# INTEGRATED SURVEILLANCE SEMINAR SERIES

CENTERS FOR DISEASE CONTROL

COORDINATING CENTER FOR HEALTH INFORMATION AND SERVICE

NATIONAL CENTER FOR PUBLIC HEALTH INFORMATICS

DIVISION OF INTEGRATED SURVEILLANCE SYSTEMS AND SERVICES

TITLE: Overview of National Health Information Technology (HIT)
Standards

SPEAKER: Steven J. Steindel

MODERATOR: Chris Braden

January 9, 2008

JENNIFER WARD, EPIDEMIOLOGIST, DIVISION OF INTEGRATED SURVEILLANCE
SYSTEMS AND SERVICES, CDC: Good morning. I think we'll go ahead and
begin now. I'm delighted to begin this 3^rd^ session of the Integrated
Surveillance Seminar Series. Welcome to all of those who are here in the
room and to those who are joining us via Envision and webinar. Just some
background information on the seminar series. It's hosted by the
National Center for Public Health Informatics, Division of Integrated
Surveillance Systems and Services. It's part of a larger Integrated
Surveillance Community of Practice which is intended to facilitate
interaction between stakeholders in the field of public health
surveillance. The seminar series strives to establish an interactive
forum for discussing the vision of integrated surveillance, identifying
issues and approaches to its achievement, and for providing a mechanism
for discussing best practices in this area. Following the presentation
by our speaker we'll have a Q&A discussion period. For the benefit of
our participants via webinar and Envision, I would ask you to please use
the microphones that are located on the table in front of you. You have
to actually press the button until the green light appears to be heard.
There's also a microphone in the back middle of the auditorium if you
would like to use that. For those participants that are joining us on
the telephone, I would ask that you please place your phone on mute when
you are not speaking. Also, please avoid placing your telephone on hold
because the music can be heard over the speaker. For those in the room,
I'll ask you to place your cell phones or pages on mute or vibrate.

We are please to have Dr. Chris Braden moderating our discussion today.
Dr. Braden is the Associate Director for Science in the Division of
Parasitic Diseases. And, I would like you to join me in welcoming him.

CHRIS BRADEN, ASSOCIATE DIRECTOR FOR SCIENCE, DIVISION OF PARASITIC
DISEASES, CDC: Thank you and welcome everybody. Good morning. I'm
moderating this session and we have an expert in field to discuss
standards today. I'd just like to say that standards that are certainly
an essential but complicated component of integrated surveillance - and,
of course, integrated surveillance being the topic of these series of
seminar lectures. Dr. Steindel will be giving an overview of some of the
standards and the groups that are working on standards - and, of course,
this is essentially the information that we would be using in order to
share data between systems and integrating the information that we use
thereof.

So, without further ado, I'd like to introduce Dr. Steindel. He's a
Director for Standards and Vocabulary at the Centers for Disease Control
and Prevention. He has a Ph.D. in synthetic organic chemistry and a
minor in quantum mechanics and has pursued a career combining his
expertise in both laboratory medicine and medical informatics. He has
been a clinical chemist at both the 3^rd^ Army Medical Laboratory, a
military reference laboratory, and at Piedmont Hospital here in Atlanta,
a 500-bed tertiary care center. He has written over 100 articles
focusing on laboratory medicine, quality control, and assurance issues.
He has also served as computer consultant to the medical care industry,
leading development to commercial custom software for electronic data
exchange. Since joining CDC in 1992, he has served on numerous internal
and external standards groups including X12, HL7, SNOMED, LOINC, CCHIT,
HITSP, and various NCVHS subcommittees. He'll be talking to us a little
bit about what those acronyms mean. In 2007, he was elected a fellow of
the American College of Medical Informatics. Dr. Steindel...

STEVEN STEINDEL, DIRECTOR FOR STANDARDS AND VOCABULARY, CDC: Thank you,
Chris. Thank you, Jennifer, for inviting me to give this seminar. As
many times as I've been asked to give an introductory seminar or an
overview of what's going on in the standards arena nationally, I always
question: What does the group want me to talk about? Based on some of
the discussions I've had with the organizers of this, I think we're
going to have a very quick presentation of the slides, because I get the
impression there's going to be some interesting and good questions and
answers coming about later. And, I'd like us to have as much time
possible for that. We hit what you need. What I'm going to be doing is
giving you an overview of what is going on nationally in the area of
health IT standards. This is not what is particularly going to impact
directly the surveillance systems at CDC or what we've been working on
for and I've been involved with for over a decade here CDC. And, CDC has
actually been working on it longer than that, and we're now starting to
instantiate systems.

First thing I wanted to bring about is, as was mentioned, standards are
really ubiquitous. We don't think about standards in that way. But, how
many people here are familiar with -- I'm sure everyone is -- with the
new fluorescent, "incandescent" light bulbs? - The ones that replace
your light bulbs. Do you wonder how you can just take that and screw it
into an existing bulb and it works. And, the reason is very simple;
every part of that is controlled by ANSI standards. So, it was designed
to replace the incandescent bulbs, because the fixtures, the voltage
which you could expect, etcetera, was all standardized. And, that's what
we're kind of trying to do in the health care industry -- is make
something that may be not as easily plug-and-play as the light bulb, but
at least much more plug-and-play than we have today. What we're dealing
with in the world is two classes of "standards." One is non-governmental
-- that's the light bulbs really. That's usually driven by market need.
People have a desire to create a standard so they can have ubiquitous
use of their goods and they don't have to worry whether my device will
work in this environment. We're seeing a play in that of those that are
interested in high definition DVDs. We have two competitive standards
going on in that area. And, the public is holding off on buying high
definition DVD players until we focus on one standard. Usually, these
are voluntary -- nobody's forcing anyone to use it. They are consensus
-- people decide by the bulk of their desires which one they want to
use. They were driven a lot by industry, because they're the people that
want to put products out there. They're also driven, as what goes on in
public health, by non-industry consortia -- groups coming together to
say, "We need this type of operation standardized." We see this a lot in
public affairs or general types of groups like that.

On the government side, we have the exact analogous situation. We have a
usually, a societal need to regulate something. Depending on what that
is, it manifests itself first in the form of the law that says the
government can regulate this. And, from that, we develop regulatory
standards that establish multiple levels of protection within society
about what you can do. And, usually, though not totally, these are
focused on the health, safety, and environmental aspects of our lives.
Some governmental standards are also involved in government procurement,
but that's a little bit outside of this. What's going on today within
the government, and for those of us who remember the \$10,000 toilet
seats or \$2,000 hammers from back in military procurement -- what
Congress said was the military must cite voluntary standards in their
procurement processes and stop making their own standards. So, what we
see in government laws and standards more and more is the citing of
private sector standards. So, what we're doing here at CDC is we're
getting more involved with the private sector in creating those
standards that both the government accepts on a consensus basis and the
private sector accepts.

We'll now move a little bit more rapidly. I felt the overview of how the
standards process works and where standards come in is very important,
because people don't think about that when they get involved in this. In
the government side, we have regulations. These are usually based on the
health and welfare of a population -- they have legitimate objectives.
Congress has agreed, society has agreed, this is the way we want to go.
There is a development process that is open and available for public
comment. A regulation is published usually as a notification of the
proposed rules making in the federal register. The public comments on
that and it may comment more than once, depending on how often it's
changed. But, eventually, it develops a final regulation which now
becomes a mandatory process that everyone must use. In the health care
arena, one of the biggest that we're facing today -- and everyone is
well aware of every time they go to a doctor -- is HIPAA. HIPAA has
changed a lot of what is going on in the administrative aspects of
healthcare. And, it is done by regulation. On the other side of the
coin, and directly analogous, we have voluntary standards. This is where
I'm mostly focusing on in this, my work at CDC, and what the people in
this room who get involved in the standards process will be focusing on.

These are based on market needs. We have a need to develop this, for
whatever purpose. There is a need to standardize electronic health
records and what they look like and how they're used. There's a need to
standardize messages that go between various health care providers, so
that I can exchange information so that it will be understood by my
fellow practitioner. There is a need to send that information to various
government organizations in public health -- for public health purposes,
quality control purposes, statistical purposes, etc. All of this is
coming under the domain of standards. The development process there is
almost totally analogous to what's going on in the public sector. We
have standard development organizations that meet, they discuss, and
they develop a consensus-based standard. They bring that consensus
standard forward to their community for balloting. It's balloted. If it
doesn't pass, it goes back into the consensus process to solve those
areas that people didn't agree on -- and this process repeats, sometimes
repeatedly over a process of many years, but a consensus standard is
developed that everyone can use. The difference here is that standard is
voluntary. *You don't have to use it*. Now, I emphasize that
deliberately, because in many cases, as it is with the light bulb, not
using this standard can be very detrimental to your goals on why you got
involved in the process in the first place.

What do we consider when we're developing standards? There are really
three areas that we look at here. First is the flow of data: Where it
comes from, when it comes, and how does the data move from one point to
another? We look at the format of the data. If we can't understand how
the data is put together we have no chance of taking it apart and
understanding it. So, that's another area we can use for standards. And
then finally, there's the content of the data -- What data elements do
we want standardized? If I say blue, I want to make sure that you
understand what shade of blue I'm talking about. And, that's what I mean
by doing data content -- in terms of this group, and that is really
public health, the area where we've had the most discussion and probably
the most contention is the area of content. When I say blue, what we
find is, we have a big problem on understanding which shades of blue
we're developing. I'm hoping that we'll have some questions and
discussions in that area.

This is just a schematic diagram that I put together and basically is
for laboratory reporting. This particular example, I believe was
developed for the cancer community, but it's kind of a good example for
what's going on. First, what we have happening is in the private sector.
There is a development of some medical content information. In this
particular case, it happens to be a pathology report for cancer. That
information is then translated into standard codes. In the cancer world,
it's using codes like SNOMED, that has numeric dates and times, it has
disease specific messages that are put together, but it's translated
into some type of standard format. It's then communicated over some sort
of communication gateway, and what we're talking about today is a
National Health Information Network, regional health information
organizations, and health information exchange networks. There are more
acronyms to describe that middle box than we know what to do with. And,
we're still working on standardizing that.

We have a filter for public health purposes that's put in that data
flow, because not every one of pathology lab report may actually be
reportable. So, one thing we do is we sift through the information, we
decide what needs to go to public health. And, finally in our world, in
the public health surveillance world, we take a look and we look at how
we actually want to handle that information. What does it mean from our
point of view? And, what we have going on, is we have standards that
exist in the pathology world. There are board certified pathologists.
They work on reports. Those reports come out meeting certain levels of
standards that exist in that world. We have this information translated
into standard codes that we can understand, packaged into standard
message formats usually using a standard developed by Health Level 7,
HL7. There's an architecture that exists that defines the way the data
flows from one point to another. And, finally, we have different groups
of people. Now, sometimes it may be the same person wearing a different
hat, but we have different groups of people developing and adjudicating
what's going on in those worlds. We have the "public health" world and
public health there is in quotes. It means all of you acting as
patients. You were the ones that were concerned about the standards that
were going on in the pathology lab, the standards for hospital care
delivery, the standards for quality. You're involved in those
discussions. We have the users of the data that's involved in the
development and packaging of the standards. That's us and that's also
the docs. We have network users, and that can be more than just us, that
is anyone that wants to plug into the NHIN. They have to be cognizant of
the architecture and what's going there. And, finally, we have the
public health system, which is us wearing our non-patient hats working
here at CDC and our colleagues and our partners who are developing the
way we interpret that data and use it for public health purposes.

As was mentioned earlier -- Chris warned you -- I would mention some of
these acronyms. And, I'm just going to look at these very quickly
because we're going to use them in that fashion. There's AHIC, the
American Health Information Community, which is an oversight
organization. There's ONC, the Office of the National Coordination for
Health Information Technology, that's overseeing this process. AHIC is a
public-private federal advisory committee. ONC is a federal group.
Health Level 7 is a national standards setting body that is a mixture of
virtually everybody. The Certification of Commission for Health IT, or
CCHIT, is a private organization funded by the government to certify
electronic health records. HITSP, the Health IT Standards Panel, is
another federally-sponsored private group that's designed to harmonize
standards and the goal individually for which each one of these means.
And, finally we have this all coming together in the Nationwide
Information Exchange Network, or the NHIN.

ONC's major initiatives come about from a 2004 directive from President
Bush, who called for the widespread use of electronic health records
within 10 years. We're about 1/3 of the way into that process. We're
looking at, still, a 2014 date for much more widespread use of
electronic health records. The rate is growing. They've set a foundation
for interoperability of EHRs through a bunch of initiatives that are
listed below including the American Health Information Community, HITSP,
the Certification Commission, developing privacy and security solutions,
developing NHIN prototypes, looking at anti-fraud policies that are
going on, looking at providing guidance for development of health IT,
and finally - two very specific initiatives, one developed out of
Katrina -- and that's using the Gulf States, as an example, to develop a
regional exchange network for health exchange. And, finally, an exchange
system where States who are involved with this can talk about how
they're doing it well -- these are the ONC initiatives.

AHIC, as I mentioned, was a public and private sector collaborative. It
actually is the group that defines the work for all the other groups.
Dr. Gerberding is a member of AHIC and CDC is very involved with AHIC.
But, what they do is they develop what they call use-cases. And, for
those who are familiar with the standards world, an AHIC use case is
actually slightly different than a standard use case in the sense that
it's much more general. They will develop the use case. For example, one
was what they called Electronic Health Records, which actually was the
exchange of ambulatory/laboratory reports. That was an AHIC use case.
There is an AHIC use case that is being developed that I will mention.
We will be extremely involved with it -- we, I mean virtually everybody
in this room and most likely all of our audience out in the ether, and
that is a public health use case focusing on case reporting. And, that's
coming down in the next year. We'll probably see it coming out of AHIC
sometime in the first quarter of this year. And, at that point, ONC will
work on it; they will develop a refinement of it. Once they develop a
refinement, the public comment process starts. And, I'm hoping that CDC
will take an active role in that public health comment process and we
can involve many of you in that.

These are the various organizations that are directly involved with
AHIC. The workgroups that are associated with it -- I'll mention
loosely. The Population and Clinical Care Workgroup is the one that's
subsumed the work of the former Biosurveillance Workgroup. One of the
first use cases that AHIC asked us to work on was really involved with
biosurveillance reporting and centered on the functions that we had
embodied at that point in time in our BioSense system. And, actually we
were very involved with the development of that use case and the
development of the standards that came with it. So, that it represented
the type of information that we wanted to flow through BioSense. And,
involved with that was developing data content standards for what was
needed for biosurveillance. There's a Consumer Empowerment workgroup
that's involved with the personal health record. A Chronic Care
workgroup which has not met really and developed, but one of the
recognized factors of AHIC is -- we are getting more and more involved
with treatment of chronic care. And, we do need the electronic standards
to represent that information adequately so people can use it to provide
the treatment that's needed as we age. And, I can tell you as one whose
aging, I'm well aware of the need in that area. We have an Electronic
Health Record workgroup focusing on two areas, one is laboratory
reporting, that's essentially done, and the second is in the area of
emergency preparedness. A lot of this involves the type of reports that
we need when we mobilize medical care regionally or even locally for a
traffic accident. How do we flow information rapidly and successfully in
those types of environments, all the way up to pandemic flu. This has
just gone through HITSP, and we will be working on what standards are
needed in that area in the near future. There's a privacy and security
workgroup -- It's developed, and as you can imagine in those of us in
public health are very sensitive to, privacy is an extremely big concern
of the public in this information flow. And, the privacy and security
workgroup is charged with developing assurances so that the public can
be comfortable with this system as it rolls out. The quality workgroup
-- it has not done that much at this time primarily because the quality
care community is still trying to develop its mechanisms for developing
quality standards. And, finally there's personalized healthcare, which
Secretary Leavitt is very interested in, and that's involved mostly with
genomics and how we're going to develop individual treatments and
medical care for you as an individual.

The next slide shows how that all interacts through the Offices of the
National Coordinator. And, the important factors to show here is that we
have the technology industry working in partnership with the healthcare
industry, and with the consumers through the office of the national
coordinator -- we're trying to bring all this together so that we can
transform technology to develop an electronic health system that will
better serve the public and improve the quality of healthcare to you. An
important factor of this is the idea that for many years the way we did
standard harmonization was we got together, we talked, and we disagreed.
That didn't work very well. So, one of the concepts that came about with
the Office of the National Coordinator was that we would form a group
with teeth, and this is HITSP, the Health Information Technology
Standards Panel. Anyone, and that actually does mean individuals, really
-- any organization can join HITSP and participate in this process.
We're one of the government organizations that's involved in HITSP. This
group is extremely active, and we'll see the type of work they do in the
next few slides. What it's charged to do, is to take a look at the use
cases that come out of AHIC as refined by ONC, and as further refined
within the process -- the consensus process of HITSP -- and point
exactly to the standards that will be used for that use case and how
they will be used. The Secretary now has the capability to recognize
those standards. And, while this doesn't have full legal teeth, what the
Secretary does when he says, "I will recognize those standards," - it
means the government is now required to use those standards in any
healthcare endeavor it funds. When you stop and think about that - that
means everything we do - because it funds us. That's number one, and you
can extend it to groups like FDA, etc. But, there's even more than that,
because we have the Department of Defense and the Veterans'
Administration. And, think about how much healthcare they pay for.
They're required to use HITSP standards. The other part of it is --
Medicare and Medicaid are federally funded. So, consequently, we're
talking about roughly half the healthcare that's delivered in the United
States needs to start conforming to HITSP standards once the Secretary
recognizes it. In December of this year, the first set of HITSP
harmonized standards were recognized by the Secretary. So far, they
don't really impact much on us, because one that wasn't recognized that
could potentially impact us was laboratory reporting, and that's not
going to be recognized until probably June of this year. But, this is
the importance of HITSP. We finally now have a mechanism to truly
harmonize standards in a way that they can move forward in a harmonized
fashion.

There are multiple technical committees in committee. There's a cross
Cross-Technical Committee; everybody has to have one that covers
everything. There's a Care Delivery, Consumer Empowerment, Population
Health, Security and Privacy, and Emergency Responding. You can see how
these parallel what's going on at the AHIC level, and that's deliberate.

There's a harmonization in process that exists within HITSP. These are
the steps that are involved. It's a lengthy process. It takes about two
years. There are literally hundreds of people involved with this overall
process. They have weekly, or more than weekly sometimes, phone calls
which up to sixty plus people can be participating in. There are four
technical committees a year. One is two weeks from now in Chicago that
about one hundred people show up and distribute amongst the various
workgroups where the various stages of HITSP harmonization depending on
which use case are discussed in detail. They produce documents that are,
you know, between I would say and fifty and one hundred-fifty pages
long, outlining what's going on in this process. It's actually very
thorough, very good, very thoughtful. I've been involved with this now,
as you've heard in the introduction, probably close to 30 years. I would
say HITSP is one of the first groups that's really sat down and focused
on this with the breadth and depth that is needed to address our needs.

What they produced though, is actually a framework. Each one of those
documents can be put together with pieces from another document. One of
the charges of the HITSP workgroup is: think reusability when you
develop something. If we need authentification mechanisms for electronic
laboratory reporting, which of course we do, let's use the same
electronic authentification methods that we're going to use for
something else. Common components exist throughout the process, and as
the HITSP process moves forward, more common components are developed.
And, these common, what happens is a past use case which may have
alluded to a common component or may not have been designed to use it
fully. Once the common component has been developed, HITSP then turns
around and they modify that previous use case so now the common
component will drive the system. It's an extremely good structure. It's
produced some very good work.

This is a timeline. I'd assume these slide sets are being distributed,
Jennifer, Right? So, I'm not going to go into this. But, this is
basically the timeline of what goes on when you develop a use case. And,
it takes about 2 plus years from the time AHIC develops it to the time
HITSP actually produces a set of documents that we can start looking at.

It also coordinates with what's going on everywhere else, especially
with regard to certification. That's the next step of this process. So,
there's a coordinated timeline that exists between -- with AHIC, so when
an AHIC use case comes down, HITSP actually has created time for their
workgroups to start using it. And, their process completes -- CCHIT has
put holes in its schedule so certification for that can start. So, this
is an elaborate coordination mechanism that is going on nationally to
try to sync up these process so that we can meet the President's
deadline of 2014. Just trying to say, "We'll do it," without planning
and coordination will not happen. One of the jobs of the Office of the
National Coordinator is to try to sync up all these pieces and let it
flow in a good fashion.

We're sitting right here. So, now you can see how elaborate this
timeline exists from beginning to end. The certification of electronic
health records is a key component of Secretary Leavitt's idea, and the
President's idea of getting EHRs to cover virtually every American by
2014. EHRs have been in existence for a long time. I happened to watch a
video clip that IBM produced based on 1961 technology. It was
fascinating because a lot of the things they were talking about are the
exact same things that we're talking about today about electronic health
records. So, we've been thinking about this and have been trying to do
it for a long time. One of the reasons we feel that electronic health
records are not being used more widely is because they aren't certified.
A physician: they cost a lot of money, they take a lot of time to put
in, they impact your workflow and your practice. Physicians are
reluctant to use them. And, the feeling is that at least if it was
certification behind it, so they would feel certainty in getting what
they're asking for; they'll be more responsive to buy the systems. So
the certification commission for Health IT was started. It was
publically funded - privately funded through November of 2004 -- and
then ONC started funding it for 3 years, and the funding runs out next
year. I don't know what's happening at that point in time. They certify
34 7 systems in their first round in January of 2007, and I believe
there's over 80 certified at this time. They're moving into inpatient
certification this year, and certifying systems as they operate on a
network starting in June of this year.

This is an example -- This just a little more illustry of details of
that history and the current status of where they are going. The
development -- the development process is very similar to what you've
just heard bout HITSP. The major difference in the development process
is CCHIT at the first stages is closed. There is a group that is invited
to join the development of that process that works on the HITSP
certification standards. They produce drafts at various stages that are
open for public comment. And, anyone can comment on the certification
criteria and it's reviewed by the group and modified. I've been involved
with the CCHIT process since it started. We actually just had a phone
call yesterday about the public comments for the interoperability
criteria that will be tested this June. They're lengthy, they're
detailed, and they do change things. Just because the group itself is
closed doesn't mean we have an opportunity to impact on it. And, in
fact, the state of Minnesota actually contributed some good comments on
the interoperability criteria from a public health point of view this
year.

Some myths are realities that we found regarding CCHIT -- first of all,
people think it's a government agency. It's not. It's totally private.
Because CCHIT does reference standards -- it says, "We will test against
this standard," people think it's a standard development organization,
but it's not. It just quotes other people's standards, and in
particular, it quotes HITSP standards. Certification can stunt
innovation. This is something we hear all the time. This is one of the
problems that are involved when you use a standard. A standard freezes
things. When you have a standard it freezes things in time. You have to
realize that. So you're saying, build things to what exist today. Build
it tomorrow to what exists today. People feel it stunts innovation. It
can. But, I'll go back to the example I started with. Look at the
replacement light bulbs that exist today. Eventually people figured out
how to use the existing standards to move things forward in a direction
we wanted to go. So, I don't think it stunts innovation, I think it
helps innovation. There's a lot of debate in that area. Finally, CCHIT
will certify EHRs that are only in ambulatory physician's offices --
and, as I pointed out, they're going after in-patient systems, and
they're going after network systems. And, they now have a -- Dave Ross
and many people in this room and maybe even in the audience, have just
joined CCHIT as commissioner, so now they're going to have direct public
health input at the commission level.

Finally, just a couple -- two quick mentions of groups - this Health
Level 7, that's a standards group that many people are involved with at
CDC and out in the ether. This is the basic healthcare messaging
standards group. It's the one everyone is involved with. It's the one
HITSP looks at. It's the one other groups look at. It's the one CDC
looks at when we want to develop public health messaging standards. The
groups that we're particularly involved with are listed on this slide --
I'm not going into them. These directly impact the work that we do. We
have probably close to 10 -- 12 people that go to the HL7 meetings 3
times a year that work directly with these committees. And we have I'd
say about 10 times that level at CDC that are working on or with HL7
standards this time.

The key terminologies that we use, these I think are familiar to many of
us because we've been talking about them for over a decade. First is
LOINC, for laboratory result names. And, we're not starting to talk
about that as a coding system. I think we'll probably get some questions
in that area -- about extending LOINC -- for some of our questionnaires,
etc. -- this talk in that area. Then, there's SNOMED, which is the
terminology that defines clinical medicine. And, we use it mostly for
organisms, but we're going probably start using it more for the factors
that we see, the answers to questions that we see when we do outbreak
investigations that are not necessarily clinical. These are both
distributed free for use. There's been a change in the environment with
regard to SNOMED, but in terms practical impact on us, SNOMED has been
always been free for use at CDC for at least close to the last decade,
and still continues that way

Get involved. We need more people involved in the standards arena in
public health. We're trying to talk and get two of our key partners,
ASTHO and NACCHO, directly involved with HL7, and using the people that
they can attract from their membership base, state public health workers
and local public health workers, to get them more involved in HL7. The
groups that you can join with absolutely no restrictions are HL7 and
HITSP. Two groups that are very important to us that only have selected
membership is the Certification Commission and the National Committee
for Vital Health Statistics, which I didn't go into as a standards
development organization, but is a federal advisory committee that
actually serves us in two functional roles. The first functional role is
vital statistics. This is the oversight committee for healthcare
statistics in the United States. So, when we talk about doing any type
of vital statistic work, population health work, that goes through and
NCVHS and in particular NCHS. So, they're very key in that area. The
other side of it, where CDC in Atlanta got really involved with it --
was the government made them, in the HIPPA law, the key advisory
committee for the government for HIPPA matters. And, what extended from
that is NCVHS became the group that advised the committee on initial
messaging standards, for clinical messages, on the terminology
standards, on the architecture for the NHIN, on electronic prescribing
messages. So, we -- there's a tremendous amount of policy-level work
that NCVHS does that directly impacts. We have several people within
NCVHS staff helping to formulate what's going on there. There are open
meetings of virtually all these groups. AHIC meets multiple times a year
-- NCVHS -- since I'm involved with several of those groups -- more
times than I care to sometimes because I'm never here. The CCHIT town
hall meetings that occur about 3 times a year -- And, by registration,
you can attend the LOINC meetings and the yearly SNOMED meetings. So,
these are all open meetings that you can attend.

Finally, for those of you who would want to contact me outside of this,
the contact information is available on the slides. Jennifer, did you
get any questions? Thank you.

CHRIS BRADEN: This is Chris Braden again. I'll take any questions.
First, from the phone link -- are there any questions from the phone
link? Okay. Do we have any written questions that are coming in via the
web link?

JENNIFER WARD: One of the questions is: What mechanisms are in place to
ensure that public health needs are being considered in the standards
development for electronic health records?

STEVEN STEINDEL: Thank you. That's a question I get a lot. And, it's --
my initial reaction to it was very funny because there was an -- and,
I've been involved in many cases, and in many cases I've been the
primary link in many of these organizations, for raising the questions
concerning electronic -- public health needs in the electronic record. A
movement was started, I guess it's now about 6 years ago, to standardize
the functional requirements of electronic health records. It was
actually started by Bill Yasnoff when he was in Washington. And, they
put together a massive HL7 effort to do the functional requirements of
electronic health records. I was assigned to be involved with that group
virtually full time until this was published. What we did here at CDC
was we convened an internal group that we developed what we wanted to
see in those functional requirements from a public health point of view.
We vetted it internally and we vetted it with our partners. And, I was
charged to make sure everyone of those points came through in the final
functional requirements. So, that was, in a sense, our initial formal
input into the electronic health record. And, I have to say this, from
day one when we first brought that forward and it continues till today,
I have found many of the people who are involved in the certification
efforts and the functional requirements efforts for the electronic
health record from the private sector, from the providers, actually
bring up the public health points before I get a chance to be on the
agenda. So, there really is, within this community, the community -- it
may not be with you personal physician or something, but within the
community that's thinking about standards in this area, there is an
awareness that public health needs have to be met by these systems. And,
we don't have an uphill battle. We do have the need to be sitting there
at the table because we are the only ones that know how those needs
should be expressed so we can be assured that they're met properly. But,
we at least are not fighting a battle of saying, "do we meet this need
versus some other need." They've already recognized that we should have
that met.

Chris Braden: We have a question coming from a Joe Gonzales. Are you on
the phone? Okay, why don't I open it up to any questions in the room?
Could you please step to the mic\[rophone\] and state your name.

AUDIENCE MEMBER: That was a nice overview. I enjoyed it. My question is
actually for happened in the last year -- because, I lost touch.
Specifically, people ask me: how has all the work that's been funded
through the BioSense initiative, how has that wiring, vocabulary,
standards across public health, how has that been used across the
greater standards process?

STEVEN STEINDEL: I think we've had two ways in which it has helped the
greater standards process. The majority and I have to say the vast
majority of those funds have actually informed the standards process by
putting systems that are based on standards in the institutions and
working with those institutions on converting their local data, their
local codes, their local information flows into the types of information
flows that our BioSense system needs. So, it has been an extremely good
learning experience both for them and for us on how to deploy
interoperable standards on a vast basis. So, that is -- that is one, the
vast part of the way the money is used. And, when people ask me about
this -- and they ask, "Has BioSense actually detected this or that?"
And, I see Jeff Tokars getting up, so I'm going to let him pick up as
soon as I finish, which I'm totally happy about. You know, that's been
number one. And, I say this has been a great research, great learning
experience for helping us move to the world of the NHIN. The second,
which is a minor part of that, is that BioSense money has gone
indirectly and funded portions of the Office of the National
Coordinator's work, portions to the projects that they're doing, some of
the funding and grants that they have put out to develop standards, and
-- you know, for better or for worse, my starting to own Delta airlines
for flying so many miles on it. You know, the funding of people here who
are involved in the standards process. Jeff, do you want to pick up,
because I'm sure you can give them a much more elegant answer.

JERRY TOKARS: My name is actually Jerry. I wanted to ask a question
about the use of standards in hospitals. You mentioned LOINC and SNOMED,
and it seems like routine knowledge that these are good standards, but
they're inconvenient, they're not intuitive. So, a local hospital will
make their own little codes for all the organisms in the test so they'll
use those instead because they're easier and more meaningful. So, and
then, we make external standards known as LOINC and that needs to be
translated -- we have to translate the local code into the standard. So,
my question is, do you think we'll ever get to the point where hospitals
actually use standard codes so we don't have to translate them, and is
there a way we can develop standards that are more intuitive so
hospitals use them rather than have to be forced to use them?

STEVEN STEINDEL: That's a very good question. What we're really hoping
is that there will be an evolutionary flow to the internal use of the
local codes - From the local codes to the standard codes. There's two
aspects of the code, when you say non-intuitive. The first is the actual
code itself, whatever number value or alpha-numeric value we use to
describe the code -- that will never be intuitive. There are very sound
informatics reasons why that will never be intuitive. It has to do with,
you don't really want an identifier code to carry information, because
what it does it restricts your way that you can organize your
terminologies, your oncologies, etcetera. So, the code will never be
intuitive. But, one of the problems with something like LOINC is
actually its organization is non-intuitive. And, I've been working with
LOINC for over a decade, and I've published in this area to try to get
them more intuitive. And, I will have to say this, while you're not
seeing it externally, we're making great strides internally with the
organization of LOINC and how it becomes more intuitive, how it can be
used more for ordering of tests, and how it can flow better. And, I have
to say it's become less of an uphill battle in the last year and a half
because the - for those in the community that are aware, Clem MacDonald
is the founder of LOINC. He's the one that controlled LOINC, thought of
LOINC, etcetera. He has changed jobs. He's no longer at Reagan Street.
He's now at the National Library of Medicine. And, his reaction to the
organization of LOINC has changed greatly. He now understands why people
were complaining about the organization -- so, there are efforts being
taken in that area. So, I do think we will have a flow to more internal
use of the standard terminologies in the next couple of years. Having
said that, we are still going to have tremendously large pockets that
will never shift off of local codes. You take a large hospital system or
you know like Kaiser Permanente which is a multiple provider system --
for them to move from local codes to standard codes would be horrendous.
We're probably always going to have is that mapping and translation
step. What we are trying to do is, is to develop ways to make that more
intuitive and easier and faster.

CHRIS BRADEN: Thank you. One more try for Joe Gonzales for a question.
Are you on the line? Okay, I have another question that's come in, the
question is: Has including non-provider or non-traditional healthcare
providers ever been part of the EHR or will it be apart of the EHR?

STEVEN STEINDEL: From the non-traditional provider point of view in
terms of inputting information and developing the models, actually
they've been involved in the processes. Alternative medicine is a
frequent testifier at NCVHS hearings so that their needs are considered,
for instance. We do look at what's going on in schools, etcetera, and
for their healthcare needs at NCVHS. And, it comes up all the time. Now
that really doesn't directly answer the question. I think what the
question is really somewhat addressed at is, you know, are we going to
have electronic medical record systems or electronic medical information
systems that exist in the non-traditional provider environments, be it
school providers, etcetera. I think the answer to that is yes. They're
already being developed. They're already people using them. I don't know
if we'll call them electronic health records. I don't know if they'll
come under the same certification rigor as the electronic health records
for the traditional providers, but I do believe as the EHRs move out in
the traditional provider space, there will be recognition of how useful
they are in the non-traditional provider space. And, they're also will
be a cry from the consumers who go to non-traditional providers to say,
I want my records kept electronically by you as well. So, I do think
we'll see the voluntary side of standards coming into play and the
marketplace trying to drive that.

RUTH JAJOSKY: Hi Steve, I'm Ruth Jajosky. I was wondering whether you or
someone else from CDC is involved vetting the data elements that are
being developed for NEDSS messaging with the standards development
organizations? And, I was also wondering, if that's true that somebody
is working with SDO on these data elements, whether that's somehow
involved in the certification and registration process for PHIN VADS?

STEVEN STEINDEL: I think the very quick answer to both of those
questions is: No. The reason I'm saying that's a very quick answer to
both questions is - I'd like to raise a question in response to that
then discuss it a little bit. Should items like NEDSS standards, NEDSS
vocabulary, NEDSS terminology go into the standards development process
or should that be a process that's handled internally within the public
health world? It has to go through a consensus building process, there's
no question about that. But, remember, what a standard does is it
freezes time, and the standards development process and standard
development organizations can be a long-term time freeze. When we have
community of practice that has a need, like for instance within public
health, we can achieve consensus because we have a need to achieve that
consensus much more rapidly than exists in the formal standards world.
So the question that I have back to you and you as the broad community
on this phone call, is not necessarily should we take the stand --
whatever we develop as terminology and throw it out to the rest of the
world and say let's discuss the needs, the utility, the modeling,
etcetera, of this. That needs to be done. But, I think the community
that needs to do it needs to be our community. Now, having said that,
once we have a consensus on what those terms should look like, how we
should form those terms, etcetera -- submitting a code to LOINC and
SNOMED is trivial. We send it in, and they post it. That's not
standards; that's really record keeping. That's not part of the
standards process. The standards process if figuring out how to create
and agree on those terms. And, I do feel we need to keep that
internally. I don't know if that directly answers your questions. In
terms of creating the vetting process in public health to do that --
right now, I don't think it exists that well, but I will tell you this:
in 6 months to a year it's going to exist from a - almost a mandated
point of view from the office of the secretary. The reason I say that,
is as we mentioned earlier, there's going to be a public health case
reporting use case. AHIC is going to produce something because the
Secretary is very concerned about the way the process is flowing in
public health. The Secretary also was very concerned in the area of
quality and that was the first set of use cases that HITSP looked at.
There's a great deal of similarity between what's going on in the
quality world and the public health world. There is a diverse set of
quality organizations that have developed their own ways of looking at
the quality arena. When HITSP started to look at this, their original
charge was to develop and point to specific quality measurements. After
a year of deliberation, what HITSP decided they could do, was they could
only point to specific terminologies, formats of areas quality
measurement. For instance, they said blood pressure, which is a common
quality measure, should be reported using LOINC codes. But, they didn't
say where blood pressure should be used in a quality measure. And then
what they said was, the quality organizations need to use what we have
said are the standards and start developing their quality standards in a
way that can be expressed with the data that's available within the EHR
using the standards we have selected. So, they then pass it off, the
actual development of the measures themselves, outside of their process
into the community of practice process. And, my suspicion is that that
is the same way that HITSP will handle the public health use case. It
will take a look at our data elements; it will take a look at the
standards that are there; it will recommend a set of standards. And,
we'll be involved in that process so we'll feed into what the
recommendations are for the standards. And they'll recommend -- like
SNOMED be used for organisms, I'm taking that off the top of my hat
because I want to get into something that's non-controversial. And -
but, they will not say what we will use organisms for.

JENNIFER WARD: As a follow-up to that question: can you clarify what
PHIN VADS is and the purpose of PHIN VADS -- especially as related to
the previous question, program-specific terminology such as NEDSS?

STEVEN STEINDEL: Can I claim the fifth? But with a little more
seriousness than that...PHIN VADS is a very -- I personally think is a
very confusing element that we within NCPHI have really not reached a
consensus on how to communicate to the community. The original intent of
PHIN VADS and what I believe should be the intent of PHIN VADS is that
it should be a repository for the terminologies that programs want to
use in their specific areas. And, they should come to -- they should use
PHIN VADS as the place where that set of terminologies is brought in,
grouped, and then distributed to people who need to report or use that
program. Now, having said that -- and the area where we get involved in
a lot of controversy and grayness -- is, there are overlapping concepts
between programs. And, a program -- and this gets to my example of blue
and blue, - there are various shades that are going on. Where one
program is talking about: they understand this concept to mean -- you
know, when you say the patient is febrile, that program may understand
it to mean that the patient has a fever greater than 100 degrees. Where
another program understands febrile where that patient has a fever over
102 degrees. So, this is where we start getting into some problems with
respect to: how do we express program need within PHIN VADS? And, that
is the specific answers to the questions. This is going to be an area
that actually is going to be, I think, in the forefront of the HITSP
discussions on how to do this because these are not, you know, there are
real reasons why one program defines it at 100 and one program defines
it at 102. Or why one program is interested in international travel in
the last 14 days and the other is in the last 3 days. There are real
reasons for that. And, we have to figure out ways to express that and
develop into terminology systems and public health systems that actually
meet your real needs. You developed that question for a specific reason,
and we have to develop a response, a way to handle it. So, I think that
where a lot of the confusion comes in with regard to PHIN VADS. Because,
we never developed a mechanism within PHIN VADS to handle smoothly those
differences

CHRIS BRADEN: We have one more question from a speaker, from a listener,
saying that you had mentioned that LOINC may be expanded to include some
questions, some epidemiologic questions. Can you give more insight into
this and what kind of questions might they consider - only related to
lab or other areas related to public health?

STEVEN STEINDEL: The reason why I said that is there's been extensive
discussion going on within the LOINC community. Several years ago,
probably about 5 years ago, they started doing this on an exploratory
basis. People realize that you could use the LOINC structures to put
survey questions into LOINC. You know, basically now when you take a
look at LOINC and it gives a laboratory result of name of serum sodium
and it then gives a response of 140ml/dl -- there's an inherent question
that's associated with result that you're getting. What the LOINC
community realized was that there are a lot of surveys that exist in
this fashion. You're asking a very specific question, and there's a
specific answer to that question. So, some research is primarily at
Columbia University, started working with the LOINC community to express
-- the first set were, I think, mental health surveys -- to see if they
could put those into a LOINC format. And, while there were a lot of
tweaks that went on with it, they actually showed that you could express
a large portion of the mental health surveys that are commonly used in
LOINC. And so, the LOINC community started looking at other types of
surveys, like ??? scores, etcetera. And they started to think, can we
express these as LOINC? And, CNS started looking at this with their long
term care facility surveys. And, they funded a project within LOINC to
express their long character of facility surveys as LOINC questions and
answers, and they're starting to use it on that basis. So, those of us
in the community may have looked at it and realized, a lot of public
health work is done in the form of question and answer surveys. And,
LOINC is developing a mechanism to create question and answer surveys --
should we extend ourselves and use LOINC as a repository for our
question and answer sets? Right now, it's being posed as a question. We
have always realized at CDC that it's probably a good idea to develop
some type of standardized repository for public health questions and
answers whether they exist as a specific survey and a group of questions
associated with that, or a subset of questions that are expressed in
this survey. So, we're looking at that as an exploratory research
question and we've been discussing it within the community. There have
been some survey questions already that have been posed to LOINC and
thoughts about putting them in there, and there's still mixed questions
as to how we will do it. So, I think the best answer to that question
is - from an informatics point of view, it's an open research issue.

SCOTT MCNABB: Steve. Hi, this is Scott McNabb of the Division of
Integrated Surveillance Systems and Services. Thank you very much for
coming down to present. Thanks Chris for moderating this. It was a very
interesting and informative presentation. You focused primarily on U.S.
standards development, and of course, we live in a global environment
now, can you sort of describe a little bit about what's happening in the
international arena and how the U.S. standards development work
contributes to the global standards development effort?

STEVEN STEINDEL: This really is, I think, a two phase question, Scott.
The first phase of it is, to a certain extent of U.S. resources have
limited capabilities of working in the international arena, so being
involved day to day with the international standards setting bodies is
something we don't routinely do. Primarily, as you can see we spoke
about already, many of us involved in the U.S. efforts are devoted, you
know -- I won't say what percent of our time, but it's more than 100% of
our time -- working in this area. So, we do not have that much time to
focus internationally. And, if we get more and more people involved,
yes, we'll have to focus internationally. I will say from a CDC point of
view and my position as a Director of Standards, we have surveyed CDC
twice now. One in 2001 and one about two months ago, and one of the
questions we asked was: Should CDC be involved -- and I mean really
involved, not just passively involved -- with international standards
work, and there's virtually a 100% response that said we should. So we
do need to find the resources and the capability to put in this. WE have
a very acute recognition, as you point out, that public health needs do
not stop at the border. Organisms just somehow do not stop at the border
crossing guard. So, we do have to be involved with this internationally.
I have to say, the resources have prevented as much as we can. Having
said that, there are many groups here in the United States that are
involved in the ISO standards for medical informatics. And, we do have
active participation, though not from the federal sector, from the
private sector in that area. What has recently happened is that the
SNOMED had moved from being a college of American pathologist, an
American terminology system, to now that is now controlled by the
international health terminology standards or development organization
which is located in Copenhagen. SNOMED is now developing more of an
international flavor. And the groups that are moving it forward are
doing it from an internationally point of view. I know you've been
involved internationally, Scott. And, I've been involved
internationally, some of the work with WHO -- both of us are involved
with some of their classification terminologies. I have to say it's not
been formal, it's been more ad hoc. Whatever can be done to make it more
formal is definitely needed.

SCOTT MCNABB: Just as a follow-up, can you give us some sort of a
gestalt on -- is the U.S. effort behind the international effort, so to
speak? I know that in Western Europe, you know the creation of
electronic medical records is, you know, very advanced and I'm not sure
whether on the U.S. side are sort of in a siloed environment, so to
speak. Are we going to have difficulty harmonizing the work on the U.S.
side? Unless we get more involved, obviously we face that risk.

STEVE STEINDEL: You know, that question has been asked a lot. You know,
where does the U.S. stand with respect to the rest of the world in terms
of the electronic -- electrification of health care? A very good friend
of mine who -- many of us in the public health community know Dan
Friedman -- was actually commissioned by NCHS to produce a report to
look at the, in particular, the health statistics capabilities of those
of our partner community - internationally - that we think are more
advance in health care standards than we are and we think are having
impact on the public health needs of their community. For those who
don't know Dan Friedman, he's a former state health commissioner for the
state of Massachusetts, and I would say, everybody considers a public
health expert. I can share a copy of the report with you -- NCHS
published it -- but, his bottom line on it was that we're really not
that far different than what's going on in the rest of the world. They
are very good, they're much better than we are about getting data. As
you point out, there's much more penetration of electronic health
systems in those communities. But, they're at the same place we are in
using the data. They have as many questions as we have, with: How do we
use the data? How do we use the systems for it? I would say our getting
involved at this time does not put us behind the curve.

CHRIS BRADEN: We have one more question from a listener. Other than
BioSense's funds, what resources are available for the medical community
to aid in the adoption of standardized codes?

STEVEN STEINDEL: One of the sad parts about the President's initiatives
is that they really haven't provided funding for it. So, I think the
best -- the answer to that question is, they're really -- other than the
funding that groups like CDC put out there to make things available to
the community, primarily responsible to our project. And, it's not just
CDC that's doing it. FDA has similar types of efforts going on and so
does ACHRQ. There really isn't that much funding that's available for
you to do the work in a provider organization. Now, having said that, we
do provide a lot of funding to increase this within public health
organizations, but the provider organizations itself, I'm sorry I have
to say we do not have much funding in that area.

CHRIS BRADEN: Okay if anybody has one more question from the phone
bridge or the audience here, we can take that now. Alright, well hearing
none I'd like to thank Dr. Steindel for giving this lecture today. Very
helpful.

STEVEN STEINDEL: Thank you very much. Thank you.

CHRIS BRADEN: Jennifer, did you want to wrap up this seminar?

JENNIFER WARD: Again I'd like to echo the thanks to both our speaker and
the moderator for this great session. And, I want to thank you, the
participants, for taking time to participate in our discussion today.
Our next seminar series will be held on February 13^th^. The topic will
be measurement and evaluation of integrated surveillance systems. It
will be presented by Matthew Samore from the University Of Utah Center
Of Excellence in Public Health Informatics. We also invite your
suggestions for future topics that would be helpful in advancing
integrated surveillance efforts, and you can do this via email at
<integratedsurveillance@cdc.gov> and you can also, through that email,
ask to join the integrated surveillance community of practice. We have
an online workspace there where you can post future topics for
discussion or questions that you have about topics that we've already
covered. And it can also -- if you have anything that you would consider
useful for others in the area of integrated surveillance, you can
certainly post that up there. And, we thank you again for your
participation look forward to seeing you at the next session. Thank you.