[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Meeting of:

THE NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

June 30, 2005

Hubert H. Humphrey Building
200 Independence Avenue
Washington, D.C.

Reported By:
CASET Associates
10201 Lee Highway, Suite 180
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS

COMMITTEE MEMBERS:

  • SIMON P. COHN, MD, MPH, Chair. The Permanente Federation, Kaiser Permanente, Oakland, California
  • JAMES SCANLON, Executive Staff Director. Office of the Assistant Secretary for Planning and Evaluation, DHHS, Washington, D.C.
  • MARJORIE S. GREENBERG, Executive Secretary. Office of the Director, NCHS, CDC, Hyattsville, Maryland

MEMBERSHIP:

  • JEFFREY S. BLAIR, MBA. Medical Records Institute, Albuquerque, New Mexico
  • JUSTINE M. CARR, MD. Beth Israel Deaconess Medical Center, Boston, Massachusetts
  • ROBERT K. HARDING, MD. University of South Carolina School of Medicine, Columbia, South Carolina
  • JOHN P. HOUSTON, JD. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  • STANLEY M. HUFF, MD. University of Utah College of Medicine, Intermountain Health Care, Salt Lake City, Utah
  • ROBERT W. HUNGATE. Physician Patient Partnerships for Health, Wellesley, Massachusetts
  • A. RUSSELL LOCALIO, MA, MPA, MS. University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
  • CAROL J. MC CALL, FSA, MAAA. Humana, Louisville, Kentucky
  • HARRY REYNOLDS. Blue Cross Blue Shield of North Carolina, Durham, North Carolina
  • MARK A. ROTHSTEIN, JD. University of Louisville School of Medicine, Louisville, Kentucky
  • WILLIAM J. SCANLON, PhD, Health Policy R&D, Washington, D.C.
  • DONALD M. STEINWACHS, PhD. The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland
  • S EUGENE STEUERLE, PhD. The Urban Institute, Washington, DC
  • PAUL TANG, MD, Palo Alto Medical Foundation, Palo Alto, CA
  • KEVIN C. VIGILANTE, MD, MPH, Booz-Allen and Hamilton, Rockville, Maryland
  • JUDITH WARREN, PhD, RN, School of Nursing, University of Kansas, Kansas City, Kansas

P R O C E E D I N G S (9:05 a.m.)

Agenda Item: Call to Order.

MR. COHN: Good morning. I want to call this meeting to order. This is the
second day of meetings of the National Committee on Vital and Health
Statistics.

The national committee is the main public advisory committee to the U.S.
Department of Health and Human Services on national health information policy.

I am Simon Cohn. I am associate executive director for health information
policy for Kaiser Permanente, and chair of the committee.

I want to welcome committee members, HHS staff, and others here in person,
and of course also welcome those listening in on the internet.

I, of course, as usual want to remind all committee members and others to
speak carefully, clearly, and into the microphone, so that those listening in
on the internet are able to hear us.

With that, let’s have introductions around the table and around the room.
For those on the national committee, I would ask, if you have any conflicts of
interest relating to any of the issues coming before us today, would you please
so publicly indicate during your introductions.

MR. HARDING: I am Richard Harding. I am the chairman of neuropsychiatry at
the University of South Carolina, a member of the committee, and I have no
conflicts regarding these matters.

MR. BLAiR: Jeff Blair, Medical Records Institute. I am a member of the
committee, and I am not aware of any conflicts of interest.

MR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
liaison to the committee.

MR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for
information technology to the director of AHRQ, liaison to the full committee.

MR. HUFF: Stan Huff with Intermountain Health Care, and the University of
Utah, Salt Lake City, a member of the committee, and no conflicts or potential
conflicts that I am aware of today.

MS. CARR: Justine Carr, health care quality, Beth Israel Deaconess Medical
Center in Boston, member of the committee, and no conflicts.

MR. WILLIAM SCANLON: Bill Scanlon from Health Policy R&D, member of the
committee no conflicts.

MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, no
conflicts, member of the committee.

MS. MC CALL: Carol McCall, Humana, member of the committee, no known
conflicts.

MR. STEINWACHS: Don Steinwachs, Johns Hopkins Bloomberg School of Public
Health, member of the committee, no conflicts.

MR. LOCALIO: Russell Localio, University of Pennsylvania School of
Medicine, member of the committee, and I have no conflicts.

MR. VIGILANTE: Kevin Vigilante, Booz-Allen Hamilton, member of the
committee, no conflicts.

MR. ROTHSTEIN: Mark Rothstein, University of Louisville School of Medicine,
member of the committee, no conflicts.

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina,
member of the committee and no conflict.

MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member
of the committee, and no conflicts.

MS. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the committee, and no conflicts.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, executive secretary.

MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the committee.

MS. BARTLETT: Virginia Bartlett, IMS Health.

MR. THOMPSON: Jeff Thompson, Wexler and Walker.

MR. MARTIN: Russ Martin, Pfizer.

MS. FRANKLIN: Angela Franklin, Blue Cross Blue Shield.

MR. TURNER: Sam Turner, Faster Cures.

MS. JONES: Catherine Jones, CDC, National Center for Health Statistics, and
staff to the executive committee.

MS. SPECTOR: Nancy Spector, American Medical Association.

MS. NARCISSI: Jean Narcissi, American Medical Association.

MS. POKRA: Anna Pokra from AHRQ, staff lead to the quality subcommittee,
and staff to NHII.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC,
committee staff.

MR. HOLLAND: Frank Holland(?), American Dental Association.

MS. AULD: Vivian Auld, National Library of Medicine, staff to the
subcommittee on standards and security.

MS. FLEISCHER: Judy Fleischer, American Optometric Association.

MR. DICKINSON: Gary Dickinson, EHR Standards Consulting.

MS. DICKERSON: Audrey Dickerson, HIMS.

MS. MEEKER: Erica Meeker, HIPAA Compliance Alert.

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics,
CDC, and staff to the NHII work group.

MS. NOLTE: Emily Nolte, National Opinion Research Center.

MS. SIGMAN-NU: Marilyn Sigman-Nu(?), America’s Health Insurance Plan.

MR. STEINDEL: Paul Steindel, American Medical Association.

MR. DE CARLO: Mike DeCarlo, Blue Cross Blue Shield Association.

MR. RODEY: Dan Rodey, American Health Information Management Association.

MR. COHN: Thank you all for joining us. I should also — Paul, would you
like to introduce yourself?

MR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee,
no conflicts.

MR. COHN: I should publicly disclose, although I don’t think this is a
conflict, that I was recently appointed an advisory member to the HIMS board. I
don’t think I have even been seated yet, but I have been notified.

Since Mark is obviously presenting and is part of HIMS, and I think there
will be other HIMS presenters, I just want to publicly disclose that.

Now, with that, let’s move into the agenda discussion. This morning we
begin with an update from the certification commission on health information
technology.

I want to welcome Mark Leavitt, who is the chair of the CCHIT, as well as
the medical director for HIMS. So, I want to thank you for coming. I know it is
a busy time for you, and we really want to thank you for taking time.

Following that, we will have a presentation. The title here is the ANSI
health information standards board panel.

It is really, I believe, an update from ANSI HISB, as well as from the ISO
TC-251, on what is happening both nationally and internationally. At least,
that is my understanding.

Following that, we have a presentation from Dan Friedman, who is actually a
former member of the NCVHS, on health statistics and health information
infrastructures in other countries, and he has been doing work for NCHS, sort
of looking at some of that. I think it should be a very interesting
presentation.

Beyond that, we will be having reports and discussions relating to work
plans and sort of updates from the subcommittees and work groups.

I think, as you will all remember, we have disposed of all action items
yesterday during our discussions, so there are actually no action items.

Now, as mentioned yesterday, we are actually not taking a lunch break, and
instead we will be taking two 10 to 15-minute breaks through the morning
basically going through, with the idea that we will be adjourning probably
around 1:15, is the expected completion time here. So, that is just to remind
everybody, as well as inform those who are on the internet. With that, I want
to once again welcome Mark. Thank you for coming, and I will turn the floor
over to you.

Agenda Item: CCHIT Update.

MR. LEAVITT: Thank you very much, Doctor Chairman. It is really my pleasure
to be here, and give you a chance to hear about the certification commission
for HIT.

As you said, it is a busy time for us. We are responding to an RFP right
now with a 30-day window. So, it has been kind of 24/7 for the last few weeks.
So, if I look a little bit bleary eyed, that is the reason.

I also look forward to answering your questions, because we really want to
satisfy the entire industry and community that what we are doing is in the best
interests of everyone.

I do appreciate the opportunity and let’s go ahead and move forward. What I
would like to cover today is a little bit about how we came to be, the origin
of CCHIT and our mission, talk about how we are organized, to satisfy that
mission, and then talk about what it is that we are doing, our scope, our
deliverables and our time line.

Then I want to talk about how we do that, our process for development of
certification criteria and test processes.

Then I will show you, not in detail because there isn’t really time, but
the concept of our work products that we circulate for public comment.

We will talk about the phase I work products, which came out about two
months, and I will give you a little preview of the phase II work products,
which are not ready, but at least give you a preview.

Then I will briefly talk about the future of CCHIT. We are at an inflexion
point in our existence. The organization is really only nine months old, but we
are at an inflexion point in responding to this federal request for proposal,
and I will talk a little bit about how we would change and what would happen if
we win the proposal and, of course, that is an if.

It is a competitive proposal situation and we don’t know the outcome, but
we will tell you what we would do, what our plans would be.

Before I start, I should ask if any committee members have any other topics
you would like me to add to the agenda, or otherwise we will take the questions
at the end.

Okay, let’s talk about how we came to be. In July of 2004, you are all
aware of the framework for strategic action that was published by the Health
and Human Services Department.

A lot of the creation of this was Dr. David Brailer, the national
coordinator, less than 90 days after he was appointed, as you well know. That
was more than the 24/7 experience. That was probably a 36/7 framework.

That framework contained four goals. It had 12 strategies to meet those
goals, and it had eight key actions.

One of the specific key actions listed in the framework was a private
sector certification process for health IT products.

It was supporting several of the strategies, although if you look at
strategy number two, reducing the risk of EHR investment, that was probably the
one that it primarily targeted.

It also would support the development of health information networks, would
support incentivizing EHR adoption.

So, CCHIT was formed concurrent with the release of the strategic
framework. An important point to make is that it is a voluntary private sector
response to a call for action.

It was not formed at the direction or mandate of the government, there was
no government funding, no statutory origins to CCHIT. It is a voluntary private
sector response to a call for action.

It was founded by three non-profit health IT associations. I work for one
of those, the Health Care Information and Management Systems Society, HIMS.

The second was the AHIMA, the American Health Information Management
Association. The third was the National Alliance for Health Information
Technology, the Alliance.

They formed a panel to nominate the first panel of commissioners, and my
selection as chairman was part of that process.

They provided the seed funding — you could call it start up funding — and
resources for the commission, and we held our first official meeting in
September 2004.

We don’t have an exact calculation, but the cash seed funding was about
$150,000 in expenditures. We are talking about meeting rooms and teleconference
circuits and that, and probably $250,000 in staff resources.

They basically detailed staff members pro bono to the commission, and I
spent about half time for six months, and I have been pretty much spending 75
to 80 percent of my time on the commission for the past few months.

In June of this year, about 30 days ago, CCHIT received broadened funding
support, and we announced this on, I believe, June 6.

We received unrestricted grants totalling $110,000 from the seven
organizations you see here: The American Academy of Family Physicians, the
American College of Physicians, Hospital Corporation of America, McKesson
Corporation, Sutter Health, United Health Foundation, and Wellpoint Health
Networks.

In addition, we received $215,000 in grants to support the development of
our test processes from the California Health Care Foundation.

I think that the bottom line here is that this shows the breadth of support
which CCHIT has endeavored to develop and is developing among the various
stakeholders.

Let’s talk about the mission. The mission statement is to accelerate the
adoption of robust interoperable HIT throughout the U.S. health care system, by
creating an efficient, credible, sustainable mechanism for the certification of
HIT products.

What do we mean by robust? We mean that IT, when implemented in the real
world by hospitals and physicians and nurses, delivers the expected benefits,
improvements in quality and safety and efficiency.

We also mean it delivers the expected protection of patient information,
protecting their privacy.

Interoperable, that has been defined, actually, for us now, and you know
that means the useful and efficient exchange of information between systems.

So, our goal is to accelerate the adoption of what I just said, robust
interoperable HIT, and to do that by creating a mechanism to certify these
products.

Now, we have some guiding principles for success, and these are three.
First is timeliness. We felt that decisive action by the private sector was
needed right now.

Health care IT adoption has followed an interesting curve. It has not taken
off the way most technologies, as they diffuse into the marketplace, there is
an early adoption part, and then they take off into the mainstream, and then
they saturate.

Everyone now has a PC. That is getting into that saturated part. Health
care IT adoption has remained in the left part of that curve so long that it
has created a situation where something is going to happen.

There was concern that, for example, there could be legislation that would
mandate HIT, and most people in the private sector, and maybe many in
government, felt that wouldn’t be the most efficient way to accomplish that.

So, we wanted to take action now. The second principle is value. We knew
that we needed to deliver value for all the key stakeholders.

Again, because this is voluntary and not mandatory, we need to satisfy all
the stakeholders and the larger health care community. Eventually, obviously,
the patient or health care consumer has to see value from this.

Finally, integrity. Potentially certification can steer and direct market
places and can impact on the success of vendors.

So, we have to operate in a very credible, objective and transparent
manner, just as the national committee here operates.

The certification itself, we felt, needed to be objective and, to the
greatest extent practical, laboratory verified.

That word laboratory has been the subject of a lot of discussion. It might
not strictly mean we take the product and we put it in a sealed room.

It simply means that you have an objective process which is not subject to
bias, and I can talk more about that later, if you like.

A few more points to clarify. Product certification is different from
organizational accreditation. There are organizations doing an excellent job of
accreditation of providers, of physicians. We are not trying to do that.

We are certifying products before they are bought. The main value comes
before the product is purchased, so that we can help influence the purchase of
products that deliver what is needed. It has nothing to do with professional
certification of individuals.

The second point is that, at this point, we feel certification is a binary
decision, a pass fail decision, not a subjective comparative rating system.

While the industry might like to have a comparative point system, and that
may be very complementary to what we do, these are basic standards that we feel
all the products need to meet.

We wanted to leave room above the line of certification for the kind of
competition and innovation that will be needed, because we are still at the
early stages of development of these products.

Finally, a voluntary process, not a government mandate. That means that the
initial certification requirements must be based in the realities of the
market.

If we want to influence the market place, we have to move them there
through a road map that shows the future direction of certification, and the
future requirements, giving the market time to respond, and develop the
products to meet those requirements.

If we were to put out an initial certification requirement that almost no
product could meet, we would not be meeting our mission of accelerating the
adoption of IT. We would be slowing it down.

Just to use an analogy — and those of you who know me know that I like
analogies, I often use them to the point of fault — but if you look at the
adoption of personal computers and computing technology, the inflexion point in
the curve for personal computer was when the IBM PC emerged.

It created a virtual standard that everyone knew would be there. The next
tipping point was ethernet networking and finally, as you are enjoying today,
wireless networking.

If you buy a laptop, you are pretty assured that, if you take it to a
coffee shop, the wireless access point in the coffee shop, and the wireless
card in your laptop will talk, and you will not have to hire a consultant, and
it will not cost $10,000 or $50,000 to make them work, as it does for a
physician office to try to make their system talk to a laboratory or some other
entity that they need information from. So, we are trying to create that
similar effect of a tipping point in the adoption of technology.

The way certification accelerates adoption is by increasing the confidence
of the providers to investment in and adopt the HIT, by ensuring that, as these
products are adopted, they will be interoperable within the emerging national
health information network.

Third, we feel we can enhance the availability of HIT adoption incentives
that are now becoming available from private purchasers and, in fact, public
purchasers and payers for health care. I show that in the diagram.

The block for providers right now is their hesitancy to implement and
purchase IT until the costs and the risks are lower or the incentives are
higher.

The problem that vendors of HIT face in lowering the cost of their products
is literally the hesitancy of the providers.

The sales cycles are very long and the sales costs are high. I was a vendor
for 15 years. The cost of selling the EHR is half the cost the doctor pays to
buy it. That doesn’t improve the product, it doesn’t help implement it. It is
just the selling cost.

It may be subsidizing our airline industry somewhat, but we probably
shouldn’t be doing that. So, if providers understand what they need and are
more confident and focus on the things they need to do to differentiate
products, I imagine that the cost and time of sales goes down. Then the money
can go into lowering the cost of the product, or developing a better product.
Either way, the industry wins.

Finally, the payers and purchasers who are now just stepping up to the line
to offer incentives — and there are some notable programs, and I will mention
bridges to excellence, but I know there are others that are providing
incentives.

If an office adopts information technology, they would be faced with a very
difficult task if they had to sort through the 200 different products on the
market and figure out which ones could provide the quality improvements and the
safety improvements and the cost effectiveness improvements that they want.

So, we can help simplify that process for them and prevent that from being
an overhead item that adds cost. So, this diagram you are seeing here just
shows it is a positive cycle that builds on itself.

There is less risk for providers, they buy more and cost less to sell to
them. That attracts investment to the HIT market, lowers the cost of HIT, and
the payers and purchasers are now able to offer those incentives with more
confidence. Those incentives help the providers buy, and you get a cycle that
builds on itself.

In doing this, again, because it is voluntary, we need to deliver value to
each of the stakeholders. We have identified three key stakeholders. We have
many stakeholders, but three that there is actually a balance between.

The first is obviously the end users, the HIT end users, the providers, the
organizations that buy these systems. Second is the vendors. Third is the
payers and purchasers who are prepared to offer these incentives. We need to
deliver value for each.

The end user needs to know that if they paid attention and buy the
certified product, they are much more likely to get a product that they can
succeed with.

The vendors have to feel and recognize that, because of certification, even
if it costs them something to submit their product, they will get a more than
100 percent return, basically, either in revenues or ease of sales or more
understanding on the part of the buyers, so that they can focus more on
improving the products and less on convincing people that it is safe and it is
not going to go away.

For the payers, we owe them the assurance that these products will deliver
the benefits they want. Of course, standards organizations are very important
to us.

Standards are the substrate on which we build certification. We don’t
develop our own standards. We take the standards and determine how to certify
against them.

Other stakeholders that are very important are the consumer, clearly,
public health, which is an important customer for the data, if I can use the
term customer. I should say recipient of data, to meet their needs. As well,
clinical research and quality organizations. We consider them all important.

Let’s talk about how we are organized to meet the needs of those
stakeholders. We have a commission. Currently we have 13 commissioners. I am
the 14th and I don’t vote.

We have formed four work groups made up of subject matter experts who serve
voluntarily. In fact, we don’t even cover their travel at this stage in our
development. They volunteer their time and their travel costs. They are drawn
throughout the industry.

The four work groups are focusing on functionality of EHRs,
interoperability of EHRs, security including privacy, and reliability of EHRs.
The fourth is a little different. It works on the actual process of certifying.

We have formed a new work group which is just a recombination of the
existing members who are now focusing on the very real practical aspect of,
let’s get these use cases written and write our test plans.

To interact with the industry, we look to organizations. Sometimes they
exist. If we want to interact with physicians, we can go to physician
associations.

If we want to interact with vendors, they actually formed an association in
response to this called the EHR Vendor Association. Payer and purchaser
associations, interdevelopment organizations, and so on.

We will outreach to individuals as well as to organizations, and when we
look at the public comment results, you will see some information about that.

It is very important, as we do this, to maintain balance and diversity on
the commission and the work groups. We pay a lot of attention to this.

The commission has a formal structure. We have to have two to four members
from each of the three key stakeholder groups, two to four representing
providers or physicians, or provider organizations, two to four from the vendor
community, two to four from the purchaser or payer or purchaser coalition
community, and then two to four can be drawn at large from other stakeholders.

We actually had some government members ex officio, although they have not
been attending since there was word that there would be an RFP. They have not
attended at all, to keep complete isolation there. Standards development
organizations and others.

Then the work groups, which are formed at the direction of the commission,
we formed these through an open call for participation.

The three founding organizations help us communicate. They have very
powerful communication vehicles out for the industry. It would have cost a lot
of money to try to get the word out otherwise.

So, we used them to get the word out and the press, and we received 275
applications to that open call for participation.

We went through a process of ranking them b qualifications and adjusted for
stakeholder balance. Each work group has two co-chairs. The two co-chairs must
represent two different stakeholders.

Each work group has an additional eight to 10 members, qualified experts
from a diversity of backgrounds. In fact, sitting in here, one of the staff
members here is on our functionality work groups, Steve Steindel.

Let’s talk about what it is we promised to do. First of all, we set our
initial scope as certifying electronic health record products for the
ambulatory care setting.

The reason we chose that is, everyone felt that is where we had the most
benefit to deliver, the biggest adoption gap, the most lag.

You know, the adoption percentage is about 15 percent overall, more in
large physician clinics, lower in solo practices.

A couple of statistics, in case some of you aren’t familiar with them, half
of all United States physicians — and there are about 700,000 physicians, and
500,000 who see patients in offices — half of those practice in a group of
four or less. Three fourths practice in a group of nine or fewer.

So, the adoption in the smaller offices, it may well be under 10 percent,
and certainly the adoption of EHRs that have safety features and clinical
decision support is well under that figure.

That is where the benefit was to be gained. The deliverables we committed
to were to deliver a pilot process first, in September of this year, and to
follow up with operational capability for certification, and a road map showing
future certification plans one to two years in the future.

The road map looks something like this. You list the requirements for
certification this year and you show the forecast requirements for the next
year and one more year beyond.

Of course, those forecasts are not perfect or precise, but it gives the
industry general direction, because the product cycles are six months to 12
months and 18 months, and they need that time to respond.

This is our current time line and this is now subject to adjustment because
of what has been happening with the federal government and the HHS strategy.

We hit our target so far. As I said, we formed the group in September,
formed the work groups in November. On April 18, we had our first phase I
interim work products available for comment.

We published them on our web site, got the word out through the
associations and the press, allowed a 30-day period for public comment and also
did open calls — we called them town calls — for a week.

We did four open ones plus approximately three more that were specific
outreach to groups that we felt weren’t getting the message, just because they
weren’t in the industry circles that we had good communication with.

We are now just getting ready to publish the phase II work products for
another 30-day period, and I will talk a little bit about those.

We will be having town calls. I will be using my voice a lot from the week
of July 11-25, just back to back one-hour town calls.

We planned to publish our pilot test requirements and start that pilot test
at the end of September. That is going to need to change, because we are
responding to this request for proposal, and it puts the pilot test date in
December, if the contracts are awarded at the end of September.

So, we will probably slide that back and spend those two months gearing
ourselves up into this new role, if we win the RFP.

So, I have talked about the phases, and I probably don’t need to go into
them more. I will point out that phase I was data gathering, go out and get the
evidence, find out what are the needs, what are the available standards, what
are the priorities among the various stakeholders for these different
functionalities, and let’s put that out there and see if the public feels we
got the evidence right.

Then, looking at the evidence, make some recommendations about
certification requirements, and that is phase II and we will be publishing
that.

I would like to just briefly explain the process the work groups go through
to do that. They start with an available standards framework. In the case of
functionality, they were the beneficiaries of a lot of hard work for a couple
of years from HL7, developing the draft standard for trial use of an electronic
health record, functionality standards.

They started with that as a framework, added the evidence of what are the
priorities from the various stakeholders, what is the availability in the
market place, what is the practicality of certification.

You know, that is considered as well. There may be a functionality that is
important, but it is just extremely difficult to test and certify reliably, and
you might not be able to.

Then they went through a decision process, and either said, we are going to
require this year, we think it is going to be required next year or two years
hence, putting it on the road map, or it is not something we need to certify.
That doesn’t mean people won’t have this feature. It just means it is not
something that we need to test.

As they look at each element, they consider the priority and the
availability as two axes in the matrix. If it is of high priority, it is
essential, and it is available, and you probably need to certify that, if it is
testable.

If it is essential, but not quite yet, or if it is not available yet, then
you could consider it for the road map, that it would appear on the
requirements in one or two years.

If it is an optional feature, not necessary, or it is unclear whether it
could be delivered and developed, then you don’t certify it.

I will show you the documents, and you won’t be able to read any details. I
just want you to understand the general structure. You know about spread sheets
on power point slides.

Anyhow, they are still up there on the internet as the phase I work
products, but the public comment period is closed. Everything is at
www.cchit.org.

This is the functionality work group spread sheet, and it is too wide to
fit on the screen. This is the left part. So, you will see that they drew the
functions from the HL7 EHR draft standard for trial use, the ambulatory subset.

They had started to develop the evidence on priorities from among the
various stakeholders. They developed evidence of availability. That is the
column in 2005 availability.

They then got into the detailed criteria and, of course, didn’t yet fill in
the phase II part, do we certify it in 2005, 2006, 2007. So, that is being done
now, and that will come out in phase II.

The interoperability work group, they had quite a difficult challenge. They
didn’t have a single standards framework to build on. They couldn’t even get
their spread sheet to look like the other spread sheet, but they did a great
job.

They isolated the interoperability challenges into use cases, particular
components of the use cases. For example, laboratory and imaging is a use case.
A component might be receiving lab results.

Since we basically don’t have any standards based interoperability now, in
the form that we want to get, they listed, what are the barriers we need to
overcome, what standards are available, what vocabularies are available, what
is missing.

That became their work product. Again, they couldn’t make recommendations,
and that will be part of phase II.

The security and reliability group also had a framework called the common
criteria, which is used for the security of products, although it may be more
complex than is appropriate for at least this year’s work on ambulatory care
products.

They were able to develop those, look at the priorities among doctors,
payers, vendors, patients, and they actually made some preliminary
recommendations.

Those were subject to change. They just thought, let’s get them out there
and see what people think about them.

The certification process group was not the developer of a spread sheet.
They had to tell us how they were thinking of certifying. So, there is a
document on there.

They developed a concept of a spectrum of test methods. On the far left of
that is something called self attestation.

Basically, the producer of the product says, I have read the requirements,
I meet them, and they sign. On the far right of that is, laboratory testing,
give us the product, go away, we will lock it in a room, we are going to test
it.

In between is something that you would call — they call it in vivo testing
or field testing. For example, you might ask the developer of the product to
put it through its paces while you are dialed in over the internet watching,
and you have a jury, for example, watching on the screen and you say, show us
that it does this.

So, they simply considered all of those as tools in an armamentarium, and
looked at the different things we were trying to certify, and which tool was
most appropriate.

Now, some of our stakeholders push us far to the right and say, put it in
the lab and beef that thing up. Some of our stakeholders say, that is going to
cost millions of dollars, you are going to make it impossible. How about just
letting us sign. The vendors, of course, would prefer that.

There is precedent. Medical devices, a lot of it is vendors self certify
the devices as meeting the requirements.

So, we are still in the process of sorting this out, but we think it is
actually going to be a mix. We think there are elements that could be self
attested, some elements that really do need to be tested in a lab, some that
are best tested in the field with a small panel of experts.

We want to keep objectivity, but we also have to be efficient and
practical. I would like to just talk about the results of the comment period in
a general way, which we found interesting.

First of all, it was a 30-day period. Many people said, 30 days is too
short, but we were working to a schedule.

So, I have developed this graph, and this shows when the comments came in.
It was all done on line and, as you can see, there is a bit of waiting toward
the end of the period.

Now, my theory is, if we gave them 45 or 90 days, would the curve look any
different? Thank you. So, we are probably going to stick with that 30 days as
the turn around time.

We were pleased to see about two thirds of the responses were from
organizations, and they had to actually check a box saying, this was approved
by my organization, not just I belong to an organization and I am responding.

The third were individuals. We like that, too, because we don’t want
individuals to feel cut off from this process.

Then, what type of source it was. About 10 percent were physician
associations and another seven percent were individual physicians.

In terms of provider organizations, about 10 percent were health systems,
and about four percent were academic medical centers. If you add that together,
you get about 31 percent or about a third of our responses were from providers.

The vendors represented 29 percent, about a third. The rest was kind of a
mix. We had other associations, we had four percent from government, one
percent from consumers — a number we want to increase — about 12 percent from
consulting organizations.

In general, we thought we were getting out there and had a good spread.
Then the other interesting fact is, we did a study on were they positive or
negative, what were the kind of comments.

This was only for comments directed to the commission. The ones directed to
the work groups were very specific, this line item needs to be changed, you
have forgotten this.

We haven’t done this kind of analysis on those. The work groups are going
through every single comment. The commission went through the comments that
were directed to us.

In general, you have about 18 percent that were supportive, about 28
percent, the largest number, constructive suggestions.

About 18 percent were requests to be included, a stakeholder that said, I
didn’t know about this, why didn’t you tell me sooner, please include us.

About 18 percent were concerns, broad or specific, but generally broad.
About 18 percent were format issues. Another principle that I see here is,
there is not universal format for publishing work products.

We offer them in PDF which the government uses as kind of a safe way to
publish things, and we used PDF when people wanted spread sheets.

We also published in a format that was easily printable, and then you had
to zoom in to view it on the screen, and we got comments saying, I can’t see
it.

So, we are probably going to publish two forms, one that says, best for
viewing, one that says best for printing.

We are trying to be very customer focused and friendly here, because we
really only exist on the good will of all these stakeholders. So, we are going
to do even better.

We also got a lot of nice positive comments about the depth of the work
and, really, we really appreciate the work of these volunteers. The
commissioners and work group members have put in phenomenal amounts of time.

The work groups have been meeting weekly to twice a week for often 90
minutes to two hours, and a lot of them are being assigned homework in between
meetings. So, it has been a tremendous effort.

What is coming in phase II? The first thing is, there is a saying, you have
to eat your own dog food. We are going to harmonize our own formats between the
different work groups.

We got some comments saying, they don’t seem to tie together as much as
they should, un-interoperable. So, we have to do that.

So, we have agreed on a common format for the work products, where we will
categorize the criteria and show the source and references, show the
priorities, availability, and the recommendations, and any lengthy discussions
go into foot notes. So, I probably don’t need to go through these. These are
just cross walks that show how we move there.

The other thing we are working on — and it is not completely clear whether
we will have these ready by July 11 for this public comment cycle, is a first
draft of use cases.

The first issue is, no one has clearly defined exactly what that means in
this new world, but we consider them to be realistic patient care scenarios
that you use for test purposes, and they would let you demonstrate that the
product fulfills the functionality, interoperability and security criteria.

We also know that we are going to need to collaborate and develop common
use cases with a number of other organizations in the new HHS health IT
strategy. So, any that we develop would not yet be subject to that
harmonization of use cases.

MR. COHN: Mark, can I hold you for just a second, because you are doing
great. I do, I think, need to not so much remind you, but maybe remind the
whole committee, as you know, we are in the middle of an RFP process, and this
is a federal advisory committee.

I just want to make sure that everybody realizes that we need to ask you to
be very circumspect in any discussions related to the RFP.

I don’t see anything going on in the overheads that is a problem, but I of
course have no idea what you may say about them.

MR. LEAVITT: I will stick to the overheads.

MR. COHN: I do need to sort of inform the committee members that, even
though the thing that you may most want to ask has to do with the RFP process
or whatever, you really are precluded from asking about it. I just wanted to
warn you, this is also a conversation that we need to warn the next panel about
also.

Do not feel in any way singled out on this one, but obviously it just is
the awkwardness of the various federal processes.

MS. GREENBERG: In a way it just shows how prescient we are as a committee,
since we invited all of you before we knew that there was going to be this
process.

MR. COHN: The information is very valuable, and please go ahead. I just
thought I should warn everybody about that.

MR. LEAVITT: That is good, and you are right, we have to be careful. I will
restate, I think the fact that we are responding is public information. There
is a list of the respondents.

The details of the response are not public yet, so we won’t really talk
about that, although it may be that at some time it does become public. I don’t
really know. So, you may get to see it in that manner.

It is very public what Secretary Leavitt has announced, and I am just going
to show a picture that talks about that.

I think you are all aware he has announced this American health information
community. You are all aware of the RFPs. That is public information. They were
released June 7.

The first is a standards harmonization process. The second is a compliance
certification and inspection process. We are responding to that.

The third is to be awarded to six contractors to develop prototypes for a
national health information network.

The fourth is to develop privacy and security solutions for interoperable
health information exchange, a contractor that will look at differences between
state policies and provider organization policies, and try to sort out that
very confusing situation.

If you drew a picture of what they are talking about, you read his
announcements, and you see these four contractors working in parallel, and you
see the American health information community and the national coordinator
working together to synchronize what is happening, and also NIST collaborating.
This is mentioned also, and having to satisfy multiple public and private
sector stakeholders.

So, in terms of the view of the future, that is all I can show you, is that
picture, and then I think I would like to stop and thank you once more for
inviting me and ask if you have any questions I can answer.

MR. COHN: Mark, thank you. I do apologize to the committee for taking all
the fun out of the questions, but I think the background and obviously the
work, I think, is very exciting. Let’s start with questions.

MR. HOUSTON: Nice job, really exciting stuff. Your pass fail certification,
is that then updated yearly, or is it — as you take different views, vendors
may stay current, may not stay current. So, is that updated continually, and is
that available on a web site as to whether somebody has pass failed?

MR. LEAVITT: Good question. Here is the structure. There will be criteria
each year. So, we expect to update the criteria.

If you think of the 2005 federal gas mileage standards and the 2006 federal
gas mileage standards, it is a similar model.

So, there will be the 2006 criteria and the 2007 criteria, and when a
vendor applies and is certified against that, that is published on the web
site, this product meets the 2006 criteria.

Now, that is permanent for that product and that version. So, they don’t
have to come back next year and retest against those six.

If they want to test that product or a newer one against the 2007 criteria,
that is fine, or that same product against the newer criteria, but it doesn’t
invalidate the fact that they met that. It doesn’t expire. We don’t need to
recheck the product.

MR. REYNOLDS: And you will include in each of your years if new standards
come out or any of those other things?

MR. LEAVITT: That is the reason to have these criteria coming out every
year, is the new standards. We couldn’t possibly certify much in the way of
interoperability in 2005 or 2006. So, we see that really coming on in 2007 and
2008.

MR. REYNOLDS: If this is available out there, one of the things we run into
a lot is that the small physician offices really don’t know the next thing that
is going to happen or really don’t know if this is going to be okay.

MR. LEAVITT: We hope this will help them.

MS. MC CALL: You actually touched on it in your response, but it has to do
with certification for interoperability.

Given the systems that you have seen, do you see a big shift that is going
to have to take place in existing vendors and systems, once interoperability
comes on line?

MR. LEAVITT: That is another good questions. I think that the newest
product developers have seen this coming.

So, I think the industry is going to be able to respond to this. The
products that have been out there the longest will have the biggest challenge,
because of the issue of all of the users that have to learn to do things a
little differently when it is interoperable.

That is the reason to have this forward looking road map. One of the
challenges we will have is, how do you deliver exciting new benefits quickly,
in a way that doesn’t disadvantage a substantial part of both the vendors and
the end user market place.

MS. MC CALL: The 15 percent base, if they are all larger practices, are
probably sitting on top of architecture that may not support over.

MR. LEAVITT: You raise an important point in terms of the timeliness. We
need to take advantage of the fact that there is only 15 percent adoption, and
that is why we are running so fast. This window will close. They will all
become permanent systems and we won’t have interoperability. That is why we are
trying to make this happen so quickly.

MR. REYNOLDS: Another quick one. Do you see this structure fitting other
things other than EHR?

MR. LEAVITT: This isn’t a topic we have discussed. At the moment, we would
like to certify a comprehensive electronic health record product.

Of course, the RFP, which is public information, asks the certification
vendor to certify inpatient electronic health records in the second year of the
contract, and the networks through which they interoperate, or the network
components, in the third year of the contract, public information from the RFP.

We discussed certifying modules, the electronic prescribing module, the
laboratory result module. Then you have to certify interoperability between the
modules, so you can buy your lego blocks and they can snap together.

We decided it was probably too big and too difficult a task. So, we are not
going to be offering certification for a subsystem that only performs part of
the task. That is our current plan.

If we win the RFP and get into inpatient EHRs, that is absolutely subject
to reconsideration, but right now, for ambulatory care, it is a small enough
solution and generally a small enough set of functions that we are going to
focus on the complete electronic health record.

MR. COHN: I am always wondering whether Harry was referring specifically to
EHR systems, or whether this might be more generally applicable.

MR. REYNOLDS: That is exactly what I mean.

MR. COHN: I actually mean more like things like some of the HIPAA issues.

MR. REYNOLDS: That is where I was going.

MR. LEAVITT: We have no plans to do that in terms of the scope of our work.
There is also evidence that electronic health records could benefit from this
process, whereas the problems of the financial systems and the HIPAA issues in
the financial systems are being already approached. There are approaches and
solutions, and we decided that that probably is not within our scope.

MR. FITZMAURICE: I have a question that deals with coordination and
collaboration. HL7 has an electronic health record technical committee with an
interoperability subcommittee.

CCHIT has a work group on interoperability. It seems to me that they both
will probably develop use cases for the electronic health record that both
define definitions — that have their own definitions of interoperability, but
CCHIT will develop a certification criteria, the HL7 functional performance
criteria will be developed by the HL7 committee.

A lot of this was started when the government financed or supported the
development of EHR functionality that led to the draft standard for trial use
of the electronic record.

So, I have a question. It is moving toward a finally balloted standard with
conformance criteria for meeting that standard.

In your opinion, would it be useful to have the work of HL7 accelerated
toward a final standard with coordination among HL7, CCHIT and AHIC for the
government, or is it not needed because CCHIT is already moving forward and
moving ahead.

MR. LEAVITT: Thank you, Mike. The certification body will not be developing
standards. Although it doesn’t really replace the work, it is actually
dependent on the work of the standards body and, therefore, anything that helps
the standards body arrive at its decisions sooner and more completely is good
for us.

We actually see it as kind of a waterfall model. The standards body
develops the standard. We figure out how to test against it efficiently.

However, since it is often the first time a standard is tested, we will
have feedback. You know some of the elements of the standard are hard to test,
or nothing does that, are you sure.

So, we will have some feedback for refining the standard. So, I guess, to
the extent the standards are in the draft stage, we would like to work with
them as early as they are available.

We are doing our prototype, we feed back information, then you have your
final standard, and your final certification probably happens a year or two
after that.

So, we see that as being a way we can work together, but we never want to
be in a position of trying to originate standards within CCHIT. We just figure
out how to test to them.

MR. VIGILANTE: Thanks, great presentation. A couple of questions. One,
among the major vendors who have most market share, the five or six big vendors
in the space, are they pretty much all represented in your interoperability
work group and, if they are, what is the — how do they play together?

That may be kind of hard to answer, but is it — do you get a sense of
commitment among them, that this is something that we really need to do, or
this is we have to kind of show up and pretend to do something. That is part
one.

Part two is, with regard to Mike’s question and your response to it about
wanting standards early and then testing against them, to what extent are the
CHI standards relevant to that, and are you looking at them and potentially
testing against them as well.

MR. LEAVITT: Good, thank you. On the first part of the question, how do you
deal with the fact that the competitiveness of vendors, or the fact that there
is some number of large ones, first, we can’t possibly have every vendor
represented. It is not congress. It is not an elected panel with one from every
single panel.

In fact, we try to create a culture that says, when you come in the door or
dial up the phone for your work group meeting, you need to leave your interests
— you bring your knowledge and leave your agenda behind.

Now, it is always imperfect, but that is the culture that we are trying to
create, and so, they are there as industry experts, not as advocating for a
particular vendor, because we don’t have enough people to do that.

Steve Steindel is here. He is actually on one of the work groups, the
functionality work group. Maybe I could ask you to share your comment, because
you have been there in those meetings, about that topic.

MR. STEINDEL: I serve on the functionality work group, but I think I will
address also some comments on the interoperability work group as well.

The functionality work group, we went through a kind of assimilation
process within the group and the group process.

In the very first meetings, there was definitely the vendors’ stake. People
were saying, I have to represent my position. The providers were saying, I have
to represent my position, et cetera.

By the time the third or fourth meeting went around, when the people were
realizing they were working toward a synergistic solution, it started to get
much more cooperative, and people left their particular company hats aside, and
started to talk about this as a group process, where the vendors would input
information not about their product, but about the products in general, and how
the functionality we were talking about could be expressed in total.

It turned out to be very synergistic, very learning, when the providers
would ask for something and the initial vendor feedback was, wait a minute,
that is impossible, there would be a lot of further discussion and modification
from both points of view, and creating a very, very good, what I thought became
a stronger and stronger set of testing criteria, and also with respect to the
road map.

Mark didn’t stress it, but the road map actually is down at the
certification criteria level. So, we could have a function that we want
expressed now, that is not expressible, but we want it expressed at a very,
very high level today from a certification criteria point of view, and drill
down.

This gets to the question with regard to CHI, et cetera. Alicia Bradford,
who is part of the CHI process, is the other federal person sitting on one of
the certification commissions, and she is sitting on interoperability. The CHI
is being brought up there consistently.

From the functionality point of view, as we heard, we are not ready to do
that today but you will see, from the certification criteria, we start asking
for standards introduction a couple of years down the line.

Those are referring to not specifically the CHI standards, but the actual
like Snomed and HL7 and LOINC, that we would be using. So, it is feeding into
the process.

From the interoperability point of view, I think to a large extent the same
type of thing has happened, that they started off with individual biases and
then developed into the use case process, and decided which use cases can be
expressed over time, and how to introduce them.

MR. COHN: We have Paul and then Carol, and then we will wrap up the
session. Before Paul starts, I just want to take a moment to acknowledge him.

Obviously, Paul is a member of the committee, but I do want to reflect
back, that actually a lot of this started in terms of functionality with an IOM
activity related to patient safety which Paul chaired.

I can still remember a weekend probably a year or two ago now where we
actually all sat down and began to draft out the initial piece on functional
standards and what sort of functionality was required, that subsequently became
the work that subsequently was fed into HL7. So, Paul, I just wanted to reflect
on that as well as acknowledge you for a second, before whatever question you
ask.

MR. TANG: I think you will relate to this, because you are an electrical
engineer as well, but in my remote past I did a little bit of design work for
IBM.

In their integrated circuit test, your design had to be 99 percent testable
using the external pins. I reflect on that because you talk about how some of
this stuff you can’t test, or you find it difficult to test.

Then this question that Mike raised about the separation between the
standards development organization and the certification when, in actuality, if
we separated the people who design circuits from the people who have to go out
and test it, it may not match.

One thought is, don’t you need to incorporate the testability criteria in
your design process. So, in some sense, a criteria for setting standards really
should be the testability.

So, instead of having a sequence of steps, get the requirements, go put
some standards around it, and then figure out how to determine conformance. It
should probably be mixed, because that is the lesson learned from the early
circuit designers, because they had to have that kind of reliability.

In a sense, your process is talking about getting that reliability in this
market. I should have preceded this, but I think your presentation was very
clear about a very clear need, and addressing it in a very clear way, and I
really appreciate that.

The second part, then, check me if I stray in terms of the RFP process, but
you started out, of course, because there was a need there, and you created
this organization that addresses that need very squarely.

Now we have this new RFP, and does the kind of persistence of the
organization depend on this in any way? I don’t know how to quite ask it.

MR.COHN: I don’t think you can, Paul. I would judge that you are straying
off into the RFP conversation. Is there another way you want to ask that?

MR. TANG: Let me try it. I am not trying to add to the RFP process. I am
trying to say, do we only need one of these around? Is that part of the way of
having this stuff coordinated, along the lines that Mike asked?

MR. LEAVITT: We believe you only should have one of these.

MR. COHN: Paul, thank you for rephrasing that. Carol?

MS. MC CALL: This is more of a food for thought question, and it is not
just to you, Mark. It is actually to everybody.

How extensible is the model into different domains? In particular — and I
keep thinking back to what we are doing in the quality work group — how
extensible is it to the development of metrics and definitions and standards
and, therefore, their certification in some way, perhaps according to a
different — obviously — definition, and then ultimately their incorporation.

So, it is food for thought, but it is a delightful presentation today. It
seems like an elegant and robust model, and I would just be curious as to your
thoughts as to how portable the mechanisms may be, in your opinion.

MR. LEAVITT: Thank you. Again, I appreciate the support that you voice.
This is going to be very interesting as we try to extend it — again, the
public and the RFP, that you are going to try to extend it to the inpatient
world and eventually to the networks.

I believe extending it to the inpatient world is just a matter of more
complexity but not fundamentally different.

Certifying the networks is fundamentally different and, in fact, the
analogy, again, to use a simple one — well, let’s just use computers. We are
certifying the plug. When we are certifying an EHR, we are certifying the
computer and the plug on the computer, but the network that you plug into, that
is the other side.

That is a different thing, and I think it will be much more heavily — it
is very technical. It is really a technical job.

When you talk about functionality of EHRs, you really get into everything,
philosophy and values. The networks really should be a black box, when you put
stuff in it comes out the same and no one could possibly crack into it and get
information.

Then you turn it over to the engineers to make sure that it does that. So,
I think it will be much less controversial and far more technical, and then we
will just have to cross that bridge when we come to it.

MR. COHN: We are finishing off right now, I am sorry. We need to finish
off. I would, however, sort of comment that actually this whole standards
criteria, certification, really does apply to everything. I mean, it is really
one of the values of the committee, where you have the high level view and then
the question is, how do you really implement it. So, I think it really does
fall in.

Mark, I want to thank you for a wonderful presentation, and I think it has
been illuminating. I am sure the quality work group may want to, at some point,
have you come, or one of your staff to sort of further discuss with them.

What I am going to recommend is that, given we are putting some breaks in
here, let’s take a 10-minute break to allow for the next group to come on, but
once again, thank you very much for making time.

[Brief recess.]

MR. COHN: I want to once again welcome the panel. It is listed here as the
ANSI health informatics standards board panel, but it is really, I think, also
talking about the ISO TC, and sort of international efforts. So, we are
obviously delighted to have you here today.

My understanding is that Audrey Dickerson will be starting, followed by
Gary Dickinson, followed by Robert Owens, Bob Owens. I obviously want to thank
you.

I do want to, once again, I think you heard at the last session, obviously
given that we are in the middle of an RFP period — and I think we have talked
about this privately also — but obviously we, as a committee, need to stay
away from discussions of things related to RFPs, and you will see me moving in
quickly if the conversation strays into that, if questions go into that.

In some ways, it is the most fun thing to talk about, but given that we are
in an open period, we obviously have to follow federal rules. So, with that,
Audrey, why don’t we let you start, and thank you all for being here.

Agenda Item: ANSI-HISB Panel. Audrey
Dickerson.

MS. DICKERSON: Thank you. Greetings. Today I am reporting about the status
of international standards in the United States.

The importance of consensus standards was highlighted in Secretary
Leavitt’s talk on June 6 at the HIMS summer summit in New York City.

Using the examples of a clock and the historic march of the railroad across
the continental United States, the importance os standards was outlined.

Standards are frequently written into laws and policies, such as appliance
energy standards in laws in Arizona and New Jersey, IT security standards into
policies in Georgia.

Globally, consensus standards are in wide use. In Japan, they comply with
all international standards and in Germany, where the government standards
building is 10 stories tall, a block long and a block wide, the German
standards minister says that Germany complies with 85 percent of all
international standards. The European Union writes SIN and ISO standards into
laws and policies within each country.

In the United States, work with consensus standards groups is considered
voluntary, and paid through an interested industry member, or out of pocket by
the standards volunteer.

Standards are part of our lives every day. The reason we can use an
electric plug for any appliance or a piece of equipment is that the plug prongs
and outlets are standardized to specific sizes.

In banking, we are able to use a synchronous transfer mode on line,
participate in commerce, and order airline tickets.

Without consensus standards, these would not be interoperable. Imagine a
city or even a town where the stop signs were different colors and the road
lines were red and green.

Long ago, in the field of music, someone decided that one nomenclature
could be used for all types. Today, with many genres of music, they all use the
same notes, lines, base and treble clef.

These are some of the roles for HIT standards. Currently, for most of the
U.S. health care system, this level of interoperability has not been achieved.

HIMS gives the Davies award for EHR implementation to hospitals, ambulatory
care, and public health. These are some of the notes after EHR implementation
has occurred: access to specialists improved by 80 percent within two years,
while unnecessary tests were prevented, less costly options for care were
identified, and number of visits were decreased annually by patient, due to
timely identification and resolution of health issues.

Medication turn around time from order initiation to delivery to patient
decreased to .53 hours. Adverse drug reactions were reduced, as pharmacist time
was redirected to working with physicians.

There was noted improvement in patient safety with compliance to ambulatory
EHR problem lists that went up to 97 percent. Allergy documentation went to 100
percent, and pain assessment to 95 percent.

There was completed encounter documentation that, on the average, decreased
from 5.2 days with paper to 1.3 days with an EHR.

Using standards, Dicom has revolutionized the radiology with filmless
departments, and internet sharing of radiology pictures to a standard from ISO
TC 215, called web access to Dicom persistent object.

Access to complete, consistent data for building best practices, research
and public health surveillance is a future goal.

Consensus standards reduced technical barriers to trade, by providing a
balance of interest between providers, end users, vendors and payers, with due
process, using a method that addresses all comments, and a draft document and
appeals process.

The cost of goods may be reduced, as standards can be used to settle
disputes using a business plan. Sharing information provides involvement of
affected stakeholders, and encourages economic research.

Demand has increased as consensus standards are implemented, tested and
certified. The re-authorized technology transfer act, public law 104-114,
national technology transfer and advancement act of 1995, provides a mechanism
for cooperative research.

As part of the consensus process, ISO TC 215 was organized in 1998. The
scope developed then is still relevant.

Standardization for health information technology to achieve compatibility
and interoperability between independent systems, reducing duplication of
effort and redundancies.

In the beginning, the technical committee for health informatics had six
work groups and two liaisons. Today, we have eight work groups and over 100
draft standards in the consensus process, including our first clinical research
document currently being balloted now in clinical genomics.

Some of the most important liaisons are listed here: The International
Electronic Electrical Engineers, Health Level 7, Digital Imaging and
Communications in Medicine, the International Council of Nurses, International
Medical Informatics Association, International Electrical Technical Commission,
Integrating the Health Care Enterprise, and Clinical Laboratory Standards
Institute.

This September, in Japan, HIMS and ISO TC 215 are hosting a global summit.
This summit will listen to HIT world leaders describe and discuss what
standards are needed for global EHR interoperability, and how global standards
developers can meet this need.

Our motto is, global standards used locally worldwide and, if you are not
using standards, your competitor is.

Consensus standards are a recognized, credible, organized business method
for achievement. All good ideas at not inside the United States.

Products for export that have one set of standards are cheaper to produce.
Import products can be compatible with our needs, can reduce duplication and
increase harmonization, can reduce errors, and increase patient safety, and we
can have global interoperability. IT plays a key role in supporting the
optimization of HIT consensus standards.

Currently, the United States enjoys approximately 60 percent of the market
share of goods. However, a new country, China, has entered the world market
place, including the market in health information technology.

Using and working in international consensus standards is necessary for the
United States to become a full partner in global health information technology.

Health and Human Services, as a department member, would be leveling the
playing field for all U.S. participants in consensus standards to the same as
global counterparts.

As recommended subject matters experts join the U.S. delegation, the U.S.
perspective becomes a part of each new standard published. The cost of goods
decreases as genres develop, not new nomenclatures.

MR. COHN: Audrey, thank you very much. Obviously, we will have conversation
and questions before all the presenters to. Gary, I think you are on next.

Agenda Item: Gary Dickinson.

MR. DICKINSON: Good morning. My name is Gary Dickinson. I am an independent
consultant. I am also chair of the U.S. technical advisory group to ISO TC 215,
and I will be following up with further information from Audrey’s presentation.

There is a handout of my slides, which includes the TC 215 work program,
which you may have some interest in, identifying the seven working groups
within the technical committee and the various work items that they are
currently addressing.

The other thing I wanted to note is that, in the handout of presenters, you
will see references to ASTM. Those are not current references. ASTM was the
original secretariat of the ISO 215 and that was taken over by HIMS here two
years ago. So, the references to ASTM are obsolete.

I wanted to identify that the United States is in a very strong leadership
position within ISO 215. Obviously, the United States holds the secretariat to
the committee in the form of Audrey Dickerson, who is the secretariat, and the
HIMS organization that supports us in a secretariat role.

We have three conveners of the eight working groups. The United States has
three conveners for three of those working groups, Michael Glickman, working
group two on data interchange, Dr. Christopher Schute, working group three on
semantic content, and Mr. Todd Cooper, working group seven, medical devices.

Also, we have a vice convener of working group four, who is Laurie Forquet.
Working group four focuses on security.

We also have several other representatives in key positions within ISO TC
215. Dr. Ed Hammond has recently been appointed as the ambassador to developing
countries, to try to draw in developing countries, those with emerging interest
and efforts in EHR and also health information technology.

Solomon Apavu(?) actually leads two different groups within ISO TC 215, the
consumer policy committee, as well as the e health task force.

We also, as a result of our secretariat, the fact that the United States is
the secretariat of ISO TC 215, we nominated the current chair of ISO TC 215,
who is Dr. Denel Sae Qwak(?) of Korea.

It is of interest to note that a number of U.S. ANSI accredited standards
have been promoted to ISO. These are a few of them: the ASTM laboratory
analyzer interface standard, the HL7 version three reference information model
has currently been approved and is ready for publication.

The HL7 version 2.5 messaging specification has not been promoted to an ISO
standard and is going through the process.

A series — I don’t know how many there are off the top of my head,
something in the range of 15 different IEEE MIB medical device standards have
now been promoted, or are in the process of being promoted through the ISO TC
215 process.

It is also of interest to note that the Dicom version 3.0, diagnostic
imaging standard, is being promoted through the ISO process, and that will be a
standard that will emerge by reference. Essentially, the ISO standard will
simply be a cover pointing to the Dicom version 3.0 imaging standard, not a
separate incarnation of that standard.

The U.S. Tag has currently 51 members, which includes a broad range of
interests across the industry. Certainly providers, standards developers,
professional and trade associations, some of whom you see here — I don’t know
if this is an absolutely complete list, but I tried to grab as many as I could
find. There are multiple members from some of these organizations. So, you
won’t see 51 total identified here.

Moving on, then, there are government agencies involved, vendors, academics
who are also providers, and various consultants are also on the U.S. technical
advisory group to ISO TC 215.

We have a good balance of stakeholders as you see, and a good depth of
technical expertise in many topic areas. We do need to fill important gaps.

That is what this slide goes to, basically. You will notice that we have
had good participation and influence in some of the working groups,
particularly working group two on data interchange, working group three on
semantic content, working group four on security, working group seven on
medical devices.

We have what i would consider to be — this is my assessment of our
participation and influence — moderate influence in working group one on data
structure, but we have had minimal influence on two of the working groups,
simply because we don’t have the experts in our groups to apply to those
particular areas. This includes working group five on health cards, and working
group six on pharmacy and medication requirements.

The working group eight is newly formed, and hopefully we will have good
representation, we expect to have good representation, in that space.

A key objective that has come out of a reorganization process within ISO TC
215 over the last year and a half or so is basically that ISO will not
necessarily produce standards in the sense of writing them from scratch.

ISO TC 215 will, wherever practical, seek to meet the need for
international standards by first adopting documents or standards produced by
others, with only those amendments which are necessary.

Second, by encouraging other suitable bodies to develop standards to
fulfill ISO TC 215 objectives, and third, by developing its own standards only
where neither of the above is achievable.

The precedents for doing this, of course, is that we start with
requirements, and I think this is something that is very interesting.

If you notice the work group structure within ISO TC 215, you notice there
are two requirements work groups working group six on pharmacy and medications,
and working group eight on EHRs.

It is a little strange to note that requirements seem to have been an
afterthought of this process, and hopefully they are now emerging as something
that is going to be important as a precedent to our specifications.

Ultimately, what we are looking at from the standpoint of requirements, of
course, is the what and the why, what is the requirement, the why being the
rationale for that requirement, but not necessarily the how, being the
implementation details of the actual specifications for implementation.

This also sets the bench mark for achievement within the standards
development process, allowing us, then, to g back and test the standards that
are produced against the requirements that we sought to achieve in the first
place.

Of course, that allows us to establish a road map for the future. So, none
of the things we talked about in terms of fulfilling these development
objectives can be achieved unless we know what the requirements are, and have a
requirements based road map, where we can begin to fill that in.

The concern, of course, is that if we develop a road map simply by saying,
well, we have this simple set of standards universally around the world, let’s
figure out where they belong, that really isn’t a road map. That is simply a
compilation of our historical vestiges. It does not give us necessarily a path
forward in terms of a road map for future use.

The key issues for the TC as well as the U.S. Tag obviously are to gain
participation of key stakeholders to promote, in particular, the user
perspectives and objectives, including consumers, providers and health plans,
who tend to be underrepresented, at least consistently underrepresented in many
of our standards development activities. That doesn’t mean they don’t show up,
it just means that they may not show up more than once.

Then, of course, to focus on the clinical care-wise focus, as well as the
technical HIT-wise focus of our efforts. To ensure balance of producers and
users, consumers of standards.

Continuing on with our key issues, we want to ensure global relevance
across the bastions of EHR and HIT, which of course tend to be the more
developed countries, to include, of course, the emerging markets in developing
countries, as well as the various ways that medicine is practiced around the
world in what I have characterized here as easter, western and alternative
medicine, although I am sure that there are many others that could be added.

The other thing, of course, is to ensure the validation of standards. We
have many, many standards that have been developed over many years that
conveniently become shelfware, because they simply haven’t passed muster of
validation in real world implementations.

One of the key issues, of course, that came out of the previous
presentation is to ensure that our standards have testable performance
criteria, not just that we wrote a neat specification, but we actually have a
way to test performance against that, from that standpoint.

So, what can government do? Obviously, the key question for this committee,
hopefully, is to insist — I am fairly dogmatic about this so that I can get to
the core of it — to insist on requirements first, to make sure that we know
what problem we are trying to solve before we go off and try to write a
specification to do something.

Insist that standards be developed as components of a strategic road map,
looking forward, again, to requirement space.

Insist on credible broad-scale validation of our published standards, not
just that we have got something neat, now we have published it, and it will
become a missive to the world, but yet does not have appropriate validation to
ensure its viability in the long term.

Again, the same thing I said before, insist on standards with testable
performance criteria, and to ensure, obviously, the competent performance
measurement process, which is what we just talked about with Mark Leavitt’s
presentation.

One of the things we found, when we did the HL7 EHR TC work on the EHR
system functional model, was that it was very helpful to have expertise, to be
able to draw in expertise that would not otherwise participate in the process.

One of the ways to do that was to facilitate their participation, to help
them with travel, meeting fees nd those kinds of things, not necessarily paying
them, although a small stipend would be useful as well, but basically to
identify experts.

That would certainly help our process, that would not otherwise be
involved, by giving them some modest inducement to participate. So, that would
be my other final recommendation for the government. Thank you.

MR. COHN: Gary, thank you very much. Bob Owens?

Agenda Item: Robert Owens.

MR. OWENS: Good morning. I am the chairman of the informatics standards
board. I was really struggling as to what to present today in terms of an
update, given the events of the last 30 days.

We just had our standards meeting last week, where we took some key votes
in looking at what we can do to facilitate coordination across the industry and
moving forward.

In fact, if you notice, I came in a little late. I was still on a
conference call this morning, continuing to work on documents to that effect.

What I thought I would do is, it seems that health care continues to try to
carve itself as a unique sector of the United States and it relates to
standards, and it is really not.

I think it is important that at least this committee understands some of
the basics as to how ANSI came into being and what the standards board
participation has been to date, and its commitment moving forward, or ANSI’s
commitment moving forward.

In a voluntary standards system, this is kind of the overview of what I
thought we would go through today. How did the standards system evolve, what
has been ANSI’s role, what are the legislation and regulations that govern the
use of standards by government agencies, who is using them, and then some brief
information on the health care informatics standards board’s accomplishments to
date, realizing that there are several, again, key things that we have done,
and mindful of the RP discussion that we need to just, I guess, speak in
generalities at the moment.

The U.S. standards system is a bottom up dispersed system. What that means,
it is kind of from the grass roots SDO level, and from those that are involved,
similar to the American Revolution of fierce independence, that you duke it out
down below, and then what rises is the cream to the top, and at that point in
time you start to forge the steel and eventually have a solid product.

If you look in the European countries, the governments are, in fact, very
much a part of their standards development efforts, and where they pay for the
development of the standards, and pretty much dictate, from the top down,
exactly what standards are developed, how they are developed, and how they are
implemented.

That is why you see, in the European community, a lot more standards
adoptions, because it is a top down system.

In the United States, especially since 1995, you have seen an increase in
the use of standards by the government agencies for both procurement and
regulatory purposes.

ANSI itself is dated back to the late 1800s, early 1900s, when you had all
these different IEEE, the National Fire Protection Association, American
Society of Testing and Materials, and so on and so forth, that came to be.

Basically, after World War I, in 1918, the Department of Commerce, in
working with ASTM, IEEE, decided to form this new thing called ANSI, and then
worked basically through NIST as a member of ANSI in the Department of
Commerce, working together to form this private and public partnership to
basically manage the standards administration for the United States.

What that means is also that all standards kinds of activities are, in
fact, managed in that joint partnership.

In 1947, as a result of World War II, basically it was the air lift, that
we were moving supplies over to Europe, and we needed a way to basically ensure
that the information that we were talking about in the depots, both here and in
the United States, and some of our allies over in the European area, we were
talking apples and apples, again getting to some discussion of
interoperability. So, ISO was created.

ANSI is one of the founding members of ISO and is, in fact, the only
pathway from the United States to the International Standards Organization
community.

Specifically, how does that tie with what Audrey and Gary are doing?
Basically, ANSI has delegated its responsibility for secretariat to him but, in
fact, continues oversight and review of the ISO TC 215.

ANSI’s board, the health informatics standards board, is one of the key
issues. Actually, it was around the table there where we actually said we
needed to take our standards in the United States to the international
community and really promote interoperability.

It was really out of that health care informatics standards board that ISO
TC 215 was birthed. We went and initially had 11 countries sign up for a
meeting in London, and eventually it became the committee that it is today.

Throughout the 1970s and 1980s, there were different attempts by the
federal government to look at how do we get better control of the standards and
develop a strong affirmation of the private sector leadership.

In the 1990s, it basically started with the different legislation and
regulation that was coming out, the National Transportation Act that was
mentioned earlier, 104-113 and OMB 80-119.

The basic principles of the U.S. system basically come down to these five
things: openness, that anyone that wants to participate or has a dog in the
fight, as it were, has the ability to be there — balance, that you don’t have
any of the room loaded by any one area, transparency, due process and
consensus,

Sometimes we tend to joke, but sometimes it really is reality. Consensus
could be a level of disagreement that everyone enjoys.

The structure of the U.S. standardization system, ANSI is the coordinating
body for the private sector to accredit its SDOs.

It looks to support itself through membership fees and sales of
publications, so that it is self sustaining, and it looks at getting entities
that are appropriate to coordinate the standards throughout.

NIST obviously is coordinating the government part of that, and looking at
the lab accreditation research specialized area.

The standard developing organization is really where all the work happens,
and they can be made up of independent professional organizations, trade, and
exclusively standards groups, basically those that are only in the business of
creating a standard.

There are a lot of SDOs out there. Not all of them are accredited by ANSI,
but a lot of them are. To get accredited by ANSI, again, you are assuming that
that basically is giving it the assumption, and we audit the fact that they
adhere to those five principles that I showed you earlier.

In the law, the National Technology Transfer and Advancement Act in 1955,
HIPAA, which you are all familiar with, the Telecommunications Act of 1995,
Consumer Product Safety Act.

In public policy, it is OMB circular, the Presidential Order, basically
directing all federal agencies to use standards related activities and
guidelines.

The Department of Defense is using the standards. Here are different
agencies that, in fact, have either adopted or, in some fashion, implemented
the voluntary consensus standards. As you can see, it goes way past the health
care sector.

Again, rather than just bore you with all the details of operating policies
and procedures, I would encourage you to go out there, read the procedures for
accreditation, at least at a high level, so you get a familiarity of what ANSI
is really about, versus it is not this big, bad brother in the sky, it is about
ensuring due process and ensuring that the U.S. standards system is the best
that it can be.

The other thing that you will see out there is links to three organizations
that are basically key within ANSI right now.

The HSSP is the Homeland Security Standards Panel. The NSP is the
nanotechnology panel, and then ANSI HISB is the Health Care Informatics
Standards Board, which is ANSI’s only board, and responsible currently for
informatics within the health care sector.

This, again, just goes through some of the specifics relative to either
congressional action, or Presidential orders and the like, as to what specifics
are out there quoted in terms of standards being used.

The key thing here is — this is — you look at, in 2003, a direct response
to the congressional GAO report. The homeland security panel was established to
basically coordinate standards across the entire United States as it relates to
homeland security, and I should add that it is not just the United States.

Part of homeland security involves international coordination, especially
when you get into the intelligence and other activities necessary to really
affect U.S. security. This panel is responsible as it relates to those
standards activities.

Then the White House Office of Science and Technology Policy called upon
ANSI in 2004, basically to come together and create nanotechnology standards,
so that there could be, in fact, terminology, nomenclature, and coordination of
the various standards toward a fast track implementation of nanotechnology.

Both of these organizations are broad based, inclusive, and I should add
the difference between a panel and a board, within ANSI’s eyes, a board is made
up of ANSI members, a panel is made up of both ANSI members and non-members.
So, that is really the distinction that you should look at, as we look at the
three different areas.

In terms of the health care informatics standards board, we actually
evolved from a panel structure many years ago.

It was looked at, that basically the panel was going beyond perhaps its
scope as a panel, in coordination, and getting more into the development, which
made it more into a need for a governance board. So, it was transitioned into
the board.

I believe it is between 10 — we are trying to look at history — between
10 and 15 years ago. The mission of the Health Care Informatics Standards Board
is to provide an environment that facilitates, coordinates, harmonizes and
promotes the use of national and international health care informatics
standards.

The purpose is to be the coordinating body for the development efforts in
health care informatics standards in the United States, and represent the
interest of standard development organizations, as well as the interests of the
users, consumers, hardware and software developers, suppliers, and the rest of
the stakeholders, again, looking at trying to ensure that a balanced
representation is there.

We monitor and publicize and facilitate the development of common
conventions for data structure, basically looking at different activities and
what we can do to harmonize the U.S. Tag.

We coordinate with them, obviously, to ensure that what goes to the
international community is consistent with what we are doing in the United
States and vice versa.

The guiding principles that we have basically developed in the Health Care
Informatics Standards Board — and Simon, I guess you were actually one of the
co-authors with Chris Schute, on a common reference model for health care
information way back when. That is an approved ANSI guiding principle as it
relates to vocabulary. So, thank you for that effort.

In terms of the terminology model, common models for implementation of
health care information exchange, and a common trust framework for privacy and
security.

In the last few years, we got the SDOs to basically agree on an approach
for coordination and conflict resolution, in essence, how do we deal when you
have more than one standard for a particular space, and how do you do your
thick gap analysis and the like.

That is done. In fact, because the SDOs have signed up to be governed by
that protocol, it has the teeth now to be able to help manage through that
process.

A strategy to address health care informatics requiring harmonization and
interoperability, and the U.S. knowledge base, those three, standard road map,
basically NIST is working with the Health Care Informatics Standards Board on a
road map project, that will create the landscape for all health care
informatics standards, if you will, what goes where. We will look to the SDOs
and other interested parties to bring that in, and we will have that road map.

You also have a U.S. health information knowledge base, which is basically
a semantic data base that is developed based on an ISO standard.

We started off with the HIPAA standards, but we will look to continue to
expand that in both of these tools, to give the SDOs a place to put their work
efforts, so that it has a common presentation and a common cross reference, and
a common use tool across the industry.

In summary, ANSI obviously has a proven track record, we believe, for
standards coordination, not just within the health care sector, but within the
entire United States and globally, for that matter, as it relates to the ISO,
and being a founding member of such.

It is working, ANSI is working, with its current health care informatics
standards board to raise the collaboration coordination to a new level. I am
going to stop there, at the moment.

ANSI is the pathway that all United States based standards organizations
need to go through to participate in the international standards community,
ISO.

As steward of the U.S. standards strategy, ANSI will continue to respond to
both public and private sector standards coordination needs as they arise.

We have kind of — just one note on the RFP. ANSI has kind of taken the
approach that, regardless of who wins any of the RFPs, at the end of the day,
ANSI is still the body responsible for coordination of standards within the
United States. So, as such, it will have to be able to work with whoever wins.

MR. COHN: Thank you all very much. I think it was a very interesting set of
presentations.

Agenda Item: Questions and Discussion.

MR. COHN: Obviously, it is time for questions and discussions. I guess I
wanted just to ask, just to start off, and this is probably more of a request
for something coming back to us as a document.

I think Audrey is probably the one to ask on this one, but I noticed Gary
sort of gave us a list of U.S. standards that had become ISO standards. I am
not sure if that was a complete list or just some examples.

I think it would be useful for us to receive something where we could
actually see U.S. standards that had been approved, as well as other standards
that were not U.S. standards that had been approved, this sort of issue in the
pipeline, so that we could sort of review that. If that is something you could
provide us, it would be very useful.

MS. DICKERSON: Yes, I can provide that.

MR. COHN: I don’t mean the 100-page version. I was thinking of a page or
two letter to sort of help us with that. Thank you.

MS. DICKERSON: There are quite some interesting standards that are making
their way through now. One, of course, is the European EHR document. That is
being balloted for the second time.

There are two draft documents now on the table for identification. Then
there are, of course, all the messaging standards, the clinical genomics one
that I mentioned, that we are looking for a U.S. expert for.

There are no standards currently in the clinical genomics area, and this,
of course, would be for hypertext mark up language.

Then, of course, there are all the security documents, PKI and a group of
them. So, there are a lot of things going through the international area.

MR. COHN: If you would reflect in the note about things that are sort of in
process, that would also be useful.

MR. STEINDEL: this isn’t a question, Simon, This is just a comment on the
very nice presentations, and timely.

I got the sense there was a specific recommendation and a general
recommendation. The first was an HHS representative to ANSI.

Right now, HHS functions through an FDA representative to ANSI, and it
would be very nice if that was formalized at the department level. That is just
a comment on that recommendation that was made.

Second, there was an undercurrent — I don’t think it was a specific
statement, but very clear that there was a feeling that the federal agencies
should be more involved with the international standards setting process.

I will say, from my point of view at CDC, I have difficulty getting the
agency involved with international standards setting, unless there is a clear
statement from the department that we be involved.

So, it would be useful if the committee felt we should go in that
direction, for a recommendation to go forward. So, I thank you for both of
those.

MR. COHN: Michael, is this on this issue, or a different issue?

MR. FITZMAURICE: It is on the testimony.

MR. COHN: What I was just going to say that that issue, I would actually
look to our standards and security subcommittee to come back with some thoughts
on that, and that may be a subject for a letter or whatever. I am just kind of
looking to our co-chairs here, to refer that as an agenda item for them to
consider.

MR. FITZMAURICE: I have a short question for each of you. For Gary, I am
not sure that you mentioned — maybe you did and it just slipped me by — that
unlike the United States have laws that they must follow ISO standards. Could
you name a couple of those countries? I don’t mean this to be a test or
anything.

MR. DICKINSON: I am not sure. Audrey referred to Germany.

MR. FITZMAURICE: I think one of them is Japan, and I think the European
countries have to follow things that have been ratified by SIN and SIN and ISO
have virtually the same standards.

MS. DICKERSON: There is the agreement. It took me a while, when they say
the VA agreement, I automatically think Veterans Administration, but in ISO
language, the VA agreement is the Vienna Agreement that says all European
standards and ISO standards that are developed in the same space are just
balloted once.

Then they are written, not because ISO says they have to be, but because
each of the countries takes the standards and then writes them into laws.

MR. FITZMAURICE: So, international standards certainly are important for
them, and probably becoming more important for us as they get more and more
into the health domain.

Audrey, you mentioned that China was a growing country, and that that is
one of the reasons why the United States should be involved in the ISO
standards, among many other reasons.

Has China expressed interest in, or does China currently participate in,
any of the ISO technical committees, and have they expressed any interest in
the health technical committee?

MS. DICKERSON: China is currently a member of ISO TC 215. We have two
levels of membership. We have the participating level, of which there are 24
countries, and we have the observing members, which are 16.

In order to change from observer to participator, all they have to do is
send a letter. China is currently an observer, and they are considering
becoming a participating member.

They have recently opened their own China informatics institute for
standards, and part of that is their health standards. So, they are really
moving far.

In addition to that, ISO is part of a group called MOUMG, which is the
memorandum of understanding management group.

ISO is a part of that, along with the International Technical Union, IEC,
and the UNECE, which is the commission for Europe.

The four of them together form a group for business process and health. TC
215 has a seat at that table. The next meeting is in Bejing.

MR. FITZMAURICE: Point well taken. A question for you, Bob. It was an
outstanding primer that you gave. You gave a history of standards that I didn’t
know about, and I have been involved in them for quite a while.

From all of you, I have learned a lot of things that I didn’t know before.
Maybe I should have, but I just didn’t.

You mentioned, in talking about one of your slides on HISB accomplishments
on the common approach to coordination and conflict resolution, you mentioned
something about a new protocol, I think.

I am not sure if you mentioned the word teeth or not, and then later on,
when you were talking about a summary you sid there are some discussions with
ANSI.

I am not sure if you said you couldn’t talk about them, or they hadn’t been
resolved. Is there something changing in the methods by which the Health
Informatics Standards Board coordinates across the standards bodies?

MR. OWENS: I think you are asking two questions. On the first question, the
protocol, yes, there is a protocol.

What we did, we basically worked with the SDOs and, in fact, we created a
work group of the SDOs and other interested parties to develop their criteria
under which they would like to be, I guess, governed, managed, relative to
standards conflict issues, including the appeals process and all of that.

Until, frankly, the RFP let, we had the protocol. All the SDOs agreed to be
governed by it and, in fact, we actually used that protocol for three instances
within health care, and actually ANSI adopted that same protocol to deal with
the telecommunications issue in another instance.

So, it is tried by fire that it works. Recently, ANSI said, well, since the
SDOs had all signed up on it at once, or under that protocol, that we could, in
fact, give it teeth and actually look to the board to be the arbitrator, if you
will, in using that protocol toward a decision, if necessary.

Again, today, the three or four issues that have been brought up within the
health care informatics standards board have been resolved in using that
protocol, but obviously there is still duplication in the industry. So, a lot
more of that type of thing needs to occur.

In terms of the second question, where do we go from here, obviously the
RFP is a statement that more than ANSi members need to be at the table, and
moving the health care industry forward.

This is where I look at it as basically everyone, for whatever reason in
the health care community, has seen the need to create their own sand boxes.

I think the RFP process, and what Dr. Brailer’s office is, in fact,
challenging us all to do, is to rethink the notion of, we all need our own
sandbox, and create one big one in which we all can work.

ANSI is basically the coordinating entity for all other sectors of the
United States for that very purpose. So, it would only stand to reason that
they would look at what they need to do to make that happen.

As I said earlier, the difference between a B and a P is that boards
typically require ANSI membership under the ANSI charter, and panel members do
not.

So, we are looking at what kind of an organizational structure would be
necessary in the health care space to, in fact, make coordination happen,
regardless of who wins the RFP.

MR. COHN: Thank you very much. Paul, I think we will have a final question
and then we will wrap up after this.

I am just reminded that, obviously, as part of the charge and charter of
the NCVHS, the international standards and international issues do fall into
all of this. So, I would remind subcommittees that this really is an area that
we are concerned, and want to make sure is successful. Paul, last question and
then we will wrap up.

MR. TANG: Thanks for your presentation. It was very clear and helpful, and
it is very clear from the whole community now that the need for standards is
there, and what SDOs and the accrediting bodies and organizing bodies
contribute to that.

Drawing an analogy, let’s say, as people need YFI standards, or other
standards about plug and play, it is really vendors getting together to make
that happen so that it is transparent to the consumer.

In some sense, that is sort of the way it has been for health care with the
messaging standards, because it really doesn’t matter to the doctor or the
nurse or whoever is using the system, how the information gets from one place
to another.

As you move to the realm of functionality, in particular in the clinical
space, it seems like you really need clinicians participating in a real way. I
think that is part of what Gary is saying in terms of the requirements and
specifications.

How do we get from the people involved in these standards development
processes intimately. You observed that there is enough end user, clinician,
participation in the process.

One limitation, of course, is the travel money, but the other is they are
just involved in their practice. What other ideas do you have for pulling in
these folks to get really vetted both the functional requirements as well as
the work flow, which is so critical to making it accepted?

MR. OWENS: To my last statement, I think that is really what we are looking
at. There are associations — the American Medical Association, American Dental
Association, American Association of Cardiology — all of these folks represent
a constituency.

So, that is expertise that you want at the table. Not all of them are
perhaps ANSI members or care to be ANSI members.

So, in order to get the input, we need to look at — or ANSI is, in fact,
looking at — what opportunities do we have to change, or what is it that we
have to change in perhaps an organizational governance structure to allow those
to come to the table.

The other side of that is, not only do you want to make sure that it is
truly provider driven. You want to make sure it is consensus provider driven,
because you don’t want any one provider coming in to the table representing how
they do it in their particular practice or institution, and have that become
the way for the entire United States.

So, I think it is about balance. I think it is about looking at morphing an
organization within health care that, again, gets rid of the multiple sand
boxes, and forces all the constituencies to work together in a single sand box,
toward a common solution that works for all.

MR. TANG: Can I follow up a little bit?

MR. COHN: Briefly.

MR. TANG: The challenge is, we have heard about the need for global
standards. You can’t get the provider — I am not sure association
representatives necessarily will infuse the information — I know you agree
with that.

How do we take the process to them? One of the ways that we used for the
HL7 draft standard approach was to actually do the regional bus trip, to try to
get more information from the field.

Maybe there is — maybe the question is, are you thinking about ways of
getting to them, rather than actually holding it in international places, which
makes it completely inaccessible.

MR. OWENS: I think what we are looking at, if you look at what the industry
is basically asking or being required to respond to, is come up with an
approach that determines your requirements, that determines specific use cases,
that determines specific standards gaps and analyses that are tested and vetted
amongst a great constituency.

You look at the culmination of all of that effort toward an outcome that
vendors can take and implement. At the end of the day, a particular provider
will probably rely heavily on their particular information system vendor to
give them what they need to do what it is they need to do to practice.

I think working collectively in that broader scope of activity, which
really does go beyond true traditional standards development into a whole use
case, and into a whole testing and methodology, that that whole group of stuff,
if you will, culminates into an information system that, through tried and true
efforts, the grass roots practitioner can provide their input like they would
in any other type of a user group, through a system vendor, and hopefully that
information would continue to bubble up through the system.

MR. COHN: Thank you all. I think we need to wrap up at this point, and I
want to thank you all for some very interesting presentations.

As I said, I don’t feel this is the end of the conversation, but really the
beginning of it. Audrey, I will look forward to getting a document from you
which I can share with the rest of the committee.

Obviously, a piece of this is clearly an item for the standards and
security subcommittee, to come back with some thinking to the full committee,
but I do want to thank the three of you for some really very interesting
discussions.

Now, what we are going to do is transition to I think our final presenter
of the day. Dan Friedman, I have seen you sitting over there. Is your stuff on
the computer, do you need to load it on, or do you have anything?

Anyway, we are very pleased to have Dan Friedman come and join us. What I
am going to suggest is that we have this presentation and then we will take
another 10 minute break and then we will go into our last session, once again,
finishing at 1:15.

Dan, obviously, I want to thank you for coming and joining us. You can tell
that I am incredulous that you don’t have power point. I have become so
dependent on them, that it is hard to imagine giving a presentation with them.

We want to thank you for joining us. As everyone knows, Dan is a former
member of the NCVHS and actually was the lead on the 21st Century vision of
statistics.

I think we also commented — and Marjorie, yesterday, actually wore an
outfit that went with the cover of the new book that you have, I think, been
editor of. So, once again, I want to congratulate you on that.

Obviously, when I talked to Dan a while ago, I had heard he was doing some
work for NCHS looking at health information infrastructures in other countries,
and that there may be some learnings for us around all of that.

I don’t think this is the end of the conversation on this particular topic,
but I wanted him to come today to at least introduce the topic and get us
thinking about it. So, Dan, thank you for coming.

Agenda Item: Health Statistics and National Health
Information Infrastructure.

MR. FRIEDMAN: Thank you, Simon. Before I get started, what time do you want
me to end, or what time do you want the discussion to end, Simon?

MR. COHN: I would think 12:10?

MR. FRIEDMAN: Okay, good. What I am going to be doing is providing you with
a status report on a project that is currently in process on the relationship
of health statistics to national health information infrastructures.

I am using the phrase national health information infrastructures
advisedly, and I am using it as Dr. Brailer has suggested, with a small n,
small h, and two small is.

I am going to start by making a few preliminary remarks, then talk about
the purpose of the project, a few words on background and methods, and outline
of the final report, and then provide you with a little bit of current status
information in terms of nation snapshots on the relationships between health
statistics and national health information infrastructures, and then some
discussion of some very basic analytic issues.

What I am going to try to do, Simon, is talk for probably around half an
hour, or until either you raise your hand and say this is excruciatingly
boring, or until I lose my voice.

Preliminary thought, first of all, thanks for the invitation to come today.
The work that I am going to be presenting, as I will make clear in a couple of
minutes, is very much an outgrowth of work that was conducted here at the
committee, both an outgrowth of the work that was conducted by the NHII work
group, as well as the joint NCVHS NCHS HHS data council work group, dear
departed work group, on developing a health statistics vision for the 21st
Century.

When I was a member of the committee, I was really privileged to work with
Simon and Jeff and Don Detmer, John Lumpkin, Barbara, Paul Newacheck, as well
as certainly Debbie Jackson and Marjorie.

I really appreciated the opportunity to be on the committee and, as I said,
I appreciate the opportunity to be here today.

I also should mention that Ed Sondik came to the committee, I think it was
in 1997 or 1998, with the idea and the request that ultimately became the
project for developing a vision for health statistics for the 21st Century, and
Ed also is essentially the sponsor of this current project.

Then, in addition, my final thanks go to my friend, Steve Steindel, as well
as Dave Ross, of the Public Health Informatics Institute, both of whom have
been extremely generous with their time, their insights, and their support as I
have tried to wend my way through this somewhat overwhelming project, as,
indeed, has my friend and constant collaborator, Ed Hunter.

As I said, this is a work in process and I am here today seeking your
reactions, comments and suggestions. I am especially interested in some
discussion of terminological and conceptual issues that I am going to be
pinpointing.

I should also indicate, for most of you who don’t know me, that I am not an
informatician. I am not a medical informatician, I am not a public health
informatician. I am a public health information content guy, with all of the
advantages and disadvantages of that.

In conducting this project, at times, I have often felt a little bit like a
stranger in a strange land, and partially, as a result, in writing the final
report, which I am doing now, I have been doing what I think of as defensive
research and defensive writing, which means that the report is about half done
and it already has over 100 pages of text, 30 pages of references, 15 pages of
tables and figures, et cetera, et cetera, which is what one does when one is
really unsure of whether or not you know enough.

The overall purpose of the project is to develop a more specific assessment
of the potential contribution of NHIIs, and especially sharable and shared
electronic health records to health statistics.

The specific purposes include describing the current status of national
strategies for shared EHRS in Australia, Canada, England and New Zealand,
especially as they relate to health statistics.

Second, to summarize key themes relating to the potential of shared
electronic health records for health statistics and barriers to achieving that
potential that emerged during interviews with key informants in those four
countries.

Third, to summarize key themes emerging from key informant interviews in
the United States. Fourth, delineate major analytic issues and the relationship
between shared EHRs and health statistics. The fifth, to propose a brief set of
next steps for the United States.

Background, as I said, this project is a direct outgrowth of two previous
NCVHS activities, the work group on national health information infrastructure
that, in November 2001, issued its report on information for health, which I am
now holding up. It is an attractive light blue color.

In that, and on the cover, there was this basic graphic. In any case, on
the cover is a graphic of three intersecting circles. One of those circles is
the health care provider dimension, another the personal health dimension, and
the third, the population health dimension.

In the report, we described that graphic as a means for conceptualizing the
capture, storage, communication, processing and presentation of information. In
other words, data sources, data collection, data streams, data analysis and
data dissemination.

In the report of the next year, on shaping a health statistics vision for
the 21st Century, we tried to build on the NHII final report.

In that report, in the health statistics vision report, we stressed the
themes of, collect data once, use it many times, re-purposing data, and
consolidating data streams, and those themes were also expanded upon in the
book that I understand Ed Sondik and Marjorie were hawking yesterday.

The project can also be seen in the context of the July 2004 framework for
strategic action both for improving population health strategy to streamlining
quality and health status monitoring, as well as Dr. Brailer’s January 2005
letter to the committee.

Underlying the project purposes is really the question of whether the basic
vision of collect once, use many times, and re-purposing of data is possible
and, if it is possible, is it feasible.

Can, in fact, we consolidate data streams within public health? Can we
consolidate data streams for clinical care, population health and personal
health.

Is it possible? Is it feasible? Is it a process of endless striving for an
unattainable goal, or is it a reasonable expectation for a reasonable and
achievable product.

As Dave Garretts of Healthlink has indicated, we need to focus on both the
completeness of the vision as well as our ability to execute the vision.

Some of you may have heard this story, and I apologize. My mother was a
public health pediatrician, who was in her early 90s when I was on the
committee and working on the health statistics vision process.

She never worked for CDC, but she was always a big booster of CDC. I used
to talk to her about the work, and I explained that I was going to CDC to do a
presentation. Ed Sondik and I were going to do a presentation on the health
statistics vision process.

Her parting words to me at the time were something to the effect of, well,
dear, I hope that Dr. Copeland enjoys your hallucinations.

That really was at the nut of it, and is at the nut of it. In Australia,
the key informants that I talked to described the notion of collect once, use
many times, re-purposing, replacement of population health data streams with
data from a shared EHR as nirvana, and that was not said in a complimentary
way. It was said with the connotation of an unattainable idea.

In New Zealand, it was described by some of the people I spoke with — only
some — as the holy grail, again, as an unattainable ideal.

In the United States some of the people — certainly not all that I spoke
to — described it as science fiction.

Terminological issues. As I said, Dr. Brailer has termed NHII a term of art
and, as I have gotten more and more into this project, I have grown sympathetic
to that characterization.

What I am really focusing on is national strategies for shared and
shareable electronic health records, and elements that support them, with EHRs
defined here as longitudinal, hopefully cradle to grave, collection of
patient-centric identifiable data that are cross provider and cross sector
within health care, not necessarily the desk top record, and not necessarily a
single record kept in a single location.

This really draws upon the National Health Service definition way back in
1998 of electronic health record, where they distinguish between the electronic
patient record and the electronic health record.

It also draws upon the ISO TC 215 drafts of definition, scope and context
of an integrated care EHR, where they really try to separate the notion of the
EHR as a repository from the notion of the EHR as a system.

Health statistics we defined as numerical data that characterized the
health of the population and the influences that affect its health.

Methods, as I said, there are four countries plus the United States, where
I have been doing my research. All of the research, I should add, has been done
over the phone and in the comfort of my home basement office. So, this has not
been in any way a junket.

The research has been of two different types of work. One is materials
review, where I have reviewed just pounds and pounds of government and other
reports, web sites, presentations, and articles in peer reviewed and trade
journals.

At last count — and I am not trying to do a complete census. There are
probably at least 30 internet based journals that have sprung up since 2000,
many of which are country specific, that deal with e health and related issues.
It is quite remarkable and quite overwhelming.

Then, the second, in addition to materials review, has been a series of key
informant interviews. These were initially funded only for the United States,
but I rapidly learned that it is absolutely essential to talk to people in
order to be able to separate out the brochure-ware aspect of government reports
from, in fact, what is going on.

As one person I spoke to in England said, the NHS reports, he described as
being useful for pushing the agenda and the time frame, rather than as actual
documentation of expectations of achievement, or actual documentation of actual
achievement.

This was really brought home to me when I spoke with one person in
Australia, who was a national level population health information content guy,
very knowledgeable about what was going on in the United States and other
countries.

He was talking to me in a very complimentary way about what was going on
here in the United States. I mean, he was just glowing in his praise.

He said something to the effect of, you really have it knocked in the
United States. You have got the vision and you are implementing the vision.

I said something like, could you expand on that. He said, sure. There is
this report, and it shows this diagram of three intersecting circles, and it
shows that population health data and clinical data and personal health data
are all one and the same, and that is what you are doing there, and I wish we
could do it in Australia.

That really brought home to me how little one can tell in terms of what is
actually going on from reading government reports.

I have interviewed around 100 people, including 16 in Australia, 18 in
Canada, 20 in England, about a dozen in New Zealand, and about 30 in the United
States.

These have all been informational interviews. They are unstructured and
largely informal. They have been tailored to each respondent.

If I were starting all over again, I would do it a little bit differently.
I did have some basic issues that I tried to cover with everybody.

The types of respondents included people at the national level with
responsibilities for population health monitoring and research/health
statistics, as well as people at the national level for the development of
shared EHR agendas, and people at the sub-national level with similar
responsibilities, as well as people with clinical and particularly clinical
informatics responsibilities.

The final report is in process, as I mentioned, and in it I am going to try
to very briefly put the development of national health information
infrastructures into a health system context, because that is something that we
typically ignore or just sort of assume, but I think is very important. It is
not going to be a full discussion.

Then I will be providing the nation specific snapshots and, since the
nation specific snapshot chapter is already 60 to 70 pages, I need to think of
another word to substitute for snapshot.

In there, I am going to be describing the locus of national
responsibilities for shared EHRs, current status and plans, EHR definition,
country specific, NHII elements related to shared EHRs, EHR storage, patient
and provider participation, patient identification, and uses for population
health monitoring and research.

Then there will be a chapter on key themes from the four country
interviews, key themes from the United States, and analytic issues.

What I am going to try to do is spend five minutes, maybe 10 minutes, and
see how far I can get with some information about my assessment of what is
going on in the four countries, and then I am going to wrap up with a quick
discussion of some analytic issues.

Why don’t I — Simon, you are the chair. Australia, Canada, New Zealand and
England. I definitely want to spend a few minutes on England. Why don’t you
choose another country.

MR. JAMES SCANLON: Why don’t we start with England, actually. Everyone
thinks they are the furthest ahead.

MR. FRIEDMAN: All right, so I am going to start with England, and then I am
going to circle back around and I can come back to Canada.

MR. COHN: That sounds fine, and then I do want to, at the end — I am sort
of getting from your presentation that you are obviously in the midst of
writing this also.

So, I do want to also offer up the option — I think what you are saying is
fascinating, even if you aren’t using power points, and we may very well want
to have you come back for sort of an update in September or November. So, you
don’t have to feel that you have to cover the whole world.

MR. FRIEDMAN: I would be glad to come back and, frankly, one of the reasons
— and I perseverated over this with Marjorie and Debbie and Hunter — one of
the reasons I decided not to use power point is that I really didn’t want to
have these comments memorialized on the internet.

That was really brought home to me when — I don’t know how many of you
know Dennis Prodie’s work from the University of Victoria, but he has done a
lot of review work on the status of implementation in England, and he does
terrific work, as well as in other countries.

In my spending hours of going through the web finding material, I came
across a power point presentation that he did at the Leeds Football Club on
EHRs in England.

I said to myself, if a presentation at the Leeds United Football Club is
memorialized — okay, so, England. England really does stand alone in terms of
its conceptualizations and its activities relating to the use of shared
electronic health records to health statistics.

Currently, the locus of national responsibilities lies in a government
agency which is important, because this is not true in all four of the
countries, called Connecting for Health.

Connecting for Health was created in March. This is also important, because
what I am dealing with is — it is like trying to pin jello to the barn wall,
and not just in England, but in several of these countries.

The actors and the bureaucratic actors change with amazing rapidity.
Connecting for Health is a re-branding of the NHS information authority, and
the national program for information technology, and it sits within the
national health service.

The basic vision of shared EHRs in England has been laid out in an
iterative series of documents, just beautifully written documents.

You can start at almost any point. I like to start with their information
for health document — yes, called the same thing as connecting for health —
that was published in 1998.

In 2001, building the information core report, 2002, delivering 21st
Century IT support for the NHS, 2004, making IT happen, 2005, creating a
patient lead NHS.

All of these documents reflect the notions of achieving a joined up system
of more integrated care, supported by patient-centric electronic health
records, which would yield improved measurement of NHS trusts — NHS hospital
trusts, NHS primary care trusts.

The EHR definition, the National Health Service, in 1998, made a basic
definition between electronic patient record and electronic health record.

At that time, the EPR was regarded as a transformation of current paper
organizational records, in other words, what I think of as the desk top record.
EPRs are now being developed through regional contractors in five regions
within England.

The EHR, the initial concept was of a summary of care encounters and
clinical events held on a national data repository available wherever and
whenever it is needed, including personal health information, demographic data,
and the NHS number.

Together with the electronic patient record, the EHR would constitute an
over-arching NHS care record and, at some point, it was called the integrated
care record.

In other words, a cradle to grave NHS care record for each patient, which
would transcend traditional care boundaries.

EHR storage would be at both national and local levels. Centrally, the
spines, the personal spine information service and the personal demographics
information service, and also centrally a relatively new development, the
secondary uses service.

The purpose of the secondary uses service is to provide timely
pseudo-anonymized patient-based data and information for purposes other than
direct care.

Then locally data will also be retained for the purposes of direct patient
care, at the GP level and probably at the strategic health level and PCT level
as well.

Patient and provider consent. The issues around patient and provider
consent have really been somewhat confusing in England and, at least to me,
continue to be confusing.

The initial conceptualization was that physicians were required to collect
data and put it in the EPR. However, patients could designate a sealed envelope
for identified data.

Having said that, sealed envelope means masking of data. Patients could
elect to mask data. Having said that, there has been a lot of disagreement
about just what this means.

Last month, there was — Lord Warner put out something called the NHS care
record guarantee, that was intended to clarify just what the NHS was promising
to patients around privacy of electronic data.

This was issued, and it is a very clear document and, right after it was
issued, the director of the care records development board, Sir Cyril Chandler,
said, well, there are several issues that have not been taken care of in the
NHS care record guarantee, such as, what goes on the summary record and what
options do patients have to control what data are recorded.

So, there you have it. England obviously has a national patient identifier,
which they spent a lot of money and time cleaning up around 10 years ago. Of
the four countries, England is only one of two countries that has a national
identifier, and the national identifier is now introduced at birth.

Uses for population health monitoring and research. Starting in 1998,
England introduced something called an integrated model for information, in
which EPRs and EHRs were intended to feed analyses for public health.

The site evaluations, the electronic record site evaluations, that were
conducted over the last half dozen years revealed the possible utility of
linked EPRs for population health.

The early conceptualizations included the development of a population
record for each individual, and the NHS developed a detailed strategic outline
case for a population record several years ago, in 2003.

Now the responsibilities for secondary uses, which means population health
monitoring and research, as well as other non-clinical uses of EPRs and EHRs,
reside in the secondary uses service.

The secondary uses service is actually not part of the NHS. It is part of a
brand new health and social care information center.

The SUS, as it is referred to, is intended to be a central repository for
health data for secondary uses. Most data would be collected or derived from
clinical systems as a byproduct of direct care.

It would provide patient based data and information for purposes other than
direct clinical care, and it would transform and pseudo-anonymize data from the
spine.

The SUS also — and it is starting with bringing together other data
collections, and right now that is what it is really concentrating on, is
bringing together, in one spot, the substantial range of data collections that
exist, as they exist in the United States, but exist also in England to support
a real complex of standards, quality requirements, criteria, targets and bench
marks, developed by the Department of Health and the NHS.

Let me just spend a couple of minutes on Canada, and then I am going to
move on to some analytic issues. In Canada, the locus of national
responsibility for shared EHRs lies in Canada Health Infoway, which is a Crown
corporation, and I think of that as essentially — in England, I think it would
be called an arm’s length body. Here we would probably think of it as a
quasi-governmental corporation.

The Canada Health Infoway is accountable to the 14 federal, provincial and
territorial governments. Its mission is to accelerate development and adoption
of electronic health records systems, to provide leadership, and to act as a
strategic investor.

In other words, it sinks money into projects, into highly defined streams
of projects. It is not an implementer.

The Infoway laid out the basic vision for an interoperable EHR framework in
its July 2003 EHRS blueprint. That is due to be revised in fall 2005, and my
goal is to finish my report, so I don’t have to revise the report.

The EHR is defined in that as a lifelong, longitudinal record of clinical
data. It will accumulate and keep clinical information about an individual
health record from womb to tomb.

It is not an operational data store, and is never the source for creative
clinical data. It is not one system, but rather, an interoperable network of
peer to peer related infrastructures.

EHR storage will include an EHR data base, including client-centric
longitudinal data belonging to multiple clinical domains, as well as storage of
individual clinical domains, without overlap between the two.

In addition, there has been described a cross jurisdictional — with
jurisdictions meaning provinces, territories and, within provinces, regional
health authorities — public health, cross jurisdictional public health data
base for surveillance purposes.

The specifics of patient and provider participation remains to be defined.
They are talking about a masking approach, similar to the sealed envelope
approach in England.

There is no unique patient identifier, national patient identifier, in
Canada, and Infoway is investing quite heavily in the development of patient
registers at the provincial and sub-provincial level.

Various advisory commissions and workshops have recognized the potential of
shared EHRs in Canada for population health monitoring and research.

Now, at the same time, the Infoway investment brief — and they are very
explicit about this — is clinical and technological. It is not public health.
It is not population health.

Public health was added. A public health investment line for communicable
disease surveillance was added in late 2004 as a direct response to SARS, and
it is really limited to SARS.

When interviewed, one of the people interviewed in a newspaper said that he
did not foresee electronic records feeding the communicable disease
surveillance data base at this point.

So, that is where Canada stands. Australia and New Zealand present some
interesting contrasts to both. Let me just spend a few minutes on some analytic
issues.

First, let me turn to some definitions. As I mentioned, health statistics
we can define as numerical data that characterizes the health of the
populations and the influences that affect its health.

This means three things. You need a numerator, you need a denominator, and
you need a connection between the numerator and the denominator.

Now, in health statistics, the denominator rules and, as Dr. Brailer said,
it is the tyranny of the denominator. In health statistics, it really is.
Having the numerator alone, having numerator data alone for health statistics
is useless.

We can divide very crudely — and I am not particularly satisfied with my
division of the issues, but some of the analytic issues in terms of numerator,
denominator and over-arching issues.

Numerator issues include EHR penetration in a particular country, EHR
penetration into primary care, specialty care, acute care, extended care, et
cetera, numerator quality, numerator data completeness.

Here, we are talking again about EHR data, EPR, and collection of data for
secondary uses, and the extent to which it fits into the clinical work flow.

Certainly, the most consistent thing I have heard in the four countries has
been that, if you are going to be collecting additional data for secondary uses
— and secondary uses always means public health, population health as well as
other things, that is always a secondary use, it is never a primary use —
there has to be either pay back for the additional clinical effort for the data
collection, for the care of individual patients, for an individual patient, or
total transparency in the data collection, and there is some work going on in
New Zealand that seems to be achieving that, or requirement for payment as
there is, in fact, in the NHS.

Denominator issues includes patient concept, and patient consent can occur
at the event level, encounter level, condition or disease level, provider
level, or even the transmission of data level, EHR penetration, unique personal
identification, data quality with a denominator, and having known denominator
characteristics.

Now, even if all those numerator and denominator issues were met and were
solved, it doesn’t mean that sharable and shared EHRs would still have any
utility at all for health statistics.

First of all, population health is not equivalent to health care and, just
as health care is only one influence on population health, so much of health
statistics derive from data that are collected outside of health care settings.
This is especially true for, obviously, population based surveys.

Second, analysis, a second over-arching issues, it is not really clear how
health statistics would work with shared EHRs, and whether or not we have the
analytic tools to cull data from shared EHRs.

It is necessary to move beyond what one key informant here in the United
States called the rural electrification model, by which he meant just shipping
data to public health departments is not nearly enough.

At a national level, even in a much smaller country, such as England,
annual EHRs would include billions, billions of health events, prescriptions,
orders, lab tests, test results, et cetera, et cetera.

That leads to obviously the structure issue, and the extent to which the
EHRs are structured, and whether or not the clinical standards and terminology
can be used to derive needed data for health statistics.

Finally, culture changes. Clearly, culture changes would be needed by
health care practitioners. As one person I spoke with in England pointed out —
and this guy was a clinician as well as an informatician — he said that the
data that is used, that is kept in the spine, would be useful to me for maybe
one out of 1,000 patients.

My jaw, from across the Atlantic, really dropped, but this is a point that
was made to me repeatedly. Health care is local, provision of care is local,
and shareable and shared EHR schemes are regional and national.

For a lot of doctors, from what I am hearing, the utility is not
necessarily clear. Culture change by public health in terms of how we analyze
the data, and whether or not we can develop the fully automated relationships
between shared EHRs and the abstraction level, and cultural changes in terms of
the population in terms of acceptance of use of what is initially clinical data
for non-clinical purposes.

That consent issue is being handled very differently in different
countries. In short, there are clearly going to be some transformative limits
of shareable and shared EHRs for health statistics, and we really need to parse
the questions in terms of what are we talking about, with much more
specificity.

I need to parse the questions in terms of supplementing current data, what
kind of data, reports and registry data, survey data, administrative health
data, complementary data.

Are we talking about linking with current data on an ongoing basis? Are we
talking about replacing current data collections. Are we talking about shared
EHRs as a source for entirely new data collections.

MR. COHN: Dan, thank you. I think it is very timely, given that I know
standards and security is being talked about from more of a low level, this
issue of derivative data.

I know populations has finally finished their long-awaited population
report. I think this is useful to it. I know quality is also having similar
issues about how to sort of make use of the new infrastructure coming forward.

Obviously, I feel I have gotten a piece of your vision as opposed to the
whole thing, but we need to talk about how we get a little bit more of that
vision. Questions?

MR. HUFF: I was just going to echo that comment, that we have just started
discussion of sort of a topic that is very — I mean, this is a great
introduction to, which is exactly this issue of, can we recognize a vision of
collecting data in a structured, standardized awy, and then use that data for
lots of other things, where we can algorithmically bill for services based on
the documentation.

Your focus was on use for population statistics and some other things, but
for research, for post-market surveillance of clinical trials, this is one
color in a large spectrum of this, and we are just starting this discussion.

So, this was a wonderful introduction to that, and I look forward to
hearing more later as well, as you formalize and write this up.

MR. FRIEDMAN: Thank you, and I very much appreciate that. There is a guy in
England named Hugh Sanderson, who wrote what is probably the only article on
this topic, which was a BMJ article in 2004, based on one of the IRDIP(?)
trials.

Sanderson — I am sure he wouldn’t mind my saying this — he said to me
that this is a completely under-researched area.

It is really true. I mean, it is just remarkable to me, how little has gone
on in this area and then, of course, how little has actually appeared in
journals.

MS. CARR: Thank you for a great presentation. I am struck by your comment
that a practitioner believes that one in 1,000 patients will benefit by the
availability of shared electronic health record. Am I saying that correctly?

MR. FRIEDMAN: He was referring specifically to what is called the personal
spine information service, which is the national level abstraction.

There would also be data that would be shared — this is what I think of,
in my very crude way, as from the desk top record, at a local level. So, he was
referring to the national information.

MS. CARR: It raises a question which has been going through my mind over
yesterday and today, which is that each presentation that we hear about this
begins with the assumption that electronic health record has quality.

We, in the quality group, have been trying to define that, and I think that
there are obvious quality elements — safety, transcription error prevention,
cross checking of medications and so on.

Have you thought about it from the opposite way? You are thinking about the
elements that will be available to build the story, but I wonder, do we need to
think about, what are the dimensions of quality that the electronic health
record can serve, being more specific?

In other words, if we want to say we are going to make patients safer, and
then we get that domain of all the things that can be safe, that seems easier
with electronic health records.

Then, as you get to higher levels, higher goals, you know, doing that cross
walk of what is it going to take to get a different kind of quality or another
dimension of quality, I am just interested in your thoughts on that.

MR. FRIEDMAN: I am keenly aware of being in a room with a lot of folks who
know a lot more about electronic health records and electronic patient records
than I do, meaning this room.

Having said that, my sense is from this, really, 50,000 foot, 100,000 foot
look at what is going on in the different countries, not that England has the
answers — and of course in England they say, oh, why doesn’t the United States
just do what the VA is doing, why don’t you do exactly the same thing — but
there, the extent of the thinking on these issues is much more — on that
particular issue, certainly — is much more developed than in the other three
countries that I looked at, partially because of the nature of contracting and
reimbursement, where it is built into the general medical services contract. I
don’t know if that is helpful or not.

MR. LOCALIO: Dan, I enjoyed your refreshing presentation. I want to preface
my question by a story. About six or seven years ago, I was working on a study.
I was the statistician, and it involved whether primary care practices in
Philadelphia had, among other things, ways in which patients could call in and
leave a message after hours.

A couple of the practices had no such facility for calling in after hours,
because both physicians reported that when they bought answering machines for
their phones is, the first thing that happened is somebody broke into the
office and stole the answering machines.

Let me ask you this. We have heard presentations about standards, and did
anybody in your conversations indicate, for example, that maybe standards don’t
help when there are not the basic resources to have an EHR or a PHR because
there is insufficient communications infrastructure, crime — I mean, were
there any barriers like that, that anybody pointed out?

MR. FRIEDMAN: Yes. This was not — at least the folks that I spoke to —
again, this isn’t a scientific sample. Having said that, there was a lot of
skepticism and, making a generalization I am not really comfortable with, the
nature of the skepticism varied somewhat from country to country.

Having said that, to me, one of the things that was really interesting is
that, for example, in New Zealand, which describes itself as a poor first world
country, the emphasis, in a very self conscious way, is on what they call the
coal face of patient care.

With a very — again, this is almost a direct quote from an official at the
New Zealand ministry of health — we don’t have the money to make big mistakes,
so we are going to make lots of little mistakes instead.

It is a very, very sort of micro level notion and, in some ways — there is
a new health information strategy for New Zealand document that should be
hopefully released very soon, but in that document what they are really talking
about is not a big bang EHR structure, but highly targeted national data
collections that would hopefully be transparent to the doc providing the data.

I mean, in terms of standards and whether or not that is a useful
discussion, I don’t think that came up in quite that way, but there was
certainly a lot of discussion about whether there was any potential in terms of
quality of recorded data, whether it is paper records or EPRs, or going from
EPRs to EHRs, whether there would be any potential at all for replacing any of
the current population health data collections.

MR. COHN: Kevin is next. I just want to let everybody know, we have a long
list of people to ask questions. We have got three minutes before we cut off
this question period and take a break. I just want to let everybody know, and I
don’t want you to feel offended, but we will have Dan back, and I think we need
to hear about the other countries.

Once again, this is a wonderful resource and a wonderful conversation, but
I just want to let everybody know sort of the rules here, so no one feels
offended.

MR. VIGILANTE: If somebody has something they feel is really important, I
will defer. Nobody is stepping up. It strikes me that, building on what Stan
was saying, that there is some intermediate level data that, while health care
data is local, research data is national.

Particularly in clinical trials, patient diagnoses, the drugs they are on,
following the laboratory tests for adverse events are definitely things,
certainly, that can be captured from the desk top EHR that would be highly
relevant to capturing at a national level or a trans-regional level for that
kind of health statistic.

I am just wondering if there was any comment or thinking around that. Then
one other point is, if you are not going to use EHRs or comparable technology
to capture communicable disease surveillance, whether natural or intentional,
how else can you do it without having a completely redundant, very expensive,
and labor intensive approach?

MR. FRIEDMAN: There are a couple of responses, one of which is, again,
there is a denominator issue that, somehow or another, we need to deal with.

Communicable disease data are really important for communicable disease
surveillance and case control. Having said that, there is a whole world out
there of population health monitoring that does not include communicable
disease case reports.

I think one of the issues — again, it is a really basic and obvious issue,
and I always feel kind of stupid saying it, but what are you going to do with
the situation in which you have got data coming for one data collection from
one data source, one health care provider, for another data source, from
another health care provider.

That is never a good way of collecting data. That is the way we did it for
years on birth certificates. Some of the hospitals had manual collections, some
of them had automated entry, but it was really not extraction. It was really
just sitting there and key entry.

That is how it is done in a lot of cancer registries now. Some of the data
are collected from hospitals essentially manually, some are extracted and some
are abstracted.

You know, my guess is that, realistically, once we start parsing — which I
am not going to be able to do in this report — what we now think of as
different data sets and different data collection and say, is it high
potential, is it low potential, is it high pay off or low pay off, we are going
to have to start saying to ourselves, well, what are the implications of each,
what we now think of as a data collection if we have 10 percent from an desk
top electronic record. What is the potential if we get 20 percent of those
data, what is the potential if we have 70 or 80, and what does it do to
representativeness and data completeness and quality.

MR. COHN: Dan, I want to thank you for coming and joining us. I once more
apologize to everyone. I chose to include him, knowing that it was going to be
a full schedule, because I wanted everyone to get a taste of this issue.

I know that we need to spend a lot more time on it. We will talk about this
as we schedule September, and I want some of your input as far as really how
much time we need to — I mean, I think we are going to have to go back and
sort of review what he said, and go into the other countries and reflect on all
the different projects that we have going on, because I think there are a lot
of learnings here.

It is wonderful that, rather than grabbing in 20 different country
representatives, or send the quality group for a trip off to Europe or
whatever, this may be as good as we can get.

Now, what we are going to do is take a 15-minute break, and then we will
come and do a last session. We will start again at 12:27 promptly.

[Brief recess.]

MR. COHN: This is our last session. Once again, Dan, thank you for a
wonderful presentation. As I said, we will, I think, be conferring and
hopefully you are available in September.

MS. GREENBERG: We talked about November.

MR. COHN: Is it November? We will figure out, based on the calendars, what
makes the most sense there. Now, in the remaining 45 minutes, what we are
talking about doing is hearing reports from subcommittees and work groups, and
then we will begin to reflect a little bit on agendas for future meetings.

Now, the good news is that we don’t have any action items. Those were all
taken care of yesterday. So, thanks for that. I think, Mark, you had asked to
be up first, if you could.

Agenda Item: Reports from Subcommittees and Work
Groups. Subcommittee on Privacy and Confidentiality.

MR. ROTHSTEIN: Thanks, Simon. On the privacy and confidentiality
subcommittee report, our most important item of business is our upcoming
hearing in San Francisco, which will begin on the afternoon on August 16 after
the executive subcommittee meeting, and continue all day on August 17.

We met yesterday to talk about the agenda for this meeting and, as you
know, this will be the fourth hearing on the NHIN held by the subcommittee on
privacy and confidentiality.

We had originally ear marked this meeting to focus on receiving testimony
from HIT experts, technologists, system designers and the like.

We have changed our focus, and have decided instead that we are now ready
to try to pull together all the many strands of testimony that we have heard
over the last six months.

So, what we have done, the subcommittee has approved five foundational
questions which will be circulated to the subcommittee members tomorrow for
final approval.

Then we will distribute those questions to a broad range of prior and
potential new witnesses that we are putting together, and ask them for input on
these more specific issues.

Many of our witnesses, over the last six months, have had obviously their
own agendas, and had their own views on the NHIN.

Now we want to kind of tie them down a little bit and ask them things that
will be of particular value to us, as we prepare our draft report.

Our plan now is to work on a draft report at our breakout session at the
next full meeting of the NCVHS which will, as you all know, September 8-9, and
definitely have a complete report and recommendations ready for the full
committee at our November meeting.

MR. COHN: I guess I would ask, as part of that, given that you are planning
on coming in with a letter and recommendations in November, I am hoping that
you can sort of think of a session that might help acquaint the full committee
with the issues, and likely — what the deliverables may be at the September
meeting.

MR. ROTHSTEIN: Yes, I think it would be fair to say that we will be
substantially along — I hope we will — at the September meeting, and it might
be a good idea to put sort of on the agenda as just an information only
session, perhaps a half an hour, that we could talk about our process and where
we are, and maybe we could even distribute a draft to talk about, and get the
input of the full committee before we go back.

We can talk about that in San Francisco at the executive committee meeting
and work out a strategy that you think would be best.

MR. COHN: Sure, that makes sense. The only thing I was adding was if you
had a speaker to sort of set the stage or something. We can decide just to do
it as a review and have you talk. I was just sort of opening up the opportunity
for you. I think Russ wanted to ask you a question.

MR. LOCALIO: Mark, would you be willing to circulate the five questions
after you have finalized them, prior to your August meeting, among the entire
committee?

MR.ROTHSTEIN: Absolutely.

MR. COHN: Mark, thank you. Would you like to briefly discuss the
subcommittee on populations?

Agenda item: Subcommittee on Populations.

MS. CARR: Don asked me to just give an update. We did two things. One is,
we reviewed the report and clarified what areas needed additional emphasis, as
was suggested by the committee.

The second was that we turn our focus to the next agenda for the
populations committee. This fell out — well, we basically got everyone’s
input. It fell out in two ways.

One is dissemination education of the report that we just completed, and
what role we might play there. . The second, in terms of new topics, we
identified a couple of areas.

One is, continuing on this theme of linkages for population data, linking
internal and external data as we discussed at the larger meeting, also health
and non-health data, and then within health VA and non-VA health data.

The second area that we focused on was gaps in current health care. Do you
want to say a little bit more about that?

MR. WILLIAM SCANLON: It was the issue that Gene raised yesterday, when it
comes down to, in some respects, basic information about both people’s use of
health services and how it is financed, et cetera, that we at best have
snippets.

We get a picture of this segment and that segment, and actually maybe you
are going to come to denominators in a minute.

It is becoming more profound of an issue as we get a sense of who is using
a service, but we have no idea of the population that might be involved that
should be using a service or potentially ought to use a service. So, we can’t
really assess how well we are doing.

MS. CARR: Then on to identified populations that might need further focus,
we previously talked about mental health, disabilities, the incarcerated, and
children of incarcerated, which Kevin pointed out is a particular group and,
following on from there, what is the impact of those populations, for example,
on communicable diseases, and are we tracking them in the institutions and,
when the prisoners are released, what happens.

We also brought up functional status yet again. I think that it remains a
challenge in terms of definition, available research, and how to approach it.

I think one of the strategies that came forward is that, since we have just
completed a very long and in-depth four year journey with the current
populations report, that we might look for something that has maybe a less
arduous road. So, we will be having a conference call to further discuss the
topics that came up today and yesterday.

MR. COHN: Great, and just to remind you, I think, based on the success of
the quality work group and their hearing just to elicit thoughts on what their
agenda ought to be, certainly that is another tool in addition to a conference
call, to sort of figure out next steps. Agenda development, it is surprising
what you find when you go around and ask. Jeff, do you want to update briefly
on standards and security?

Agenda Item: Subcommittee on Standards and
Security.

MR. BLAIR: Harry Reynolds and I co-chair the subcommittee on standards and
security. We had a meeting this morning where we had to do a little bit of
regrouping because one of the major topics that we were considering for our
July subcommittee meeting is off the table.

I don’t think I need to go into what it is or what the background to that
is. I am just going to go ahead and focus on where we are going from here.

On Tuesday, July 26, and possibly the morning of July 27, we will have our
hearings. They are going to focus on three principle topic areas.

In the morning of the 26th there is an array of topics, and I will go into
them in more detail in a minute. There is an array of topics related to follow
up on our recommendations for e prescribing for last year.

In the afternoon of the 26th, Stan Huff will be taking the lead in
beginning our exploration into capturing information once at the point of care,
clinically specific information for patient care information, and then using
derivatives of that information for clinical research, public health and
reimbursement, major topic.

Then the third major topic area will be an array of things that have been
on our plate, and that we want to look at for September and December hearings.

Now, going back to the first one, because there are a bunch of items
related to that, which would be the morning of the 26th, which is the topics
related to follow up on our e prescribing recommendations of last year.

Those recommendations identified areas of gaps and limitations in e
prescribing standards, and the industry has done a fantastic job in addressing
those limitations and gaps.

There are several of them where they are reporting back to us. I am going
to mention a few of them. One is transferring industry developed transaction
protocols into an ANSI accredited standards. In this case that ANSI accredited
standard will be NCPB script, and that is taking these transaction protocols
for communicating formulary information to the prescribers, for communicating
medication history to the prescribers, for being able to provide information on
sigs — that is the Latin term sigs, not special interest groups — which is
user information for patients, that is what we mean by sigs.

The fourth one would be the status of standards for prior authorization.
So, those would be the four areas that we would be hearing from, probably from
either the standards development organization, NCPDP, but there may be some
others.

Now, in addition to that, in the morning, other related issues related to
this are some related interoperability issues related to e prescribing, and an
update possibly — we want to leave room for this — there may possibly be an
update on the status of federal guidelines, information, related to the pilot
test for e prescribing that begins in 2006. So, we may hear some of that during
the morning.

We may also possibly hear something with respect to the e prescribing MPRM.
So, those are maybes, but we will just have to see, and Maria Freedman will
fold those into the morning agenda, to the degree that we can accommodate them.

Then I have already mentioned that, in the afternoon, Stan Huff will take
the lead on the secondary uses of clinical data.

If we are able to — and it depends on how many folks we can wind up lining
up for these testimonies. We have the possibility of doing all of this during
the day on the 26th, or of having some of this information flow over to the
morning of the 27th, before the NHII work group, then, would begin its agenda.
So, we will try to do them back to back. Any comments or questions?

MR. COHN: Sounds good. Now, given that, I will also just mention briefly
the NHII work group.

Agenda Item: NHII Work Group.

MR. COHN: The NHII work group is actually having a meeting sort of to
follow the standards and security work group.

Whether that starts at the beginning of the morning on the 27th or midday
will be based on their agenda, and we expect that it will be a full day
meeting, whether two half days, or a full day. We will figure that one out.

The work group has been holding a number of hearings on personal health
records and what I would almost really describe as the personal health
dimension of the NHII.

This is really a first letter intended to update the Secretary sort of
about what we have been hearing, issues that we are seeing, knowing that this
is a sort of new area.

I think we have all heard there are a lot of issues around definitional
issues and others, and all of this stuff, which will be brought out in the
letter.

It is the hope of the work group that we will have that first letter for
action at the September meeting. So, once again, this is not the final complete
report, everything that you have ever wanted to know about personal health
records or dimensions, but I think is a statement and update of where we are.
Hopefully, after that, the group will figure out sort of the work plan for the
year.

MR. BLAIR: Can we just check with Harry in case there is anything I left
off?

MR. REYNOLDS: I think that was great.

MR. COHN: Bob, I wanted to let you talk about the work group on quality.

Agenda Item: Work Group on Quality.

MR. HUNGATE: Thank you. I have got a little more to say this time, as
usual. We ended up 2004 having completed our series of two hearings in June and
September, where we really, I think, came to understand better than we had
before the serious lack of efficiency, if you will, between the desires for
quality data and the performance measurement area, and the ease with which
those could be collected within the clinical area.

That turned out to be basically what one of the early slides in our next
retreat — which Simon has encouraged us to do, and which was very productive.

It ended up epitomized in a slide that Brett James presented, where we had
on the right-hand side knowledge for improvement and, on the left-hand side,
information for accountability.

It articulated very well the problem that is occurring here, where the
frustrations on the purchaser’s side, and the pay for performance side, are
leading to demands that are, from a clinical view, counterproductive in the
delivery of care.

This is a problem. That was further amplified, in a way, by a comment that
Steve Jencks made. Steve spent all two days with us at the retreat as a full
participant and very helpful, and I will say more about that in just a minute.

He made the observation that probably the most important thing that CMS had
done in the last year was to agree with Jacob on the specifics of the
measurement of AMI, that they had agreed on the way in which those measurements
should be made, and had saved lots of money within clinical institutions in
that process. That was a harmonization of measurements that took place because
they realized it was needed.

I was jumping ahead a little bit of the content of where we were, but it
illustrates — it says that there is a way to deal with some of these things,
that people getting together and making the measurement the same solved the
clinical problem in terms of its collection.

After Brett James went through a very nice presentation that described the
need for science in making the measurements be valid measurements, his
presentation was followed by Don Detmer, ex of this committee, who introduced
the business of complexity.

Brett had used diabetes as a place where things are well developed, the
measures are science adjusted and good.

Don Detmer’s slides showed a tiny corner within the domain of medical
issues where that kind of science existed. Another one, clear down at the other
end, where it was kind of all unknown. In between was the complexity zone, as
he described it.

The label of the slide was life in the complexity zone. That kind of moved
us into the realization that there is, between the quality improvement model
and the health information technology model, a need for an intersection between
them. Don Detmer expressed it as an intersection of this sort.

That was later followed by Steve Jencks’ encouragement of the quality work
group to come up with a vision of this whole structure of information, pointing
out kind of that we were working very hard on the infrastructure, and that is
coming along, but we haven’t paid the attention we need to yet on the knowledge
base.

That is where quality seems to fit, is in this issue of the development of
a vision of what is going to happen with the knowledge base.

I think that meshes, ties, very closely to what Dan is going to talk about
in the standard, of the secondary uses of clinical information.

So, you know, that is overlapping information that we need in that other
discussion, and you see the need for there, and I don’t know how we grapple
with that structurally within our own work plan. I think that is something that
we need to talk about a little bit probably in the August retreat.

We also are very conscious that it is important to get a structure done
quickly. You know, if this is going to be useful, it has to be done fairly
soon.

It will be a little hazy. It is not going to be all Ts crossed and Is
dotted. It may be more process oriented than specific all answer oriented.

We heard very strong support for the need for this kind of a vision. Now
others from the committee may want to add to that, but I wanted to tee that up
a little bit for the full committee.

I think that, if we are to be successful in doing that, what we do has to
be very transparent to the rest of the committee as we deal with it. Questions,
other comments?

Hearing none, I would add just a couple more sequelae to that. I am proud
of the people who signed up for the challenge.

We have an active, committed group. Marjorie can attest to the quality of
the discussion that takes place, as can Simon.

We are a little thin on the ground in participation within the agencies
that could use the result of what we are doing.

I think we are not well understood across the rest of what is going on, and
we have a missionary job in order to attract the kind of participation we need.

We heard interest in the products from CMS, from AHRQ, but we haven’t
gotten quite the feeling of contribution that we will need to make that be
successful. That is based on my observation of what successes are in the NCVHS
system of moving agendas. It takes the committee itself and the staff support,
and we are going to need help.

MS. MC CALL: Just to amplify some of the things that Bob has been talking
about, the two days that we spent together were absolutely fascinating for me.

Part of that could be still due to my newness, but when I look at
everything that is coming through, and all that has happened, even in the near
term with AHIC and all of that, everything is right, and yet something is still
missing.

We heard Dr. Brailer talk a little bit about it. With all that is needed,
it is still a means to an end, and I don’t think we have adequately anticipated
what the end will require.

So, I think that there is something vital that is missing. So, that is what
our summit began to hunt around, and I think that is what Steve Jencks was
talking about.

We heard it called out again and again by the people that were there, that
there is something missing. All of these things end up becoming tightly
related. Some of them need to co-evolve.

I think, to Jeff’s comments earlier about some things that you will be
working on, those become vital to the work that we would like to pursue as
well.

I think that it signals perhaps that there is obviously a sea change as a
result of some new things that are coming, and everyone is running real hard
for them. I don’t mean just within NCVHS, across the board you can hear it,
these 30-day RFPs, these 36/7 days.

I think it is incumbent upon us to look at the role that we can play, and
to enable those things that can’t happen naturally, and to ask ourselves what
will be required of us.

So, we are starting to look at that and we will give that more flesh and
give what we learned a clearer voice in those two days, but I would love to
have the opportunity for us to come back and share it more completely, more
deeply, and then have a discussion around what the implications could be for
how we, as a work group, and also as a full committee, and some of the other
subcommittees, can all begin to contribute in an aligned fashion around that.

MR. COHN: I just want to comment and congratulate the work group on sort of
embarking on this new area. Certainly my sense is that we are talking about an
area we haven’t come upon exactly the location in that area, or exactly what
the house looks like yet, or whatever, that we are going to be working on,
which is fine.

MS. MC CALL: I was going to say — my side comment was, I can see it in my
head, but I think it is incumbent upon us to try to articulate it. If I can’t
describe it, then what good is it.

MR. COHN: And what our part is. Are we building the house? Are we
architecting the house? What is it that we do around all of that, which is
really part of our work plan development.

I obviously look forward to that. That is something we are hoping to hear
more about when we get together as an executive committee, I think we will be
talking probably more about when we get together as a full meeting in
September, and we begin to talk about work plans for 2006.

Now, the other thing I would suggest — you heard me mention this to the
privacy subcommittee also — is if there are presentations, perspectives or
whatever, that really help flesh out for the full committee.

This is based on the long experience we have all had, that you are there
thinking about this a lot, you were there for two days. Jeff Blair wasn’t
there, Stan Huff wasn’t there. I was there only for one day.

The question is not that we want to sit through those two days, but more if
there are things that bring the knowledge of the full committee up, so that we
understand it better, that we are full partners with you going forward, that is
obviously one of the purposes of the full committee meetings.

Especially when a work group comes up with an agenda or an idea in a
different area, you know, you really need to make sure that you are bringing
everybody along, and sometimes everybody sees different pieces of it. Once
again, it is an opportunity.

MR. HUNGATE: We will accept that opportunity and see that it happens.

MR. COHN: Great. Any other comments about the question work group?

MS. GREENBERG: Just from the point of view of me trying to get an idea of
these presentations, what the plans are for meeting dates, the contractors you
will use, the need for conference calls, all of that. This is a good time for
us to get all of that together.

It is my understanding that there is going to be a conference call of the
work group in the next few weeks or something, and Bob is going to be working,
Susan Kanaan has been working with the work group on summarizing the hearings,
and with Carol, putting together the summary of the hearings, and Bob would
like to continue working with her on creating this document coming out of the
hearings. Then also, they are interested in possible site visits.

MR. COHN: That is an update, Marjorie? It sounds like you are giving the
executive committee discussion.

MS. GREENBERG: Not really.

MR. COHN: I just wanted to clarify that.

MR. HUNGATE: We will need to talk more about some of the specifics.

MR. COHN: In some ways, that leads us up to the executive subcommittee
comments.

Agenda Item: Executive Subcommittee.

MR. COHN: I think, as you know, the executive subcommittee has been holding
conference calls. They met for a half day, when was that, earlier this month? I
think you saw some of the briefing materials that came out of it, that really
were critical to our ability to, I think, engage successfully with the
Secretary.

So, thanks to all again, and I think it is that sort of work obviously that
the executive subcommittee, with the assistance of everyone, needs to be
mobilized around.

Now, the executive subcommittee will be meeting in mid-August. They are
likely, I think, to have a conference call potentially in July, only because we
need to finalize the September agenda of the full committee, and if you meet in
mid-August and you have a meeting of the full committee on September 8 or 9,
that doesn’t exactly give you enough time to do all of that.

MS. GREENBERG: We actually have to post at least a tentative agenda prior
to that.

MR. COHN: That is right, exactly. That is, I think, the point. So, those of
you on that should expect to be queried in the near future about that.

Now, the summer meeting of the executive subcommittee is really meant to
sort of take off where we sort of last left off, which is sort of looking at
sort of what are the work plans, what are the goals, both of work groups,
subcommittees and the full committee, to begin to try to rationalize them
together into something that makes sense, and is also consistent with
appropriate resource use and all of that, and really sort of focus on what we
are planning on doing in fiscal year 2006.

That is really, I think, what the purpose of all that is. We will obviously
be coming back and talking more about that at the full September committee
meeting, but that is obviously why I have been asking everybody to think hard
about goals, work plans.

I know Marjorie would add in resources and staffing issues and all of that,
just so we make sure that we are aware of what needs to happen as we move into
the next fiscal year.

I guess I would mention that to all the subcommittee chairs, as well as
other interested parties, that we work on a budget just like everybody else.
Jim, did you have a comment on it?

MR. JAMES SCANLON: We are really sort of winding down in fiscal year 2005,
so the executive committee meeting will be the opportunity to think of resource
requirements for beginning in October 2006.

In addition to the routine, the regular routine meetings and so on, if any
of the chairs of the subcommittees envision bigger requirements for bigger
analytic work or consulting work via contract, let us know that as well, so
that we can factor that into the 2006 planning.

MR. STEINDEL: When do you need that information?

MR. JAMES SCANLON: Certainly we would like to discuss it at the August
retreat. The other thing is I guess, Simon, to all the subcommittee chairs, at
least if we are going to know some expenditures.

The other thing is, I hope everyone is leaving, in their work planning,
some room for change, depending on what comes out of the AHIC.

So, it is just a matter of keeping — just bear in mind you might have to
substitute or redirect, or depending on what — we are fighting hard to be
involved. That means, if we are asked to do things, we had better be prepared
to do them.

That is the only thing. I think this coming six months will be very fluid
in that respect and, to the extent that we get tasks, it may replace some other
planning.

MR. COHN: I guess flexibility is a good thing. I am trying to think of what
else. I want to go and talk about the September agenda and what we are seeing
so far, but I am just looking to Marjorie and Jim to see if there is anything
else we need to talk about in terms of before that.

MR. WEINZIMER: Marjorie, is there anything that we should know that would
be useful in terms of planning for O’Neill’s presentation?

MS. GREENBERG: In the executive subcommittee meeting? Rob just mentioned
that actually Dr. O’Neill is the chair of the board of scientific counselors
for NCHS, who spoke to us yesterday, who will be participating in the executive
subcommittee retreat in August, as well as Dr. Sondik, who is actually
liaison to the committee in any event.

We hope that all of the executive subcommittee members and liaisons will be
able to be there. I believe we do have a discussion section in the agenda,
which we are working on and which we will discuss in the conference call, to
discuss the relationship with the board, the possibility of a joint meeting in
the future, which we have talked about, and sort of follow up to some of the
discussions yesterday.

I don’t think she has to prepare anything formal. Do you have anything to
add to that? That will be part of the agenda.

MR. COHN: I actually wanted to bring up one other issue, and this is just,
I think, sort of a heads up to the full committee.

Obviously, I think — and this is not alluding to the BSC or anything like
that, so we are back to the previous topic — you know, given the accelerated
environment, there may be a need for letters or other communications that are
going to come out either from the executive subcommittee or from the chair.

In normal times, we may often wait for a full committee meeting to discuss
them prior to sending them. In this accelerated environment, I just want to ask
for all of your forbearance, that some things may just have to go to the
executive subcommittee in a conference call or otherwise to get out.

Obviously, that is nothing substantial where we are talking about major
recommendations for directions, but various communications or there may be just
things that I pen, reflecting on ways that we can help or otherwise.

I just want you to all be aware of that, but once again, I think it just
reflects an accelerated environment. I guess if any of you have any major
issues about that, please let me know or please state them now, but obviously
we will use good judgement in whatever it is that we may say, and obviously
will be sharing them with you, but sort of the same way we did that fact sheet,
for example.

MS. GREENBERG: We will use e mails and conference calls, and if it is
something that really needs to be like of a recommendation nature or whatever,
we can have an open conference call, open to the public. We have options.

MR. COHN: I just want to have you be aware that we are obviously responding
to the accelerated environment.

Agenda Item: Future Agendas for NCVHS Meetings.

MR. COHN: No, September, what we are seeing in terms of action items is —
remember that 2003-2004 report that we talked about yesterday, that is coming
back again, and that will certainly be an action item.

There is also, particularly if you are new to the committee, every year we
produce a report on administrative simplification, otherwise known as HIPAA,
and I think that will be coming forward as an action item.

You should also expect a letter on PHR coming forward, hopefully, as an
action item at that point also.

Privacy, I think there will be some sort of a briefing beginning to prepare
us for what is coming forward from the privacy subcommittee

I am actually expecting that there will likely be potentially some sort of
either short or medium sized letters coming out of standards and security,
although those are, I think, to be determined.

Now, other issues that we have are a briefing on the AHRQ report on quality
and disparities. There is a topic discussion on NCHS, look at the
re-engineering of the death certification system classification method.

MS. GREENBERG: I think it is the whole re-engineering of death
registration. You raised this, Ed, and we can discuss that on the conference
call of in San Francisco, too, if you think that would be a good time to make a
presentation.

MR. COHN: We will see. That is a good question, about whether it is there,
but we can figure that one out. Now, the other piece — and obviously Dan’s
presentation, the presentation from the ISO TC 215, I just want to remind
everybody that actually international standards and all of this is really
within the scope of the committee. It is in the charter, it is part of its
responsibility.

I think we have gotten so involved, often, looking at the United States
environment that we sort of forget these other influences.

Certainly we will be inviting Dan back, and I think we need to negotiate
whether that is September or November based on the schedule, and Marjorie’s and
Dan’s preference, but we are obviously happy to — the invitation is open to
have you come back and give us more, because I think that was very important.

I think the other piece is that we are going to want to have probably
Marjorie update us on the WHO activities. Is that November?

MS. GREENBERG: Because we are having our annual meeting in October. So,
November would be good for that.

MR. COHN: I think we are all aware that Marjorie has many meetings in
Bangkok and other exotic locations that we would like to hear more about.

MS. GREENBERG: And whatever book you are pushing, just tell me the color of
the cover. Did you mention as an action item the 2003-2004 report?

MR. COHN: Yes, that was the first thing. Now, are there any other issues
that you think we need to be talking about in September? Obviously, feel free
to e mail us if things come to mind. We will look forward to seeing you all
together again on September 8 and 9.

Now, final question as you all run out, I do want to — for the record, it
is 1:09, the chair does run these meetings on time — as I did at the last
meeting, I just want to reflect for a moment on how the meeting went, any
suggestions for improvement.

Let me start off by saying that I Felt, and we sort of observed, that the
meeting was rushed in terms of the agenda items.

I think from now on we will have more time for the data council and
department updates, which was an area of particular rushing. I think we just
need to make sure that we are allowing hopefully more time for discussion.

It is not a great pleasure having to cut people off with very good
questions. So, we will make sure that we do that. Justine, you sounded like you
had a suggestion also.

MS. CARR: Simon, thank you for the annotated agenda. I found that helpful.
I think also, if you could introduce the speakers to just keep us oriented into
how this element fits into our work in this area, because I am unfamiliar with
a lot of the work that was presented yesterday and today, infrastructure and so
on.

I think it would help us if you could sort of say, this is important to you
because it links to whatever, I, for one, would find that helpful.

MR. COHN: Maybe another piece is, as we work on the annotated agenda, maybe
there is a sentence sort of relating to that, that the reason this might be
important to you is, which might also help. I do think having them actually
start off that way, would be a useful thing to do.

MS. CARR: I mean, as you go along, it be comes clearer, but I think knowing
what to focus on and where we are going, I would do better with that.

MS. GREENBERG: I hope you all noticed, we are continuing to update and
provide an acronym list.

MS. CARR: The abbreviations, and I thank you for that.

MR. COHN: Any other suggestions for improvement? Okay, well, if you have
any — the chair is always willing to hear ways we can do this better.

MS. GREENBERG: As is the executive secretary.

MR. COHN: And the executive subcommittee. Anyway, with that, I want to
thank you all. The meeting is adjourned.

[Whereupon, at 1:15 p.m., the meeting was adjourned.]