[This Transcript is Unedited]
Renaissance Hotel
999 9th Street, N.W.
Washington, D.C.
DR. ROTHSTEIN: Good morning, everyone, and welcome to the meeting of the subcommittee. It is my understanding that we are not going to be broadcast on the Internet, and therefore we can dispense with the introductions, as everyone --
DR. BLAIR: It sure would help me, Mark.
DR. ROTHSTEIN: I have had a change of heart on the introductions. I will begin. I am Mark Rothstein, nominally the chair of this subcommittee, subject to being overruled at any time.
DR. HORLICK: I'm Gail Horlick, I'm at Centers for Disease Control and Prevention and I'm staff to the committee.
DR. COHN: I'm Simon Cohn. I am a practicing physician and national director for health information policy for Kaiser Permanente and member of the committee.
MR. FANNING: I'm John Fanning in the Office of the Assistant Secretary for Planning and Evaluation of HHS.
DR. SCHWARTZ: I'm Paul Schwartz. I teach law in New York City Brooklyn Law School.
DR. BLAIR: Jeff Blair, Medical Records Institute and member of the committee.
DR. ALTARESCU: Louis Altarescu with the Office of the General Counsel at Health and Human Services.
DR. MC ANDREW: Sue McAndrew, OCR. I am with the privacy team.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation and member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology, Agency for Health Care Research and Quality, liaison to the committee and staff to the Subcommittee on Standards and Security.
DR. SCANLON: I'm Jim Scanlon, HHS, Office of the Assistant Secretary for Planning and Evaluation, and I am executive staff director for the committee. I believe I will be Parliamentarian this afternoon.
DR. GREENBERG: I'm Marjorie Greenberg from the National Committee on Vital and Health Statistics and Centers for Disease Control and Prevention, and executive secretary to the committee.
DR. RAWLINS: Marietta Rawlins at NCHS.
DR. KOO: Denise Koo, epidemiology program office, CDC.
DR. JACKSON: Debbie Jackson, NCHS staff.
DR. WILDER: Tom Wilder, American Association of Health Plans.
DR. JONES: Kathryn Jones, NCHS.
DR. ADLER: Jackie Adler, NCHS.
DR. ROTHSTEIN: Thank you. With the consent of the subcommittee and Parliamentarian, I would like to propose that we take up the following issues this morning. First, a discussion of the meeting dates and timetable, including not only the meeting itself, but the subcommittee deliberations following the hearing, and our plan for developing recommendations and getting it through the full committee, et cetera. Then we need to spend some time on the format of the hearings, the topics and the speakers that we plan to invite, and in what manner.
Now, if I could just ask Louis Altarescu to come to the rescue and tell us what the latest version of the timetable is that would be acceptable.
DR. ALTARESCU: The dates that you had given I think were August 23 and 24.
DR. ROTHSTEIN: The 21st, 22nd and 23rd.
DR. ALTARESCU: Right. The Department is fine with those dates.
PARTICIPANT: What did you say?
DR. ROTHSTEIN: The Department is fine with those dates.
DR. ROTHSTEIN: What is the last date on which you would need the full committee's recommendations? So in other words, how much time do you think we would have after the close of the hearing to submit some final recommendation to you?
DR. ALTARESCU: About one hour. I really can't say now. Maybe we can get back to you further on that. But in terms of scheduling hearings, which I know you need to proceed on now, you can proceed with those dates.
DR. COHN: Mark, realistically, if we are talking about a 21st, 22nd, 23rd hearing, likely the earliest that this committee could come up with a letter recognizing that it is on a sensitive topic, it is likely to be the 25th and 26th of September. So we just need to be aware of that.
DR. ROTHSTEIN: Because that is the next meeting of the committee.
DR. COHN: Realistically, I think it is going to be hard a week later to get -- maybe I'm off on this one, but it seems to me that it might be very hard doing a conference call to get full agreement from the committee on a letter related to privacy. I am just being very realistic, especially when we are talking about that. Everyone else can ponder about that.
DR. FITZMAURICE: I want to ponder a little bit. I would suggest that given the best of -- getting any changes in the privacy rule out. But after the sets of hearings, usually we have a session where we say, all right now, what did we hear, what do we think the main points are, and probably a communication of those main points a week after the hearings would be helpful to OCR, even if it doesn't carry the full weight of a letter that reaffirms the main points and specifies some exact wording, in September. The earlier the better.
We probably will have a good deal of the changes done in draft form, and somewhat ready to go. Having the backing of NCVHS, having perhaps something they didn't consider at the time, but came up in our hearings, would be helpful to have a week after our testimony, even if it is not the official word. I suspect they are going to have staff here listening as well. But they don't want to go off in a different direction than NCVHS does and attribute it to NCVHS, so some kind of reaffirmation of, yes, this is what we think we heard based on our discussions. We will send you a letter. It could be something unofficial say from the chairman.
DR. ROTHSTEIN: Yes, and it may very well be that OCR staff attending the hearings and listening to the testimony will say, oh geez, we hadn't thought of that, and maybe we need to tweak some of the language to prevent this unintended consequence of the reg.
DR. GREENBERG: That may be adequate. If it is feasible, I think something in the idea of findings could be provided. But I don't think -- you could not provide recommendations, because they have to go through the full committee.
DR. SCANLON: If we work backwards again from the publication of a proposed rule with any modifications, which would be October or later, because the full committee meeting is late September -- I'm just trying to see what actions would be required at what point -- the 24th of September, at which point the recommendations will be deliberated and acted upon. It is very close, but it could be done.
I think the question would be, will it still be -- will that still provide information in time to help with the NPRM, or would we be behind?
DR. ALTARESCU: There is the NPRM, but from the NPRM to the final is a period of time for public input. So your recommendations or any elaborations that come out of the hearing will contribute to the development of the final rule.
So contributing to the proposed rule would be very helpful, of course, but any comments that you have after it is proposed, obviously we want to hear and will be helpful in developing the final rule.
DR. ROTHSTEIN: As a question, you think it is possible that the NPRM could actually be issued before the 24th of September?
DR. MC ANDREW: Anything is possible. Is it likely?
DR. FITZMAURICE: It may also snow on that day.
DR. MC ANDREW: No, not likely.
DR. SCANLON: It is just impossible to predict months, and HHS doesn't do that anymore, because it is just impossible.
DR. ALTARESCU: We have a whole new team, of course, who had not been involved in the rule before. We are dealing with all of these issues with them, and the Secretary of the Administration has to take a position. So these things take time.
DR. COHN: I will make one comment and I will close my mouth about timing, because you heard offline the comments I made.
As I listen to this, I continue to be concerned that late August appears to be late in the process, as opposed to early in the process. Now, if we are all convinced that within one hearing we can come to completion around all of this and put everything together and have clarity, which is elusive in this area, I am certainly comfortable with the dates that you have identified in late August, but I do think we should just mull for a moment over whether or not -- as we are listening to this, we are making a few too many assumptions to go for late August.
DR. ROTHSTEIN: Simon, I appreciate those concerns and I share those concerns, but we are going to be late one way or the other. We are late if we want to have a hearing let's say at the beginning of August. In other words, we are late in getting that organized. If we go for the end of August date, we are going to be late in the HHS process.
I think that all things being considered on this, I would prefer to be late in the HHS process and be fairly confident that we are going to have an excellent hearing, that if we contacted the right people, that it was inclusive, that it was well planned, et cetera, even if our input is delayed until conceivably late in the deliberation process at HHS, or even possibly after the NPRM comes out.
The other alternative is to move it forward. I am not that comfortable that we can pull this off, given the number of people who want to testify. Even though we have identified only four main issues, they have so many subparts to them, I'm just a little concerned about that.
DR. GREENBERG: I agree with you, although I understand what Simon is saying. But I think we should maybe look at least in terms of trying to identify a date for a second hearing in the fall. As Louis said, there is going to be the NPRM, so it is not that a final rule is going out in September, early October. So if issues don't get resolved or you don't feel you have enough input to make recommendations, you can have a second one as input into the process.
DR. ROTHSTEIN: So backup dates, but not scheduled until after the first hearing.
DR. ALTARESCU: So once we publish it as a proposed regulation, we will get somewhere between 11,000 comments and 50,000 comments, which are the numbers of comments that we have gotten in the previous efforts. So we will quite frankly have plenty of public interest.
But where you might be helpful, what you might think about, is that once it is proposed as a rule, then you have something more substantive to respond to. So I would think you yourselves could come up with additional recommendations or actions or input, based on what we have published, rather than a second round of hearings.
DR. GREENBERG: I think you might want to consult selectively or something as you are developing your recommendations. So there is an opportunity there, not necessarily an open hearing, just, y'all come, but --
DR. COHN: I think having dealt with the other HIPAA transactions, certainly hearings in the middle of an NPRM process, once the NPRM is released, are not particularly enlightening or helpful, since everyone is busily writing their responses to the NPRM at that point. Traditionally, where the NCVHS has been really valuable in terms of our partnership with HHS has been helping guide HHS in the development of the initial NPRM. So you should just observe that.
DR. ALTARESCU: The other helpful perspective that the committee provides is that unlike the comments that are sent informally, which is one perspective, the committee hearings allow for some cross examination, and they allow for panels to have one view and then another view, which actually allows you to go this a little more deeply than one organization's detailed comments.
So I think what I am beginning to conclude is that almost regardless of the process and the timing, the information and the interchange and the insights that come from an NCVHS hearing are worth -- even on a parallel track alone, are probably worth pursuing for the purposes of the staff that would be involved in writing the regulation and others as well, then any formal recommendations the committee might want to make. I would think that would be -- the initial set of recommendations might almost be the platform for later as NCVHS recommendations, when the NPRM may be out.
This is a moving target obviously, just like the standards. It is not like you can suddenly hold still and get a thorough examination there and then move on to the next step. This is a moving target. Things have to be done in parallel.
DR. ROTHSTEIN: And I think you make an excellent point about the opportunity to question the witnesses. You have to expect that many of the comments for example are in the form of advocacy, so they say the sky is going to fall unless you do this, this and this, or you don't do this, this, and this. If you say, couldn't you avoid that problem if you merely did this? Those are the kind of give and take that you can't get in writing.
DR. ALTARESCU: Plus the dialogue, in terms of, if you have a panel of people with different points of view, then you can have a dialogue back and forth that may help a better understanding of the effort.
DR. SCANLON: It sounds like whatever date we pick is going to be imperfect, and it also sounds like our options are very limited. So it sounds like if we could just simply make the best that we can with the dates that we have, and go forward.
DR. ROTHSTEIN: Okay. Well, without objection, Simon's caveat noted for the record, we will proceed with the dates of the 21st, 22nd, 23rd of August.
Now, those dates are not full days. We have a half day on the afternoon of August 21, and then a full day on August 22. We were going to schedule in deference to the other committee that was meeting only a half day on the 23rd, so you guys are not going to be here forever. But let's just see what the arrangement would be.
One possibility would be to conclude the hearings by the end of the second day, by the end of Wednesday, in other words, have a day and a half of hearings and then a half day of committee deliberation on what the hearings informed us about, and where we should be thinking in terms of recommendations. Or we could have a half, full and then another half, in other words, two full days of hearings, and after the hearings work up with staff some summaries, and then proceed to the recommendation stage later on.
Are there any thoughts about which of those plans is best? Two full days, given that we are only having on hearing?
DR. FITZMAURICE: I think if I understand the combinations, you have a day of hearings and then a half day of hearings either before or after that full day, is that right?
DR. ROTHSTEIN: No, we're going to have a half day first and then a full day second, and possibly another half day or a half day of committee deliberation.
DR. FITZMAURICE: The only comment I wanted to make is that when you are setting up these hearings, often it is harder to get everybody in on a one-day hearing, it is easier to get them in on a day and a half; those who can't make the full day can split over to the half. I think you've got that covered, either way you go.
DR. COHN: I do apologize, it is about 5:30 in the morning in California.
DR. GREENBERG: And you've been here since Monday.
DR. COHN: I know. I am actually feeling it today, I'll tell you. This is just an observation from the other subcommittees that a number of us are involved with. The assumption that we can go for a day and a half and then have another half day at the end to put it all together is assuming that everyone is going to be there for the entire time. Our observation at least from other subcommittees is that people tend to come into groups, tend to go out of groups, they are here but they're not here. You know what I am describing.
Our experience has been generally that it makes a lot of sense, rather than waiting to put it all together at the very end, that in each half day or day, you devote some time to putting it together right then, with the idea that you can modify it as you go along, but waiting until the end is a relatively high risk issue, at least in our experience of other subcommittees.
DR. FITZMAURICE: I just want to echo what Simon says. You lose people who can only come for one day or who are in and out. So that is an advantage of summarizing every day. Frankly, sometimes you forget, and it helps to have reinforcement from somebody else on testimony that you heard that day.
DR. ROTHSTEIN: Let me explain timing needs for the topics. We have identified four issues that we want to talk about: consent, minimum necessary, research and marketing. It seems to us on the conference call that many of the people who want to testify will want to testify as to more than one issue. But they seem to break out in the sense that the marketing might be a discrete issue, whereas people who want to talk about marketing are not necessarily going to talk about consent.
So what we thought we might do -- and this is for your consideration -- would be on the first day to talk about marketing, that half day, and then the full day and perhaps the full day and the next half day, depending on how you want to slice it, to talk about the other three issues. We will have panels of people as opposed to panels of topics, or else the AMA is going to have to testify three times.
Does that make sense? And then after the first day, we could have a recap of the marketing issue, and get some idea of what was said, and then whenever we decide to stop the second part of the hearing, we would try to put together the issue on minimum necessary, consent and research.
DR. ZUBELDIA: If you can get the people on the second day to stay over for the third day, that would be okay. But I think it is positive to have a recap in the presence of the testifiers that testified that day, because they a lot of times contribute to that dialogue.
DR. ROTHSTEIN: Well, it would be an open hearing for sure, that is, an open committee deliberation. We would certainly invite anyone who wanted to, to attend and perhaps make known the fact that we might have some additional questions by way of clarification as we try to synthesize all that we heard.
DR. COHN: I'm sitting here trying to decide in my own mind whether marketing is truly a separate issue that you can get a whole new set of testifiers in on. In some ways, what you're saying I think does make some sense.
I guess the question is whether or not that is the first issue we should be dealing with, and the last issue that we should be dealing with, at least from my view of all the issues that I think about privacy, marketing is -- yes, it is an interesting issue and I am concerned, but it is the last morning issue.
DR. ROTHSTEIN: The reason I suggested doing it first is because we have that half a day on the first day. So the only other option is to have a half day, then another half day on the other issues, and then marketing at the end. We are stuck by the time block that we have. We only have a half day on the 21st, because it comes at the end of your other hearing.
DR. COHN: Let me give you a different conceptualization, which might be that we start on the main issues on the first day with a recap at the end of the first day, go the next day on the same issues, try to deal with that by the end of the second day, and then the third morning basically talk about marketing specifically.
DR. ROTHSTEIN: If we do the marketing -- are you talking about the marketing hearing on the morning of the 21st?
DR. COHN: Yes.
DR. ROTHSTEIN: Okay, and when would our deliberations -- our deliberations would be set in sequence. In other words, we would start on the big three the afternoon of the 21st, and have that afternoon all day on the 22nd and have a rolling summary, and then the morning of the 23rd have our marketing hearing followed by some sort of pulling things together.
DR. COHN: Once again, I am just thinking of what is important. I have my own view of what is important, I recognize, and I may be alone on that one. But I just think of it as a secondary issue, as opposed to the others being a little bit more primary.
DR. GREENBERG: Are you able to stay for the 23rd?
DR. COHN: I will try to make myself available the 23rd.
DR. ROTHSTEIN: Oh, I see now what you're doing. You don't think marketing is very important, and that was going to be your last day.
DR. COHN: No, I am intending to be there. I think my concern is to make sure that we're doing a good job on the big three.
DR. ROTHSTEIN: No, I understand, and I certainly didn't want to give the impression that I thought that was more important than consent or all these other --
DR. BLAIR: Mark, one other benefit from laying it out that way is that essentially on the end of the day of the 22nd, you really can complete the deliberations on that first day and a half, because marketing is -- at least as I perceive it to be -- a rather different topic. So you really have a chance to wrap up a lot of that on the day of the 22nd, and then deal with marketing the morning of the 23rd.
DR. GREENBERG: One of the things that I would say about marketing is, it certainly is related to consent. That is a big part of the issue, that it is very related to consent. But that doesn't mean that the people talking about marketing can't talk about other issues.
DR. COHN: Or vice versa.
DR. GREENBERG: Right.
DR. HORLICK: Just because it is August and people's schedules -- if we are carrying the major issues over two days, we may have a little more flexibility, if someone can't come one day they can come the next day. That may be important.
DR. ROTHSTEIN: Although if we decided to do it with say a provider panel, --
DR. SCANLON: I was thinking the way Mark is now, in terms of how do you want the perspectives organized. If you did that from the point of view of say covered entities and their various submissions, but you had a consumer on a patient protection panel, that would cover things like marketing as well as informed consent.
You could set a panel up, in other words, of consumer representatives, patient representatives, and ask them to look at informed consent and marketing and any other issues they might want to raise. There might be less of an interest for research. In other words, you can ask for a perspective and ask them to comment on the four areas, or you can take each area and divide it up into these various perspectives.
Marketing is understood by very few people. I'm not even sure that many people understand what the provisions really are and what the options might be, but it is basically a consumer protection. I guess the providers or the plans would have another perspective on it.
DR. BLAIR: Given what Jim has said, and given the experience that we have had in pulling together hearings that go over several days, it almost seems like there are iterations that you go through as you try to schedule the people. You wind up identifying the topics, you wind up identifying the panels, you start to contact the individuals. You get anywhere between 50, 70, 80 percent of them that could be available at the time that you want them to, and then you start to juggle.
My thinking is that as long as we have identified the major topics, maybe if Gail takes the lead on this in terms of contacting people, she could lay it out, and then she may have to modify the agenda based on availability.
DR. GREENBERG: I do think this makes it obvious why we cannot have the hearing August 7. It takes awhile to organize something like this, and I think that this gives us enough time to do it.
DR. FITZMAURICE: Just to follow up on what Jeff and Jim said, if you wanted to define the panels the way that Jim said, here is a provider panel, here are doctors, here are hospitals, here are universities, here researchers, then you could structure their testimony in a letter that comes out from Gail that says, we invite your testimony on the following topics, any one or more of the following topics, and then pick the major topics that you have identified that we are going to get the consumer deal on those four topics, you'll get the provider deal on those four topics, and run through the covered entities and on to the people who would be affected by them. That is just another way of phrasing it, but I'm picking up on what Jim said.
DR. COHN: So you are thinking not to have a separate marketing hearing, but just basically ask every one of the question that anybody chooses to answer as they go through.
DR. FITZMAURICE: Because if you've got AMA and the AHA testifying, do you want them coming in four different times, or do you want to hear what the AMA and the AHA have to say about this, this and this? They may not devote very much space to marketing, or they may devote a lot of space to marketing. But it gives them an opportunity to structure their 10-minute testimony and devote the time that they think is more important, and we will draw them more out in questions.
DR. ROTHSTEIN: We will invite them to testify on any of the issues, but if we have a panel of marketing companies, for example, or pharmacy benefit managers, whatever, it might be on that third morning.
MR. FANNING: Apropos your comment yesterday that this was not an opportunity to as it were re-litigate already settled issues, you might consider how the structuring of the panels encourages or discourages that. To the extent that a particular organization has one chance, they will express their views on a series of things, and they may well repeat what they said in comments on the original NPRM and then comments on the final.
So if you do it that way, let a particular organization testify, I think you are going to have to emphasize to them that it has to be focused on the particular topics that you are asking about.
DR. ROTHSTEIN: We will do that in the letter that we send out, in the oral communications, as well as at the hearings. I don't want to cut people off, but I will remind people that this is not a general gripe session, and that we have three areas. If you want to make a contribution on behalf of whatever position you have, to the extent that you focus on whatever we are interested in, that will help.
DR. COHN: I just want to say that one of the strategies you can use is to invite them to submit written testimony. We may get those 40 pages of comments out of the way, but ask them to focus in their oral testimony on specific issues.
But I would also say that you are probably going to have to do a little more than just suggesting to them that they do X, Y and Z. I think it is going to require a fair amount of organization and structure coming from the whole subcommittee. I think there will be a tendency for everyone to want to go back to their original comments from the final rule and from the revised final rule in March and April.
DR. ROTHSTEIN: I'd like to ask the more experienced committee members about the issue that you raised regarding written submissions. When I think about written submissions, I think about reading them. I think it would be really unfair to ask people to submit something in writing, whether it was specifically prepared in advance of this testimony as opposed to just rehashing their point, without a fair degree of confidence that the committee members or the subcommittees were actually going to read what was submitted. We could get thousands of pages.
DR. GREENBERG: Give a page limit. I think you should have written testimony, because you want to have a fairly modest amount of time for their opening statement. Then you really want to be able to ask questions and have discussion, et cetera. So by giving them the opportunity for written testimony, they can get things down that they feel they need to be on the record about. But you can give them a page limit.
DR. ZUBELDIA: Marjorie, is it possible to get the written testimony a week in advance so we have time to read it before --
DR. SCANLON: You can ask for it, but it is very hard to get.
DR. HORLICK: We always ask for something in writing. If it is Power Point slides, depending on the type of presentation, or an outline or the text of what they are going to say. We usually get somebody -- they bring a disk that day.
DR. ROTHSTEIN: And we permit them to use Power Point?
DR. HORLICK: Yes.
DR. SCANLON: I think the experience will be very similar to what the Standards Subcommittee goes through. Many of the same organizations will be testifying. Some won't do written testimony. They just come in and they say whatever they were instructed to say by their organization. Others actually give you written testimony, and others give you very long written testimony. It just depends on the organization.
My guess is, we are not going to see anything more than their comments on the final rule. Why would they? Why would they give you more than that? Then their oral testimony, they would bank on it a little bit more, unless we give them specific questions.
It is very difficult for an organization to pull together formal comments on a complicated regulation like privacy. I am thinking of their own clearance processes. I'm just not sure they are going to be able to prepare a lot of new material. My guess is, they will fall back on their comments on the final rule.
DR. ROTHSTEIN: How about if we invite them to submit written testimony with a page limit, say, ten pages double spaced as a maximum, and say that the earlier in advance of the meeting that it is submitted, the more likely committee members will have a chance to read it.
DR. GREENBERG: You don't have to say that. It would be valuable to have it in advance.
DR. SCANLON: Even the Congress doesn't get it too far in advance.
DR. ROTHSTEIN: Maybe I shouldn't say that. Maybe it is understood. Advance submission would be greatly appreciated.
DR. GREENBERG: There is the whole issue of having copies available. So if they are going to bring it with them, they have to bring --
DR. COHN: I guess I want to clarify -- because I'm getting a little worried here. There is written testimony and there's written testimony. And written testimony oftentimes means the testimony that you have written down that then you deliver. I think what we are really talking about is supplemental information. We want to have written whatever it is they are saying, because otherwise most of us can't remember it on to the next discussion. But in addition, what we are doing is offering them the opportunity, if they want to bring X number of pages of other information that we don't want them to go through verbally with us.
DR. ROTHSTEIN: My inclination for your views is to ask the witnesses to keep their initial comments brief so that we can have the give and take.
The other thing that occurs to me is that my initial inclination also is to have panels of like-minded people, in other words, have an industry panel, have a consumer panel, et cetera, as opposed to having three consumers and three marketers, let's say, and then we'll be spending our time refereeing the conflicts among the testifiers.
DR. FITZMAURICE: That is actually the fun part of the hearing. It makes a very interesting discussion. But I think you're right on how you want to structure it.
DR. ROTHSTEIN: Fun notwithstanding, you don't think it is a good idea?
DR. FITZMAURICE: No. I'd like to have the fun, but I'd like to have it, not like-minded, but like-industry.
DR. HORLICK: It would encourage people like consumers to stay for the marketing panel, so they could contribute to the discussion.
DR. FITZMAURICE: And they do. They come up with comments afterwards from the audience.
DR. COHN: I don't know, I need to think about that a little bit. I am just reflecting on the many hearings that we have all sat through, and hearing six people saying the same thing without anybody disputing between themselves doesn't get you -- I think what we are trying to do is develop some consensus to understand the conflicts and possible resolutions to the conflict, is I think what we are trying to do, as opposed to just understand their positions. The only way you are going to be able to do that is to create some environments where you see some differences in positions. Then you can ask them, what about that person's position, what about your position?
I just bring that up. Mike describes it as fun, but from my view, it is more a question of, geez, we are just not trying to understand what the position of a particular industry segment is, I don't think.
DR. ROTHSTEIN: What occurs to me is the logistical problem of, you have got three provider representatives there; who are you going to seed that panel with to be the antagonists? John, do you have any feelings on that, how we get contrary views presented in a constructive way?
MR. FANNING: By having a panel that includes people both from the consumer and privacy advocacy community and people who may be pressing for more and wider use of information, and then just as was just discussed, you can say, what do you say to Miss Goldman's objection --
DR. ROTHSTEIN: Just to pick a name at random. So you would support the idea of this mixed panel?
MR. FANNING: Yes, probably, yes.
DR. GREENBERG: We had talked I know on the phone about having providers and the plans and all of that. I can see the advantage of this also, because otherwise, what you end up with is a consumer panel, and they are kind of marginalized. I think it makes more sense to have the different views probably.
MR. FANNING: Yes, I think so.
DR. GREENBERG: But people also will give you their preferences as to whether they are comfortable being on a particular panel. I do have a problem with just one consumer or privacy advocate or whatever. It is sort of like, they also follow their whatever.
MR. FANNING: Yes. By this point there is a classic progression. Any hearing or discussion of privacy, there are representatives of the provider community, of the pharmaceutical industry and perhaps some other group, followed by Jan Laurie Goldman. That is a regular Congressional hearing.
One may say about that, it is desirable to have them all at the table, so that you can have exchange among them. But maybe we could come up with a newer and more imaginative style for that.
DR. BLAIR: Maybe we could have the consumer viewpoint represented first, and then have the industry reaction to that second, just change the order.
DR. SCANLON: Have a privacy perspective on everyone.
DR. ROTHSTEIN: What I am searching for is an organizing principle to put the panels together. I had originally floated the idea of having panels by topics, and then there was a fair objection to that on the theory that well, the same organizations would have views on all these topics, and you can't have them testify four different times. So what do you think would work best as a practical matter? And how are we going to organize these panels, as opposed to just saying, panel one, bring them out and then panel two, bring them out?
MR. FANNING: Mark, with your original suggestion, was there consensus that that was not the right way to proceed, by topic?
DR. GREENBERG: The problem is that people are going to want to talk about consent, they are going to want to talk about minimum necessary. They may well want to talk about research, too.
MR. FANNING: Okay, I appreciate that. But I think a better and more focused exchange can occur if it is per topic, rather than an organization reciting all its grievances.
DR. GREENBERG: You've got a good point there.
DR. COHN: Have a mixed group focusing on --
MR. FANNING: On the particular topic. They may have to stay around, or ideally send different people to engage the different topics, send people with sufficient in-depth knowledge to engage per topic.
DR. ROTHSTEIN: That was my original preference. One of the things that I had not thought about that makes that option more attractive is the opportunity to submit written comments, which gets their objections or proposals on the record, and then we just want to talk to you about research, and that is why we have asked you to come here.
DR. ZUBELDIA: I also think that a panel per topic is probably more productive. If you give the AMA ten minutes to talk about all four topics, they probably are not going to get very far. They are probably going to need more time than that.
Also, even though I like the idea of having antagonistic panels, where you have a little friendly discussion, you may not be able to do that with all panels. So don't make that as a requirement. There may be some panels that are more homogeneous and you don't get that kind of antagonistic discussion.
DR. GREENBERG: But if you do by topic, you are more likely to have heterogeneous --
DR. ROTHSTEIN: And we may well need just for logistical purposes two panels on topic A and two panels on topic B, because you can't have a panel of 50 people. Michael?
DR. FITZMAURICE: A couple of things, one on getting the testimony ahead of time. A lot of organizations, you are working on it right up to the last minute. You're getting a vice president's comment on this, a vice president's comment on that. We're lucky if they bring a disk, we're lucky if they bring it on paper, and we are happy to have Power Point, because when somebody talks without anything to remind us of what they said, we often don't get all of it. So I'm not sure how successful we will be getting testimony a week or two weeks ahead of time. It would be desirable, but just the review process -- when we go through regs and everything else, it's, give me a deadline and we'll get it done by that deadline, but we're working up to that deadline. When people send comments in, that is a good signal for us. They send them on the last day; they have all this review.
Secondly, if you are going to invite a big important organization to testify and you say, we want you to testify just on consent, they will start off saying, I'm glad you invited me to testify on consent, and here is what I have to say about consent, they will say it, and we also have some additional topics that we feel are just as important, and they will spend all the time they want until you chop them off talking about their topic. So you can't just focus them -- because they are being paid good money to get all the viewpoints across.
Then thirdly, it is kind of the role of the committee to be antagonizing, rather than have two people, a consumer and the use of an information advocate. They probably talk at the same panels at four or five conventions during the course of the year, so they get along, they know where all the hot buttons are. They may push for the hot buttons and ignore the other hot buttons that we think are important. It is our job to ask them questions and to draw it out, not their job to put on a good show for us.
DR. ROTHSTEIN: So what you're suggesting is, we need subpoena power and contempt power. So I think we have some marching orders so far, in terms of our dates, the organization of the meeting in terms of what order to put the different topics in, as well as the structure in a broad sense of the panels.
Now I'd like to --
DR. COHN: I heard something diametrically opposite from Mike about how we are structuring this, but I will not pay attention to his comments.
But having said that --
DR. FITZMAURICE: I think it doesn't matter how you organize it, it really doesn't matter.
DR. COHN: That is sort of my conclusion too, as long as you get the people there, we'll get a lot of value. The question is, there are a couple of other fundamental issues about how you are organized. One is, you have people come in, you have six people for an hour and a half and you have them give ten-minute presentations and you have 30 minutes for question, then take a break and the next group come in. Or you do it where you get six or seven people and you spend the whole morning or the whole afternoon. I just think we need to think about the pros and cons of both of those.
I don't know which is the right answer for this one, but we need to think about what would make sense in terms of what we are trying to get.
DR. BLAIR: Fortunately, we have a very able person in Gail Horlick, who has had a lot of experience pulling these together, has a wonderful track record, giving these sessions that have been very informative to us. I think with the information that we have given her now, she can probably do the best balance that can be done. Nothing is going to be perfect in how we wind up creating that agenda.
DR. COHN: Jeff, I am actually talking about the difference between a panel versus a roundtable discussion, is all I am referencing, which are things we have done both of. I am just trying to think in my own mind -- because they do require different structures, and I don't think you want to decide that, Gail, as opposed to have us give you guidance on which we want. I am just bringing up the issue, are we doing panels or are we doing roundtable discussions?
DR. FITZMAURICE: Just another comment on that. Sometimes you won't know until you can get one particular group together, and there are times we had to mix them together to get good panel sessions, too. And it turned out to be a roundtable, as you said.
DR. ROTHSTEIN: I view the selection process as one in which the subcommittee members will be intimately involved, and we will keep you posted via e-mail and conference call, if necessary, and let you know how we're doing. So it is going to be a -- you're not going to get something in the mail two weeks before saying, this is it. So we will be working on this as we go along.
What I would like to move to now is some discussion of the topics. In other words, we had already decided upon these four broad areas, but what we need to do I think is focus somewhat more narrowly. I'd like to ask Louis and Sue if they could help us, not to put you on the spot, but I am. Do you have any more specific guidance for us as to what you are looking for within each of these categories? In other words, we've got the minimum necessary, research and marketing. Were there particular areas that are under review, and there is discussion and, more information would be helpful to us on A, B or C?
DR. MC ANDREW: They vary within the topics. I think consent presents two fundamental issues. One is, we know there is a real workability issue with having a prior written consent in all instances, because there are a number of necessary and unavoidable initial contacts that are made between patient and provider; they are not in a face to face or other kind of environment that permits the prior consent requirement to be fulfilled.
We don't really need any more information from pharmacies on this.
DR. SCANLON: They have made their point.
DR. MC ANDREW: They have made their point. But what we don't necessarily know is what the rest of the universe may be like, who else may have a similar problem. We do know that in the case of referrals, one provider to another, the same type of issue can arise. If your primary care physician is referring you to a specialist or to a hospital for surgery and you haven't had any prior contact, it is unlikely you would have had prior contact with the specialist and unlikely that you may have had prior contact with the hospital, the same kind of issue can arise with those entities getting prior consent. That is, we have a handful of those issues, but our suspicion is that there are others.
DR. ROTHSTEIN: The issue was suggested to me about teaching hospitals and consent to share information with students on rounds and that sort of thing. Is that something that you are considering?
DR. MC ANDREW: We are not convinced that that is a real problem with the way the rule is structured. But it may well be that there are other kinds of interactions where hospitals bring people in from the outside to do various and sundry, and we just don't have that -- all of those interactions covered by either falling within the treatment, payment, health care operation categories that we set up that are governed by the consent. But we think that the people that are concerned about students in a teaching hospital, that those are basically fine under the rules, and that we will basically be able to treat that with the guidance.
The other aspect of consent is really a particular question for the AMA and other docs, who during the final rule strongly supported having a consent, the ethical obligation to have a consent. When we went out and required a consent, there was a lot of stepping back. Now, clearly the provider community is somewhat split on this issue. Institutions, hospitals, are clearly very opposed to consent. We have a lot of -- the AMA and independent docs, particularly those in sensitive practice areas like psychiatry and the psychologists, who are very supportive of consent. The AMA seems to be waffling a little bit.
I think we would be interested in knowing more about how they perceive this ethical obligation, how do they make it work now, what do we do in the rule that now gives them heartburn, and is this something we can fix without throwing out consent.
Minimum necessary is again an area where it would be helpful to know if there are real problems, real burden, in making this concept work. I think the comments that we have gotten to date have been relatively unhelpful.
DR. ROTHSTEIN: To date, not today, right?
DR. MC ANDREW: Right, to date.
DR. ROTHSTEIN: We haven't checked today yet.
DR. MC ANDREW: A lot of heat, little light.
DR. SCANLON: So could I just follow up? Have we seen in the comments a desire for more operationalization of that principle? Have people just been opposed to the very notion of minimum necessary? Or do they say we don't know exactly how you operationalize this. Are they giving extreme examples?
DR. MC ANDREW: We get two comments generically. One is, it's fine, we do it now, but don't make it the standard. Don't judge us on how well we operate. It should just be some sort of underlying principle that is not measured, and we all just do the best we can.
DR. ROTHSTEIN: An ethical, not a legal obligation.
DR. MC ANDREW: Right. The other comment we got is, we understand it is reasonable, but what do you mean by reasonable. Is this reasonable, is that reasonable, only they don't really give you the this and the that. It is, what is reasonable, give me reasonable. So you are kind of left with, it was purposefully flexible so that you can mold it to your unique situation, needs and work force. We can't possibly conjure up all of the interactions that would go into your particular procedures. If people have scenarios or real concerns about how this would operate, it hasn't come out in the comments to date.
DR. COHN: I guess the other question on that one would be -- to my view, minimum necessary, the big issue there is that nobody knows what it means. So you get lawyers and consultants out in the field, giving absolutely the most Draconian view of this whole thing and scaring everybody. I am presuming within your guidelines to be published soon, we hope, that there will be additional clarifications in this area, and the question will be, what other issues are there beyond that. Is that a correct set of assumptions around that? I presume this will be part of your guidelines, in some way providing some sort of clarification?
DR. MC ANDREW: Yes.
DR. ALTARESCU: I don't know whether it would be helpful if people want to try to articulate what they would define as reasonable or what they are concerned with, what would be over the line, and whether they wanted to offer some comments on that.
Where we have been very specific in the rule, sometimes we are charged with micro managing, or where we are saying, you only have to do what is reasonable, we are challenged with not providing sufficient guidance. I could understand both perspectives, but it does make it difficult for us. So there may be help there.
There has also been some confusion in regard to, the minimum necessary standard does not apply for disclosures or requests in regard to treatment. But we didn't specifically say that it doesn't apply to uses for treatment. But that will be clarified in the guidance, and we think that is easily resolvable in practice. So that should not be an issue.
DR. MC ANDREW: I don't know, I think I would disagree a little bit. I think really, we do get a lot of comment about whether even applying the standard internally to the institution in a treatment setting makes any sense.
So if commenters want to provide some specific examples or some suggestions on, in the treatment area, the way the rule is written, is this too narrow in allowing these conversations between providers, not within an entity and not between an entity and say a plan that is coordinating care.
DR. ROTHSTEIN: What about research issues?
DR. MC ANDREW: One caution. That is, once research enters the conversation, it then tends to take over the conversation. So you might want to really corral the research topic into its own little universe.
DR. ROTHSTEIN: And ask very pointed questions to address?
DR. MC ANDREW: And also, it cross cuts a lot of the other topic areas but it comes at them from a very particularized perspective. I think we would be interested in knowing whether we have through the IRB privacy board waiver process and the informed consent/authorization process allowed enough research access to information of those avenues, efficient.
We have had some interest expressed in moving research more into the health care ops kind of universe, as opposed to looking at it as an external use of data, some discussion, where does it fit within the industry would be interesting.
Also, we have had a lot of comments about the particular groups that entities have to go through in order to get the IRB waiver, what are the standards. I guess my recommendation would be to keep away from those, as it tends to be a very unexciting technical discussion. I think it is something that we would get directly from the research community, rather than in this kind of public hearing.
DR. ROTHSTEIN: Simon, did you want to comment?
DR. COHN: We are both whispering over here. I am still struggling to understand what the research issues are. I have thought about them a lot and asked a lot of other people, and I am just not sure that any place that does research in a serious fashion -- by that I mean, if you are doing research and you don't have an IRB, maybe there is a problem there, but maybe there is a problem anyway. But if you have an IRB and you are actually doing bona fide legitimate research, I'm still struggling. Maybe we will hear testimony that will enlighten all of us on this one, but it seemed to me that it was actually pretty well covered in the rule. Maybe there are some little pieces where clarification needs to occur, but --
DR. ROTHSTEIN: One of the things that I have experienced, and Robin Soo touched on it yesterday, is, there is so much misperception out there. There are researchers that I have encountered who are scared to death of the regs, and have never read them. So I think part of it may be that, and that is of course better addressed through OCR's educational and outreach programs. But there is something to be said for allowing the public to voice their concerns, even though we don't think they are justified.
DR. SCANLON: And hopefully there will be some foundation.
MR. FANNING: In this regard, may I suggest that you include among the people testifying someone from the protection of research subjects community?
DR. ROTHSTEIN: Maybe somebody from Greg Kosky's office or someone who has IRB experience or something like that.
MR. FANNING: Possibly, someone who is on Greg Kosky's advisory committee, for example, because these things intersect very closely. With respect to Sue's reference to whether research maybe ought to be considered more under operations, I would note that within a particular institution now, the use of information for research in the institution is research which must be reviewed by an IRB. The fact that it is in house doesn't get you out from under the protection of human subjects rule.
So I think clarification of those rules and of the ethical thinking behind those rules would be helpful in such a panel.
DR. FITZMAURICE: I'd like to suggest another area that is particularly thorny, that is, public health. How does data get from a covered entity to a state department of public health, when the state law doesn't specify the specific data elements or the specific mandate to collect a certain body of data, but gives a general authority? I know that is a case where there will be a lot of questions. It may be a case where a particular guidance could handle it, rather than a revision of the privacy rule. But I think those issues need to be brought out and developed, because some of the people feel like they are not certain how they can get a stronger voice in this.
DR. COHN: To me, the issue I think is disclosure. Isn't that really the issue?
DR. FITZMAURICE: How do you cross the fence of disclosing the data of covered entities to a public health department or an organization acting on behalf of the public health department.
DR. COHN: Right. I think there is an issue called disclosure, and I think this is one of the -- what I keep hearing is people scratching their head about having for example to track disclosures, or get approval. I don't think you need approval for that disclosure, but you need to track a required disclosure, for example, that sort of thing.
DR. FITZMAURICE: That is different. I think the burden is on the provider to keep track of disclosures beyond treatment, payment and health operations. I am talking about, there are public functions going on with data, that a gentleman's agreement, a handshake, not directly mandated by the legislature, but a hospital association in a state for example may collect that data voluntarily -- we are talking individually identifiable hospital discharge abstracts -- and then give some of abstractions of that data to the public health department to head off any further intrusion into getting hospital data, that could be mandated by a state legislature.
The privacy rule, by emphasizing the public health law and the state law regarding this, seems to be putting up a barrier, whereby the organizations are saying, we can no longer turn this over to public health departments, a specific state hospital association saying that.
DR. ZUBELDIA: A similar and maybe related issue is between the insurance companies and the stop-loss insurance companies, where they have to send all the data through, and they are not covered entities.
DR. SCANLON: There is a whole list of authorized disclosures in the regulation. Public health is clearly one of them. I'm not sure that there is an issue that is created by the reg. There may be an issue in interpretation or perception.
DR. HORLICK: Yes, I think that is it, because I have been at several meetings of the AMA meeting, where it has come up that attorneys are now advising providers that they should get something in writing and have an agreement, just to be on the safe side.
DR. SCANLON: They need to comply with state --
DR. HORLICK: Because they are not sure -- if there is not a specific mandate, they are not sure whether it goes under the public health exception. I have heard that a number of times, which is interpretation. It might be something the guidelines could --
DR. FITZMAURICE: I have had the AMA lawyer call me and raise these questions, and felt that there are barriers, raised questions of, do you have to have a business agreement between the hospital and the hospital association, or does each hospital have to have its own business agreement. The lawyer's opinion was that each hospital had to have an agreement with all of the other hospitals in order to permit the sharing that a state hospital association normally does with this data. The problem of research was less of a research, I think we can work out research with IRB approvals and data use agreements, but they could not solve the problem of how to get data to the public health department.
DR. SCANLON: They don't mean a notifiable disease?
DR. FITZMAURICE: No, I mean hospital discharge abstracts.
DR. SCANLON: So it is a very specific case.
DR. FITZMAURICE: And sometimes disease specific information, that may contain addresses or zip codes to allow a geographic analysis of this, where de-identification doesn't solve the problem.
MR. FANNING: Mr. Chairman, I think these are important questions. I think they will have to be addressed by our department in perhaps more detailed guidance. I am just wondering whether they lend themselves to the type of discussion that you are hoping to have at this meeting. I don't think a parsing of the regulation about -- with someone saying, you come under that, it is okay, is a useful exercise for a committee of this sort.
DR. FITZMAURICE: I agree, but to find the problems and to have them not being told, you are covered because you come under this, they have the problem before guidance comes out on that. Just like you might have guidance on consent that would take away a lot of the issues, until that happens, people will want to testify on these problems.
DR. COHN: Let me just try again, because I am still missing the overall principle here. I had thought that the initial issue is disclosure, and maybe it is the business partner agreements? Is that what you are referencing as the issue?
DR. FITZMAURICE: It is a problem, and I am not focusing on the solution.
DR. COHN: No, I'm talking about trying to make generic the issue that you are describing. I am hearing a very specific problem that you are describing, and it appears to me that it falls in the overall class of business partner agreements and issues around that. Am I mistaken?
DR. FITZMAURICE: It would probably be under the general term of disclosure. If it is handled without business partner agreements, that is only part of the solution. But it is generally the issue of, how do we get information for the public good or how does a government get access to a database. That could be another way of describing the issue, more, how does a covered entity release information for the public good to a --
DR. COHN: So it is under the generic discussion of disclosure then?
DR. FITZMAURICE: Yes.
DR. COHN: I'm just trying to figure out where this fit, and I guess I was getting confused. I guess I should ask our guests, are there issues around disclosures that are in play or for discussion, or that you would like to hear about? That is another issue that I had on my list, the tracking of disclosure, for example.
DR. MC ANDREW: Actually, the final rule did not get all that many really critical issues on the -- what we call the 512's, the public purposes. There are some discussions that we are continuing to have with the FDA, to make sure that we got that component of public health right. But I don't -- nothing really comes to mind that I think would necessarily lend itself to adding it to your public hearing agenda.
DR. ALTARESCU: We are dealing with hundreds of requests for clarification of each of the provisions in the regulation, including disclosure to public health and everything else. So we will be developing a lot of guidance. A lot of it will be in terms of frequently asked questions on the website, and a lot of it will be providing guidance internally within the Department to other components. Maybe we should talk in terms of questions that you are getting and sending them on to us.
DR. FITZMAURICE: I would assume that they would be talking to you about the same questions. That is why they are calling me, but they should be calling you, too. I assume that they have already voiced that. There have been meetings in Chicago on this.
DR. ALTARESCU: Right. We don't have the most organized way in terms of questions, questions coming from a lot of different people through a lot of different sources, including the hallways here. But I think what you have in mind that is helpful is, you are concentrating on four different subject areas, and trying to sort out some of the solutions and issues regarding those. But there will be dozens of these other issues, and that will be dealt with in the process of developing guidance.
DR. ROTHSTEIN: Sue and Louis, could you talk about the marketing issues?
DR. MC ANDREW: Marketing. I think that with marketing, it is -- I would agree with the comments that were discussed earlier that it is its own little -- it has its own little constituency. It is not something that was broadly at issue.
I don't think we got -- this is the struggle on marketing. I think the rule that we came out with was trying to make a very fine cut in the practice and I think it is just too complicated. I'm not sure that we understand what we did in the rule.
DR. SCANLON: Few people understand it.
DR. MC ANDREW: We have tried to explain it in guidance, and nobody understands the guidance. So the question that we are struggling with in coming to this complex theme that we wound up with was trying to define the activities that consumers were really concerned with, what is it -- where in the continuum of communications between them and their docs or the plans and their enrollee, at what point does it stop being useful, meaningful health information and it becomes simply commercialization or opportunism for the entity that is putting out the material, and what is the consumer sensibility in receiving this information, can we corral it, if they are upset, can we make it stop for them.
We really struggled in trying to figure out where those lines were between what is a real treatment communication and what is something more extraneous. Clearly, at one end of the continuum, if the doc has an interest in Merchant Tires and is passing out flyers to his patient list about Merchant Tire sales, that is probably at this end of the authorization and he ought not to be using his patient list to bombard those folks with the tire sales information. If it is a drug, is that a health related communication or is that a marketing communication? Even advertising his own services, at what point does that become a commercial intrusion into the individual.
So I'm not sure that we found the right line. We would be very interested in knowing on a broader basis what kinds of things cause discomfort and what is the source of that discomfort. We assumed it was because they were getting these things in the mail and they didn't know -- they thought that the doc had given their information over to some telemarketer, and now they were getting bombarded with No-Doze and all sorts of things. Does that fear go away if we require those kinds of communications to identify the source as the doc so they are a little less afraid of the mailing? Is it just the mailing itself that is the intrusion?
We had a lot of consumers comment that we ought to go back to the proposal that required individual authorizations for any kind of marketing activity. I'm not sure that that would fly with the industry, but it would be interesting to explore with those folks why they are so concerned about these kinds of communications.
DR. ROTHSTEIN: So would you agree with my inference that the marketing section, the kind of guidance you would like from the hearings is really broader than the other topics, in the sense that you are rethinking the underlying premise behind the regulation, and that unlike say research, where your advice was to make sure that we stay very narrowly focused, here we might solicit broader conceptual argument.
DR. MC ANDREW: What is marketing?
DR. ALTARESCU: I guess I agree with what Sue is saying, but when we say what is marketing, a lot of what we are talking about is what specific activity should require prior individual patient authorization.
So as Sue ran down the list of some of these things, most people say, I would think, that it would be okay for my doctor to send me information about a drug that he thinks would benefit me, but without my getting a specific authorization from my doctor for him to send me that information. So where do we cross the line?
So if people both from the consumer point of view and industry could say at what point should no information go to an individual patient unless that patient says yes, I want to receive that kind of information, then that would be helpful to know where to draw that line.
DR. ROTHSTEIN: Thank you. Michael?
DR. FITZMAURICE: As Sue and Louis were talking, it struck me that they have gotten comments about a lot of different problems, and what they really would like are solutions to specific points.
One thing that Gail might do in the letter that she sends out to the testifiers is to encourage them not only to raise the problems that they have, but to pose solutions that might be considered for those problems.
DR. MC ANDREW: Yes, I would say that the Secretary is very big on solutions. Don't come to me with problems, come to me with the solutions.
DR. ALTARESCU: And we are hearing from them what their problems are, so we are getting that.
DR. ROTHSTEIN: There are two points that we need to cover yet, one of which is going to take a lot longer than the other, so I'd like to move to the one that I think we can do quickly. That is, how can we procedurally allow the public to comment at the hearings, in addition to those people that we have specifically invited to participate.
We had talked at the conference call about making time slots available at the end of each of the sessions, and invite in the Federal Register notice individuals to contact Gail to get a reserved slot, and then also have signups the morning of the hearing for additional slots that were not reserved, to give individuals and groups who were not specifically invited an opportunity to address any of these issues.
Any comments from the subcommittee members?
DR. COHN: How many hours are you going to devote?
DR. ROTHSTEIN: They are going to be asked to -- they are going to be given two minutes.
DR. COHN: I don't mean per person, I mean in total.
DR. ROTHSTEIN: We have to work that out.
DR. FITZMAURICE: There is probably nothing more sensitive than privacy. In all the hearings that NCVHS has had -- and we had a nice occasion in Chicago, where there were cameras from three television networks, statements read, and the head of NCVHS and the head of the privacy committee went in front of national television the next morning to explain what happened.
DR. ROTHSTEIN: What happened?
DR. FITZMAURICE: What happened was that there was a strong objection to use of some information for privacy by one of the members, use of private information. There were responses from people who talked about legitimate uses of it. It went on from there. Eventually, the furor resulted in the vice president saying we will not have an individual identifier until we can protect this information and Congress saying, we're not going to let you spend any budget authority on this or proceed with the final implementation of an individual identifier until we give you permission.
So this is only to say that Simon's statement wasn't facetious. The public may have a lot to say. If you are trying to focus comments specifically on the privacy rule, then you may want to do as you are doing with invited testimony, some direction or some choosing, or saying there are limited time slots, and we will pick among people who will apply, to provide some kind of screening to avoid the disappointment of people who don't have the hours that may be required to hear from everybody.
MR. FANNING: It might be wise to go over the requirements in the Federal Advisory Committee Act, just to be sure what you are legally obliged to do. I think there may be an obligation to provide some period of time for the public to comment. In any case, we have done that at previous hearings of the privacy subcommittee, and it worked perfectly well. There is obviously a limited amount of time, so not everyone who might want to say something can be accommodated.
But as I recall, that did not become an issue at any hearing that we had. Typically, time was left for a statement not longer than five minutes by people who had signed up in advance or as you say had registered the day of the hearing.
DR. SCANLON: And assure them that -- if time runs out, I guess that would be the only issue, or are we prepared to stay -- if you started this at 3 o'clock or 4 o'clock, would you be prepared to stay until everyone was finished, or would you just tell them, we would be happy to take your statement?
MR. FANNING: We can get further legal advice on this, but I don't think you have to guarantee that everyone who wishes to speak publicly gets to do so.
DR. ROTHSTEIN: The others can talk to you in the hallway.
DR. SCANLON: They can leave their written statement.
MR. FANNING: Yes.
DR. FITZMAURICE: I think John and Jim have the best approach to this.
DR. BLAIR: May I ask a question on this? I am trying to think in terms of the way in which NCVHS can be most helpful. It seems as if you pretty much constructed an agenda where you have targeted on issues where we are looking for guidance and solutions.
If we wind up having an additional session which is open ended, aren't we in a sense parallelling the public's ability to comment on NRPMs and final rules, which they already do, there is already a vehicle for that. I sort of feel like whether we allocated an hour, two hours, four hours or five hours, it is only duplicating what is already available to the public in expressing their concerns, and it is not as good a use of the time of the committee to sort out solutions, as vehicles that are already available to the public.
DR. ROTHSTEIN: No, I apologize for not making this clear. The public is going to be asked specifically to comment on the exact same topic that the invited guests are asked to comment. It is just an opportunity for uninvited guests to comment on the same issue.
DR. BLAIR: Okay, thank you for clarifying that.
DR. COHN: That's a very good idea.
DR. ROTHSTEIN: The other thing we need to do, and we don't have time this morning, but we can make a start, is to identify the individuals and the groups that need to be invited for each of these four main topics. So we will be -- Gail and I will be meeting and soliciting your input. To the extent that you supply us with organizational names, individual names would help us immensely, who at what group to contact, because many of these are huge associations.
DR. MC ANDREW: I have lists by the topics of the people that commented.
DR. ROTHSTEIN: Wonderful.
DR. MC ANDREW: This is from the March --
DR. SCANLON: From the comments on the final rule.
DR. ROTHSTEIN: Oh, excellent.
DR. SCANLON: Thank you very much, Sue.
DR. ROTHSTEIN: Thank you on behalf of both of our panels.
DR. MC ANDREW: We would be also willing to share the comments.
DR. ROTHSTEIN: Thank you. That would also help us to frame the questions. I want to give people a chance to break before the main committee meeting begins at ten. Is there other business that we need to discuss? Kepa.
DR. ZUBELDIA: Now that Sue mentioned that she is willing to share the comments, are the comments going to be on the website?
DR. MC ANDREW: We are working on it. They have been scanning them in since the end of March, taking time.
DR. ROTHSTEIN: The next thing that you will get from us, I hope within a couple of weeks, is a mock schedule that will not be filled in, but it will reflect our planning on, here is how many panels we think will work, and here is how much time and how many people are on them, and where possible, a few names filled in. hen we will ask you to comment -- well, we don't have to ask, I know you will feel free, and help us firm it up. Then this will be a work in progress until we reach a final point.
We have a draft Federal Register announcement that we are continuing to work on. That will be completed in due course. John, you had a comment?
MR. FANNING: I guess my comment was that we should try to think perhaps of other organizations or people who have not commented in the regular scheme -- in the existing comment processes. Obviously, some of those people will be appropriate, but again, we risk their saying again what they have already told us twice, and to the extent that we want this to be a more interactive, imaginative process where the committee can contribute something truly new, new people commenting might be helpful.
DR. ROTHSTEIN: New people in analogous areas, say in the consumer protection or banking, or wherever these general issues have been dealt with, some experts on IRBs, as you suggested, or the ethics of disclosing types of information? I think what we need to focus on is, we are not revisiting the regs, we are revisiting a subset of the regs, where certain rough edges have been protected, and even within that, a subset of that subset where public discussion and hearings and give and take would be helpful to us.
DR. COHN: While we both want to do new, I think we also need to reflect on previous things that the NCVHS has recommended. It may be appropriate for us to go back and look at our recommendations to the Secretary of a couple of years ago, not with the idea of reopening every issue, but it may be that some of the solutions that we actually did hearings on may be useful as we reflect on the issues that are being presented.
DR. ROTHSTEIN: I thank you for that comment.
MR. FANNING: And the committee commented twice, once before we issued rules and then again comments on the NPRM.
DR. SCANLON: Chances are, the likelihood is that the guidelines will be out before the hearing, if you want to get additional information in these areas.
Then number two, just to follow up, it will be important to have a goal statement for what it is we hope to accomplish. It will be in the Federal Register, what we are aiming to accomplish.
DR. ROTHSTEIN: Exactly, this is what we are doing, this is not what we are doing, would be very helpful. We will reiterate that both in the phone conversations when we invite these people and in the letters confirming.
So thank you all, and thank you especially, Sue and Louis, for your help. You will be hearing from us.
(Whereupon, the meeting was adjourned at 9:50 a.m.)