[This Transcript is Unedited]
Hilton Embassy Row Hotel
2015 Massachusetts Avenue, N.W.
Washington, D.C.
Agenda Item: Call to Order, Welcome and Introductions
DR COHN: I want to welcome everyone; I know most of you have all ready been through two hours of meetings. I want to call this meeting to order. This is the second day of meetings of the National Committee on Vital and Health Statistics. The National Committee is a statutory public advisory committee for the US Department of Health and Human Services on National Health Information Policy.
I am Simon Cohn; I am Associate Executive Director for Health Information Policy for Kaiser Permanente and chair of the committee. I want to welcome committee members, HHS staff, and others here in person as well as those listening in on the internet.
Let’s now have introductions around the table and then around the room. For those on the National Committee I would ask if you had any conflicts of interest related to any of the issues coming before us today, would you so publicly indicate during your introduction. I want to begin by observing that I have no conflicts of interest. Jim –
MR. J. SCANLON: Good morning, I am Jim Scanlon with the HHS Office of Policy Planning and Evaluation and I am the Executive Staff Director for the Full Committee.
DR. STEINDEL: Steve Steindel, Center for Disease Control and Prevention, liaison to the Full Committee.
MR. BLAIR: Jeff Blair, Loveless Clinic Foundation, Member of the Full Committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, liaison to the Full Committee, Staff Standards and Security Subcommittee and the Quality Workgroup. Did you want us to indicate whether we had conflicts of interest or not Simon? I do not have any conflicts.
DR. STEUERLE: I am Gene Steuerle; sorry it is hard to follow Michael because he has so many titles. I am from the Urban Institute, a member of the Committee, no conflicts.
MS. McCALL: Carol McCall, a member of the Committee and a member of the Quality Workgroup, no known conflicts.
MS. AMATAYAKUL: Margaret Amatayakul, contractor to the ad hoc workgroup.
DR. CARR: Justine Carr, member of the Committee and the Quality Workgroup on Standards and Security, Beth Israel Deaconess Medical Center and no conflicts.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, a member of the Committee, no conflicts.
DR. GREEN: Larry Green, member of the Committee, University of Colorado, no conflicts.
DR. W. SCANLON: Bill Scanlon, Health Policy R&D, member of the Committee, no conflicts.
MR. LAND: Garland Land, member of the Committee, with NAPHSIS, no conflicts.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the Committee, no conflicts.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the Committee, I have no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield North Carolina, member of the Committee, no conflicts.
DR. WARREN: Judy Warren, University of Kansas, School of Nursing, member of the Committee, no conflicts.
MR. ROTHSTEIN: Mark Rothstein, University of Louisville School Of Medicine, member of the Committee, no conflicts.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and Executive Secretary to the Committee.
MS. FRANCIS: Leslie Francis, University of Utah, member of the Committee and no conflicts.
(Introductions around room.)
DR. COHN: Okay, I want to welcome everyone today. Now let me just talk about what we are going to be doing in terms of the next couple of hours of work. We are going to start off by talking about the Enhanced Protections Report. You all have copies of a redline version of all of the recommendations and observations which we will go through and make sure that it comports with our conversations yesterday and you are generally in agreement with it. We also obviously have a redline version of the landscape and introductory material. We didn’t make copies of that but we have it on screen to go over. We will start off with the observations and recommendations going until we have John Loonsk coming to present to us around 11:30. Now that is going to need to be relatively brief and succinct just because we will need to get back into this letter. The intent will to be for us to finish discussion with the letter before we break for lunch.
PARTICIPANT: You are really putting the pressure on boss.
DR. COHN: I just want to make sure we have a chance to go through it and properly consider it.
Now after lunch we will be spending some time talking about work for the workgroups and subcommittees and sort of what has been happening over the past couple of days as well as plans for the remainder of 2007 and 2008. We do have a revised document on Subcommittee and Workgroup Operations which I think we will be able to pass out but we will probably be discussing in February. This is you remember was something that we had talked about in September, we were going to make revisions to and we’ve done that but it would probably be best if you have copies of and look at and then we can talk about it as a February item. As I said we will be adjourning at about 3:00 this afternoon.
Any questions before we launch into the Enhanced Protections Report? Okay, with that Margaret and Harry, I guess Harry since this is the observations and recommendations and I’ll let you introduce the section here.
Agenda Item: Enhanced Protections for Uses of Health Data, “Secondary Uses” ACTION
MR. REYNOLDS: Last night we tried to incorporate all of the things that we heard yesterday so hopefully as we go through this you will see some of your work incorporated and some of your questions and issues.
Margaret what I would like to do since you would be best at seeing what you deleted and everything why don’t you walk us through, we are going to go a section at a time. It is important to note the document that is visible does not match your line so we are going to go section at a time so stay with us on the written document. Look up there and then find it. I’ll make sure that we stay in the same sections and go slowly so that everyone knows where we are. Because of different printers and different formats it just didn’t come out the same so excuse us for that but we do have your other comments in there and we will take that under advisement to make the numbers right. So with that Margaret please start through.
MS. AMATAYAKUL: So the Guiding Principles section we included some of the language that you were looking for and do you want me to read this paragraph?
MR. REYNOLDS: Yes.
MS. AMATAYAKUL: As NCVHS considered the testimony and its task to develop recommendations for enhanced protections for uses of health data in light of new technologies and health information exchange. It recognizes that there are significantly diverse viewpoints both in the public and within its own membership. As a result it adopted the following guiding principles which help it develop a centrist approach to recommendations recognizing that there is much more to be learned about NHIN. Evaluating each recommendation against these guiding principles helps assure that differences in perspectives are considered and that the recommendations strike a balance between assuring benefits from optimal uses of health data but not at the cost of reasonable privacy protections. Protection should and then the list is there and number five, build upon existing legislation and regulations whenever possible. We did have a comment that I found late last night after we all left that suggested a change to read, build upon existing legislation and regulations when that is the most efficient approach. I didn’t know which to pick up.
MR. BLAIR: Why qualify it? Why don’t you just say build upon existing laws and regulations period?
MR. FITZMAURICE: I agree because it is always a tradeoff between resources available or benefits and costs.
MR. REYNOLDS: Anyone have a problem with build upon existing legislation and regulations period? Leslie?
MS. FRANCIS: I like the where possible because it suggests that there may be times where it just isn’t desirable to do that and I wouldn’t qualify it just to efficiency because there might be other reasons why it is reasonable to junk a current framework.
MS. MCCALL: I concur with Leslie completely. I am comfortable with whenever possible.
MS. WARREN: I guess I am trying to figure out a time when we would build something that did not comply with legislation and regulation.
MS. FRANCIS: Not complying is different from recommending a change and I think there will be times when instead of building upon existing regulations new frameworks will be in the offing but that at least needs to be out there as a possibility.
MR. HOUSTON: I would propose rather than possible, I would say simply use the word “appropriate.”
MR. REYNOLDS: Okay other comments? Thank you Margaret moving on.
MS. GREENBERG: I have some issues with this new language in this paragraph. I’d have to think about whether it is substantive or wordsmithing but I assume it is maybe the latter and we can deal with it offline.
MR. HOUSTON: Can I actually make a point? I think there is some wordsmithing; I am going to assume that we are going to stay in large measure away from wordsmithing and we should give comments back to Margaret.
DR. COHN: Exactly, I do want to remind everyone that we are looking at substantive issues there will be time if you have wordsmithing pieces to get that in and post all of this and then if anything sort of rises to a major substantive issue we will have to adjudicate that. Okay Margaret?
MS. AMATAYAKUL: Under Observations and Recommendations other than putting the first paragraph in a box and adding, to HHS has a variety of means to promote the data storage of principles and achieve enhanced protections, there was no change in the introduction.
MR. REYNOLDS: Okay so that takes us down to number one. Everybody in concurrent, Margaret?
MS. AMATAYAKUL: Number One on Observations and Recommendations on Principles of Data Stewardship for Accountability and Chain of Trust within HIPAA there were a few wordsmithing changes. When we get to the middle here, without assurances of proper de-identification methods being employed and without –
MR. REYNOLDS: Hold on one second. So we are on our document, we are on page 19. So it would be everything prior to that Michael?
DR. FITZMAURICE: Two things, one is that under one Observations and Recommendations on Principals of Data Stewardship for Accountability and Chain of Trust. Chain of trust, most recent line one is 19 and 20. The chain of trust is not in the attributes listed on the previous page that is, these principles include responsibility for attention to and accountability, transparency. I would either take it out of the observation or have the committee consider having chain of trust as an attribute of data stewardship.
MS. AMATAYAKUL: I can fix that.
DR. FITZMAURICE: Yes, but which way does the committee want to go on it? Does the committee want to include chain of trust on page 17, line 94 that it is one of the attributes of data stewardship and it would go along with accountability, transparency, individual participation? Or does the committee want to take out chain of trust from the observation title that is on line 19.
DR. COHN: Okay well I think Margaret is suggesting we do just include accountability, chain of trust up there I’d really think this wordsmithing but are people okay with that?
DR. FITZMAURICE: Then secondly, we talk about data stewardship principles; we don’t have a list of them anywhere in here. Are we saying our recommendations are the principles, or that they should be developed by somebody?
MR. REYNOLDS: If we say, these principles include?
DR. FITZMAURICE: We say that, which principles are we talking about? Do we have a list of principles, Margaret?
MS. AMATAYAKUL: I think what we did yesterday was change this to, these principles include responsibility for attention to accountability et cetera and then -
DR. FITZMAURICE: I have no problem with that statement. It think it is good as it stands but we talk about these principles, do we know what they are or should somebody develop them? That is all I am saying.
DR. STEINDEL: Mike I think there is a look of, we don’t understand what you are asking because we have a list of what these principles are.
DR. FITZMAURICE: You have a list of what the principles apply to; you don’t have a list of what the principles are. Above you have principles that apply to the recommendations, if you want to call those stewardship principles it is fine with me.
MS. AMATAYAKUL: We talk earlier in the document about the HIPAA privacy and security rules actually being sort of the foundation or founding or initial set of data stewardship principles that we are building upon that. I don’t see the HIPAA privacy and security rules as being sort of a list of principles that you could just check off exactly.
DR. FITZMAURICE: True but we can check off on the list of the principles right above the Observations and Recommendations. I don’t see a list of data stewardship principles so if we are talking about it in the abstract we should make sure that the reader would understand that we are talking in the abstract about data stewardship principles not saying that we have them and here they are. Or if we have them we should list them out.
DR. WARREN: Right and we had talked about that yesterday. About taking that list we were talking calling “attributes” and really making a list that would be much like the list on 17 that starts, protection should; we would say data stewardship principles should and then we take each one of those attributes and really turn them into a stem like this. That would be the list of principles that Mike is talking about.
MR. HOUSTON: Can we just delete the words, “on principles,” or “principles of?” So Observations and Recommendations on Data Stewardship for Accountability and Chain of Trust-
MR. BLAIR: Could you talk to the microphone? Could you repeat that in the microphone?
MR. REYNOLDS: I am assuming that we are on 19 and 20 still really getting into the core, why don’t we simply say the Observations and Recommendations on Data Stewardship for Accountability and Chain of Trust within HIPAA.
DR. STEINDEL: He is talking about the title for one, the bold title and I would object to removing the word “principle” but and making it a noun.
MR. FITZMARUICE: I am past the title on to the second point I wanted to raise and that is we talked about data stewardship principles throughout. We don’t list them. We may not have principles for data stewardship.
DR. COHN: I guess I am going to jump in here. I don’t know if we need to adjudicate this right now but I think this gets down to sort of fundamental questions of what your definition and framework around what principles means. I don’t know that everything needs to look quite like that to be a principle. I think our view is that really the principles are all of our recommendations is what I think is really intended here.
DR. FITZMAURICE: I would accept that that we think the data stewardship principles are following our recommendations.
MR. REYNOLDS: Simon why don’t, we will work with Mike on this. In other words is there anybody on the committee that has a problem with the fact that we work this out? Because you are not changing the content, you are not changing what we are saying, and in the way it is structured, or how we list it. Margaret moving on -
MS. AMATAYAKUL: We were in the Observations part of One and the substantive change is, here without assurances of proper de-identification methods employed and without an awareness of the uses made of de-identified data covered entities are unable to describe what uses may be made of individuals’ data and are not able to confirm other proper and reliable methods of de-identification are being used. The risk of information being re-identified continues to increase as more public data bases become available and techniques for re-identification become more sophisticated.
I think this was Paul’s suggestion yesterday that I just want to make sure we got right.
MR. HOUSTON: That was one of the key subjects that came up the re-identification. Okay? Margaret move on -
MS. AMATAYAKUL: There are some other wordsmithing until we get to 1.1 and in 1.13 we added, covered entities should specify in their business associate contracts that there must exist a contract with protections equivalent to the business associate contract described above, et cetera.
1.14 following from the same stem that, any organization that supplies the identified health data.
Then 1.2 we attempted to bullet all of those. I don’t think there is any change in wording except for in 1.21 where, this recommendation may be accomplished by HHS issuing guidance of all practical scenarios for a covered entity fails to appropriately manage a contractual violation by a business associate that could result in violations to the HIPAA privacy rule for a covered entity.
MR. REYNOLDS: Just substitute the word “address” rather than “manage.”
MS. AMATAYAKUL: Okay 1.3 stays the same.
Then under Two, Observations and Recommendations on Data Stewardship for Transparency, I have some footnoting problems that I’ll fix later.
In the section on the bottom of page 22 and going to the top of 23 where we discuss the difference between authorization and consent, we made some changes to these two paragraphs so I’ll read them.
The first issue associated with the use of an authorization as intended by the HIPAA privacy rule is that it does not require an authorization to use or disclose to another covered entity protected health information for treatment, payment, or health care operations so long as the entities have a relationship with the individual who is the subject of the protected health information. An authorization however is required for other uses and disclosures that are enumerated and I specified the sections. However, the privacy rule permits a covered entity to obtain a consent for uses and disclosures for treatment, payment, and healthcare operations by covered entities. Consent in healthcare more commonly refers to the permission given by an individual to a provider for providing healthcare services and, in parentheses, which may include interviewing, examinations, specimen collection, and treatment of the individual as well as use of health information. In summary the use of the terms authorization and consent and when such are required or permitted causes confusion.
The section on consent in the original HIPAA privacy rule was modified in 2002 from requiring to permitting consent. This still allows covered entities to obtain consent as desired and to follow more astringent state laws containing consent requirements for uses and disclosures of protected health information for treatment, payment, and healthcare operations. Some public comment urged a return to the requirement of consent for all uses and disclosures of protected health information. NCVHS did not believe that it was realistic to recommend a reinstatement of this requirement at this time but to build upon the HIPAA data stewardship principles to afford privacy protections and to evaluate ways to manage individuals’ authorizations in a NHIM. See Recommendation 812.
MR. REYNOLDS: This plays a lot off of one of Mark’s comments yesterday about say what we say. Say why we did or didn’t do something.
MR. HOUSTON: Yes, one comment on the second paragraph, you used the word “afford,” “principles to afford privacy protection,” that phrase. There all ready are privacy protection so I don’t want the implication that there aren’t any and I would propose that we use a word rather something like the word “enhance” so that the phrase would read, build upon the HIPAA data stewardship principles to enhance privacy protections and evaluate ways to manage individuals’ authorizations NHIM.
DR. CARR: I think this reads better, my only question is it is appearing under the transparency and the part about transparency is that the words “consent” and “authorization” are not clear in the lines of the public. The rest of this really I think is appropriate to the discussion about uses of health data under TPO. It explains the history of the consideration of consent and I think it would be I would make the recommendation that we move it to where we talk about that quality remains under TPO, whatever that section is.
MR. REYNOLDS: Okay let’s see what the other questions are on it and then we will decide if everybody likes it once we get it like we like it then we will decide if we are going to move. Okay so Jeff?
MR. BLAIR: Margaret I like what you wrote very much. There is one word that it is our justification for the decision and we said, NCVHS doesn’t think it is realistic. Maybe that is the right word or maybe it is not but it left me in a feeling like, why? Why is it not realistic and I am perfectly satisfied with us going down this path. Maybe I just need to understand why that was the word that was chosen.
MS. AMATAYAKUL: We tried out a lot of words.
MR. REYNOLDS: The point is, the reason why we made this statement because obviously going all of the way even though we heard some testimony that there is technology available to do all this right now, we don’t feel that it is pragmatic be it or realistic to be there yet. We don’t feel that going in and going ahead and reinstating this consent at this time is realistic. Obviously these things will be continually considered as we go along, Simon do you want to make a comment?
DR. COHN: Yes, I am actually thinking we went through this a number of times and I am actually wondering if rather than adding words like that maybe we should say, NCVHS does not recommend reinstatement of this requirement at this time but instead recommends that we build on rather than, I think that we tried all sorts of ways and this was about 10:00 last night.
MR. REYNOLDS: I have got Marjorie and then Michael.
MS. GREENBERG: I would support that because if in fact that is what you mean, because by saying that we don’t think it is realistic it implies that you think it is a good idea but it is not realistic. I am not sure that is what you mean.
Also I think to say reinstatement of this requirement actually, since at the time the privacy rule went into effect this had been removed. I don’t really think it would be a reinstatement, it never was a requirement. It was a proposed requirement but the final rule that was implemented did not include it. Am I correct on that? So it sounds like, well we had required it and now we don’t and I think that is misleading.
DR. FITZMAURICE: NCVHS did not believe it was realistic to recommend reinstatement of this requirement at this time but to build upon the HIPAA data stewardship principles. I don’t know where they are. I know in HIPAA -
MR. REYNOLDS: Let me do this Mike, we got that. Okay? I promise you we have it as a committee. We understand that those principles –
DR. FITZMAURICE: This is the HIPAA data stewardship and they don’t exist. There are principles for selecting standards under HIPAA, about 12 of them, they are listed as an example of what principles are but unless we can footnote this I don’t think it is accurate.
MR. REYONLDS: All right, any other changes to this? John, I am sorry Paul was on my list. Paul and then John -
DR. TANG: So as we look back at 1.1 and 1.2, I am just applying the concern that consumers had about where the data is going and unless I have missed something you are saying you must have a business associate contract. It must follow the chain of trust and it should be transparent but nowhere did we reinforce that. You shouldn’t do anymore than the HIPAA covered entity should be allowed to do. To apply that example that we had on Monday if they put in the fine print, we plan to sell your data and they are transparent about it they could do that activity. I am just applying the test that caused the concern to what we are recommending and I don’t find that we have actually excluded that behavior in these two sentences.
DR. FITZPATRICK: I would think even a provider can’t do that. HIPAA does not permit a provider to sell my data. Paul is right it is not transparent.
DR. TANG: It is not clear. It seems like we would want to reinforce since HIPAA does say that a business associate should be bound by what the covered entity is allowed to do with their data it would be nice for us to reinforce that here, because that is at the root of what we are trying to prevent.
DR. CARR: But isn’t it true that what happens with the identified data is not covered by HIPAA?
DR. TANG: But they didn’t have to do anything according to the HIPAA de-identified. They chose their own method of scrubbing pieces of the identity out.
DR. CARR: So what are you saying?
MR. REYNOLDS: I am not, Paul help us out I am really struggling with what you are trying to add that would not all ready be covered by the law and would make us want to make -
DR. TANG: So today there are companies that will take your data for a HIPAA authorized transaction and then continue to go on to do other things that it would like to do. The things that we put in here don’t necessarily preclude that or at least in a clear way. That seems to be the number one motivation for this exercise.
MR. REYNOLDS: Margaret?
MS. AMATAYAKUL: Let me look at 1.12 for a moment. Covered entities should specify in their business associate contracts terms that explicitly describe what HIPAA de-identified data may be used and to whom HIPAA de-identified data are supplied. It is up to you I mean it doesn’t say you can’t use that data for anything. It is basically saying, I know upfront what you are telling me you are going to use this de-identified data for. I could say no I don’t want to sign this contract.
DR. FITZMAURICE: That is suggesting as a reminder to the writers that they can’t do some things with the data and their business associates can’t do those same things either, no matter whether they sign a contract or not.
DR. TANG: So as John indicated, many of the contracts he is presented by third parties include describing in a transparent way at least to the person signing the contract that they plan to do things that are not permissible under HIPAA. This would say as long as you put it in your -
MR. HOUSTON: De-identified data, as soon as it is de-identified sufficiently it falls outside of HIPAA. That is simply an issue of the fact that there is a lot of people taking de-identified data as, whether it be a business associate or otherwise and this is sort of one of these qualitative value judgments as whether that type of practice should be occurring.
DR. FITZPATRICK: I don’t think we are talking about de-identified data here. Some vendors use identifiable data for their own purposes because the providers signed a contract that permits them to do it but it is not permissible under HIPAA.
MR. HOUSTON: Okay I see because I thought there was this issue of using de-identified data which is typically what then occurs. They take it and de-identify it and use it.
DR. CARR: I think there is two parts to the answer to Paul’s question. In this document what we have done is we say that, any organization that supplies de-identified data for a specific purpose will ensure that the de-identification process follows HIPAA. That takes care of one that you can’t just partially de-identify if you are supplying de-indentified data it has to be HIPAA de-identified.
The second part what you do with it I think is where we got into the decision to hold further hearings because although we understand the things that we have talked about in that article on Monday, there are other uses of de-identified data and we didn’t want to address them here without having further hearings so as to avoid unanticipated consequences in the recommendation.
MR. REYNOLDS: Michael you seem to be saying that we are not dealing with the de-identified.
DR. FITZPATRICK: What I think that we are not dealing with strongly enough and that the providers could use a reminder, is that they can’t agree that somebody else can sell their clinical data that is identifiable. Even if they sign a contract saying, yes you now own this data you can do with it what you want, you can sell it. They don’t have the right to do that under HIPAA. So you must see patient authorization for that.
MR. REYNOLDS: Why would we want to restate HIPAA?
DR. TANG: Because that is the primary problem that we are addressing so many people who are the root cause of this discussion. Many people in their contracts, third parties believe that they are protected and indeed probably they are by just disclosing up front to Mr. Houston that I plan to go sell your identifiable data and when that person signs it they feel like they have they have free reign -
MR. HOUSTON: This wasn’t a question but actually a recommendation back to I think it was Simon. If we are going to change the wording regarding whatever we are going to call this reinstatement or this, however we want to word it if we are going to make it a recommendation then we should just simply make it Recommendation 2.1.5 that we recommend that not to be included within HIPAA the reinstatement of the requirement or however we are going to word it -
MR. REYNOLDS: Well it probably ought to be 2.11 because everything else would then build off of it. If we are saying that we are not going to do it. We are saying here is what we are going to do instead.
DR. TANG: Right but I think the point is that we are saying that we should make a recommendation of this, I think it was Simon’s point and if that is the case we should simply add it as a recommendation.
DR. STEINDEL: I didn’t hear any comment to make this a recommendation. The only comment I thought I heard was to move this.
MR. HOUSTON: No, Simon made the comment that rather than say, NCVHS did not believe that it was realistic to recommend reinstatement of the requirement he said NCVHS does not recommend the reinstatement of this requirement at this time.
MR. STEINDEL: But I don’t think there was a recommendation to make a recommendation of it, to make it a formal recommendation. Justine’s comment was to take the paragraph itself and to move it to the section where we talk about operations.
MR. REYNOLDS: We are not dealing with Justine’s yet.
MR. HOUSTON: I am reacting to what Simon had proposed in terms of revised wording which was, in fact a rec - making a recommendation and if that is the case then that part should be put out as a separate recommendation. That’s all I am saying.
MR. REYNOLDS: You are saying that we use the word recommendation; recommend is somewhat of a term of ours so, Simon?
DR. COHN: I guess I don’t have a strong feeling about this however it just doesn’t feel much, and since we are not recommending that they do anything it is sort of like I guess we could get in front of every section saying we support HIPAA or something. I thought it is in the recommendation section and it is part of the observation but as I said, I guess I don’t really care is the truth.
DR. STEINDEL: I actually do Simon. I think if we make this a recommendation with a number in front of it, it is going to be a lightening rod.
MR. BLAIR: What if we just use the word “support?” NCVHS does not support changing. I think that is a good way that you move it out of the discussion of whether it should be a recommendation. I think once we put it as a recommendation we are going to have -
DR. STEINDEL: Okay, that is fine.
MR. REYNOLDS: Justine now let’s go back to where you wanted to move now that we have got it like we want it. Where do you want to move it to?
DR. CARR: To seven.
MS. AMATAYAKUL: I would like to suggest that this be kept here and maybe something added to seven. The reason I suggest that is that, I read this document to Jeff and after every half a page he asked me what is the difference between consent and authorization and I was like saying, Jeff wait a minute I’ll get there, I’ll get there, I promise I’ll get there. So the earlier we can put this in I think the better off we are. But we could add it to seven as well.
DR. CARR: I think what I was saying was having the difference between consent and authorization makes perfect sense to have it there but we go on to say more that is, what line was it?
MR. REYNOLDS: We are not changing the content or the meaning, we are deciding where to say it best, is that a fact?
MS. AMATAYAKUL: Yes, so the recommendations on transparency on 2.1 had some wordsmithing changes. Let me run 2.14 by you. A transparency should be achieved through making information available about the specific nature of protected health information disclosed to other organizations such as public health. HHS should issue guidance to covered entities to incorporate references in the MPP about what types of protected health information is disclosed to other organizations such as when legally required or permitted for public health purposes and make this information available to individuals upon request.
2.2 is Recommendation for Education on Uses and Protections for Health Data. Somebody suggested that change. HHS should develop and maintain a multifaceted national education initiative that would enhance transparency regarding uses of health data and emphasizing the benefits relating to quality measurement reporting and improvement in an understandable and culturally sensitive manner. I think somebody suggested we add that.
MR. REYNOLDS: Comments? Yes, Mark.
DR. ROTHSTEIN: I have some problem with the language in 2.2, specifically the clause and emphasizing the benefits relating to. That reads to me like it is sort of propaganda. I would be happier if it read simply, an enhanced transparency regarding the uses of health data for quality measurement recording and improvement and do so in an understandable and culturally sensitive manner. I think that -
MR. BLAIR: What is being removed when Mark says that?
MR. REYNOLDS: All he is doing is he doesn’t want it emphasized; he is making it more matter of a fact. Is that a fair statement Mark? It is just a matter of fact statement that that should be included in the education period. It is not selling it.
DR. FITZMAURICE: Could he read that again please?
MS. AMATAYAKUL: HHS should develop and maintain a multifaceted national education initiative that would enhance transparency regarding uses of health data for quality measurement, reporting, and improvement in an understandable and culturally sensitive manner.
DR. COHN: Well I think the only problem was we thought that there needed to be an educational thing that also included so would suggest for quality, you say including -
MS. MCCALL: I would like to include research in the list if possible. Research is a big component later on so -
MR. REYNOLDS: Moving to three.
MS. AMATAYAKUL: Section Three, we did flip the two recommendations, 3.1 and 3.2 and we added in 3.2, which is Recommendation on Obtaining Authorization for Use of Personal Health Information Not Covered by HIPPA Protections. HHS should take applicable means to ensure that uses of personal health information held by any organization not covered by HIPAA i.e., HIPAA covered entities, business associates and their agents must obtain an authorization from the individual for collection of personal health information and for any uses or disclosures other than the maintenance of the personal health information. See also Recommendation 9.1.
DR. FITZMAURICE: My clarification, when we have the i.e. there, held by any organization not covered by HIPAA and then, i.e. HIPAA covered entities, business associates and their agents. It implies to me that we are saying that those organizations are not covered by HIPAA, that they are an example of any organization not covered by HIPAA.
MR. REYNOLDS: We put that in there so to make sure you found that one.
MS. MCCALL: Couldn’t it say i.e. other than?
MR. HOUSTON: The added, I am just not sure what in an added language what you mean by, other than maintenance of personal health information.
MS. AMATAYAKUL: I think the question somebody posed was, what is the authorization needed for? So I was trying to say what it was needed for.
MR. HOUSTON: Could we simply say authorization from the individual for the collection, use, and disclosure of personal health information?
MS. AMATAYAKUL: Four? Four is Observations and Recommendations on Principles of Data Stewardship for De-Identification. We did some wordsmithing taking out the extra example words.
Recommendation 4.2 was some substantive change, Recommendation on Uses of De-identified Data, NCVHS heard that there are significant concerns surrounding uses de-identified data and that these warrant more thorough analysis. NCVHS will conduct hearings to determine how to structure guidance for best data stewardship practices. Topics which should be addressed may include but not be limited to uses, statistical de-identification process to meet a certain threshold for certain probability of re-identification, uses involving sale of de-identified data, exposure from re-identification, and allowable uses of de-identified data.
MR. REYNOLDS: That covered a lot of what we talked about yesterday as to how we worded it and how, Christine I like some of what you brought up yesterday. Mark -
DR. ROTHSTEIN: Do we want to add to that list of potential of group based harms? Didn’t we discuss that yesterday?
DR. FRANCIS: I thought we discussed that earlier and that was something that I was going to bring up because I don’t know where -
MS. AMATAYAKUL: It is in the background. I did do that in the background, or I tried to anyway.
DR. ROTHSTEIN: Shouldn’t that be one of the risks in this list of risks that we are setting up?
MR. REYNOLDS: The fact that it is missing would maybe generate more questions than the fact that it is in there and what we do or don’t do. Okay, five.
MS. AMATAYAKUL: Five is Observations and Recommendations on Principles of Data Stewardship for Security Safeguards and Controls. Here we added in the recommendation of the inclusion of the vendors. Recommendation 5.1, recommendation of technical data security management approaches the last sentence now reads, this guidance for security management should also be directed to organizations that are not covered entities that maintain and or transmit personal health information as well as to vendors of health information technology.
MR. HOUSTON: I am looking at the sentence starting on line 66, and to insure that their business associates and agents are fully compliant with the HIPAA security role authorization access authentication audit control requirements. Why do we need the language authorization access authentication audit control requirements? Why don’t we simply say, ensure that their business associates, agents are fully compliant with the HIPAA security role or something of that sort?
MS. AMATAYAKUL: Are you referring to in the actual 5.1 there where I –
MR. HOUSTON: I would, where your cursor is at right now, I am just recommending that we delete to the end of this sentence.
DR. WARREN: Well for me when I read that, I mean if I were really, really familiar with the security rule it would be okay to put the period there but I think it kind of reemphasizes that these are the four areas that we are talking about.
MR. HOUSTON: My concern is that somebody might think that is an opportunity to not have to comply with anything else that is in the HIPAA security rule.
DR. FITZMAURICE: We could put afterwards, including access authentication because I agree with Judy, it is explanatory, it helps people understand this.
MR. HOUSTON: I just want to make sure people don’t think, oh I am going to get out of free card; it is not one of those –
MS. AMATAYAKUL: Next is Observation Recommendation Six on Principles of Data Stewardship for Date Integrity and Quality. And 6.1 the Recommendation, we didn’t make any changes above. Recommendation on data quality and data integrity HHS data stewardship guidance should address the precision, accuracy, reliability, completeness, and meaning of data used for quality measurement for quality improvement as well as other uses of health data.
MR. REYNOLDS: Comment, okay moving on.
MS. AMATAYAKUL: Observations and Recommendations Seven, on Oversight of Specific Uses of Health Data. We have two sections here; uses of health data for quality measurement, reporting, and improvement within healthcare operations. NCVHS considered whether there were or should be boundaries around what quality activities are included in HIPAA’s definition of healthcare operations which may be outside of that definition and may call for greater choice for individuals whose data are included. Although we may have been asked for a little bit more specificity in certain areas at different times from ONC it seemed like this was pretty much of interest to you to keep.
We also added to tell the story a little bit better maybe I should summarize the first paragraph, in addition to that first paragraph, we talk about the definition of quality assessment improvement being within healthcare operations about the organized healthcare arrangement that is possible. Several testifiers observed that they had instituted oversight processes. Then we added that, testimony was also heard that suggested the desire for a wider role for individuals in deciding whether to permit their health data to be used for quality assessment activities. We cite a study, in a study on authorization bias for data based research study reported by Harris 3.2 percent of individuals actively declined participation while another 17.5 percent did not respond and then some additional information.
Then at the last part just before the recommendations we added a little paragraph, having heard the testimony concerning the benefits and potential risks to individuals that may arise from uses of health data for quality measurement, reporting, and improvement NCVHS believes that enhanced protections for such uses of health data should build upon the protections afforded by the HIPPA privacy rule while remaining as part of healthcare operations.
MR. REYNOLDS: Yes, John?
MR. HOUSTON: I just want the opportunity just to read through it just one more time. The question I have, if it is all ready in the privacy rule about the protections that are to be applied to health data use for quality purposes. Why does there need to be an enhancement of it and if it is all ready part of healthcare operations why do we need to restate that? I guess I am confused.
MR. REYNOLDS: Justine.
DR. CARR: We spoke about this this morning in the quality workgroup that as we look forward to longitudinal episodes of care, data will come from different sources and map to an individual to be able to see longitudinal outcomes. The issue had come up in the AHIC quality workgroup in particular about whether that definition of quality covered all of those sources of data. I think that we have the answer here in organized healthcare arrangement so that even if it is not the same institution it is still a fair and organized healthcare arrangement. It is still considered quality and still covered under operations and if anybody from HIC wants to comment, yes?
MR. HOUSTON: If that is the explanation I think we need to look hard at what an organized healthcare arrangement allows you to do from a data collection and use perspective and where its bounds are because I don’t think you can simply extend that to NHIN or some broader data collection scheme. I don’t think HIPAA would then permit the use of identifiable data absent of patient authorization and as such I don’t think you can even fit it under healthcare operations. I mean I think the whole idea of an organized healthcare arrangement is a fairly self-contained set of activities that a group of covered entities are doing on a specific patient population where they all have some relationship or potential relationship with that patient and once you get out of the four walls of that organized healthcare arrangement you will lose the right to do healthcare operations. I think HIPAA is pretty specific that there has to be anybody involved in healthcare operations quality related activities using patient data have to have a relationship with that patient before they are allowed to do it on an identifiable basis.
MR. REYNOLDS: The reason that we put this in was back to the idea of saying, we heard the testimony and we have decided kind of to do this. Looking back at the recommendations in 7.1 and so on I think that says the same thing.
DR. CARR: Well I think that John’s raising an important point. This is a very important point. This is the important point because of the issue that de-identified data is not useful in trying to assess quality outcomes and so identifiable data is needed and the question is under what umbrella or what protection? Yes, Steve -
MR. REYNOLDS: On 7.12 we talk about cross organizations. I am struggling with, I thought I understood John’s question I am struggling with where we went after that.
DR. STEINDEL: I think John’s point is very correct but I think it is covered in 7.12 where we say, that the organized healthcare arrangement as defined by HIPAA which is clear. It has got to have a direct relationship with the various members of the organization and then we go on in section eight and we specifically start talking about, okay what happens when we deal in the world of the NHIN that is different.
MR. REYNOLDS: Okay because I think there is, we have to be very careful that we –
DR. STEINDEL: Wait, I think we are in total agreement that the world of the NHIN is different and we have a separate section that deals with that specifically.
MR. REYNOLDS: Okay so back to, we added that new paragraph trying to address comments, questions, and issues that came up yesterday. Rereading it again this morning in the light of day which there was no light last night when we did this that is for sure, I am not sure that where it is with the recommendations right after necessarily creates any kind of a crescendo or anything. Anybody else feel that is necessary to remain?
DR. ROTHSTEIN: That goes to my concern from yesterday that we only had one side of the issue and what was added about the Mayo study was sort of the other side of the issue and this is the, okay we heard this, we heard this, now this is what we have decided. If anything is to be dropped, I mean I think you need something at the end saying that, we have heard both sides of this and this is what we have decided. So I mean I don’t care how you change that around but I think that is logically an important piece of this.
MR. REYNOLDS: What we could maybe change toward the end of that is to say, we heard this testimony and so on and we believe it should stay in operations and the following recommendations are -
MS. MCCALL: Well do we want to handle it like we did the prior one which is it doesn’t stay a recommendation but before you get into recommendations we support what we have done you know 15 minutes ago.
DR. COHN: I think that is what this is. I think this fine.
MR. REYNOLDS: Good, Paul.
DR. TANG: Maybe this is wordsmithing, that last sentence I sort of think you mentioned builds a crescendo like the other shoe is going to drop and then it says, and we are not doing anything when in fact I think what we meant was after considering the testimony concerning the benefits, protections employed, and potential risks to individuals. You see what –
MR. REYNOLDS: Okay. Good. Moving on, please.
MS. AMATAYAKUL: So the recommendations there didn’t have any changes.
The next section in this is uses of health data for research. We added that this was the definition we have there was from the common rule was also the same as the privacy rule. There is a section on, there is several important issues however in uses of health data for research variations and interpretation of research regulations, and in this section we added to that ending paragraph there, other gaps in research definition were also identified by NCVHS such as surrounding decedent research representatives from the OHRP indicated to NCVHS that OHRP was working on clarifying the element. There is a recommendation that relates to that later.
DR. FITZMAURICE: On the sentence right above where Margaret read the sentence reads, the FWA which is the Federal Wide Assurance, the FWA is the process in which the institution has voluntarily elected to apply the FWA to all human subjects’ research conducted at the institution regardless of the source of the support for the research. I would suggest we don’t mean FWA there we mean the common role. Otherwise it is a circular. Institution has voluntarily elected to apply the common rule to all human subjects’ research. If in fact that is what the FWA states.
MR. REYNOLDS: Margaret are you going to add -
MS. AMATAYAKUL: I would like to go back to Julie from OHRP, I think she submitted this and reviewed it also for us. If I could –
MR. REYNOLDS: Michael if she verifies it then –
DR. FITZMAURICE: Yes, but even if she verifies it, it doesn’t say what it means. It doesn’t say what applying the FWA means. It means you send it to the institutional review board so it is not clear. If she says it then she will give you words of clarity to say, here what it means.
MS. AMATAYAKUL: So there were no other changes in the observation section. 7.2 on Harmonizing Research Regulations, and 7.3 Quality Research Guidance, 7.4 Wide Dissemination, 7.5 on Transitioning Quality into Research remain the same. Then we added 7.6, Recommendation on Further Investigation into Uses of Health Data for Research. NCVHS identified certain areas that require further investigation such as research based solely on data from electronic health records and decedent research. It also heard the potential value for common oversight of quality and research within an organization. NCVHS will further study these areas and make recommendations as appropriate.
MR. HOUSTON: I think that goes a long way, the only question I would have and it is one of mandate, I don’t know whether it is necessarily NCVHS that needs to study these or whether there needs to be some involvement with is it OHRP or whomever else that oversees research. The other issue is I don’t believe it is, you know there is other types of research that clinical trials and the like, they are not federally funded that may also be at play here so there is a lot of islands here. I want to make sure we capture them all and get the right people involved because it is a fairly complex undertaking to do. I like the point, like the section, I just want to make sure we are accurate as to –
MR. REYNOLDS: Carol did you have a question?
MS. MCCALL: It wasn’t with respect to 7.6; I guess it is on 7.3 and 7.4. It is more than wordsmithing but it is our use of quality/research as kind of a hybrid term when prior we have taken pains to actually separate these topics out. We have said they are in fact; they tend to be conflated anyway. We are trying to separate them and then we have got this hybrid term in here so is it that way for a reason in terms of this -
MS. AMATAYAKUL: Quality and research?
DR. CARR: Yes, we are using a recommendation for quality/research guidance when in fact this section is dedicated to research and we have all ready gone through quality. So there could be a specific reason for using that slashed term but I wanted some clarification on that.
MS. AMATAYAKUL: I wonder if it might have been because this isn’t the research section but the issue is when quality evolves into research so then this is sort of quality/research question or overlap.
DR. CARR: Is the issue where there is overlap and whether it is quality or research.
MR. REYNOLDS: So Carol would say quality and research overlap, rather than quality/research?
DR. FRANCIS: How about quality and research overlap, or when quality shifts to research?
MS. MCCALL: As long as we capture that that is what is happening otherwise I think we are perpetuating what is something that we all know to be ambiguous.
DR. TANG: I am trying to salvage some kind of recommendation out of this section instead of think harder. So the one that I am going to suggest that we make into a recommendation is under 7.6 right now it says, potential value of common oversight, could we recommend that there be common oversight over quality and research added institutions?
DR. COHN: I guess I will speak for myself on this one just responding, I thought it was a very interesting recommendation that came up yesterday for the first time in all of our conversations.
PARTICIPANT: Interesting – good or bad?
MR. COHN: I don’t know I think it is something that is very interesting but I sure wouldn’t want to start recommending things that came up without hearing some public input on them. That was sort of my suggestion was that we need to put it into something where we need to hold further hearings on -
MR. REYNOLDS: That’s why we didn’t drop it off. One of the reasons we recommend that we follow up on is we not either say, do it or say, we don’t know what to do but somebody else figure it out. Leslie.
DR. FRANCIS: If we say NCVHS will take the lead in further study of these and development of recommendations as appropriate and we have said we are doing it but we are doing it with others.
DR. TANG: I thought we were asked to do that in the first place so I am a little hesitant to have something better to say.
DR. FRANCIS: I think we can’t have something to say better to say about the quality research interface right now without exploring it.
MR. REYNOLDS: Our feeling right now, we haven’t had any testimony or anything else on this subject and what would be the pros and cons, pluses or minuses. Then we would just be recommending that. We haven’t had any review, we haven’t had an open process, we haven’t had public input, we just say, hey do it.
DR. TANG: You don’t consider the Mayo input or Mario Canes(?) input to be relevant to this?
DR. STEUERLE: Paul we haven’t examined by size of institution or the nature of institution, just all sorts of -
DR. GREEN: I agree with the thrust that we don’t want to claim to know more than we know here. In that spirit on page 31, in the cutoff lines, it is line 35, differences between quality activities and research we have a sentence here that declares that there are important differences between quality and research. I go back and reread the material before and after, it doesn’t suggest that we know what those are. It really cuts to the point about our new recommendation 7.6. This is what requires attention. I am not sure but what that sentence should be deleted or revised to say something more honest about our position which is that we heard testimony that it is confusing but what the important differences are between quality and research. But to just make a blanket statement that we know for sure, and in this point in 2007 that there are very important differences between quality and research I don’t think comports with the rest of our letter. It actually reads fine if you just take that sentence out and keep going.
MR. REYNOLDS: Margaret you got that? Go back one page under differences between quality activities and research -
DR. GREEN: It actually reads fine if you just take that sentence out and keep going.
MR. REYNOLDS: Yes, the sentence that said, there are also important differences between quality and research and Larry said we don’t expound on them.
DR. COHN: Are you suggesting that we just remove that sentence which is probably an easy solution.
DR. GREEN: I think that is an easy way to stay out of trouble.
MR. REYNOLDS: Justin – with her hand way in the air..
DR. CARR: I’m short, Harry. So here we are taking things from the Hastings Report and this MD Anderson is from the Hastings Report. Margaret O’Cain is from the Hastings Report, and so we have selected those things and to say, here are some things that people do and then we’ve made the recommendation that we need to look at it more carefully particularly with regard to institutional size and so on. I agree with what Larry said that this is confusing so I don’t know that we have said that this is confusing.
Secondly, is it appropriate for us to take two examples out of the Hastings Report to say, this is how they do it?
DR. GREEN: Well see one of our examples says that they have a way of distinguishing research and quality. Our next example says, I don’t think you can make the distinction.
DR CARR: Yes, again it goes back to what I was saying yesterday about if we are going to hold a hearing on something I think we ought to not say what we are thinking we are going to find before we hold a hearing.
MR. REYNOLDS: So what did you decide that we are going to change?
DR. CARR: Well I am wondering if we should take that out. If we should just have something rather than talking about MD Anderson, just that the boundary between quality and research is confusing. There are some models that institutions have found and we need to have hearings about it.
MS. MCCALL: To amplify that that would be my recommendation that we literally walk into it that way. We have language at the bottom of page 31 starting on nominal line 46; it could be rephrased to move up to the beginning. This is another group that has grappled with. What we could actually say is a number of entities grapple with this and here are some different examples of how they approach it. There does not seem to be a linguafranka(?) you know around this and we recommend therefore the following.
DR. CARR: I would just use them as citations rather than specifically highlighting a particular organization.
MS. MCCALL: Just as examples perhaps taken to extremes, not meant to necessarily to imply that we have sufficiently surveyed the landscape.
MR. REYNOLDS: I know there were some other hands, there needs to be a substantive comment. We are coming back to all of this so we, Leslie, if you need to say something right now.
MS. FRANCIS: What I was going to actually say was that it is weird there because there are two bullets there and they are the same bullet, distinguishing quality, differences between quality activities and research. That’s weird. So if what you did was just take out differences, that second bullet head I don’t understand this right now.
DR. COHN: Now we need to sort of take a break and take a deep breath what we will do is to start sort of right here and I think Margaret will take us offline for the next half an hour to 40 minutes and then we will sort of start up again.
DR. COHN: We are very pleased to have John Loonsk join us and John thank you for your forbearance in terms of us running significantly late here but we did want to try to make it through as much of this as we could. I think everyone knows John. John is one of the Directors for the Office of the National Coordinator. John we are very pleased to have you joining us.
Agenda Item: John Loonsk, Director, Office of the National Coordinator
DR. LOONSK: Good morning to the Committee. First I want to thank you for all of your hard work on the secondary uses activity. Clearly secondary uses are not secondary in importance as we all now know and so it is very appreciated.
What I am here to talk about today is an update on two other activities though specifically and that is work on the standards affront and work on the nationwide health information network and the trial of limitations. I had hoped to give just a brief update on both of them and then hopefully we will have a little bit of time for question and answers.
So to begin with just as a very high level of overview of standards in the National Agenda we have priorities being expressed in the form of use cases leading to standards harmonization on the healthcare information technologies standards panel and inoperability specifications which are then going forward for use in several different contexts including certification criteria to be used in the certification commission for healthcare information technology. The leveraged and enforced in stark(?) and kickback regulations in terms of ensuring interoperability for donated systems to be implemented in federal systems, in federal contracts as per the executive order specified therein and also to be used in the next step activities of the Nationwide Health Information Network.
The standards that we are concentrating on are indeed data and technical standards that we hope to demonstrate tangible interoperability. We are particularly focused on standards for health information interchange between organizations versus inside the firewall of a particular organization although at times that line is blurry at best. Its standards for security and confidentiality controls are being worked. Its standards to support functionality are of electronic health records versus interoperability are clearly also important but take a backseat in terms of advancing the interoperabilities work in this regard. As such one of the important goals of this activity of standards in the national agenda is to have testable implementation specifications. We feel that whether it is being done in the context of a developer using a system to test that they have implemented a standard correctly as their developing software, whether it is in the context as sort of certification of that software or system to insure that it is indeed interoperable in the way it is specified.
The testing aspects of the standards are an important consideration; this area that we are continuing to advance as we move along. We have identified through this process inspection testing of the standards and specifications, implementation testing to feedback to the standards harmonization process and then indeed developing tools and capabilities for developers and certification to have definable, testable implementations because that is the target in terms of getting to interoperability between systems.
To describe these dependencies, testable interoperability is based on having very specific standards and specifications that are agreed to by all. That is based on having a valid process for identifying the standards, this is the harmonization process and that is based on having an appropriate context for the standards being used. All of this is by way of introducing where we are on this relatively complicated diagram. There is a handout that is being passed out as well so that you can take this and study in your free time at home.
Basically what this describes is the various aspects of the standards process that we are now engaging as part of the national agenda. It lays out three cycles or three turns of the crank as Secretary Levitz says and where we are relative to each of those. At the top level we have the 2006 so called 2006 use cases feeding into the first turn of the crank. In the middle we have the 2007 use cases feeding into the second turn and then at the bottom we have the 2008 use cases leading into the third turn of the crank.
For each of those cycle timelines there is an identification of the high level standards to be used. There is the development from HITSP of a specific implementation guidance. How those standards need to be used with a kind of detail that can express interoperability then there is a time for acceptance, implementation testing, and consideration by the industry. A year has been identified as the timeframe both in the context of this certification commission and in the context of the executive order for having implementation level guidance that is available that developers can target to implement in their systems.
So identification of priorities, harmonization of standards, and then a year’s worth of time between the acceptance of those standards and implementation guidance and when there can be an expectation that they are implemented in systems. That cycle time essentially between the harmonization process, the prioritization process, the use case work has come out to be about two years. Where we are right now in this first cycle is we are on the verge of the December timeframe for Secretary Levitt to recognize the first round of interoperability specifications. They were prioritized back in the first use cases, the implementation guidance and the standards were made available for a period of a year and then Secretary Levitt will move from having accepted these by virtue of recommendation from the AHIC to recognizing them in December of this year.
When they are recognized that is the term that kicks in the specifications in the executive order that they need to be considered in all upgrades and new federal systems that are related to those healthcare activities. That year timeframe is also being used roughly for consideration by the certification commission for the time between having detailed standards available and when they can put into the criteria that require that those standards are to be used and are to be certified in the systems that they are certified. So roughly a two year process, where we are right now is at the tail end of that first cycle relative to the two years as represented at the top.
We are also simultaneously engaged in activities for the next turn of the cycle, next turn of the crank and are initiating activities for the third turn of the crank relative to the next round of activities is just beginning. So the status of these essentially is that I describe the status of the first round of standards, the second round as represented by the 2007 use cases for emergency responder DHR, medication management, quality, consumer access of clinical information are being worked inside of the healthcare information technology standards panel with an intended delivery date of their first round of interoperability specifications in the first quarter of 2008. Then those will be advanced to the AHIC, the American Health Information Community, and they will then proceed through the same year’s worth of time before they are to be considered for recognition.
Where we are with the third round is that we are in the process of the use case development for the next six and if you will notice we are ramping up from a throughput standpoint here as well. The first round had three, the second round had four, this next round has six use cases that are being advanced and these have gone through one round of public comment and then an early stage of the prototype use cases. They will go through another round of public comment probably in January with an intent of having them available when HITSP finishes its work on round two.
Having gotten through most of a cycle for this apparatus we have also been trying to work to refine it and a number of things have been considered. We have commissioned a panel from the Institute of Medicine to look at the cycle. We have been working with the AHIC to try to get the use cases available earlier so that there is more time. There has been a time dependency which we think we can work to eliminate. HITSP has been working to try to alleviate as much as possible demands on volunteers, volunteer burnout being a consideration. HITSP has also been trying to work to be a telecommunications, teleconferencing, and other methods to try to decrease the demands on volunteers while still having them be the decision makers on the standards through the process that has been described to indeed have staff do more to support them. We have increased the funding for HITSP this year so that they have more staff to do several different things including these types of activities to try to refine the work that they are doing.
HITSP and CCHIT have a joint working group that is working to coordinate the timeframes and the considerations between HITSP and CCHIT relative to standards, moving through this overall process. We have identified a need to have at times CCHIT and the NHIN go back to HITSP and give them, and get a preliminary read on directions for standards as they move forward. So in an area that certification is considering or an area where the NHIN has particular needs we are trying to implement a process that they can get input from the HITSP panel even though an interoperability specification is not available in that standards area to get a sense for the direction that HITSP in that area and try to use that as those two activities move forward.
Finally in this regard we are having CCHIT and HITSP give input to the AHIC process as well to make sure that the gaps and issues that they see in terms of certification and standards harmonization are fed back into the prioritization process as we move forward. This is the listing of priorities that relate to the different use cases I have identified. I talked about the first three rounds. The fourth round of more granular priorities has been taken back to the HITSP, CCHIT, also to the AHIC working groups that produced it to revalidate that these are the priorities and to also see if there are additional priorities that need to be added to feed into still the next round of these activities.
So a whirlwind tour through a fairly complicated series of activities and I think that we have learned a lot from the first round. We are clearly emphasizing in the context of both certification, there was an announcement recently where the Certification Commission has begun a project to for example develop testing software for the CCD, the summary record that has been harmonized by HITSP but to be able to have some freely available testing capabilities to ensure that that summary record is implementable, that it can be proven that it is implemented correctly, and to eventually use also for the actual certification process where a juror would review the indeed implementation. All of this beat going to the point where we have to test to show that these standards are implemented properly if we weren’t going to demonstrate through tangible interoperability. So Simon I have some slides on the NHIN I am not sure if you want to pause and take questions here.
DR. COHN: Actually why don’t I let you go through and then we are going to be very constrained on questions at this point so why don’t we let you do the whole presentation and then we will hopefully allow at least allow a couple of questions.
DR. LOONSK: So the other activity that is moving at a rapid clip is the Nationwide Health Information Network. The general context here as to refresh people’s minds is this is about a network of networks to securely connect consumers, providers, and others to have or use health related data. All of those non secondary, secondary users that we are talking about in this context and others, we are not building a national data store to support the NHIN as a network. We are not having a centralized system, a network of networks and we are getting to this through the shared architecture, shared standards, standards that support particular services and obviously there will need to be processes and procedures to ensure that this is advanced as well. In this regard we are defining a NHIN health information exchange as a health information exchange that actually implements this shared architecture. These standards and these processes are when there is a compliant health information exchange it will be one of those that actually implements those in very specific ways that are attestable and demonstrable.
Health information exchanges that we are building this out of can take several different forms. We are using the term HIE in a broad context that could include classic jurisdictional, regional health information organizations at the state or regional level. It could also include integrated delivery systems that do health information exchange; it could include potentially health plans or health data banks that are doing health information exchanges. We thing they all have an important role in this process and that it is important that the NHIN is a broad tent to advance use activities moving forward.
In that context we view there to be some core services that need to be considered for health information exchange as a platform for building this network of networks. Some of those core services that I think people can understand at a particular level is common approach to patient look up and information retrieval, the ability to route information securely and deliver it to where it is needed. We would put in there routing of several different types of information. We have prioritized this summary record as a particularly important type of information that needs to be routable in this context. We think that will have great value and traction.
There is the need to support certain services around consumer access controls so that needs to be done in a way that is common among the participants in the NHIN, then the provision of electronic data for reporting and other uses. Indeed having these core services enables a great number of capabilities. I would mention that this is among other things I mentioned before that this is an opportunity to test and implement the standards that we were talking about in the context of HITSP. So that is certainly a priority here.
More broadly the NHIN in this context is a network of networks that shares these standards will provide as a capability consistent and standardized access to provider organizations nationally. It will allow for regional and state based information management, i.e. not centralized data store for these purposes and for a number of reasons that you all are very aware of. That is an attractive methodology for managing sensitive information. This is a secure and reusable infrastructure that we anticipate building specific health initiatives on. On the top here I point to the use cases because they are important to test in terms of the standards but is also an example in which specific functionality; quality is certainly one of them but many others are to be supported on this common infrastructure moving forward.
Where we are with this, is the first step was prototype architectures. The second step is to specify and test and that is where we are now. That is the trial implementations phase. Then we are driving toward as the policies and procedures come into place, production systems and in 2009-2010 timeframe for initial production.
Meanwhile throughout this process we are taking information and needs and issues out of the NHIN and feeding them into other aspects of the national agenda and we are taking particular requirements that have been specified by other aspects of the national agenda and feeding them into the NHIN process as an example that work NCVHS did on functional requirements and others. The privacy and confidentially work was written as part of this process as well.
We are pleased that we have awarded nine awards to regional or jurisdictional health information exchanges. That doesn’t mean that that is the only type of health information exchange we are interested in. We think this is a good starting point because these regional jurisdictional HIEs are interested in non-proprietary exchange of health information securely and to meet a variety of different goals and many of them are doing this. They are moving data now and part of the advantage of working with them is we think that they can contribute strongly as an attractor to bring others into this activity. The goal here is to make it attractive enough for others to want to participate, to develop the specification and approaches for that to happen, that groups and organizations really see the value of connecting to these services and that it is appealing to them to want to connect and implement this and share their data in an appropriate and secure way.
As an attractor to that these nine HIEs are one piece. We also announced at the last AHIC meeting that there is a federal consortium for federal providers and care and others who are going to be participating in the trials and limitations and we hope to continue to advance the health information exchanges in the broad context I alluded to before adding them to this process. There has been interest expressed by others in joining this as well. We are very enthusiastic about that and hope to in the future have additional announcements for those who are joining.
This year their work is sort of broken up into two pieces. One is they need to develop the specifications for the four capabilities that I alluded to before, that not all of that has been detailed to the extent necessary to develop a network of networks that is a substantial portion of their first part of their work. The second part of the work is they are actually going to implement and then demonstrate them. Then at the end we are going to have actually demonstration in place of this health information exchange inside of and between these different health information exchanges for the four functions that I alluded to as the core services and also for the first seven use cases.
We offered out to these HIEs the opportunity to do two of the seven use cases in the first round that were advanced. Interestingly enough of the seven all of them were top priorities for one or more of the HIEs. There are clear differences in these health information standards. What works in one jurisdiction is not necessarily what works or is ready in another jurisdiction but among them all those priorities actually each found root in one place or another. Although they don’t all agree on which ones they are prioritizing across the board the top priorities represent all seven use cases. That is a useful thing going forward so we can test the standards and test the implementations as they move forward as well. There will also be use cases demonstrations at the end of this year also. To accomplish this we have created what we are calling the NHIN Cooperative and it includes a series of different working groups that are developing the specifications and working on some of these issues. You will see testing again prominent there.
I also point to the so called, DURSA working group which is about data use and reciprocal support agreement. There is a working group that is targeting having the data use agreements in place for this first round of work, for the trial implementations not point to point data use agreements because if you think about the math in that it gets very complicated very fast. Not just having ten or more health information exchanges that all would need point to point data use agreements with each other but also to think about all of the provider organizations and others that connect to those health information exchanges and you can see that it basically advances exponentially. The concept of the DURSA working group is to come to a one to many arrangement where there is a common approach to implementing those and clearly some of this is about substantiating trust models for how these health information exchanges and the providers they connect will work with each other in this broader environment.
They are also working on reciprocal support in a network of networks that is not just about data use, it is also about how do you establish that if there is something that needs to be addressed in a different HIE that they will support if you are still in another HIE in terms of tracking a problem, responding to needs, and even just providing data in a timely fashion and appropriate fashion. This work is now ongoing and we are going to have a forum.
In the last round we had three public fora for the NHIN. We are looking to continue those public fora; the first one is going to be held December 11th and 12th in Long Beach, California. There was a strong suggestion that not all activities actually occur inside the Washington Beltway, shockingly enough and so we are taking this on the road starting in Long Beach which is one of the sites of one of the awardees. We hope to have some sessions in other places as we move through this year as well. Culminating in some very public demonstrations of these capabilities that will be done in the context of public fora also at the American Health Information Communities and potentially elsewhere.
We are very excited about both of these activities moving forward. I think they both represent very substantial progress toward a lot of the vision that NCVHS and others has articulated in the past for moving forward with the capabilities for health information technology.
DR. COHN: John, thank you very much. I really appreciate the overview. Now I think as I have all ready explained to you we are under some very tight time pressures trying to get this report out. What I am going to suggest is that we may have time for about three questions with the idea being that it will take a much longer period when we get together in February and hopefully really you will have a little more time at our leisure to go through this.
I saw a couple of hands up, one was John Paul. Leslie I think you had your hand up?
DR. FRANCIS: I actually was going to suggest that Mark maybe could ask the question about how all of this interrelates with our privacy and sequestering.
MR. HOUSTON: A comment and a question. I think one thing is the one year sort of process to get these standards adopted seems like a very short period of time which concerns me but the one thing that I did want to comment on and I question about is related to the what is it called the DURSA which I think is a really important thing. One question is where is there more information about that and are you going to use that model also to develop? I think there is sort of a security framework and everything from how we provision providers into this framework and deal with access logging and things of that sort of, is there going to be sort of a similar model for that as well?
DR. LOONSK: First to your standards comment. I just want to make sure that it was clear that the year that I am talking about is from the availability of the fully detailed implementation guidance to when there could be an expectation for it being implemented. That indeed in the federal sector for example that year then leads to not that it is retrospectively implemented but that it needs to be considered for all upgrades in new systems. If you take that year and you consider that at the far end about upgrades and new systems and then you realize that actually what we want is to have them engage from the get go in this process it is really a much longer process. We are hoping that people are paying attention at the start looking at those standards, recognizing the high level name standards that are being considered, participating where ever possible, and their representatives participate in the specification of those and that all takes it much farther back.
We agree that DURSA projects are very important in terms of moving this forward. We are doing two things with it and so let me be clear. That is a very challenging timeframe for their work to accomplish this and so we have broken it into efforts for the trial implementations where we can depressurize some of the particularly problematic issues through them being trial implementations and not production systems, but doing that in a way that sets the framework for actual production so these two goals are both clearly on their timeframe. We do think that that group is much broader than just data use. It is about reciprocal support. It is about ways in which the various participants need to advance security and security practices as well. We have a technical working group on security as one of the working groups of the cooperative but we also think that they are very much issues like you allude to in the context of the actual implementation of reciprocal support.
MR. HOUSTON: Is there a place to go for detailed information on DURSA?
DR. LOONSK: In their initial stages they are moving very fast. It is co chaired by two of the HIE leads and one of the things I should make sure is pointed out is these working groups are being lead by these HIEs. So far that has been going very well and it is important from the perspective of this is not a top down development process but very much a bottom up.
There will be information available at the forum in December and after the forum. The products of this will all be publicly available as they advance. We will be looking to work out how to make those accessible to those that were interested as things progress but they are all going to be publicly available.
DR. ROTHSTEIN: John, NCVHS is working on recommendations for the Secretary on the issue of sensitive health information and consumer controls and it would be very valuable to us if you could go into a little more detail about your consumer access controls and where you are with that.
DR. LOONSK: First of all let me reiterate that we did as part of this contractual procurement actually reference the previous NCVHS recommendations in this regard as needing to be considered in these implementations so let me just say that.
Secondly we feel that consumer controls and consumer services are a very important part of this next step of the trial implementations and there is a variety of different activities that are referenced here in the core services that include allowing the consumer to identify their location of choice or a network personal health record. They can specify this is where I want my personal health record to be stored. The implementation of access controls at that intersection, the implementation of controls at the HIE level has also been described in the core services and a variety of other consumer support. We would be glad to come back to NCVHS to discuss those in greater detail. I don’t have those specific services on the slides in front of me but I would be happy to do that in greater detail when we have more time.
DR. FRANCIS: Could I just interject here? One of the things that concerns us is the risk that as things get designed the only choices are going to be are you in or are you out? Rather than an option to for example sequester mental health records but otherwise have your information in the network. We are deeply concerned about design moving before those things can be thought about seriously. Of course we are utterly aware of the technical difficulties of anything like that which is partly why our letter hasn’t gone anywhere yet but it is a serious follow up to the June letter. So the question that I would at least like to press is how can we be sure that we know what we need to know now so that the horse isn’t out of the barn?
DR. LOONSK: Well as I think you know there is a full spectrum of opinions on this particular area. We are with the NHIN think that in this trial and limitation phase have implemented an intermediate step which would allow for more granular control than in or out. Would consider the ability to say you are in or out. Now we have shied away from opt out because there are the capability that is suggested here is where a consumer could identify themselves as not wanting their information to be electronically exchanged as a potential technical tool versus having to opt out every time they experience care or experience some ancillary organization that is potentially recording their information and making it available electronically. Again we would be pleased to talk to the subcommittee or to talk to the NCVHS more specifically about what is going on in this regard around the trial implementations. It is clearly an area that is still maturing and we recognize the sensitivities you expressed about not having technology go forward that isn’t in line with more sensitive controls but you know there is a reason we are doing trial implementations right now versus production systems. Some of these policy issues relative to how this moves forward is our prominent in that consideration.
DR. COHN: Now Larry I think you have I hope it is going to be a short question. You are the last one and then we will wrap up this section.
DR. GREEN: Sure, I want to express my admiration for your coming back and your keeping going. I want to just convey a question that we heard yesterday in a presentation. It is clear from your presentation how important use cases are for driving the agenda, it is where things start. The question is when will there be a use case for primary care?
DR. LOONSK: The use case process which I didn’t talk in great detail about is generated from priorities that are expressed from the AHIC. AHIC’s principle role here is to prioritize activities. If you think about that I chart like graphic I had where there are all of these granular priorities on the right. They tend to be more granular than that and there is a reason for that then primary care as an example. Essentially what we are trying to do is foster an integrated system where these different aspects are working together. One of the risks in the use case process in general is to have stovepipes, to think about a narrow area and to only address that particular area. I am not saying that primary care is narrow but what we are doing from a process standpoint is to try to coordinate across them. What we have done and this is perhaps more involved than we can get into now is we have tried to identify more granular priorities than that and to try to than make sure they work in a couple of different contexts. Clearly primary care is a critical consideration for the priorities moving forward. I don’t think that a primary care use case will come from the AHIC but elements of primary care activity have been considered in almost every use case to date. Those that have not been considered should be advanced through this process. I would commend to you your representatives to this because we are in the process right now of doing this next round of priorities and the thing that would be most helpful in that regard is to identify a little more specifically those priorities in primary care that you don’t think have been addressed yet in the existing use cases so that they can be put on the agenda and everyone understands the importance of them moving forward.
DR. COHN: Well, John, thank you so much and as I said we will book you for a much longer period in February so we can have a little more dialogue. Margaret we need to get you back up going here. We do apologize for everyone. I know I am being sort of like a slave driver here but we obviously do need to try to get these recommendations and observations all together.
Agenda Item: Enhanced Protections for Uses of Health Data, “Secondary Uses” ACTION (continued.)
MR. REYNOLDS: Okay we are starting on number eight is that correct? We made a few changes. We were trying to figure out what to do with 7.6. I think we got 7.6 adjusted didn’t we Margaret? Margaret tell us where we should be here.
MS. AMATAYAKUL: Well I did two things. I worked on seven and I also tried to work on 1.1.1 a little bit for Paul. Can we take that first would you mind since it is here? For 1.1.1, covered entities should specify in their business associate contracts, how about adding what I have got in green there, terms that exclusively describe what identifiable health data may be used and for what purposes by both the business associate and by any agents with whom the business associate made contract. Specificity in the contract allows the covered entity to describe such uses to individuals and determine any potential changes over time. The addition is the contract must not permit the business associate to use or disclose identifiable health data that the covered entity is not permitted to use or disclose.
MR. REYNOLDS: Any comments? I am good with it once we put “ways” in.
MS AMATAYAKUL: Then I wasn’t sure whether you wanted to add that to 1.1.2. So the contract must not permit the business associate to use or disclose, I would repeat the same thing except instead of identifiable, put HIPAA de-identified. I wasn’t sure if you needed it in both places.
PARTICIPANT: State that again?
MS. AMATAYAKUL: In the 1.1.2, it would read, the contract must not permit the business associate to use or disclose HIPAA de-identified health data in ways that the covered entity is not permitted. I just wanted to be doubly sure.
MR. REYNOLDS: Okay next.
MS. AMATAYAKUL: In Seven, under Uses of Health Data for Research, I kept the bullet variations and interpretation of research regulations with the other gaps there. Then I kept the bullet distinguishing quality activities from research and in here it says, testimony to NCVHS described a full spectrum of how organizations addressed the quality research conundrum and I should add the term that we used before there. From requesting annual IRB review of quality studies such as the New England using a decision tree framework to guide internal activities in determining when an activity is not researched such as from group health to considering any study with intent to publish research which was from Mayo.
I left in the comment that John Lumpkin made about good quality improvement activities, chairing important characteristics with research.
Then I took the other two examples out. The MD Anderson and the rest of that and then left as sort of an introductory sentence to the recommendations, as the nation seeks value driven healthcare clarifying research regulations and distinctions between quality activities and research are critical to address.
DR. WARREN: Since we took those two examples out, I would like to have as a reference to this section, I don’t know exactly where to reference it, but reference the Hastings Report. I think everybody pretty well recognizes that so it may be right up in there just put a footnote and then down in the –
MR. REYNOLDS: Okay any other comments? Did we do it, go ahead. Did we change anything? Are we set with 7.6?
MS. MCCALL: Can you go back up to read the lead in and show the lead in now to the actual recommendations? Because it seems like it falls off, it doesn’t segue way well.
MS. AMATAYAKUL: As a nation seeks value drive healthcare clarifying research regulations and distinctions between quality activities and research are critical to address.
If you would like me to write a little bit more I can but –
DR. COHN: Yes, probably “to address” needs to be removed.
MR. REYNOLDS: Carol are you good with “to address?”
MS. MCCALL: Is critical, I mean clarifying is critical. It just left me saying critical to address what? Just so these naturally follow –
MS. AMATAYAKUL: Then 7.6, I didn’t make any changes since we talked last.
MR. REYNOLDS: Moving to eight.
MS. AMATAYAKUL: Eight, there were no changes in the observation part and no changes in the recommendations themselves.
Then nine is Observations and Recommendations on Additional Privacy Protections. Here in 9.1.2 on expanding the definition of covered entity under HIPAA I added other examples may include HRA vendors and personal health trainers. Such action should not inadvertently weaken existing privacy protections such as allowing employers to gain more protected health information than they currently have as one choice.
Then we had a second choice because we couldn’t decide last night, I think it was too late. Care should be taken to ensure that organizations that today primarily utilize aggregated health data such as employers not be included in the definition of covered entity thus potentially enabling them to have access to more personal health information than they currently have. You need to decide which of those two you like.
DR. ROTHSTEIN: Actually I have a third suggestion. If we go back to the sentence that says, other examples that sentence is okay. Then I would change the wording. Instead of actions I would make it legislation because we are talking about more narrow legislation. Such legislation should not inadvertently weaken existing privacy protections. Then I would add for example, some commenters expressed concern that organizations that today primarily obtain aggregated health data such as employers’ sponsors of health plans not be included in the blah, blah, blah. Because I think that is what we were trying to do. Did I lose you?
Primarily obtain aggregated data such as employer sponsors of health plans not be included – and the rest is the same.
PARTICIPANT: -- not be included –
DR. ROTHSTEIN: It is the same as the last three lines in black.
MR. HOUSTON: I have got a couple of questions. Is aggregated defined?
MS. AMATAYAKUL: In the glossary. We are trying.
MR. HOUSTON: I ALso have a couple of points but I also HRA, what does HRA stand for? Health Risk Assessment, thank you.
I would propose in this particular case we have two cases where you are
using the word “vendor” or
“vendors” in this paragraph and I would probably say like in the
first case the vendors of personal health records. I would say
“providers” because some people would say they are not selling
anything they are just providing it to you.
MS. MCCALL: Or providers of blank, blank, blank services.
MS. AMATAYAKUL: Suppliers of?
MR. HOUSTON: The vendor has a connotation of a commercial relationship and that isn’t always the case and I want to think somebody if they are not selling it to you feels they have some additional rights, same thing for HRA vendors, suppliers something.
MR. REYNOLDS: Paul, you had a question?
DR. TANG: In that same sentence suppliers, personnel (?) systems that are not covered entities. Because we want to convert people who claim to be business associates to be covered entities and have the responsibilities and accountabilities of disease.
MR. HOUSTON: He is right there is a gap. Because he is saying if it is a business associate or they don’t have to become a covered entity and that is what you really want them to do. It is a good catch.
DR. ROTHSTEIN: I don’t understand that. We are talking about closed legislation.
DR. TANG: We want to include people who are not covered entities to be covered entities and a business associate is not a covered entity.
MR. REYNOLDS: You are right, agreed. I agree now, I got it. I had to get refocused on a section sort of a donut hole here. Okay anything else on that? Margaret -
MS. AMATAYAKUL: There are no other changes.
DR. ROTHSTEIN: I have a, just a minor change on 9.2. In the second sentence I would just add a few words, this includes drafting the laws, making it illegal for employers to discriminate on the basis of disability in hiring, promotion, discharge, relative terms, blah, blah, blah, because the ADA and those type of laws are the ones that deal with health information and employer’s use of it.
MS. AMATAYAKUL: Can I just ask is it on or in hiring?
DR. ROTHSTEIN: It is in hiring.
MR. HOUSTON: It is not discriminate based upon disability, it is discriminate based upon access to this data because there may or may not be a disability per se.
DR. ROTHSTEIN: The way it is currently worded, I mean I understand what you are saying, but it says this includes strengthening the laws making it illegal to discriminate. The way the current framework is that there are laws that prohibit discrimination on the basis of disability. If you want to change strengthening you would have to make it, to enact laws prohibiting discrimination on the basis of healthcare –
MR. HOUSTON: My concern is what happens if something isn’t a disability but an employer decides that they are going to discriminate based on some data type.
DR. ROTHSTEIN: That’s why the current laws need to be strengthened because they wouldn’t be protected now.
MR. HOUSTON: But that is why I would say don’t say based on disability and say, based upon access to this data because that is how you want to strengthen them is to expand beyond the disability –
MR. REYNOLDS: Mark does the fact that we reference the NCVHS letter that only discusses disabilities -
DR. ROTHSTEIN: Actually the recommendation from June 2006 is more general but when we use the term at the end of it, “with or without reasonable accommodation” that is really sort of ADA language. My attempt was to try to link the discrimination to the statute that uses that language.
MR. REYNOLDS: But does that, a lot of us still feel that linking it to discrimination is one thing, making it seem that we are only talking about disabilities is another thing. That is what we don’t want to have happen. Margaret –
MS. AMATAYAKUL: Would it help to say, this includes strengthening disability laws making it illegal?
MR. REYNOLDS: No.
MR. HOUSTON: I think it really does Mark actually limit the scope of this recommendation by saying, when you discriminate based upon disability. I just think you are getting much more, the recommendation has much more breadth to it to make changes because you could argue that one form of again, if it is not a defined disability even if they have access to the data and they decide not to make a hiring decision based on data –
MS. MCCALL: That is precisely the fear. I would recommend removing the word “disability” and the rest of it I think reads fine.
MR. REYNOLDS: Simon that would conclude the discussion.
DR. COHN: Let me just ask for a second, what I want to do is now go quickly through the first part but are we all okay with what we have just seen?
DR. LAND: I just want to ask the question on that very last section there. Are we saying that we are saying the employers cannot discriminate in hiring a person that smokes?
DR. ROTHSTEIN: I think we say this includes strengthening laws but that doesn’t say how much they are strengthened or what that would apply to.
MS. MCCALL: Well it says making it illegal for -
DR. COHN: Margaret do you have, nothing?
DR. ROTHSTEIN: So the short answer to your question is no, I don’t think we are saying that. It is a great example.
DR. LAND: It appears to me that way but maybe I am reading it wrong. If they have got data from a former employer that a person smokes and they are in the process of hiring him and says, no I am not going to hire you -
MR. HOUSTON: That would not be discrimination I don’t think.
DR. ROTHSTEIN: In half of the states it would be.
MR. REYNOLDS: Okay, sticking with the program, what are we doing here?
DR. COHN: I guess the question that I bring up for everybody is do we need that second sentence at all? Just take it out.
DR. REYNOLDS: Not a bad idea, just take it out. Everybody in? Okay, now that completes our first part of that discussion. Is everybody okay at this point?
DR. COHN: Now remember for the first part what we want to do is look at the changes. We do once again this is that issue of the recommendations that we all need, sort of need to finalize at this point. There will be minor wordsmithing that occurs throughout the document and especially in the earlier parts so we can talk about those next steps but let’s at least look through what we have here. Margaret do you want to share any substantive, I don’t think we need to see however -
MS. AMATAYAKUL: No, the one question that I had was we had protected health information, personal health information, and HIPAA de-identified health information, we took the flash health data out. It seemed to me that we were using health data throughout the rest of the report just in general.
DR. COHN: Can I make a comment here because I think you initially had personal health information/personal health data. Michael was looking at where it said personal health information and personal health data. I actually think if we put a slash mark and leave it personal information/personal health data it sort of solves that duel usage issue. It probably won’t bother Michael too much. So is that okay with everybody?
MR. HOUSTON: We just took it out before. Originally we took it out.
DR. COHN: Well I think we took it out there but Margaret is commenting that we didn’t take it out everywhere in the document. I think she was going to do a global search so I think this allows us to use both terms.
MR. HOUSTON: I just think it is more precise to find all of the terms and just make it all the same. That was my original comment.
DR. FRANCIS: We use it interchangeably; I mean data makes more sense where we are talking about a data set that contains personally identifiable health information.
DR. ROTHSTEIN: Could we make it personal health information and personal health data as used in this report or -
DR. COHN: Sure, okay that is even better. Margaret does that solve problem one?
MS. AMATAYAKUL: Yes. We did add at the beginning of major themes from testimony about uses of health data a sentence that says, NCVHS observes that enhanced protections for uses of health data is a controversial topic with diverse viewpoints. NCVHS heard a wide range of testimony on several major themes concerning uses of health data. Major themes include assuring benefits while reducing the potential for harm and then would go on.
DR. CARR: It just reminds me that we were going to put a couple of sentences in the introduction about the goal. I don’t know if we have done that yet. That the goal is balancing, take what we have in the principles and put that as an introductory statement under purpose and scope at the very beginning.
DR. COHN: Are you going to make a note there Margaret?
MS. AMATAYAKUL: I am not sure exactly where she is referring. Are you referring to -
DR. CARR: We discussed yesterday we didn’t want to just begin by saying, the Office of the National Coordinator asked for this but rather that we wanted to take a line from the section on the principles that really is a statement of our goal. To support benefits from uses of health data while protecting privacy.
DR. COHN: But that is no new information that is moving some things from earlier from later on. Okay good.
MS. AMATAYAKUL: So then beyond the major themes we receive some examples. For example at the point of care, this is in the section describing benefits at the point of care for instance, speedier access to health records for those affected by Katrina hurricane disaster would have improved health outcomes and likely saved lives.
Then under Clinical and Population Research Can Be Strengthened for example, studying a population with autism might allow understanding of the environment or biological of increased incidence of autism, and potentially earlier detection.
Under Disease, Surveillance, Control, and Prevention, I added “surveillance.” And then the example, for example public health could potentially detect on a timely basis areas of the country where HIV is suddenly spreading thus alerting health officials to take speedier action to save lives.
MR. HOUSTON: Question eight, rather than using HIV, could you use something like an infectious disease? HIV is probably not a good example something that is going to spread rapidly. Let’s just say an infectious disease.
MS. AMATAYAKUL: Then I added personal health management is aided by individuals having access to personal health information that may be compiled within a personal health record supported by HIE. Individuals who monitor their own health may lead healthier lifestyles, may be in a better position to pay attention to early warning signs of illness, and be better able to coordinate their care among multiple providers.
I think we had risk of discrimination and personal embarrassment may be amplified as electronic health data become more widely available through enhanced ability to automate health data collection, compile longitudinal data, re-identify data that had been de-identified, and share data through HIE. There have long been concerns that personal health information has been used to make decisions that adversely affect an individual such as an employment et cetera.
Then I took these paragraphs for potential for group based harm and misinformation from the older version. I don’t know if you wanted both. Potential for group based harm may arise when data are aggregated without regard to appropriate sample size or do not adequately explain the findings. For example there is a potential that classifying diseases is more prevalent in certain ethnic or racial groups of people or in certain communities can put all members of the group or community in a compromised position. As de-identified data are aggregated across multiple data bases there is also the increase possibility of re-identifying certain individuals within the group.
Then the misinformation was misinformation and therefore areas in care delivery, and misguided quality comparisons, or inadequate data to ensure public health for advanced research. Such unintended consequences of enhanced use and exchange of health data can occur when sample sizes are limited by virtue of privacy concerns. For example if a given group of individuals has a propensity to distrust privacy protections that group may be underrepresented in a clinical study that could benefit them. Even when an individual holds information from a given provider such as information about taking a certain drug, there is a risk that the information might be vital to a treatment decision and the lack of such information result in a poor outcome.
DR. COHN: So this is basically choosing one or the other I think, I am not sure if I see use for the second one but -
MR. HOUSTON: Yes, with regards to the first one rather than saying that, the part that talks about “put a group in a compromising position.” I think would be more accurate to say, could cause members of that group to be discriminated against. I think that is the point that you are trying to make is that there could be discrimination based upon prevalence of a disease in a certain ethnic or racial group. I think it is more accurate to say that discrimination might result.
MR. BLAIR: John would you accept a “might cause” instead of a “could?”
MR. HOUSTON: Might is fine, the wording to me was just, didn’t accurately describe the issues.
DR. W. SCANLON: As I remember I think the reason we dropped this before because we are getting now into the area of research methods as opposed to the data and this issue of what is the appropriate sample size. We had this discussion yesterday when we were talking about measures that our report is about data not measures, not research, et cetera. So we are again straying into this new territory.
DR. FRANCIS: Well I am the one who brought it back up and I don’t think we need to comment on particular research methods but what we are commenting on here is a risk associated with secondary uses and a risk associated with secondary uses is group stigmatization even if the data are de-identified. That is the only point here and that point I think need to be out on the table.
DR. W. SCANLON: But there is also, if a perfectly valid study comes to this conclusion a group can potentially be harmed because the conclusion is right.
DR. FRANCIS: And that might be a reason I don’t want my data included in that study, that I fear that. I might not want my group to be studied and that is something that is about a possible question that people might have about secondary uses. So I mean I don’t associate this problem just with bad methodology I think it is a problem generally but I am happy to take whatever compromised language people want as long as the possibility for group harms gets signaled somewhere.
MR. BLAIR: Leslie what is the wording that you feel most comfortable with?
MS. AMATAYAKUL: I was just suggesting that perhaps taking out the wording I highlighted leaving it, potential for group based harm may arise when data are aggregated for example.
DR. COHN: Okay that takes it out of that. Justine did you have an issue on this one?
DR. CARR: I don’t. Well I would separate, there is two parts. One I would separate out, are we talking about “poor technique” which I think we don’t want to talk about so I would take that off the table. Then I still don’t understand this; that an accurate report about a condition in a group is creating harm because you are saying because people wouldn’t put their data -
DR. FRANCIS: Suppose there is an accurate report that HIV is more prominent in Haitians, in Haitian immigrants. There are actually studies that showed that. I mean at one point there were high prevalence levels of a particular disease in a particular immigrant population. That of course doesn’t mean that everybody gets it. It might have been a perfectly good study but it also resulted in employers not wanting to hire Haitians. Now if I am somebody who is a member of a group I might not want my data in, even if my data are disaggregated, I mean de-identified in an aggregated data set. Now we may perfectly well want to say look that preference shouldn’t go anywhere but I think at least it needs to be identified as a possible harm so that it can come up in discussions of transparency.
DR. CARR: But it also is a benefit. The identifying that a group, just as we say there could be an infection in the Midwest we are going to, it goes both ways I don’t deny that.
DR. LAND: I mean that is basic public health epidemiology, is looking for high risk groups and publishing it so that you can take action. If we say it is a harm than we are throwing out the whole basis of epidemiology in the United States.
DR. FRANCIS: No, I am not saying that identifying a high risk group is necessarily only a harm but I am saying that that there are harms, there are benefits associated with identifying a high risk group but there can also be harms to that group. One of the things that anybody needs to be careful about when you do good public health is you have to worry about the possibility that your data may be misused in discriminatory ways. It is discrimination not to hire Haitians because there is high prevalence of HIV in Haitians.
MR. HOUSTON: What if in the first sentence where the italicized harm we change that from harm to discrimination to make it clear that I mean discrimination to me has a specific connotation to it which
DR. ROTHSTEIN: I would oppose that because it includes stigma as well. There are intangible harms that may result and let me just say on this point, this is an issue that is not unique to this document it was part of the National Bioethics Advisory Commissions recommendations and reports. There is a whole record of IRBs taking action on this basis. If you presented a proposal to an IRB to do research on even de-identified information if it were in a particular ethnic group or racial group and could result in group based stigma the IRB would require you to get sent. What this is saying is it is really kind of very traditional analysis of the risks to individuals. We are not breaking new ground here.
DR. COHN: I think I would also mention that obviously just looking at the recommendations this area is where we are saying that we are going to investigate further. Remember this is not causing a major waterfall effect down in the recommendation area. Now Jeff and I am going to let Margaret review what we have there.
MR. BLAIR: There is a real concern here but I heard you wind up saying that your concern is that the data might be misused and I think that we also recognize that there is a lot of opportunity for benefit so we don’t want to throw the baby out with the bathwater. If we could be more focused on the concern about misuse rather than impair the completeness of the data for the opportunities what it could benefit. If we could separate that out and target it in on the concern about potential misuse instead of just wind up saying that people should opt out because they are concerned that there might be misuse.
DR. COHN: I don’t think anybody is going to opt out here but Margaret do you want to review. You have been typing as we go here.
MS. AMATAYAKUL: This isn’t a section of harms. Potential for group based harm may arise when data are aggregated and maybe I could add something about misuse and misused or misinterpreted or something. For example there is the potential that classifying disease is more prevalent in certain ethnic or racial groups of people or in certain communities might cause members of that group or community to be discriminated against even as aiding high risk groups by supporting further research. As de-identified data are aggregated across multiple data bases there is also the increased possibility of re-identifying certain individuals within the group.
MR. BLAIR: Those are different ideas.
DR. COHN: Let’s get rid of that last sentence. I think it has all ready been somewhere else. I guess the point I would make also is it is probably not supporting further research but maybe interventions? Supporting beneficial interventions? I thought doing something rather than -
DR. MCCALL: It supports new health services and treatments.
DR. ROTHSTEIN: Can we just make a slight change to add at least subject to stigma as well as discrimination? Because a lot of it would be -
DR. W. SCANLON: I wouldn’t, Margaret just added, “and misused” in the italics and I wouldn’t do that because I think that the misuse is not necessarily on the part of the analyst, the misuse is on the part of the people –
MS. MCCALL: Isn’t it misuse of aggregated data and results?
DR. W. SCANLON: Well the data are not necessarily being misused it’s the results, while potentially correct are then being misused by someone in the public.
MS. AMATAYAKUL: Potential for group based harm may arise when data are aggregated and results potentially misused?
DR. CARR: I had a very similar comment. I guess that is all.
DR. COHN: Are we okay? I mean I think that putting something in here especially since there is at least some aspect of a recommendation makes sense. Now I don’t know about that second whole area, I would recommend that we remove it. The misinformation I mean I don’t know I think you were sort of thinking one or the other I think is what you had -
MS. AMATAYAKUL: We had both of those and we didn’t address them so I brought them both back.
DR. COHN: Are people okay with removing them? Okay so are we okay at this point?
MS. AMATAYAKUL: You had asked for specific uses of health data for a little introductory sentence setting that up. NCVHS sought and heard testimony describing issues associated with those uses of health data that are most relevant to the current debate concerning HIE and NHIN including uses for treatment, payment, and healthcare operations, quality measurement reporting and improvement, research, public health, and in monetary or other value exchange. Those are the topics that we cover here.
Then I did the same thing for Uses of Health Data and Research. Testifiers identified two important issues; I am just setting that up.
Then I called this section Uses of Health Data Involving Monetary or Other Value Exchange. Many organizations obtain monetary or other value for uses of health data and many of these uses maybe beneficial. For instance, researchers may purchase de-identified data to enable a broad based study of disease. NCVHS however heard many concerns that relate to the sale of health data where the data may unduly influence individual or provider decision making. Where the data may be able to be re-identified and cause potential harm to individuals such as for insurability or even where identifiable data are sold to direct marketers.
Then we talk about the requirement for authorization for marketing is the same. Then I added, these privacy, I think this is what Paul had added before and we fixed this example yesterday.
DR. TANG: I think one of our points now that we have used the word “de-identified” without the HIPAA modifier, since I am not sure what that means. The second point that we made was HIPAA de-identified data generally are not very useful so it is pretty unlikely that researchers would go purchase a HIPAA de-identified data set to make use of it when in fact with IRB approval they can get identifiable information and treat it in a confidential manner. That is what we wanted to emphasize.
Another example of -
MS. AMATAYAKUL: Could we just take one at a time? So what would you like this to read instead?
DR. TANG: Unless other people correct me this isn’t an example where we do find that there is evidence that things are being sold either outside of HIPAA or out of concern to consumers. This actually is not a concern and it is permitted and what we heard is it is being handled well.
MS. AMATAYAKUL: We are saying it is a benefit, except you are saying it is not a benefit.
DR. TANG: Well I just think it is one of those things where you raise it in the wrong place and we have introduced a concept that may be –
MS. AMATAYAKUL: Can we come up with a better example of a benefit?
DR. COHN: Yes Paul, are you objecting to having a benefit there?
DR. TANG: I don’t see that this would give me an example of where data is sold to researchers.
MS. AMATAYAKUL: Paul we are going to take this out, give me a different example.
DR. COHN: Well Paul, let’s stop for a second before we start adding new, this is meant to say, there is monetary things going on, some of which are good but we also heard concerns about X. So is there a problem with that initial example? You seem to be upset that it is an okay example.
DR. TANG: That the use of de-identified was imprecise and that saying people go around buying HIPAA de-identified data seems to be against another thing that we learned which is it is not very useful in that form. It just contradicts previous findings.
MS. AMATAYAKUL: Don’t they still buy it? They do buy it, we have heard -
MS. MCCALL: Your example was right, you can go to an IRB, you can get a waiver, you can buy the data, you can do the work, you can hold it confidential, blah, blah, blah.
DR. TANG: It has nothing to do with de-identified –
MS. MCCALL: It has nothing to do with HIPAA de-identified as a defined term. So that is a fact but I guess I am still, so then your conclusion would be what with respect to this paragraph?
DR. TANG: I guess if you took out the HIPAA de-identified. That would fix it.
DR. COHN: Well but I don’t know why would you, I mean do you want to say, they purchase data under IRB approval or –
DR. TANG: Under an IRB approved -
MS. MCCALL: The point is I don’t think we should specify what another entity finds useful. It could be HIPAA de-identified, it could be under IRB approval, the point is it is all -
DR. TANG: I am not going to worry about it. So then another kind of example is in addition to things like insurability or employability it is the use of data, well the example we had on Monday was use of data to promote more expensive drugs.
DR. COHN: Would the data maybe unduly influence individuals or provider decision making? Well remember we are going to be doing additional hearings in some of these areas. Okay is this wordsmithing Margaret?
DR. TANG: No, it is not pointing out the problem that drove us to this exercise.
DR. CARR: What are we trying to accomplish here and then what is working and what is not.
DR. TANG: What is not clear here, I thought what caused us to go through this activity was because there are uses, we used to call them secondary uses that consumers were not aware of, that also involved the exchange of money, and could come back and lead to effects on their care or let’s say the cost of their care. If we could state that clearly in this section that would give the motivation for why we are trying to come up with these policies, to one to understand them, two to oversee them or regulate them or make them transparent.
DR. GREEN: Maybe the issue is the sale of health data without patient consent where the data may then unduly influence -
DR. CARR: The data can only be sold if it is de-identified? I mean without consent or a waiver.
DR. TANG: It is not permitted to be under HIPAA but what we have found is that it is being -
DR. CARR: So we have permissible and not permissible activities happening. There are sanctions for the sale of identifiable data but one of the tricky things is the definition of de-identified perhaps. So that is an issue, what’s being called de-identified is not HIPAA de-identified.
DR. TANG: Then the ability for business associates, non covered entities to further use and disclose data has not been clear at least in their minds. Then the consequences because they are not covered entities there is no recourse by the individuals involved.
DR. FITZMAURICE: The hammer would fall on the covered entity, not on the business associates assuming the covered entity follows the right procedures.
DR. COHN: I would just remind everybody that as we are talking about all of this stuff this is why we deferred it into an area requiring further evaluation.
MS. MCCALL: What you just said right now is a much clearer explanation of the core issue than what is there.
MS. AMATAYAKUL: Since this isn’t a recommendation why don’t we take this back and rework this and send it around but I do recall yesterday we heard that you want to describe some of the benefits as well. So we need some examples.
DR. CARR: There is monetary exchange of data that is fully compliant and acceptable and no one has an issue with and there is exchange of data that is in a grey zone because the definition of de-identified is not correct. Then there is the exchange of data that is not permissible but it is happening anyway. I think you may want to consider looking at the title which implies that it is somehow about the monetary exchange and that is really not the issue. It is about permissible and impermissible and whether or not they are captured in the value chain.
DR. TANG: In fact this may be all of the way up front because it is the reason we got called into this.
DR. COHN: No Paul, actually this is not the reason we were asked to do this work. This is part of what we discovered as we went through all of this. I do think it is something that we obviously need to have in here. Now so how do we want to deal with this particular issue? It sounds like we have gotten everything else resolved. So we do obviously have to vote on it. It sounds like Margaret is going to try to work on something in this area. This is obviously not a recommendation area but this is just more making sure that we are more accurately describing the situation or the issue that we are concerned about that we intend to further study. Part of the reason we are taking further study is what you just heard over the last five minutes is that we lack some clarity about this. I mean Paul has a very clear idea. I am not quite sure that I have the either the sense of clarity or agree on all of the pieces of it but it is something that we need to further evaluate. We need to be a little tentative about this one because we are all ready sort of seeing that there is something out there that we heard concerns about and we need to more sharply define it as well as come up with issues and solutions.
DR. TANG: I am not sure I understand what part is not clear. For example there are things that are going on that are impermissible under HIPAA that is pretty clear. We heard about things that are impermissible that we need to help clarify in some people’s mind or make it transparent that this is happening so it can be addressed.
The second piece is we heard very clearly about what the lack of the term de-identified how de-identified truly is not “de-identified” in the common lay understanding of that term because over the past ten years more and more public databases have become available and better algorithms are combining the data have become available and they will continue to be so. We had very, very clear testimony on that so neither in both of those cases of the three things that we have talked about is there a lack of clarity.
DR. COHN: I guess what we would say is what we have done is decided that we need to get additional clarity and figure out exactly what we may want to do as well as the clear cleavage lines are around all of this. I am just reflecting on the recommendations we have because I think much of this we have sort of decided to hold additional hearings on which I think you have agreed to that concept. But you do, we need to come up with something here that sort of makes sense and truly reflects the idea. Jeff do you have a solution to our problem?
MR. BLAIR: My thought was that additional study is fine but I thought that we were offering a solution to a complex situation at least an interim solution. The interim solution that I thought was so important in this case, I think it is one of the most important recommendations in this paper is that because it is so hard to sort out what is right and what is wrong in terms of other uses of data other than patient care here. Since we can sort it out and since study make take years and years and years, at least if we had a very strong recommendation for transparency upfront so that the patient wouldn’t be surprised, so that the patient wouldn’t feel manipulated or tricked or misrepresented that transparency was the interim solution until all of these other things can be sorted out.
MS. MCCALL: I would add one more piece that I think is strong. It is the linking all of the way through the business associates agreements. All of those pieces actually would stop at least some of what you had outlined Paul. I believe that to be the case.
DR. COHN: Obviously additional guidance from HHS, the de-identification really needs to follow the de-identification.
MS. MCCALL: If in fact, if those need kind of punched up to say, remember when you read that paragraph this recommendation actually helps resolve that, if that needs punched up and made clear. When I went through that was clear to me.
DR. COHN: Well in that case I guess are we okay at this point recognizing that we need to work on this area? Now I guess my question at this point is recognizing that we need to work on this which to my view could be sort of wordsmithing, review by the committee, emails and all of that, are we comfortable moving forward with the recommendations and the report knowing that this area needs further refinement.
MR. REYNOLDS: We also have to fix the data stewardship principles question that came up this morning.
DR. COHN: Whatever it is that we need to follow up and there will be further wordsmithing throughout the document as we review and find out more pieces and Harry thank you so that’s yet another piece of this. Obviously any of these areas we will review and send out to the committee for final review but I guess what I would say is the passage of this means that we are not having further conversations about the recommendations or the substance of them or the observation section except for wordsmithing at this point. Is everybody okay with that, any further conversation about all of this, all in favor of this report?
On motion duly made and seconded, the motion was unanimously approved.
MS. AMATAYAKUL: Can I just add one comment? Thank you for passing it. But also thank you for the opportunity and your patience and working with me.
DR. COHN: Well unfortunately we are not done quite yet. I have all of these sentences to work on. Number one obviously we will be working on things and sending them around for further review and input in terms of those sections so it won’t be finalized until we get everybody’s agreement on that. What we will do is now take about a 40 minute break and come back for the final session.
(Luncheon recess taken.)
DR. COHN: I want to thank everyone for hanging in there and obviously thank you for having finished actually the action item for this meeting. Thank you for all of your hard work. Now in the remaining 45 minutes, 50 minutes of this meeting what I think that we are going to be doing is A; talking about what has been happening with the subcommittees and workgroups. I think as you can appreciate the ad hoc workgroup on uses of health information. Hopefully it will be a group that will be able to discharge in the next couple of weeks once we make all of the final changes to the document and get it out to everybody for review. Hopefully by mid-December those of you who have been part of that activity, we will thank you when we relieve you of that duty which is obviously the point of the ad hoc workgroups.
DR. STEINWACHS: Simon we also thank you for doing away with the word “secondary” because it was secondary to the overall report. I thought it should be “primary” you know primary uses of -
DR. COHN: So anyway what we are going to do is spend some time talking about subcommittee and workgroup activities. I think what I am going to suggest is, Justine do you want to lead off by talking about the quality workgroup?
DR. CARR: I would be delighted. Representatives from AHIC quality workgroup joined our meeting today to review the AHIC quality vision roadmap draft. Roadmap outlines necessary components for future state in the development of HIT capabilities to achieve the quality workgroup vision. Components include several areas where NCVHS has held hearings, generated reports and recommendations. These include the following four: one is data stewardship, second is matching patient’s to their records, a third is coding improvements, and the fourth is something that we talked about yesterday, quality data sets including ambulatory care although not specifically primary care.
At the meeting we agreed upon the value of aligning NCVHS quality workgroup with AHIC’s quality workgroup. There are two next steps, one is that we will be generating a summary of the relevant work all ready done by actually various quality workgroup but also some of the work done by standards and security on matching patients and their records over the last four years. We will put that together to share with AHIC. The second thing will be to discuss and develop a plan for holding hearings on data stewardship.
DR. COHN: I am sorry develop what on data stewardship?
DR. CARR: Holding hearings on data stewardship develop a plan. As I said we discussed it at the meetings but it needs to come back to the executive committee. There is also some work the AHIC quality workgroup is discussing stewardship in more detail with George Isham and other folks a week from Friday. I am going to dial into that and between that and discussions with you and the executive committee will come forward, will come to some plan.
MR. HOUSTON: Regarding data stewardship, I haven’t talked to Mark about this but since it has come up in this context, stewardship is something that I from a privacy component I think there is also an interest as well and I don’t know if that isn’t a topic that maybe should be also dealt with with the privacy subcommittee maybe jointly or otherwise. I forget what is on our agenda but I would hate to miss the privacy component on data stewardship because it is huge.
MS. GREENBERG: Is your hearings with quality on data stewardship would they be primarily related to the quality agenda or more broadly?
DR. CARR: There is a specific interest from the AHIC quality workgroup to have that but because of the work on the report we have just concluded it is a broader topic so I don’t think it would be exclusive on that.
MS. GREENBERG: Data stewardship has become a committee wide I think issue and I think in light of this recent report this is proof. The question I was going to ask was if you had a timeframe for generating this summary. I am assuming you might want contractual support to work -
DR. CARR: Yes, in fact Carol what our hope is as you know we have done, we had a report due the full committee from the quality workgroup in February of ’06 that summarized things and although we didn’t bring that to a formal light of day we would like to append that as some of the work as well as the update on the 2004 candidate recommendations which we now have an update on what happened with all of those. Mary Beth is going to help us also go back through some of the documents that the full committee has that are relevant to this work plan and Carol and myself and if Susan could help us that would be terrific.
MS. GREENBERG: That is why I wanted to know what your timeframe was because we should actually talk to her just to see –
DR. CARR: I think our timeframe would be pretty short because we want to make the information available in a timely fashion for the AHIC quality workgroup. I think that its, well I am not going to say I don’t think it is going to be a lot of work because the last time I said that I was; hopefully it can be done in a short amount of time.
MS. GREENBERG: By February or by June?
DR. CARR: Yes, by February for sure.
DR. COHN: Okay, Gene and then Jeff.
DR. STEUERLE: Justine I am not sure how to say integrate what our subcommittees, well you’ve done our subcommittee too, our subcommittee on populations and quality, but when I think of the term stewardship I am reminded of there was this one parable in the bible about these three stewards, two of them went out and doubled the money and the one who took the money and put it in the ground and hoarded it was the one that ended up being condemned. I think sometimes stewardship means making sure certain types of errors don’t happen and the end result in government is often that the data is well at all and that is with respect to quality too. I am wondering if you hold hearings on data stewardship the extent to which one could integrate in the concern that we often have in the population subcommittee which is not only are we developing the data we should but even the data that are developed are not adequately used, they are not accessible to people on the outside. I guess we have the concern that the people on the outside might abuse them or might you know violate some privacy concern but often the data could help us solve problems and is not being adequately used. I don’t know whether there is some way to integrate that side of the story with your hearings.
DR. CARR: In keeping with our sort of integrated sort of agenda of last year, it sounds like privacy populations and quality and actually the whole committee might be involved in this.
DR. STEUERLE: Like I said I would hope the word stewardship doesn’t evolve to a narrow meaning of protection.
DR. COHN: Now Jeff Carol had her hand up on this issue. Were you also on specifically this last comment?
MR. BLAIR: Not stewardship but on quality, especially quality.
MS. MCCALL: I was going to make a very similar comment about it being a broader interest kind of cross subcommittee that perhaps we might take a different approach, an integrated approach that says, there is in fact an explicit link, you know raise your hand as a subcommittee if in fact this could be a set of joint hearings. Each there to actually listen with a different kind of ear right, and that the ear that we would be listening with would be with respect to quality but there would be others with respect to standards and security, or privacy, or whatever the issues are and that what emerged was in fact what I think what Michael was asking for earlier which are among other things perhaps a set of principles around data stewardship that we can actually bring forth as a full committee. Just as a friendly suggestion.
DR. CARR: I don’t mean to imply that there hasn’t been tremendous work done in many different arenas and I think that one of the things that we talked about today is of pulling that together, maybe not because AQA George Isham for example has done a great amount of work but I think your suggestion is a very good one.
MR. BLAIR: Justine, I have a suggestion for a testifier. The AHIC quality use case focuses on measuring improvements in quality of care outcomes and it does so and it is sort of the end points of course it is the healthcare providers that wind up measuring their quality and then making that information available to all different forms of payers and to consumers. Now when you first think about that, at least when I first think about that I think about what a struggle it must be to be able to get this adopted and implemented because there are sensitivities. There is a health information exchange network called Care Sparks. Lisa Jenkins is the CEO. She has helped craft community wide not only a business model for their health information exchange based on quality data and that use case but it is so lucrative that that’s what is causing her some problems in terms of being classified as a nonprofit. So this is a very unique situation where a community has actually pulled together on this quality use case in a manner that is extremely positive so her name is Lisa Jenkins and if we could just have her testify I think you will learn a tremendous amount.
DR. CARR: Thank you, I think we heard about Care Sparks at the last AHIC meeting, the big meeting in Chicago.
MR. BLAIR: She testified in Chicago along with, you were there? Okay. That’s right you were there. Of course you were there.
DR. TANG: Let me ask you a question on how you see NCVHS working with the quality workgroup of AHIC working with AQA a little bit on the relationship so there is, or do you think it is all ready fully orchestrated?
DR. CARR: No, we spent time talking about that today. The request was initiated by AHIC quality workgroup so I appreciate their reaching out and I think it is a great alignment but we are the meeting on the 14th will be an opportunity to hear about these different things and to carefully carve out who does what so that there wouldn’t be duplication. Again I think we add value sort of at a higher level not all at the detail level but more as a kind of pulling together level. We talked about that today.
DR. COHN: Of course just to remind everyone that obviously this is just being sort of brought up it will also be discussed at the executive subcommittee and other places. I didn’t make this in my comments yesterday or this morning but as we get involved in big projects we just need to be very thoughtful about it because there is only so much bandwidth for the full committee. It usually is an opportunity issue. Opportunity costs you do one thing but don’t do another. We just need to make sure on an ongoing basis that we are doing the most important things you know picking our spots where we can really make a difference on this.
DR. CARR: So exploring that. What we are going to do though is that summary report to kind of pull together and let folks know what is available. We are exploring the stewardship issue.
DR. COHN: Okay Justine thank you, Don do you want to talk about populations?
DR. STEINWACHS: Population subcommittee, our session today assessing where we are on the current activities, plans for future activities and let me just walk through quickly on those.
Under the leadership of Bill Scanlon, Kevin Vigilante and Doug Benning, we have been looking at measuring preparedness. We started out calling it surge capacity, we have broadened that some. We slowed down a little bit because it seemed that, Simon, you recruited Bill and Kevin to another activity so there seemed to be a hiatus there. Bill kept saying, I am busy. I said, I don’t understand this concept of non-secondary uses so we are picking that up again and there are a set of interviews that are going on. The idea of trying to combine that with the hearings that we had to produce a report, a letter report at least, to the Secretary and then decide where to go. We are hoping that those interviews can get done by the February meeting and then a letter after that.
Part of it is also we are looking for information on what was learned from Katrina on measuring preparedness and Jim Scanlon has been looking for a compilation that hopefully did not disappear in the disaster that was put together trying to assess what was it possible to measure.
The second is has been we have produced a letter and got a response from the Secretary on data linkages which includes the issue of trying to increase access link data recognizing link data almost always increases the risk of loss of privacy and because once you link then things become more identifiable than they were before.
The discussion lead to I think a very good point that data linkages actually probably cuts across other substantive areas the committee is currently dealing with or will deal with. It certainly cuts across preparedness how you put together a information relevant to that. We thought maybe the strategy would be whether it is every year maybe every other year maybe to have a half day session and sort of invite people back both from the department but from other agencies so before we’d included education, we included IRS, we included the census, we had social security, CMS, and others. Trying to assess what progress is being made on increasing access while still protecting the privacy concerns and try and use that maybe as a kind of way to maintain momentum on maximizing the value from the data sets that are all ready in the possession of the government to address health issues and improve the health of the public. The plan would be either 2008 or 2009 to have another half day session and to have this on some periodic basis whether it is every year or every other year.
Then we have three potentially new topics to consider. One was brought to us by the Board of Scientific Advisors of NCHS which I call, Harmonization of Vital Statistic Across the States, and Garland very appropriately really focused very heavily on mortality data and the concern of mortality data. The transformation process that is going on trying to bring people into a new generation of data collection but over the next decade the data are not the same across the states so you can’t Garland you can probably say it better than I can but you can’t pool together mortality data across the country anymore and birth data both. It was also pointed out, which I hadn’t realized I am going to have to hang around with Garland more is that I had forgotten that we no longer collect marriage information, divorce, and termination of pregnancy. It reminds us of some of the very basic functions that need to be addressed.
We had on the telephone Jennifer Madden from the NCHS and we were talking about how to proceed and I think what became very clear is that we have got two committees with agendas and how that is going to really work I don’t know but we decided to do the following: National Academy of Sciences is going to have a workshop in April on vital statistics. Garland is going to be there as we have been having input into the agenda try and see where they come out with other specific, very specific questions we might peruse because I think there is a grave concern among NCVHS staff that there are a huge number of issue out there and if you don’t pick something wisely you are going to sink a lot of resources and maybe not get a lot wiser at the end of this process.
Then after that I think we are going to have a small group get together, Garland, myself, a few others on our side and a few from the BSC NCHS and talk about is there something here that we can do together that is valuable at this time or is that a future activity? There is a lot of interest in doing this I think mainly because it was the first idea of doing something jointly with the BSC and so it is a learning experience for both groups is the way I would view it. Over what is a very important set of areas or issues we face on national health statistics.
DR. COHN: Maybe I should just ask a question here and you may be done but explain to me, I guess I sort of missed the, you have now joined with the BSC on activities?
DR. STEINWACHS: We haven’t quite joined. This came to us I think as you know Simon that since the creation of the BSC we have been talking about ways to work together and we certainly opened the door that on things that we are doing we would certainly welcome their involvement or input. I think sort of the flip of that has also been true Bill has been attending the BSC meetings and been representing us there as a liaison and we have had a liaison at times at our meetings. This was really brought by them to us as an idea for something to work on together and I think what happened was initially we sort of said, yes and then the complexities and maybe potential challenges of actually doing something useful became clear. We haven’t given up on it but I think it is just going to be a much longer process to see is there something here to work on.
DR. STEINWACHS: If I can just add the BSC is in some respects in a transition. They have a new chair, Erma Elo who was our liaison, is now the new chair of the BSC and they have had I think at least five of their members who are new as of their last meeting. Part of the discussion at the last meeting was their work plan. They had committed I guess about two years ago to reviewing each of NCVHS’s programs one by one and they have been through two or maybe three at this point. There was actually a fatigue factor setting in because they were moving very fast through these. It was impressive but it was tiring to watch. They were asking themselves, can we keep up this pace so there is an issue with what they do with respect to the reviews of the NCVHS programs and then other things. Since we had the joint meeting a year ago in September and vital statistics was the topic that we discussed at that joint meeting. There is recognition that there is interest in both committees this became a point of discussion but it still at discussion level at this point.
DR. STEUERLE: Another topic which we have talked about with the whole committee a few times, the general area was to go back to the division for health statistics for 21st century and look at updating it maybe in a couple of ways. One is trying to put more specifics in it appropriate areas and the other is to integrate into it what has been going on both in the population subcommittees as well as committee as a whole, as we talk about electronic health records and other strategies that might be the building blocks of health statistics in the 21st century.
What we discussed was really a need to put some more specificity to what it is we might do and this is also something that Ed Sondik has been very supportive of he would like to see us do it too. In part I think it keeps alive and reinvigorating sort of a framework that I think NCVHS finds useful and we have found useful many times. Marjorie and I, NCVHS staff of the committee and so on, a small group of us are going to have a conversation to try and draft a page or two as sort of a proposal about what we might do and to discuss that and to try to make a decision at the February meeting on how we might proceed. We see it also as an opportunity to draw in the work we have done on data linkages possibly draw in areas on preparedness because that is not something that is particularly been highlighted that I remember in the vision for the 21st century. It may be a way in a sense to continue to sort of draw in what we are doing in and integrate it into a large division.
The third new area and one around which there is a lot of enthusiasm, and I’ll let Larry say a few words he has been tackling the question of how do you measure whether or not someone has a medical home and how do you measure the performance of a medical home. Do you want to say a few words? I said it all. Larry has trained me well he said, Don say this and you are all right. So we are actually enthusiastic about the possibility of moving ahead with that fairly rapidly, it seems to be in traction on lots of quarters and it raises very interesting questions particularly for NCVHS data collection and others when you do the National Ambulatory Medical Care Survey if you tap into this. The emergency department survey I guess is now in the field but in a sense there. Are there different places health interviews say, how would you begin to tap into the measuring extent to which people are getting a strong primary care model or not. Another way to view this is to try to measure the extent to which people are getting what we would think now as a high quality primary care experience.
The next steps include trying to identify staff who might support this and Mary Beth and others were making suggestions because within HRSA there is the primary care bureau and there may be staff support from there if possible. Someone was identified NIMH who has an interest in this area so the medical home is actually supposed to integrate mental health as well as medicine. That is one of the next steps, to look for potential staff support. We hope would be if this moves ahead early in 2008 it would be possible to have a first set of hearings among those people. CMS is doing medical home demonstrations about what the ways in which they are trying to approach measurement of both the presence of a medical home and its performance what are some of the issues and gaps that they see and at least pull together an initial document which addresses the extent to which there seems to be common approaches or gaps or other things. Then think about where we go from there. That is our current slate at this point and we are trying to wrap up some things at the same time move ahead.
DR. WARREN: I would just suggest as you are working with medical home to contact NAHIT, the National Alliance for Health IT. They have got a demonstration project out in New Orleans looking at establishing medical homes down in that area. If you are looking at testimony or just contacts they would be really good.
MR. BLAIR: Actually I think it is part of the American Hospital Association isn’t NAHIT a sub, or grew out of that?
DR. COHN: I think they are sponsored by a variety of entities I believe. They are one of the sponsors though. I think they are chair member is Scott Wallace.
DR. WARREN: I know I was part of a team that went down there to look at some of the medical home issues and to talk about health IT and their use. They are really trying to put together some demonstration projects and stuff that works so they would be a good resource for you.
DR. STEINWACHS: I expressed interest in medical home because I anticipate as I age I may need one more and more and more at some point. Enlightened self interest is that okay?
DR. COHN: No, comment but it is probably general agreement from all of us. Well great, privacy -
MR. ROTHSTEIN: Thank you, the subcommittee met this morning, our plan is as follows: to move ahead with our sensitive health information letter. At the moment we have decided to have a series of conference calls and where we are now as we have no longer a two draft system we have a single draft that we are working from and our main task now is to try to be responsive to all the comments that we heard yesterday. We are going to be going through the draft sort of line by line and addressing issues that were raised at the full committee discussion yesterday as well as other issues that have been brought forward by members of the subcommittee. It is our intent to have a letter for consideration by the full committee at the February meeting.
Beyond February there are no shortage of topics that we could consider and let me just go through a few of those that are possibilities and these have gotten approved by the subcommittee.
We heard from Ed Sondik in September about the possibility of the subcommittee and the full committee assisting NCVHS with a difficult issue that is being considered internally now and that is the rules for disclosure of DNA in clinical data to researchers in particular from the NHANES files. Many groups are considering their repository practices now. The Corelle(?) Institute is another one that is reviewing it’s confidentially issues.
The other issues that seem logical for us to follow up on, our privacy letter dealing with sensitive information as you will recall is limited to disclosures for treatment purposes. We left in a band the issue of disclosures of sensitive information for other purposes and that would be something that we might want to consider as well as other issues from the June 2006 letter that where we said, here is an issue we are not taking a position on it at the moment. It requires further study and so forth and that’s where our last two letters basically came from. Follow ups to the 2006 letter and there were at least a half dozen topics that we left hanging out there in 2006 with the intent that we would study them in more detail and bring forward additional recommendations to the Secretary. That is basically where we are. Maya did you want to?
MS. BERNSTEIN: I was only thinking about in terms of getting the letter that we are working on now to the committee in February. We have a document on committee procedures but it was useful to us and I think to the committee last time to have advanced drafts before we were prepared with them to the committee so that they could have a good look at them before we got to the sitting down around the table together so that is not the first time that people see them. We act at time with the I guess it was the 2006 letter actually had people invited to participate in the calls for the end of the process.
DR. ROTHSTEIN: It may be appropriate when we get to that point to have an open call for the full committee and allow people to review the draft and make suggestions before it is finalized and then sent to the executive subcommittee.
MS. BERNSTEIN: The only other thing is that when the executive committee considers the schedule for the February meeting keep in mind that it might be a contentious letter again and that we need some time to go through that letter and to have a discussion with the committee at that time.
MR. BLAIR: I would hope that the next time that we review the letter we keep in mind the tremendous value of how well organized and structured it was. I read that letter cold without being familiar with it before hand and every time I began to identify a concern or an issue that next sentence or the next paragraph addressed a concern on all I did today is talk about the one sentence where that was not true but it was so well done that it is compelling for education for a lot of folks that might otherwise either not appreciate what it takes to do this or be reluctant to take it and Mark and Maya I really would really leave it to you, I don’t want to let the nits, the details, the critiques rip apart the coherency, coherent it was understandable and I think that has great value because sometimes our letters are so detailed, so precise that it is like wading through mud. Everything is technically correct and precise and the committee has pulled it together but this letter was compelling and coherent and I hope we don’t lose that.
DR. ROTHSTEIN: Thank you Jeff, we will have lots of opportunity to talk about the letter but I think an important thing as we go forward certainly at the subcommittee level and I hope at the full committee is the recognition that even though there may be parts that people disagree with it is so important to get this issue out there, to get people talking about it and thinking about it creatively and to do it sooner rather than later.
MR. BLAIR: Believe me I agree. Marjorie would tell you that I agree with you.
DR. COHN: Mark, thank you and we will obviously look forward to the next version. I guess I would even though we only have draft workgroup and subcommittee activity pieces the only pieces I would just advise everyone on is before things start going out to everybody they need to have fundamental support from the subcommittee or the workgroup in advance of that. I think that we have gotten ourselves into trouble where we thought we have had agreement and then they get distributed and somehow we are all talking about three versions ago of the document itself. That would be the only advice and obviously I will be there with you so we will be making sure that all happens. Leslie?
DR. FRANCIS: Yes, just to link the red in the committee operating procedures -
DR. COHN: That is for your review today, to be discussed in February.
DR. FRANCIS: Okay it is a little too strong on that point because I think we didn’t have full agreement on the content of the letter when it went around but we had agreement that it was really important to get input at the stage where we were.
DR. ROTHSTEIN: I don’t think Simon is referring to yesterday’s letter so the point is well taken I think.
DR. COHN: As I said we will continue to wordsmith that operational document.
Okay thank you, Harry and Jeff. Do you want to talk about standards and security?
MR. REYNOLDS: We have a hearing in the end of January; we are going to be talking about ICD-10 we are going to be talking about e-prescribing we always have to keep an eye on MPI obviously to be a good subcommittee we are going to now have to add stewardship like the rest of you but we haven’t figured out quite how to put that in there yet. So that is the main thing that we are focusing on to keep it brief.
There are plenty of standards coming out, there are plenty of things that we are having to keep an eye on and this will be a big event for us starting to look at ICD-10 and getting further updates on that and we will have a conference call in the next week or so to finalize that agenda and exactly what we want and make sure we get covered, any questions?
DR. COHN: Questions or comments? Well, what do we say we sort of rundown the last couple minutes here? Now we obviously have a Full Committee meeting coming up in February on the 20th and the 21st. As I said this is once again right after a long weekend so we will make sure that the books and everything get out to everyone in advance. I think what I am hearing so far is that we will have it sounds like two action items. One will be the privacy letter on sensitive information and then the other is the documents you are putting together for quality workgroup representing the work that has occurred over the last several years.
I guess we will also potentially depending what comes out of this hearing in January maybe have a standards and security letter, maybe not.
MR. REYNOLDS: At this time I would say no.
DR. COHN: Now I think as I have comment before I am struggling to make sure we have enough time in the meetings for conversation and working on things and we certainly are reminded by this meeting that we need to have adequate time for the privacy letter. I guess that I am also hoping that we can start getting in some external perspectives and external speakers. I think I mentioned yesterday that I thought especially given our medical home conversations and all of this that, and our previous conversations around ICD-10 and ICD-11 that inviting someone like Chris Shute(?) to talk about the ICD-11 plans and all of this. It might be a very useful conversation for us to have as a Full Committee.
I am also sort of blanking on other presentations that we may want to schedule. We obviously have a list of additional things and we will work with the Executive Subcommittee to sort of finalize that.
MS. GREENBERG: Do you want to hear what some of them are? There is a ASPE project on personal health records that you want to hear more about. We had to put all of these aside for this meeting because you know why. CDC contracts, the public health situation awareness, I am not quite sure what is happening with that but that was on the list. Then there is a National Academy Study which was just finished on advancing standards and to help IT. I think that has been released. ONC commissioned it.
DR. COHN: You mean this is the mini report you are talking about? We should ask ONC just to update us on that at the next meeting.
MR. BLAIR: Marjorie on the accelerating public health situation with the CDC contract we are told that is supposed to be announced in mid-December, by December 17th.
MS. GREENBERG: OHRP guidance and research I am not quite sure what that was.
DR. ROTHSTEIN: That’s the I think the department wide taskforce or working group –
MS. GREENBERG: It is referencing the ad hoc report so I don’t know what the appropriate time is to hear about that.
DR. ROTHSTEIN: I spoke to Sue McAndrew earlier about that and it is proceeding at a measured pace.
MS. GREENBERG: We also got an autonomous list but we also received a letter from AHIMA and AMIA October 3rd actually asking to be on the November agenda but that wasn’t feasible but they have done a report on healthcare terminology and classifications a central piece interoperability and they have asked to brief the committee on this report. It would actually probably be appropriate with the ICB-10, ICB-11 all of that so we could try to schedule them for those two items for February, anything that I have missed?
DR. COHN: So the good news is that there are things that we can talk about that aren’t necessarily only reports we are working, I see Leslie has a worried look on her face.
DR. FRANCIS: Didn’t I hear earlier that John Loonsk was coming back for a longer discussion.
DR. COHN: Yes, they are sort of standing items.
DR. FRANCIS: Well it might be useful to have him for a genuinely longer discussion.
MR. BLAIR: One think that I might say because it seems like there is some synergy here with did you say AMIA and who else is going to be talking?
MS. GREENBERG: AMIA and AHIMA.
MR. BLAIR: Those two well if that is going to be a topic and ICD-11 is going to be a topic then some of the pieces that John Loonsk did not have time to present was a very interesting process to move from the HITSP standards to implementations, specifications. I have learned a lot that I just didn’t know before. I think it is going to be very important for those of us especially in standards and security but all of us to understand how it gets, the difference between the standards and getting to multiple standards for interoperability. It is a very interesting process.
DR. COHN: So that is something that we should be asking John Loonsk to talk about. So that will be part of our and that is a very good point. We will make sure he covers that.
MS. GREENBERG: Leslie did you have some particular things you wanted -
DR. FRANCIS: How the privacy letter is actually being taken into account in their deliberations. Part of that is going to be well, timing wise we are going to have the sensitive information letter so it would be useful I think to have an -
DR. COHN: Let’s take that offline I think that we can sometimes the expectation of people having answers like that on their sleeves especially when they don’t even know what the questions are and sometimes they could but they may not be able to answer them because they don’t necessarily know what we are recommending.
MS. GREENBERG: The other thing is the 60th anniversary symposium and I propose that we kick off that discussion of the executive subcommittee conference call which you would like to have one in December. We can talk about the February hearing and other related issues. If we are going to really try to do something for this and Larry and I spent our lunch hour talking about it actually but I think like June 2009 is what we should be shooting for so I think it is not too early at all to be talking about it.
DR. COHN: So the executive subcommittee will talk about it. Okay now recognizing the people that I am beginning to see people walking out the door here. I actually just wanted to transition now to what we traditionally do at the end of the meeting which is an opportunity for a little bit of reflection. I realize that it has been sort of an exhausting meeting at least I thought it was sort of an exhausting meeting but obviously what we are always trying to do is make these meetings better. I am going to open up the floor for any comments people have about ways that we should be organizing the agenda better, other things that we should be doing to make it a more valuable experience for the attendees or to make us more productive, so comments? Carol?
MS. MCCALL: I guess I like the conversation that I have heard in the last twenty to thirty minutes in the following sense. This has been very kind of heads down, very focused and intentionally so. So I think it is good to then tack in a different direction which is to open it up and explore and hear more. So I am glad that that will in fact be one of the broader themes so that is a good thing in terms of how to alternate.
The other is I think as you go into the executive subcommittee is to think about where the best synergies are because as you said before we have to pick very carefully where we spend our time. I just see lots of opportunities where there is more overlap all of the time and I think that would if we pick with that being even more than a tiebreaker that that could add a lot of momentum to what we do and a lot of value to what we do. So you may find as you deliberate as a subcommittee that there are things that you want to say, you know this is a common theme running through. The example being maybe data stewardship just as one but there may be others that you will find and so I’ll be excited to see what comes out of that conversation.
DR. COHN: Do the people wandering out the door have any comments? No? With that we will adjourn the meeting. Thank you all, happy holidays.
(Whereupon, the meeting adjourned at 2:55 p.m.)