larry again, about my fundamental issue with
this letter. And it’s back to this notion that, while all of this is going on
in Washington, in the IT industry and all over the regulatory world, it turns
out the American people are continuing to figure out new ways to get sick and
to harm themselves. And they’re still continuing to show up in the offices of
psychologists and doctors and emergency rooms, etcetera, etcetera. And they
somewhat ridiculously expect to get care, while all of this is going on.

This transformation, that managing the delta, has to have as a foundation
element, that as we do this, we still have to take care of our people. That’s
the great risk of this grand idea, is that the progress we’ve made on doing a
better job of improving the quality of the health care delivery system comes to
a screeching halt because we’ve got a brilliant flash of insight about where
we’re going to land in 2025.

DR. CARR: We have to exchange something before we exchange everything,

DR. WARREN: As I have been listening to the dialogue, one of the things that
happens in this committee is our love of editing, line by line. And as the
executive subcommittee has met numerous times since the PCAST Report came out
on this letter, it’s almost like every time we meet, we reevaluate as if from
the beginning, what we believe in. And so, when I saw this list, to me it
helped lift us out of the letter, to say, because we’ve never had 100 percent
or even close to a consensus among the Executive Committee on the points in the
letter. There is always been some nuances coming out.

So when I see this list, I feel much more comfortable that the letter’s
going where it is. And then, we can start adding in some of the richness that
Matt has crafted into the letter of the hyperlinks, to previous work we’ve done
and why we’re coming from where we’re coming. So I’m not sure where these
things go, but I like the way that you’ve done them.

I also like the idea that, we have them all there so we can look at the
verbs, because that’s always been one of the points where we’ve disagreed, is
the strength of the verbs used.

DR. CARR: So at this juncture, what I’d like to do is, I think the letter
would be strengthened by building out a little bit in the introductory
paragraphs, to include these things which foreshadow the rest of the develop.
There’s some minor edits I would see, sort of conventions in the letter. I
think, as a group, we ought to talk about ourselves as NCVHS, not us or we. And
in terms of letters to the Secretary, I don’t think we need to say, we sent to
you, we simply need to say, in our letter of, because that’s who we send the
secretaries to, little things like that.

Let me start by this, is there any objection to expanding the opening
paragraphs to incorporate this? I’m hearing none, then Judy’s point, and I was
taken by the verbs, because the verbs are everything in this. We can put a
bunch of issues, and some are big issues and some are need to have and nice to
have, and our verbs need to represent that. And again, we can work offline on
this. I’m happy to work with Matt and whomever else, but I want to just get the
feeling of the Committee, the beliefs.

So the Committee supports, is compelling in or out, the bold vision of a
nationwide interoperable health information system. Applauds, maybe it’s too
self-serving, applauds PCAST support for concepts that have been priorities for
NCVHS, letters from us, why not. Committee recognizes significant gap between
the report vision and the current state. And then, this sentence, the Committee
advocates for an approach to interoperability that can be achieved on an
accelerated timeline, while using an incremental approach, building on progress
to date, while at the same time evaluating innovative models and the related
considerations regarding technology, clinical value, privacy protection and the
attendant governance and policies.

MS. GREENBERG: I think we need to make that two sentences.

DR. CARR: Yes, okay. But I think that’s what we’re trying to say all of
that. We’ll make it two sentences.

MR. QUINN: Something fine there is that it supports the goals of HITECH. The
timeline of HITECH and the current making sure the trains run on time for that,
while at the same time, supporting broader transportation later.

DR. COHEN: Do we need a however in there, if this is the point where we
transition between general support and our concerns for caution?

DR. CARR: We have a lot of howevers in the thing. And again, it made it hard
to do that, and we can work on this, as well. But I think this is what we
advocate for. We, NCVHS, are advocating for a little bit of what you said and a
little bit of what we’ve been saying, and not have any howevers. This is it,
this is what we’re about. And then, we have a lot of howevers in some of the
other languages.

The Committee urges that we build upon data standards work. Are we urging
that, and are we building upon data standards work and privacy work? We’re
urging that we not throw out all the work that’s there and we built upon what’s
there, and that’s true for standards and actually that’s true for privacy, as

MR. QUINN: Well, build upon existing standards work representing concepts,
and invest in the underlying research and standards, etcetera, that will be
required to support the new framework. So we’re identifying all of these things
that are going to be needed, prior to moving to the rail gauge.

DR. WARREN: So Matt, help me remember, because it’s been a while since I’ve
read PCAST. But they were basically advocating for a total break from our
traditional standards work, just to leave that by the rail side, that’s the old
gauge, and completely go into a more internet-type tagging. And I think that’s
where we have the major disagreement on standards.

MR. QUINN: In order to keep the trains running on time for now, we’ve got to
do what we have been doing and continue to look for efficiencies there. At the
same time, the trains of tomorrow, in order to support them, the high-speed
rail system, we’ve got to do some research on how to do that before we just
change over. We just can’t change over today, it’ll be very disruptive to
what’s going on, the needs of today.

DR. CARR: So urges that for the near term, does that make us look for the
near term?

MR. QUINN: To ensure the success of HITECH.

DR. CARR: We continue to build upon standards work, let’s see, on data
standards work representing concepts, while investing in.

MR. QUINN: While recognizing the need to invest in underlying research in
standards and privacy necessary to support the new framework, new architecture.

DR. CARR: Is that what we want to say?

DR. SOONTHORNSIMA: What you’re saying, I think, is don’t jump into this. I
wonder if that’s even important enough of a statement?

DR. CARR: Do we then want to also add that, not only we urge, but we now
caution about the approach.

DR. SUAREZ: I think the part, I mean, in looking at this again, I think
there’s some ordering that can be done. In the first three, we applaud,
recognize and support. We are now needing the next three to say, however, we
caution, we don’t agree. So the first are positive, and then the negatives, and
then the recommendations.

DR. CARR: Supporting, applauding, recognizing, now we’re advocating.

DR. SUAREZ: No, that’s what I’m arguing, that it doesn’t go there. We need
to say first, we support, we applaud, we recognize. Then we need to say,
however, we caution that the approach of metadata tagging, we don’t agree with
this part, we don’t agree with this part. And then, at the end, we advocate.
That’s the order, we applaud, however, and now we advocate.

DR. CARR: So we applaud, we caution and urge and then we advocate. And so we
caution that the approach to metadata tagging, what may have unintended
consequences for privacy and meet national standards. I’m sorry, I got lost
here. Do you suggest language?

So are we okay with trying to craft an opening paragraph that lays these
things out, and now onto our recommendations and development? Okay, great.

MR. QUINN: The main focus, in addition to sort of framing this, is that
concepts in the PCAST Report that align with NCVHS priorities include, and we
have a pretty long list of things there. Do we want to try to narrow that down
or keep those?

DR. CARR: This list, I think this is fine. It’s our letter, our work. I
might reorganize is a little bit. Okay, so let’s go through then the letter. I
had a couple of minor tweaks, but this is your opportunity, having read the
letter, if you have a suggestion. So we’re going to put some introductory
language, and then we’re going to have the concept. Well, let me ask what
others think. We have these concepts in the PCAST Report that align with NCVHS;
do we want to spell them all out?

I think one thing that would be important, you’re right, these are the ones
that align, and then later, we get to the ones that don’t align.

DR. HORNBROOK: This is just a question – whether one of the concepts could
be supporting appropriate access to health information for safety and high
quality of medical care. Is that something that we’ve already said and it’s
obviously, but I didn’t see it on the list. We say involved in their care, but
we don’t say anything about safety and quality.

DR. CARR: I can’t think of any safety things that we’ve done in the Quality
Committee. We had the letter on public reporting. I don’t think we’ve talked
about the quality of care, rather we’ve talked about use of data on behalf.

DR. HORNBROOK: Maybe I’m just being sensitive to the fact that safety shows
up so much in all of my research priorities.

DR. WARREN: You raise a good point, but I’m quite sure, at least when I was
Chair and Co-Chair of Quality, call me remiss, but I don’t think we addressed
safety. Plus, I don’t remember any comments about safety in the PCAST letter.
So if it’s not in the PCAST letter, it probably should not be addressed.

MR. QUINN: This list right now is focused on NCVHS priorities. Would it be
more powerful there to say that aligned with past NCVHS work or past NCVHS
letters? And then, it’s less abstract or it’s less concepts, yes, and it really
brings to a head that we’ve been working on these issues for a while. And that
we have letters and recommendations in the past that address these concretely.

DR. CARR: I had just a suggestion on the second bullet, enabling universal
data exchange, thereby fostering network effects. I had a lot of trouble
reading that sentence. Is that what we mean, enable universal data exchange,
thereby fostering network effects that increase the utility of information,
both for individual patients and in aggregate?

DR. KLOSS: Is it the phrase, network effects, that’s troubling you?

DR. CARR: The whole sentence, it took a while. I think I was the one that
added enabling. It was very cryptic in the beginning.

DR. KLOSS: But networks was so fundamental to the PCAST Report, that I
thought it was good to bring that phrase in here.

DR. CARR: So by enabling universal exchange, we enable network effect, we
foster network effects. Another bullet, enhancing possibilities for using
information in ways that protect against unintended linkages to individuals, as
opposed to saying, cannot be linked, because there are times when linkages. All
right, any other suggestions on that?

I had a question on this, sentence two. The PCAST Report, intentionally
importantly, calls for transformative, not incremental, change in our nation’s
approach to building an interoperable use of health, it said health
infrastructure, but I think we meant health information infrastructure.

DR. SCANLON: Justine, can we go back to where you were. It’s the sentences
that follow that bother me. This is the tone that I raised when we had our
phone meeting. We are endorsing sort of their objective, and I think the
discussion earlier suggested that we’re all behind sort of where we want to get
to. The issue is the path and the speed that we move along that path.

We’ve endorsed it, and then the rest of this paragraph and the bulk of the
paragraph is saying, wait a minute, this might be a risky journey, and it’s
like we’re going to scare people away. To me, I’d like to just go to the next
paragraph which says, incremental approaches, here’s what you need to think
about in your incremental approach. Because I think if we are so lukewarm that
we give sentence that we like the ultimate objective, and then we give a lot of
warning about the risks, people come away worrying more about the risks, than
they do about the goal.

DR. CARR: I agree with you that the balance.

DR. SUAREZ: But I thought I read in there that the reason for we being
concerned is not the ultimate end of the journey, but the sweeping way in which
the changes were expected to be done.

DR. SCANLON: Even though PCAST may have implied that, that also to me
suggests that we think HHS is, in some respects, naïve enough to try it in
a sweeping way. They are going to say, January 1st, 2017, everybody’s going to
do X, and they’re not. And so this is going to be this question of how do they
get there. And Jim can maybe address this, the issue is, what’s the department
going to do to get here? And I don’t think they’re going to propose a single
rule that says we’re going to do this. There’s going to have to be sort of a
whole process.

And the one problem, I mean, I understand sort of this need for
incrementalism. And one problem of government being incremental is it really
does slow things down. You can’t imagine how many times you hear government’s
this lousy business partner because it changes its mind. It asks for something
new tomorrow that it shouldn’t ask for yesterday, and I’ve got to change all my
systems, I can’t do that. And we end up sort of with years, if not decades,
proceeding before we get real change.

So I think there is this concern that we don’t put too much in here about
the impediments, with respect to how we get to the goal, or at least link them
too closely with our endorsement of the goal. I think we’ve got to be clear. We
like the goal here. I think all of our earlier discussion was we worry about
the root or the path, but we really like the goal.

MR. QUINN: I think that it makes sense, based on this discussion, to have a
sentence that says this vision can be achieved, but we must be deliberate and
judicious in our movement to the new architecture. That’s a way that says, the
steps to getting there, it won’t just happen on its own. There’s got to be some
really direct things. And I don’t know how far we want to go in
recommendations, but there’s go to be maybe recommend funding work on X or Y
and grants or contracts.

DR. CARR: Let’s just keep going, but I think that’s right, the balance,
because I agree with you, it sounded like it’s great, now let me tell you
everything that’s not great. I think keeping that is helpful, and if we don’t
need as many sentences, because again, the number of sentences about good and
bad is not equal.

Any questions about the next paragraph? While NCVHS supports the goal of
PCAST vision, the recommendations in the letter address critical steps needed
to bring this vision into reality, while maintaining current progress. So I
think that is a fair and balanced sentence. So maybe we’ll work a little bit
with what it’s about, offers observations and recommendations regarding the
establishment of aggressive, did you want to say aggressive, 3 to 5 year
incremental plan. Do we want to say, because accelerated, we’ve given the time
frame, so I don’t know if it’s redundant to say accelerated here. All right, 3
to 5 year incremental plan for transitioning from the current state of health
IT to one that will support the goals envisioned in the PCAST Report. So are we
okay with that?

All right, Observation 1, any comments about Observation 1?

DR. COHEN: In the recommendation, in the first sentence before embarking,
when we say HHS should work with health care, could we add, and public health?
There are a couple of places where we do reference health care, and I’d like to
expand that to include, and public health.

DR. FRIEDMAN: This gets into another terminological issue. We don’t have a
good word for going back to the Learning Health System. All the folks who do
all the Learning Health System stuff, the quality community, the public health
community, the research community and the emergency preparedness community, and
probably other communities. Some people use the term population health to
embrace all of those, and if this Committee can endorse the use of that term,
to have that meeting, I think then population health could be used there.

But I think the insertion, which I agree with, actually needs to be a
broader set of stakeholders than just public health. It’s got to be the quality
people, the research people, the disaster people.

DR. CARR: I agree with you. I think it’s not point blank. How about Learning
Health System, start using that term. In some ways, if we could say something
like that.

DR. COHEN: We could just say stakeholders.

MS. GREENBERG: We could just say work with all stakeholders.

DR. CARR: We’ll just say with stakeholders, okay. I do think we’ve got to
get Learning Health System into our text. Also, I realized, Marjorie, we have
to revisit our glossary of terms. Usually new members, about 15 minutes into
it, can count 15 to 25 acronyms they’ve never heard of, so I have it on my
drive, we’ll have to update it. Any comments on just continuing down, health

DR. SCANLON: I think that first sentence of that health care organization,
that sentence implies a much more structured health care system than we’ve got.
And also maybe envisions a future that may never occur, so I’d like to make it
more generic. It is health care organizations and providers are confronted with
rapidly escalating demands, to integrate and coordinate care and quality
measurement, using health IT systems.

ACOs, we have an uncertain future, medical homes, also uncertain future,
depends on the bargains between payers and sort of providers. So I think just
being less specific here would make this.

DR. CARR: Health care organization and providers.

DR. SCANLON: Are confronted, right.

DR. FRANCIS: Justine, there are a couple of places where we use short-term
at the end of that paragraph and at the beginning of the next paragraph, and I
think we should say near-term rather than short-term, because short-term sounds
like a quick, evanescent fix.

DR. CARR: Okay, Bill, did I get everything you wanted? Everybody agree with
confronted with rapidly escalating demands to support quality measurement

DR. SCANLON: Instead of new care models, to integrate and coordinate, and
just make it that. That’s the function that we’re interested in, the model is
not the critical thing.

DR. CARR: And?

DR. SCANLON: To integrate and coordinate care. And then, take out everything
up to the end of the parentheses.

DR. CARR: Using health IT systems stays in, okay. On to the next paragraph,
we recommend identification of near-term opportunities to exchange some, in our

DR. KLOSS: I had a question about that paragraph, and the three numbered
inclusions below. I guess I just didn’t understand what points they were
underscoring, and it seemed to me that it disrupted the flow of the discussion
about the DEAS.

DR. CARR: Although I was a participant in this letter and I love the letter,
I still struggle with this, that it’s not quite the same thing that we’re
talking about. And spelling it out like that, I mean, what we said in that
letter or after those hearings, that we want to have a library of data elements
that can build measures, so that’s what was similar. But the final three
recommendations, I think, are broader and in a different direction. And so, I
wonder if we might be able to just reference the letter, but talk about the
fact that we were advocating a library of data elements or something. Am I
remembering this correctly, Bill?

DR. SCANLON: We were also a little schizophrenic when we were writing that
letter. There was both the interest in measures and the interest in data. And
the question is, we tried to keep both of them in there.

DR. CARR: I think we want to stay away from the measures. I think we want to
talk about the fact that we had that concept of elements building measures, and
not get carried away with harmonizing measures and stuff like that. That’s not
relevant to this. So I agree with you, would others, let me hear any
alternatives for keeping this in, as opposed to shrinking it to the data
element language that we can find?

And then, we would simply talk about that concept and not have all of this
language in there. And then, while there may be value, moving onto the next
paragraph, while there may be much value to be realized from a DEAS-based
environment, we should work with stakeholders. Well, again, is it we should
work with all stakeholders? We should work with stakeholders? Anyway, to
explore the feasibility of such a system, both technically and operationally,
as well as new policies.

Now, onto the paragraph about metadata tagging and DEAS mechanisms. Any
comments or questions? Continuing on the next paragraph that begins with

DR. FITZMAURICE: Excuse me, just a question about the data tagging. It would
seem that we’re not against data tagging, we’re against tagging the privacy
metadata to the data elements. Is that right?

DR. WARREN: From Stanford’s perspective, we’re against the meta tagging.
Who’s going to keep track? Meta tagging is supposed to replace our traditional
standards. The problem is, who’s going to standardized the meta tags, so we’re
back into the same thing.

DR. FITZMAURICE: That’s a governance problem that has to be resolved if you
go to metadata tags, yes.

DR. SUAREZ: There’s already work being done by the SMI framework. There’s a
power team, actually we’re part of a team that is working on metadata
standardization. So I don’t think we are, according to my reading of the
letter, I think we’re again metadata tagging, whereas metadata tagging of
privacy information, at the data element, at the most granular data element
level. There is metadata tagging of providence of the data, which I don’t think
we’re against it. But it’s the granularity level which we are very concerned

DR. CARR: Is there a domain called here are privacy tags, I mean privacy is

DR. SUAREZ: Well, the idea was that people would be able to tag at the data
element level, five or six specific aspects of privacy, including who can see
this data, for what purpose, when, how.

DR. CARR: So it’s the permissions?

DR. SUAREZ: And those are the kind of elements I think we were not

DR. CARR: So are we clear on this?

DR. WARREN: I thought that the PCAST Report was talking about using meta
tagging in other kinds of data, other than privacy. And that’s where I have
concerns, is with the other stuff. Yeah, they were going do it in standards and
we’re going to meta tag everything.

DR. SUAREZ: There are two things that the report talks about, in terms of
data tagging, privacy and providence. Basically privacy aspects of the data and
then the source of the data, those were the main elements about the meta
tagging in the report.

DR. WARREN: I was under the impression that they were saying, throw out X12,
throw out HL7, throw out all of all those, and replace them with mark-up
language, A.K.A., meta tags. I’m getting lots of other head shakes that they
had the same impression.

DR. FITZMAURICE: I don’t think they were that specific about what to throw
out. They simply thought that having meta dated tags on a bushel basket full of
variables meant that you could then sprinkle them into a document that says, I
want this kind of a variable here, and that variable would jump into that
document. And then, you could read the document because the data elements have
metadata tags that show their place and where they came from.

DR. FRIEDMAN: So I think a simple way to think about it that may be helpful
is to think about a data object, a data atom, as having a payload, which is the
data itself. And then, different kinds of metadata tags, which would convey the
providence, the identity, information about the data, what those data mean, and
privacy. And I think that to, and I’m not sure anybody is implying that this
should be said, but the whole world, as you well know, is actively engaged in
pursuit of metadata standards.

The digital library community has these Dublin Standards for digital
information objects, that are internationally accepted standards. So the
concept of having standardized metadata is out there and established, and
certainly there’s ample proof out there of the feasibility of standardizing

DR. CARR: So let me get a time check, Marjorie or Debbie, somewhere where
are we on our agenda?

MS. GREENBERG: At noon, we were supposed to move into our standards update.

DR. CARR: I think we need to get our major concerns, and then take it
offline and work on this, and then maybe circulate something at the end of
today even, so folks have it.

MS. GREENBERG: Well, or tomorrow morning.

DR. CARR: Well, even if people can get it tonight, at the dinner.

MS. GREENBERG: Well, we could electronically maybe connect.

DR. CARR: Let me just say this, Observation 2 in Recommendation 2, any
specific comments on this or concerns? Okay, moving on, Observation 3.

MR. QUINN: Do we want to talk specifically about ACOs on this?

DR. CARR: The ability of our digital infrastructure to support consistent
reporting for ACOs and other patient-centric models will be important. I think
it is fair for us to mention it there. We are advising the Secretary on data
strategies for initiatives, and this one certainly.

DR. SCANLON: Let me just make it a more lasting document. There’s data
reporting for value-based purchasing of all forms, and ACOs, if you’ve been
following the flack over the rule, what their future is, is not clear. So I
would say data reporting is the concept that we’re worried about, not for a
particular purpose.

DR. CARR: Ok, so can you make a recommendation here?

DR. SCANLON: It was just to take out consistent data reporting for quality
or for monitoring purposes or something, or quality. Well, the reporting is
really for quality monitoring.

DR. CARR: And so you want to take out other patient-centric models, just
leave the models out.

DR. SCANLON: We’re doing a sort of value-based purchasing program with
hospitals, we want to do it with physicians that are in individual practices.

MS. GREENBERG: You want to use those words, value-based?

DR. SCANLON: No, again, we’re getting into specifics. The concept is data,
because we also want to use it for things like hospital compare, just to be
able to report it.

DR. CARR: Observation 3, any comments, concerns?

DR. FITZMAURICE: How does it read again, the recommendation above it?

DR. CARR: Decisions to implement the approach in the PCAST Report should be
linked from the outset with strategies to align the technology with national
standards efforts and policies on privacy and confidentiality.

DR. FITZMAURICE: The one above it raises a variety of privacy, security and
standards concerns. I think our focus is on putting the privacy metadata in
with each data element, that that’s the focus of the concern.

DR. CARR: That’s a good point. Did we address security and standards in this

DR. SUAREZ: There are two pages of that.

DR. CARR: Right privacy, and did we address security?


DR. CARR: So Recommendation 3.1 is about privacy and is this all about

DR. SUAREZ: 3.1 is about both national standards for the metadata tagging,
which is the surefire right after Recommendation 3.1. The entire paragraph is
about specifically that point.

DR. CARR: The national standards efforts and policies, all right.

DR. SUAREZ: And then, the remaining page 5 is about the privacy.

DR. CARR: And then, 3.2 is about legal requirements for special handling of
defined categories, and 3.3 is decision to move forward with the PCAST approach
should be linked from the beginning with strategies to align
privacy/confidentiality policy, retaining a long-term commitment to tandem
development. Policy should guide technology, not vice versa. Such policy must
recognize that consumer privacy preferences and consent matter, but they may
not be the only way to earn the public’s trust.

DR. FRANCIS: I was just going to say, with respect to your comment, Walter,
I’m not sure we actually say anything about security.

DR. CARR: I think we say for privacy and standards.

DR. FRANCIS: And standards, but I don’t think there’s anything specifically
about security.

DR. CARR: Okay, so we’ll go back and check on that.

DR. GREEN: Justine, I want to speak, not to disagree with the content of
everything under Observation 3, but it starts on page 4 and goes through page
5, keeps going through page 6. It’s over two pages long. And there are places
where, in terms of its construction, it goes back and revisits observations.
Observations wind up landing in their recommendation section. And I think it
weakens the messages and the recommendations, so if it’s possible to go back to
your notion about trying to get something out tonight, I would suggest that we
ask for an editor’s help, to take Observation 3 and organize the observations
under the observations, keep the recommendations in the recommendations, and if
at all possible, just simplify this.

I think our messages are weakened by the length and some redundancy and
repetition, and I would just like to advocate that this section of the letter
be edited for crispness.

DR. WARREN: The other part that I had on these three observations is always
before, our standard in these letters have been observations should be verbs,
so telling someone what to do. And we go back and forth between some of these
being verbs and some of them just being statements. And so, I think we need to
edit that.

DR. SUAREZ: One natural place to actually separate, and maybe that is a
completely separate recommendation, it’s precisely the standards. The standards
part was added inside this, but you can take Recommendation 1, and only deal
with the standard part, 3.1, and the paragraph that follows up to on page 5,
the end of the first sentence, before it states, NCVHS has emphasized the
importance of developing appropriate privacy and confidentiality. All that
aspect is a completely separate standalone recommendation on standards.

DR. CARR: If you could make a few notes. I’ve been watching Linda nod her
head at different places, and I’m thinking she’s a very good editor, having
reading various things out of AHIMA, so as a kind of an unbiased participant,
we’ll try to make a first pass and share it with folks. If we take out anything
critical, we’ll put it back in.

So that takes us through 3, and then 4, recommend new patient identifier
methods, evaluate existing approaches. And again, I’m just taking out the
personal pronouns.

DR. MAYS: Let me just comment a little bit on the ones that you want to use.
Here, where you said information such as names, date of birth, gender and other
demographic information, there’s kind of a movement afoot, particularly when
the federal government is involved, about using gender.

And kind of the lawyers are the ones more talking about this, is that for
example, when we do our reservations to travel, and they want you to put in
your gender, individuals who are transitioning gender are actually getting very
upset about what this means in terms of having to track their gender, when they
think that there’s such a fluid change in it for them. So you just may want to
think about that, because later down on the line, there’s going to be a
challenge to the federal government about this use of gender, so you might want
to pick something else.

DR. CARR: I think we’re quoting a letter that we previously did, so at that
time, that was the recommendation.

DR. MAYS: Well, it says, this includes the use of reliable, highly sensitive
standards. I’m sorry?

DR. WARREN: We haven’t specified the standards for reporting gender yet.
This is what Bill was getting at, depending on what you want to do. California
has a standard with seven genders in it.

DR. CARR: Before we go on, I want to make sure that the language here
represents what was in the letter, at the time the letter was written, which
was 2006.

DR. SUAREZ: I personally extracted that it is exactly the same language.

DR. CARR: I don’t want to add a new voice, but simply to say thought has
been given to this, and that may or may not prove helpful.

DR. FRIEDMAN: So reading this once and reading it again, what isn’t clear to
me in Observation 4 is what the point is. You basically say, we wrote a letter
and that’s great, anchor this in the letter, and then you summarize what’s in
the letter, and then there’s no argot. So I think there’s almost a paragraph
missing here.

DR. CARR: Yes, there is. Although Marjorie said there are no topics you
can’t bring up at this committee, a sensitive issue has been national patient
identifier. And just a heads-up, everybody, we started to go down that road and
then thought the better of it. It was brought up around the time of HIPAA, for
those who don’t remember. And it was Congress who said, you may not have that
discussion. So we, as advisor to the Secretary, and Secretary being bound by
what Congress has forbidden, try to skirt that, but I see your point.

DR. SUAREZ: Let me suggest one thing, because I do agree, Chuck, with that.
I was reading that and the only thing that it says is evaluate, in the
Recommendation Number 4, that’s the only word that’s actionable. My suggest is,
right after the paragraph, in essence, we recommended back then progress, as
thus, we recommend that guidance and methodologies be developed to help the
industry achieve better improved patient matching methodologies and system. And
in fact, that is already underway under the Standards Committee, patient
matching power team, and recommendations from there would come out and some of
them will become guidance.

DR. CARR: So if we say something like this, and we can go back, but evaluate
existing approaches to patient identity matching, in order to develop guidance
for industry for better patient matching or something along those lines.

MR. QUINN: Will there be different approaches needed than today for
identifying patients, unique patients, with the proposed future, metadata
tagging based inoperability versus what’s today? Or did the report just
highlight shortcomings today that will be shortcomings in the future if we
don’t fix them?

DR. WARREN: To me, that recommendation, if you scroll back up, when you say
guidance for industry for better patient matching, it’s not. It’s guidance to
industry for linking patient data, to provide quality, safe patient care, back
to Larry’s comment. That’s why we want to match the data, it’s not all that
other stuff. It’s for linking patient data to support high-level quality,
clinical decision making or patient safety care or whatever.

DR. OVERHAGE: I think the PCAST Report goes well beyond that. The PCAST
Report is not specific to patient care.

DR. WARREN: I know, but our recommendation, I think, should have the patient
care piece. That’s what we’re saying.

DR. FRIEDMAN: I think getting the matching right is important, no matter
what you’re doing.

DR. CARR: Right, to ensure the functionality of the system really. Mark, do
you have a recommended alternative language?

DR. SOONTHORNSIMA: I’m not sure, are we opposed to what they’re trying to
do, or are we, yes, we go along with it, but we need to be prudent perhaps,
because if we’re not strongly opposing to what they’re suggesting, you wouldn’t
methods, than just go ahead and support it.

DR. OVERHAGE: But they haven’t recommended a method for matching. They have
said, use whatever data is available to try to generate a match and expand on
what is available, without any evidence that it works.

DR. FRIEDMAN: And I think that’s exactly the point. I think that’s the
essence of the argot. The argot is, we recommend going into this with a solid
basis and understanding of what works and doesn’t work in matching, and how
well different techniques work, and what the error rates are, and whether the
error rates are acceptable, instead of going forward as a leap of faith. And I
do think that was really the spirit of the letter.

DR. FITZMAURICE: Justine, suppose you said evaluate new and existing

DR. COHEN: So what industry to industry guidance in this, develop guidance
for accurate? To industry, can we just eliminate guidance for? And also, is the
focus only on patients or would it be clients and other systems? Are we talking
generally about individual identifiers or just a focus on the clinical setting
for patients?

DR. WARREN: If I’m hearing you right, it’s the word clinical, that you’re
seeing clinical as a focus.

DR. COHEN: Yes, it’s an individual.

DR. SUAREZ: There is also one additional idea would be, in order to develop
standards and guidance, because it’s really standard what we need to look into,
and guidance, as well, but we need to start with the standards part of it.

DR. CARR: My last question is, is the closing paragraph the right ta-dah?
NCVHS wishes acknowledge the visionary leadership displayed by PCAST. At the
same time, the Committee believes that the nation has made significant progress
toward adoption and Meaningful Use of health IT systems in recent years, that
the nation should be recognized as foundational.

NCVHS wishes to acknowledge the visionary leadership displayed by PCAST. At
the same time, the Committee believes that the nation has made significant
progress toward adoption and Meaningful Use of health IT systems in recent
years that should be recognized as foundational. NCVHS urges a focus on the
areas in which an approach is both aggressive, but also incremental over the
next 3 to 5 years, which will result in early wins necessary to move forward
progress in critical areas. I don’t know, I was trying to edit it a little bit.
Is this what we want to say, assuming we get the English right?

DR. FITZMAURICE: One way of saying it more bluntly should be recognized as
foundational and not discarded, but that may be a little too blunt,
particularly for a closing paragraph. I think that’s the sense you’re trying to
say, though, is don’t toss out what we have, build on it.

DR. FRIEDMAN: It occurs to me that incremental is not the word you want,
rather cumulative.

DR. MIDDLETON: Partly I think some of the tone of the original PCAST Report
came from the fact that it was vendor-initiated in some ways. I don’t want to
call out any names, but I wonder if we want to sort of set that part of this
record straight, too?

MR. QUINN: I think it’s important, in addition to us saying that we need to
keep the progress in critical areas moving along, that we need to initiate.
We’ve identified in this letter some areas that are necessary underpinnings for
the new approach, and that we need to initiative work in those areas, while not
disrupting forward progress in the critical areas.

DR. GREEN: I’m pretty comfortable with this paragraph. This is no place for
howevers. I think, like Mike was saying, I think being a little more blunt and
direct here is a good idea. But the only word that I don’t see there, that has
been important in our discussion this morning, was accelerate. And this notion
about being foundational and supporting and contributing to, this is an
opportunity to say, do this and you’ll actually wind up accelerating. That’s
the idea and we don’t have it in there.

DR. CARR: Focus on an approach which is both, what about aggressive and
accelerated? Do we want both of those words?

DR. SCANLON: What about the second to the last line, where you say to
maintain forward progress to accelerate progress?

DR. CARR: Good idea, excellent. So this is great, thank you for taking the
time away from the rest of our discussion. But I think it is very important to
have clear thinking on this, and to represent it well, and I think we did it.
So Marjorie, where are we on the agenda?

MS. GREENBERG: Well, we are at 12:30 and we were supposed to break at 12:45.
I guess I would recommend that we go until 1:00, and Walter, if you could, I
guess, condense your 30 minutes.

DR. CARR: And then what happens after Walter?

MS. GREENBERG: We’re then supposed to have lunch.

DR. CARR: Yes, and after lunch?

MS. GREENBERG: And then, at 1:45, we’re coming back for a briefing on the
Community Health Data Initiative.

DR. CARR: So I’m just wondering if it would be helpful for Walter to blend
his two presentations.

MS. GREENBERG: That wasn’t his, that was a different presentation.

DR. CARR: Oh, that was.

DR. SUAREZ: My suggestion is just break for lunch now, and then come back
and do the two briefing standards.

MS. GREENBERG: That’s fine, break early for lunch, that’s fine.

DR. CARR: And where is lunch?

MS. GREENBERG: While we’re thinking about lunch, we also want to account for
dinner. But let’s first answer the first question about lunch.

DR. CARR: What time are we reconvening, Marjorie?

MS. GREENBERG: Well, we were supposed to reconvene, so I’d suggest, at 1:45,
I’d say we should come back at 1:30.

DR. CARR: 1:30, okay, we have an hour. And then, for dinner, do you want to
get a hand count? Dinner is our most important time for the Committee. It’s
where we debrief and have a lovely time.

MS. GREENBERG: And we’ll also be recognizing our, I don’t want to say
departing, our retired members, and of course, welcoming the new members. And
it’s on your agenda book.

(Whereupon, a luncheon recess was taken at 12:34 p.m.)

A F T E R N O O N S E S S I O N (1:35 P.M.)

DR. CARR: Recess is over, so who’s up next? Let me just point out that if
you have your computer, you can go to the site and use the conference code
tree, and you will be attached to the internet. Walter, I guess just find your
thing on the desktop.

Agenda Item: Standards Update

DR. SUAREZ: Thank you. For those on the phone, this is Walter Suarez. I’m
one of the Co-Chairs of the Standards Subcommittee. And I guess have the
challenge of doing a delta just to follow one of the themes of the day. One of
the challenges is doing a delta between the lunch and this topic, and the other
challenge is, of course, taking you from the PCAST letter that we had before
lunch and grounding you into some of the work that we are doing on the
Administrative Simplification.

So the top is really kind of a journey review of where things have been and
where we are going and what work we’re doing on the Administrative
Simplification. At the same time, it’s, of course, our selling pitch for the
new members to join our subcommittee. It’s a lot of fun.

So it was funny, when Justine put the timeline, you remember that arrow with
a lot of years, even years on top and odd years on the bottom. The starting
point was 1996 and it’s an important date because I think for 60 years, since
the Committee has been in place, there have been really no change in the law
that created the Committee in terms of expanding or adding responsibility,
except until 1996 when HIPAA law wrote specifically an expansion in the
responsibilities of the Committee, and expanded its membership, added members
and expanded the expectation that the Committee will have a very concrete role
on Administrative Simplification and under the whole HIPAA regulations.

So we have been deliberate in terms of the work that we have been doing
consistently since that time. And for those that thought HIPAA was sort of
something of the past, because we thought everything was done now, welcome to
2011. We are about to embark into the next phase of HIPAA with the
implementation of some of the new standards, and of course, the work that needs
to be done out of the Affordable Care Act.

So to start, I thought it would be helpful very quickly, and I’m going to
run through this. I thought it would be helpful to start with some quick
overview of some of the regulatory landscape, the ecosystem of regulations that
we have out there and requirements that are being imposed in the health care
industry. And then, focus on the Administrative Simplification components of
the Affordable Care Act, or maybe some people might be calling HIPAAll,
specifically operating rules, you heard that term from Justine earlier, some of
the concrete things about operating rules. They are actually written in the

And then, just give you a quick update on the status of the work on the
subcommittee over the last year and a half, which have been quite intense. And
then, what we have in the coming year and a half roughly, I guess.

This slide used to say, the perfect storm, now I call it the persistent
storm, because it’s persistently giving us new requirements, it’s coming ever
year basically. And as you can see, usually the perfect storm is like three
different things of the weather coming together. There’s four and more of those
coming together, so HIPAAl, which is the next generation or the standards and
codes, and then HIPAAll, this new requirement under the Affordable Care Act.
And of course, we have all the Meaningful Use and the standards and
certification criteria around ERH.

Health reform, with all the new items, and then other certainly state laws
and other regulations that affect how we conduct business and health care, and
particularly in the standards world. So all of this is sort of coming together,
well, it’s been in place for a few years, but over the next 3 or 4 years, it’ll
be exploding in front of us basically.

So here is a quick review basically from the HIPAA transactions, codes and
identifiers. We are implementing a new version of HIPAA standards, starting
January 1st of 2012, the 5010 HIPAA standards. A major transition from the
current version of all the standard transactions in HIPAA Administrative
Simplification, the claims, claims payment, eligibility, enrollment, all those.

We’re implementing ICD-10, a major, major transition on codes, starting
October 1st, 2013. We have a new identifier, this is some of the new things
coming out, starting in the third bullet here. These are all the new items from
the Affordable Care Act, new identifiers, health plan identifier, new
transactions, to establish standards and requiring the health care industry,
including EFT, claim attachments.

Acknowledgements is something that is not in the regulation, but as we will
talk about tomorrow actually, there’s a lot of interest in industry
establishing that as a standard transaction in health care. Operating rules,
and then the possible areas of standardization, which is sort of the next
steps, staying ahead of the regular distance standard transactions that we do.

HIPAA privacy and security, another major area, and you heard from Joy
Pritts earlier all the things that are happening, so I’m not going to go over
those, but this is another major area of regulations that are coming up. Of
course, the big one right now that we’re focusing on is the accounting of
disclosures, regulations, but we also looking for the final rule on breach
notification and the HITECH updates for the privacy and security, which is
expected to come sometime in September or October of this year, so that’s
another major one coming down.

And then, we all know about Meaningful Use and all the staging and the
moving towards using Electronic Health Records, adopting and using them in
meaningful ways, and then establishing standards and criteria to certify those.
There’s also the HIE’s, the Health Information Exchanges, 56 or so of those
that are still very much in developmental stages and trying to be some
important element in the industry, state and regional HIEs.

Health reform, there’s some important things about health reform that are
not just purely about the market reform, but that affect electronic health
information exchange and health information technology. So the health insurance
exchanges and the essential benefit plans, a lot of talk about the eligibility
mechanism, or the mechanisms to automate and to simplify the eligibility of
people, and the ability for people to say, well, this is who I am. What am I
eligible to enroll in, and then the enrollment process.

All of those things are going to be different in the scheme of the health
insurance exchange reform. We do have standards for those, and now we have to
think about how to apply those standards into this new world of enrollment, of
checking the eligibility of people to enroll into these systems.

Accountable Care Organizations and other interesting player or view, I
guess, depending on how that evolves, but how they will be exchanging data
between them, both administrative and clinical. And then, all these other
regulations, state regulations and other activities, like all-payer claims data
bases, privacy and security at the state level.

E-Prescribing is another major area that continues to be an important driver
in terms of standards. Now the new in-health, mobile health movement and the
option of use of medical devices and the standards for those medical devices to
communicate data and exchange data. And of course, the privacy around those,
too, but all those are forces that are driving more and more into coming to
some sort of a rationalized framework of standards, and making sure that
there’s a good harmonization of all those, other wise, yeah, we’ll have a lot
of different standards to do the same thing.

Well, this is sort of the picture that shows what’s coming up in the next
five years. On the top, it’s mostly the HIPAA stuff, basically all the
regulations, when they are going to be published and when they are going to be
expected to be complied with. And then, on the bottom is sort of a Meaningful
Use, although there’s a couple of things about other things there. But it is
just a pictorial view of the complexity of what is coming up. And this doesn’t
include a lot of other regulations that are expected to come out, so very, very
brief kind of picture of what this means for all of you.

Now, I’m going to focus next on then Administrative Simplification
provisions in the 2010 Affordable Care Act. There were two major sections on
the Affordable Care Act that talks about Administrative Simplification. Section
1104, which was the big portion of it, that created the requirements for
operating rules. And the most significant portion of that section is about
operating rules. But it also salvaged the requirement for health plan
certification. This is a new thing for health plans. Before and until now, we
all were implementing HIPAA, and not having to really certify that we were
implementing HIPAA, using the standard.

Well, starting December of 2013, the expectation is that health plans only,
this is not provider, will have to basically certify a test to the fact they
are in compliance with HIPAA, with the standards for the transactions, the
operating rules, the implementation specifications. So major change, and it’s
not an easy thing to have your CEO sign a letter saying, yes, I am in
compliance with all these transactions. It’s a very legal and very deliberate,
I guess, statement that we don’t have to do today. So an important
certification expectation coming own the pipe for health plans.

We have unique health plan identifier, and I’ll talk a little more in detail
about each of those. Electronic fund transfer is a transaction that is now
required in the provisions, that we need to establish a standard and have an
implementation of that in the health care industry. Claim attachments is
another one that is coming down. There are also provisions on penalty fees and
some refinement on the penalties that will be carried forward and into the

And then, HHS Review Committee, there’s some language in the regulation that
talks about the HHS to establish a Review Committee to review the regulations
and review the implementation of the standards on how things are going. And it
actually says, NCVHS could be that Review Committee, and that role could be a
role that NCVHS plays. And so the building of the monitoring of all this is
evolving over the next year. It’s going to be an important responsibility.

The other section is section 101019, in which the Affordable Care Act talked
about sort of the next areas for standardization. They did, of course,
reference the fact that HHS will be in concentration with NCVHS, but as well as
with HIT Policy Committee and the Standards Committee, and SDOs and others, on
looking at this future areas. It also talked about ICD-9 and ICD-10 Crosswalk,
a technical notation about the fact that the crosswalk itself will be
considered and treated as a code set under the HIPAA regulation, which is
giving it a lot of power to it.

And then, the next round of standardization and the areas to be considered
included provider enrollment, so the process of enrolling a provider into a
health plan, for example, the standardization of that process. The
applicability of standards and operating rules to Worker’s Comp and our auto
insurance, to areas that were exempt from the HIPAA standards, but that
everybody wants to see them be part of the standardization of transaction.

Standardization of financial audits in health care and then the consistency
in claim edits across health plans. These are new areas that we, as a
committee, will be certainly in a very unique position to explore into the

These next two tables are primarily for your reference, in terms of the
dates and times when a particular element is expected to be done. So for
example, the unique health plan identifier, the rules are to be adopted by July
1st of this year, and then by October 1st of 2012 is when the health plan
identifier needs to be in place and in effect.

The same with all this other rules, you can see the sequence of how, at some
point, regulations, for example, the eligibility and claim status, operating
rules, regulations, are expected to be published in July of this year, and then
the compliance date is January 2013. So this gives you much more a timeline
sequence of events. So these are the two slides, I’m going to skip those two.

Talk a little bit about operating rules, very important new area. So in the
original HIPAA law, it’s important that we all remember two very critical
concepts that the HIPAA regulations and the law said basically. You have to
establish a standard for a transaction and an implementation specification for
that transaction. So when we say we’re going to do a claim, we’re going to use
a standard design, defined by a particular entity, standard development
organization. And then, we’re going to use an implementation specification, the
guide on how to implement that standard.

Interestingly enough, when you read the standards on certification criteria
regulation for Meaningful Use, they use the exact same concept. The standards
for EHRs are divided into two types, standard itself then the implementation
specification, which defines the guide on how to implement those. Well, respect
to administrative transactions, the Affordable Care Act created a third level,
a third category of standards, and they call it Operating Rules. And that’s
what creates sort of the three legs of this new approach for this
Administrative Simplification.

So what are the Operating Rules? They are defined in the Affordable Care Act
as the necessary business rules and guidelines for the electronic exchange of
information, that are not defined by a standard, or its implementation of
specification, as in this section, so very critical elements. There are
business rules and guidelines that are not defined in the standard already, or
the implementation specification.

What are they intended to do? Well, basically the law says that these
operating rules are intended to do these five things, enable determination of
an individual’s eligibility and financial responsibility. So when I’m going to
the doctor, the expectation is that the Operating Rules, along with the
standards and the implementation specification will, for sure, and very
deliberately and very specifically tell me, as a consumer, how much do I owe,
as a provider, how much am I going to get paid roughly. I mean, the concept is
establishing that in a very clear way.

Be comprehensive, requiring minimum augmentation of paper and other
communications. So they’re famous now that, even though we have all the
standardization in HIPAA, we still have to depend on the phone or follow up
kind of communication for certain things. And the intent is to minimize as much
as possible, any paper follow-up or any other communication follow-up for that
type of transaction.

Provide for timely acknowledgement, and this is where acknowledgement comes
to play, because the word acknowledgement was there somewhere in the rules. So
we believe that is a very important element, but provide for timely
acknowledgement, response and status reporting, that supports a transparent
claim and denial management process. So these are all aspects of what an
operating rule set will help do. And then, describe all data elements in
unambiguous terms, require that such data elements be required or conditioned
upon set values in other fields, and prohibit additional conditions.

So this interestingly enough is truly what the standards already do and the
implementation specification already do. They define the data elements. Not so
much in the current version in very unambiguous terms. They have alto of
flexibility and that situation and all kind of conditions. And so, that’s part
of what created a need for some of these establishing and operating rules.

What are operating rules at he end of the day? Well, the Operating Rules
like they are defined are business exchange conditions or relational. When I
establish a relationship with an entity, we’re going to exchange claims and
claim payment information. We’re going to use the standard that is in HIPAA and
implementation specification, but there’s a lot of other things outside from
the actual standard that we need to agree on. For example, the performance and
system availability requirements, so I’m going to send you this, I’m going to
expect you to process that. I’m going to expect some sort of a response within
a certain time, those kind of expectations are things that are part of what
Operating Rules define.

The connectivity and the transport requirements, and the security and
authentication requirement. These are elements that are part of the message
transport mechanism, that are not necessarily part of the standard itself. The
standard defines the format and content of the payload, but the actual
transport mechanism and some of the security elements of that exchange are then
defined through operating rules.

The business scenarios and expected responses, things like that, are the
kind of things that are covered in Operating Rules. And then data content
refinements, that is probably the most difficult one because, in reality, the
standard is the standard, and the standard defines the content and the format.
But how much a Operating Rules gets into tweaking, if you will, to use a term,
those data elements and convert or define, or redefine, some of the rules in
the standards into this definition of the data elements. This is still a very
challenging and difficult area, and we’re still working towards defining better
that, I think is an important element.

As many of you probably are familiar with, a standard, when I’m sending a
claim, there are some data elements are what we call in the standard are
situational data elements, elements that only need to be sent if the following
conditions are met. A lot of the data elements in the current vision, the one
that we’re implementing in 4010, a lot of situational situations, a lot of
situational data elements.

And so, they created a lot of openness in terms of how we interpret this and
that, and created a massive expansion of the number of what you might have
heard of as companion guides, guides that were written by health plans to
clarify the standard, because the standard had so many situational elements.
The health plan had to tell the provider they’re sending that claim, well, this
situational data, you need to say this or do this, because that’s how we define

I think the next version of 5010 is going to close a lot of that kind of
ambiguity and flexibility, if you will, in that. So that is what, in many
respecting, the Operating Rules play, filling the gap of the flexibility and
lack of sort of closeness, in terms of the standard. So that’s what an
operating rule really ultimately does.

There are a few other things that are valuable about the Operating Rules.
Certainly the biggest one, of course, is reducing the staff time, spending
phone calls and checking websites to reconcile transactions when payments are
received with remittance advice and things like that. More accurately and
efficient transmission and transaction processing, so a lot of this is really
to try to enhance this goal of Administrative Simplification, to make sure that
providers don’t have to spend a lot of time on the phone with payers, trying to
respond to a transaction.

There are some discussions about what Operating Rules can do. At some point,
we talked about they could serve as an intermediate step, a transitional step,
between a version today and a version in four years. If we wait for four years,
there’s going to be things that are going to change, and because the strictness
of the regulation on establishing standards and adopting them and using them,
makes us we cannot use anything but the standard today, then how do we fill in
some of the needs and some of the gaps that we have found for the next version.

It was some idea that maybe the Operating Rules could do that. I think
there’s some challenges about that, filling the gaps in current versions, while
we wait for the next version, is a very touchy area, because at the end, the
standard development organizations truly control the standard and are
responsible really ultimately for the standard. And tweaking this, as I have
said before, it might not be the most technical word, but adapting, modifying
any of that element in the standard itself, could create a disruption. And what
is it that we’re actually implementing, is it this standard, plus this changes,
or what?

So there’s still a lot of movement towards trying to come up with better
ways of defining and completely clarifying what is a Operating Rules, and where
that’s an Operating Rules really ends and where the standard begins, and how
they complement each other. We are new to this world really, even though
Operating Rules have been in place for a few years. We’re new to this new role
of adopting these Operating Rules as a national standard that is going to be
required for everyone to us, and then, how that relates to the standard itself
and to the implementation specification.

This is a reference to companion guide, which actually were mentioned in the
original CMS regulations on HIPAAs transactions and code sets. That’s what 45
CFR. So they actually said, you know the companion guides exist and entities
create companion guides, and they’re not going to go away, even as we move into
operating rules. They might reduce the size and the need and the number of
those, but I think they might continue to be.

But the critical part is that no companion guide can change the definition,
data condition or use of a data element. They cannot do that, because that’s
violation of a standard that hasn’t been adopted in regulation. Add any data
element or segment to the maximum defined data set, the standard itself defines
the data set. We cannot have a companion guide that says, oh, by the way, send
me this other thing, and send me these. You cannot modify that standard.

Use any code or data element that are either marked as not used in the
standard, or not in the standard itself. So if the standard, as we adopted it,
when HIPAA regulations says this data element is not to be used, then a
companion guide cannot come and say, oh, well, turn it on and we’ll start using
it between ourselves. That’s a violation of HIPAA standards. And then, change
the meaning on the intent of the standard’s implementation specification.

What are our responsibilities, with respect to operating rules at NCVHS. We
have two main responsibilities. The first one is that we need to select and
inform HHS on entities that are selected as the offering entities for these
operating rules. With respect to standards, we had an easier kind of way around
because there are standard development organizations. There’s a national
process in which standard organizations are vetted and all that and approved,
so ANSI, for examples, accredits standards and organizations, so there’s that

And the operating rule world, we didn’t have anything like that, so we at
NCVHS are responsible for vetting, if you will, entities that want to be become
authoring entities, and we have a set of criteria in the regulation that says
the characteristics of an authoring entity of an operating rule should be the
following, and we have to evaluate that. So the first step is evaluating and
informing HHS on entities that want to become operating rule authoring.

The second one is about the operating rules themselves, as we have to
review, select and then inform HHS on the recommendations to adopt a specific
operating rule or operating rule set. So that’s two different roles about
Operating Rules that we have.

So where are we with the work that we’ve done? So I’m going to go very
quickly through some of this. Unique health and identifier, this is a summary,
so we completed our environmental scan, and this is sort of a process that we
follow. So for our new members that are going to be hopefully joining our
subcommittee, this is sort of the standard process that we’re going to be
following. We usually complete an environmental scan. We’re fortunate to have
very knowledgeable people work with the Committee to help us draft those and
gather all that, do the research and come back with. This is the environmental
scan about this particular topic, the health plan ID in this case.

And then, we hold hearings, that’s the way that the Committee learn about an
industry perspective on that particular topic, and we have hearings on July
19th through 21st, last year, on the health plan ID. And then, we draft a
letter with observations on recommendations, those are kind of the two elements
that we usually put in our letters. In the case of the health plan ID, this is
where the recommendations, a copy of the letters are all on the NCVHS website,
so I’m going to go into the details just in the interest of time. But you have
all the kind of summary of each of these letters in your slides.

What is the rulemaking process underway? The rules are expected to be issued
by the summer of this year, so July probably, although I have heard that there
have been, for the health plan ID, potentially a delay, waiting for September
of this year to be issued, the health plan ID rules. And this will be interim
final rules, the two ways that HHS can write them, well, there’s many ways, I
suppose, but two ways would be Notice of Proposed Rule Banking, an NPRM, where
people then can comment on and the regulator has to respond on all the comments
and they publish a final rule. And the other one is when the Secretary receives
authority by Congress to expedite the process through an interim final rule.
Then, the Secretary can write in for a final rule, which become effective
immediately, as they get published. It doesn’t mean they become effective and
people have to comply with it immediately. It just become effective
immediately, but then the rule says the compliance date is this or the law
even, in the case of all these administrative transactions.

So we expect that we’ll have an interim final rule on the health plan ID
later this year, and then the compliance, as you saw in the other picture, is
October 1st of 2012. October 1st of next year is when the health plan ID is
expected to be complied with.

Then we get into a lot of the Operating Rules. The Affordable Care Act said
you have to take transaction by transaction, and look at Operating Rules for
those and authoring entities and Operating Rules, and then recommend to the
Secretary the authoring entity and the operating rule for each of the
transactions. And nothing in the law says the same Operating Rule authoring
entity has to be for all of the transactions. We have to go through that
process one by one.

So the first two transactions we went through were eligibility and claim
status. Again, summer a year ago, exactly, we had the hearings and we made a
recommendation to the Secretary on September of last year, and we expect these
rules to actually come in a month. In about a month, we expect the publication
of the interim final rule on Operating Rules for eligibility and claim status.
The compliance date for this is January 1st, 2013 for the eligibility and
claims status Operating Rules.

And then, the rest is really then the next set of transactions, so the next
one was EFT, electronic funds transfer in the electronic remittance advice,
ERA, and there will be a test at the end. We live in a world of acronyms.
Anyway, the EFT is a brand new transaction, it’s the traditional banking EFT,
but applied to health care. So when a health plan submits an order to the
health plan’s bank saying, please transfer this amount of money from this
account to this other bank to this account. And this other bank and this
account is the provider bank and provider account. That exchange between the
health plan and the bank is what is considered to be the EFT within health

EFT in the banking system, of course, is a bank to bank transfer of funds.
But within the health care industry, the definition of an EFT is going to be,
the one that’s been recommended anyway, the transaction between a health plan
and the health plan’s banking entity to transfer that fund. So we had a really
interesting discussion about this. We engaged basically the banking system and
the banking system is certainly very interested in this. So we got in the
hearing that we had, and we needed to do two things, by the way. We needed to
establish, first of all, the EFT standard, the standard for that transaction.
And then, we needed to talk about okay, the operating rules for EFT and for
ERA. So those two were a two-step process that we followed.

So at the hearing, we had an environmental scan that we’re hearing and then
a first letter to HHS in early part of this year, recommending the standard for
EFT. And then, a second letter, which was published later on, recommending the
authoring entity for the EFT and ERA operating rules. And so, that’s what
happened with the EFT and ERA. We’re not going to get into the details of the
elements in that, because it’s a lot of richness around that, but that was one
of the activities. This is the summary of the recommendations on the second

Now, interestingly enough, of course, we don’t have today, EFT and ERA
Operating Rules. So the first step was, well, we think that the most
appropriate entity to author these Operating Rules should be this one. And
then, we expect that the Operating Rules will come to us later this year for a
review and for a recommendation, because that’s the second step that as a
committee we have to take, review the Operating Rules and then make a
recommendation to the Secretary of those Operating Rules. The rulemaking
process, the rules are expected July of next year, so we have still a year,
although for rule-making process, that’s not a lot of time. And then, the
implementation happens even in 2013 later on.

The next one was acknowledgement. This was a little outside of the
requirements from Affordable Care Act. Affordable Care Act didn’t say any
place, oh, you should adopt a standard. We did have the word acknowledgement in
one of the Operating Rules, but in reality, the industry had been calling for
this. We have a report every year from the Designated Standard Maintenance
Organization, the DSMO, the group of all the standard maintenance organizations
in the administrative transactions in health care that tells us every year how
things are going. And some years, they come back and make recommendations
saying, we should adopt a standard for this, or we should move to the next
version of this standard.

So last year, in February, they came to us and said, we think that the
industry is ready to adopt a standard for acknowledgements, acknowledgements
meaning basically the exchange, when I send a claim, I want to know if the
claim got to the place and got received okay, and a quick acknowledgement back
is a good thing to have. And a lot of organizations actually are doing it
today, and the same with other transactions. So we had an incredible hearing
earlier this year, to talk about acknowledgement. There’s a lot of consistent
and clear sense of agreement about the need and interest in adopting this. And
so, it was very good to see that.

And so, we’re making recommendations, which we will be reviewing with you
all tomorrow, just in an overview. Then, tomorrow morning, we’re going to be
reviewing actually the letter with the subcommittee, and then we will come back
to the full committee with the letter of recommendation on acknowledgements,
later probably in July. We’ll probably have to do it by phone or something like
that, before we wait until the September meeting. Anyway, that’s another
specific set of recommendations that we’re making and this is very important.

One element about acknowledgement is that HHS does not have the authority,
because it wasn’t included in the Affordable Care Act. HHS doesn’t have the
interim final rule, the expedite rule making authority. So for acknowledgement,
we’re going to have to go through the regular rulemaking authority process,
meaning publication of a notice of proposed rule, comments and then final rule.

And then, because it’s a new standard, and under HIPAA and a new standard,
the sector has to give two years to the industry to adopt it, and we have to
wait for two years to adopt that. We’re working with HHS and with CMS to find
ways in which we can move very quickly that process, seeing there’s so much
consensus around the acknowledgement. We hope that the whole rule making
process can be expedited, even with NPRM and all that, and quickly.

We’re also talking about, with all this new changes in the administrative
transaction processes, and the adoption of standards for operating rules and
all this, there’s been a lot of discussion about, so how is this process really
working. And we want to see ultimately a lot more orderly and expected way to
deal with this. We don’t want to be changing things, one time every eight
years, and the next time three years and the next time five years. We want some
more organized, orderly phasing and transitioning to the next versions.

So through the hearings that we had in April, and we will continue to have
some of those discussions, we heard from the SDOs, the Standard Development
Organizations, from the Data Content Committees, from Operating Rule authoring
organizations and other entities, about the process and what needs to happen
really and what places where we can improve that process. And that’s one of the
things we’re going to be continuing to discuss and ultimately, we hope, making
formal recommendations about.

We should really establish an every three year transition, for example, of
version. Why should we wait for ten years before the next version comes out, or
why should we do it every one year, that quickly. We should define a timeframe
that makes sense, and then work with everybody involved, including vendors, of
course, standard organizations, operating rule, authoring entity, vendors,
everybody, to make sure that that is a deliberate, expected kind of process,
and not really a surprise kind of a process. Anyway, that’s one of the new
activities, or activities that we will be coming up, in terms of recommending
kind of a revision of the current process in terms of standardization.

And then, finally, the agenda for our next set of activities. So here is
what we’re having in 2011, so we completed all these activities that have a
checkmark, and to this week and this meeting, we’re going to hear from the
DSMO, the Designated Standards Maintenance Organizations group, about the
status of things, and we’re going to have a hearing on Friday on the status of
the implementation of 5010 and ICD-10, another major transition that we’re
going through. And every year, we have a hearing to take the polls, if you
will, the industry around that, and make any recommendations in terms of
improving or accelerating, perhaps, occasional efforts to make sure that people
are aware of things.

We expect to issue a HIPAA report to Congress. It will be the 10th HIPAA
report to Congress, and we’ll talk to you tomorrow during our report back to
you about a very quick overview of this 10th HIPAA report to Congress. This is
a special opportunity, as Justine mentioned, to really look back and say, what
is this journey that we started almost 15 years ago now, 16 years ago, and
where are we in that journey and where it’s coming up into the future? And is
there an end to the journey, or is this a journey that will continue? And so,
we’ll talk about that tomorrow.

And then, later this year, we have two specific activities, we have a
hearing on Section 10109, and this is the areas of next standardization, where
we see opportunities for the next phase of standardization. I mentioned
provider enrollment and auditing and things like that, so those are things that
we will be convening a hearing on. And then also, we’re going to have a Part 1
of a hearing on claim attachments. Claim attachments is a major area for health
care that can be standardized quite a bit, and the expectations, we need to
have regulations to establish the standard. We’re going to have a fair hearing
that will give us an overview of where things are with claim attachments, the
status of the standards today, the directions of the claim attachments, the
work that is being done by standard development organizations and all that.

We don’t need to fortunately have to make recommendations on the standards
yet because the regulations are not due until July or January of 2014. So we
have still a couple of more years, but we decided to do a first kind of hearing
later this year, to take the pulse again of the industry around claim
attachments. And then, expect next year, or early 2013, to have the hearing
where we will hear from the industry, this is the standard that we recommend,
so that we can then go to the Secretary with the recommendations or the
standards to be adopted for claim attachments.

And then, coming up in 2012, the implementation of 5010, so we will probably
have hearings as well, on how things are going with 5010. The planning and the
transition for ICD-10, which will happen the following year, in 2013.
Preparation for operating rules for eligibility and claim status, their
compliance date is January 1st, 2013, so we want to know how things are
evolving. Preparation for the health plan ID compliance, which is October 1st
of 2012.

We will hear also the DSMO Report, we will prepare our 11th HIPAA Report to
Congress, and begin working on the Operating Rules for the next round of
transactions, all these ones that are there, and work on the attachments. I
think with that, I’ll turn it back to Justine.

DR. CARR: It is incredible, it’s extraordinary. And it’s intimidating, and
thank God we have experts in this room who help carry us through. But the
concept that I stay with is when I think about going to an ATM to get my money.
I don’t have to call anymore, they don’t have a phone right next to it anymore,
and they know who I am, whether I go to a Century Bank or a Bank of America,
and they know how many accounts I have. I share them with my kids.

And they know all the things that I would want them to know, so that I can
get out the cash I need. And when you think about going to a physician today
and they ask you what’s your co pay, and then you find out weeks later what was
covered, what wasn’t, and all the phone calls and all the back and forth,
that’s what we’re talking about. We’re trying to make it as seamless as your
bank card at the ATM machine. And kudos really to the Standards Committee for
just mastering this and helping us understand it. And if it looks like a
formidable amount of work, it is.

And yet, the hearings that we had, they’re just very, very interesting and
we all learned together, and we have the great leadership of Judy and Walter,
and of course, all of our consultants from industry and representatives from
the other agencies. So it is critically important to this committee, and it’s
an intimidating agenda, to be sure, and it is complex material. But when we
work together, we make a lot of progress, so thank you very much, Walter. We
look forward to tomorrow. I guess now who’s up, Leslie and Sallie. We’re
hearing today about the community data initiative, what we learned from the
hearings. But as you listen to it, think about where we go with this, and what
our next step.

Agenda Item: Briefing on Privacy/Populations May
12th Workshop and DHHS/IOM Health Data Information Forum, June

DR. FRANCIS: Let me start by saying that we’ve held two sets of workshops.
The first workshop was led off by the populations subcommittee, Larry and
Sallie, as the Co-Chairs. The goal of that workshop was to explore some of the
exciting ways that communities are actually using data as a learning system.
How do our communities gathering, analyzing, and feedback looping to
themselves, data in ways that they can use to improve their community.

Some of the speakers at that initial session actually came to the health
data forum last Friday, and there were many other examples of tremendously
imaginative and helpful uses of data. But there’s a challenge in this for
privacy and security, and so the second hearing or workshop, we didn’t really
think of them as hearings, we thought of them more as brainstorming sessions,
was about these are new uses of data, and new combinations of data,
particularly if we’re relying on clinical data or administrative data for
public health ends, or if we’re combining data sets in the way some of the new
initiatives are.

We need to think about how to makes sure we do it in a way that doesn’t
scare people off. And there are actually fears out there. Denise Love from
NAHDO, who will be here tomorrow, and who was at this second session, talked
about lock box problems with data. And I think we’re really on new territory,
with respect to the question of how do you try to figure out mechanisms for
community trust and what are some best practices? And that’s what the second
hearing or workshop was about, about exploring. Some of the challenges, HIPAA
just says public health, well, it’s an exception. And de-identified data isn’t
even protected health information. This is territory that HIPAA didn’t think
about, HIPAA just passed it along. States have very different views in some of
these regards.

And so, we’re really trying to explore with people what are some of the
innovations that have been out there. For trying to figure out how to get
communities involved in planning data uses, understanding data uses,
communicating data uses, getting community feedback about the appropriateness
and forms of protection. I think it wasn’t easy. We could find more about
people wanting solutions or suggestions, than people having actually got much
in the way of solutions or suggestions. Mia did Yoman’s work in the face of
what was, at the time, as we were planning this, an impending government
shutdown, as did other staff, to get this put together.

And I just want to commend to you, Susan’s lovely summary, and point out a
couple of the high points, at least for me, I think that we’ll be building on.
So we heard from various community groups who were using data, we had the
Colorado folks back, talking about community engaged research. We learned from
NAHDO about how it’s mistrust and worries about privacy and confidentiality,
but it’s also a lack of standards in this whole area, that they’d like health

We heard about the importance of transparency, about data use practices. We
heard about the importance and the significance of educating communities,
engaging communities. What are some of the methods for engaging community. We
also heard about some reasons why de-identification potentially is a misleading
way to think about these issues. And we left the day, I think, with the
knowledge that we’re on a trajectory here, with respect to those kinds of
questions, that it’s uncharted.

And I think what our next steps, or least my own suggestion as to our next
steps, this is part of what the subcommittee will be talking about, would be to
actually write up something that looks like example exemplary cases. So if you
were going to try to use a consent model, here’s what it would look like. If
you’re going to try to use community-engaged research, here’s what it would
look like. If you’re trying to use some kinds of educational and transparency,
here’s some ways people have done that. to sketch out some model, I don’t quite
want to call them use cases, but it’s kind of like that.

And nobody’s done it and I think that’s’ the next step for us, because all
over the place, I don’t know whether you’re familiar with the Texas blood spot
controversy, with the newborn screening blood spots, and the fact that people
became afraid that they were being used for purposes that were nefarious or
whatever. And the result was that they were all destroyed, and a tremendous
potential public health resource was lost. So I’ll stop there.

DR. CARR: And Sallie or Larry, do you want to speak about the earlier
hearing, particularly with regard to the observations and preliminary findings,
I think a number of which are calls to action.

MS. MILAM: I am looking in Tab 5, and there’s a summary of that earlier
hearing that Justine was referring to. And I think the information that is
relevant to this discussion is found on pages 10 and 11, and it really explores
the depth of that delta in the Learning Health System. And obviously, privacy
is an area that was identified that needs some attention, and there’s a huge
range of opportunity there. But there are a lot of other opportunities, as
well, and they’re listed here for you. When you look at page 10, you can see
that communities need help with analytics. They need access to more granular
data. They need better tools. There are a lot of things that communities
actually need.

We also heard that public health needs a better health information
infrastructure. There’s a huge opportunity here. There’s a lot to do, I think
we’re going to have to choose where we’re going to focus, building from these
workshops. There are other opportunities through Meaningful Use, so we’re going
to have to figure out, when we meet in a few minutes, where we’re going to
focus next. So this is an invitation to all of you to join Population Health.
You’d be working on the delta, you’d be on the cutting edge, and I think it’s a
huge opportunity to do some good. Larry?

DR. GREEN: We think we have spotted a fairly stunning, fairly rapidly
emerging organic process going on from coast to coast, at the community level,
where communities have figured out that health is a community affair, and that
when data gets turned into information into wisdom, it has to be applied
locally. And our people are not waiting for us to figure this out. They’re just
muddling along, getting it done. And we very rapidly identified the committees.
We don’t really know if they were exemplars. They’re just who we knew about and
who volunteered to show up. We do know that what they reported was
extraordinarily interested, and it looked very promising to us.

So a second thing we did which is, I think, a very hard thing to do is we
spotted something that does not exist. And across both of these hearings, it
was clear that there is a void, there is a missing infrastructure that enables
this union of the health care system and the public health system and
communities, to come together to use and reuse data to improve their health.
It’s just not there.

These communities that reported out in our workshops, they are pulling this
together with string, volunteerism, local foundations that give them a $9000
grant. It’s heavy lifting that they’re doing. But we saw examples of where it
matters, it matters to people at the community level, so this is pretty
exciting. I invite you to think back to Jim Scanlon’s opening remarks about the
goals of the Department of Health and Human Services, and then run back through
Chuck’s report from the ONC about where they are and working on the delta, that
might become our watch word. And go back to Blackford’s list of six issues. The
workshops we just completed are about that. They are right in the center, it’s
like a vortex, and this stuff we have been talking about today, and something
is trying to happen here.

So our Chair has asked all the subcommittees to keep her informed about what
we’re going to do, and at a 24-month window. Well, we’re about 5 months into
that 24-month window, and we know what we’ve done in the last 5 months. And in
about 5 minutes, we’re going to try to get clear about where we go next. As a
teaser and only as a teaser, not to foreclose your thinking, but I’m very fond
of this notion that we grow in the direction of the questions we ask. And
Sallie and Leslie and Susan, bless her heart, we are so indebted to Susan
Kanaan for organizing this and keeping us moving forward.

The sorts of questions that you might want to think about, one of them would
be is how can the public and private sectors properly facilitate data sharing
and use for public benefit at the local community level? We do not know the
answer to that question. Another one might be, where does this rising tide of
local health initiatives intersect federal policy, pertinent to measuring the
health of our communities, in ways that are actionable in the community?

So come and help us figure out better questions, or proper questions, or
bite-sized questions and the place to go next. And that’s really what our
agenda is next, and we feel well-positioned to pursue that. We also have some
instrumental issues that we want to deal with. We’ve got to figure out
staffing, and I will join Sallie, we’re in recruitment mode. We’d like to
spread this work around, and tell our new members, if you’re interested in what
we just talked about, come, but come with your sneakers on.

DR. CARR: That was great, perfectly said. I will say when we talk about, if
we’re allowed to talk about cost and the economy, when you hear the work on
primary prevention and healthy living that’s being done in the communities,
it’s ultimately a tremendous impact on cost.

DR. FRANCIS: I didn’t want to leave privacy out of the recruitment.

DR. CARR: I think the Privacy and Population Health have been working
together, and I think we’re looking more and more to have that
cross-fertilization, because these issues do cross-fertilize. And I think that
one of the key things is there will always be, I don’t remember, was it Chuck
saying it or someone, one more unintended consequence or challenge.

And I think that coming out of this, we want to say here is the good, the
Learning Health System, that is within our reach, and this is where we’re
headed and this is how we’re protecting privacy. But I think we want to be very
clear that we are headed toward a Learning Health System, and again, the
collective wisdom will help us get there. I saw some other hands, Blackford.

DR. MIDDLETON: Well, speaking on behalf of Quality, let me just make the
pitch. On behalf of Paul Tang and myself, for anyone who’s really looking to
have a good time.

DR. CARR: Actually Raj, I didn’t give you the opportunity to introduce
yourself as being at the meeting. Could you just say your name, where you’re
from, and if you have any conflicts related to the work of the committee.

DR. CHANDERRAJ: Yes, I am Raj Chanderraj. I’m a practicing cardiologist from
Las Vegas. Unfortunately, I had to go to the emergency room this morning, but
otherwise, I’m here through the meeting for the next two days. I have no

DR. CARR: You had a real live patient care encounter this morning, that
perhaps could add value to quality, privacy. Your privacy is gone. So the one
thing we didn’t get to do this morning is really hear more depth, the richness
of everyone in the room. And I’m wondering, Marjorie, if that’s something that,
during dinner, we could kind of go around and hear more about what folks are
doing, so that we can get onto.

MS. GREENBERG: We have, I think, a separate room, so we can have some
privacy when we do that.

DR. CARR: All right. Any other comments? Marjorie, anything you needed or
wanted to say?

MS. GREENBERG: No, I think all the subcommittees had an opportunity to try
to lure people. And as those of us, and most of the new members were on the
phone orientation that we had, but we’ll be continuing this tomorrow afternoon,
and we hope to have at least co-chair from each subcommittee. I think we give
people an opportunity, new members an opportunity to hear and engage, but
before they commit. Everyone serves on at least one subcommittee. I think
Walter’s on three, I don’t think we have anyone on four, and I actually
wouldn’t recommend it.

But we are also trying to do a lot of cross cutting activities, as you said,
so you can engage with another subcommittee, even if you’re not on it. Also, we
have something that we call a corresponding member, so if you want to be a
member, and count as part of the quorum for a particular subcommittee, but
you’d like to get be included in all the communication around another
subcommittee, but not actually be an official member, you can tell us to do
that, too, and then might intrigue you so much that you’ll become a member, I
don’t know, but we’re pretty flexible.

And also, this came up. These subcommittees are obviously around the areas
in our mission, in our charter, etcetera. But the subcommittees are pretty much
determined by the full committee itself. So our charter and our legislation
only include responsibilities and functions. It doesn’t specify the
subcommittees. So this is a fluid area, though we have kind of coalesced around
these four area, and anyway you cut it, we’re going to be working in these four
areas. But just a little background there that will give you some perspective.

I think that Populations and Privacy are meeting next, and they’re meeting
together. They thought they might separate, after some initial discussion, they
probably only have about an hour and 15 minutes, so I’m not sure if that will
happen. So we tried to have everyone not have a lot of concurrent things going
on. And then, at 4:00 is the subcommittee on quality. Jeannine, could you tell
us again where we’re meeting?

MS. JACKSON: This is the basic meeting room, and just as we did at the last
meeting, the core meeting set up is in here, which means the transcripts and
the recording. We understood that Privacy and Populations would meet for a bit
in the beginning, and if they wanted to break off, whichever subcommittee is
going to separate and go into another meeting room, that session is not
recorded. Just so you know, we do have a room set up down the hall, it’s Room
1434, where you go through the door on this floor and go all the way down. But
on the way, there’s a nice area just right on the side of us, if you get caught
and just want to sit down and relax there. The dial-in and everything is in
this room, just so you’re aware of that.

DR. CARR: And dinner is at 6:30, so where do we meet, when and where do we

MS. JACKSON: For here, we found out that we can go by Metro, there’s a
trolley or cars, or it might be easier to just get taxis from here. So we would
think we could meet in the lobby at about 6:00 and gather, and then just catch
taxis down for those who want to do that. Others might want to go out on your
own and go earlier, do shopping or whatever, down in the downtown Alexandria.

DR. CARR: So this meeting is adjourned. Thank you very much and see you at

(Whereupon, the meeting adjourned at 2:42 p.m.)