[This Transcript is Unedited]



Subcommittee on Standards

September 16, 2008
Hubert Humphrey Building
200 Independence Avenue SW, Room 505A
Washington, DC

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 352-0091


Agenda Item: Discussion — DEA letter

Agenda Item: Charge and Portfolio


DR. WARREN: There are two things we need to add, and I think you have them. One is the DSMO report and there was nothing to report, so we don’t need to have a hearing. The report is in your pile for you to peruse.

DR. OVERHAGE: I have a question and it is just my ignorance. What does this report tell me?

MS. TRUDEL: This is the annual report required by HIPAA of the DSMO to keep us on track of —

DR OVERHAGE: I guess that is the question — so this is all standards?

DR. STEINDEL: No, only HIPAA. Only the NCX12-N standards and the SureScript(?) that was part of HIPAA.

DR. SUAREZ: We receive periodically — every month we receive 15 to 20 requests for review issues around standards that HIPAA established. The DSMA process looked at all those comments and changes and this is a summary of all those.

DR. SUAREZ: Who send this?

DR. WARREN: Lynne Gilbertson — she is the secretary of the DSMO.

MR. BLAIR: Actually the DSMO is five different — X12, NTPP — HL7 for health attachments only.

DR. WARREN: They also have the Dental Association committee and NUCC.

DR. STEINDEL: Have we received the report in this fashion before”


DR. STEINDEL: No, I meant no having to hold a hearing or anything like that.

DR. WARREN: This particular time they didn’t have anything to act on.

DR. STEINDEL: I think my question is how do we introduce it into the NCVHS web pages — received or something like that. It is just a formal process question.

DR. WARREN: Now I am going to be really stupid. Dow e take minutes of this breakout?

DR. STEINDEL: No, I don’t think so. We have the transcript. We are rolling on own here and probably the best thing to do is for the co-chairs to send a letter to Harry, as the chair, saying we received the DSMO report. There is no comment. Can we please forward this?

DR. WARREN: The other one was we need to act — my understanding from what our chair told us — the last discussion we had on that quality data stewardship, just to take a look at it and make sure that the standards stuff id appropriate. That much has been with our own planning and charter discussion.

Jeff and I had a little talk and given the work that we have been asked to do we would like to reorder the agenda a little bit. The first item we want to cover is the DEA letter and try to get that written out. Then we would like to go to our charter and make sure our charter meets all the edits that we discussed on the phone. You should have the charter in your pile of papers there. Then we want to look at our portfolio and we did not make copies of this — can you get copies?

Then if there is any time left over we would like to talk about strategies concerning our response to the NPRM 15010 and ICD 10. That is going to be at the end. Jeff and I talked about it. We have some alternative strategies if we don’t get to it to handle it, so don’t feel that we need to cut short any other discussion first. There will be more opportunity before the deadline.

Anything you want to add?

MR. BLAIR: No, that’s perfect.

Agenda Item: Subcommittee Discussion — DEA letter

DR. WARREN: So with that several people have given me their versions of the letter and recommendations they have for rephrasing things, and while I am getting them — I thought I had them right here –any responses or comments to the group, discussion on this letter?

DR. SUAREZ: I heard a number of things during the conversation. I have to say I was not certainly prepped on the discussions that happened in the early stages, back in 2003. It sounded to me that there were some recommendations made by NCVHS to the Department, not in response to an NPRM, but generally recommendations about e-prescribing.

DR. WARREN: MMA required that NCVHS recommend standards for the implementation of e-prescribing. That is how we set about about a year, year-and-half of holding hearings from the entire sector. Then we wrote a letter summarizing what our recommendations were.

DR. SUAREZ: Those were not in response to an NPRM.


DR. SUAREZ: They were just a summary.

MR. BLAIR: Actually that was in response to Congress, which designated the —

DR. WARREN: If I could just add for Walter some context. The hearings occurred over a period of three or four months and there was an initial set of standards that were set forward in September 2004 that formed a basis for our first standards rule and our pilot. There was initial consideration and then this March 4, 2006 letter was the second set of recommendations that came out of that same set of like four month’s worth of hearings.

DR. SUAREZ: Okay, because I think it seems to me we spend a lot of time in this letter talking about PKI, which is not an issue any more. This is almost like you could have taken out PKI because the NPRM itself recommended that. And then concentrate on some of the issues that the NPRM actually talks about and that can be brought from the recommendations of the hearings.

DR. STEINDEL: Walter, I think you need to look at the revised letter, the one that we just got. We got a new one and the only reason I pointed that out is that Denise has made some significant modifications that I think are very good in re-emphasizing the letter and clarifying some of the points that came up in the discussions.

My only comment about the revised letter that I have on quick read, is the url that should be referenced is actually the url to the letter, not to the NCVHS site in general — that’s minor.

MS. TRUDEL: The other thing somebody pointed out this morning was that the proposed rule does not require PKI. But that is not to say they won’t receive comments from people that they should revert to PKI. I don’t have a preference in this way, but it is true that there is something that they took out, that we liked that they took out, it is nice to say that we liked that they took it out.

MR. BLAIR: Also some clarification — the problem with PKI was not with PKI itself. The problem was that it required a virtual re-architecture of the sure scripts network, which would have been — here we are trying to accelerate and move forward e-prescribing as quickly as we can. If you look at the DEA’s position they want to be able to have things that are so sure that they can take something to court. That s why they have their separate procedure for controlled substances.

Now they didn’t seem to recognize and still seem to be unwilling to recognize that if things are in an electronic form you already have much more documentation than you had before, as controls have. The PKI, to be specific about it, bound the signature to the document which was closed. If you open the signature as SureScripts network has to do to be able to route it to a pharmacy, you break the seal. If you break the seal you have no way of tracing back that it wasn’t diverted, okay?

In the testimony we received, it was saying please agree to something that is — and we understand your needs for security and bringing things to court, DEA, but please don’t do something that will either delay the implementation of e-prescribing or be incompatible with the processes, because if doctors have to switch from one process for controlled substances and another process for the 85 percent that is e-prescribing, it is going to be a deterrent to adoption. So that was the point.

DR. STEINDEL: I think that is what your point of the objection to PKI. I think that objection applies to what they produced in the NPRM. They replaced PKI with something else. But we haven’t heard hearings in that area so we can’t make that comment.

MR. BLAIR: And that is the point I am trying to make in terms of what is the value of this letter. The value of this letter is, okay, you end up taking PKI out, but all the reasons why we objected to PKI are still valid.

DR. STEINDEL: That is why I think the phraseology of many of our previous recommendations are still very important.

MR. BLAIR: Walter, did that help clarify what is going on?

DR. SUAREZ: Yes, absolutely. I think it does. I just finished reading the new version of the letter. I don’t know how to proceed if we are going to go —

DR. WARREN: If you are comfortable that we discussed the background and where we are here today, I think probably the best way for us it to read through the letter. I would be glad to read it. Karen is going to scribe, so jump in we they talk too fast.

I read it right the first time this morning. I didn’t reverse words or anything else like I did on the phone. I felt that was pretty good.

DR. SUAREZ: It is a short letter so we can go through it and take it apart.

DR. WARREN: As far as I can tell, the only changes in that paragraph are change “in” to “on” and to add a url at the bottom. The url needs to be the url of the letter, not of the NCVHS web site. So unless people have — put the in back in instead of the on — I have to say on is more technically correct. This is where we got to a lot of the comments. I think part of it is the page break and part of it is — even Bill Scanlon was telling me that because he wasn’t part of the hearings he did not really understand, or he did not remember all of the sequence in the way things were.

When we started of at the top of page two, his comments were just say the NPRM did a lot of the things we asked for, however we still have concerns. I have heard that from a couple of people. Given his comment, let’s just read through the paragraph.

Most importantly, in the testimony leading to our March 2005 recommendations, e-prescribing networks, software developers, providers, standards development organizations, and prescription transaction standards developers — that’s heard — all expressed concerns to NCVHS regarding potential DEA security requirements and authentication. Specifically, the use of public key infrastructure or PKI, a framework of policies, protocols, and digital signature technology in e-prescribing. Testifiers concluded that PKI would, among other things, impose significant additional costs for e-prescribing networks, which are struggling to establish an adequate business case for their services and delay the adoption of the use of e-prescribing as a result of the cost and burden to install and maintain PKI.

MR. BLAIR: May I suggest a modification? The path we were all going down and up until now, we say most importantly it is the DEA’s proposal of PKI — I think we have to wind up saying it is the DEA’s proposal of — let’s see — proposal of a security solution that is not compatible with the rest of e-prescribing that would cause additional delays in the implementation of the networks and that would affect the business case, namely, PKI, and put it that way, that way, when you get to the latter part of the letter we could wind up saying we have taken out PKI, but you haven’t addressed the specific objection.

MS. TRUDEL: Jeff, K see what you’re saying, but of we jump forward two more paragraphs I think some of the changes that I think Denise made actually say that.

MR. BLAIR: Maybe, when you are leading up the PKI, instead of saying namely PKI, namely the disruptions caused by PKI or the concept questions of PKI or the effects of PKI — something like that instead of saying namely PKI, itself.

DR. WARREN: But in our letter we mentioned PKI. Remember we don’t have any additional testimony or anything. Because of the kind of letter this is, a summary of a letter we have already sent.

DR. SUAREZ: I do have a question on the additional language, the additional sentence in the fourth row that says regarding potential DEA security requirements on authentication, where are those back then? That is a part we might be missing.

DR. STEINDEL: We heard testimony from DEA on that.

DR. SUAREZ: So DEA was planning — it was suggested that they were looking at PKI as an alternative and then the rest of the industry was reacting to that?

DR. WARREN: I don’t think specifically they said they were going to use PKI. PKI was one of the things they were concerned with.

DR. STEINDEL: Didn’t they specifically talk about PKI in the joint hearings we had that were not in NCVHS?

MS. TRUDEL: But their proposal at that time was very specific. You are absolutely right.

DR. STEINDEL: And they came into our testimony.

DR. SUAREZ: They published their proposal some place> They made it known to the industry that their proposal was —

MS. TRUDEL: They indicated their position in the course of this hearing that resulted in that letter.

DR. STEINDEL: And in public forums that they were involved with. Now they never released an NPRM — did they ever release an NPRM?


DR. STEINDEL: They never released an NPRM with PKI. I think we have seen some of those in another venue.

MR. DICARLO: As an outside, I think they leaked a draft NPRM before actually publishing it.

MS. TRUDEL: There was an NORM and we have seen it within the federal space. I don’t know if it was leaked publicly or not.

DR. STEINDEL: But in answer to your question, Walter, it was in our testimony and it was very public that they were planning this route.

MS. TRUDEL: Right, no secret.

DR. WARREN: What is your pleasure? To continue reading the letter?

DR. STEINDEL: I have no major issue with what they are saying — with what was said here.

DR. SUAREZ: I think it looks fine.

DR. STEINDEL: And in the context of what is coming on it becomes clearer.

DR. WARREN: Jeff hasn’t heard the rest fot he letter.

DR. STEINDEL: That is what I was going to say, in the context of the rest of the letter, Nancy.

DR. WARREN: Next paragraph, and this is the next to the last one, Jeff. At this time the NCVHS recommended that HHS and DEA work together to reconcile different agency requirements in a manner that will address DEA’s needs for adequate security of prescriptions for all controlled substances without seriously impairing the growth of e-prescribing in support of patient safety as mandated by MMA. Finally we stated the need for HHS to evaluate emerging technologies, such as biometrics, digital signatures and PKI, for higher assurance authentication, message integrity and non-repudiation in a research agenda of e-prescribing.

Perhaps the effect rather than the repeated. I’ll change that.

DR. SUAREZ: Yes, I think the repeated was confusing.

DR. STEINDEL: My only comment is that when you read this you said at this time, and it is at that time.

MS. TRUDEL: And I think we should say it would address the signature question(?) — I’ll make that change.

DR. WARREN: You have to understand, I would never write at this time, because what other time is there?

DR. STEINDEL: Just an interesting aside comment based on this letter. DEA’s NPRM clearly states right at the beginning, our mission is not e-prescribing and we are ignoring it. That is paraphrasing but it is fairly complete.

MR. BLAIR: And that is true and that is the reality.

DR. STEINDEL: But we were saying very specifically the two agencies should mutually come to an acceptable way of approaching this.

DR. WARREN: So we are all right with at that time, and changing repeated to stated improves things.

Okay, so the last paragraph. Since the time of our recommendations, we acknowledge that the DEA has, in its current NPRM, migrated away from its call for the use of PKI for purposes of authentication. However, we continue to believe that many of our original observations and recommendations as stated above are still relevant and ask that they be considered for inclusion in any comments that the Department of Health and Human Services may make in response to this notice of proposed rulemaking.

MR. BLAIR: May I make the suggestion — it is so general in the way we said it, and many ore still relevant, I think a lot of folks would wind up saying why or what are they? If we could just add something to wind up saying we observe that the solution the DEA did pick still has many of the issues and concerns that we raised before.

DR. STEINDEL: I don’t think we can say that.


DR. SOUZA: Without the hearings?

DR. STEINDEL: Without hearings. They have taken a different approach.

DR. WARREN: DO we have to use the word many? Can we just say believe that our original observations and recommendations?

DR. STEINDEL: I think now that we have explicitly stated that they moved away from PKI, in the sentence before which we didn’t’ have in the previous version, then I think we can remove the many of.

MR. BLAIR: Why can’t we say that what we are concerned about is the fact that the solution that they have come up with doesn’t address the issue.

DR. STEINDEL: Because that is our opinion.

DR. WARREN: That is the opinion of this group, not of people in the professional groups.

MR. BLAIR: Then let me ask you this. We don’t normally inject our opinion. We gather the opinion from our testifiers. Here is a case where there is no opportunity to have hearings and testimony. Why is it not appropriate for us, as a committee, to indicate that the concerns we expressed — this is our judgment.

DR. STEINDEL: I think that is something that has to be discussed at the Executive Committee level.

DR. WARREN: And that is departing radically from —

MS. TRUDEL: I think that is what we are saying. We are saying we continue to believe that the observations are relevant. I don’t think we should say we continue to believe are still relevant — probably one or the other. And we are simply asking them to go back and look at the letter again.

DR. STEINDEL: I am perfectly happy with the way it is stated. But I am concerned about Jeff going one step further, which is what he suggested.

DR. SUAREZ: Maybe Jeff is going two steps further and maybe there is an intermediate step which is — Jeff, not to put it in those terms, to draft it that way — but it is something like we believe that a new approach should be evaluated within the same context. Sow e are not judging that the new approach —

DR. STEINDEL: But they took a new approach.

DR. SUAREZ: I know, but that new approach should be evaluated against the same considerations that we are using to argue against PKI. That is the point.


MS. TRUDEL: We lost our quorum for a moment and we need to bring Mark up to date before we go on.

We are on the second page. There is a change down here to change the url to specifically point to the letter. And then at this point we are arguing or discussing these two paragraphs and Jeff’s concern is he would like to state more explicitly that the DEA’s current proposal still carries with it a lot of the concerns that we had previously, and others are saying that we think we implicitly send out in the last paragraph. That is the point of discussion — am I right?

DR. WARREN: You said that much better than I could have.

MS. TRUDEL: That is because you were reading and I was ascribing.

DR. OVERHAGE: I guess I am a little bit with Jeff on this one. I wonder if the last sentence, though, in the first paragraph — finally restated the need to evaluate these merging technologies blah, blah, blah — but we sort of don’t give them any what were we thinking, evaluate them in what way? That they work, that they are secure — no. Rather we would like them to evaluate them in the context of their workability, their adoptability, their implementability for e-prescribing and use for clinicians.

MS. TRUDEL: The missing link is that we keep going back to the original letter and commending those original recommendations to the Secretary. I have a question for Walter. I am not sure that your points were made in that milieu or not.

DR. WARREN: But given that, the issue is that people are going to see this two-page letter and they don’t remember that one, even though we put the url to the original one, this should stand alone. Am I hearing that?

MS. TRUDEL: I don’t know that it should. I don’t think it possibly can. There is too much here.

DR. WARREN: Then when we send it forward this should actually be as an appendix. Would that satisfy your concern?

DR. SUAREZ: I think it should, but let me point out one thing. When you read the second page, the first paragraph tells the Secretary PKI is not good. The second paragraph says we believe that emerging technology, such as biometrics and PKI, ashould be considered. So we are translating PKI was not good. Now we are saying PKI should be considered. The first sentence in this last paragraph said we have knowledge that PKI was eliminated and then I the last sentence we say, however — and that however is an issue — we say all this evasion should be — at the end of the day it is not clear whether we —

DR. STEINDEL: Walter, I disagree with you. We didn’t say in that first paragraph on thaty page that PKI is not good. What we said is we have concern with the use of PKI in an e-prescribing environment.

DR. SUAREZ: That is what I said.

DR. STEINDEL: No, you said PKI is not good. We just said flat out we have concerns about it. This was expressed by our testifiers. We acknowledged in the letter we sent to the Secretary back two years ago, or whatever it was, that okay there are people who want to use PKI. We don’t think it is going to work. Let’s do a research agenda and include that as part of the mix to see what works and what doesn’t work.

MR. BLAIR: Steve, let me give an additional proposal. In that same paragraph where we wind up introducing PKI, later on in that paragraph we give the reasons why PKI is not okay. I don’t remember, with my les than perfect memory, exactly what words we used as we ended that paragraph but we probably said words to the effect that it is not consistent with the e-prescribing – something to that affect. Is that right? Maybe you could just pick the words.

What I am really suggesting is that we use those same words in our final concluding –

DR. STEINDEL: You mean from the original letter?

MR. BLAIR: From the original letter, as to the fact that there new solution doesn’t – is also not consistent. Whatever those words were, let us use those same words –

MS. TRUDEL: Actually, interestingly there are three recommended actions that speak to this. One says that HHS and DEA and state boards of pharmacy, should recognize that current e-prescribing network practices that are in compliance with HIPAA security and authentication requirements as a basis for securing electronic prescriptions.

Recommendation 1.2 is that they should work together to reconcile the different agency mission requirements in a way that addresses DEA. I think we noted that in the letter.

Then there is a third one that I had forgotten about actually and, boy, we were really smart. We said 2.1, HHS should evaluate emerging technologies, which is biometrics, digital signature and PKI, in a research agenda for e-prescribing and all other aspects — but that is what they didn’t do.

MR. BLAIR: Even if they didn’t do the research agenda, if they simply made their solution consistent with e-prescribing so that there is not a separate process —

MS TRUDEL: That is the recommendation 1.1 that they should recognize current e-prescribing network practices that are in compliance with HIPAA security and authentication requirements.

MR. BLAIR: Yes, and I think we ought to repeat that I our concluding piece.

DR. WARREN:: Based on that — and I think I see what Walter is struggling with and now I’m worried — paragraph one on page two, we say that PKI is a problem and we have given some recommendations there. But in two we say we ought to research PKI which, in that last recommendation was there, but I don’t think we really fully focus on that. And in the final one is that we acknowledge that they migrated away from PKI, but we still think all of our recommendations are okay(?), but somewhere in there we need to say that their new approach needs to be researched because —

DR. STEINDEL: Why don’t we modify it like this — however we continue to believe that many of or our original observations and recommendations including — and then add the thing that states, two bullets that state we should use the HIPAA security and e-prescribing requirements and that we should do research in the area of how these security methods — the research that we recommended before should be done.

MR. BLAIR: The only reason that I don’t want to repeat the research is it is a further delay. I’d like to have a solution as quickly as possible that would be compatible with e-prescribing so we could move forward. So if you did the first of the two that you say but not the second, I think that would be good.

DR. STEINDEL: I think the main one — to me the main issues of the NPRM was first of all our recommendation that the agencies, that the Department and DEA sit down and understand both of their needs and work out a common solution — that that was not done. That, to me, was the biggest problem.

MR. BLAIR: Is that actually a fact that they never agreed to sit down with HHS to resolve a common issue?

MS. TRUDEL: There are a number of different discussions. That whole process is laid out in the testimony that HHS and DEA set forth at the Judiciary Committee meeting last December. There were discussions, but there was never a meeting of the minds.

DR. STEINDEL: And there is actually an explicit statement in the NPRM that says that. That is not our mission.

MS. TRUDEL: We did have that joint two-day conference a couple of years ago and a number of discussions after that.

DR. WARREN: Let me ask this. When we look at the letter, is there any disagreement with the intent?

Let me rephrase it. It seems to me that the last sentence in paragraph two that is throwing everybody off. What we have tried to do is paraphrase the recommendations from the letter in that one. What may be in there is the whole use of the word PKI — what I am wondering is if we could put and other encryption technologies instead of using the word PKI?

DR. STEINDEL: In actual fact does that sentence really add anything? Could we just drop it?

DR. WARREN: Only we need a number of recommendations in here. They may not all be relevant. There is the research agenda, the current network practices, there’s the working together to reconcile differences, and so which one is the one that we feel the most strongly about in terms of being a concern?

DR. STEINDEL: We expressed it.

DR. WARREN: And it is the first one.

DR. STEINDEL: Which is work together.

DR. WARREN: Well, is it the work together or is it the recognized current practices?


DR. WARREN: It is the recognized current practices.

DR. STEINDEL: Actually we don’t say that in this letter. We drop that.

MR. BLAIR: You know, in a sense —

DR. STEINDEL: This version of the letter dropped that.

DR. SUAREZ: To me what is the message we want to view to the Secretary in terms are we saying specifically – or are we saying somewhere that the ultimate selection of the NPRM that is not – criteria of not impairing or limiting or affecting the implementation of e-prescribing.

DR. STEINDEL: I think the message we want to send the Secretary is that DEA, NPRM in its present form, is incompatible with HHS’s mission of promoting e-prescribing. That is the bottom line.

MS. TRUDEL: I think it is a little unusual for an advisory committee to tell the Secretary that something is contrary to his agenda. Perhaps we want to restate that?

DR. STEINDEL: I think we did a good job of stating it.

MR. BLAIR: Can I back up again? Can I react? We fiercely protect our independence. Okay? In those cases – NCVHS does. Is this case I think in fact, the purpose of this letter is to give HHS something as a tool that will help them in their negotiations with DEA. Therefore, I’d like to look at it a little bit from Karen’s perspective in this case. If this letter doesn’t help you – help you – HHS, in negotiating with DEA then I don’t think it has a purpose for us to do it.

DR. STEINDEL: I think the tool that would be very, very helpful is if we actually held a hearing and have some very specific comments to make on the end charge. Which we cannot do. That would be a very powerful tool.

Now, beyond that tool what we really are just saying in this letter, what it gets down to is we made some god points in the previous letter – DEA/NPRM does not meet those points – reread the previous letter. That is really what it comes down to and how helpful is that, Karen?

MR. BLAIR: We probably ought to reference especially points this, this and this.

DR. STEINDEL: Because it is going to the Secretary.

DR. WARREN: It is another thing to also think about. Harry and Jeff and I did have a phone conversation before the letter was drafted. One of the things that came up in that phone call was that in many instances NCVHS told Harry write letters to the Secretary, time goes by, the Secretary either responds to those or in this case DOJ has responded by having the EA relationship PRM. So what role will NCVHS have in that. One of the roles we can do is to remind the Secretary that we held hearings on this a year, two years ago, and that these were our comments. That way it doesn’t require any hearing. It is just saying here it is, we are bringing it up to your comments attention, even though staff may already know about it and they are already looking at it, it is at least a formal reminder that we have done this.

DR. SUAREZ: But had you taken one step farther, without making judgmental decisions, if you took it one step farther saying we believe that the NPRM, or we have concerns with how the NPRM is framed within this particular area, that does not meet the original recommendations.

DR. WARREN: My understanding, because I asked the same question, that it is very poor form for a committee in one department to make negative comments about the actions of another department. The only people we can talk to is the Secretary that we report to. So we need to be somewhat circumspect in our comments in that we are not critiquing the Department of Justice. We are just saying, remember we had these hearings, remember we made these recommendations, we still have concerns.

DR. SUAREZ: We still have concerns.

DR. WARREN: It is what we said here in the last paragraph. So go back — because we haven’t changed our minds, the original recommendations still hold. So you aer thinking about your comments, and however secretaries comment on each other’s stuff, then remember that we did this for you.

MR. BLAIR: Thank you for saying that because I missed that point and it helps me explain why you took the position you did, that you want the ambiguity.

MS. TRUDEL: HHS is already discussing how to address the comment. Frankly the most important thing right now is to look at the public comments and see what they say. The comment period isn’t over yet, and many of the comments we have gotten so far may not be up on the web yet. I think a lot of the people who delve into it most deeply will probably use almost the entire comment period just so they have their comments fully explicated.

DR. WARREN: Will Secretary Leavitt make a comment within that forum? Or does he have a different way —

MS. TRUDEL: No, it is different. There will be discussions within the executive branches on what to do next.

MR. BLAIR: Then given this discussion, and I am circling around to a different position, so I will just ask you directly. Karen, is the letter, the way it is, in about as good a form as possible to help HHS?

MS. TRUDEL: I would say if you attach the original, I think this works.

MR. WARREN: So instead of putting the url, we

DR. SUAREZ: On the last paragraph, adding specifically we would like to point out a selection of the technology of NPRM and the effect it would have without making any judgment in terms of the negative – but just to point out that specific element of NPRM.

I think we told you before that the PPI approach was not good and we are specifically alerting you to process of the lecture element.

DR. STEINDEL: I think Walter, that is dangerous.

MS. TRUDEL: Obviously, there might be a compromise. What if we said we continue to believe that our original observations and recommendations as stated above are still relevant in terms of preparing the group for e-prescribing?

MR. BLAIR: I like that.

DR. STEINDEL: If we would have had this conversation three hours ago – we actually could have gotten it down to two words instead of three.

Karen, instead of stated above – can we say as attached or do you want to refer to the restatement?

MS. TRUDEL: Restatement.

Agenda Item: Charge and Portfolio

DR. WARREN: Our next editing pleasure is our charge. I think I have it reformatted the way people said they wanted it done. I did not change any of the phrasing on there. We had approved the phrasing that we have here and we wanted it bulleted so we could follow the context. It did add number 5, which we inserted.

Since it is a formatting issue – it is still difficult to read.

DR. OVERHAGE: Reading this now, the one thing that jumped out at me was in the first paragraph we say, including the implementation. The bullets don’t seem to carry that forward. Wee talk about the impact of standards – we don’t say implementation.

DR. WARREN: I think from all the comments made today, implementation probably needs to come somewhere in here. We had talked about what was the best way to go from one standard version to another and implement things.

DR. OVERHAGE: I guess I was looking ahead, too, being a bad person – to the process issues and our little diagrams like harmonizing standards.

DR. SUAREZ: I think one of the suggestions before was using the word adoption. Part of the discussion and the deliberation that we made here is not so much about implementation but the adoption of standards. There is adoption and implementation.

JIM (ASPE): In terms of sustainability, it is one thing to say that you are going to adopt standard acts but it is another thing to know that it is actually going to be updated and maintained and be integrated —

DR. SUAREZ: Adoption and implementation –

DR. STEINDEL: I am having a little problem. How did this discussion deviate from what is in item number three?

DR. OVERHAGE: I guess my question was that in two and four, we use only the words standards and health information technology of standards and don’t talk about the other pieces. I agree we touch on them in three. Maybe that is good enough?

DR. STEINDEL: Yes. I think it is confusing. I mean we are actually introducing the concept of implementing and we can add some other words to that list if we choose too; developing, coordinating, adopting, whatever, but I think we are handling that part of that in three.

DR. SUAREZ: Three takes care of it but to promote a continuing process of developing, coordinating and implementing. I don’t see the word adopting.

DR. STEINDEL: No, I said we could add words to that list. I was just talking I general about why doesn’t number three cover what we were just talking about.

JIM (ASPE): Implementing standards is ambiguous because it seems to me that initial use or getting people to start to use them. But really what I am thinking more is a life cycle approach to these things.

MR. BLAIR: For my benefit, could you tell who is speaking.


MR. BLAIR: Thank you, Jim.

JIM (ASPE): It is more of an issue that looks more at the overall impact of the life cycle of standards and how they get integrated.

MR. BLAIR: Did we not have – I thought we had something like development selection, implementation, and maintenance.

MS. TRUDEL: From our perspective, when we say implement we mean incorporate into ongoing business processes. And modification and maintenance is something that happens the next –

DR. STEINDEL: I agree with people – the list we have now is vague.

DR. WARREN: Instead of the list do you want to use the word lifecycle?

DR. OVERHAGE: My only concern with lifecycle is that you could take a very narrow interpretation and think about the lifecycle within HL7.

DR. STEINDEL: If we do use the word lifecycle – we would say lifecycle included and then list some stages. Your wording it slightly ambiguously so that if we find something else it slips into lifecycle.

MS. TRUDEL: From a standards person perspective, lifecycle means what happens inside the SDO and from a IT person’s perspective, which I am, lifecycle means the implementation process and it starts after adoption and begins with analyses, design, testing. So we want to add the word adopting and maintaining to the chart?

DR. SUAREZ: I would just say developing, coordinating, adopting, implementing and maintaining standards. That would cover it.

DR. WARREN: Where?

DR. SUAREZ: At the end of three.

DR. WARREN: Developing, coordinating, adopting, implementing and maintaining standards.

DR. OVERHAGE: Let me take one more pass at my concern and make sure that I am okay with this. We say advise the Committee on strategies and then make recommendations to the Full Committee on impact. I am making sure that we are not implying in here that we are not going to make recommendations to the Committee on the impact of implementation and coordination because they are going to advise among strategy and then we are going to make recommendations.

MR. BLAIR: Is it that we made recommendations on the impact or is it we have considered the impact when we are making the recommendation? Basically we hear from the industry and they wind up saying, to what degree will it impact them and that we make recommendations that consider those impacts?

DR. WARREN: We have written here, to make recommendations on the impact of standards.

DR. STEINDEL: I think Jeff is right on that consider the impact of standards.

DR. OVERHAGE: Maybe you rearrange three and four. Maybe you take where the two is, we are going to serve as a public forum. The new number three, currently number four, we are going to consider any impact, and then we are going to advise the committee on strategies.

That might help my worry.

DR. WARREN: Tell me how you are rephrasing that.

MS. TRUDEL: We now have one, two, four, three.

DR. OVERHAGE: We like Walter’s list. Three becomes four, four becomes three, and four is now rephrased something along the lines of consider the impact of standards, including this list.

DR. STEINDEL: No. I think it should still say make recommendations to the committee considering –

DR. OVERHAGE: Fine. How is making the recommendations to the Full Committee on this list of things and advising the Committee on Strategies, including public information, education, research and development — how would I explain that difference to people?

MS. TRUDEL: They are the same.

DR. WARREN: Strategy, to me, has to do with the whole list that we were talking about — adoption and maintenance and things like that. It includes some educational efforts and research recommendations and there are other things in there than what we might put in formal recommendations.

MR. BLAIR: This may be the example or reveal whether this is right or wrong and maybe strategy is not the right word. When I think of strategies I take a look at where — we had this very ambiguous phrase in the HIPAA law about PMR, patient medical record. And we basically, on our own, decided that meant electronic health records, EHRs, and we would up coming up with a strategy back in 2000 where we said we were going to deal with message format standards, terminology standards and whatever goes with it. So it was like a four-year strategy.

The first thing we did was message format standards, which was HL7 and IEEE and all of those pieces, and the next thing we did was come up with a construct with a criteria for selecting the terminology standards. And that was based on clinical specificity and the fact that they were non-ambiguous.

So I think of those as strategies. We didn’t just do it. We said here is our strategy. Does the Full Committee approve it? The Full Committee approved the strategy and then we executed the strategy.

MR. REYNOLDS: I think we did some of that in e-prescribing, too, didn’t we? We talked about public compatibility and some of those other things and then we actually turned those into — but those were strategies in how to streamline and how to move things along. But then they actually became physical recommendations because the Committee bought into it as a strategy. Now it has manifested itself as we seen it come back.

MR. BLAIR: Another aspect of the strategy is if the Committee agrees on the criteria for selecting standards, that is I think a strategy, establishing criteria or guiding principles for the selection of standards.

DR. STEINDEL: I think, Mark, our 5010 ICD 10 letters are all under the present advise on strategy.

MS. TRUDEL: I think a lot of the recommendation s that are made are cropping(?) because a number of the NPI recommendations were on the impact of standards, but some of them also had to do with public information and educational efforts. I would suggest maybe leaving three and four separate simply because there are so many words in there, but make the verbs the same.

Three is now making recommendations to consider the impact of standards, and four is advising the Full Committee on strategy.

DR. STEINDEL: And change that to make recommendations to the full Committee on strategies.

DR> WARREN: So we have that on both of them?

DR. STEINDEL: Both of them.

MS. TRUDEL: So what we are saying is they are similar in that the subcommittee is making recommendations. The distinction is what they are making recommendations on.

DR. OVERHAGE: So them my question is what is it that is unique about the impact of standards that we would spend eight lines on it?

DR. SUAREZ: I think the number three has the clear intent to do something — make recommendations to do this. So it defines the purpose of the recommendation. Number four — we’ll leave it the way it is. I mean if we are dealing with a change, to make recommendations to the Full Committee based on the impact of standards, recommendations for what?

DR. STEINDEL: I think the purpose of four is to give the list of the areas that we are going to make recommendations in. We are not going to make recommendations on fire safety standards.

DR. OVERHAGE: So why not say that the scope of our standards activities will include a list that we have.

DR. WARREN: This list comes straight out of HIPAA regulations of what we are responsible for.

MR. BLAIR: Let me make an observation. I am not sure whether this gets us in trouble or not. We don’t always consider the impact of standards. There are certain things where the industry has come to us to enable something and basically the impact gets short shrift. On the other hand, when it comes to things like going from ICD 9 to ICD 10, oh, boy, we need to call in the Rand Corporation to look at the impact of standards.

So there are some area where we do and some areas where we don’t. Does that make a difference in the list?

DR. STEINDEL: No. It is how we treat the work for the particular topic.

MR. BLAIR: I just didn’t want the list to become a mandatory set of items that we have to do a gold standard selection.

DR. SUAREZ: It seems to me that number four, what we do is make recommendations to the Full Committee on the adoption and implementation of standards. Additionally we advise or make recommendations to the Full Committee on strategies that promote the continuing process of developing standards. What is missing from number four is teat recommendations are on something about the standards for all this list of standards. We make recommendations on the optional implementation, whatever catch —

DR. STEINDEL: Correct me. Number four is basically a paraphrase of what we are required to do under HIPAA>

DR. WARREN: Yes, it is.

MS. TRUDEL: The new number four or the old number four?

DR. WARREN: The original report.

DR. STEINDEL: It is a paraphrase of what the law says.

MS. TRUDEL: It is relevant to HIPAA, but that is only one of the things –

DR. STEINDEL: I was just commenting from Walter’s point of view. Why should we have this as a separate list? One reason we should have it as a separate list is because it is one of the things that the law requires us to do.

DR. SUAREZ: I like having the separate list. The part that is missing for me is the action verb — make recommendations on the adoption and implementation of standards for all this. We make recommendations on the impact of standards. We are not making recommendations on the impact, or making recommendations based ont eh impact of standards —

MR. REYNOLDS: We hear testimony on the impact and then we make recommendation on what we should do.

DR. OVERHAGE: Is it only based on impact?

DR. SUAREZ: That is why I was dropping it based on impact. I was just saying number four should say make recommendations to the Full Committee on the adoption and implementation of standards for and then the list. So that defines the scope of the committee.

MR. REYNOLDS: What about adding the word implications? You said adoption, implementation — I like implications.

DR. STEINDEL: I don’t mid using implications. It has the same sense. But I don’t like dropping the word impact because it actually gives us a charge on what we should be looking at. If we just say, you know, make recommendations on adoption, we can make recommendations on adoptions pulling it out of the air.

DR. OVERHAGE: I think that is why Jeff was suggesting some wording like considering — which I am probably including. Does that imply we are considering only if that is the only thing on the list.

MR. BLAIR: I don’t want to introduce this too soon. I have a different perspective to add when you all feel it is ready.

SPEAKER: It’s ready.

MR. BLAIR: Here’s the perspective is basically we derived this list based on our past practices and we are reaching the stage where the standards development processes, plural, have become a chore and they are dealing with new issues, a new sense of urgency and new complexities for harmonization. They are getting tested in new environments such as NHIN. They are moving into a different stage.

Between Mark, your suggestion that we start to examine these standards processes and how they work together and if they are working as well as possible, and the SDO summit that has come out, and comments that Rod Kolodner has made to me as well, this probably will be a major agenda item that we will have during the next six months, is how do we constructively look at everything that is going on, find where the impediments are and see what we can do to improve all these processes collectively.

DR. OVERHAGE: Isn’t that strategy?

MR. BLAIR: Yes. That is my question and if that is the answer then that is fine. I just wanted to make sure that this document, what I said, would fit within this document.

Karen, you had a comment.

MS. TRUDEL: Yes, the way I think the discussion has modified the two, the new item there talks about recommendations on standards themselves. Whereas four is the strategy that affects the process.

DR. OVERHAGE: I got that in reading it.

MS. TRUDEL: It is process versus subject matter.

DR. OVERHAGE: And we are going to make recommendations for both.

MR. BLAIR: I don’t remember, do we have in here the word process?

DR. WARREN: Yes, a continuing process of developing, coordinating, adapting, implementing.

MR. OVERHAGE: On the issue about the word impact, which I agree we need to leave in there — making recommendations to the Full Committee considering the impact of standards as well as other factors — or something like that. I just worry about narrowing the scope too much.

MR. FERRER: We don’t know what the impact — that constant we do not know. So how do we cover ourselves on that?

MR. REYNOLDS: If you add that then that takes care of my word implication. Impacts is a very focused implication. So I am okay with that.

DR. OVERHAGE: We have standards, we have process and that covers it.

DR. WARREN: I want to take us back up to two. I would like to delete through a variety of mechanisms, so we start out with the verb provide.

DR. STEINDEL: Can we change it to rule? I think this is even more important. We had the discussion today on data stewardship and we saw how if we do expand in that area, it is going require good collaboration.

DR. WARREN: This is brand new. I have not been part of it nor have I seen the charges of the other subcommittees, but certainly I think we are going in the right direction with everything that has happened in the last couple of months, actually the last two years.

MR. FERRER: Do we really have an obligation to do that?

DR. WARREN: Even though we are the better subcommittee.

DR. STEINDEL: I like the word rule, but I was going to suggest subjugate.

DR. WARREN: Much as I hate to say this, do you know what they call the French who worked with the Nazis? They called them collaborators. So there is only the dark side to rule.

MR. REYNOLDS: On six, tell me what you mean by the word implementation.

DR. STEINDEL: Could you put it in context and read six to me?

DR. WARREN: The recommendations for the Full Committees annual report to Congress on the implementation of HIPAA administrative simplification.

MR. REYNOLDS: My question was implementation. You can say yes, it is in. You can go all the way from yes, it is in to lessons learned.

DR. WARREN: Is Congress calling it the implementation of the simplification or can we just delete the word?

MS. TRUDEL: Can we just call it the annual report to Congress on HIPAA administrative simplification.

MR. REYNOLDS: I am okay with that. Then that les us say anything we want to. Implementation says you can only talk about the things that have been implemented, you can only talk about — you know, it doesn’t beg all the other subjects I think we are going to have.

DR. WARREN: The other thing I just noticed is up in the first paragraph. We had the law, number and everything else specified, and I just put HIPAA in there.

DR. SUAREZ: What are you meaning here on the introductory paragraph — the development of a nationwide network, another legislation or ONC initiatives — I am just asking is our charge larger in the sense that it should cover HHS?

The other piece that I thought was missing is something on the development of NHIN, but it doesn’t talk about health IT or HIT in the sense that there is really —

DR. WARREN: It raises another historical piece. We actually had a task force that looked at recommending standards for NHS(?).

MR. REYNOLDS: How about something like possible associated subjects like HIT. What you are doing is leaving a door open. And those are just examples. It can be any associated subject that we may want to consider. So for example, today we talked about PHR. An associated subject to me is sensitive data, which is actually in privacy, but if you said on PHR you could do certain things, but we call it sensitive data and we would have it outside privacy.

DR. WARREN: I am going to keep NHIN in here as an example. The only reason I feel strongly about it is the last couple of reports that I have head out of NHIN never refer back to that wonderful, what was it, sixty days that we had to do health standards requirements/

MR. REYNOLDS: But you know that most of the RFPs include them. So back to Blackford Middleton’s comment today, it is actually showing up.

MS. TRUDEL: Can I read what I think I heard? Including implementation of the administration simplification provisions, which I will spell out, the Modernization and Improvement Act of 2006 and associated health information technology subjects, such as the Nationwide Health Information Network.

DR. STEINDEL: I thought we were going to include HHS in that.

MS. TRUDEL: Once we said associated HIT subjects such as, what was at the end, which was and related legislation or initiatives to be duplicative?

MR. FERRER: Redundant?

DR. STEINDEL: I think in this case being a little bit redundant adds clarity.

DR. SUAREZ: I would drop the firsthand — HIPAA and MMA —

MS. TRUDEL: And MMA, associated HIT subjects across the nationwide health information network and other related legislation or HHS initiatives.

DR. WARREN: So we have our charge. So our next task, because our fearless leader is sitting at the end of the table — actually this was designed by Harry. Our portfolio and where we want to go. So we can debate now what we want to add.

DR. STEINDEL: Judy, in defense of Harry we have not been working on this for four years. We have been evolving this for four years, adding and subtracting as new issues come to the forefront, which is what this is supposed to be used for.

DR. WARREN: So this is like our dashboard. So Harry came up with the format, the template, whatever and as life goes on we go in and make sure that each of the categories really do represent what we are looking at and help us not leave anything out.

MR. REYNOLDS: One of the things that is going to be rally important for the Full Committee is once you agree to whatever this is and start establishing what you want ot hold hearings on, it gives it an anchor against what you are trying to do in general. It doesn’t just make it something that you pulled up and started working on. That is what I want from all of the committees. So Judy, if you are wondering, or anybody in the room, you read the charter that you are supposed to be coordinating with other committees, right now you don’t have a thing you could pick up that would say to you where you might even want to think about crosscutting unless we make it a crosscutting issue. That is the thing that I hope these end up doing. I don’t care about format changes but that we all know what we are supposed to be looking at and doing, and can share it with each other and nobody has to wonder what they are doing.

DR. WARREN: So we should walk through this so we know what we want o be doing. One of the things that we have to start looking at is what kind of hearings do we need to set up in the coming year. Who do we want to hear from? What are the topics that need to come before us.

MR. FERRER: Agenda contributors you have CMS and CDC, two offices of HHS, and you have HHS listed there. There’s FDA and I suggest there are a heck of a lot more. This just does not feel good to me.

DR. WARREN: What do you want there?

MR. FERRER: You’ve got HHS, Steve — wouldn’t you consider HHS to be sufficient?

DR. STEINDEL: Actually what this is listing, I think, from an enumerated point of view, is some of the liaisons.

I will give you my comment right now, to be blunt. There is no talk within CDC about replacing my position at this level. So I don’t know what CDC is going to be doing with respect to NCVHS after September 27th. So CDC actually is appropriate in this list right now.

DR. WARREN: Let’s go back. Is this a list for liaison?

DR. STEINDEL: It is not complete. VA is a liaison and NLM.

DR. WARREN: Or is this a list of people who can contribute to the agenda? Because we have industry.

MR. FERRER: VA and DoD come in all the time. I don’t know if they should or should not be but you have some major players who are not even on the table here, yet you have sub-setted HHS.

MS. TRUDEL: The whole FHA initiative is going on.

JIM (ASPE): There is the Indian Health Service.

MR. BLAIR: We have only had one time in I think the last six or eight years where we have had representatives from the Indian Health Service.

DR. STEINDEL: Judy, I think what we should have here is HHS agencies. I think CMS, with respect to this subcommittee, CMS should be listed also as an agenda contributor because of our legally enumerated roles in HIPAA and e-prescribing. So CMS is actually a big driver of the agenda because of that. So I think HHS agencies should be listed as a list. CMS should be listed separately. I am not sure about ONC. I think CDC should be dropped and included in the list of HHS agencies because we do not list the full set of HHS agencies that are liaisons.

MS. TRUDEL: If you leave CMS on that list I am going to get beat up.

DR. STEINDEL: Karen, hat is your prerogative at CMS to request that. I was just stating it just from the point of view of the way I viewed it.

DR. WARREN: I think if we put HHS agencies that would guide us.

DR. STEINDEL: Then you have a question as to whether or not you want to leave ONC separate, and I say no.

MR. BLAIR: Can I suggest that in addition to the HHS agencies, we also have HHS offices, like Jim Scanlon. Offices and agencies.

DR. STEINDEL: The other thing we should include in the agenda contributors is other federal health care agencies.

MR. FERRER: And leave it broad like that. There are so many — rural health, blah, blah, blah.

DR. WARREN: Other federal agencies involved in health care.

MR. BLAIR: Other federal health care agencies.

DR. STEINDEL: There is a subtle difference between the two. I think either way is fine.

MS. TRUDEL: Under audiences I would take out WEDI.

DR. SUAREZ: I was going to say that. WEDI is not really an audience. It is a contributor.

MR. REYNOLDS: I think this is great, guys, because it has been sitting like that for three years and nobody cared. I want them updated.

DR. WARREN: So we want to change this to AHIC successor — the new name?

MR. FERRER: AHIC’s successor is a private entity.

DR. STEINDEL: AHIC’s successor is industry.

I looked at that list that Mary Jo was showing and said, well, HINS does that and AMIA does that, a whole list of groups that do the exact same thing.

MS. TRUDEL: And where they advise the Secretary, ONC is included.

DR. FERRER: ONC comes in with these quick, fast, furious requests and they dump these initiatives on NCVHS —

MR. BLAIR: That never happened to us.

MR. FERRER: It has happened in the past. Is that the reason why ONC is still here?

DR. WARREN: WE are at the point of saying who we want. As Karen pointed out, if our audience is the Secretary, then anybody under HHS gets this, which is ONC. So given that we have three audiences — the Secretary, Congress and industry.

DR. STEINDEL: That is fine, but there is one thing about ONC. It’s out child. It was created —

MR. FERRER: Yes and no.

MR. BLAIR: We recommended that there be an office created to try to provide leadership and coordination for the development of health information technology. They were created for that mission and it is an extension of a lot of things that we can’t do ourselves. So I feel like there is a special relationship.

MR. REYNOLDS: Let me put it this way. If you put on ONC you have to put on CMS. That’s my input.

DR. STEINDEL: I’m sorry. I thought that Walter was just asking. I wasn’t arguing that it be separately listed on the chart. I just thought you were just asking about ONC so I was describing that I think we have a special relationship with them. I guess we could say we have a special relationship with CMS, and up until now with CDC.

MR. FERRER: But the father of all this is HHS. Or mother.

DR. WARREN: We only have about ten more minutes. Is you comment relevant to audiences?

MR. DICARLO: I was going to ask if you thought consumers were part of your audience.


DR. OVERHAGE: Are they an audience or somebody we attend to? We don’t make recommendations to them. I guess they watch what they are doing.

MR. BLAIR: We do ask for their testimony.

DR. STEINDEL: And we actually have produced recommendations that were geared to the consumer, so I think they are an audience.

DR. WARREN: What I want to do, given the time, is bounce over to the other side, look at process. Is there anything in the section of process that we need to change?

DR. OVERHAGE: You could argue for aligning it better with our charter, instead of conduct hearings, act as a public forum and instead of prepare recommendations — it is kind of a minor thing.

DR. WARREN: I think that is a good one.

DR. OVERHAGE: Line it up better with the=rds we used in the charter.

MR. BLAIR: I like that.

MS. TRUDEL: I wish I had thought of that.

MR. BLAIR: Mark, are you saying we should harmonize the portfolio?

DR. WARREN: Let’s notch down to who we give regular updates to.

MS. TRUDEL: No, get regular updates from.

DR. WARREN: You get those from people?

MS. TRUDEL: The arrow is going in.

DR. WARREN: Sorry — anyone else that we need to get regular updates from?


BILL (ASPE): We believe CCHIT is separate.

DR. SUAREZ: WEDI and DSMO would be separate, SDOs would be separate.

BILL (ASPE): And would you put in AHIC, too?

DR. WARREN: WE do get regular updates from CMS.

MS. TRUDEL: Why is this relevant in terms of focus and portfolio? I can see where it is marginally relevant to process.

MR. REYNOLDS: I will tell you I put it on there personally when I was just learning so I had a checklist. I’ll be honest with you. This is a great way for me to have a one-page thing on who I had better be thinking about..

DR. STEINDEL: I think there is no different between these and the agency contributors.

DR. WARREN: It is our cheat sheet now.

DR. SUAREZ: So the contributors should have DSMOs, SDOs.

DR. WARREN: I would like to have DSMO up there in particular, because we do have staff connections there.

DR. WARREN: So what is your pleasure. DO you want to do subjects to develop or current hot issues?

MS. TRUDEL: We did audiences, we did agenda contributors, we did balanced portfolio, we did process and we took out regular updates.

DR. OVERHAGE: Current hot issues — isn’t that what you are going to hold hearings on?

DR. WARREN: That is one of the things we need to talk about.

DR. WARREN: Looking at the five things we have up here — notice that number five really needs to be data stewardship. That naming has changed and that fits right in with what Justine has asked us to think about that.

DR. CARR: I am not sure it is a topic unto itself or it is a framework that applies to topics as we think about them. I don’t know if it is a project that we would want to have a separate ad hoc committee about stewardship or rather that we would want o articulate attributes and considerations that incorporate as we address various issues.

DR. STEINDEL: Regardless it is still a hot issue.

DR. WARREN: Yes, it is one of our current issues that we want to be sure we focus on. There is not strategy in here or whatever it is. It is just that we are going to be looking at what we do with data stewardship in the future.

DR. SUAREZ: It is one of the crosscutting issues because data stewardship from the privacy perspective is important.

DR. CARR: I am trying to align quality —

DR. OVERHAGE: I like number 2, which is identify and address standards gaps for NHIN.

MS. TRUDEL: You want to keep that?

DR. OVERHAGE: No, I want to get rid of it because we have way too many standards for NHIN now and way too much more work to do to implement the things that we have today. It just confuses the issues further.

BILL (ASPE): I might be more evaluate than define.

DR. STEINDEL: I don’t want to drop any — I agree with Jim, I don’t want to eliminate something to do with looking at standards with regard to the NHIN. You can rephrase what we want to do.

DR. OVERHAGE: If we are going to do that I would like to expand that just a little bit then and focus, if yo look on the subjects to develop under 3, the harmonizing standards I think falls directly underneath that, and definitely a hot topic because I think that is a serious problem with what is happening with HITSP and a serious problem with what is happening with IAG.

MS. TRUDEL: So should 2 then be evaluate NHIN standards and harmonization?

DR. STEINDEL: That sounds reasonable.

DR. OVERHAGE: That would be reasonable. I like that.

BILL (ASPE): And I think that is a major, major problem.

DR. OVERHAGE: I do. I don’t want to lose it, but I don’t think we need a gap analysis to find more to make(?).

DR> STEINDEL: I think HITSB is doing a very good job of creating more and more gaps.

MR. BLAIR: It is now 5:30 and Judy and I were talking about, when the executive retreat occurs in the second week in October, that the morning of the 14th we would have a get together for three hours, three-and-a-half hours to begin to maybe finish off what we are doing now and to plan our hearings for the next nine months after that, nine to twelve months. So my thought is we really ought to adjourn at this point. I know I need to get back for some calls. Is that okay, Judy?

DR. WARREN: Yes. Just to give you a heads up, what Jeff was talking about is during the executive committee retreat in October, and we were thinking that everybody on the committee will either be in town — with the exception of Mark, who we could hook up by conference call, because there is no need for him to be here for a three-hour meet. We don’t have all the arrangements planned out yet. We are still working with Marjorie. But is that something the group is willing to do?

Time to adjourn. Thank you.

(Whereupon, at 5:30 p.m., the meeting was adjourned.