[This Transcript is Unedited]




November 18, 2008

Radisson Hotel Reagan National Airport
2020 Jefferson Davis Hwy.
Arlington , Virginia 22202

Proceedings By:
CASET Associates, Ltd.
Fairfax, Virginia 22030

List of Participants:

  • Harry L. Reynolds, Jr.
  • Jeffrey Blair
  • Justine M. Carr, M.D.
  • Walter G. Suarez, M.D.
  • Judith Warren, Ph.D
  • J. Michael Fitzmaurice, Ph.D
  • Jim Sorace, M.D.


  • Committee Discussion

P R O C E E D I N G S (4:35 p.m.)

MR. BLAIR: I think we are going to have to truncate the agenda a little bit, so I am going to ask you all as a group as to what we choose to do. I think we have come to consensus as to the purpose of the NCVHS standards initiative and what the four questions are that would reflect that.

The other thing that I think we could leave to a later time is the last agenda item, which is the preliminary list of the folks we send the written testimony to. I think that could wait for a later time. Also, the draft letter that would go for written testimony, we can leave that to a later time. So I think we are down to two items. I think I will let the group decide which one we should spend our time on.

PARTICIPANT: What are the two that we are down to?

MR. BLAIR: The two that I think would be the most worthwhile for us to consider discussing, and either of them may take all of our time so I don’t know, one is the calendar.

If anybody is on the phone, could you identify yourself? One of our choices to start with would be the one that is called the Calendar of Activities for this standards initiative, and the other one is the proposed four days of hearings. Those hearings are — the first day of those hearings would be immediately before the full committee meeting in February. Day two and day three would maybe be some time in April or May, depending on when we decide to have it, and the fourth day would be the day immediately preceding the June full committee meeting. Then the subsequent meetings we have would probably have to be conference calls for us to create each of the draft recommendation letters until we get to the full committee meeting in September.

So which of those two would all of you wish to start to discuss and look at first, the calendar or the way we have broken out the hearings for the four days?

DR. WARREN: I think if we look at the breakout that will give us a better understanding of the four days.

MR. BLAIR: The panels, very good.

DR. WARREN: So the makeup of the panels.

MR. REYNOLDS: Can I ask a more generic question?

MR. BLAIR: Sure.

MR. REYNOLDS: After what we heard today in the full committee, especially the transition to AHIC 2.0 and some other things, and HITSP might go, I think it is absolutely paramount that we do this, however we figure out how to do it.

One of the things that I sensed today is — and this might be my naiveté more than anything — is that one of our reasons to have this was, some people around the country are selecting standards, selecting being the key word, not necessarily vetting, not necessarily having it go through the significant process.

DR. FITZMAURICE: Nor fully specifying them.

MR. REYNOLDS: Correct. So I think it is extremely important for us to weigh in, including everything we did in the other room. If somebody doesn’t weigh in, at least to frame this discussion.

So I am willing, stepping back from my other position, I am willing to do everything I can to make this happen, because this is sentinel in the development of everything that is going forward.

MR. BLAIR: Can I add a little bit? I think I just referred to this, as a very interested person within — I’ll just say as a very interested person that a lot of these recommendations would influence. They have indicated that they are very, very interested in our doing this as providing information and guidance to them as well as to the broad structure of how the federal government supports standards initiatives.

The other piece is, when I shared a little bit of this information with them, I said, for us to do a quality job, a deliberative job and hear from all the folks that we need to and make it through and write up the recommendations correctly, it will probably take until September. They indicated that they would probably be present at all of the hearings, and they would be taking that information as it came. So if they needed information earlier, they know that they would have it by the finish of the June hearing.

DR. WARREN: I want to comment, and then Walter. Based on everything we have heard today, from our initial discussions that we heard from our Executive Committee process, the whole dialogue we just had on what Quality is bringing through, but also the dialogue with CTSA. The research community is coming in.

If we really are going to get quality data to better the health of the country, it needs to come as a byproduct of all of our services. That is going to require standards and terminology to do that.

So yes, I think this stuff is even more important. The only thing that I am still unclear about is that as Quality goes forward with its hearings, they do plan on talking about standards and terminology for PHR. So I am not exactly sure where the interface is, but I am willing to be loose, and it will evolve.

DR. FITZMAURICE: It will go before the full committee in any case.

DR. SUAREZ: I absolutely agree, this is paramount. I think there are different ways to look at this, which is what makes it challenging. One way of looking at it is, we have this nice picture nationally of how things are working and how AHIC decides some things and HITSP harmonizes and CCHIT certifies tests, and then the industry. That kind of a process seems to in pictures flow nicely, but there are a lot of challenges embedded in all those processes. I’m not sure that there is that good of a transition between those steps.

Those places where AHIC and HITSP interfaces and HITSP and CCHIT and HITSP and NHIN interfaces is where I think there has been a lot of gaps and a lot of drops. We are seeing NHIN implementing some things and connecting, but not necessarily using the HITSP standards, and CCHIT certifying things that do not necessarily reflect the AHIC priorities or even the HITSP standards.

So there needs to be a topic on standards and all of these questions that we would ask to the perspectives of all these groups. We need to decide which is going to be the focus of the questions.

DR. SORACE: When you really step back and look at the big picture, there is one comment that I am going to make that is fairly straightforward, and that is that we have no idea what the cost is of sustainability and long term maintenance of standards.

And we don’t do a very analytical job as to what the national adoption will be and what the maintenance processes will be for updating and sustaining an adoption of that. I think we have to look at that in a little more detail.

This comment is going to come completely out of left field. There has actually been a lot of experience in the computer science industry in the 1980s and 1990s, basically looking at expert systems and artificial intelligence. A lot of that is something we might want to look at on the back burner in terms of guiding what standards are actually sustainable over a long period of time.

They came up with — they found that as narrow uses cases, they found it very hard to run a sustainable program of this scale. I know that it is sort of out of context right now, but it actually does start putting a limit as to what your ambitions can be.

MR. REYNOLDS: But I would play off of that. I think the whole reason we talked about having this is that up until now, the standards have come from organizations that take the responsibility to develop standards. Take NCP. NCP is the perfect example. Whereas, the standards that are now coming forward are just coming forward out of some effort I won’t even define. It could be some effort. It could be a pilot, it could be a use case, it could be something that people have sat around and said this is a good thing. But the problem with that is, the minute you pick it, how do you sustain it?

Some of the organizations that we are talking about right now are not — they select, they don’t sustain. They choose, they don’t build. They don’t have a process.

Let’s take NCP. As a process they are continually meeting, evaluating, challenging, voting. Then it comes forward from the group. That is the thing that I think we are facing as a dramatic challenge.

MR. BLAIR: We only have what, 45 minutes or something. Would it be okay if I introduce the way we have tried to pull this together, a little bit structured? Is that okay?


MR. BLAIR: If you look at your handout, one of your handouts is the four days. Now, please understand that before those four days occur of hearings in January, we would be sending out written questionnaires to a much wider group of testifiers. That is another one of the papers that was at the end of the list for us to look through. Maybe we can do that by e-mail to expand all of the wide folks of written testifiers that we would get.

So from the written testifiers, we would then pick the ones that are most representative and the ones that are most diverse. But that would narrow the group so that we don’t wind up having 20 to 25 professional associations and 20 to 25 vendors and 20 to 25 standards organizations and 20 to 25 terminology developers.

So that was a mechanism. If all we have is four days, then we have to have a process for trying to get the most out of those four days of hearings.

If you look at that, you will notice each day has a theme. The first day is to give us a running perspective. So the first morning of the first day is to hear from the federally funded agencies that are involved in either coordinating standards, selecting standards, harmonizing standards, setting up use cases, priority. So the first morning is a government perspective.

On the first day in the afternoon is an industry perspective. These are the organizations that have tended to have tremendous influence over time in terms of standards. They are either entities that have grouped together standards or packaged them or otherwise influenced the standards development process greatly. We can change the names or we can modify these things, but I am stepping through at a high level the thinking behind this.

So the first day gives us both a government perspective and a health industry technology perspective.

The second day is all of the standard development organizations. Again, the way we are able to trim down the number we hear is because we get written testimony from a large number and then select which ones we would hear from.

Notice please that we tried to make sure that none of the panels would ask a testifier to testify for less than 15 minutes. Every one of the panels has 30 minutes after an hour of testimony is received to ask questions of the testifiers. There are four panels every day. At the end of the day there is also an additional 30 minutes before we close at five for us to try to pull together in context through our open discussion at the end of each day. So there is a little bit of a formula there.

The third day moves into several other areas or categories. You might think of this as, we want to hear from the folks that are involved in either standards development and coordination or implementation or usage, but we also want to hear from organizations that are affected by these standards as well.

So I’m not sure this particular diagram has done it completely right. We could look at these and decide we need to add something or refine it.

The fourth day tries to hear from the vendors. The vendors are special drivers. They don’t adopt the standards. It is very difficult for a health care provider to implement it. Usually the major vehicle there is the health IT vendors. We used to focus primarily on EHR vendors, but now we have e-prescribing vendors and we have health information exchange vendors. So it is a little struggle to try to get to them, but again we are going to get written testimony before we wind up hearing from these folks.

Then the other pieces that you wind up seeing there are quality and privacy and transactions. When you get more and more towards things like the Nationwide Health Information Network, you are getting more and more into the need to translate data to meet interoperability standards.

Anyway, that is the overview of these four days. Let me turn it to you, Judy, and let’s receive comments and critiques and tomatoes.

DR. WARREN: No, not tomatoes. Comments?

DR. FITZMAURICE: I feel like I want to testify right now, but it is not appropriate to testify. I think we have seen a lot of good things that have been done and some things that can be done better.

I think the new Administration coming in will benefit greatly from NCVHS’ thoughts. Maybe September is too late. Maybe we give a foreshadowing letter ahead of time. Do we want to hear from the same old people who will say our standards are the best and the way we do it is the best? Or do we have some mavericks out there who have maybe some crazy ideas, but we can pick and choose among the crazy ideas as well as from the people who are currently doing standards.

It is with a sense of some frustration and yet with a sense of accomplishment that a lot of people have pulled together and done some good things. There are ways they could have been done better. I would like to hear from implementers of standards to find out what they want to see in the final package coming out a HITSP process and AHIC process. What is it they want it to look like? They probably don’t care how it gets there, but what do they want to see at the end of the road and how do they want to see it? Then we will take that to heart.

MR. BLAIR: Michael, are you thinking of implementers other than the vendors, the providers and the medical groups?

DR. FITZMAURICE: I am thinking of people who have to move the data around, let’s say hospitals as well as the hospital vendors, health plans as well as their vendors and their IT staff. I want to hear from the people who have to work with the standards to get a job done.

MR. BLAIR: They are on the list there, but do you feel like they don’t have enough weight in their presence there?

DR. WARREN: We don’t have hospitals.

MR. BLAIR: We have the PDHA, we have the PCP, the AMA, the BCBS of America, and also the American Health Information Plan, I forget the name.

DR. WARREN: So that is one of those things we need to list and everybody start fleshing them out. I think we can ask for as much testimony we want, and then cherry pick to who physically comes.

DR. FITZMAURICE: I can’t take an interoperability specification to an educational session with Congressional staff, should they ask me, which they never do, or to my family. I can take a couple of simple tables that say here is the output, and if you want to get into the weeds, hire a medical informaticist, hire a vendor to make it happen. But you know where it is going. You know what to put into a context. I want these variables to be the same in my lab system and my pharmacy system, my radiology system. I don’t care how you do it or what boxcars you use, but I want to be able to communicate.

Our outputs can be better. So we need to give the guiding force that says here is how the outputs can be better.

MR. REYNOLDS: I want to play off Michael’s. This is not about the current old school. In my opinion this is not about NCPDP, this is not about X-12, this is not about HL-7. That process has worked, it is sustainable, and it continues on.

This is about how do we allow innovation and moving things forward. Once it becomes whatever somebody calls it, because in some cases you would call it a standard, in some cases you would call it a vehicle to get to a use case or a vehicle to get to some end, not necessarily something that moves the whole infrastructure.

I would like to also lay on top of the filter that so far, the industry is the only adopter of things required by the government, or NCPDP is the only one that is really different. We are not starting on new things. That is why this idea of whether AHIC and ONC stay separated, because when it goes out to the private sector there is going to be a whole different deal going on.

So I like that approach. I would love to hear from the HITSP’s and the CCHITs and the others about how they have driven it forward, and then ask the questions that have been the bellwether correct things from the SDOs. So now that you have selected that, under whose jurisdiction is it updated, coordinated? If I am a doctor who is going to buy a system and you say that is certified, how do I know that is going to be okay next year and who is going to add to that when we want 16 more pieces of data and we want this or that. So I would like that.

My last comment. I don’t like the questions. I think the questions like what does your organization do, so they tell us, and then where does your organization fit outside or inside. It is outside the Beltway, is what I would say. The FDA’ers are inside the Beltway and some of these others are outside the Beltway. So I still don’t have anything that makes me want to do something.

The third is, what is not working well. They are not going to say what they are doing is not working well necessarily. They are going to say whatever else isn’t working well. Then how can we improve, and they are going, I don’t know.

Where I am going is, I think we are into adoption, sustainability, things that people would do, things that people would do and know that they are safe. For example, NCPDP, we have had standard streamlining with NCPDP ever since the start.

So I am just concerned that after we get this — I’ll play off of what you said earlier, Jeff, and what made me think differently about it. You said we are going to take the best of these responses and use them.

MR. BLAIR: What do you mean the best of the responses?

DR. WARREN: To frame them in for testing.

MR. BLAIR: No, I was saying that we pick some of those that would be representative of the mainstream and some of them that are representative of diversity.

MR. REYNOLDS: I understand that, but I’m not sure answering these questions is going to educate us any more as to where the differences in models are and where the differences in how they are doing, and where we would be concerned philosophically. That is the only thing I am saying.

DR. SORACE: From my experience on the docket project, most CHRs, and I am willing to bet most PHRs will fail to become adequately populated with the data to begin with for patient care purposes. We are still in an environment in which we are far from achieving a plug and play environment for these types of health care records nationally out there.

I really do think we are back to the domain approach. So I think you have to look at what data types you need to sustain basic patient care. The e-prescription industry has been by far the most successful in coming together as industry and doing that.

I think you have to look at the actual structure of the lab industry, and in full disclosure I am a pathologist, and how they are structured and what their barriers have been. I think you have to more analytically analyze what it takes to incent that industry to move towards producing electronic data.

MR. BLAIR: The only reaction, we only get four days of hearings. That is sort of a stretch. So we try to cram this into a limited —

DR. SORACE: But still, you probably would want something that could give you an hour of overview as to what lab industry standards and data flows would look like in the domain. You probably would want somebody to give you an hour or so of exposure as to what imaging might look like and what that domain would be in terms of standards that would be used to EHR.

MR. BLAIR: Are you saying we would or we wouldn’t?

DR. SORACE: We would.

DR. WARREN: Let’s hold that. Those are very different than what we have on the agenda. The purpose of the hearings was to re-look and re-evaluate the process as it currently stands. We heard lots of complaints, concerns and good points about the current process, all the way from looking at SDOs to looking at ONC to looking at AHIC to looking at HISPC to looking at CCHIT, all of those things.

So if we are going to change the purpose of this hearing, —

DR. SORACE: I am just suggesting that you need to hear from the affected industries.

DR. SUAREZ: You just said the most important part, which is, what is the purpose of this? I think it goes back to the point of, in many respects we are trying to evaluate, be an external evaluator of the process.

Now, we want to understand the problems at different places. The places where we need to focus on in terms of the focus.

I submit to you that there are six places, and one of them is not applicable to us. The first one is priority setting. We need AHIC. We can bring AHIC in and question them regarding the priority setting.

The second one is standards development. Now we have a standards group. There is a new group many of you might not have heard of, it is called the SDO Summit. That is yet another group that is now building on the standard development groups that don’t have —

MR. BLAIR: Actually that is where some of the issues came up that caused us to cerate this thing.

DR. SUAREZ: Exactly, right. So we need to discuss what are the issues of the standard development stakes? That is the second one.

The third one is standards harmonization. Now we need to talk about what are the issues around standard harmonization, including two major things.

MR. BLAIR: Do you realize you are repeating exactly what is in the purpose statement?

DR. SUAREZ: I am hoping. HITSP and HISPC, which is policy harmonization. So technical and policy, that is the third issue, standards harmonization.

The fourth one, certification. That is CCHIT and others, not just CCHIT as the only body that certifies in this country. There are all the certification groups.

The fifth one is testing. That is NHIN. We have an incredible opportunity to look at what is the problem with testing. There are a lot of issues around test.

MR. REYNOLDS: Testing is not just any — testing is in everything that we are doing right now.

DR. SUAREZ: Exactly, testing is not just anything, but it is testing of all the HIEs, testing of the EHR products, testing of PHR products.

The last item is adoption, which is the most important one, adoption and implementation. That is where we talk to the people that are in the hospitals and the clinics and CMS and IHS, Indian Health Service, who are saying, what is happening with adoption, why are you able to adopt.

So that is my submission. Then inside each of them we have a set of questions that we ask them, maybe not the same questions to all of them, but we have to construct a series of questions around them.

DR. FITZMAURICE: As Harry was talking, it prompted more thoughts from me about whom do I want to hear. I want to hear from Canada, why they went the way they did, how do they think that applies to us. I want to hear from the U.K., someone who can tell us why it failed or how it is succeeding, but slower than they thought, what role standards played in it, and what they would invite the U.S. to do with our health system, would they have us follow the same standards path, use of the same standards that they are using.

We need some people who have had some success and had some failures. I think it is not just about standards. I think it is about government and it is about public good and about the role of the government, but I want to hear how all that plays out.

MR. REYNOLDS: That is why I made a comment, probably a little more aggressively than I meant to, on the elements. First, what is their purpose. We have them come in, what is your purpose, why do you think your purpose drives adoption, what is the sustainability of what you create, what is the value of what you create, and what is the harmonization with other things that are going on.

DR. WARREN: One more time.

MR. REYNOLDS: Purpose, adoption, sustainability, value and harmonization. What I am trying to be more and more careful of is, those of us that are out in the field doing this, you want to help innovation, but where does innovation turn into standards. That is the thing that I am struggling with.

So for a use case or something else it is innovation. So if you take a lot of the use cases that originally happened, only for discussion, you don’t see them showing up. Some of them are moving forward, some of them aren’t, so you don’t know — it comes and it goes and it comes and it goes. Whereas, NCPDP, and we will just use that as an example, comes, stays and sustains. So I am willing to spend money on it.

MR. BLAIR: Harry, I think all of those questions are good questions and we could use those. The thing that I am thinking of is, one of the things that we wanted to try to surface was what different entities feel is broken or if not broken, not working well.

MR. REYNOLDS: You’ve got one in there. We have got a question on that. I don’t have a problem with that one.

MR. BLAIR: Good.

MR. REYNOLDS: I was just going through the things that I know. Again, I do this in my day job, and I am always trying to authorize money to do something. I am sitting here going, somebody has got to help me, that what I am about to write a check for is going to be here tomorrow. I didn’t just group up a lot of other people to go with me and just jump off the cliff because there is not the real infrastructure.

DR. SORACE: I think testing and adoption are the real stumbling blocks that people get to. In the current structure, what entities are the most experienced and can address that? In the current group of people, what entities are going to discuss the problems of testing and the problems of adoption?

That is my question. Parenthetically, I still think we have to get back to the fact that we need to get the labs and the imaging centers and the end implementers of the standards to start to tell us what the needs are for testing and adoption in their environment. Other than, we need to be paid for it, because that is not something that we can address through the standards. That is something that is going to be part of the value case. But what are the technical hang-ups from their point of view, at what point wouldn’t it meet their business needs.

So I am getting back to the question of who is representing the testing and the adoption in the current four days?

MR. BLAIR: I think we have got almost a full day on that. It doesn’t show up with the label of testing, but if you look at the fourth day, both of those two panels are vendors, and the vendors are going to — they are kind of like users. We try to get different kinds of users in there, plus we have hospitals as users, medical groups as users.

DR. WARREN: We have IHA on day three.

MR. BLAIR: One of the things that I might suggest as a way to try to accommodate this. I have got a paper towards the end there, where I list about 15 different IT vendors. There was no way that I could get them also.

Those are the ones we had asked written testimony for. Then from the written testimony we would select the ones that, number one, which ones are mainstream ones and which ones would give us diverse opinions that would be able to represent the diversity as well.

But let me suggest this. Normally I would agree with everyone that has suggested additional testifiers. Maybe the balance isn’t right. May I ask each of you to look at all of those panels, cross off all those that you feel we don’t need to hear from, so that there would be room to add more testifiers in the areas where you do feel we need to hear more.

Also, there is another handout in this folder here where it is all the folks that we should ask for written testimony from. Please give us more folks. That was just examples that I put down there, and the examples are right off the top of my head real quick. I came up with 12 to 15. I know we could easily get to 25 or 30 on each of those.

So please fill in the additional folks we need for written testimony, and then mark up the panels, cross off the ones you think we don’t need to hear from, add new panels for those where we need greater emphasis. Is that fair?

DR. WARREN: So the process is right, we would take two of these —

DR. SUAREZ: I offered a suggestion, or maybe I should just send it via e-mail, about reconfiguring these days.

DR. WARREN: There are two things that we need. One is, take the laundry list of testifiers, look at it, add to it anybody that you see is missing. There are quite a few people that are missing.

The second thing is, take a look at four days’ testimony and see whether or not the panels themselves are okay, not who is in them, but the categories of panels. We can pull together who is in them later on. But that may help us get across the bump.

What I can do is, I will send out an e-mail with those documents in it to everybody, and they can all reply to the whole group so that we will all know what is going on.

MR. REYNOLDS: I’m not sure that some of those things I put out there aren’t our goals, everybody’s goals, industry’s goals. Industry’s goals are value, adoption, sustainability and harmonization. So if I am working in this industry, those are my goals, aren’t they? Value, adoption, sustainability and harmonization.

Basically, if I am going to spend money or I am going to do something, whether I am told by the government, I do it of our own free will, or whatever we do, those are the kind of things I want to know. That is called return on investment, that is called wise things, everybody is going to be together. So if I am going to talk to everybody in this room, I want to know that if I dial your number, you have got a ten-digit number and I dial it, I am going to get you.

So maybe those are our goals rather than just our questions.

DR. SUAREZ: Some of them don’t apply to — when you say harmonization, are we talking about harmonization of standards?

MR. REYNOLDS: Yes, harmonization of standards. Everything I am saying here is standards.

MR. BLAIR: There are four groups that work at that. There is IEG, there is HITSP, there is CCHIT, and what was the fourth group on harmonization?

MR. REYNOLDS: Then the real question is, how does your entity make that happen? What do you do, how do you do it, and how do you make that happen? Again, I can go back to NCPDP and I can take every single one of these and I can tell you exactly what they do and don’t do. I am not rooting for them; I am using somebody that has been a bellwether example for us. We have sped up everything about ten times faster, maybe 100 times faster than anybody else, because they came forward with those things.

Just input, not right, not wrong, just a personal opinion.

DR. WARREN: The other group that we don’t have on there, we have had several groups across time who have had demonstration projects, so they would go into that last piece. So testing, sustainability, adoption. Some of the early e-prescribing demonstration projects, certainly these ones with PHRs that are coming out.

The other big demonstration project we heard about today is CTSA, where we are seeing academic medical centers who have very active medical informatics departments that are struggling with how do you share data.

MR. REYNOLDS: The Secretary kicked off 1200 projects around the country just recently, where he went out to states. He went into individual practices. That is a good example.

MR. BLAIR: One of the things that I maybe want to add is, the way these four days are crafted, the panel topics and themes that came from our meeting in October when we met the morning of the 14th, October 14. So that group at that time said those were the categories they think we should hear from.

Today we have come up with additional ones, and it is a good thing to revisit this. But I am going to ask you to play fair when you wind up saying that we should look at more things. Play fair.

MR. REYNOLDS: What more things?

MR. BLAIR: In other words, additional testifiers or additional topic areas. I think that is fine, but you need to do it and show what you would take off, what you would replace, to keep it within four days because we have a four day constraint.

MR. REYNOLDS: I don’t think any of mine changes any of it.

MR. BLAIR: No, yours don’t all.

DR. SUAREZ: My suggestion is to reconfigure the structure, what it would probably reduce in terms of the focus of whatever it is.

The point is, I can see clearly a matrix of these five evolutionary phases of standards development, harmonization and implementation with your purposes. These are the questions for each of the groups, what is your purpose, what is your sustainability, your value.

MR. REYNOLDS: The value of what you create.

DR. SUAREZ: The value that you create, yes.

MR. REYNOLDS: I am challenging the viability of what they put down and how long will it stay before somebody else gets excited.

DR. SUAREZ: But I think there is one question which is the most significant one and the one we are missing, I think, and it could be turned into the challenges. Why are things not working? What are the things that are not working? What are the reasons why things are not working?

That is what we really want to pull out. I can even draft the answers of some of these questions for some of these groups, what is my value, what is my sustainability.

MR. BLAIR: Absolutely.

DR. SUAREZ: But I will have the challenge.

MR. REYNOLDS: No, I am going to pick at that word. It is not their sustainability.

MR. BLAIR: Most are really good questions for those involved in the standards development process or implementation or whatever. But for those that are users, we probably will want to focus more on what isn’t working for them or difficult for them or what they are dissatisfied in.

So we probably will have to come up with a modified set of questions for the users, as opposed to those that are part of the standard development process.

DR. SORACE: In your opinion as part of NCPDP, is part of the reason why they have been successful simply because the industry pulled together to do it and they had broad industry buy-in?

MR. REYNOLDS: The value is, they pulled together and came up with something.

DR. SORACE: And then they created their own standards.

MR. REYNOLDS: And then they adopted it, and then they showed how they sustain it, and then they worked on harmonization, because they said, we all agree.

DR. SORACE: And that they had a value business case going into it, as to why everybody is going to get a bottom line return.

I will submit that simply that level of industry buy-in and knowledge of industry has been lacking in these other standard developments. That is what I keep coming back to. Because of that you don’t get standards that labs can adopt readily, which is where we are now, with some of these other things that have happened.

The radiology community strikes me as somewhere in between on this, because they had to adopt standards to work within their organization, because they are buying scanners from GE and — and they had to talk to each other.

I think to really understand the adoption process you have to understand the business interests of an industry that is supposed to be the end adopter and broadcaster of the information to the standard. I’m not sure you can achieve that by reverse engineering it from what a vendor or an SDO wants from these people.

MR. REYNOLDS: Or I will use another example that is exactly the opposite, is the CCR and the CCD. Pretty well matched, but I’m not sure that Google, Microsoft, WebMD and everybody has accepted the single way to do it.

If I have a person that I work with, five different people, and they all use a different PHR, I can produce one record that would go to any of them, and I don’t care. Those are the differences that we see on the street when I am trying to do it.

If you told me, I don’t care how many PHRs are out there or how many of our 3.6 million people want one. If I know that all I have got to do when they sign on and say they want it, that I can send the CCD, and I can go out to my records, find the CCD, send that sucker, I don’t care. You made a big difference in my life. Versus, I got to chase Google and figure out what they are doing and I got to chase this and I got to chase that.

That is the kind of thing that we see on the street. So that is how simple it is. If they all got together just like NCPDP did and say, okay, guys, I know you all are going to work with us. Here is what we want, here is what we will do. We will go wherever you want to go. We will go to HITSP, we will go to this, we will go to that, we will go to the SDOs, we will make it happen. That would be cool. That is good stuff.

DR. SORACE: Not to recap the history, but there was an industry standard called E-Links which the labs got together to produce. That is exactly what they did.

DR. SUAREZ: That is exactly what HITSP is so concerned about it, because E-Links is not the HITSP standard.

DR. SORACE: And HITSP went out and — I’m not saying whether it is right or wrong, but historically they completely re-engineered it. Now we are at a point in time where we are going to have a great deal of difficulty getting the standard implemented.

MR. BLAIR: That is why your point is so important. There are good reasons why E-Links was created, why LOINC was created, why HL-7, OBX codes for messages were created. They all had valid reasons why they were created.

Your point is that if we are going to wind up giving useful guidance in terms of the processes, we have got to somehow understand what drove all of those, so that we could give overarching guidance for what processes can improve what we have now.

Is that correct? Have I articulated what you said?

DR. SORACE: I think that is part of it. Also, you can begin with the standard that is basically one that an industry says that we can produce. Then you can also have more of a targeted standard for health information exchanges and reuse of information, which is really the HITSP use case.

But at some fundamental level, if you don’t even get LOINC coding going into 5,000 labs out there, you are not going to get either one of these guys. You need to start with an achievable standard, in my opinion E-Links, and then try to migrate to something.

MR. BLAIR: Can we sum this up?

DR. WARREN: The problem is, that is exactly why we need to have these hearings, because of mistakes like that one, or train wrecks or whatever it is. But I don’t think the hearings are to rehash those.

MR. REYNOLDS: I’m not saying you should. You use the best examples and move forward.

DR. SUAREZ: The other aspect is the scoping that I wanted to mention. HITSP has been very careful to insure that the scope of the work that we do at HITSP stays in the inter-organizational exchange, not in the intra-organizational structure.

So the standards and the harmonization that we do are for messages that go outside an organization to someone else, whether it is within a health information exchange, NHIE, or between HIEs.

Now, it so happened that NHIN decided that they are not going to do intra-NHIE harmonization; they were just going to do inter-NHIE, which is one of the restrictions that they have. But we are in this to try to go all the way down to the adoption of these types of harmonized standards across the board, not just in between NHIEs.

So I wanted to make a point of that. But then we are not going inside the door of one organization to try to standardize how they —

MR. REYNOLDS: That was our HL-7/X-12 discussion.

DR. WARREN: So we are right at 5:30. I know several of us have day job meetings that are coming up.

Where I have that we are at is, I am going to generate an e-mail and send it out to all committee members. You will get the documents that are in your folder. We want you to add to the list of testifiers. We want you to take a look at the structure of the testimony. It cannot go beyond four days. So if you are adding testimony, you have got to take one out.

We also are still generating questions which have a relationship to scope. I will put out the two lists of scopes that Walter and Harry had. They are very close. I think they only differ on line one item. They will help people come up with questions.

Anything else we need to do? Then I have one question for Justine. Do you want anybody from this committee to join you guys tomorrow in Quality?

MR. BLAIR: I thought you were going to say we are not up to your standards.

DR. CARR: It would be great.

DR. WARREN: To continue the dialogue we have been having.

DR. CARR: I think so. It would make it very rich.

MR. BLAIR: Thank you, everybody. We had a short amount of time and we jammed a lot in, but I think we made really good progress in the time that we had.

DR. WARREN: Just one more closing. We only have Mike and Dan as our visitors or observers. Any comments on our process? I noticed your faces, and you have been smiling and nodding and all of that stuff. Anything we missed that you think could be added?

MR. BLAIR: Actually there is something that we missed.

DR. WARREN: No, just a minute. Dan.

DR. RODE: I have been in standards since 1989. One of the things that I have learned is that the use of the standard, the sustainability and the rest comes out of industry guidance. One of the biggest things missing, still missing, in health care is agreed-upon authoritative industry guidance.

As you were talking, I was thinking of the long term industry right now having a major problem with Health and Human Services, because they want to adopt a new standard and they asked Health and Human Services to also include the chi standards that support it. CMS doesn’t want to use the chi standards.

So you have got an industry that has finally bought into standards, not gotten the other standards. I will be honest with you, that has been an issue ever since we did the first X-12 standard in 1991. That is why NCPDP worked, is because they brought a subset of the industry together.

Now, had they brought the physicians into that discussion, I’m not sure you would have arrived at a standard as fast. But at least the subset they got, which was an important subset, was able to do that.

I don’t know if we can do that in different sectors of the industry, but somewhere along the line we have got to face the fact that we have got to have a uniform guidance in the use of standards. It is not just the standard itself, but it does impact harmonization, it does impact all those other pieces that you have identified.

DR. WARREN: You said that you had one thing that you forgot, Jeff.

MR. BLAIR: Let’s let it be. I think we have got plenty on our plate to move forward with, and we will probably wind up having a conference call, and we will take the next steps.

DR. FITZMAURICE: Thank you, Jeff.

(Whereupon, the meeting was adjourned at 5:40 p.m.)