[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
November 16, 2001
Hubert H. Humphrey Building
330 C Street, N.W.
Washington, D.C.
Reported and Transcribed by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
DR. COHN: - reports from the subcommittees and the workgroups, and hopefully adjourn at about 12 noon Washington time. With those comments, let's have introductions around the room. I would ask any of you, if you have any issues or anything that you need to announce in terms of issues that will come before us today and you need to recuse yourselves about, I would ask that you do that at the time of your introduction.
MS. JACKSON: I 'm Debbie Jackson, NCHS staff, sitting in for Marjorie Greenberg.
DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health, member of the committee.
MS. COLTIN: Kathryn Coltin, Harvard Pilgrim Health Care, member of the committee.
DR. SHORTLIFFE: Ted Shortliffee, Columbia University, member of the committee.
DR. MAYS: Vickie Mays, University of California Los Angeles, member of the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
DR. LENGERICH: Gene Lengerich, Penn State University, member of the committee.
MR. ROTHSTEIN: Mark Rothstein, University of Louisville, member of the committee.
MR. SCANLON: Jim Scanlon, HHS, Executive Staff Director for the committee.
MS. CONON: Susan Conon, writer for the committee.
MS. ADLER: Jackie Adler, staff to the committee.
MS. LAVULET: Sylvia Lavulet, AAHP.
MS. JONES: Katherine Jones, NCHS.
MR. HARNICK: Tim Harnick, American Association of Health Plans.
MR. GOVERNON: Mel Governon, Walter Reed Army Medical Center. Before my retirement from PHS I was FDA representative to the Data Council and subcommittees of this group.
MR. FANNING: John Fanning, HHS.
MS. GREENBERG: Barbara Greenberg, ASPE.
MS. ALD: Vivien Ald, National Library of Medicine.
MS. HORLICK: Gail Horlick, Centers for Disease Control Prevention, staff to the committee.
MR. HERRERITY: Dan Herrerity with the American Health Information Management Association.
MR. RYAN: Mark Ryan, Department of Veterans Affairs, Health IT Sharing.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of this committee.
DR. COHN: And for the record we actually have a quorum present. With that, Mark, I would like to turn this over to you to lead us through the revised letter.
MR. ROTHSTEIN: Thank you, Simon. Everyone should have a copy of the revised draft, and it says on the top, Draft 11/16/01. This is the revision that we put together between the close of yesterday 's meeting and today. It reflects the changes that were discussed at the committee meeting itself, as well as continuing discussions that took place at the subcommittee meeting.
Let me just take you through very briefly, should I read the whole letter?
DR. COHN: You are going to have to read the whole letter.
MR. ROTHSTEIN: That is what I said is I 'm getting ready to read the whole letter (laughter) in its entirety.
"Dear Secretary Thompson:
As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the National Committee on Vital and Health Statistics (NCVHS) monitors the implementation of the Final Rules that adopt the health data standards required by the Administrative Simplification provisions of HIPAA."
And let me read the first page and then I will stop for comments, because this is essentially unchanged.
"On August 21-23, 2001, the NCVHS Subcommittee on Privacy and Confidentiality held public hearings on the implementation of the final rule "Standards for Privacy of Individually Identifiable Health Information" that was published on December 28, 2000. More than 30 people, including health care providers, payers, researchers, members of professional organizations, other users of health care information, and members of the public testified on four key issues identified by the Department of Health and Human Services' Office for Civil Rights (OCR) and NCVHS: (1) the requirement for consent in order to use protected health information for treatment, payment, and health care operations; (2) the requirement that covered entities make reasonable efforts to limit the use and disclosure of protected health information to the minimum necessary; (3) the effect of the rule on research; and (4) the marketing provisions.
The focus of the hearings was to explore practical issues in implementing the final rule, including unintended consequences of the rule, possible inconsistencies, and areas needing further clarification. Panelists were asked to provide specific suggestions for possible modifications of the rule. Additional written comments from testifiers and others were also received.
In an October 1, 2001 letter to you, NCVHS addressed the consent requirements and the minimum necessary provisions, and provided recommendations for you to consider. This letter contains our recommendations on the research provisions. Since OCR staff attended the hearings and received copies of all the written comments, including comments that addressed issues that were beyond the scope of the hearings, OCR will have the opportunity to consider these additional issues not covered in this letter.
NCVHS will continue to seek public comments on the implementation of HIPAA administrative simplification provisions. In light of widely voiced concern about the lead time needed for implementation, NCVHS respectfully recommends that modifications to the privacy rule be made and disseminated as expeditiously as is possible."
So at this point let me pause and entertain comments or suggestions.
DR. COHN: Everyone seems satisfied with that.
MR. ROTHSTEIN: Okay, let me read the next paragraph and then stop, paragraph by paragraph now.
"Witnesses expressed concern that the additional costs and administrative burdens they believe will be generated when researchers comply with the privacy rule may have a detrimental impact on researchers ' access to essential medical information and, therefore, on researchers ' abilities to pursue their mission. There was also concern that fears of the civil and criminal penalties for the improper use and disclosure of information create a disincentive for covered entities to share information with researchers, even when the disclosure to researchers is permitted by the privacy rule. On the other hand, written testimony from others expressed the view that the privacy rule may build public trust in research and help insure that researchers receive complete and accurate health information for their studies."
DR. ZUBELDIA: Mark, the sentence, there was also concern that fears, it seems to be redundant.
MR. ROTHSTEIN: Okay. Well let 's take a look at that.
DR. ZUBELDIA: I would say there was also concern or there was also a fear.
DR. COHN: It is concern that the other people would have here.
MR. ROTHSTEIN: Okay. Any other comments. Okay. Next paragraph.
"NCVHS is committed to maximizing access to protected health information that is essential for research, as long as the information is used with respect for the privacy of the subjects, under careful safeguards to insure that identifiable information is truly needed and the information will be protected against misuse."
MR. ROTHSTEIN: That was a paragraph that was, well you will recognize changes.
"The committee makes the following recommendations:
1. Relationship between the Privacy Rule and the Common Rule
Several witnesses expressed concern and confusion about the relationship between the privacy rule and the Common Rule. Witnesses questioned the privacy rule 's layering of additional privacy protections on top of the Common Rule 's requirements.
NCVHS recommends that HHS, through coordination between the OCR and the Office for Human Research Protections, provide interpretations, guidance, and technical assistance to help the research community in understanding the relationship between, and congruence of, the Privacy Rule and the Common Rule for protection of reearch subjects with respect to the standards that institutional review boards (IRBs) and privacy boards apply in approving use and disclosure of protected health information for research."
DR. COHN: So this is new, you added this.
MR. ROTHSTEIN: That 's correct.
DR. COHN: It is quite a long sentence.
MR. ROTHSTEIN: It is.
DR. COHN: I mean I don 't think we need to wordsmith, I mean if we decide to pass this we can pass it with wordsmithing changes. I was just, this is more than one breath certainly.
DR. ROTHSTEIN: This was a group project and I will not identify the author of any sentences (laughter).
DR. COHN: I think Dr. Shortliffe has a comment.
DR. SHORTLIFFE: Well I don 't have a fix, but let me see if I can convey my concern. I thought that in the discussion yesterday there was a clear sense of tremendous confusion generally about specific examples of researchers needing access to data, and a sense that the true meaning of the rule was not well understood, that there was a lot of misinformation, that people are imagining problems and therefore being very conservative in their interpretation of the rules, in ways that in fact may be detrimental to research in individual institutions, even though that was not the intent of the privacy rule as written.
And somehow or another that sort of angst out there in the community is not reflected in this somewhat dry description of the nature of the problem. And I am a little concerned that we are not getting across in this letter that incredible level of frustration and confusion that is out there, that somehow or another that needs to be highlighted, and that is my concern about this. I know this is trying to address that discussion yesterday, but somehow or another, you know, that sense of angst is just not captured.
MR. ROTHSTEIN: Well let me say that I appreciate that comment. Several of the other specific points addressed that issue.
DR. SHORTLIFFE: When we go on?
DR. ROTHSTEIN: Yes. And this one specifically addresses the concerns about the relationship with the Common Rule. You will see at the end that issue come and de-identified information, recruiting research subjects, accounting for disclosure, education, all of these areas, and so maybe the cumulative effect of raising that issue will make that point.
DR. SHORTLIFFE: Maybe what I 'm really suggesting is another sort of introductory paragraph before you get to these points, that basically sets that scene, that sense of confusion that highlights it as a sort of overarching issue. I think it is the overarching issue out there, it is confusion and not really knowing what to do. And what concerns me is this tendency for IRBs and institutions to simply do nothing or to be stultified with fear that they are going to overstep the bounds of what the privacy rule requires. And this doesn 't quite say that, that we are almost having an overreaction or are at war because of the confusion, a tendency to extreme conservatism in the interpretation of the rule.
MR. ROTHSTEIN: I have a suggestion. If you look on page 2, how would you feel about inserting a small paragraph between the first and second paragraphs on the page that makes that point in sort of an introductory way.
DR. SHORTLIFFE: I think that would be great. I think that would really help a lot. And then you will have these specific examples spread through the six points.
DR. COHN: People satisfied with that? Vickie.
DR. MAYS: I guess I want to make sure that we are clear about what the concern is, because I think what you express as a concern is not necessarily everyone 's concern. You are talking about confusion that exists with researchers or IRBs. Sometimes the confusion that may exist may be at other levels, and I don 't want it to seem like it is the researchers confusion. I guess I think that in terms of the way in which it is laid out here, I 'm not sure of the need to emphasize this confusion as much as to emphasize a solution.
And I think that the way in which it has been discussed here, which talks about wanting guidance, I mean there 's three things, interpretation, guidance, and technical assistance. I think that after that process if we still have the confusion, then I would say let 's come back in and like emphasize this. But I don 't know, I guess I'm a little concerned the angst that is there, I think what we are doing is giving a solution as opposed to needing to push any further that there is all this confusion.
So I mean I 'm happy with the three things that are asked for, which I thought was really pretty good, because I don' t know how you can not come out of the confusion if they offer and give all three.
DR. SHORTLIFFE: Well just to counter that, I mean I understand what you are saying and I agree that it is the recommendations for what we should do that are most important. I also point out though that these letters become public documents, that the community will in fact read them. And I think it would mean a lot to the research community that follows the activities of the NCVHS for them to see some mention of our recognition that this is an issue for them.
Right now I am not sure that we are conveying to the community at large that we hear them, we understand their angst, and that in fact we are trying to make sure that gets addressed. So in part I am talking to the public as well as to HHS in making that suggestion.
DR. COHN: Well I think what I 'm hearing is a paragraph which we need to decide whether we want to do. Somehow the word anxiety maybe needs to be expressed in that paragraph, because I think, Ted, that is what you are expressing, that regardless of anything else, there appear to be a lot of anxieties from the research community. And I think that that is what you are trying to express, that tone.
DR. SHORTLIFFE: And they have a tendency to believe that we do not understand that anxiety, and I would like to suggest that maybe we've heard them and recognize it and while staying within the constraints of what we believe the intent of the law is and of the rule, we are trying to make sure that some of the causes of their angst are addressed.
DR. COHN: I thing we have heard obviously two different approaches here. Vickie is saying that we don 't need a paragraph, Ed you are saying we do need a paragraph. I think we just need to like make a decision.
DR. MAYS: I 'm accepting of one that talks about anxiety (laughter).
DR. COHN: Okay, an emotional stamp.
DR. MAYS: Yes it was the confusion one that I had problems with. The anxiety one, I can go with that.
DR. COHN: So Mark, are you happy with that resolution? Okay.
MR. ROTHSTEIN: So far the two changes that I have noted that need to be made are to add some anxiety (laughter) to the first and second paragraph, and to split the sentence or make two sentences out of the long recommendation paragraph. Okay.
DR. COHN: Everyone satisfied so far? Okay.
DR. ROTHSTEIN: Okay.
"2. Consent versus authorization.
Some witnesses recommended that the privacy rule be modified to characterize use or disclosure of personal health information for research as an element of treatment, payment, and healthcare operations, and thus permitted under the patient 's consent to these activities. This would permit use or disclosure of protected health information for research without either obtaining the patient 's authorization or seeking approval from an IRB or privacy board. NCVHS believes that research, though an essential medical activity, is not directly related to patient care.
NCVHS recommends that the privacy rule continue to require either individual authorization or a waiver from an IRB or privacy board to conduct research involving protected health information."
DR. COHN: Questions?
MR. BLAIR: I think he captured what we were suggesting.
DR. COHN: Very good.
MR. ROTHSTEIN: Okay.
"3. Use of De-identified Information
Witnesses expressed concern about the difficulty of conducting research on health data that has been de-identified according to the privacy rule requirements. It was asserted that the standards for de-identification are too restrictive (essentially stripping off all identifiers), such that the data have minimal value for research. Other alternatives, such as hiring a statistician, were perceived as unduly burdensome.
NCVHS recommends that HHS/OCR reconsider whether the provisions of the privacy rule dealing with the use of de-identified information unduly interfere with research and, if so, search for options to reduce the undue interference."
MR. BLAIR: In the sentence that says it is asserted, that was asserted by the testifiers?
MR. ROTHSTEIN: It was asserted by the witnesses.
MR. BLAIR: Witnesses or testifiers, somehow indicate who is doing the assertion.
MR. ROTHSTEIN: Thank you.
DR. COHN: Do we want to make a comment that the NCVHS may continue to provide guidance on this issue or explore and provide guidance, or do we want to -
MR. ROTHSTEIN: Well I think we have a general statement at the end that we are continuing to evaluate. What I don 't want to do is promise that we are going to do something and not be able to do it, because we still have to deal with fund raising and marketing and all these other things.
DR. COHN: Okay.
MS. TRUDEL: Simon, I 'm sorry to take you back to number 2, but I think there may be an important clarification to make. In the last sentence of the first paragraph under the consent versus authorization, the sentence now reads NCVHS believes that research, though an essential medical activity, is not directly related to patient care. I would be more comfortable if that sentence said records based research. There' s an awful lot of research that is patient care, and I think we need to make a distinction, because the earlier part of the paragraph is talking about the use of personal health information and I think that really what you are talking about here is records-based research.
PARTICIPANT: I think that is an excellent suggestion.
MR. BLAIR: Could I suggest if you are heading down that path, that you consider retrospective as opposed to concurrent, research that is after the fact of patient care as opposed to concurrent with patient care.
PARTICIPANT: I think there is records-based research that is quite prospective.
DR. COHN: Yes. Well I guess the question is records-based research.
MR. ROTHSTEIN: So the suggested modification of that sentence would be that NCVHS believes that records-based research, though an essential medical activity, is not directly related to patient care? Is that it?
DR. COHN: Well I guess the question is I'm just trying to think if we want to just limit this whole discussion to records-based research, because I think the way it was described to was the wider view of research, and I think maybe, I agree with you there is something funny about that sentence. The question is I don 't know that we are saying that research is not always synonymous with patient care.
MR. BLAIR: I thought just maybe I am missions the point, but I thought to separate this from patient care, we were talking about research that was retrospective, after the fact.
DR. COHN: It depends on the research.
MR. BLAIR: But if it is not retrospective then it is involved with patient care, so that is different.
MR. ROTHSTEIN: Well I appreciate the point, and of course what we are trying to say is that research is a different activity that one would not normally anticipate would be subsumed within treatment, payment, and healthcare operations. We didn 't say that very artfully, because as was pointed out of course clinical research is an integral part of medical care in many settings. So this was a sentence that ended a paragraph that does not happen to be the same paragraph that it currently ends (laughter), and that I think is the problem.
PARTICIPANT: Maybe we don 't need the sentence at all.
MR. ROTHSTEIN: Well I would be happy to omit that.
MR. BLAIR: But the point is that research isn't the same.
DR. ZUBELDIA: Well Mark, I think you just used a sentence that maybe we can just drop it here and that actually it just understands that research, although an essential activity, is not subsumed as part of patient care or treatment, payment and health operations.
MR. ROTHSTEIN: But do you think if we just say that it is sort of, we don' t address the issue of why we feel that way. I mean that is where we were initially questioned when we made this sort of statement, that it was just sort of a conclusory statement without indicating the reasons behind it. And then when we got into the reasons, people were saying well I have a problem with exactly how the reason is structured. If the committee is comfortable just saying this, without going into an elaboration, we can do that.
DR. ZUBELDIA: I don 't think we need to give the reasons for everything that we are recommending for, it would make the letter a book.
DR. COHN: What is the desire of the committee on this one? Should we just remove the sentence?
MR. ROTHSTEIN: So it seems like we have got three options that have been presented. One is we can add records-based to research, the second that we delete the sentence entirely and replace it with nothing, and a third is that we delete the sentence and replace it with a different sentence as sort of a conclusory sentence that says that although very important, research is not, NCVHS does not consider research to be subsumed within treatment, payment, and healthcare operations. So those are, as I see it, the three options.
DR. COHN: I sort of think if we can come up with a last sentence here it would make it a little more complete, and probably your last suggestion is, at least in my view, is I think what the intent was here. Are you comfortable with that?
MS. TRUDEL: Yes, I 'm fine.
DR. COHN: Okay.
DR. ROTHSTEIN: Gail, do you have that language? Okay, the language is something to the effect although very important, research is not generally considered to be subsumed within, or NCVHS does not consider research to be subsumed within treatment, payment, and healthcare operations. Just a second please. Okay, we were back at number 3, use of de-identified information, and we had made one minor change in the second sentence, it was changed to it was asserted by the witnesses that the standards for de-identification are too restrictive, et cetera.
DR. COHN: Further comments about 3 about de-identified information?
MR. ROTHSTEIN: Okay, on to number 4.
"4. Recruiting Research Subjects."
DR. ZUBELDIA: Before we get to that. In this recommendation we are recommending that HHS reconsiders, but we are not stating a position as to what we believe should be. Should we state a position?
MR. ROTHSTEIN: There was widespread disagreement in the subcommittee about the position that should be adopted. There were a couple of different proposals that we discussed. One was to somehow change the definition of de-identification to recognize in fact that absolute de-identification may be problematic and that we should accept a lesser level of de-identification in the interest of furthering research.
There was also a rather strikingly different proposal that would recognize that -
DR. COHN: Mark, I don 't mean to interrupt you, but I mean Kepa was part of this conversation, and I would suggest strongly that I think the conclusion of that conversation was, is that no one felt that they had enough information to make a recommendation on this. Am I correct?
MR. ROTHSTEIN: Yes, I think that there was disagreement and my personal view and Simon 's and others were that it was sort of late in the day to try to develop a new approach to this problem, and that the most appropriate thing for us to do would be to have a recommendation at this level of vagueness.
DR. COHN: Yes, I think the feeling was, at least from my view, was is that there are many good ideas that the NCVHS may choose to explore and hold hearings on, but there was nothing that anybody should make a recommendation on coming from this committee. Mark, I don 't mean to interrupt you, I just didn 't want to open up another discussion of all the possible options that we consider to solve this problem. I think we concluded as a subcommittee that they were all of merit, they deserved further evaluation, but that it was premature to try to come up with a solution to this problem right now.
MR. ROTHSTEIN: Okay. Simon, that 's fine. I just thought if I tried to describe the problem it would be self-evident that the solution was not with us.
DR. COHN: Vickie, did you have a comment?
DR. MAYS: A different point. I 'm looking at like in 3 and 4, and I want to jump ahead to 4, but it is a general issue that I want to raise, where we are asking that it is HHS and OCR. Would it benefit us also to be asking the Office of Protection of Risk to Subjects to also be these, because again I think part of proactively, maybe if they are in this discussion earlier, a guidance is also there, so that when this thing goes down to the level of entities, that whoever their IRB or whatever way they are going to go to be in compliance, that there is maybe some guidance there.
MR. ROTHSTEIN: Well we do have in recommendation 1 a recommendation that OHRP be involved with OCR, but that does not carry through, you are right.
DR. MAYS: Exactly. That 's what I am asking, because it would seem like for 3 and maybe 4 it might be useful. I mean I'm a little nervous. I don' t want them to actually make it more restrictive. But working it out early might be very helpful. I don 't know about necessarily for 4, I mean, well the accounting for disclosures. But in the user de-identified information and recruiting resource subjects, it could be helpful.
DR. COHN: John, do you have a comment?
MR. FANNING: May I suggest that it might be appropriate not to mention OCR here. This is the committee 's recommendation to the Secretary, to be carried out through whatever mechanisms and agencies are available. Now you were specific about it in a particular matter here where you mentioned the two components of the department, but that was because of a specific interaction between, you know, the world administered by this outfit and the world administered by that outfit. But I just wonder whether what you are talking about could be achieved by just saying HHS, and possibly making a more general remark somewhere that post coordination among various parts of the department that deal with the provider and research communities is necessary.
MR. ROTHSTEIN: I think that 's fine. What we tried to do in this letter is to track the October 1st letter and there was a discussion at the full committee meeting about that precise point before the October 1st letter, whether it should be just HHS, and I think that' s the way it was initially, and we were convinced that it should be HHS/OCR. So I mean that is the committee 's prerogative. I'm happy to change that back.
DR. MAYS: OCR is separate from HHS, isn 't that true? It is a part of it? Oh, okay.
MR. SCANLON: (Comments off mic) You said HHS and it would include every agency, - the other research agencies -.
DR. COHN: Actually I am sort of convinced by John' s comment that probably we ought to remove OCR from here and leave it HHS and it sort of solves Vickie 's problem and gives them latitude on and flexibility and OCR screwed it already anyway.
MR. ROTHSTEIN: I 'm happy to do that.
DR. MAYS: But will be add a sentence either like near the end or something like that calling to attention at least those two agencies in particular, so that they have some sense of, because usually they are not going to think about the Office of Protection of Risk of Subjects sometimes, but I think we do want that type of coordination there. So if there is a sentence later near the end of something that calls this to attention I would be happy.
MR. ROTHSTEIN: We will strike the OCR wherever it appears, and also look for appropriate places to make a comment about coordination among the various HHS agencies.
MR. FANNING: Yes, that seems appropriate, and I think it is not limited to the Office for Human Research Protection, because the research granting and conducting agencies are also part of this in terms of informing their grantees and the like.
DR. ZUBELDIA: But we are not changing recommendation 1 are we? Recommendation 1 also mentions OCR and I think it needs to stay as is.
MR. FANNING: Yes, because that is about a specific issue in which we have identified the two units.
MR. ROTHSTEIN: Are there any other comments on number 3. Okay, number 4.
"4. Recruiting Research Subjects
Witnesses raised concerns about the recruiting of research subjects. As the rule currently reads, it is permissible for researchers to use protected health information (e.g., search the records of former patients based on diagnosis) to formulate a research design. However, without either individual authorization or IRB or privacy board waiver, information derived from the medical records may not be removed from the premises of the covered entity. Witnesses expressed concern that unless the results of the analysis of the medical records can be retained, then researchers would be required to search the records a second time after IRB approval of the study protocol.
NCVHS recommends that HHS provide guidance on alternative ways to develop research protocols under the privacy rule to minimize the researcher' s burden in recruiting subjects."
DR. COHN: That 's very good. Comment?
MR. ROTHSTEIN: Okay, thank you. And this is a typo, this should be number 5.
"5. Accounting for Disclosures
Several members of the research community expressed concern about the provisions requiring an accounting of disclosures of protected health information for research. Specifically, researchers were concerned that covered entities would refuse to share protected health information for research because of the requirement of accounting for all disclosures.
NCVHS supports the accounting for disclosure requirements as serving a basic right of individuals to know who has obtained information about them. However, in view of possible confusion or misunderstanding in the research community, NCVHS recommends that HHS provide interpretations, guidance, and technical assistance to aid the provider and research communities in maintaining the accounting in ways that are convenient and practical."
MR. FANNING: I have a drafting suggestion. The committee might want to consider striking the term in the research community. The misunderstanding may in fact be in the provider community that wonders what it has to do to record the disclosure. So if you just struck those words.
MR. ROTHBERG: In view of possible confusion or misunderstanding, NCVHS recommends, okay.
DR. COHN: Other comments? Great.
MR. ROTHSTEIN: Okay, number 6.
"6. Education
NCVHS received testimony raising a variety of concerns regarding research. On closer examination, some of the testimony contained assertions at variance with what the rule actually says. NCVHS believes that this indicates considerable misunderstanding of the effect of the privacy rule on research.
NCVHS recommends that HHS make the research provisions of the privacy rule a priority for its education efforts."
MR. BLAIR: I guess I was looking for the word clarification of the research rules a priority for education. I didn' t hear the word clarification.
MR. ROTHSTEIN: The, I mean we are certainly willing to consider that. Clarification to me at least implies that the rules are somehow unclear, whereas the problem that we observed is that people either hadn' t read or totally misunderstood the way the rule reads, and therefore even though we have called for clarification in several of the prior recommendations, in this area we just think that the word needs to get out to providers, professional organizations, et cetera, about the requirements of the rule, as opposed to clarifying the rule.
DR. COHN: Jeff? Looks like you want to say something.
MR. BLAIR: After your response, I guess I still feel as if the purpose of the education is to provide more clarity. Maybe I'm, I know you are trying to keep it as broad as possible.
DR. COHN: Paul.
DR. NEWACHECK: I agree with Jeff. I think that we are missing something here. Maybe we could add at the end to the sentence to say to insure maximum clarity within the research community, something like that.
MS. TRUDEL: I think John 's point is relevant. It is the research and provider community.
DR. COHN: Yes. You know this is something actually where I support Mark on, only because we use clarify in a particular fashion here and suddenly we are now referring to clarity in another way as we move further here now. I think we are all sort of saying the same thing in the sense that we want to make it understandable to the research community. So I think what we are talking about -
MR. ROTHSTEIN: Yes, I interpret the word clarity as clarification, guidance, et cetera, when what we are really talking about is outreach and education efforts. But I mean I am happy to change as the committee sees fit.
DR. COHN: Maybe this is something we need to poll the committee on for their views. I actually think that, my own view is that this looks pretty good the way it is, and I think education includes making things understandable, which I think is Paul what you were describing and I think Jeff a lot of what you were describing, whereas I tend to think clarification are more formal documents coming from OCR in a host of different ways.
MR. ROTHSTEIN: Yes, I think they are very accurately describing the goal of education.
DR. COHN: But I would look to the, I mean we can do either. Other comments, Vickie, Ted.
DR. MAYS: I guess it is fine the way it is, but I think that we put it maybe on the end and just broaden it it is also okay.
MR. ROTHSTEIN: Or we could put it in the, such as NCVHS recommends that in order to insure the clarity among, you know, affected individuals and entities, that HHS make, or at the end, or at the beginning (laughter).
DR. COHN: This one is getting confusing enough. Is there a particular motion to amend this?
DR. SHORTLIFFE: I think we need to ask what it is we envision the problem to be, what we are trying to solve with this. Even sitting around the table here yesterday, several people acknowledged that somehow or another they hadn 't managed to read every page of the privacy rule, and most researchers aren 't going to. Most researchers have a question. They have some idea, they have some study they want to do. It may be retrospective or it may be prospective. And they are trying to figure out how they can define what the parameters are that the privacy rule has established, within which they must live in order to do the research that they want to do. And they are having a lot of trouble figuring out how to do it, especially because even their IRB members have not read, digested, and totally understood the privacy rule and all its details.
So the challenge here is I think to have a whole bunch of scenarios, types of questions, you know, FAQs of all sorts, well indexed, where you basically get some kind of an answer to a very specific kind of question that you as a researcher need an answer to in order to decide how to comply, and that you hope your IRB will then take seriously rather than because of their confusion fail to interpret as was intended when the rule was written, and instead be even more restrictive than is required.
And that is why there is anxiety, I won 't call it confusion, anxiety, you know, they don 't know, and when they start reading the privacy rule, you know, they nod off, and it is just not fun reading at bedtime and we recognize that. So somehow or another there is a responsibility here to help people figure out how to apply the privacy rule to their kinds of situations as they arise.
It seems to me that is the very practical goal here. Whether that is education is not clear to me, and that is why I've been having trouble deciding how to phrase this. Ultimately it is trying to allow people who have very specific questions about what is or is not allowed under the privacy rule to get answers to those questions so that they can proceed with their research activities. I 'm not sure how to take that observation and convert or address it in this paragraph however.
MR. ROTHSTEIN: Well I would only respond by saying that when we heard from Kathleen Fyffe yesterday, I think the way she described her role is precisely to do the things that you suggest, and so I think that in a general sense HHS and OCR specifically have identified the need to do that and have made a commitment to that. The purpose of this provision here is to say that within the broad universe of privacy rule topics to cover, we think that research should be right at the top, because there is perhaps a higher degree of anxiety involving research than perhaps any other area.
DR. COHN: While not completely address what Ted was commenting on, I think what you are saying, we all agree with what you are saying. I wonder if it is education and outreach efforts, and technical assistance.
MR. FANNING: I mean elsewhere you use the term interpretations, guidance, and technical assistance, but I think this is more education and outreach. It seems to me that what the committee was talking about here was, well what Mark just outlined kind of thing.
MR. ROTHSTEIN: So would the word outreach help or some other terms there?
MR. BLAIR: Could I? The education I thought was useful. You were distinguishing it from guidance and technical assistance and all of the other pieces. As you were reading it, the only thing that was missing to me was there wasn 't in that phrase, in that sentence, what the purpose of the education was, what was the education trying to fix. Now above that, when you described the problem, you described a variety of ways that they either misunderstood or they actually didn' t find things that were actually in the rule, because the rule if 1,500 pages, and even if somebody, you know, it is daunting for somebody to go through.
So all I was really suggesting, so that you distinguish this particular remedy from the other remedies that we are recommending, is that you just simply say in that sentence what is the purpose of the education. And I think it is as simple as we are providing education to help reduce the confusion or help reduce or help clarify.
MR. ROTHSTEIN: How about if we, let me read the last sentence, well I' ll read the whole thing, it is so brief. Received testimony concerning research. On closer examination, they were not in accord with the rule. NCVHS believes that this indicates considerable misunderstanding of the effect of the privacy rule on research. How about before we get to the actual recommendation we just say to promote better understanding and to facilitate compliance, NCVHS recommends that HHS make the research provisions of the privacy rule a priority for its education efforts, education and outreach efforts.
DR. COHN: Hey that sounds great. Vickie, are you okay with that?
DR. MAYS: No, I want - from the very beginning.
MR. ROTHSTEIN: Okay, I 'm sorry, this would be at the start of the recommendation, to promote better understanding - would you rather have it just to promote better understanding?
DR. MAYS: Yes, I guess the reason I get a little nervous, on the other side as a researcher, about facilitate compliance is that it means that once we are educated, if we are not in compliance we are responsible. And I don' t know the quality of the application yet, so (laughter), I guess it just made me a little nervous here, the word compliance.
DR. COHN: Well Vickie, the only problem is that once this becomes law, you have to comply regardless of what we say in the letter.
DR. MAYS: No, that 's true, that' s true (laughter).
DR. COHN: And until that time, regardless of whether you are educated or not, you don 't have to comply. So I don' t read this letter and compliance as -
DR. MAYS: Alright, I guess just compliance things always make me nervous.
MR. ROTHSTEIN: It sounds like you are going to be doing psych visits thought, right. Well if that is okay, let me just go to the conclusion here.
"NCVHS is continuing to explore a range of other issues related to the privacy rule, including marketing, fund raising, and disclosures to the Food and Drug Administration. We will provide you with recommendations on these issues as soon as possible."
MR. FANNING: Mr. Chairman, from the discussion last night, I think the issue was not only disclosures to the Food and Drug Administration, but disclosures, the relationship to regulatory activities of the Food and Drug Administration. The disclosures are often not to the Food and Drug Administration, but to for example a manufacturer.
MR. ROTHSTEIN: How about disclosures associated with the requirements of, would that work John?
MR. FANNING: Yes. Is it right before that paragraph that we are going to have this observation about coordination among the various parts of the department, is that the idea?
MR. ROTHSTEIN: Yes. And Simon, how should we proceed now, given the fact that there are a number of changes that have been suggested.
DR. COHN: Well, I guess what I would explore with the committee at this point is similar to our report yesterday, that potentially we should consider acceptance, recognizing that there is wordsmithing. The wordsmithing will go to the Executive Committee for final approval prior to publication of the letter. Is that -
MR. BLAIR: Is that as a motion?
DR. COHN: I was looking to see if that was the process that the committee would like to employ for this. Jeff, are you comfortable with that one, do you want to make that as a motion?
MR. BLAIR: I 'll make that as a motion.
DR. COHN: Okay, is there a second?
MR. ROTHSTEIN: Second.
DR. COHN: Okay, any discussion?
DR. ZUBELDIA: Will we have an opportunity to see the two additional paragraphs that you are going to be adding, or will it go just to the Executive Committee?
MR. ROTHSTEIN: Yes. I would anticipate distributing to the entire committee.
DR. COHN: Okay, so this will be basically the same process as yesterday, where everybody gets a chance to see the additional paragraphs. I want to make very clear that the basic information here is not open for further modification. I mean we 've done some wordsmithing changes, comments on whatever is modified, you know, if there is wordsmithing issues, but we are not going to re-discuss the recommendations. Is everyone okay with that? Similar once again to our passing yesterday, that we are not reopening the recommendations.
PARTICIPANT: Shall we vote?
PARTICIPANT: So moved.
PARTICIPANT: So moved.
DR. COHN: I guess we have a second already. Any further discussion? Okay. All in favor raise your hand? Opposed? Abstentions? Well this passes.
PARTICIPANT: Congratulations Mike and Gail.
MR. ROTHSTEIN: I have two brief announcements Simon, and then I' ll turn it back to you. First is the members of the subcommittee will be receiving an email at the beginning of the week, asking them for available dates during the weeks of either January 17th or 24th, for a two-day hearing on the issues of fund raising and marketing, and so you will get a chance to respond to that.
And second, I want to thank the staff to the committee and particularly John Fanning and Gail Horlick for their work with us, as well as Mike Fitzmaurice for his very detailed comments on the first draft, which made this work so well. Thank you.
DR. COHN: Actually Mike, I want to thank you for the committee. I think you have done amazing efforts to turn this letter into something that we could actually vote on and pass on to the Secretary today, and really you have my heartfelt congratulations and appreciation for that effort.
With that what we will do now is to move into the report from Dr. Sondik on NCHS statistical activities. After that we will go through a brief review of subcommittee activities and hopefully adjourn.
DR. SONDIK: Well it is a pleasure to be here this morning and be able to give you an overview of NCHS. The slides may be a little bit different than the handout, but they are pretty close. I 've tried to do a little bit of editing. I' m not going to cover all of NCHS in the three and a half hour of slides that I have here. There are a number of things that aren' t there, but what I hope I do is give you a flavor of activities at NCHS and I hope some of the issues that face us and some of the challenges and some of the ways we are dealing with existing challenges.
There 's one in particular that I' ll talk about right at the close that I think certainly falls under the area of the letter that you were just discussing, that having to do with privacy and confidentiality, which is becoming a very, very interesting issue, and I say interesting because there are certainly ways that we can deal with this as it faces us, which I 'll get into, but in dealing with it we sort of close some avenues which we really don't want to close, in order to be able to keep other avenues open, or even open them more widely.
So with that let me go into this and give you this update, and I' m going to go through these slides very quickly, learning from the Brian Burns school yesterday that it is possible to do 180 slides in three and a half minutes. Just kidding, just kidding.
Well I think almost all of you, if not all of you, know who we are, but for compulsive purposes I put in this slide that says that we are the principal health statistical agency that is located in CDC, that is parentheses located in CDC. We 're one of the agencies, oh doesn' t that look good, you 've missed all the good slides up to now (laughter), let me go back.
I was amazed that I got it to work frankly. Yesterday I was in my office late in the afternoon, and this machine was sitting on the table and the slides were right on it, and about a half hour later I looked over and there was nothing on it and the machine was just off completely, wouldn' t start, nothing would happen. And all I can figure is that the power went out in the outlets in my office. I never thought to try an outlet way outside my office. In any case happily it worked, or we hope it worked.
So anyway, here we are for an update, and you know something about CDC. But we, as NCHS, we are one of the Federal statistical agencies like the Census Bureau, like the Bureau of Labor Statistics and so forth, which gives us a significant measure of independence. We are not tied, I'm preaching to the converted here, but we are not tied to any implementation program, and as such, there really are no issues in that sense in terms of pressures one way or the other on the types of information that we publish.
On the other hand we work very closely with the components of the department and increasingly with, and have for many years, with other elements of the Federal statistical system, and with the academic, and to a degree with the private sector as well, in trying to produce a set of information that is most important for policy and for tracking the health of the country, monitoring the health of the country.
I thought I would begin briefly with budget. The budget actually over taking more than a decade look, has gone from, in total, from something less than 80 million dollars a year to now more than 120 million dollars a year. We have the peculiarity in our budget of a line that is called the one percent funds, which is a, the one percent is money that is tapped from a variety of agencies within the department but not all, and used for evaluation purposes. A significant percentage and growing percentage, as you can see, of our funds up to 2001, came from that fund, and less and less money from a direct appropriation.
Now we don 't know what the situation is going to be for 2001. What you are seeing here is what the President proposed. Now what Congress will dispose is not clear. It is clear in terms of magnitude I think. We 'll have a 5 million dollar increase this year. But what is not clear is exactly how it is going to be split across these different funds, and the House has said one thing, the Senate has said something else again. But we think it is pretty clear in terms of the total.
In addition to this, we have additional funds that come from our relationships and agreements with other agencies, particularly NIH and other parts of CDC, which add to this total, probably on the order of about 20 million dollars a year.
So this picture which shows the one percent funds and how it is increased over time actually may be different in 2002, but as I said, this is the President 's proposal. My bias, which I state unequivocally, is that we receive more money, we should be receiving a direct appropriation. I think it is better for the agency, I think it is better for the agency as a Federal statistical agency for that to happen. But there certainly is a rationale on the basis of the law, that underscores the one percent funds, reviewing what it is we do as evaluation not only of HHS programs, but evaluation of programs across the United States, and continuing to evaluate the health, the health status of Americans.
So I thought what I would do is go quickly through the major data programs, and one of the themes underway, it has been underway for awhile now, but I think is really into high gear, has to do with re-engineering. It is very important that the programs of the center take advantage of the technology that is available today, and the advances in data bases and the management of information, and so we are in the process of doing that.
And one of the most exciting is right at the beginning of this, which has to do with vital statistics, and I 'll mention all of these as I go through the slides. But the major ones I 'm going to cover are vital statistics, the health interview survey, the health care survey, NHANES, and I' ll probably mention NSFG, the national survey on family growth, briefly.
Now we coordinate the vital statistics program for the United States. The programs are actually, as you all know, really state programs represented, in fact led, by some of the people in this room. But our role is one of a coordinating element to that. We have had a number of changes in vital statistics recently. One is moving from the ninth to the 10th classification of the ICD. A second has been adopting a new standard for age adjustment, going from 1940 to 2000. Interesting, we really haven' t heard very much about this. I am surprised. I think it hasn' t reached some communities yet.
Clearly it doesn 't change the trends, but it does change the magnitude. An example that is sort of near and dear to my heart is in Cancer. What this will have the effect of doing is in effect raising the cancer rates, because we are now weighting the older of the population more than in the past. So it is going to have the effect of "raising the cancer rates." Obviously it does change the age specific rates at all, but overall it has that effect.
And one of the most important trends in cancer has been to pursue the disparities in cancer, particularly between the black, the white, and the native American communities, and what happens with this is that the gap was quite clear in 1940 and is less clear but quite distinct in the 1970 standard that the National Cancer Institute has used for years, is even less when we adopt the 2000 standard.
And we have published papers on this, but I expect that we are going to be hearing more from communities as they look at the data and feel that perhaps something is happening with the statistics that is trying to make a point. The only point here is that the 1940 population was so out of date, did really not relate in its distribution to the way we are today or the way we will be over the next 20 or 30 years, that I personally and panels, more than one panel of experts that we brought together, strongly lobbied for this change. So we have adopted the years 2000 population as the standard.
And we have developed expanded content, when I say we I mean the community has developed, again through a coordination effort from NCHS, expanded content of the birth and death certificates. For example, on the birth certificate we have added new certificate information on smoking, on infectious diseases, on participation in the WHIP program, on fertility therapy results, and height and weight. And on the death certificate there is new information related to motor vehicle deaths, as to whether the individual was a driver or a passenger, whether tobacco use was a contributing factor, and pregnancy status at the time of death.
Related to these certificates has been an extensive program to improve data quality. I think the last time, and I wasn 't tracking this I admit 10 years ago when there was another certificate change, but there was less emphasis on how to make these changes. This time there has been quite a bit of emphasis, including detailed instructions and definitions and field testing of the instruments and the like.
Now one of the critical needs in this is to re-engineer this system, which is particularly on the death side. The birth side has been re-engineered over the last several years, but not as fully as I would like to see it and I think it could stand. So re-engineering the vital statistic system is very important.
I think the characteristics of a re-engineered system in this case in a way are pretty clear and pretty simple. One is that we need to identify communications channels and of course the ever critical standards that go along with those channels. We need automation at the source, the very source, which one could argue is in the funeral home, but in fact may be elsewhere as well. We need flexibility in this system to meet the fact that we have more than 50 systems out there and they all don 't operate in the same way.
It is important that we have a basic set of content, and in fact the standard certificates give us those. And in order to have the system work, as we all know from the involvement and deep thought that has gone into HIPAA and computer based systems, protocols and standards are critical. It is also clear, and these slides actually on the re-engineered system come from a joint effort between the center and NASIS, and the ideas here are really the product of both of us working on this initiative together, and one of the emphases that was very important was that the system cannot only serve in one direction. It has got to serve those who are inputting the data.
So it is critical that those who provide the data get something out of this, get something out of the change and see this as value added. It has got to be a system in which the architecture of it is open, in which we can use it to, we again the very broad we, to hang other applications on it. And of course it has got to be quite secure.
The need I think is quite clear, and why should we be doing this now. Certainly that we need to look at the quality of the data. There' s always issues over the quality of mortality data, despite the fact that it is the principal measure of health in the United States, and for that matter across the world. We 've got a variety of new and emerging data needs that the system cannot make now because it is simply not flexible. Timeliness is important. The system of the states working with the Federal government has made tremendous improvement in timeliness. It used to take years for the data to come out. Actually the data is now coming out essentially within months, not a few months, but nine months, six to nine months, the preliminary data. That is very, very important.
There is a variety of health needs in the, I think just about for example the events of 9/11, underscore that, but there is also an expectation I believe on the part of a variety of publics, from the research public if you will, to the public in general, that this system should be able to provide information very, very rapidly, and information that is really of very high quality. And I think it is important, that is why I put it on the slide, I think it is important to have it here. I think that expectation is there and I think we have to underscore it and work to meet it.
The foundation is in place. I mentioned the standard certificates. Yesterday Brian Burns mentioned a project under the Quick Silver, which is this E-government project, that it turns out Social Security had submitted, and we are, the department is collaborating with Social Security on this project. They are very interested in re-engineering the vital statistic system, because every hour saved is money in their pocket in terms of learning of a death, quite literally. So in terms of the cost benefit from this, the cost side of the benefit, the benefit in terms of cost, is very, very clear to them.
They need, believe it or not, for their management, a rationale for pursuing this in terms of what it will do to improve health. So we are working together on this. We have learned, it is not as if we are entering this de novo, we have learned from the electronic birth certificate, and the fact is that many states are already moving forward with this. So if we can help to coordinate and advance this at the same time, we are in the best position.
In addition we have the CDC development of NEDSS, which has been a significant step forward in the epidemiology in public health communities, and that seems to be coming along quite well from what I can see, and I think what we will be doing with this absolutely has to link with that, and as I see it, NEDSS provides at least a basic model, and of course there have been tremendous advances in technology. So this slide asks the question why now, and I think one of the major reasons is that the technology is here. And this is showing a slide of the NEDSS systems architecture, which would take another hour to go through, but I won 't bother to do that. But I see this system as very much following that model.
In terms of next steps, we are with NASIS forming a coordinating committee for identifying resources, and the E-government project is an important potential component of this. We need to develop a transition plan as we move forward, because clearly not, I use the term dual here, because it is clear that not every state is going to be in the same position. So we need ways of collecting information from perhaps from different certificates, and merging it all together. We want to implement this obviously on a state to state basis instead of in one fell swoop, which I would think would be a "swell foop" if somehow we tried to do this across the country at one point in time.
Of course we need the architecture, but we also need to reach out to the many, many partners that are involved in this, which are funeral directors, people in laboratories, the public health community in general, and so forth.
So that is a brief update of vital statistics. On the NSFG, the national survey on family growth front, one point I wanted to mention in particular, that is why I put the slide in here, is we are beginning a new cycle, cycle 6, not to be confused with dog food (laughter). NSFG is going to include men. This is a major step forward and I hope I 'm not speaking from the standpoint of gender bias here, but it is very important in looking at the issues that NSFG deals with, which are families, sexuality, and the like, that we be talking to both genders, and we are going to be doing that in this new cycle. And it is just about to get underway, it has been pretested. And planning is now underway for another cycle in 2005.
When we talk about the major components at the center we often don 't mention NSFG, we don' t mention the longitudinal survey on aging, which I am not going to mention today. But these are really very critical. We have a number of these programs that, along with the four major surveys, including vital statistics, that give us this picture I think of number one the vital statistics, which are really I think the foundation that we built on, number two health status, which we get in a number of ways, one of which from a health and nutrition examination survey, which I am about to mention.
And the third area is on the health system itself. It is information that we get from our family of health surveys. The country builds on this, but the country gets information from a variety of other sources, including the expenditure data from ARC, a variety of information in depth from CMS, formerly HCFA, a well of epidemiology studies. And all of this obviously gets integrated together.
Let me mention about the health and nutrition examination survey and where that is. It began in earnest in its new round in 1999. In the past the survey has run in two pieces. Each round of it has actually been six years divided into two three year segments, each being a representative sample of the United States. We have changed that so that now every year is a representative sample of the United States.
And it is going to be a challenge, but our intent is to keep it in the field all the time, and to produce data from it on a biannual basis. We actually will be able to produce data on an annual basis, but we need to be careful here about confidentiality. And I 'm going to mention a number of areas in which we are producing data on an annual basis, but the micro data sets, the detailed data, we see coming out on a biannual basis. But that is subject to discussion and we want to get it out as rapidly as we can. We do not sit on this data, we do not wait for the staff to produce a variety of reports and papers based on the data. As soon as it is ready to go it goes, and it goes to all the collaborators essentially simultaneously.
This program especially uses, we work with a variety of collaborators across CDC, across NIH, and other agencies, and for that matter people outside of the Federal government. But they work within, through the Federal agencies. So we have a new statistical design, a new communication system, which enables us to get this data out much more rapidly, and a variety of new research protocols.
The picture on the screen shows a mobile exam center, which I think you can see. It is actually four trailer trucks that are actually interconnected, and I have a couple pictures in here besides this. Many of you have seen this before so I 'm not going to belabor it, and many of you have actually visited the trailers. There are three sets of these in operation at any time. Actually two in operation at any time and a third one that is going to someplace else in the country. So it is a large logistical effort.
The design is to see 5,000 people, respondents, every year in these mobile exam centers. Part of that is an hour to an hour and a half home interview prior to that, then the time in the exam center is a good solid three and a half hours. And I mentioned communication, but the communication now is online, electronically, from these mobile exam centers, both to the contractor, who is Westid in Rockville, and to NCHS in the command center in Hyattsville.
Our goal is to release this data within one year of close. On your slide I think it says six months. I think six months is possible in certain cases, but to release a micro data set we are talking more within one year, and we think, because as I mentioned, confidentiality, we probably want to do micro data every two years.
How have we been doing with HANES. Well one way is in terms of the response rate. When we began this anew in 1999, we actually went to 12 stands as they are called, locations, and took a sample within each location. You can see it is a little more than 300 people per location. We had a 72 percent exam rate. That means 72 percent of the people we contacted went through both a home interview and an exam. In 2000 and 2001 we went up to our targeted 15 stands and we had an 85 percent exam rate overall.
But the most recent stands, believe it or not, are over 90 percent in terms of exam rate. And this may be a function, it is hard to generalize from this, it may be a function of where we have been and the nature of those communities, because this is very much a community type of thing. Or it actually may say something about the perception of the public and the government and the willingness to work with the government, because this has always been an issue on the part of some respondents of course.
We have done well in the past with HANES, but actually these most recent response rates are really quite extraordinary. Well some of the innovations in HANES are helping to produce, from the clinical data collected from HANES, and I didn 't mention this, I think most people know, but the information we collect in the mobile exam center is clinical information on the individual. It is not self-reported information, it is all a variety of measurements. In the home we get self-reported information, although some of it is actually what I would consider to be objective, having to do with diet and implements and cooking facilities and that sort of thing.
So for the first time, and I cannot underscore the important of this, we have a representative sample of the U.S. for which we have a variety of environmental exposures, including chemicals, metals, pesticides, and I' m sure there will be well more than 27, 27 was the first shot on this. Up to now most of this data comes from samples of opportunity, and there' s a lot of generalization from those. This gives us a representative sample of the U.S. We worked very closely with NCEH, the National Center of Environment Health, and our plan is to produce this report on environmental exposure annually.
This shows mercury and gives the distribution, both here in children and then in males and females, and what I am showing here is the web site. Again the hallmark of all of this, if HANES is involved, in fact if the national center is involved, the hallmark is that we get the data out rapidly, and we make it available as widely as possible. So this a slide, from the web, that shows the report on the CDC web site.
Some of the things that are happening in 2002 is that we are linking with a survey that the USDA used to conduct called the CSFII or the Continuing Survey of Food Intake for Individuals, took me two years to know that and get it right, and we continue to be actually in collaboration with them. Our plan is, and I underscore plan even though we are very close to this, I would even say commitment, is that we will do a 100 percent second day recall on all individuals on their diet. As it is we get a recall on the first day, recall meaning they tell us what they ate on a typical day or a particular day for that matter, and we are going to get a second day, in the past we got it on 10 percent, but we are going to do it on 100 percent.
We are going to have HPV testing on women from vaginal swabs. There will be serologic testing for HPV 16, antibodies, going to get vitamin C. And while this is on the slide, this is actually, maybe a little iffy I learned as of yesterday. We were going to do dermatology, very important I think, for digital images for hand dermatitis and psoriasis in persons aged 20 to 59. But I heard yesterday that the camera that we use for this may not be quite ready. We are missing some of the software information from the manufacturer, and we just may not be able to get it in. We go through very expensive testing on all of these individual components, because obviously if there is a problem it makes the data useless. So if it is not in starting in 2002, we expect that we will put it in in 2003.
We will also experiment in 2002 with a different form of collecting data on food intake, the food frequency approach. The National Cancer Institute is a collaborator in that and they are very interested in that. And we are going to be looking at an activity monitor worn at the waist for an estimate of physical activity during the day. Since 1999 we've been actually getting a measure of physical fitness for the first time, again representative measures of physical fitness in terms of leg strength and ability to walk at various speeds on a treadmill. So this is going to add considerably to that.
This is just a slide that shows that in fact we have produced data from 1999, this for obesity, and this shows in one side of this for 1999, the other for HANES 3, which was from 1988 to 1994. Of course since 1999 we only had, in this case, 1,600 people. But what we can see from this is that the country continues to move up the scale (laughter) in terms of obesity. Now this is something that one can determine in a variety of different ways, but what is important about this data is that this is clinical data. It is not what I tell an interviewer, it is not what I wish to be, it is what is, and it is critical in terms of a hard and fast baseline.
This shows that folate concentrations have increased in women age 15 to 44, and in fact the data was published and made the newspapers and could conceivable be quite important in reducing birth defects. And this is a slide that shows the continuing drop in blood lead levels in children ages one to five. And in fact this is one of the slides that we always use, the department uses, when we talk about the power of data to influence public policy. This drop from 76 to 80 down to a level of 15 down to 3.6 in 1988 to 1991 was due to the HANES findings published in concert with CDC and EPA and led to getting the lead out, which led to these changes.
This is a picture inside one of the exam centers which shows a person being measured. This shows a person about to go into a sound proof room for the audiology test, a complete audiology test is done. Actually, we don' t have a picture of this, but most data on any exam that we get comes from what do you think, what would you guess, most data intensive if you will exam. It turns out to be the dental exam, very, very broad. Now that doesn' t include, we actually do a dexascan, which in that sense is probably, since we have the scans is more. But the dental exam there' s an incredible amount of data, and this serves as the principal, in fact almost the only source, of epidemiology data for the Dental Institute at NIH and that means for the community in general. So it is kind of interesting.
This picture shows a person about to undergo the interview, the diet interview, and they are looking at a glass and I guess getting a measurement as to what it means, whether the glass is half full or half empty I suppose. It is a lovely staged picture. People don 't get to wear these lovely blue outfits that we give them, these paper outfits that they walk around in. Despite all this, we get these response rates, you know.
I don 't remember frankly whether I discussed the growth charts. I 'm not sure that I did, because this is not over the last year. But a couple of years ago, after almost a decade' s worth of work with the research community, we in concert with that community revised the kids' growth charts and I like this slide which shows the kid superimposed over the charts. We had a major release of this data. The growth charts which almost all of you have seen if you have had kids, these are the ones that get reprinted in a variety of forms and pediatricians use. In any case, this was actually a significant analytic and research piece of work, it is simply not taking it out of a survey. These charts combine a variety of different surveys, a variety of different sources, mainly HANES, but not only HANES, and of course that is all available on the web.
This is a little bit more about the environmental chart, I guess I didn' t take it out, showing some of the things that are measured. This looks like one of the HANES vans, but in fact you can see this sort of rectangular protuberance from one side. There is one on the other side as well. This is a program that I think I have mentioned here before called Community HANES. This is not one of the HANES vans, but this is a van designed to be able to go where the set of four trailer trucks cannot go. This is totally self-contained, doesn' t need to be hooked up to anything. It has got generators on the back, handles sewage itself and so forth. And we look forward to using this in a variety of places from inner city to Indian reservations.
All we need is the resources to do, but there is a great deal of interest in it, particularly in using it, by the way, along the border, the southern border. There is an initiative on border health between the department, between several different departments, and we are actively talking about using it there. And we have the resources, at least physical resources, to be able to do this on two or three defined populations annually, have 2,000 in each sample, and it would run parallel to NHANES.
Now the health interview survey, as I think Jim mentioned yesterday, is really perhaps at the core of the data collection efforts within the department. We try to link to it. The link I think is less actually a physical or data link, but more of a general link to the type of information that is collected. And it sees 40,000 households a year, 100,000 persons a year, the chief source of information of disability, on the use of health services and risk factors, and on self-reported health status.
We are in the process here of re-engineering this and also marketing, if I can use that term, its survey capabilities even more heavily that we have in the past, and I 'm going to show you some of the supplements to this that we are expecting coming up, and I think you can see that we are doing that. We have gone through a process of again re-engineering of this from a 1997 redesign of the questionnaire to a redesign of the more technical side of this, and I 'll be happy to answer questions about this later, everything from a new language for the survey instruments themselves to building a meta data information system for the survey.
Upcoming supplements include a healthy people supplement in 2001 to serve as a baseline for health people, one on children' s mental health in 2002, very exciting I think, complementary, an alternative medicine supplement, more on healthy people, and one on children with special needs. Another on mental health, again related to children in 2003, one on cancer screening, and perhaps others.
Obviously because of a variety of limitations, including the burden on the respondents, there 's only so much we can do in terms of this. But the design of it is extremely flexible, because every week is a representative sample of the U.S. in HIS. So it means we can actually go in and out of the field very easily, or we could, if we could handle the logistics, and we are working on being able to handle those logistics, it means that interviewers have to be able to handle adjusted or changed questionnaires, which in one sense is not that difficult for the experienced interviewers that we have, but training is critical and we have to find ways of doing effective training.
Another activity is the SLAITS, the State and Local Area Integrated Telephone Survey, which I have discussed here before. This allows us to develop results for 78 areas that cover the United States, and again it is a phone survey. And this didn 't exist oh I would say six years ago, and it was a germ of an idea with several people within the center, and it has now moved to the point where there are a number of activities underway with this, including early child health, children with special needs, there' s great interest now in asthma prevalence, and including the evaluation of the SCHIP - healthcare surveys which look at hospitals, ambulatory care, emergency care use, and surgery.
The physician and hospital surveys continue, but we have postponed for awhile the long term care survey, and are directing resources instead to an assessment of the healthcare system and the data needs. And it is very important with the way the healthcare system is changing that we be sure that this program is relevant and that it can produce data in a very timely fashion.
We are working on reconfiguring these and changing the way we do these. In the past these have just been mail surveys that go to the institutions. There are a variety of other ways that these can be done, and people from our Office of Research and Methodology are working with people from the healthcare surveys, considering a variety of new ways that we can produce this data.
Let me talk a little bit about data releases. The center has been criticized in the past for taking way too long to produce its data, particularly from the health interview survey and from HANES. And I showed you that the HANES is getting out much more rapidly, and now HIS is also becoming a mechanism in which we can produce data very rapidly. We have an early release program, sounds like the data were in prison doesn 't it (laughter), but they are not, and we are using the web for this and we are looking at a number of different indicators and producing these estimates before we produce the set of micro data.
One of these for example is cigarette smoking in adults, which we produced here using just the first quarter of information from 2001. This actually came out now about a year ago, in fact the data has been out. Health insurance measures, this is again another health people measure having to do with participation in physical activity.
We 've had a number of major releases this year, of course having to do with life expectancy and looking at the overall information on deaths. Again this information has now been out for months, much more rapidly than we have seen it before, including smoking during pregnancy and doctor visits and this sort of thing. Teen births, medication, the prescription of medications and so forth, all of these have came out.
We also have produced again, once again, the Health United States, and in this year we focused on, in a chart book, urban and rural health, a comparison of that, and these are some of the measures from that, dental visits in the past year, tooth loss, and you can see in this chart how the likelihood of total tooth loss in this case goes up as we move from the metropolitan areas to the non-metropolitan areas of the country. And in general, for most of the measures we have seen in here, health gets worse as we move out of the metropolitan areas.
We also continue to work with our compatriots in the other statistical agencies and produce integrated reports on kids' health. The one on the screen is America 's Children, Key National Indicators for Wellbeing. It covers economic security and health, behavior and education, because it really is a problem I think when we try to look at, we are looking at the health of any given population and we only look at health measures. We' ve got to look at measures that go beyond health as well to put the health measures in context. We are also doing that with another forum of Federal agencies on key indicators of well being for older Americans.
We had a number of international activities that have been discussed in here already, a least some of them, the launching of ICF, you saw the report yesterday on that, and in particular I am struck by the amount of interest, and I mentioned it here yesterday and I mentioned it at Data Council, on the interest across, particularly the developed countries of the world, on how to evaluate their health care systems performance. It is a critical thing and we really don 't know how to do it.
WHO has attempted to do this in their report, in the World Health Report in 2000, but it really is not a satisfactory approach to getting a handle on how well our systems are operating and the comparisons across systems. And there was a meeting last week in fact which I attended, and in fact spoke on behalf of the Secretary, on health systems performance and the U.S. interest in this.
And you 've got the slides on the rest of this so I' m not going to go through it, but we 've been involved in mortality coding on an international basis, and an international injury meeting, and one of the things that I think is really kind of neat, we worked with the people from Hungary on the development of the Hungarian health interview survey, not exactly the same as the one that we produce here, but one in which there are enough elements that we can compare across countries. And we are also involved in the healthy Egyptians program.
Now activities that are in planning or underway have to do with a data users conference that we are planning for 2002, much more intensive work than we have had in the past on developing summary health measures, whether these are quales, dales or the like. We are part of an interagency committee that is bringing together people from across the department who have interest in this.
And very important, we are developing a policy that is almost ready for release on how we release micro data, very important, because there' s, we always have one collaborator or another who feels that they need the data before anybody else, and we need to put in place a set of rules by which we all play by, if you will, all aimed at getting out the data as rapidly as we can.
We 'll continue our re-engineering. We continue to propose a longitudinal studies program, and one of the aspects of this is a major study on children that has resulted from collaboration between, at least the idea has resulted from a collaboration between the EPA and the department, and this is now moving forward with a department-wide planning effort.
We need to continue work on different methods and modes of data collection, whether it is the, something that I think certainly has a role in this, the use of the Internet, use of devices, personal computer devices, hand held devices, and as I mentioned before summary measures research, performance assessment research, and electronic data records, very important that this be pursued. And all of this needs to be linked with the development of activities at the state and the local level.
I think that the balance between confidentiality and data access is the greatest challenge that faces us. The more data we collect, the more difficult it is for us to release it unmasked. The reason is that the more data we have on an individual, for NHANES we have 5,000 pieces of information on an individual, the easier it is to be able to break the confidentiality. So we have to find ways of producing this data in ways that researchers can use it, but at the same time we preserve the confidentiality.
And one of those is to do this through a data center, a protected environment in which researchers can work and not be constrained to a limited set of data. And we have a data center and that is getting more and more use.
The 21st Century vision process has been, was that discussed in here, the 21st Century, well it is partner to, I see it as an adjunct of the national health information infrastructure that was discussed yesterday, and we are looking forward to a final report relatively soon, and I 'm very pleased to say a volume of commission papers that will really be the foundation I think of health statistics for the 21st Century, and we are hoping for that when, Dan, two years?
DR. FRIEDMAN: Yes, hopefully early January 2003.
DR. SONDIK: January 2003.
DR. FRIEDMAN: Just make it 2003, let me retract January (laughter).
DR. SONDIK: Okay, right around the corner, in terms of planning ahead, right around the corner. Building for the future, this is our new building in North Carolina. I am very pleased to have this. It replaces the huggle that we were actually using. It was the original I think research triangle park building, one of those temporary buildings that stay. This is the design, as you can see here, for our new office building in Hyattsville, actually it is not, it is the Getty Museum (laughter), but one can always wish. This is our conference room in the new facility we are going to have in Hyattsville (laughter). I think this actually if Versailles, or something akin to Versailles.
But I am happy to be able to show you what our new building actually looks like, even as we speak. It is a hole in the ground, but it is more than we have had in the past (laughter). It is actually being built right next to our current building. It is going to be a building entirely devoted to NCHS, which is going to be a great boon to us in terms of maintaining confidentiality, and it will mean that people will find it much easier to walk around and not have to use their key cards everywhere. And it will mean that the ATF is not directly in our building, which they are now. But I feel safer because they are in our building.
I have another few views of this. But it is great actually. This is actually looking out my window as a matter of fact. It is actually great to actually see progress on this, and we are expecting this at the same time as that volume, Dan. No actually we are expecting this to be done in a year and a half, and they continue to tell me that despite the fact it is only a hole in the ground right now, they are on target for January 2003. That' s it.
DR. FRIEDMAN: That 's what I keep telling Oxford University Press too.
DR. SONDIK: Okay, but you don 't say it is a hole in the ground though.
DR. FRIEDMAN: No.
DR. SONDIK: So that is sort of an update. The confidentiality, the access issues, the release issues, the pressure is to get more and more data out on specific topics, and at the same time be able to release the micro data as early as possible are all real challenges for us.
I think the challenge which I didn 't put here, which is the greatest, is that we need the research. We need to boost our research programs. I' m really pleased that we have three centers for excellence in health statistics that we have been funding over the last few years, and that a real plus. And we work with the other statistical agencies on a small amount of investigator initiated research, but it is very important that these statistical efforts be built on a solid foundation of investigator initiated research.
But unfortunately we don 't have the resources for that. But I hope that through the budget process we will see these resources in the future. That 's my hour, three hour, took longer than I thought, I 'm sorry.
DR. COHN: Well Ed I want to thank you. Unfortunately we are a little stretched on time right now. I guess the question is are there any major questions that need to be addressed right now? I was sort of thinking that we might want to have him come back in February, because I actually think that the future initiatives, future directions, probably deserve some conversation, and you obviously unfortunately taken all the time and then some just with the presentation. How do people feel here?
DR. NEWACHECK: Just one comment. I think it would be helpful maybe when you come next time, Ed, if you could tell us how we could be helpful to you. Think a little bit about that.
DR. LENGERICH: Just in light of the future conversations, also I would be curious about the anthrax, if that has really affected what NCHS is doing or how that is affecting you all as well.
DR. COHN: Well we really do appreciate it. I see people are beginning to wander off in various places. But I guess is what I am going to offer or suggest, we had already talked about February about an update on the international activities going on with the NCHS and all that, and perhaps we could have you come back. And I think Paul 's comment about rather than just a presentation, more of an interactive discussion about directions, how we can be of help and all that I think is always a welcome discussion.
We know that at some point we are going to have a Board of Governors, I don 't know if that has been established or otherwise.
DR. SONDIK: Not yet. Currently these things are being held in the department, but we will pursue that, and as we discussed in the past, I think there is a great complementarity between this group and that group. For example, one of the issues and challenges for us in something like HANES is how do we rotate pieces in and out and components of it, and that is a detailed science question, and one certainly that this group would have an interest in. But we need a group that is able to really concentrate on issues like that, and that 's what I see as our Board of Scientific Counselors would do.
DR. COHN: Except we haven 't even had time to discuss that and we are sort of out of time. But let 's plan in February to get a little more into sort of the future issues and a discussion and as much as, I mean it was very useful to get an update on what is happening with NCHS, but obviously we would like to try to be of help if we can, so that would be useful. Anything else on this before we move into sort of the wrap up? Vickie.
DR. MAYS: Can I just ask that in the next update if we could have a discussion on like mental health and physical health. It is a growing interest in that and it seems like you are moving in that direction in terms of behavior and physical health, because it is becoming increasingly important in the survey.
DR. SONDIK: In fact part of this, if not prompted by but certainly correlates with the interest in summary health measures, which you know, the basis is that we need to be able to combine morbidity with mortality in some fashion, or at least we need to look at both, if not combine. Combining I think is an issue, but we certainly need to look at both and we would be happy to do that.
DR. COHN: Okay, let 's go into the wrap up. And I think as you have noticed, we have lost our quorum, so hopefully nobody had anything we needed to vote on.
DR. COHN: I did want to notify you of the Executive Subcommittee business, that there was one piece of business, I think it needs to be voted on, we addressed that the NCVHS should serve as an advisory mechanism to the Secretary on the national quality report. How we are going to do this is as yet undetermined, but this is something that the Executive Committee felt should move forward. We can discuss it further in February. I'm sorry, I' m missing the microphone. Anyway, that we would serve as an advisory mechanism to the Secretary on the national quality report, mechanism to be determined. Hopefully we will know a little more by February and be able to discuss it a little further at that point. So that is just a bit of information I don' t think requires a vote. Otherwise you have already received the update on the Executive Subcommittee. Dan did you want to comment about anything else on the health statistics for the 21st Century?
DR. FRIEDMAN: Just that words in prose form, as opposed to outline form, are being put on paper, looks really, a very rewarding collaboration with CDC and Ed Hunter from NCHS, Skip Parrish and I, and with a lot of help from Debbie and Rob Winezimmer, and hopefully in December we'll get the first, hopefully in December we will get the draft of the first 80 percent of the report to the workgroup. In addition responses to our letter soliciting recommendations are coming in and Dr. Sondik also sent out a letter to the Data Council and other agencies. I understand they are also going to have a meeting of NCHS staff around it as well. So that is where we are.
DR. COHN: Okay, great. Keep up the good work.
DR. COHN: Okay, very briefly on the Subcommittee for Standards and Security, there 's actually going to be two sets of hearings between now and the next time the full committee meets. The first is going to be on December 13th and 14th. We are talking about PMRI, patient medical record information standards. Day one, day two will be reviews - implementation of HIPAA administrative and financial transactions. The second set of hearings will be on February 2002, the 6th and 7th of February, which will be on local procedure, I mean basically on procedure code issues, local codes, additional codes that may need to be added to the HIPAA, list of procedure codes, other issues that may come before the subcommittee for consideration around that before they are forwarded to the full committee. Other dates into 2002 for the first half have been identified. I think they will be on the web site if they are not there now. They are actually on the web site for review.
I think Mark has already made a report for the Subcommittee for Privacy and Confidentiality. Vickie, would you like to talk about the Subcommittee on Populations?
DR. MAYS: The Subcommittee on Populations is currently planning to have a hearing on February 11th and 12th, looking at some of the issues on the measurement and collection of data on race and ethnicity. We are in the process of having some further discussions on how broad that coverage will be, but currently we are in the planning stages for that. Part of that is the hearing that we actually were going to have during the September meeting when we had several of our Federal partners coming in. So it is a continuation of that, but we are actually going to broaden it to look at, I think most of the individuals coming in then were going to do population-based surveys, but we will actually broaden it to also include data users, administrative data and so on. So I assume pretty soon our data will be up and information on the web.
DR. COHN: Great, thank you. Kathy, would you like to talk about the workgroup on quality?
MS. COLTIN: We have a meeting scheduled for the afternoon of December 12th. We scheduled it right adjacent to the meeting of the Subcommittee on Standards and Security. We are hoping that this will be a meeting where we can do some coordination with other subcommittees, because the topic area is that we 'll be hearing from a panel around some of the issues involved in collecting information relative to patient safety issues, and we know that there are privacy issues involved there, not simply from the patient perspective, but from the provider perspective as well, and wanted to extend an invitation to those who are on the privacy subcommittee as well to attend that session. I think it is from 1 to 5.
DR. COHN: Okay, so this information will be sent out to probably basically the full committee for information. Hopefully, especially the Subcommittee on Standards and Security since they have a session for the next two days, many of them will be able to attend and others as well.
MS. COLTIN: Right. We are trying to schedule it such that as many of the full committee members might be able to attend as possible. This is the type of session that in the past we have generally had at full committee meetings, but because of the cancellation of the September meeting and the tight schedule we had for this meeting, and what we feel is actually an urgency to kind of wrap up some of the presentations that we have heard and the hearings we have held around quality measurement issues, data issues relative to quality measurements, that we can actually produce a report, we wanted to hold a session prior to our full committee meeting in February, and so we are trying to schedule it to facilitate attendance by as many as possible.
DR. COHN: Questions about that?
DR. COHN: Well future meetings for the full committee are February 26th and 27th, 2002, June 26th and 27th, 2002, September 25th and 26th, 2002, and November 19th and 20th, 2002.
Now for our February agenda I think, obviously we will be fleshing it out, but issues that were brought up at this meeting included hopefully a presentation relating to research, IRB sort of plus HIPAA, and I think we have already recognized the interaction and dependencies in our privacy letter. So hopefully we will be able to have I think Ray Koski and others to be determined come in and have a discussion with us about those issues.
There was also an obvious issue from yesterday around PKI and digital signature standards. We actually asked Kepa to take a lead on trying to put together a panel on that that included Federal, state, and private players in this as well as the HISB, to sort of figure out where we are with that and digital signature.
Marjorie before she left yesterday had also volunteered to write us an update on international affairs in relationship to NCHS and the responsibilities of the NCHS, and I think we even extended an invitation to Dr. Sondik to come and join us for that discussion, as well as hopefully we will be able to have a collaborative discussion on next steps and activities of the NCHS.
So hopefully that will be all put together. I think there was some note that we probably needed a public health/surveillance update, emergency preparedness update. We will ask John to take the lead on that one since he obviously is a state health director.
And those were the items that I saw. I don't know if there were any other.
PARTICIPANT: We had a carryover item too, - September meeting, the presenters from GAO on records linkage. We did ask them. So that is the consideration - the agenda is getting so packed, if that should wait.
DR. COHN: I would say probably it should wait unless there is something critical about that that needs to be handled in February. Also defer that to John for final determination as the agenda comes together.
Now is there anything else we should be looking at in February? Okay. Well I want to thank you all. As you know, I am sitting in for the Chair. We want to thank you all for your help and assistance keeping this a successful meeting. The meeting is adjourned.
(Meeting Adjourned at 12:05 p.m.)