THIS TRANSCRIPT IS UNEDITED

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY

March 4, 1998
Break-Out Session

Hubert H. Humphrey Building
200 Independence Avenue
Washington, D.C.

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
703-352-0091

TABLE OF CONTENTS

Review Agenda - Bob Gellman

Current Legislative Activities - Bob Gellman

Future Subcommittee Activities


PARTICIPANTS

ROBERT M. GELLMAN, JD, Subcommittee Chair. Privacy and Information Policy Consultant, 431 Fifth Street, SE, Washington, DC

JEFFREY S. BLAIR, MBA, Vice President, Medical Records Institute, 4348 Sprucebough Drive, Marietta, Georgia

KATHRYN L. COLTIN, MPH, Director, Clinical Measurement Systems and External Affairs, Harvard Pilgrim Health Care, 10 Brookline Place West, Brookline, Massachusetts

DON E. DETMER, MD, Senior Vice President, University of Virginia, PO Box 9016, Charlottesville, Virginia

KATHLEEN FYFFE, MHA, Federal Regulatory Director, Health Insurance Association of America, 555 13th Street, NW, Suite 600E, Washington, DC 20004

RICHARD HARDING, MD, Medical Director, Psychiatric Services, Richland Memorial Hospital, Two Richland Medical Park, Suite 508, Columbia, South Carolina

M. ELIZABETH WARD, MN, Assistant Secretary, Epidemiology, Health Statistics, Public Health Laboratories Division, Washington State Department of Health, PO Box 47811, Olympia, Washington


PROCEEDINGS (8:35 a.m.)

Agenda Item: Call to Order. Review of Agenda.

MR. GELLMAN: We have two things to talk about. First, we had a workshop in January on data needs and another workshop at the end of January. One was on identifiability and one was on data registries.

I hoped to sort of have a written summary of it, but it just didn't get done in time. So, I would just like to offer some general conclusions from it, something that may turn into a report or a letter to the Secretary, or something like that.

Essentially, on the issue of identifiability, what became clear is that this is a much harder issue than we thought before.

Every legislative proposal, including the Secretary's, tries to distinguish between identifiable and non-identifiable records, with the point of sort of not regulating non-identifiable records. So, it is clearly an important thing. All the bills, by the way, have different standards.

That distinction just doesn't work clearly any more. Whether something is non-identifiable depends in large measure on what other information is known, or knowable.

The background has shifted, because the amount of

personally identifiable information that is available from public or commercial sources has grown significantly in recent years, and trafficking in that information has also grown significantly in the last decade, fueled by cheaper computers, the internet, and the commercial sale of personal information. There is a ton of stuff out there on everybody.

Another thing that became clear from the discussions was that the health and statistical agencies have always been aware of this problem, and they continue to be aware of the potential for the identification of individuals from publicly-released information, including public use data tapes.

I think the explosion of information from other sources means basically that they have to continually re-examine the policies that they have in place, to make sure that they are not putting stuff out that can be identified inadvertently.

I am not sure that I would call that a recommendation, but that seems to be a conclusion, and I am not sure that any of the agencies themselves would struggle with that.

I think it is true that everybody else who deals with data that they sometimes consider to be non-identifiable, also has to pay attention to the issue.

I think that perhaps IRBs need to pay more attention to this. It is not so simple any more to say, well, there are no identifiers on it. I think perhaps we may need some kind of mechanism for them to be alerted to the issue.

From a legislative perspective, it seems to me that relying on a single word -- identifiable, non-identifiable -- simple doesn't work as a regulatory mechanism any more. It is a much more complicated concept.

We have to recognize that those who receive data without overt identifiers -- name, address, social security number, what have you -- people who receive this data may still be able to identify particular patients.

So, some other mechanism, either a substantive mechanism or a procedural one, may be needed in order to protect individuals against identification in these environments.

I am not sure that there is a simple response to this that is possible. Mechanisms that may be appropriate include the use of contracts or legal restrictions, that would prevent those who are receiving data from actually undertaking the effort to identify individuals.

The goal here is to continue to allow socially beneficial uses of data for research or public health or what have you, without impinging on the privacy interests of the individuals.

I mean, I think that was always the goal, and I think that there is not that much evidence that that has not been fulfilled. But I think the threats are greater and the background has shifted. So, I think there needs to be more awareness.

That is sort of the conclusions that I came away with from the workshops. Anyone have any comments, thoughts, additions, complaints?

DR. HARDING: The only thing is that issue of things being overtly identifiable, and then, in fact, I think we have to say difficult to identify, as opposed to non-identifiable.

It just sounds like her presentation was so boggling, you know, how she can identify just about anybody, that we really have to come up with some better terms.

MR. GELLMAN: I think that is true.

MS. FYFFE: Just for context purposes, are we talking about the workshop where the person from MIT was here?

MR. GELLMAN: Yes, Latonya Sweeney, yes.

MS. FYFFE: Okay, which was held in January.

MR. GELLMAN: January, that was the first of the two. Yes, I think Latonya Sweeney's presentation was very impressive and a little bit scary. I just don't think enough attention has been paid to this issue anywhere. I think it has to be.

Agenda Item: Current Legislative Activities.

Let me move on. On the registry side, I mean, the second day was looking at the issue of sort of what is a registry, a disease registry, what have you.

One of the conclusions I came away with is there are lots of different registries for lots of different purposes.

There is lots of diversity here and there are lots of different structures for registries. There are public registries, there are private registries. They have different purposes, different funding sources, different everything.

There is no catalogue of this. I am not sure I am proposing to solve that particular problem, but there simply isn't -- there are laws establishing registries at the federal level and at the state level, but there are plenty of registries for which there is no legal structure, which is not necessarily a problem.

There is no comprehensive regulatory structure for what is a registry. There is no way that registries are blessed and determined to either be a registry or not be a qualifying registry. It just hasn't mattered up until now.

It is perfectly clear that any type of health privacy legislation will affect the flow of health records into and out of registries in some way.

The committee is on record as strongly supporting the work of registries for research and public health and similar purposes.

I didn't see anything come out in the day's meeting to change that conclusion.

None of the legislative proposals, I believe including the Secretary's, mentions data registries directly, but they all would affect it in ways that are actually difficult to discern, because you have to sort of figure out what this registry is and what its purpose is and which section of which bill it falls under and how it would be regulated.

So, my conclusions here are that data should only be for health -- patient data should only be -- of course, this folds over into the identifiable and non-identifiable thing a little bit -- but patient data should only be provided to registries that are conducting some kind of recognized and beneficial activity, however that is defined.

The registry at the end of the line, if you will, is the marketing company who wants to have a mailing list of people with arthritis and says, I am a registry.

I think we probably all agree that someone who is solely interested in commercial marketing isn't what we have in mind as a registry.

At the moment I suspect, though, the rest of them is we know it when we see it. I don't actually think for most -- none of the registries we have run across, I don't think anyone had the least bit of problem with.

They were all doing, you know, perfectly suitable, useful work that no one would want to interfere it, and that is the second point.

I think it is important that legislation not unduly interfere with the flow of information into registries, that they are good things, they carry out good work.

The third point is that they need to be brought under whatever new legislative framework evolves with the goal of providing data subjects with some assurance that their records are reasonably protected once they enter a registry.

I think that clearer rules may actually be useful because of the international scope of privacy regulation these days.

Whether information can flow across national borders will be a much more important question come October of this year when the EU data protection directive takes effect.

I haven't really found good examples where registry data, at least on an unidentifiable basis, whatever that happens to mean, is flowing across international borders, but I think that as more and more attention is focused on more and more obscure diseases, you are going to need a bigger denominator in order to be able to find the cases that are necessary to fulfill the purpose.

I think that the solution to this -- and I don't have a specific one -- may well be that there is a need for a statutory definition or process to say this is what a registry is, and registries that meet this purpose can get access to records.

I don't necessarily suggest that we get further into this, to write the provision. You could have a substantive definition. You could use IRBs to approve or disapprove registries. You could allow the Secretary to set up a mechanism to do it.

I am not sure that we need to resolve that on our own, but the point is that there probably will need to be some kind of legislative recognition of the existence and operations of registries.

That is sort of the point, that this is an issue that needs to be on the table, that people need to think about, and I don't think it is overwhelmingly difficult to resolve. Any thoughts?

DR. DETMER: Just that I agree with you as far as the bills to date presenting some definitional problems. But I think there might some social good.

I am just basically agreeing with your comment that it is not in the current legislation that I have seen and it does need to be there.

It presents some problems in terms of what is the kind of registry that we would consider the kind of registry that we would approve of, if you will.

MR. GELLMAN: Right.

DR. HARDING: So, tell me what we would approve of and what we wouldn't; not to pin it down here, but basically that a registry would be being used for research and improved quality of care or finding -- you know, the kidney registry or something like that, that is finding donations, that everybody is understanding -- but then, what is the bad news that we wouldn't approve of; anything that is used for marketing?

MR. GELLMAN: I am not sure. This is one of the reasons that I am not necessarily bringing forward a specific, you know, legislative proposal.

DR. HARDING: Right.

MR. GELLMAN: I don't know that we want to get into necessarily trying to make the distinction; only that the term registry, or the concept of registry -- because not everything calls itself a registry -- may require some recognition in the law, and that we need a standard or a process.

It may well be that instead of writing, you know, a specific definition that says these are exactly the purposes that registries should fulfill and anyone fulfilling any other purpose doesn't qualify, it may be that you write a very loose standard and say that a registry is something that meets this very broad test and that has been approved by an IRB, the Secretary of HHS, or some other mechanism.

I am not sure you are going to be able to write a definition that, by itself, is going to be able to make the distinction, you know, between good and evil, you know, qualifying and non-qualifying registries, without the application of people looking at it and saying, yes, this is something that we want to support, this meets one of the general purposes of public health, research or treatment even.

That might be as broad a definition as you require, because those are all purposes that are recognized in all of the bills as something worthwhile. So, it may not need to go beyond that.

DR. DETMER: One way you could say is that they use the data for the purposes for which it was collected, in meeting, you know, the legislative intent.

In other words, if they go outside of that, then they wouldn't be -- they may think they would be a registry, but they wouldn't be --

DR. HARDING: Can a registry be a for-profit organization?

MR. GELLMAN: Yes.

DR. HARDING: I don't know if there are any.

DR. DETMER: I don't know of any.

MR. GELLMAN: But if they wanted to be and they otherwise meet the terms, I don't know if that is a problem. If they are making their money selling names, you know, on a mailing list to people, that might be more troubling.

MR. BLAIR: What about disease management, There are some drug companies that use them as a treatment mechanism.

MR. GELLMAN: Actually, if you hold that thought, we will get into that in a minute. That is sort of the next subject.

MS. FYFFE: Excuse me, isn't there some protection already within the proposals, against registries selling information for commercial gain because of the criminal penalties in HIPAA Title II?

MR. GELLMAN: Well, not necessarily. Yes, there are criminal penalties for marketing of health data. There is also plenty of health data that isn't subject to the legislation that is, today, currently marketed.

You can go buy mailing lists of people by disease from commercial sources. Those lists probably don't come from health records.

They come from patients who probably, not knowing what they are doing, disclose information about themselves to companies who solely engage in the purpose of collecting this data to sell it to others.

There is nothing that anyone has ever proposed, or is likely to ever propose, that will stop you from sharing your health information with anyone you want.

The goal is to prevent your doctor and all the other people behind the doctor from doing that.

DR. HARDING: It seems like that is something, though, that we should look into, that if people get snookered by 800 numbers, that they ought to have informed consent as to what they are getting and what privileges they are getting, when they call the 800 number and want a free safety kit on diabetic infections or something, that they are really putting their names into circulation, and they don't know that.

MR. GELLMAN: Let me bring up the next issue. By the way, what I hope to do with those two workshops and sort of the discussion that I just presented is essentially turn that into some kind of a letter, perhaps, to the Secretary from the committee.

I mean, I will present this at the full committee meeting, if no one has an objection, and see if there is sort of general agreement on the conclusions from everybody.

Then, perhaps, we will do a letter and try to get that into the works, maybe, and if it seems appropriate, circulate it and get it approved and put it up.

I think it will contribute at least a little bit to the current debate. I think the workshops themselves seemed to be well received and people liked the discussion and people especially came away from the first day on identifiability shaking their heads and saying, you know, we are losing all our bearings here. So, we have accomplished something, if nothing else.

The question is, what do we do next, and we have already sort of jumped ahead here with comments from Richard and Jeff.

Agenda Item: Future Subcommittee Activities.

MR. GELLMAN: I have passed out these stories that appeared in The Washington Post starting on February 15, about the use of prescription information, essentially, for what appears to be marketing purposes.

This was a big local story. Giant Food, one of the major drug stores in the Washington area, and CVS, which is a pharmacy chain, were making patient information available to a third party company called Ellensis.

Ellensis was sending mailings to the patients, supported by Glaxo Wellcome -- about whether they were taking their medication.

I think the example that was used in the article was they were writing to people who were taking nicotine medicine, whatever those things are called.

MS. FYFFE: Nicotine replacement products, yes.

MR. GELLMAN: Yes, thank you. And saying, you know, you stopped filling your prescription, you know, and we hope you are cured but, if not, come back and buy some more drugs.

The companies defended this by saying this was helping their customers stay healthy. Perhaps that is so. I think you can make an argument for that.

The fact that the companies themselves, the pharmacists, if you will, were motivated to do this by the fact that they were being paid by the drug companies sort of undermines the argument that they were putting forward about their motives.

In any event, I think that this is a big issue. I think that we had some testimony about this last year when we had the six days of hearings. Revco was a drug chain that testified that they were doing this.

DR. HARDING: Owned by CVS now.

MR. GELLMAN: Yes, and we don't know to what extent this is going on. I don't know whether there are any managed health care plans doing this.

In theory, anyone in possession of health data could make the same argument. It could be a doctor, a pharmacist, a hospital, an insurance company, anybody.

If they can make the connection, they have the data, and this is something that had an interesting impact.

Last week, there was a health privacy hearing and Bennett and Jeffords were about to introduce a bill that had a variety of shortcomings, I thought.

They looked at their bill and they discovered that -- I am not sure how they would characterize it, but I would characterize it as it authorized these disclosures, or it would have allowed the pharmacies or the providers or the health plans or even your employer to disclose health information for this purpose. That is the way I read their bill.

So, they pulled the bill back for retooling. I don't know when it will appear. It may be soon; it may not be.

In any event, it seems to me that this whole issue of the use of medical information coming out of the medical care system for marketing purposes needs to be looked at.

We have got FDA requiring drug companies that are advertising to have 800 numbers, and people call up and say, send me information on drug X.

Well, people aren't calling just to get junk mail. They are calling because they probably have the disease that drug X cures.

Now the manufacturers have information, name and address of people who have made these inquiries, even if you don't go beyond that. It is clear that that is a valuable list.

Information can be collected over the internet, about people who download information, who register things. There is information that comes from all sources.

It seems to me that this is something that is worth looking at and this is what I am suggesting ought to be the next subject that we take up.

MS. WARD: As I recall, at last year's hearing we had one large health plan talk about the fact that they had frequently been asked for names.

They liked the information, the health education information that several of the pharmaceutical companies produced, but their policy was to take that and then put their own name on it and send it out, that they would never give their names out.

That was purely voluntary and purely their own, they thought, better policy to make for their enrollees. They commented that there is certainly nothing out there that would prevent them from being less ethical.

MR. GELLMAN: Yes, I think this is a very hard issue. You know, people ask, well, how do some of the other bills that have been proposed, do they support this kind of activity, do they prohibit it?

The answer is you have to work really hard to figure it out. The question is, what is this activity. You can call it marketing. You can call it treatment. I am providing my patients with information about better pharmaceuticals, and I consider this to be treatment.

There are questions of medical ethics in terms of doing this, if you do this on your own notion as a provider, and you tell your patients, here is a better drug, I think you ought to think about taking it, or here is a better treatment. That is maybe one thing.

If you are being paid to say that, does that raise ethical questions? I mean, I think there is a whole slew of questions around here.

DR. HARDING: There is a truth in advertising or a truth in marketing kind of issue. In this case the letter said -- it was a letter going out to the patients from CVS.

It says, recently a new product was introduced at CVS pharmacy. We encourage you to contact your doctor.

Now, if they had said, we are doing this because we are getting paid a fee by Ziban in order to increase the sales in our stores, then that would be the truth and that would be a straightforward shot at people.

Here, they are kind of saying, as a provider of care, we are so concerned about you that we feel that you should contact your doctor, and that is a little bit different than the truth.

MR. FANNING: Let me point out that the story does say that the letter was signed, your CVS pharmacist, and in fine print the letter noted that its mailing was supported by Glaxo Wellcome.

I, in fact, saw the form given out in the drug stores that said this program existed. At the bottom it did say, this is supported by either a named pharmaceutical company or generically stated.

So, in one sense, that cures the truth in advertising problem. That doesn't mean that there are no other issues.

DR. COHN: I was going to say that truth in advertising is only one of many issues around this area. I was actually just thinking as you were talking, that certainly there is not a week that goes by that I don't get a call from somebody about some sort of a disease management something or other.

I mean, you can take this cut as into marketing, or the issue gets to be, well, gee, what are appropriate ways of dealing with disease management.

I think on one level we all think that physicians and other health care providers should be able to proactively inform patients or a population about good things to be doing, healthy activities.

Where does that begin to move across the line, and that is more than just pharmacy. There are a lot of people trying to sell disease management services. This one is probably at the far extreme.

MR. GELLMAN: I think you are right. I think that is exactly the same issue. This thing isn't easy. The reaction, of course, to the newspaper stories here was that -- this story appeared on Sunday. By Tuesday, Giant Food had backed out of doing this and on Wednesday CVS stopped doing it.

By the way, there were some suggestions in the story -- and I haven't tracked this down -- that the disclosures by the pharmacies to the third party company were illegal under local pharmacy rules.

I haven't seen anything definitive on that, but the story reported that Safeway considered doing this and went to, I think, the Maryland Pharmacy Board.

They said, we are not so sure this is legal, and Safeway decided not to do it. I mean, that is another element of all of this.

I think there are a lot of issues here, but it is very hard, because I have tried in legislation I have done in the past to address the marketing issue.

You can't come at it directly because there can be a fine line between marketing and treating your patient. So, I think there are questions here of professional standards, of disclosures.

Giant Food, by the way, could have done this without using a third party company. You know, would that have made a difference, if they didn't hire somebody to send the letters, and didn't make a disclosure to a third party, or would the third party just be considered an agent of Giant Food in doing this, and really, what difference does it make who does the letter.

Does that particular thing -- anyway, there are all these things.

DR. COHN: What I was just going to ask is, does it make a tremendous difference between whether it is a prescription drug versus a non-prescription drug?

MR. GELLMAN: It may. I don't believe any of the pieces of legislation proposed would regulate information about non-prescription drugs.

The definition of what is, you know, a health care service or health information would only include things that are prescribed.

Then you really get off into the question of, you know, what is a drug, you know. I mean, if you buy a low fat cereal, is that a drug? I don't think we want to answer that one.

DR. DETMER: You are getting personal here.

MR. GELLMAN: That was the way everybody, I think, resolved the question. It was an easy line to draw. If you need a prescription for it, it is covered. If you don't, it is beyond the scope of regulation.

DR. HARDING: When you get into herbs and all the rest that are coming, it is getting complicated.

MR. GELLMAN: I will give you some political advice. Talking about regulating herbs and all that other stuff is not a good idea. If you go on the internet now, you will get lots of letters.

In any event, I am proposing that we deal with this as a next issue. I don't think it will be easy. I don't think we will be able to get -- Jeffords, at his hearing last week, tried to get Giant Food and CVS and Ellensis to come and testify and they refused.

I am not sure that they are going to accept our invitation, but I think that we can find ways to put this issue out on the public record.

I am not quite sure how we will structure this thing, probably more as a hearing rather than as a workshop. We are going to need to have people come in and tell us what they are doing.

DR. HARDING: Has there ever been any suggestion that this is being done at other levels; for instance, an HMO giving information or advertising to their lives?

MR. GELLMAN: The answer is, I don't know. I have heard rumors, but every time I have tried to track them down, I haven't been able to do that.

This kind of flow of information, sort of commercial marketing, if you will, can come in a whole variety of ways.

At least at some level, it is quite possible to make distinctions between one way and another way and say that even though the substance is the same, the form is different and, in terms of confidentiality rules, if you are not breaching confidentiality we are now left in the question of whether this is an appropriate thing for a physician or insurance company or health plan to do on their own ethical --

DR. HARDING: I think it would be very appropriate for an HMO to be educating their members and telling them that you ought to take care of your diabetes better, and so forth.

The issue would be if they are being paid by Glaxo to send out that information on their product, so to speak, to me.

MR. FANNING: Dr. Harding, from a cursory survey of some of the business articles on this, that is going on. The companies, the pharmaceutical companies, are offering their services to HMOs. In some cases, the HMOs find them useful services and purchase them.

In other situations, they regard them as marketing efforts and do not want to get involved. Again, it is complicated. There are many levels of this and many of the HMOs consider it a highly desirable thing.

To purchase the service, if you will, from someone else is not necessarily bad.

DR. HARDING: Then, though, is that same company selling them the medication and do they have an exclusive, et cetera, et cetera.

MS. WARD: Yes, they do.

DR. HARDING: It gets darker and darker.

MR. GELLMAN: Yes, you got it.

DR. HARDING: That is a multi-billion dollar industry.

MR. FANNING: Again, that differs in some instances, among the articles I have read. The company said -- the pharmaceutical company -- said, look, we are here to save you money in your program. If that involves using some drug made by someone other than us, that is all right. We will include that in our program.

Now, in others, obviously, the HMOs, as I read in these articles, have their doubts because of the very question you raised.

MS. COLTIN: In this particular case, in fact, there were a number of health plans in Massachusetts that were very upset to learn about this.

It was an understanding about the patient reminder portion, and that was viewed as actually positive and good; you know, continue to take your medications and to comply.

Then, the marketing pieces in some cases were advocating medications that weren't on the HMO's formulary. So, this was being done without their knowledge.

So, they were not only getting it from the consumers in terms of being upset that this was happening, but they were getting it from some of the health plans as well, that they were not pleased that this was going on.

MS. FYFFE: I might not have my facts correct on this, but I think that recently the FDA has come out with proposed rules or guidelines about pharmacy benefit management companies, and also the type of informational materials that managed care organizations can have.

The only thing I do remember is that the comments are due in April. Do you know what I am --

MR. FANNING: Yes, and I can provide that later. The Food and Drug Administration issued guidelines governing the behavior of pharmaceutical manufacturers with respect to this sort of promotion by their subsidiaries.

It is part of the regulation of advertising. I will bring you the FDA document which is out for comment. It is not a rule. It is a guidance of some kind.

MR. GELLMAN: Just another little piece of the puzzle, I believe that the Center for Democracy and Technology has filed a complaint with the FTC about collection of drug information over the internet.

I don't know where that is going, but this is an issue that is sort of wandering all over the place, and could use some organization and some thought. So, that is what I propose.

I am not sure when we will do this. We are going to have to sit down and try to figure out -- there are just a lot of dimensions to this. There are a lot of people to try to figure out, we have to hear from.

Sometime in the spring, probably, try and hold one or two days of hearings, depending on what it is worth, on this subject. If that sounds good to everybody, we will go ahead and do that.

Has anybody got anything else?

DR. HARDING: Is there anything new on the Hill about genetics, that topic?

MR. GELLMAN: From what I have seen -- and I haven't really worked this issue very hard lately, last year my conclusion was that the genetics issue was sort of hotter than the medical privacy issue. I am not sure that is true right now.

I haven't seen much activity on the genetics front. There are a whole bunch of proposals. There are a zillion bills up there.

I haven't seen or heard of -- and I may be out of the loop; I don't know if anyone here knows -- that the effort has been made to, you know, coordinate all that interest and come up with a common draft. The answer, that is what I have heard lately.

DR. HARDING: It has just kind of been silent lately.

MR. FANNING: That is my impression. One thing to note is that the administration issued a paper about genetic discrimination in the work place.

The Department of Labor published that and it is on their web site. I can give you the citation or we can make copies, actually.

DR. HARDING: I would appreciate that.

MR. GELLMAN: One of the, I think, realizations that have sort of permeated more and more people lately is the recognition that it is really hard to distinguish between genetic information and other information.

There seems to be a genetic component to just about everything. So, the notion of saying, we are going to have rules, whether they be rules for discrimination or rules for confidentiality or rules for anything, that only apply to genetic information, it is not clear what that means any more.

DR. DETMER: I also think that the recent vote on the Senate floor on the cloning business, showing how carefully this language has to be crafted to, in fact, do what you want and stop what you want, allow other things to happen, too, I think if anything has sort of been a cautionary story as well, as far as trying to manage this easily --

MS. FYFFE: Following up on Bob's point about the definition of genetic information, if it is overly broad it would include such simple things as urinalysis and blood tests.

DR. HARDING: Or family history. That is one of the bullets you have to put in Medicare.

MS. FYFFE: Yes, exactly. Another question, you said -- I think someone said yesterday that Kennedy had introduced?

MR. GELLMAN: It was Lahey's bill that Kennedy cosponsored. That was the medical privacy bill. I don't think he has done his own bill.

MS. FYFFE: That was S1368, was it?

MR. GELLMAN: Yes.

MS. FYFFE: When was that introduced?

MR. GELLMAN: Last fall? I don't have the date.

MS. FYFFE: Have we taken a look at that? I mean, was there anything new and interesting?

MR. GELLMAN: Ask me later. No, we really haven't taken a look at it.

MS. FYFFE: Any new twists?

MR. GELLMAN: It is another bill. You know, I am not sure on the broader scale of things that it -- the problem with all the bills formally introduced to date is that none of them have Republican sponsors who are chairmen of appropriate committees, so none of them are forward-moving vehicles. They are simply there with a bunch of ideas that may be useful and may not be.

That is why the Bennett-Jeffords bill, if and when it comes, will become the leading bill automatically, simply because Jeffords is chairman of the Senate Labor Committee with jurisdiction over this issue. So, that instantly becomes the one and only leading bill. If there is no other business, we are adjourned. Thank you.

(Whereupon, at 9:14 a.m., the meeting was adjourned.)