DR. GELMAN: We are meeting today to discuss a work plan for the future. I have circulated a paper with a bunch of ideas on it. I'll just run through them very quickly and invite comment.
The agenda items, there are six of them that I have listed. The first one is health privacy legislation. We have already really done our recommendations, but there may be additional things that we can do to assist in the legislative process, raise issues or focus attention on something or what have you. So I think that if the opportunity arises, we should be flexible enough to consider that.
The second issue is one that came up constantly in the hearings, that is, when is a record identifiable and when isn't it. It is not a black or white category. It seems that it is much more of a continuum from identifiable to non-identifiable, and it is not necessarily clear that there is such a thing as a non-identifiable record. It all depends on context and intent and motive. I think there is a lot more work that can be done to explore the nature of identifiability, and to see perhaps if it is possible to formalize categories or at least to lay them out. I think that is a very interesting and very important issue.
The third item is that of registries. This is another issue that came up from time to time in our hearings. There are lots of different kinds of disease registries. As far as I can tell, there is no definition of what constitutes a disease registry, yet people disclose medical information to registries all the time. I think that no one has really collected the facts on registries. I don't know if there is a registry of registries. So I think this is another area that is worthy of further explanation and exploration.
The fourth issue is certificates of confidentiality. HHS has a program that provides certificates of confidentiality to qualified researchers. It basically makes research records immune from subpoena. I don't know that much about the program, other than I have seen some of the legislation and the rules. But the question is, how well is the program operating, and does the same concept make sense in other areas, is the scope of the research definition for the program as broad as it might be, and will that help solve problems in other areas. The problem of researchers getting subpoenas is one that occurs in lots of areas, and there have been a number of court cases and some very interesting issues that float around there. So I think that is something worth taking a look at.
The fifth issue is that of provider confidentiality. We have been talking mostly about privacy, patient privacy. There are confidentiality interests of a different sort that relate to physicians or even to health plans, possibly to insurers. They have data which may raise to the level of being a trade secret or confidential business information in some contexts. This has come up from time to time in various ways, but again, I don't really think the issues have been laid out clearly or comprehensively, and that is something we might do.
The sixth issue on the list is that of pharmaceutical marketing. We could not get testimony at our hearings from pharmacy benefit managers, to find out more about what they do. There is clearly much more intensive use made of personal information than is common in other parts of the health care industry.
I think that the use of personal information, the availability of personal information may expand. The FDA has recently approved broader advertising for prescription drugs. It requires drug companies to have 800 numbers and websites. Although this is not necessarily the intent of the regulation, this creates a data collection device for whoever happens to be running the 800 number. If you call an 800 number asking for information about a diabetes medication, then one can assume that you have diabetes. The question is, what happens to this information? It is not medical information in the sense of having a doctor-patient relationship, and we are creating perhaps totally unregulated databases of patients by diagnosis. So I think there are a whole bunch of issues that relate to pharmacies that are worth looking at.
Anybody have any comments, questions, other ideas? The floor is open. Harvey?
DR. SCHWARTZ: First of all, I'm really impressed with how you captured so many of the ideas from the testimonies that we received. I think that basically they are all excellent, in my opinion.
There was one other area that I seem to remember from the testimony that might be considered as well, perhaps. That related to the issue of IRBs. I was wondering if perhaps some of the people on the subcommittee might consider, just as with the certificates of confidentiality, that perhaps there might be a need or it might be worthy to explore expanding the scope of IRBs in other settings, like let's say, in the private sector, not for profit and profit areas, where there might be some things like research or quality assurance taking place, and perhaps the subcommittee might consider exploring some of these types of issues as well.
DR. GELMAN: Well, I don't think that is a bad idea. I think that the IRB issue is probably -- maybe someone knows this for sure -- I think it is being looked at by NBAC, the National Bioethics Advisory Committee. So we might not want to duplicate efforts.
I think the notion of IRBs as a control method for non- federally funded research for private companies is a good one. It is one I have tried to sell to various people, but I'm not sure there is anything out there to look at right now. So I think I might list that one as a secondary issue.
DR. WARD: I think related to that though is a linkage between the certificate concept and the provider confidentiality. That relates to when entities are doing quality assurance. That is usually the issue they have, is how to protect the quality assurance, the data about patients from subpoena, and how to protect the provider's information about them, as they do quality assurance. So the providers will be open to participate and not think that their practice will become published as they are trying to institute improvements for practice.
So I don't know that it is an IRB title, but I would like to talk about quality assurance inside entities when we get to the whole idea of protecting from subpoena and protecting providers.
DR. GELMAN: I know that there is legislation, I think at the federal level and at the various state levels for dealing with peer review and providing that. It may well be that what you are suggesting is other, common functions, similar functions that may not have the same kind of protection.
DR. WARD: And it may be that what we will recommend in a particular kind of model legislation that each state should pass, or consider whether this is going to be such a universal activity as we evaluate what is happening to our health care system. We might want a national legislation. But we could also -- I think states are doing a variety of things, and it may be that people are doing so many different varieties of things that we are back to the similar problem we have got with 50 different versions of patient confidentiality and legislation.
DR. SCANLON: On the IRB issue, the NBAC is actually doing, as you said, a review of the agency practices in terms of IRBS and the rule for the protection of human subjects.
But perhaps further along in the year when they get a little further along, it might not be a bad idea to have at least a report from them in terms of what aspects of IRB performance they are looking at, and particularly to look at the privacy and confidentiality. But it would be more as a liaison reporting type function.
DR. GELMAN: Yes, I think that is a good idea.
DR. SCANLON: Secondly, Elizabeth, relating to what you said, this is unrelated to IRB in terms of the protection of research information. Even at the federal level, CDC and several of our agencies, we might want to throw this into the hopper as well, in addition to the certificates program, where you have specific legislation in several areas that can protect the identity of participants in statistical studies, including establishments, not just individuals, but establishments.
This is applied sometimes to the nosocomial infection program at CDC, where hospitals participate for prevention purposes, but obviously they are not all that interested in publicizing any of these things. So you can protect that information while encouraging the quality improvement.
So we might want to throw in the federal agency statutes that are used for surveillance, and protect that kind of information.
DR. GELMAN: Yes, I think that is a good idea. Basically, what you have both suggested is broadening the focus of that not so narrowly to certificates of confidentiality, but look at other things, and I think that all makes sense. Got any thoughts?
DR. HARDING: Yes. I think all these are good. It is kind of like Christmas; which one should we go after here first? But a couple of things that I just wrote down as I was going through.
One kind of goes along with IRBs, but some way to look at the cost containment research of a for-profit entity. Is that research? Is it seen as that? Of course, the concern being that there be discrimination coming out of something like that, not that there is, but the concern being that there would be, and some way of looking at that quote research.
The other would be, one of the things that always made the hair stand up on the back of my neck during the hearings was this issue of employer-employee, when the health insurance plan is administered by the employer and access to the employee's records, and again, the discrimination that could potentially come out of that.
I know that is very complicated, but the same thing goes with -- you were talking about the pharmaceutical marketing, those benefit plans, having the knowledge and then giving back that knowledge to the employer seemed like something that isn't intended.
Also, as you brought up, this issue of databases being used for commercial use. That always is a concern to me, as opposed to a registry that is helping people find appropriate kidneys. Around the country, that is no problem, but when databases get into other things, and the registries and so forth, I agree, that is an area that is always a concern.
DR. GELMAN: Good issues, and they are all hard. Got any easy issues we can deal with? I'm not prepared today to say let's go pick some dates and do something. I think one of the problems that we face right now is a staff limitation. John found the staff to the subcommittee, and he is all tied up in the Secretary's legislative proposal, and that is why he is not here this morning. I think there is going to be a lot of fallout from that for awhile, so I don't think we are quite prepared to say, let's pick dates. I think all of these issues will take a lot of time. They are going to take a lot of work. It is not like the health privacy stuff, which we have all done for years, and we just had to set up hearings and who to call and all that sort of thing. A lot of this is going to take some original work and some thought to figure out how to frame the issues.
One of the ways that it might be useful to go at this, instead of just having events that are hearings, where you just invite people up to give testimony, I am more inclined, at least for some of the issues -- and I don't think a real decision will come until later, to do things more in a workshop format. Perhaps we have a table just like this with the committee members and the witnesses all sitting around, discussing things, perhaps with some presentations from the witnesses, but allow for as much interaction between all the participants as we can get away with.
I think that as you get into more specialized areas, I can see this particularly when you are dealing with the issue of non-identifiable versus identifiable information. You're going to get into a lot of -- you're going to need some more heavyweight statistical expertise than -- I can't speak for the other members of the committee, but than I have. It will be useful to have some of that available to us.
Marjorie?
DR. GREENBERG: Yes, I was just going to mention that that is clearly an area of real interest and concern to the National Center for Health Statistics. We have been doing various things, but I think we would welcome the committee's involvement there, and help, because it is a continuing issue for us.
DR. GELMAN: My other thought on this -- and this just makes it harder, and I don't know if we will be able to pull it off, but the format we used before for hearings was to have two days in a row, basically to make it easy for people coming in from out of town, instead of asking people to come in for a one- day event. If possible, maybe to do the same sort of thing, but to have two days on two different subjects. I'm not sure any of these will warrant two full days, but perhaps to have two days, one day on -- I'm not quite sure what we would do first, although I think the identifiability thing might be the first issue, because I think that is really -- it is a little hotter than the rest. It has also got an interesting genetic component to it, and genetic privacy has been a hotter issue of late in Washington, and the general medical privacy stuff, I think that is also worth looking at.
I'm not sure about the other issue. It may just depend on what is available and what we have time to develop. But if there is something that someone is really anxious to see first, we can consider that. There are a couple of subcommittee members who aren't here, so I guess reaction from them informally --
DR. HARDING: I think it may be helpful after the Secretary presents to Congress, so we may have some direction too from that.
DR. SCANLON: Or some follow-up, we were thinking.
DR. GELMAN: Yes. I don't know what the reaction will be to the Secretary's proposal. It is possible that it may revitalize the issue a little bit. It just seems pretty moribund right now. It may not, and I don't think we're going to know until it happens, and see how the Senators react and how the public reacts. It is unpredictable. So that may drag us back more into the legislative thing, although all of these issues in one way or another relate to the legislation. They really are all an exploration of smaller issues that are essentially important to the legislation.
The one that you mentioned, Richard, about what is research, that was another very common theme at the hearings, and a very difficult issue for the legislation and one that is very difficult to deal with.
DR. SCANLON: It might be worth, maybe at a subcommittee meeting fairly early, maybe the next one even, finding out a little bit more about the NBAC and where -- this is like the evaluation of IRBs and what they do cover and what they don't. So I'm wondering if maybe even early in the plan, we might want to have at least an information session with NBAC to tell us where their evaluation is.
DR. GELMAN: Well, that's a thought. But first of all, I'm not sure that the whole committee might not benefit from hearing of some of what is going on at NBAC.
DR. SCANLON: No, the subcommittee.
DR. GELMAN: I'm thinking the full committee. It's a good idea, and if everybody were here, it would be worth doing. But I'm not sure it's worth asking people to drag themselves all the way to Washington just for a briefing from NBAC. So we might be able to incorporate that into one of the regular meetings.
I am sort of thinking that the earliest we could be ready to deal with any of these issues is maybe December. It is already September, and the fallout from -- the Secretary is testifying before the Senate. She is likely to be testifying before the House pretty soon on the same thing. So that is going to be very time consuming for people. I think we can get some of these issues underway at least to begin thinking about them in a couple of weeks.
Again, I don't want to pick dates, because I just don't think we're ready for that. We'll have to do that by e-mail and see if we can get something cooked up by then. Got any thoughts? We're almost done here.
DR. SCHWARTZ: Can I rase an issue, particularly while Jim is here. I thought it is a very good idea to try to encourage as much discussion as possible with witnesses. I was wondering if it might also be worthwhile to consider perhaps development of a planning strategy, maybe two prongs, one with the assumption of minimal resources, no more staff, nothing else, and then maybe one -- how can we do all these things, and what would you need in terms of staff and other types of support, and perhaps Jim or other people could help in that regard, to see whether that can be brought to Vera.
DR. GELMAN: Well, I always assume a bare-bones approach to everything. There is nothing in any of these issues right now that jumps off the page to me to say, let's go out and spend a lot of money developing something. I think you need to do the informal work first, and then try and make a decision later. If there is money to do something and there is something to do at the same time, then that's fine. But I am just assuming that we are going to sit around and talk about these issues for a while, focus attention on them. A lot of these questions are below the surface. There are too many bigger issues that soak up everybody's attention.
DR. COHN: I was just reviewing your agenda items and thought it was inappropriate to make any comments until I had seen what your ideas were.
What I am saying may have been completely redundant from what you discussed previously. There was an issue that was brought up during our hearings last year, and I'm trying to think of how best to describe it. I think it was an issue of ownership of clinical data.
DR. GREENBERG: Sheila was concerned about that issue.
DR. COHN: Yes, and I just noticed, it wasn't referenced in any way as any of the items that needed in any way to be discussed or pursued. I don't know exactly how we should pursue it, but I did remember it being a relatively big issue that kept coming up again and again. I don't think it should get lost.
DR. GELMAN: No, I think that is a good issue. In some ways, it comes up in some of these things we have talked about, but it may be worth a look, cutting across on that angle.
I think that the commercial exploitation of information is likely to make this ownership issue a much bigger one. I am sitting around, waiting to see a lawsuit between two major health care institutions over rights to exploit patient data. It is only a matter of time before we get one. That is the kind of thing that will really bring that issue to the surface. So I think we can add that to the list.
What I will do is, I will revise this, add the suggestions that we have had. There is clearly a lot ore stuff that we aren't able to do any time too soon, and people can think about their priorities. I'm going to suggest that the identifiable records thing is first, and then try and figure out what else we can do with that. We can discuss that during the course of the day, if there is something that you think is very important to you. I'll try and figure out what to do, and we'll probably discuss by e-mail when to do it. Marjorie?
DR. GREENBERG: If you wanted to, we could try to arrange at least during your breakout session at the November meeting maybe to have people from NCHS or others you might identify on the identifiable issue.
DR. GELMAN: When are we meeting in November?
DR. GREENBERG: November 5-6.
DR. GELMAN: All right, yes. Yes, let's think about that, how we can use that time.
DR. GREENBERG: That would be low staff effort, to get people in like that.
DR. GELMAN: Well, actually, that might be a time to use for an NBAC briefing.
DR. GREENBERG: I thought you were saying you wanted that for the whole committee.
DR. GELMAN: I don't know, it is a thought.
DR. GREENBERG: Actually, at the executive subcommittee meeting after the June meeting, there was this NIH workshop on genetic data that was mentioned. I guess it is going to be next week, September 16 and 17. The group decided, it says in the minutes, to ask for a briefing by Kathy Hudson and Barbara Fuller at the November NCVHS meeting.
Now, assuming NBAC is involved in that workshop -- or no? It's not?
DR. SCANLON: No, it is actually a different --
DR. GELMAN: But that is a thought as well. Perhaps we could -- I don't know how much time we'll have at the November meeting, I'm sure we don't know yet. Also, one of the problems at NBAC, they don't really have a staff yet, so maybe by November they will.
DR. SCANLON: They are using the NIH staff.
DR. GELMAN: Yes, but they don't have a permanent staff, although I'm not sure permanent is the right word to use. But in any event, they don't -- and I think they are getting warmer in that regard, at least according to the rumors. So both of those things are good ideas, and we might want to do that in November, because I'm not sure we are going to be prepared with any of these real issues, nor do I necessarily want to stuff any of these issues into a two hour window.
DR. GREENBERG: Yes.
DR. HARDING: If you send out anything by e-mail, please don't put it in UU in code. I'm on Compuserv, and they just got bugged by AOL last night or something, and I will never find a way to use Navigator and go through this and that. I appreciate it very much.
DR. GELMAN: Anyway, anybody else have anything?
DR. HARDING: I have a thank you. Who wrote the minutes to the last meeting?
DR. GREENBERG: The last full committee meeting?
DR. HARDING: Yes.
DR. GREENBERG: Our reporter, Susan Canaan. Actually, I must say, this round, in order to get it -- usually I review them before they go out, but I only reviewed the executive summary so we could give her all the --
DR. HARDING: Well, I really want to give her credit, because she encapsulated the debate and the differences without making it very clear, and how we discussed things. I thought it was an excellent summary and report, and I just wanted to thank whoever did that.
DR. GREENBERG: I don't know if she is here right now, but she was here yesterday. We'll give her that feedback.
DR. GELMAN: If there is nothing else, the meeting is adjourned.