American Health Information Community

EHR Workgroup Meeting #11

November 7, 2006

**Disclaimer**

*The views expressed in written conference materials or publications and
by speakers and moderators at DHHS-sponsored conferences do not
necessarily reflect the official policies of the DHHS; nor does mention
of trade names, commercial practices, or organizations imply endorsement
by the U.S. Government.*

**[\>\>]{.underline}**

Go ahead, Judy.

**[\>\> Judy Sparrow:]{.underline}**

Good afternoon, everybody, and welcome to the 11th meeting of the
Electronic Health Records Workgroup. Just a reminder, to tell you that
all of these meetings are designed to meet the requirements of the
Federal Advisory Committee Act, which means we\'re acting in the public
domain. Notice of the meetings have been set forth in the *Federal
Register*, and the meeting is being broadcast over the Internet,
recorded and transcribed. So I would ask that speakers speak clearly and
distinctly and please identify yourself before you speak.

Also, the public will be allowed to speak at the end of the meeting, and
I think Matt, you have a few call-in procedures. There\'s nobody here
from the Workgroup in the room at the moment.

**[\>\> Matt McCoy:]{.underline}**

Okay, we\'ve got several people who are called in today on the phone.
I\'ll run down all the names. Connie Laubenthal. is here today for John
Tooker from the American College of Physicians. Both our Co-chairs,
Lillee Gelinas and Jon Perlin are here. Mike Kappel is here for Pam Pure
representing McKesson. Ken Waldbillig is here for Mark Lewis from EMC.
Jason DuBois from American Clinical Lab Association. Robert Smith from
VA. Howard Isenstein Federation of American Hospitals. Dan Morreale from
AtlantiCare representing George Lynn.

Anybody who we\'ve missed? Okay. I will just repeat what Judy said for
the members who are calling in on the phone, please speak clearly,
announce who you are before you start speaking so everybody listening
remotely will know who is talking. And keep your lines muted when
you\'re not saying anything.

**[\>\>]{.underline}**

So Matt, I do hear that we don\'t have anyone from CMS joining us today?

**[\>\>]{.underline}**

We do not yet.

**[\>\>]{.underline}**

Okay. All right. Thank you.

**[\>\>]{.underline}**

I think that\'s all our opening business.

**[\>\>]{.underline}**

And hopefully everyone on the Internet sees the Workgroup agenda. And
the next order of business, Jon, I think Jon, I think is the acceptance
of our meeting summary from our October 13 call. We had great attendance
on that call as well, and a number of presenters that helped inform our
work around the financial business case critical components, as well as
others. So are there any comments or additions or corrections to the
minutes? The meeting summary.

**[\>\> Jonathan Perlin:]{.underline}**

This is Jon. I would add particular thanks to the staff office for
really capturing very, very rich testimony. They were terrific
presentations. And I thought the office did a very nice job of trying to
summarize the depth and breadth of material covered in a very long
Friday afternoon call.

**[\>\>]{.underline}**

I agree with you, Jon. I\'m amazed. I can always depend upon the meeting
summary to really capture the meeting. So whoever does that, take all
praise, you do a great job.

**[\>\>]{.underline}**

I will basically thank our support staff here in the room. They\'ve done
a wonderful job. So thank you all.

**[\>\>]{.underline}**

So do we, Jason, Connie, Howard, anyone? Do we accept these?

**[\>\>]{.underline}**

Yes.

**[\>\>]{.underline}**

As submitted?

**[\>\>]{.underline}**

I accept.

**[\>\>]{.underline}**

Yes, I accept.

**[\>\>]{.underline}**

Okay, great.

**[\>\>]{.underline}**

So do I.

**[\>\>]{.underline}**

Any other opening remarks, Jon, from your standpoint?

**[\>\> Jonathan Perlin:]{.underline}**

Just again, to acknowledge all the presenters last time. It\'s
interesting, I\'ve already heard some feedback from people outside \--
people aware on the community call, and I note two things. One, there\'s
traction on this. And two, among the people who really reviewed the work
products or followed along on the Webcast, they were very empathic with
both the challenges and opportunities as so well articulated at a
variety of levels and I think the discussions last week or last time
also set the stage for looking at health records not in the private
office, but in the large-scale setting. And I\'d note that this is not
just in both the private practitioners office, as well as the large
provider system setting, a challenge in the United States, but had the
privilege of attending a meeting in Washington where there was recent
review done, I\'d commend to the Workgroup\'s attention, the work of
Commonwealth Fund which essentially did an analysis of some of the
leading countries\' implementations in health records.

The good news or reassurance is that there are some universals in
healthcare and life and that some of the challenges in terms of
capitalization and motivation, and transcending paper are fairly
universal, but the positive is that I think there\'s a ringing
endorsement that with direction these systems can be implemented in an
interoperable way in a reasonable amount of time, and the work of this
group is tremendously important.

In terms of putting into place the steps, the priority list that we
worked on not at the last meeting but the meeting prior to that, was I
think, in retrospect, a particularly important document and very
parallel to the sorts of documentation that country presenters,
particularly European countries, Denmark as an example, had identified
as the sort of task list toward getting toward interoperable health
record, and albeit smaller but entire countries. So let me thanks the
members of the Workgroup, and, Lillee and the office for the leadership.
I think that these things are necessary prerequisites and do focus us in
the right direction toward getting to the clipboard list world that
Secretary Leavitt envisioned and that (indiscernible) articulated as a
goal for all of America.

**[\>\>]{.underline}**

You know, Jon, it strikes me, given the Commonwealth Fund report and I
know that there\'s a lot of lessons learned. When we think about our
broad charge is around facilitating adoption of health IT, perhaps a
future Workgroup presentation could be around these best practices for
IT adoption in countries other than the United States. We starve for
business cases and best practices that can help fuel adoption in the
United States. And I\'m fascinated by your remarks, I was fascinated by
what I read in the paper yesterday. So I would just put that out as part
of our agenda going forward. I know we\'re looking for better practices
in the United States, and I think Karen, you had led us in the direction
of Cleveland Clinic and we also want to dive a little bit more into the
Veterans\' Administration system, but maybe we should broaden our
horizons for a global perspective for best practices, not just
domestically.

With that, I think it\'s time to move on to the portion of our agenda
where Jodi Daniel was going to help us with a CLIA update.

**[\>\>]{.underline}**

That would be great. Thank you, and Jodi is right here, Jodi Daniel.

**[\>\> Jodi Daniel:]{.underline}**

Good afternoon, everyone. As everyone knows, the recommendation that was
put forth by this Workgroup to the AHIC and was accepted by the AHIC
about CLIA said that ONC should review the possible models for
exchanging clinical and historic lab information and determine which
would require CLIA or HIPAA guidance regulatory changes and/or statutory
change.

We have been working very closely with our friends over at CMS to do
just this. I\'m sorry I wasn\'t able to be here for the last meeting to
give an update, but we have, and had by September 30, identified models
and identified where there might be opportunities for guidance or
regulatory change. We don\'t have specific policies at this point or
recommendations. We\'re still working those out. But we have identified
the models and some areas that we\'re working through with our friends
over at CMS.

So I just wanted to give a brief overview and report back on where we
are. I will give the one disclaimer that I am not a CLIA expert. I\'m
working with the folks that are CLIA experts that couldn\'t be here
today, so if I say anything that sounds slightly off, I apologize. I\'m
going on my best information and knowledge of the CLIA law.

Background. I know everybody knows this, but just for anybody who might
be listening on the phone, basically CLIA was passed to ensure accurate,
reliable, and timely testing regarding the location of the test and
covers all phases of the testing process from specimen handling and
analysis and to result reporting.

Section \-- in the regulations, Section 493.1291-A stated that the CLIA
regulations provide for laboratories to have adequate systems in place
to ensure test results and other patient-specific data are accurately
and reliably sent from the point of data entry to the final report
destination. And Section 493.1291-F provides that the test results must
be returned to the authorized individual or the individual who used
those test results, who is responsible for using those test results.

Those are really the two sections that we\'ve identified as areas that
we\'ve been talking through. The models that we talked about were
clearly the very simple model, which is what occurs on a regular basis
now where the lab sends to the ordering provider the lab results, either
directly or to the provider \-- directly to the provider, could be in
paper now or to the provider\'s EHR that\'s consistent with existing
approaches on paper for sending lab results.

But the two models we\'ve identified where there may be some issues or
some confusion are where the lab sends the test results to the ordering
provider through an intermediary. For instance, through a network or
RHIO.

The third is where the lab, instead of sending it to the ordering
provider would send test results to a treating provider \-- a provider
who is treating the patient, but isn\'t the provider who ordered the
test. And there is some questions there about how that would work under
CLIA.

I think the first one first, where we\'re talking about a lab sending
information \-- sending the lab results to the ordering provider through
the intermediary. The issues that we have discussed with the CMS are in
Section 1291-A, which requires that the lab ensure that the test results
arrive accurately, reliably, confidentially and only hold the labs
responsible for the report getting to that final destination.

So there\'s some questions there about can this be done through an
intermediary. What happens if the \-- if all of the lab data, the lab
report data doesn\'t get to the provider, if it was required under CLIA
but the intermediary didn\'t send all the information and the like. So
we\'re looking at some issues there. Those issues may \-- there may
somebody guidance that we can do there to help address the problem, but
there also may be some opportunities for regulatory changes. And again,
we\'re still working through how to best address those.

With respect to the third model, where the lab is sending information to
a treating provider who didn\'t order the test, this gets to a couple of
issues. One, on authorized persons, since they can only send the lab
test results to an authorized person, and there have been questions that
have come up about who is responsible for using the test. It\'s language
in the regulation.

Again, we\'re looking at how to interpret that language and whether or
not there may be opportunities to provide guidance to clarify if that
could be made available to \-- if the lab results could be made
available to any treating provider, again we\'re talking with CMS about
that. And then there\'s also the issue about authorized person, which
implicates State laws, since the federal regulations defer to State
laws, and State laws define authorized persons. One thing we\'re doing
there is we have just started \-- or just signed a contract with the
National Governors Association Center for Best Practices, to create a
State Alliance for e-Health which will look at various State policy
issues across the States and work toward consensus across the States.
And one of the issues that we\'ve asked them to take a look at is this
very issue, is to look at State laws that, State CLIA laws that define
authorized persons to figure out if there are State approaches to
addressing this issue as well.

So that\'s sort of a nut shell of some of the issues we\'re thinking
about and looking at, and the models that are \-- that we\'re looking at
to identify the issues and identify potential solutions.

And happy to take any questions. I can\'t give specifics on our
deliberative process, as far as the policies, but we\'re hoping to have
some more information, you know, hopefully pretty soon, once we work
through some of this with CLIA, the CLIA folks. We\'re really trying to
figure out how to meet both the goals of CLIA and not try to do damage
to the CLIA laws, but also try to meet the goals of electronic health
information exchange with respect to lab data. So we\'re trying to come
up with solution that is meet both the goals we\'re talking about here
and the goals that CMS has for implementing CLIA.

**[\>\>]{.underline}**

Thank you very much, Jodi.

**[\>\> Carolyn Clancy:]{.underline}**

Jodi? This is Carolyn Clancy. Is there a legal definition of either a
treating provider, presumably this is the person whose fingers are on
the keyboard or the pen. Or other providers seeing the patient within a
period of time?

**[\>\> Jodi Daniel:]{.underline}**

I\'m not aware of any definitions for those terms. I think there might
be an opportunity in talking about responsible for using and perhaps
defining some parameters there, but I\'m not aware of any legal
definitions that would come into play.

**[\>\>]{.underline}**

And the CMS.

**[\>\>]{.underline}**

And does CMS have the latitude to create definitions through a reg or
technical amendment?

**[\>\>]{.underline}**

Sure, they should be able to define terms in their regulations or
statute, probably through regulation. If there\'s ambiguity they might
be able to do it through guidance and we haven\'t worked through what
might require guidance or regulatory change. There\'s no reason they
wouldn\'t be able to create definitions at least through regulation.

**[\>\>]{.underline}**

Thanks. I mean, I\'m just thinking about Medicare beneficiaries who see
anywhere from six to eight to high double-digit number of doctors in a
particular year. You know, so the concept of who is the treating
provider gets real interesting.

**[\>\>]{.underline}**

Right. And I think that\'s something that we probably will need to talk
with them about and one, to see how comfortable they are, since their
rules are one of the goals of their rules is protecting confidentiality
of lab data, that\'s something they\'re going to care very much about to
make sure that not anyone can get access to the lab data but only those
who have \-- who are, quote, responsible for using the lab data and how
do you define that. So I think that\'s something they would actually
very much care about, and we\'ll talk with them more about.

**[\>\>]{.underline}**

Thank you.

**[\>\> John Houston:]{.underline}**

This is John Houston. I apologize, I came in late. Can I ask a question
as a follow-up?

**[\>\>]{.underline}**

Sure.

**[\>\> John Houston:]{.underline}**

You used the word treating physician.

**[\>\>]{.underline}**

Yes.

**[\>\> John Houston:]{.underline}**

I thought CLIA had indicated that it was the ordering physician that was
entitled to receive the report back.

**[\>\>]{.underline}**

Treating physician is not a CLIA term. I was just saying that \-- that
was sort of my description of who else might be trying to get access to
the lab data to treat a patient.

**[\>\> John Houston:]{.underline}**

Okay.

**[\>\>]{.underline}**

The CLIA talks about authorized persons, and it talks about an
individual responsible for using the test results.

**[\>\>]{.underline}**

Okay.

**[\>\>]{.underline}**

My understanding, again I\'m not a CLIA expert, is that there are folks
who interpreted that to mean only the ordering physician.

**[\>\> John Houston:]{.underline}**

Okay.

**[\>\>]{.underline}**

And it\'s not clear if there\'s some latitude to define that more
broadly. So that\'s what we\'re investigating. It doesn\'t say the
ordering physician. It says individual responsible for using the test.

**[\>\>]{.underline}**

Is Jason DuBois on the phone?

**[\>\> Jason DuBois:]{.underline}**

Yes, I\'m being patient.

**[\>\>]{.underline}**

I gave my disclaimer. I figured you were on the phone.

**[\>\>]{.underline}**

I have a follow-up question as much for Jason. As I recollect, I thought
Pennsylvania State law spoke of an ordering individual, ordering
physician, is there variation in State laws that reinterpret or State
CLIAs differently?

**[\>\>]{.underline}**

Yes.

**[\>\>]{.underline}**

I can answer that or Jodi can.

**[\>\>:]{.underline}**

Go ahead, Jason.

**[\>\>:]{.underline}**

Okay. Actually, CLIA is kind of the benchmark, and then States are
certainly permitted to make more stringent laws and in many cases they,
do like Florida, like Georgia, and that\'s in many cases, that\'s why I
think you\'ve heard staff here talk about how they\'re making it more of
the new NGA contract and have States look at this whether their State
laws in particular are creating problems for the transmission of these
lab test results. That\'s certainly been the case in Florida for some of
our members, whereby part of the Medicare health support program had \--
they had these third-party providers that were not affiliated with the
physicians office trying to get the lab results from the laboratories
doing the work. And they couldn\'t do it because it wasn\'t going
directly to the ordering physician.

So States certainly can make and have made the laws that are more
stringent than the CLIA statutes and that\'s actually one of the issues
that we\'ve identified, and so Jason hit it on the head. We\'re trying
to work with States to look at those laws, and see where they might
interfere with appropriate exchange of lab data for clinical care, and
see if there are potential solutions that could be developed at a State
level to address those. So we\'re working directly with CMS on looking
at the Federal law issues, and then we\'re going to be working through
this new State Alliance with NGA to try to address \-- identify where
there are those State laws and they interfere with the closure to other
treating clinicians, again, non-defined term. And to work with them on
potential solutions that they may be willing to implement at a State
level.

**[\>\>]{.underline}**

I did have a comment on the question that Dr. Clancy brought up, but
also a question. My first one is, the ordering physician define is
certainly maybe helpful but doesn\'t answer the whole problem because
there are other entities that are not physicians themselves that, like
access to this data and certainly for treatment purposes, not the least
of which may be disease management organizations, or RHIOs, and that\'s
kind of a good segue into my next question. I know another one of these
difficult setups was not only from the laboratory through the
intermediary to the ordering physician, not from then what the physician
has the test results and decides to share them with other entities, but
how about where a laboratory is sending them directly to the RHIO? Have
you guys talked about any kind of guidance or changes to regulation in
regard to that particular scenario?

**[\>\>]{.underline}**

You mean not to any particular provider, you mean to the RHIO for
keeping a database or something like that.

**[\>\>]{.underline}**

I\'ll give you a great example. If I\'m not mistaken in the Indiana
Research Institute setup, they operate in such a way that physicians
sign a VA agreement with the RHIO, and actually the lab result, once
performed by the laboratory; then sent directly back to the RHIO and not
the ordering physician, so they\'re actually then populating that result
to the physician, they have a VA agreement with.

**[\>\>]{.underline}**

I think that would be \-- I mean, that\'s basically the intermediary
model that we talked about through \-- that it would go through a
network or RHIO, before going to the provider or that would be sort of
the vehicle to get it to the provider so there would be some kind of
intermediary that would receive the report and be passing it through to
the provider.

**[\>\>]{.underline}**

Yeah.

**[\>\>]{.underline}**

I can see that in one \-- I can definitely see that, but I guess I\'m
kind of creating a distinction between a RHIO-type entity and then
vendors themselves who are changing the content and appearance of that
electronic result.

**[\>\>]{.underline}**

Yeah, I mean I think we basically lump those together. What I just
talked about as a model, I was lumping those together. I said through an
intermediary. It could be a network or vendor. I think both of those are
issues, they may pose some slightly different concerns, although there
are a lot of similarities there. Since the lab is responsible for
getting it to the person responsible for using it or to the authorized
person. If they\'re sending it through an intermediary, whether it be a
vendor or a RHIO, that raises questions with their obligation to get it
to the final report destination.

**[\>\> Ken Waldbillig:]{.underline}**

This is Ken Waldbillig. I\'d like to ask a question. This conversation
is relative to informed consent relative to the ability for the circle
of trust to be created a priori. That is to say that it\'s very
difficult to establish the potential interrelationships and the need for
access. But yet my question comes back to the concept of rules-based
access control to the information, regardless of whether it\'s an
intermediary or not. So is there any legislative thought to the
definition of methods to supply that informed consent to the established
circle of trust? And then once you have that initial circle created,
methods to update it as needed.

**[\>\>]{.underline}**

I\'m not sure I quite understand the question. I mean, we\'re looking at
here whether or not CLIA posed any obstacles to sharing of lab data. So
there isn\'t a consent requirement that I\'m aware of in CLIA.

Clearly, HIPAA would apply, the HIPAA privacy rules would apply and
HIPAA security rules would apply. So as information is being shared for
treatment purposes, that\'s usually a permissible disclosure under the
HIPAA privacy rules. If there are \-- if they\'re sending it through an
intermediary, there may be other requirements like business associate
agreements, or there might be other ways that it could work depending
upon how the network is set up. But we would be looking to existing law
to at this point to identify what kind of privacy requirements would
need to be complied with and we haven\'t at this point identified HIPAA
privacy or security rule barriers to electronic sharing of lab data.

**[\>\> Connie Laubenthal"]{.underline}**

This is Connie Laubenthal with ACP. I think that under some of this
it\'s really guided primarily by State law, because in many States the
ownership of the laboratory data is the physician\'s, not the
patient\'s. It\'s not up to the patient who gets, it it\'s up to the
physician who gets it because it\'s in the medical practice laws of
various States that it says the physician orders the laboratory tests,
the laboratory tests must be reported back to the physician who was the
authorized person. So a lot of the way that HIPAA allows things is not
the same way that CLIA would allow things because CLIA does defer to
those State laws.

**[\>\>]{.underline}**

Absolutely. And I think those State laws actually are \-- limit the
ability to share information beyond what would be permitted under HIPAA
in some cases, particularly because of those State laws. And under HIPAA
State laws that are more stringent or more protective of privacy remain
in effect, so I think that\'s exactly on-point and accurate. And you
know, again to the extent there are State laws that would preclude
appropriate sharing of lab data, you know, electronic sharing of lab
data for clinical care, we would be asking the State Alliance the NGA is
setting up to take a look at those. There are some State laws like that
that we are aware of. And we\'ll be looking at those and seeing if there
are \-- if there are opportunities or \-- and interest in the States to
modify those consistent with the discussions here.

**[\>\>]{.underline}**

This is Connie Laubenthal again. I was wondering if I could ask a
question. What I wanted to know is during your discussions with CMS, was
there any discussion or maybe it\'s not far enough along down the trail
yet, regarding if there were any changes to regulation or guidance, how
that would be monitored by the inspectors of the laboratories?

**[\>\>]{.underline}**

I\'m sorry, I\'m not following. If there were changes to regulations,
how the inspectors would \--

**[\>\>]{.underline}**

Yes, I\'m particularly thinking about in a RHIO model or something along
that lines, if the CLIA regulations were changed such that \-- or the
State regulations were changed such that they could release data to a
RHIO, you know, would \-- had there been any thought about how the
inspectors would go about verifying that the data was actually getting
to the RHIO, to the record ordering provider, et cetera, et cetera.

**[\>\>]{.underline}**

Yes, thanks for clarifying. I understand your question now. We have had
those conversations. Those are very much coming up when we are talking
about the disclosing information to an intermediary and their concerns
about making sure that the information is appropriately, one. protected,
and two, shared with the authorized user. So \-- and that in fact all of
the data is there intact and in the right format. So that\'s actually
one of the concerns about using an intermediary. As I understand it. And
it is something that we\'re talking about, about whether or not there
may be approaches, again guidance, regulation, and whether or not
inspections or certifications, what kind of approaches there might be to
providing comfort in the disclosure to those intermediaries.

So all of that is on the table.

**[\>\> Jason DuBois:]{.underline}**

This is Jason again. Can we talk a little bit about timeline again? I
know that you guys had been aiming for this November 7 date of the EHR
Workgroup call to have some deliverables ready to talk about here at the
Workgroup and then likely share then with the community later on.

Where are you guys going from here in terms of working with CMS on some
more concrete solutions?

**[\>\>]{.underline}**

Well, my understanding, and I\'m not obviously a member of this
Workgroup, so I\'ll defer to Karen if she has other thoughts as well,
but the recommendation was \-- that we should review the possible models
and determine where there are areas in HIPAA that may require guidance,
regulatory change by September 30. We have done that.

As far as what policies we end up proposing, if it\'s a regulation
obviously we will go through a proposed rule and get comment. We\'re
still working on internally, and typically a rule-making process, the
options and decisions on what\'s proposed would be worked internally but
there obviously would be opportunities for comment by anyone who is
interested in doing so. So I\'m not sure that there is that we would
necessarily vet options with the community. I think our charge, as I
understand it, is to \-- is to remove the barriers that were identified
\-- to identify barriers as requested by this Workgroup and by the AHIC,
to try to assure that the information could flow appropriately
consistent with the breakthrough. So I\'m not sure what the November 7
deadline was, but I\'m not aware of a November 7 deadline.

**[\>\>]{.underline}**

I just know that the community had kind of hoped to have some not
resolution, but some action on it in a short time frame. And that\'s
really all I was hoping to get at.

**[\>\> Karen Bell:]{.underline}**

Jason, this is Karen Bell. I think that was a September 30 date that we
needed to identify the models and think through guidance versus
regulation. But that was really as far as that recommendation went. So I
think what we were hoping to do today was to update everyone on the fact
that we\'ve looked at the models, we\'re looking at options for guidance
and looking at options for regulation.

But that it is unclear at this point whether CMS \-- where CMS will go.
So we can\'t really come back to you and basically say that there\'s a
recommendation that CMS will go in a particular way with CLIA. Or that
there will be other legislation. So this is primarily to inform everyone
that there is ongoing work, we have identified the models, we\'re
looking at guidance, we\'re looking at regulation. But so in essence we
met the September 30 request, but we don\'t yet have any further action
steps and we are continuing to work with OGC, and CMS to see if those
action steps could come forth.

**[\>\>]{.underline}**

Like I said, if there were any proposed regulatory change, and I\'m not
committing that we\'re doing that, but it is something we\'re
discussing. If there are any proposed regulatory changes that would go
through a full public process of full notice and comment process. I
don\'t believe that there are added steps of taking it through the AHIC
to come up with specifics. We\'re sort of in the sausage-making process
at this point and trying to work through the options through the
department.

**[\>\>]{.underline}**

Okay. Thank you.

**[\>\>]{.underline}**

Of course, we have gotten lots of input from ACLA, and we appreciate
your input and your insights and a lot of help you\'ve provided in our
providing to understand what some of the issues are.

**[\>\> Jason DuBois:]{.underline}**

Happy to help support the Department.

**[\>\>]{.underline}**

We appreciate it.

**[\>\>]{.underline}**

Thank you very much. Happy to report back, and we\'ll look forward to
having some more news in the future.

**[\>\>]{.underline}**

Thank you very much, Jodi. And I would just like to interrupt for one
minute, this is Karen Bell, to let you know that Bart Harmon has joined
us here in the room as well, from the Department of Defense. So we have
a fairly robust group today, and thank you all for joining us.

**[\>\>]{.underline}**

May I comment on one other thing?

**[\>\>]{.underline}**

Lillee and Jon?

**[\>\>]{.underline}**

Please.

**[\>\>]{.underline}**

I also wanted to share with everyone that last month we had a formal
presentation of the work being done by GW, and Harvard on adoption
measurements, and the work that has been done with the first annual
report on adoption in the United States. You may recall that David
Blumenthal and Sara Rosenbaum were here earlier to our Workgroup and
presented some information on that.

The interesting thing is that the latest figures indicated that the
adoption rate is actually a little different than what they initially
thought. We\'d been thinking that it had been about 17 percent in
physician offices. However, if you are less specific about what an EHR
might be, and you consider almost any type of electronic support, it\'s
probably a little higher, 25 percent. But if it you really get down to a
more specific definition, from an EHR, one that has the basic
functionalities of the IOM that we had talked about earlier, then it
turns out the rate is even below 10 percent. About 9.3.

So we are internally here readjusting our thinking of our baseline in
physician offices. We\'ve had a lot of discussion with the Blumenthal
group and GW. And we are, as I say, rethinking what baseline adoption
and physician\'s offices is right now and it\'s really only about 10
percent. So I just wanted to call your attention to that and to the fact
that the full annual report is available on the Web, at rwjs.org.
That\'s the Robert Wood Johnson foundation who actually put the report
out for us.

So thank you very much for the opportunity to share that.

**[\>\> Jonathan Perlin:]{.underline}**

Karen, this is Jon Perlin. Let me just comment on that. I had the
pleasure of doing the presentation of this report at the Commonwealth
Fund meeting last week and it\'s terrific work and I think that it
behooves all members of the Workgroup to really take a look at this
because it amplifies some of the testimony that David Blumenthal
provided to AHIC a few months ago, and that really dives into a great
deal of depth of understanding the levels of functionality and their
location and really what the opportunities are to make the improvement.
So it\'s just a phenomenal resource.

**[\>\>]{.underline}**

Maybe we really do need to dive into that, Jon, if it\'s something that
we need to at least illuminate a little bit more.

**[\>\>]{.underline}**

I think I\'m either having David Blumenthal or his co-author perhaps
present that to the group would be useful, and they can whittle it down
to a fairly succinct summary.

**[\>\>]{.underline}**

Karen and Judy, can we make that happen?

**[\>\>]{.underline}**

We certainly can; we\'re putting that on the list, along with the
Cleveland Clinic presentation and the VA presentation. Both of their EHR
systems.

**[\>\>]{.underline}**

Great.

**[\>\>]{.underline}**

And we\'ll talk more \-- we\'ll see what we can do about the
international as well.

**[\>\>]{.underline}**

Thanks.

**[\>\>]{.underline}**

Thank you.

**[\>\>]{.underline}**

More we know, the better we can do.

Jon, are we ready to move on to the gap analysis?

**[\>\>]{.underline}**

I think we are.

**[\>\>]{.underline}**

Karen or Judy, who will lead this discussion on our behalf?

**[\>\> Karen Bell:]{.underline}**

It\'s probably going to be me. This is Karen Bell. Before we begin, I
just would like to set up the context for this report. Again, for those
of you who might not have been on the call early yes, Alicia Bradford I
think did a fabulous job pulling together the \-- some of the
information that has come through from all of the wonderful and
excellent public testimony that we\'ve had over the last several months.
And grouped it in five different categories. Actually, ones very similar
to the ones that came from the Blumenthal report. Privacy and security.
Medical, legal and regulatory issues. Technology issues. Organization,
cultural issues. And then lastly the financial, business case issues.

And what we were hoping we could do today is to run through these with
one goal in mind. Actually two goals in mind. The first one is to
recognize that ultimately, we will be making recommendations to the
American Health Information Community, which they will then consider for
recommendation to the Secretary about ways that we could either remove
barriers or further enable health IT adoption in primarily physicians
offices, because we\'ve been working in that realm up until this point,
and while we certainly will be going into other areas, particularly
inpatient shortly, we do need to make recommendations on the ambulatory
side.

So as we go through these, we think about what could be, at least some
early recommendation types that we might want to think about for the
future. And then secondly, what other public testimony or what other
gaps should we be considering? And I\'m just thinking a little bit
already from an earlier conversation for Dr. Clancy, Carolyn, the
question about what is it that constitutes a treating physician? Just
having that sort of definition might be something that we should be
addressing as time moves forward here and we could put \-- consider that
perhaps to be one of the gaps we need to work on.

So that over the course of the next few meetings, we can address the
gaps, bring in any other information we need, and then begin to flesh
out the critical recommendations that this group will want to make to
the Secretary through the AHIC or to the AHIC and then ultimately to the
Secretary moving forward.

We have some time. We initially thought we were going to try to get
recommendations to the AHIC by December, but as it turns out, the
Secretary is going to be in China on December 12, and there are many
other interesting things happening as well. I know that a number of you
will be attending IHIE. So that that meeting is likely to be a call-in
meeting to address some of the use case priorities that were discussed
at the last AHIC meeting on the 31st of October.

So the timing on these recommendations goes well into 2007. So we have
January, February, perhaps even into March, depending upon how our
processes go. But again the ultimate goal is that the Workgroup will
formulate some very specific recommendations and if not every one of
these five areas, at least some of them that the American Health
Information Community can consider and then perhaps move on to the
Secretary.

So we need to make sure that we have all the information here in front
of you to be able to make that process occur.

So are there any questions about the process or the timing? Hearing
none, I\'ll just continue.

**[\>\>]{.underline}**

Thank you.

**[\>\> Karen Bell:]{.underline}**

As I mentioned earlier, we put information and data in five different
categories. It\'s not complete, it\'s not perfect, but it\'s designed to
at least get some discussion going and to help us think through the
process. The very first of these was privacy and security. And I know
that on, you\'re on the call and you\'ve been very much involved in the
Privacy and Security Workgroup. While we didn\'t give you any heads up
on this, I\'m wondering at this point whether you have any thoughts on
additional work that this group should or can be doing on privacy and
security, knowing that you\'re overseeing a lot of recommendations that
the group made and off the Privacy and Security Workgroup to address.

From your experience and from your past work, do you know of any other
gaps that we need to fill at this point, or any other recommendations we
should be moving towards? And then I\'d open it up to everyone else.

**[\>\>]{.underline}**

That\'s a loaded question, wow. I think my dilemma is this with regard
to Privacy and Security and Confidentiality Workgroup. It\'s that right
now they\'re focused very specifically on a couple of key specific
issues that they\'ve identified, or the Chairs have identified. And
really they\'re focused today on the issue of identity-proofing. And so
I guess my response in one sense is going to be that this Workgroup
needs to tee up what it thinks are the predominant privacy concerns, the
securities concerns, confidentiality concerns that need to be addressed
by that Workgroup. I\'m trying myself, trying to pull in the stuff I\'ve
done with NCVHS, to make sure there\'s some understanding of the key
issues. I my thought again is that we need to make sure it\'s clear to
them exactly where we think the issues lie. And one of my concerns right
now, and I\'ve said it in the Workgroup; that we\'re right now, that
Workgroup is focused really solely on identity-proofing and that\'s just
one little piece of a bigger issue related to privacy and security. And
so I want to make sure that that group understands that there are \--
understand there are other issues that these other Workgroups feel are
important in order to address the broader issues that are associated
with NHIN. And I think if you look at this list, you know, CLIA is a
great example of an issue that really needs to get on everybody\'s radar
screen, and I know it\'s being handled and in a way that Jodi indicated
earlier, and but it\'s also being \-- I don\'t think necessarily people
that are outside of this Workgroup here necessarily know that it\'s
still an issue that needs to be addressed. So again, I think we just
need to continue to inform that Workgroup of all the different things
that we see as being barriers. Not that I\'m not trying, but again I
think it helps to have the chairs also reiterate some of these issues.

**[\>\>]{.underline}**

You know, I want to just let you know that in most of conversation that
is I\'ve had, as I try to cascade what we do in AHIC to broader groups,
and I don\'t know whether you had numbered these, Karen, by priority,
but I will tell that you privacy and security is the one that trumps all
in many respects. And I think if we\'re able to make some sound
recommendations here, it will go a very long way toward adoption. I\'m
not saying that the other issues aren\'t critical. They are. They most
certainly are critical. But this privacy and security piece is the one
that seems to trump in most of the conversations, as well as financial.
If I had to put two side-by-side, where there\'s more exasperation than
innovation, it would be privacy and security, and the financial piece.
So I don\'t know how much more testimony we\'ll have to hear on that \--

**[\>\>]{.underline}**

I don\'t think we need \-- personally, I don\'t think we need to. I just
think we need to continue to raise the issues of privacy as being real
important overall to this Workgroup and offload that part of the work to
the other Workgroup. But I still think it\'s vitally important that we
raise the fact that there\'s a lot of issues other than
identity-proofing. I think we\'ve probably done enough root work on that
and we need to look at some of the real compelling privacy issues. And I
know I raised \-- I sent the entire group the NCVHS letter on privacy,
which was sent regarding NHIN, which was sent to the Secretary, and I
think that was a real good laundry list of issues that really are going
to get in the way of things like what we\'re trying to do to get
adopted, if they aren\'t addressed.

**[\>\> Bart Harmon:]{.underline}**

This is Bart Harmon. There have been a number of sidebar discussions
within DOD, and in conjunction with other groups. It seems like what
we\'re bumping up against is almost a quantum step or paradigm shift up
to this point, two organizations or five organizations or six
organizations that all knew each other, got together and agreed to trust
each other to access each other\'s health information, and the quantum
leap to trusting a cloud of affiliates who we may have no direct
relationship with seems to be something that gets a lot of us stuck.
It\'s hard to know how to make that leap of trust from a patient privacy
perspective and legal perspective, into trusting a crowd of people in a
consortium, many of whom will have no direct relationship or knowledge
at all. I just throw that out, I\'m sorry it\'s not a constructive
recommendation, but maybe if we recognize that if there is any agreement
that we\'re bumping up almost a quantum shift in what we\'re trying to
accomplish, we might realize where some of this additional sticking
points are. The laws all seem to be written in with that in mind and
many of the RHIOs are close groups of organizations that all know who
each other there\'s a greater sense of trust there.

**[\>\>]{.underline}**

Good point.

**[\>\>]{.underline}**

I\'m wondering, in the interest of moving this agenda forward on privacy
and security, whether it might be helpful to re-circulate that letter to
everyone, and consider whether or not this Workgroup would like to
either take it as is or make some modifications to it. And essentially
use the Workgroup itself can submit that letter on its behalf. In order
to really push the privacy and security issues forward. Is that sort of
a step that sort of begins to make sense?

**[\>\>]{.underline}**

I\'m happy to receive it. I think that\'s a good idea.

**[\>\>]{.underline}**

Okay, so as a followup item here, we will re-circulate that letter that
Jon had put together. And ask everyone to consider it, consider its
language and consider how we might either use it or use parts of it \--

**[\>\>]{.underline}**

You\'re talking about the NCVHS letter, right?

**[\>\>]{.underline}**

Yes.

**[\>\>]{.underline}**

Our collective wisdom, not my letter.

**[\>\>]{.underline}**

Thank you.

**[\>\>]{.underline}**

Sure.

**[\>\>]{.underline}**

On how we might either take parts of it or use it in whole, and support
it as part of a possible recommendation coming from this group. I\'m not
saying it would be, but just something to consider.

**[\>\>]{.underline}**

I think DOD has it spot-on. We have to discuss methodologies for the
creation of that circle of trust from the cloud.

**[\>\>]{.underline}**

Honestly, I think the problem I see right now is that there\'s a lot of
detail that need to occur but I think there\'s a lot of policy that
first had to be decide upon before getting to the detail about the cloud
and how you trust and proof identities and things like that. We can\'t
create the detail and the architecture and the like until we understand
how we\'re going to deal with the policy issues related to privacy.

**[\>\>]{.underline}**

So your sense is that we have the policy issues first, and then the
architecture and technical solutions flow from that. Does that make
sense to everyone else?

**[\>\>]{.underline}**

Absolutely.

**[\>\>]{.underline}**

Karen, there was a term used at our September AHIC meeting that I think
really resonated with \-- and VA members as well \-- is the term "policy
interoperability," as important as technical interoperability. And you
know, I just \-- I concur with that.

**[\>\>]{.underline}**

My biggest fear is that people start going down the road to engineer
solutions, technical solutions, and nobody has a strong common sense of
what the policy is that they\'re trying to develop these solutions
around. You can develop a lot of different solutions technically. And at
the end of the day they\'re based on somebody\'s understanding of what
they think the policy might be.

**[\>\>]{.underline}**

The cloud might exist in the policy demand, because at the end of the
day you\'ve got to be able to come up with a few ideas that make
assumptions about that policy cloud. And I think someone said it
already, the more that you have knowledge about, what those policies
are, the better decisions you can make relative to the detail. But if
it\'s policy clouds, we have to engage, there\'s obviously an impact on
the timing.

**[\>\>]{.underline}**

This is very helpful. I\'m taking away, forgive me if I\'m putting words
in people\'s mouths, our need to really articulate a sense where clearer
policy needs to be articulated within the federal government with
respect to confidentiality and privacy. Particularly around EHRs. And
subsequently there will need to be this technical applications put in
place. But I think having that NCVHS letter via John would be a good
place to start.

**[\>\>]{.underline}**

The letter is on the NCVHS Web site and I can send it if need be, but it
might be as quick for whomever wants to circulate it to go to the
Website and it should be there. It\'s a letter on privacy of the NHIN.
So I forget the exact title but it\'s really \-- that\'s what it\'s
intended to be and fairly exhaustive letter, quite long.

**[\>\>]{.underline}**

Is it clear by looking at it that we can glean where we make
recommendations?

**[\>\>]{.underline}**

The letter itself has a variety of recommendations and some of the
recommendations are crouched in what further needs to be done to come to
an answer.

**[\>\>]{.underline}**

Does it address the State regulatory issues that may have some diversity
in them?

**[\>\>]{.underline}**

I guess to some degree, but I don\'t think to the degree of speaking
about CLIA and the like.

**[\>\>]{.underline}**

The CLIA interrupt is obviously a critical component to, it but the same
issue holds true, is that we need to establish the \-- some level of
clarity in the policy space that not only at the national but the State
level. Some of the same security issues we talked about at the State
level are more stringent than CLIA.

**[\>\>]{.underline}**

Well, let\'s not mix security and privacy because we\'re talking about
two different issues. I think we\'re still talking about privacy.

**[\>\>]{.underline}**

Right, thank you.

**[\>\>]{.underline}**

And with that, just one more question, forgive me for the granularity of
the question. But in the recommendations in the letter, is the
government sector addressed and is the private sector addressed, or is
it more global overall?

**[\>\>]{.underline}**

Global. I went to the Website and I looked up \-- the title of the
letter just so you know, it\'s "Recommendations Regarding Privacy and
Confidentiality in the NHIN". So it\'s specifically speaking of the NHIN
as opposed to private versus government. And it\'s actually accessible
from the very front of the NCVHS Web site, ncvhs.hhs.gov. There\'s a
green box at the middle of the front page and fourth letter down. It\'s
there. Click on it, it will come up.

**[\>\>]{.underline}**

A last question, it\'s been some time since I read that. That\'s
applicable also to EHRs?

**[\>\>]{.underline}**

No, because there was \-- it\'s really intended to be applicable
directly to NHIN, recognizing that provider EHRs really were governed by
HIPAA and by State laws that really needed to necessarily function a
little bit differently, and there still needed to be a separate set of
rules for those. Because what I think the expectation was, what a
provider could do with its information in order to provide care may be
different than the way that information may flow over the NHIN, and the
rights of the patient, otherwise. So it really was intended to focus
directly on NHIN. And not try to displace in large measure HIPAA, though
it does \-- I think there\'s still some thought that there might be \--
need to be broader applicability of HIPAA as well as maybe some other
changes necessary to support the concept of the NHIN.

**[\>\>]{.underline}**

One of the things \-- I don\'t mean to complicate this, but one of the
things that has come up in talking with other physicians, and I\'m not
sure whether it belongs in medical or legal or the privacy and security,
is the secondary use of clinical information. And this is an important
feature, for instance, if we\'re talking about quality reporting. Where
information is going to another source. To assess the quality of
clinician care. Research is another example where information can be
used for second area purposes, it comes from an EHR.

**[\>\>]{.underline}**

Appropriately anonymized, I\'m sure.

**[\>\>]{.underline}**

And we certainly talked about appropriate anonymization for public
health. But when you get into some of the other issues, research, et
cetera, I\'m not quite sure how that would go. But I\'m throwing out to
the group, do you think that\'s an issue that we should be thinking
about in terms of the privacy and security as well?

**[\>\>]{.underline}**

By the way, the letter does speak of secondary uses, just so you know.
And I think secondary use is definitely fair game from my perspective,
because I think one of the areas that I think is going to cause a
backlash from patients and consumers, will be that if they find out
it\'s NHIN, which is being touted as a way to improve healthcare and
services provided directly to them, now if they find out there\'s all
these secondary governmental use, some will they really didn\'t want to
sign onto.

**[\>\> Howard Isenstein:]{.underline}**

This is Howard. Some of you should be aware AMIA, came out with a white
paper on the topic of secondary uses of data and a lot of stuff on
privacy and security in there.

**[\>\>]{.underline}**

I\'ll tell you, a great person to work with, to speak to about second
area use is Mark Rothstein who is the chair of the privacy subcommittee
at NCVHS, quite compassionate and compelled authorizations and things
like that.

**[\>\>]{.underline}**

Should we have a presentation on that?

**[\>\> Carolyn Clancy:]{.underline}**

I think that would be terrific. This is Carolyn. And we\'re struggling
with this issue a bit as well because we\'ve put out this draft guide to
patient registries. Which if any of you have extra energy, we\'ve we\'re
open for extra comment until the end of the month. They struggled with
this issue as well. I don\'t think it\'s just government uses or quality
reporting. I think it\'s a whole array of purposes and I actually think
it\'s an area where policy interoperability is going to be quite
crucial. Now, how much of that the community takes on and how much of
that is articulated for their consideration and trying to figure out
what the boundaries of their specific role is here; not so clear to me.

But just to make it very focused for one moment, you know, the same data
from an electronic health record that can be used for quality reporting
can also support public health functions and so forth, which is good.
That\'s the whole point. At the same time, however, that often means
there are multiple parties who think they\'re in charge. And we kind of
hear that up the wazoo.

**[\>\>]{.underline}**

One of the things I hear and I get the sense, there\'s a great concern
out of consumers this is like sort of another version of a land grab.
That all of these people that are doing research and public health and
other types of things, all this data is being \-- this great opportunity
to do things that they otherwise couldn\'t do before. And this is, I do
hear people say they\'re concerned that they don\'t mind that it\'s for
purposes of treatment, but boy, I can\'t believe fill in the blank that
X is doing what \-- wants to do what with my data?

**[\>\>]{.underline}**

It\'s awareness of those elements that would potentially be used for
secondary purposes, versus the individual information as to what \-- I
mean, you start to look at the elements themselves, right down to the
ZIP code, you know, and anything above the ZIP code essentially is
blocked. For all potential uses. The real question is who is in charge.

**[\>\>]{.underline}**

Yep.

**[\>\>]{.underline}**

Right.

**[\>\>]{.underline}**

Who is going to set the mandate, the regulatory policy that says this is
the only methodology for anonymization that will support the secondary
application of the information.

**[\>\>]{.underline}**

And you realize one thing, too, is that no de-identification is going to
be perfect, and there will be still concerns out of individual to say,
you still can\'t de-identify my data enough to satisfy me that my data
won\'t become available to whomever. An opt-in and opt-out process is
going to be required.

**[\>\>]{.underline}**

That\'s the only way I think they\'re going \-- they\'ll still say I
want it for my treatment but I can\'t believe you allow this data used
for other purposes. And there are people out there that really believe
that this is something they should be able to do by default without any
thought that the patient has any right to opt in or opt out.

**[\>\> Carolyn Clancy:]{.underline}**

This is Carolyn. I think all of your points are reinforcing why policy
has to drive architecture and not the other way around. Because if
architecture comes first, then suddenly it all becomes too costly. To
get \-- you know, to explore \-- that limits the space in which policy
considerations can be discussed. And you know, my sense from the State
contracts that we are doing with ONC is that people are still getting
their heads around what secondary uses actually mean.

**[\>\>]{.underline}**

Right.

**[\>\>]{.underline}**

And to be honest, there\'s a level at which we\'re all getting our heads
around what that means.

**[\>\>]{.underline}**

There are uses for the data that we haven\'t even thought of yet.

**[\>\>]{.underline}**

Yes.

**[\>\> Bart Harmon:]{.underline}**

This is Bart. I was in the two-day AMIA offsite meeting putting together
that white paper and if we think making health information available for
healthcare purposes is complicated and multidimensional, it\'s probably
a magnitude greater when we talk about secondary uses, and there\'s a
lot of really a lot of concern among well-informed patient groups
because they realize how the Internet works and how technology works,
and once you let the cat go you can\'t get it back in the bag. There\'s
a lot of concern. Maybe somebody models where the patients could be more
empowered to decide case by case, although I don\'t know that we\'re
well-informed enough to know what those models would be.

**[\>\> Jonathan Perlin:]{.underline}**

I agree. This is Jon Perlin. I think there\'s another aspect which is
educational. I think a lot of us are so sensitive to the privacy
aspects, the impositions on the use of our personal data for business
purposes. But at the same time, we expect of our healthcare systems,
care that is a certain quality. We\'ve not emphasized there is
potentially a social obligation to contribute information to a greater
understanding for knowledge development. I note that the Institute of
Medicine has recently started a clinical round table on learning health
systems. Again, another aspect of secondary uses of health data, natural
byproduct of clinical activities, new knowledge that would be a common
good. And it\'s been pointed out in some of the other countries that
referenced a while ago, with respect to the Commonwealth Fund meeting
there\'s an expectation that knowledge contributes to national dataset
for public health improvement for discovery, et cetera, and so I would
just note that we not lose track of an educational lift in terms of
helping to articulate the good uses, the good secondary uses, of these
data, as a social good that\'s probably desirable while simultaneously
respecting privacy. And so given the privacy sensitivity, I want to make
sure we leave a marker on the table that there are good social values
that we would also seek to support. And I know \-- I believe the
Secretary also has articulated that interest.

**[\>\>]{.underline}**

You know \--

**[\>\>]{.underline}**

That\'s the crux of it, yeah.

**[\>\>]{.underline}**

I know that this whole secondary use piece, Karen, I know the staff are
busily writing a lot, but I just get down to the granular level and see
the manual process that\'s in place right now around quality data
reporting. Quality performance, clinical performance, whatever you want
to call it. And I agree with Jon, at the end of the day, how are we
going to get past a 45 percent defect rate in the clinical care in the
private sector?

**[\>\>]{.underline}**

There\'s only one answer. You have to have real-time evidence. You\'ve
got to be able to get to it.

**[\>\>]{.underline}**

You\'ve got to be able to get to it. So I think these are the gnarly
issues we\'ll have to deal with and not shun them. But there\'s a huge
education for the public, around this issue. There\'s no doubt about it.

**[\>\>]{.underline}**

Let me throw another argument out there. What happens, though, if this
fails on its face, simply because of the fact that there is such a
concern from the public that data \-- their data is unilaterally made
available for a variety of secondary uses, and that because of that, the
people frankly get upset and there\'s a huge outcry against it? The
reason why \-- what I\'m trying to get at is that the first and most
important thing is to provide data for the purposes of treatment. And I
think that then the secondary uses are just that. They\'re secondary.
And I\'ve heard people say what\'s wrong with at least from the
beginning, saying the only thing we\'re going to use this data for
initially is going to be for the purposes of treatment. Once we have
that down and figured that out, then we should go on to the next tier of
things, the secondary uses which have great value to our society, but
really need to be second in the discussion about making this data
available.

**[\>\>]{.underline}**

The only way to capture it in the first place is because there\'s going
to be clinical value to the data.

**[\>\>]{.underline}**

That\'s the point. So lead with that and allow people to be comfortable
with the value they perceive out of a NHIN, and then after they perceive
the value, then you start to say there are these great secondary uses
and now we need to explore those in some kind of framework, rather than
trying to throw everything together at one time and people having a gut
\-- a response that\'s like I don\'t like this. And I\'ve heard it
already, and I think it\'s going to continue, and we have to be mindful
of that.

**[\>\> Ken Waldbillig:]{.underline}**

Any change is difficult. I think that \-- and this is Ken Waldbillig. I
wanted to just say that the rationalization for an electronic health
record is to improve the quality of care for the individual first, but
then to learn from the evidence, obviously, it\'s empirical, we know
that. What we\'re talking about is the ability to allay the fears of the
masses that have an opportunity to opt in or opt out. In that
environment, I think that it\'s difficult for someone to be upset if
they choose to opt in, as long as they have a rational way to decide.
Right, they\'ve got supporting evidence to make a decision. So it\'s
really not \-- the line \-- the Rubicon can be crossed only if you have
\-- I\'m not quite sure what kind of consent you named it in your
letter, dedicated consent, I guess it was. The key was \-- the key word
was consent. And once you achieve the consent, then you have the
opportunity to tremendously enhance the evidence opportunities to
improve care across the Nation.

**[\>\>]{.underline}**

Whoever brought up, and I got lost in the track of who was making which
comments, the concept that perhaps we start with clinical value. I think
the challenge with that is actually clarifying what we mean by clinical
value. And I\'d sort of be interested in what Jon thinks about that his
experience at VA. If clinical value is what happens one-on-one between a
clinician or organization and a patient, and I\'ll use that term
generically, that could include other people who have some impact on
patient care directly. That\'s one thing. If clinical value is being
able to examine patterns of care for groups of individuals with similar
characteristics, you know, then I think the boundary lines between
primary and second area get kind of interesting. The other point I\'d
just make is I never overlook the opportunity to learn when a bunch of
smart people are sitting around, you know, also examining this issue and
I think Markle is taking this on in a serious way which might be one
pull of the debate but it would be interesting to see what they\'re up
to.

**[\>\> Jonathan Perlin:]{.underline}**

This is Jon. Just respond briefly to Carolyn\'s point. I think you\'re
right on target. I think as the electronic health record became
understood by the patients as reliable source of their health
information, I think there\'s some understanding that it\'s also useful
for helping not only them as a patient with diabetes, but patients with
diabetes in the VA. And so I think that line does get blurry, and concur
with the opportunity to learn. But that it needs to be framed around the
value to the individual. I think just bluntly, we can count on people\'s
appropriate self-interest, yet I think what we need to convey is that
self-interest is also well served by being able to under the health
service delivery in a more sophisticated way than paper allows us. But
what becomes blurry is that the term "secondary uses" then, you know,
does unfortunately encompass the things that they think people would
positively respond to, as well as things that people have become sort of
socially concerned about in terms of their privacy.

**[\>\>]{.underline}**

Jaded, actually.

**[\>\> Mike Kappel:]{.underline}**

This is Mike Kappel. As an action item, I\'d hate to lose suggestion
that Dr. Clancy just put forward. And Markle Foundation and Connecting
for Health certainly has done a lot of work on this area and I would say
their work as really been two-tiered. The first tier was focus on what
are the policies associated with privacy in the network health care
system or network health care environment. And I think if we have
longer, since we might have until March before publishing final
recommendations, it might be worth the time to review those policies as
they were developed. I think they can do that fairly succinctly.

And second is as Carolyn mentioned, they are moving on to policies,
similar policies regarding secondary use of data. But I don\'t think \--
they are just beginning that process and I don\'t think they\'ll have
much substantive to add. But it would be interesting to at least learn
their plan to tackle it could we can take advantage of the lessons
learned there.

**[\>\>]{.underline}**

Well, we\'re certainly going to have a lot of followup from this
discussion. So we will get back to all of you in terms of how \--
actually will ask you exactly what it is you would like to \-- out of
the extended list here, what you would like to hear at the next
Workgroup, because we have lots of different options here from AMIA, the
Markle Foundation, as well as policy review. We even have the
possibility of hearing from Indiana in terms of how it\'s dealing with
privacy issues in CLIA, and RHIO. So we will look at some options here
and get back to you in terms of what you would like to hear at the next
Workgroup meeting.

Then we can think forward how to put forward some recommendations that
really will move the adoption agenda forward.

**[\>\>]{.underline}**

I would still, again, with regards to privacy specifically, I think we
should be looking at what recommendations we make to the other committee
in terms of doing research and testimony and work on \-- rather than
trying to do it ourselves.

**[\>\>]{.underline}**

Uh-huh.

**[\>\>]{.underline}**

Which I\'m not sure whether that\'s implied or not with what you just
said.

**[\>\>]{.underline}**

No, we\'ll certainly look to see what everyone else is doing as well.
But in terms of information us, clearly there is \-- there are some gaps
in terms of what everyone has heard and everyone has been exposed to. So
I think we can at least address some of those gaps at the next meeting.
Are there any other comments on the privacy and security piece?

I\'m going to move along into the medical/legal aspects, and apologize
for the fact when this was first put together, some of Peter Basch\'s
comments were cut off at the end of the presentation here, so I\'m just
going to add to you for those of allow have the written or the printed
out copy and are not looking at this on line, at the very end the
discussion on the unresolved medical/legal questions related to the use
of an EHR, and health information exchange, and that\'s where the
document cuts off.

So those issues have to do with a \-- the question of does access to an
EHR elevate the standard of care? Will information access via a HIE,
information exchange be considered part of a medical/legal record or
just a source of information? There was the question of outdated
documentation schema, particularly in the era of fast-moving upgrades to
21st-century medicine. And then lastly, what about anticipating new
errors, caused by HIT, or HIE-enabled medical care, where a new error
from an EHR is faithfully propagated through pull-down lists and a
number of other approaches rather than being caught and modified early
on. And then the other issue that he was concerned about was a
measure-centric rather than patient-centric care. So I do apologize for
those having not printed out, we will fix the document so that it will
print, and send you another version of that.

But that aside, you have here listed a number of issues related to
medical/legal concerns that may inhibit the adoption of EHRs. We\'ve
already had the discussion on CLIA, and there will be some followup on
that. But I\'m wondering, in your own review of the document, whether
there are things here that jump out as being particularly important,
that you would like to hear more about, or some areas that perhaps we
again need to add a little bit more in terms of gap analysis and assure
that you have all the information you need to think through
recommendations in this area. I\'d also just add that there are a couple
of other places in the document that you have, Chuck Parker from
Masspro, outlined physician concerns about some certain legal
implication when you have additional data available via health
information exchanges. Or patient-centered aggregation of data that may
influence physician decision-making. And then the concept of malpractice
really was also mentioned by Dr. Rippen in her presentation a while back
but we didn\'t have very much information on that other than the concept
that there\'s a possibility that there are some areas where you do get
malpractice relief for EHR use. So I just wanted to point out that those
are in other parts of the document but they are certainly referable to
medical/legal issues as well.

I guess my first question is whether or not you would be interested in
hearing more about malpractice relief. Hello?

**[\>\>]{.underline}**

Yes, we\'re still here.

**[\>\> Lillee Gelinas:]{.underline}**

This is Lillee. I mean, I can tell you that I hear an awful lot about
that. I was just at the board meeting of one of our regents last week
and the CEO brought up that issue very specifically, almost exasperated,
saying I don\'t know how we\'re going to get over this hurdle.

**[\>\> Jason DuBois:]{.underline}**

Hi, this is Jason Dubois, similarly, I think it\'s a big issue for many
of our member companies, including the pathologists that work for them
that we struggle to see some way to abate the problem and the costs
affiliated and it\'s starting to restrict care across the country.

**[\>\>]{.underline}**

Are you saying malpractice relief or are you dealing with the issue of
not having complete information and the risk issues associated with
that?

**[\>\>]{.underline}**

I think it\'s relief from the cost of malpractice, not so much
malpractice relief. But as one can document better, then there is the
possibility that malpractice rates could perhaps be decreased.

**[\>\>]{.underline}**

Financial implication.

**[\>\>]{.underline}**

So because of the adoption of \-- you mean a physician\'s use of the
NHIN?

**[\>\>]{.underline}**

Not NHIN, but an EHR.

**[\>\>]{.underline}**

An EHR, okay.

**[\>\>]{.underline}**

Now, on the other side of the coin, there are the concerns that a number
of clinicians have raised about their responsibility to patients or when
managing large amounts of data that they\'ve not had before. So I think
it can be a double-edged sword which is why it might be helpful \--

**[\>\>]{.underline}**

That\'s the issue I\'m more interested in, because I think physicians
are going to say I\'m overloaded or what happens if there\'s certain
data available that I don\'t see because maybe it wasn\'t available at
the time I requested it, or how am I going to be expected to take all of
these volumes of information and the time I have, distill that down and
make a decision. What happens if I miss something?

**[\>\>]{.underline}**

Cornerstone is the ability to classify the data at the point of
ingestion, essentially a value statement placed on data and then
establishing an information life cycle to the data such that from a
liability perspective when both State or Federal regulations say that
data should no longer exist, that there are automated methodologies in
place to remove the liability.

**[\>\>]{.underline}**

I\'m thinking more immediate. Issue of data that \-- I mean, if the
physician is now overwhelmed with an enormous amount of data
theoretically available to him or her, how does that person, that
physician, make a critical decision without fear they\'ve missed
something simply because the data is somewhere and they haven\'t seen
it?

**[\>\>]{.underline}**

That\'s a reasonable question. The fact that the data exists in other
forms today doesn\'t change the fact that it exists.

**[\>\>]{.underline}**

But if it\'s something in theory now patients expect to be readily
available. Oh, I had this test done somewhere else, why didn\'t you see
it? Or you know, if you have a PHR, where the patient every day is
charting their blood glucose levels and they have diabetes, is it now
the expectation that physicians are going to be able to see that
something is going wrong with that patient? Some trend? And that data,
should data be available if that patient is inputting into a PHR in.

**[\>\>]{.underline}**

The responsibility for the physician to know that it exists is tied to
their inclusion in the circle of trust at the beginning of the care
cycle. Or throughout the care cycle, if they\'re added to that circle of
trust. So there are some responsibilities, I would think, from a
clinical perspective, if in fact they were added, giving access to that
patient\'s information. And they chose not to look at it. And it became
evident essentially that was value to believe the care, then there\'s
some implied responsibility. If it was electronically made available to
them.

**[\>\>]{.underline}**

I\'ll give you a great example, though, I had this discussion about
three or four months ago with a group of radiologists at one of our
hospitals who was concerned with some of the technology they have now in
some of the CT scanners they\'re running. And they were very concerned
that what happens if I\'m brought in on a consult to look at a specific
part of a CT scan, related to the patient\'s specific complaints, and at
the periphery, at the edges of the image there\'s something else that
boy, if I was looking at, that\'s also abnormal and needed to be dealt
with. Am I going to be responsible for looking at the entire image or
what the patient \-- the part of the image associated with the symptoms
or the complaint that the patient was concerned with?

**[\>\>]{.underline}**

The reason for the exam in the first place, to find a specific malady,
and based on the radiologist\'s interpretive focus is not concentrating
on what might be a peripheral area that had had an abnormality, is your
point, correct?

**[\>\>]{.underline}**

Well, the physicians are asking that. They\'re asking what their
obligations are and it\'s becoming more acute because of the amount of
data that we can now collect and store off of these images.

**[\>\>]{.underline}**

Even in the old days, I mean, where the films were hand-tanked, fixer
and developer were used to improve the latitude of these films, and the
change of the technology, rapid processing, 90-second processing
emerged, and of course the old radiologist would say of those rapid
processing films are terrible relative to the original methodology for
developing the films. But it doesn\'t matter. At the end of the day, the
images that were there presented the information and they were forced to
give that cursory review of the entire volume of information that may
not, because of rapid processing technology of the day, included lots
more films because there was just more to be done in that protocol. So
if the clinical protocol defines the volume of information, there\'s a
reason for it. There\'s a clinical discipline, a protocol that\'s
established and best practice, essentially that says if we\'re looking
for this malady, here\'s the protocol. In the information is there, the
question is, is he or she going to look for that information and does it
become a liability if they don\'t see it? I think that thread continues
back to the beginning of the diagnostic process and has for some kind.
The question is, are we litigious to the degree to which now because the
information might be electronically available to more individuals, for
secondary purposes, that we increase the liability of the physician?
That\'s a challenge. That\'s.

**[\>\>]{.underline}**

That\'s the point, though.

**[\>\>]{.underline}**

Yes, absolutely.

**[\>\> Karen Bell:]{.underline}**

One of the things I\'m wondering \-- this is Karen Bell. Whether or not
we would like to hear from a couple of good malpractice lawyers in this
arena that might be able to help us really clarify some recommendations
of what could be possibly be recommendations going forward. Is that
something the group would find helpful?

**[\>\>]{.underline}**

Yes.

**[\>\>]{.underline}**

Yes.

**[\>\>]{.underline}**

Karen, framing it around recommendations, because we can hear testimony
all day long.

**[\>\>]{.underline}**

Yes.

**[\>\>]{.underline}**

But the so what, what\'s our responsibility here, what are our
recommendations.

**[\>\>]{.underline}**

It might be better to speak to somebody, an attorney that has an ethics
background, too.

**[\>\>]{.underline}**

Okay, we can certainly bring in several for that type of public
testimony. So thank you.

Do you have a comment, Bart?

**[\>\> Bart Harmon:]{.underline}**

Just that I believe I have heard attorneys say that there\'s an
obligation to exercise due diligence to look for things that are
reasonably be available to include picking up a telephone, digging
through stacks of paper, and clicking on a screen. I think it would good
to hear from those people to validate that. The rules may not be that
different just because it\'s available electronically.

**[\>\>]{.underline}**

Did you capture that? That\'s a great point.

**[\>\>]{.underline}**

Well, I think we have two issues there. One, how physicians can mitigate
their liability. And then to understand a little bit more about
malpractice relief and that may go back to the reimbursement model. With
your permission, I\'ll move on to the next section, the technology \--
technological section.

**[\>\>]{.underline}**

Good.

**[\>\>]{.underline}**

And we have had a lot of very, very good testimony in terms of the
technology, and I actually took the prerogative, which you are free to
edit to your heart\'s content, of thinking that the kinds of comments
that we have here actually fell in five categories. So I\'m just going
to throw those out to you and see if they make sense.

One, clearly were a lot of issues around interoperability and we have
spent quite a bit of time determining which data elements are most
important to be made interoperable in the near term and later. But the
second one was mentioned in a number of places, and that is the immature
state of clinical decision support. A third one is technical support or
better technical support for care coordination, care across multiple
clinicians or multiple sites. A fourth one is the ability for physicians
to essentially do population health management on their own population.
They really in terms of being able to assess the degree to which
they\'re taking care of their patients the way they would like, without
having it being reported anywhere, and then fifth, is the area of
usability. Making sure this \-- the technologies truly are not only
affordable, but also very easy to use, very user-friendly for the
clinician. And I don\'t know if those of you who have read all of this,
or whose memory is better than mine in terms of all of the points that
have been made over the last few months, can comment on those five
options or can add to them. That might be a good point for us to discuss
whether or not we need to think through hearing any more testimony about
any of these areas. Do you want me to run through them again?
Interoperability, immature clinical decision support, support for care
coordination across multiple sites, ability to self-assess, do
self-assessment through EHR on your own population, useability.

**[\>\>]{.underline}**

Karen, one thing that strikes me is, again, I think the state of, the
state is different in the government sector than it is in the private
sector.

**[\>\> Karen Bell:]{.underline}**

That's true.

**[\>\>]{.underline}**

And I keep making that distinction because it presents a dilemma in some
respects around recommendations.

**[\>\> Karen Bell:]{.underline}**

Should we be thinking primarily in terms of the private sector, here?

**[\>\>]{.underline}**

If we are, we should make that clear.

**[\>\> Karen Bell:]{.underline}**

And use our knowledge base from the public sector to inform the private
sector?

**[\>\>]{.underline}**

I'm looking for advice from others, but I just see a drastic difference.

**[\>\> Jonathan Perlin:]{.underline}**

This is Jon Perlin. I think it's not just contextual in terms of the
experience, for example, in VA, of having implemented it, but
(indiscernible) boundaries in terms of health records. (indiscernible)
It just is a non-boundary. So I think that distinction is, it may tee up
some of the regulatory opportunities to facilitate adoption, as well as
from the experiential or contextual component, some of the history that
led to adoption.

**[\>\>]{.underline}**

We were able to break down the barriers more quickly than I think the
private sector would currently be comfortable with, so I think defining
the private sector, within the context of this document, as kind of the
focal point, would be best.

**[\>\>]{.underline}**

I would agree.

**[\>\> Karen Bell:]{.underline}**

Okay. We'll make that clearer. Thank you. Your thoughts about missing
information, gaps in testimony that you'd like to hear on the technology
side, or do you think we've pretty much covered it?

**[\>\>]{.underline}**

I'm comfortable with what we've heard, Karen. This is not one where I
think there's a huge knowledge gap.

**[\>\> Karen Bell:]{.underline}**

Okay. And unfortunately, Blackford Middleton could not join us today,
but I'll certainly get his input as well, and if there's anything
additional he thinks is important, we'll certainly share that with you
publicly.

Moving on then, into the next large category, the
cultural/organizational changes that are necessary to help the adoption
process, and again, I think we're really talking here, primarily in the
private sector again, but we've heard, again, a lot of really good
testimony, and right in the beginning, I remember that you, Connie,
presented all of the wonderful things that the ACP is doing, as well as
the AAFT, IHIE, in terms of adoption assistance. We know that CMS is
doing a lot in this area, but that, as the Blumenthal study pointed out,
it's hard to really help clinicians make that jump from paper to bytes,
or to electronic use, without a lot of support, whether it's consulting
support or tools, to really help them make the workflow change, get
their office changed, set up the geography different in their office, so
while there's a lot going on, I guess the question that I have of you
is, is there more that can be done, and if so, what kind of a
recommendation can we make on it, and if we need to hear more in terms
of what's being done then we'll have to look and see if we can find more
information on support for workflow change.

Carolyn, you're still on the line?

**[\>\> Carolyn Clancy:]{.underline}**

Yes, I am.

**[\>\> Karen Bell:]{.underline}**

Your, now one of the things that we had talked a little bit about at
another time, when Scott was with you, was some of the work that's being
done through AHRQ, but we didn't have very much of that listed here. Is
there something that perhaps someone from AHRQ can suggest in terms of
how to better support organizational change in physicians' offices?

**[\>\> Carolyn Clancy:]{.underline}**

Without question. We're also doing a little work with IHIE, I want to
say this is coming up in a few weeks, essentially focused on the
challenge of distributing this wisdom across fairly heterogeneous sites
to get to some common lessons, or pearls, I guess, in terms of making
this work for your practice.

**[\>\> Karen Bell:]{.underline}**

So that might be something that could be of value.

**[\>\> Carolyn Clancy:]{.underline}**

Yes.

**[\>\> Karen Bell:]{.underline}**

Well, that would be great. We're going to have to find some way to
better support physicians who want to more forward with EHRs through the
transition process. I don't think people quite realize how painful it is
unless you actually go through it, so I must say both Richard Baron and
some of the other doctors who have presented, Ken Ralston, I thought
were quite eloquent in the pains of, describing the pain. So anything we
can do to minimize that would be good.

**[\>\> Connie Laubenthal:]{.underline}**

Karen, this is Connie Laubenthal, with ACP. We're actually involved in a
grant project right now, dealing with a number of practices around the
country, and doing some workflow analysis and also looking at their
practices in a more global view, including the implementation of EHRs.
I'm not really sure at this point, since I'm not directly involved in
the project, as to how much would be publicly available as

far as information of the progress of that project. But I think it might
be something that if \-- you know, I could check and see \-- and
there\'s a potential for the Dr. Michael Barr, he is the head of that
project.

**[\>\>]{.underline}**

Sure, that he might be \--

**[\>\> Connie Laubenthal:]{.underline}**

That he might be available and I think he could provide a lot of light
since he\'s just physically been in 36 different practices in different
areas of the country.

**[\>\>]{.underline}**

That would be great.

**[\>\>]{.underline}**

It\'s a group practices, I\'m sorry?

**[\>\> Connie Laubenthal:]{.underline}**

Yeah, they\'re group practices of varying size.

**[\>\>]{.underline}**

Different clinical disciplines or \--

**[\>\> Connie Laubenthal:]{.underline}**

Well, they\'re internal medicine practices, though I think there\'s some
subspecialty like gastroenterology, versus general internal medicine. So
he may be able to shed some light on that. I\'m not sure whether it\'s
to the point where it can be public knowledge or not. I\'ll have to
check to see if that\'s a potential.

**[\>\>]{.underline}**

That could be great, Connie. We\'re really \-- I don\'t think we have
another Workgroup meeting \-- when is our next Workgroup meeting?

**[\>\>]{.underline}**

January.

**[\>\>]{.underline}**

We don\'t have another one until January. So we have a little bit of
time before the next meeting. That would be great.

**[\>\> Connie Laubenthal:]{.underline}**

I think their report that will be public, I think is in late December.
But I\'m not 100 percent sure of the time frame, so that might actually
work out. I\'ll be back in touch with you about that.

**[\>\>]{.underline}**

Okay.

**[\>\>]{.underline}**

Thank you all. Actually, if my bones have any sense at all, they\'re
probably going to have to be focusing more on what we might think about
in terms of the financial area, the business case area for EHR adoption.
So I\'ll move into that right now, and I think you\'ve put it quite
nicely, Lillee, a little bit earlier when you said security and privacy
and finances are the two biggest issues with respect to physician
adoption of and EHRs.

Again, we\'ve had quite a bit of testimony here that\'s come from a
number of different sources. On how much should actually cost to
implement an EHR, what it costs in terms of lost productivity. What it
takes to get the productivity back. We\'ve heard about some creative
ways of perhaps offsetting the cost. We also heard about a couple of pay
for performance programs that transitioned from rewarding for system
adoption, to rewarding for outcomes, recognizing that it takes several
years of implementing and working with the system to actually get to
better outcomes. So there are a number of approaches that we\'ve heard,
and again my question to you all is whether or not you would like to
hear more about any one of these particular areas. As we start thinking
through any possible recommendations that we might be able to make in
terms of helping physicians deal with the adverse business case that
they have right now.

**[\>\>]{.underline}**

You know, just a small thing, Karen, when we\'re talking about this
financial domain, so to speak, if we could note the business case there,
because for some, the financial metric may not be the totally
encompassing area of what is the business case, because the business
case includes a number of parameters. And they even bring in some of
those cultural and organizational factors. But if we could maybe in
parentheses when we\'re talking about that critical component, put in
the business case so it\'s clear that\'s what we\'re trying to achieve.

**[\>\>]{.underline}**

Right.

**[\>\>]{.underline}**

I was struck by just a personal doctor\'s appointment I had two weeks
ago at my dermatologist and I was fascinated by their completely
electronic EHR. Huge practice here in South Lake, Texas, just
unbelievable. So I had the opportunity just to sit right there and talk
to the staff and to the physician about the business case. And the
physician said there\'s no way they would go back, that it was a very
short period of time, where implementation took place. It was arduous in
terms of scanning and moving what was the paper record into the
electronic format. It was amazing how much the staff applauded it. So
I\'m wondering if there\'s something around the business case in terms
of staff retention, staff satisfaction, some of those things that may
not be as transparent if everyone thinks we\'re just talking about
money. But it\'s all those factors that go into successfully running
large physician practice. Not just the physician adoption per se.

**[\>\>]{.underline}**

I would suggest an assessment of the total cost of ownership \--

**[\>\>]{.underline}**

There you go.

**[\>\>]{.underline}**

The TCO, relative to the hard cost, yes, but more importantly, which I
think you\'re alluding to, is the soft cost. Over the life of the
technology investment and human resource investment required.

**[\>\>]{.underline}**

Uh-huh.

**[\>\>]{.underline}**

Now, one of the other things you mentioned, Lillee, was this was a large
physician practice, and clearly one of the things we\'ve learned from
the Blumenthal study is that there\'s a definite disparity between the
larger practices and the smaller physician practice. And that\'s the
adoption gap that we\'re trying to deal with right now. So I think that
maybe one of the things we might want to put a little bit more emphasis
on it really looking at what\'s the difference in those two settings.

**[\>\>]{.underline}**

Thank you, Karen, maybe I did not frame that correctly. This physician
practice only has two physicians.

**[\>\>]{.underline}**

Okay.

**[\>\>]{.underline}**

It\'s huge in terms of patient reach. And my curiosity was piqued
because of the throughput that this practice is able to accomplish and
clearly when you talk to the staff and you talk to the docs, it is the
electronic enabling of the work. Everything from prescriptions going
straight to the pharmacies electronically, physicians being able to
bring up medical records at home, or look at lab reports or X-rays or
whatever, very similar to what I saw in the Veterans\' Administration
when I was talking to physicians making rounds at the VA Medical Center
there, you know and talking to the physicians about how there\'s this
seamless process that occurs. I was just fascinated by that. I\'ve been
looking for it in the private sector just to see where the beacons of
light are, and there are some.

**[\>\> Ken Waldbillig:]{.underline}**

I would like to further suggest \-- this is Ken. That Blackford is not
on the call today and in his absence I\'d like to reference his work of
October 6, where he mentions the financial impact net benefit or total
provider of 34 billion, the payers, labs, the numbers are staggering. So
from a financial metric perspective, and investment strategy that would
include maybe State and Federal government, to try to seed this problem,
this financial barrier to make the incentives so compelling that we have
just a hard approach to overcoming the adoption issue. Ultimately to
save lives.

**[\>\>]{.underline}**

Would it be helpful if we started off doing this type of a summary for
you to get this kind of a conversation going, would it be helpful for
you if we were to then go back and write a more comprehensive summary of
each topic, particularly this one, that looks at all of the various
issues, how they\'ve about addressed in a way that might sift out
possible ways of thinking about recommendations? Or do you \--

**[\>\>]{.underline}**

I think that\'s a good idea.

**[\>\>]{.underline}**

Or do you think we have enough here?

**[\>\>]{.underline}**

I think you have enough here.

**[\>\>]{.underline}**

Okay.

**[\>\>]{.underline}**

Is there anything else you would like to hear? One of the things I was
\-- I would just throw out. I\'ve been hearing from a lot of payers,
that they\'re supporting e-prescribing. And in fact some are even doing
pay for performance around e-prescribing, because there is a return on
investment there for the payer. And it clearly addresses patient safety.

The problem, and I don\'t need to bring this to any of you, is that
e-prescribing is just one small subset of the use of health information
technology, and it\'s not a full-fledged EHR and certainly not a
full-fledged interoperable EHR. But I\'m just wondering if that\'s
something of interest that perhaps you would like to hear a little bit
more about? Or whether you think that\'s too narrow in scope for us to
address?

**[\>\>]{.underline}**

Why would you say it would be too narrow?

**[\>\>]{.underline}**

Because e-prescribing is a stand-alone, not integrated necessarily. In
fact, most of it is not integrated into an electronic health record and
our charge is electronic health record.

**[\>\> Jonathan Perlin:]{.underline}**

This is Jon again. Let me note one of the interesting conversations at
the International Health Policy Forum, e-prescribing in a number of
countries was a segue in adoption. One of the interesting pivot points
that allow people to get traction. So both an endorsement for that
perspective, but also a note that maybe it\'s not out of bounds either
if it becomes a catalyst toward broader \--

**[\>\> Jason DuBois:]{.underline}**

This is Jason DuBois. Just to build on that point, I think the
Department has already come out on that. I mean, with the latest
release, they demand an e-prescribing component be a piece of whatever
electronic health record hardware or software is donated, that it has to
include an E-prescribing component. They\'ve already stepped out to say
this is so important it has to be part of whatever software you\'re
donating.

**[\>\>]{.underline}**

That\'s very true. And again, I think there are arguments on both sides,
that\'s why I presented it. It certainly sounds like it might be
worthwhile for us to at least hear what\'s being down around
e-prescribing and various approaches that payers are using to pay for
performance and otherwise to support that.

**[\>\> Robert Smith:]{.underline}**

This is Rob Smith from Department of Veterans Affairs. I would really
endorse that as well. I think that one of the things that could be part
of this particular section on sort of cultural issues are the pathways
to adoption and this could be an important stepping stone, as Dr. Perlin
pointed out.

**[\>\>]{.underline}**

Okay. We will certainly explore that a little bit more as well.

And you folks didn\'t know it was going to come down the pike, we have
lots more to do, right? Any other questions or comments about this
particular exercise or where it\'s going?

**[\>\> Bart Harmon:]{.underline}**

This is Bart Harmon. I really hesitate to step into this, but maybe use
I\'m a neutral third-party to it, it\'s a little bit safer. There\'s a
perception among some private practice physicians to my understanding
that pay for performance is frequently a pseudonym for withhold, if you
don\'t do what we want you to do. And they pay the full rate \-- the
full rate customer gets for paying for performing, not more for pay for
performing. I know there\'s a feeling out there whether it\'s true or,
not that 300 billion plus at stake in terms of savings and yet there\'s
no formula to act to truly pay that savings back to the people that are
delivering the healthcare. I apologize if that\'s a big sticky ugly
subject that shouldn\'t be ventured into. There is a way to pass those
savings back to the people actually delivering care and align the
incentives. I think it would go a long way to help adoption.

**[\>\>]{.underline}**

Well, thank you for your comment because it really is the issue with the
business case. Yeah. Misaligned business case.

**[\>\>]{.underline}**

I just don\'t know, I haven\'t heard of anyone really proposing things.
I\'ve heard of studies that talk about hundreds of billions that could
be saved, and \-- but I haven\'t heard recommendation that is could help
align those things and what they might be is over my head which is why
I\'m hesitant to even bray it up.

**[\>\>]{.underline}**

A lot of people call it risk sharing, a new term is gain sharing. I
think that\'s what you\'re alluding to is a way to incentivize the
physician community to \-- if they\'re going to take risk, there\'s also
going to be a joint gain.

**[\>\>]{.underline}**

The whole paradigm is being perceived as the latest stick by many
providers rather than carrots ever being offered.

**[\>\>]{.underline}**

You know, with Jon and Bart here, are there incentives, are there
incentives, gain sharing types of options in the government sector that
worked that could inform the private sector?

**[\>\> Jonathan Perlin:]{.underline}**

You know, let me start on this one, is that I think it\'s interesting
point that in VA there really were no gain sharing. It was the really
the ability to look at data publicly and compare outcomes. Generally
they were more at the aggregated level of a clinic or facility. Not to
reward a specific provider.

I would also note in the private sector, that there\'s a lot of
regulation around what can and cannot occur with respect to gain
sharing, but I think we have to acknowledge at this point that was very
fairly brought up that a lot of \-- and we heard this from the \-- in
our physician testimony, last meeting, that a lot of the lift is helped
\-- has helped to be on the back of the front line clinician with the
dividend really returning to a different entity, in that instance the
payer. And I think in the VA community what was \-- one of the conducive
factors was that provider at large and the payer at large were one and
the same entity and so the efficiency gains were enjoyed by the same
group that that took on the lift.

Let me switch to Bart and ask your comments.

**[\>\> Bart Harmon:]{.underline}**

I think that\'s probably one of the reasons you\'ve seen the DOD, and VA
move out fairly smartly, that we are providers and payers at the same
time, and so those incentives are inherently aligned by virtue of who we
are in that regard. And in the case of our providers, they\'re generally
salaried one way or another and if they see one less patient in a given
day because they\'re implementing an EHR, that\'s not an expense to the
individual provider, so there\'s no misalignment in incentives in terms
of punishing them for what we want. The organization makes the
commitment to do this for the greater good and the organization incurs
whatever expenses are required to make it happen. And recoups any
benefits that come through having healthier populations. I just don\'t
know how to extrapolate that well to the non-government world where
payers and providers are separate entities. I haven\'t seen any good
models to make that happen yet.

**[\>\> Jonathan Perlin:]{.underline}**

Let me \-- Jon Perlin again. Let me just note I think there are some
experiments nationally and my understanding and perhaps others on the
call that are more knowledgeable, that there are entire communities
essentially where provider groups and payer groups have essentially
identified a way of structuring incentives for implementation of
electronic health record on the bet that improves quality as well as
efficiency. Utilization. And I think there\'s a good bit of that going
on in Boston. That may be particularly informative toward trying to get
to this \-- I believe, most fundamental question of aligning the
incentives and making the financial case viable.

**[\>\>]{.underline}**

Blackford said it during the last meeting, his experiences, and I think
that he clearly stated that a standard order sets had emerged as a
result of that pliability between payer and provider.

**[\>\>]{.underline}**

One of the things we can do is check with Blackford to see how far the
evaluation of the project in Boston is going.

**[\>\> Jim Sorace:]{.underline}**

This is Jim S. I just hopped on from CMS, I apologize for being late.

**[\>\>]{.underline}**

Hi, Jim.

**[\>\> Jim Sorace:]{.underline}**

I actually might \-- I can talk with him tomorrow.

**[\>\>]{.underline}**

That would be great.

**[\>\>]{.underline}**

Any other comments on this at this point? Because if not, I think we are
fairly close to the end of the meeting.

**[\>\>]{.underline}**

We can all go out and vote now.

**[\>\>]{.underline}**

That\'s right. We\'re done a little bit early today.

**[\>\>]{.underline}**

A little more civic duty.

**[\>\>]{.underline}**

Great.

**[\>\>]{.underline}**

One of the reasons we were crisp today, Karen is the great work that was
done putting this document together.

**[\>\>]{.underline}**

Yes, thank you.

**[\>\>]{.underline}**

And I have to tell you, when I first saw, it I don\'t think I had an
appreciation for just how much we had considered in the course of this
Workgroup. So I really want to commend all the Workgroup members because
this just reflects a whole lot of listening time, and knowing that we
need to move to analysis time now and recommendation time. But I know
this is tough work, but thank you very much.

**[\>\> Jonathan Perlin:]{.underline}**

Jon Perlin. I would just amplify and add to that and I thank Lillee and
the staff at ONC for their leadership. Lillee, reminds us that we have a
task at hand which is to translate the analytic into the recommendation
to help to direct this process forward. So we have a good bit of work
ahead.

**[\>\>]{.underline}**

And we do need public comment to make sure we\'re on target. Karen, is
this the appropriate time? Matt, I see you\'ve put a \--

**[\>\> Matt McCoy:]{.underline}**

In sections of this always, members of the public who are following
along on the Web can see the call-in number and brief instructions on
their screen for making a comment. And if we\'ve had any members of the
public call in to this meeting during the course of it, they need only
press star-1 on their phones to get buzzed through. We\'ll give it about
a minute and I\'ll jump in and let you know if anybody calls.

**[\>\>]{.underline}**

The date for the next meeting?

**[\>\>]{.underline}**

We don\'t have that date.

**[\>\>]{.underline}**

Do we have the next meeting set, or we need to set it?

**[\>\>]{.underline}**

We\'re still working on the date. We don\'t have the exact date yet, but
we\'ll let you know.

**[\>\>]{.underline}**

I know it\'s January, but we\'ll let you know as soon as we have it, so
you can plan appropriately.

**[\>\>]{.underline}**

2007 calendar \-- the 2006 calendar was very helpful for me.

**[\>\>]{.underline}**

Yes, it was.

**[\>\>]{.underline}**

We are trying to do several things. We definitely want to avoid Friday
afternoons, so we were very careful about that. And we are trying to
arrange the Workgroup meeting so that they fall at times when it works
better with the AHIC meetings as well. We\'ve had some situations where
we\'ve had a Workgroup meeting, then an AHIC meeting and then a
Workgroup meeting, and it\'s been hard to coordinate the work across all
of that. We\'re really trying very hard to keep that coordination in
2007.

**[\>\>]{.underline}**

Well, and it\'s really been helpful, too, to have cross-Workgroup
representation, having Carolyn here is extremely valuable, knowing
she\'s heading the Quality Workgroup and the convergence of some of
these issues across Workgroups. So as you\'re planning in the future,
just making sure that we\'re allowing that to take place is very, very
helpful.

**[\>\>]{.underline}**

Thank you.

**[\>\>]{.underline}**

Absolutely. I\'m delighted you\'re staying with us, Carolyn. I was a
little nervous for a while there.

**[\>\>]{.underline}**

We need you.

**[\>\>]{.underline}**

I could never leave this group.

\[Laughter\]

**[\>\>]{.underline}**

We need you.

**[\>\>]{.underline}**

Getting deep in here.

**[\>\>]{.underline}**

Do we have any public comment, Matt?

**[\>\> Matt McCoy:]{.underline}**

Not today.

**[\>\>]{.underline}**

Okay.

**[\>\>]{.underline}**

Well, Jon, why don\'t you take it over and take us out?

**[\>\> Jonathan Perlin:]{.underline}**

Well, let me just, on behalf of Lillee and myself, let me thank
everybody for your participation, very robust discussion, and indeed a
very nice change of phase from analytic into really taking it to
product. The concrete recommendations that allow us to meet the
objective of making electronic health records more available to
Americans in, to go back to the President\'s deadline, now eight years.
So many thanks to everybody, and many thanks to the ONC staff and all
who participated. See you next time.

**[\>\>]{.underline}**

Karen?

**[\>\>]{.underline}**

Thank you.

**[\>\>]{.underline}**

Thank you, all.

**[\>\>]{.underline}**

Bye-bye.