[This Transcript is Unedited]




November 28, 2007

Hilton Embassy Row Hotel
2015 Massachusetts Avenue, NW
Washington, DC

Proceedings by:
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Fairfax, Virginia 22030
(703) 352-0091

P R O C E E D I N G S (8:15 A.M.)

MR. ROTHSTEIN: Good morning. I’d like to call to order meeting of the Subcommittee on Privacy and Confidentiality, the National Committee for Vital and Health Statistics. We are not on the Internet, but we are being recorded. So for the record, I would like to ask everyone to identify themselves and indicate if they have any conflicts of interest.


MR. ROTHSTEIN: Good morning, and thank you for coming early. We’ve got a very important agenda this morning. And I want to start by talking about yesterday’s open committee meeting and what our response to that ought to be, which I think is really crucial. On reflection, I think it was, in fact, a good idea to present the unapproved drafts to the full committee to get their input. It would have been, I think, a mistake to show up in February with even a subcommittee approved draft, and then have the full committee voice its concerns to the degree they did yesterday.

Having said that, on reflection I have to share with you some of my disappointment at sort of the bottom line that came out of yesterday’s meeting. And these are very difficult issues and people have different views, but at my most pessimistic I got the sense that there was nothing that we could say in the letter that would satisfy some people that we ought to send a letter on this topic. And that, I think, would be really a mistake, because it’s not like we can pretend these issues are going to go away. These issues are very important, and if we don’t weigh in on them, somebody else is going to do it, and NCVHS will just be sort of not at the table. And so I think that personally it would be really an adjudication of our responsibility not to send a letter on this topic. And so I think if there are people that are on the full committee who don’t think is an appropriate topic or that it’s not timely at the moment, I would disagree with that view. And I don’t know how hard a view that is, but I think that I would be prepared to go ahead with a letter, even though a few people might think that we should not have a letter.

Now, having said that, that doesn’t necessarily resolve the question of what sort of letter to send. It seems to me that there are two options for this subcommittee. Number one, the first option, would be to basically use the same framework that we have. In other words, we could spend this morning reconciling the two draft versions and come up with some agreed single version of the draft letter. And then on top of that, go through a list of the comments that were made yesterday at the full committee meeting and seeing which ones we wanted to try to incorporate into this unified letter draft that we have.

The other more radical proposal that is possible is to say, okay, we’re agreed that we need to send a letter on this topic to raise the awareness at both the department and beyond the department, for the Congress, for the private sector, for the health care profession and professionals, that this is an issue that needs to be resolved. We could list various options, some of which we already do list in the letter, and say, basically, that this is topic that needs, really, great attention and research and pilot projects and we need to get moving on this, without picking from the menu of options that the draft versions did.

Now, I recognize that there are pros and cons of both approaches. If we go ahead with the letter, we will maybe have less than cohesive support from the full committee, and we’ve tended over the years not to want to do that. There are, I don’t want to say problems, but there are certainly concerns with this approach. I mean, personally, I don’t think any approach to this problem is particularly great, but I think some are better than others, and simply listing the various options may really not advance the debate very far.

The other approach, going back, has the advantage of not locking us in to an approach, while still raising the issue as being very important. The downside to that would be that I don’t know that it does a great service to the audiences that we’re trying to reach, because anybody who thought about it could come up with the five or six options that we’ve identified. And we do have expertise. We have thought about these issues long and hard, and heard from a variety of witnesses. And the other downside it that if pulled back and went to the more general letter, I don’t see, personally, how we could make the February deadline. And the reason that I say that is that it would have to be a different kind of letter. We didn’t really explore the other options in the letter to the degree that I think would be appropriate in a letter setting out all the options. And I think that we would maybe have to rewrite the sections on — so, for example, we rejected the notion that individuals should have the right to control their records item by item. We kind of dismissed that out of hand, and we would maybe have to consider that, you know, what are the plusses and what are the minuses, and lay that out and et cetera, for all the other things. And given the time table that we have, I don’t think that we could get a letter completed, through the subcommittee, and ready for February, of that more general variety. And then we’ve got major planning problems, because then the next meeting is June and then there is this transition. We’re going to have a new subcommittee chair, we’re going to have a new full committee chair, and we may well have several new members of the full committee, et cetera. So the timing is not good on that.

Now, what I’d like to do with your consent is just to open up the discussion from the subcommittee now, and get a sense of where the subcommittee members feel we ought to go as between the first option being, all right, let’s polish a unified draft and try to work in the comments, versus this suggestion that has come from some subcommittee members that maybe we ought to kind of change the focus of the letter. And I hope I fairly presented the options to everyone.

So let me go with John and Leslie, then Paul and Jeff.

MR. HOUSTON: I’m personally really disappointed myself. I think that a lot of time and effort has been put into this letter, and I thought numerous times we were really close, if not ready, to take this letter forward. And I’m just disappointed that, A, it can’t even get out of this committee, when I think it’s a sound letter, sound with some minor wordsmithing. And I think, frankly, the purpose of NCVHS is to make recommendations, and I think it’s not to provide options. Options are worthless. And, you know, a point that Leslie made yesterday, I guess I’m going to get a wrong, but when you’re putting in curves, I guess if you put the handicapped cutouts, whatever they are, at the beginning, it costs you nothing more. But if you try to put in later, you know, it costs you a whole bunch of money. And I think we need to get out in front of this. I mean, there’s a lot of architectural discussion going on of what should an NHIN be. And I think it’s very important philosophically to get out in front with some recommendation as to architecturally how sensitive data should be dealt with in that setting. I don’t think that it is premature, nor do I think it’s inappropriate to make that type of recommendation I think we, at least in the current drafts of the letter, seem to be making.

I think I recognize that we’re making a fairly high level recommendation. I think there’s a lot of opportunities still to dig down into the detail and refine it so that it is workable, that there are issues that aren’t, you know, complete flushed out. And that’s not the intent of this letter, is to flush every detail out. But I think we have to get out in front of it. I think that if we don’t, somebody else will. I think, frankly, the recommendation that somebody else is going to make is going to be very similar to the one I think we’re trying to make. So I think it’s ridiculous that we can’t get this letter out. I think it’s ridiculous that there’s such a disparity here and people seem to be entrenched in positions, and I don’t think that’s the purpose of this committee. I think the purpose of this committee is, frankly, I think people have to try to gain consensus. And I think the purposed of this committee is that sometimes you have to say, you know something, I don’t necessarily agree with this in its entirety, but it’s within the right spectrum. I do that often in this committee. I don’t necessarily personally agree with something somebody is proposing. It is reasonable? Yes. Is it something that I can support? Yes. And the overall, in the aggregate, when you look at the entire letter, whatever that letter might be that we’re dealing with, on this issue that we’re dealing with. Do I support the people that are the experts on this? Yes. And I don’t think that’s happening here.

DR. FRANCIS: I actually read the discussion a little bit differently, slightly less pessimistically. And I’m going to try a sort of middle ground suggestion. The way I read it, there are some people who wish this didn’t have to happen, but nobody really a full answer to Harry’s the-bus-doesn’t-have-any-brakes point. Now, I didn’t hear anybody supporting the view that one of the other alternatives could be better than this one, which is what the second alternative would really have us thinking through in a serious way. But I did hear people think that there are significant — this is the best of a bad deal, in certain kinds of way, but there are some particularly huge problem areas with this. And the four that I heard were how to handle emergency situations; that’s the break the glass problem. How to handle medications; that’s the do you deal with decision support, do you have it figured out in such a way that you don’t sequester medication history. And how do you define some of the categories? So, for example, Paul’s point about whether we could figure out a way to define anything under social history that would make any kind of sense. And then, fourth, how do physicians get used to it in their practice in some way or another? There may have been another.

What was the other one that was subject of some discussion? Maybe I’ve got them all.

MS. GREENBERG: What was the issue of indicating that —

DR. FRANCIS: Oh, yes, the flagging. The question of should we indicate at all that anything has been sequestered. Now, my recommendation would be that we start with this letter. We say we fully recognize that this is hard, but something has to be done. That’s the first point. Then we take this and we say, we recommend that this is the best of the approaches, but it has areas that are particularly difficult. And we talk about how it requires further study, and we flag the areas that we’ve encountered that we think are of particular difficulty, and we take it from there.

What I would do is incorporate the concerns, because I think they’re real, I think they need to be studied. We don’t have answers. I mean, I don’t have an answer to the question of — some of it’s a technical answer, some it’s a normative answer, to how you solve the break-the-glass emergency problem. I don’t have it right here and now, but it’s something that we think needs to be in here, because if it isn’t, then there’s no way to get access to the sequestered stuff. Of course, there would be no way to do it now, but then we don’t have an improvement with an NHIN, which is part of what we’re trying to balance here.

So I think what you did was, in a way, we have the very strong this letter, and then the alternative you suggested was essentially way too far over on the other side. So I would take this letter and flag the difficulties in a more upfront way, and say this is absolutely urgent to get working on these, because this has to happen.

DR. TANG: I guess I, too, am not as pessimistic. First, I would sort of almost discount the second option. I think we used the second option in the June letter and showed how ineffective such a letter can be, so I would not even want to consider the second option. We can’t ignore what was said yesterday, because it’s very, very valid. And even though it represents what you called a few committee members, probably the majority, if not the uniform opinion of the physicians had a certain concern. They may be a countable on the committee, but they represent a huge number of folks that are important to the practice, to health care. And above all, we have to not only do no harm, but we want to help use this, what we’re trying to bring to the world, to improve care and you can’t do it by tying the physicians hands and being able to — it’s either make their job harder or make it impossible to do the right thing. That sort of has to be our primary.

And yet, I think we can achieve a balance where we can assure and reassure patients that their information will be taken seriously and handled appropriately. So I think there is a compromise out there, and I think it’s by working with the draft that we have, and I think we just have to, as Leslie said, incorporate their concerns. And I think the more concrete we make definitions of any kind, whether it’s categories or the methods, the better we will be able to deal with it and reconcile the differences of opinion.

MR. ROTHSTEIN: Thank you.

MR. BLAIR: I think that the ideas put forth in this letter are important. I thought that it was written so well that it made a very compelling case for these, and I don’t want to lose that. So I’m going to give you a balance here, because on the one hand I really want this letter to go forward as well as we can in terms of pulling everyone together. And then for folks like me that have, in my case, and I’m going to give you a solution on this, I’m leaning to both sides and then what I’m going to suggest is, hopefully, a way to accommodate folks that have very, very severe concerns. And my severe concerns are that I don’t want these ideas to be derailed because they’re discredited. I don’t want that to happen.

So in my case, and maybe I didn’t articulate it well enough because I didn’t seem to get my point across yesterday. Technically we could do what’s in the letter, except for one sentence. And the dimension is how much freedom do we give to people, individuals, to change their minds, change their mind again, and change their mind again, and then hold the system accountable for information that was sent out beforehand, before they changed their mind the last time.

And I’m not going to make a definitive position that technically it’s impossible, but I think for folks like me that have the severe concern, I mean, you know, I’ve been on the committee for, what, ten years like this. I’ve never written a dissent. But this one, in my part, would require a dissent. I don’t want to go down that way. I think my concerns could be accommodated very simply. And it may be also the same for Larry and for other folks as well on theirs.

I’d like to keep the concept of this letter intact, because if we can achieve the basic ideas in here, then we get very close to representing the concerns of the public, because I think it does a beautiful job of reflecting that and addressing the concerns of the public but there are other folks involved. There’s the physicians. There’s the folks that are building the networks and the EHR systems. And there’s other parties besides the public and I just want to make sure that they don’t derail what is a beautiful letter, that really does make an attempt to balance things.

So here’s my suggestion, which I think could be accommodated by two or three sentences. Like if there’s a section at the end which indicates that a majority of the NCVHS supports this, and I would agree with that, but that there are — and it doesn’t have to have names on the individuals. I don’t care whether it does or not. But there’s certain issues that still need to be resolved. My issue might be able to be resolved with further research and exploration, or further testimony beyond this period. After the letter goes out, further exploration into the technological feasibility of giving people the individual choices of changing their minds and changing their minds again, and how that would be done. Where are the boundaries on it? Maybe we can do that with certain limits or constraints, but not just open-ended. Okay.

So all I would do is, I would be asking for more research into the technical feasibility of giving them that privilege. We could call things a right. We could call things a privilege. We could call things an option. Okay. That’s up to the subcommittee and the committee. But I think that if we do it that way, where there’s a section at the bottom for people to express concerns, in my case two or three sentences. Some people might require a paragraph to express their concerns and make a suggestion for how they could be addressed. We could keep the body of it intact, because the body of it, I think, does preserve the leadership of the NCVHS in identifying these issues and coming up with, I think in an intellectually beautiful way, of trying to address the concerns of the public. And I don’t want to lose that position. And I share Leslie’s and Paul’s comments that I don’t feel as depressed as you do, or concerned as you do.

MR. ROTHSTEIN: I’m not depressed, and I don’t want to sequester anything related to that.

DR. FRANCIS: Jeff, could I ask you a question? If the way we structured this were to, for example, raise the problem of how, as a technical problem, how could someone add a new category? I think it’s really easy for someone to come along and say, oh, I no longer want that category sequestered. What’s harder would be to figure out how to add a new category, or you’ve got the same problem with break the glass. How you figure out how to keep something out of the record once the glass has been broken, if people —

MR. BLAIR: Well, I’m not even thinking of break the glass. What I’m thinking of is Jeff Blair winds up saying I’m concerned about three categories out of the six. And for two years that is my choice. And then, all of a sudden, I decide that I want to add a fourth category, and when I add that fourth category, where do you put the limit? At the health care providers? At the local HIE exchange? At the Nationwide Health Information Network? And am I going to have the right to say that from that day, when I make that decision, a year’s worth of information that has maybe gone around the whole nation maybe three or four or five or six times, that I now want to be able to retrieve and dismiss that information. To go back and find that information, wherever it might have been, okay, and then sort of recall those areas because I’ve added something new, or if we wind up saying that we’re going to redefine the categories and you have a whole class of people that now have expanded the category to include something else that wasn’t there before, then they expect — I don’t want them to expect something unrealistic. I don’t want them to expect that as of January 1st, 2010, I’ve now rescinded everything that had been gone out before.

MR. ROTHSTEIN: I’d like to use the prerogative of the chair to ask that this discussion be put on hold for a while, because we’re getting into the nitty-gritty of topics. And I’d like to just explore where we’re going this morning.

I’m going to recognize Simon, and just for the record ask you to identify yourself.

DR. COHN: This is Simon Cohn. I’m chair of the committee and late, so my apologies.

I guess I should just — it’s hard for me not to somehow respond to Jeff. And while I’m very understanding of his technical issue, actually, in my readings of the letter I didn’t see this all touched. So it appears to me to be more of a question of along the area of R&D.

So, Jeff, rather than it being a major obstacle, it’s something that isn’t even there.

MR. BLAIR: It’s in one sentence. I’m reacting to one sentence in there, which wound up indicating that we understand that in the future the categories may change or individuals may change, you know, and we have to have flexibility for that. And that may be true, so I just want to do a caveat on that.

DR. COHN: What I was actually going to comment on, I was actually just going to support what Leslie was sort of commenting about. I guess, as I read through the document, and like most of us we’re up to version ten or version 11, yeah, I did like Paul’s reorganization. I thought that that made some sense. I just, as I said, I think in my view a lot of the issues and sense that I’m getting from other committee members, and maybe also myself as I read it, has really more to do with the sense of tone almost, than really what’s in there. I mean, some of it has to do with the sense of how certain we are, how certain that this is the solution, and well, geez, R and D is just a little detail at the end on X, Y or Z. I think my general view is, is that this is a very promising part of the solution. We need to be evaluating it. What we’re trying to do is to get the secretary to take this area seriously and put additional attention into it.

I think what I’ve described is a major R and D agenda in all of this stuff. And I think that sort of what Leslie is saying also, which is recognizing we really don’t have a lot of the answers to this sort of thing. And so I just really see it as, like many things that we do, it’s a question of how much we emphasize that, which I think is what Leslie was saying.

Now, I do have to say that I think broadly and conceptually, I think I feel comfortable with most of this. When we dip into the examples, as you go into mental health and substance abuse and all of that, you know, we do have a recommendation that speaks of the fact that we really don’t know what the categories are that need more input and all of that. And yet I keep, myself, getting stuck. And once again this is just soft of my view of the world, where I look at mental health, for example, and I recognize that I think it’s the third leading cause of visits with primary care is depression of some sort. And so I look at mental health and I’m trying to figure how in the heck a primary care physician would be able to document about depression or a mental status exam, or whatever, and so I get sort of stuck on some of these examples. So I think we just need to be very, very careful with how we frame even any sort of examples or instances or whatever, because those are the things that people are reacting to. But once again, I think that’s more of a, you know, into the specifics of fixing up the letter.

MR. ROTHSTEIN: Okay. On the list I have John, Leslie and Harry, and at that point, unless somebody else wants to add anything, I’d like to see if we could get a vote on the direction to go in. John.

MR. HOUSTON: Having heard the flip side of this issue from physicians within my own health system, there is a great interest out of many of them for wanting to see the sequestering of information, even within a local EHR, let alone within the framework of a NHIN. And I’ve heard a lot of feedback that they’re concerned that their patients are going to go elsewhere or decide not to get services if they can’t provide them with those additional protections. And I think that that’s one of the key factors in all of this, is that today, you know, we’re trying to improve the state of things. Today, in many contexts, physicians don’t have any information when the patient walks into the ED. Obviously, the best would be if everybody trusted that we’re going to do the right thing with information and that as a result, all of this information was globally available, but whether it’s rational or irrational fears out of patients as to what information is and should be made available, there are concerns, and that compels people to either seek treatment elsewhere or not to see treatment.

But I think what we’ve proposed does try very hard to respect the patient’s ultimate right, or I shouldn’t say right, the patient’s concern. And to try to give the patient a certain amount of control over the record. And again, I understand the perfect world where we would like to be in, but I hear too much of the opposite, and so I still think that, you know, we don’t have perfect solution here. And as Simon indicated, we’re even not even proposing specific categories and categories may change and, you know, it may be very well that architecturally there needs to be a way to undo a block, that if a patient decides that they did something, and you know, oh my god, I did this and I should have done that. We’re not even to those architectural issues, but I think the biggest fear that I have right now is, and I think I said this before, is if the train leaves the station with some other recommendation out of some other group, and architecturally it’s incorporated into whatever the NHIN is, we may find that what we have is far worse than what we’re proposing, or nothing at all. And I think that’s the worse thing we can see happening.

This letter has been out there — this group has been working on this letter for so long, I thought this letter would have been out the door eight months ago. In fact, we all said this has to be out the door before the summer. I think that’s what we all said at one point. It’s true. And so we’ve got to move forward and I don’t think we’re off base. I think we have some disagreement about maybe some of the detail, but I don’t think we’re asking for a lot of detail here. And we certainly don’t have a perfect environment and we have a lot of differences of opinions, but I think that at end of the day what we’re proposing really, in my mind, is sound and is something that we really need, a recommendation that we may need to make now.

MR. ROTHSTEIN: Thank you. Leslie.

DR. FRANCIS: I’ll pass, because Simon said what I was going to say about Jeff’s point.

MR. ROTHSTEIN: Okay. Thanks. Harry.

MR. REYNOLDS: I can support where we’re going. I was one of the ones that threw out the other option and it did exactly what I hoped, was that everybody decided we weren’t quite as bad as everybody had thought. So sometimes it’s good to put the differing opinion out there just so people realize that maybe that going there is not a good thing either.

I would come up with probably adding a couple more, a couple of recommendations, would be my recommendation, because I, as with a lot of subjects, I get emotional. There is significant concern from members of the committee, full and sub, on some of this. And so I thought of one here, and again, I forget the wordsmithing, but focus should be given to how sequestering affects doctor/patient relationship, and if it has any unexpected consequences in the care of patients.

Again, I think the whole issue is, and I’ll play of Simon’s comment a little bit ago, how good are we at picking these categories? How good are we is exactly what it means. What does the technology look like? What does it mean and what does it do? So I think that starts to say really take a look at this. And we called it the human factor in one of ours, but the human factor were in kind of a general comment. This is saying, wait a minute, you got a doctor and a patient here in the end, and one is holding the information back philosophically, not right or wrong, and the other wants it. And so I think that’s a significant divide.

The other one would be along the lines, again, if we’re asking for research, along the lines of Jeff had said, and I had written this prior to even Jeff saying it, but this idea of evaluating the types of rules that would be necessary as people would want to change this, because it does change that landscape dramatically. I saw nine doctors and only had certain information sequestered, and then I decide next week I want to change it, well nine doctors already have it. It’s already in the system. It’s already in the database. It’s already for research. It’s already there. And then I come back and go, time out, I told you I didn’t want that that way. So that’s a real issue. I’m not trying to fix it through technology. Those are the kinds of issues that I think if I’ve listened to what patients might want to do and how it would affect a doctor and/or the whole industry, and if I listened to where doctors are concerned with their relationship and their information and so on, that would be my two recommendations. And then I would be more than happy to — I mean, if the committee doesn’t like them, that’s fine, but I those are two real significant things that will — if I was asking for a research project personally on this, leaving those out, we better be right on what we’ve selected, then. And we better have it be so simple that it doesn’t add these complications, because we haven’t really gone very far in actually asking for those two. Thank you.

MR. ROTHSTEIN: Thank you, Harry. Marjorie.

MS. GREENBERG: Again, I guess I tend to see the glass as half full usually, but I thought the discussion was very good yesterday. I absolutely agree with you that it was necessary, I mean, because you can’t start having that level of committee engagement on a day that you actually want to get approval or the meeting you want to get approval. So that was important. And the way I kind of saw it was, first of all, I actually didn’t hear anybody say this is not something that this committee should weigh in on. I felt that although there were clearly different views on where different recommendations should be, maybe they just didn’t speak up or I didn’t hear them, but I didn’t hear a strong voice for, you know, let’s not touch this. It’s too controversial or it’s impossible, we can’t come up with any consensus. So in that sense, I thought that like gave you the green light to continue and suffer, I guess. So that was, I thought, very important because you could have had a strong voice of people saying, no, we’re not ready for this.

The only one of the things that you had kind of rejected that I heard anyone trying to make a strong case for was Don Steinwachs’ in relationship to the age of data. You might want to relook at that, but anyway, that was the only one of the ones that he rejected that I actually heard someone really feeling it had maybe more weight. And the way I kind of heard the discussion was that they were where this subcommittee was, you know, like six months ago or something. And so I think because they hadn’t been involved, those who had not been involved in the discussion, so they were kind of really engaging themselves in these issues for the first time. And having, in some respects, intelligent but gut reactions, and it reminded me of months ago. So that also made me think that, you know, it’s kind of a learning process here.

And at then end of the day I definitely support the idea of going ahead with this letter, trying to work in the concerns, exactly what has been said around the table. I mean, if you couldn’t do it, I would go with the other alternative would be better than nothing, but I think we’ve gone too far to have to, you know, bail out on that. And because these issues are so contentious and so controversial and hit at so many different values, to me it would not be the worse thing if, in fact, there was one or more minority opinion, because it would reflect the reality out there. But I think at the end of the day it won’t happen. I think that like Jeff said, and others, you would be able to probably get some language in there that people can at least, as John Paul said, say generally, this is a reasonable letter and I can go with it. But if it comes to the fact that on some issue you would have to water it down to the extent that you don’t feel it would have value, then that will be the person’s decision. A member always has the right to craft a minority opinion. And one or two even out of a committee of, I don’t know, 17, would not, I think, derail the letter. But I actually think that at the end of the day that probably won’t happen. So that’s my view.

MR. ROTHSTEIN: Thank you. Simon.

DR. COHN: I did want to make a couple of comments about the letter and since we’re sort of beginning to talk about it a little bit. One is, as I looked through this one I did realize that as we talk about further evaluation, since I think we’re recognizing a lot of this letter really needs to be, yes, we know this far, but really there needs to be a lot more done. I did notice that there is, for example, no recommendation that has to do with exploring the liability implications, which if you think about it would be a major issue for any physician even touching this. And when we make a sentence, we comment that we realize it will never be possible to have a system that perfectly sequesters that as scant reassurance to anybody who was trying to figure out how they would actually do something like this. And so I think we need have some recommendation on that.

Now, the other thing, and this is just maybe more of a conceptualization that I guess I would ask all of us to think about, and I think we keep somehow talking about well, we do this, but we can’t do the other things. And somehow the letter comes forward and says, this solution as opposed to any other solutions. And I guess as I looked at the legislative landscape and regulatory landscape, the reality is is that our definition because of HIPPA as well as state laws, there is going to be a considerable amount of sequestering the data that relates to provider or notes, that relates to the type of provider. And psychoanalytic notes are one example. My understanding is that the actual rule that has to do with drug and alcohol, and Gail, maybe you can help me with this one, that it isn’t the type of note, it’s the provider type and the actual setting of care. That is correct, isn’t it?

SPEAKER: The substance abuse?

DR. COHN: Yes. I mean, so it isn’t a primary care provider providing substance abuse it is more of a —

DR. BERNSTEIN: (comment off microphone)

DR. COHN: Exactly. That is not well stated here, so I think what we’re talking about is recognizing that we’re looking for, you know, sort of additional protections, recognizing that that exists. And so it isn’t like, well, we discarded these other ideas as being unworkable, it’s really that maybe there’s a screwdriver for certain things and there’s a hammer for others. Not everything is a nail. And that we see this is an additional protection that would be very valuable, as opposed to what we’ve discarded in these other views. Just a thought about how to frame it a little bit. And if you think I’m misstating that one, you know —

MR. ROTHSTEIN: No, that’s fine. Well, to get us rolling on this task, I propose the following: What I hear from the members is that you would like to proceed with some form of the letter that’s based, at least to a degree, on the drafts that we have. So what I would suggest is the following plan. That first, we try to reconcile the two drafts that we have; the committee draft or the draft that Mia sent out and Paul’s draft, and work to getting a unified draft. That would be step one.

Step two, then, would be to consider additional things that we need to add, such as Harry’s point and Simon’s point. And then step number three would be then to go back and see the degree to which we have satisfied the concerns that were expressed yesterday, and then review them and see where we can modify the language or somehow address those concerns.

Is that acceptable? Okay. So each of us should have a copy of Paul’s edits and the draft, and the thing that says at the top, “Unapproved Draft Number 10”.

DR. FRANCIS: Would it make sense to make some suggestions as we go along about some things we might do with this draft that are responsive to the discussion, as we reconcile? Because my first thought would be that there should be a new second sentence here in the first paragraph. And that that second sentence should say something like — that this is urgent and — it should convey two themes, one is the urgency, because networks are being designed. And the other is that we are going to flagging some serious questions for further research in this that need to be undertaken now, essentially.

MR. ROTHSTEIN: I think substantively I agree. I think that would help. But what I would like to suggest is that the sooner we have a single document that everybody is working with, the easier it will be everybody.

DR. FRANCIS: Right. I was only saying that because I think that will solve — that sets a tone that would have readers not think that we’ve solved everything. And I think having something that says that will effect how I respond to which of Paul’s changes I want to see incorporated. That’s the only reason I wanted to say that.

MR. BLAIR: Mark, can I just specifically react to that, because I want to support that. And I wanted to support Simon’s observation. So I think if it could almost be done in one sentence to indicate that this letter, you know, recognized that additional study needs to be done on liability issues and technical feasibility issues, that virtually can cover my concerns and it’s so simple to do and I know just where it would go. Anyway, you can put it in different places, but I think that that would accommodate certainly my concerns.

DR. COHN: I was just going to comment, and I don’t want have us waste too much time with this one, but I reviewed Paul’s document, as I’m sure you have, and with the distinction of — when we get down to page 4 there’s some comments he has about the examples, but it’s really just reorganizing, as best I can tell. And the first three pages, three and a half pages are the same anyway. And I sort of like his reorganization. I think it makes sense.

DR. FRANCIS: I’m totally fine with Paul’s suggestion on page — Paul’s first suggestion on page 2 is to add implementation of computer based decisions support. That, I don’t have any trouble with. The thing that I had trouble with is down at the bottom of page 2, which is related to my wanting to put that sentence in. “NCVHS concludes that one way to enhance,” and I think that’s too weak. Maybe the best way is too strong, but I would put in something like either most promising, or one important —

MR. HOUSTON: Why don’t we simply say, as NCVHS recommends, because that’s what we’re doing in this letter.

DR. TANG: Instead of concludes, correct? NCVHS recommends.

DR. FRANCIS: We don’t need to put in the best, but I think we need to flag it more than one. We need to say one important or one very promising or the most important to explore.

MR. HOUSTON: This is a recommendation letter. Let’s just simply say what we mean and mean what we say, which is we recommend this.


MR. HOUSTON: Otherwise, it’s —

DR. FRANCIS: Yes. How about recommends enhancing the privacy protections of individual health data by affording? Take out best one, important, all of that.

MR. ROTHSTEIN: Okay. I just want to raise a point that is, I think, very important. There are two separate things that we’re saying here. Number one, this is — you’re on page 2, correct?

DR. FRANCIS: Yes. I’m on page 2.

MR. ROTHSTEIN: This is the section of the importance of individual control. Then when you get to page 4, when we talk about sequestering, the language that he has revised says, is the most promising alternative, which I think is fine. Because it says this is what we are favoring and so forth, but in the importance of individual control, that sentence needs to be sort of, in my view, really unequivocal because we are strongly supporting that. Right?

SPEAKER: Where are you?

SPEAKER: Yes, I’m a little lost.

SPEAKER: Because I don’t see anything that you’re describing on page 4, so I’m not sure where —

SPEAKER: You have a different version.

DR. ROTHSTEIN: I must have a different version. I will wait to see what’s on the screen, then.

DR. FRANCIS: What I would be entirely happy with would be to say NCVHS concludes that — no. NCVHS recommends enhancing the privacy protections of individual health data by affording. Individuals, okay?

MR. ROTHSTEIN: I have no problem with that.


DR. FRANCIS: Recommends enhancing the privacy protections of individual health data by affording individuals limited control over.

SPEAKER: That’s really a factual statement.

DR. FRANCIS: Yes. That’s what we are recommending.

MR. ROTHSTEIN: Okay. And while we’re waiting —


MR. ROTHSTEIN: Okay. So while Mia is getting us up and running, is it the case that we are okay with — okay. I do have the right draft. I’m working from the draft that Paul sent. So we’re okay with page 1. We’re okay with page 2 down to the importance of individual control. We’ve now revised that sentence in the last paragraph to read as Leslie modified it, which we’re going to see in a minute. So we’re okay with that change through page 2.


MR. ROTHSTEIN: So the change is on page 2 in the paragraph at the bottom that begins, “NCVHS”. There it is.

DR. FRANCIS: That sentence should read, “NCVHS recommends enhancing the privacy protection of individual health data by affording individuals.”

MR. ROTHSTEIN: Okay. We’re caught up. Thank you.

Now, on to page 3, I assume nobody has a problem with that carryover paragraph, right?

I want to raise something in the following paragraph, and that is whether we should include footnote one.

SPEAKER: We should what?

MR. ROTHSTEIN: Whether to delete or keep footnote one and that is the reference to the testimony. Now, Jeff, I’ll read the sentence and leave out the footnote form.

It said, “The NCVHS heard testimony that US and foreign health care systems, where individuals have the right to put restrictions on disclosure of sensitive health information, people rarely elect to do so, but they strongly value having the right and ability to do so.” And we dropped a footnote that talks about the Mayo Clinic and so forth. I think this might be a lightening Rod.

DR. BERNSTEIN: Gene was not so happy with this.

MR. ROTHSTEIN: Gene was unhappy with it, and I think it might hurt us more than help us by including it.

DR. TANG: What was Gene’s comment? Remind me.

MR. ROTHSTEIN: Gene’s comment was that well, if 3.2 percent of the Mayo people opted, and only one in 10,000 patients in Denmark, that’s 30 times as high and blah, blah, blah.

DR. BERNSTEIN: Can I just explain what this actually is?


DR. BERNSTEIN: So when I went to review the testimony with Hetty’s assistant, actually, so Dr. Harris was talking about a particular study where they looked at how many people would opt out of sharing for the particular purpose of their research at the Mayo Clinic, because there are people who have been coming to the Mayo Clinic to be treated. And understanding that the Mayo Clinic does a significant amount of research and she also described that that’s one of the reasons that people go the Mayo Clinic is because they know that this is happening. They expect, for the most part, that their clinical information is going to be used in research and that sort of psychically may be one of the advantages of going to the Mayo Clinic, that not only do you get this good treatment, but you know that you’re going to be involved in research. So she was testifying that there is this small number of people who opt out.

Mr. Johannson(?), you know, we actually wrote back to him and asked him some more specific questions from the subcommittee that were presented to him after he had testified. It was talking about the general health care system in Denmark, in a context where there are very strong national data privacy laws, so that people understand that, and his just sort off the top of his head estimate was, well, maybe one in 10,000, but it was not the result of any kind of study. So he’s the guy who is our expert on the Denmark system, but this one in 10,000 number is not a result of some kind of controlled study where they know that that’s really the number. And it’s also in a completely different context. But I think the idea was just to give the sense that in these two very different areas, basically a small number are interested in opting out, but they feel that it’s important to have the choice. One, in the context of having this strong national privacy law that their legislature has passed, so there’s sort of a national sense that it’s important to have that right. In the case of the Mayo Clinic, they have clearly made available this option for people because the Mayo Clinic thinks it’s important.

I wouldn’t take too much into Gene — you know.

MR. ROTHSTEIN: I understand. We have Simon and then Leslie.

DR. COHN: I was actually going to comment on the footnote also. Now, be aware that you’re also going to see that information coming up in the report coming up later today, except it’s not referenced the same way. It’s actually 3.2 percent opted, 17 percent didn’t respond, and so we just need to be aware that within three months we might send out documents that are somehow footnoting this information. I guess I have a question about whether it’s germane, given that at least the first part of it is germane related to what we’re talking about, is disclosure of sensitive health information, as opposed to the general view of opting out. Now, I don’t remember testimony from Mayo being related to disclosures related to sensitive health information. I remember it being more of a general opt in/opt out of whatever for a variety of reasons. So I’m thinking that maybe the second part of the footnote makes sense, but the first part doesn’t.

DR. BERNSTEIN: Well, this is information that people want to opt out of, even though it’s not necessarily in a particularly sensitive category. It might or might not be. The study, as I recall it, and I wasn’t in the room, I was just reading the transcript, was actually trying to figure out, well, how many people — I don’t know if I remember this right.

MR. ROTHSTEIN: Here’s my argument. This is not a letter that documents every natural assertion that we make, and by dropping this footnote it calls special attention to this, which is, I mean, it takes lots of qualifications to put it into context and may do more harm than good. So that was the question that I’m raising, and the other half of that is can we just drop it and not harm the letter.

DR. FRANCIS: I would actually drop even a little more, and I would recommend something that reads as follows: The NCVHS heard testimony that in health care systems where individuals have the right to, people rarely elect to do so, but they strongly value. And then I would drop the footnote. You could if you want to drop a footnote. I would stop it right after page 13. I would cite the Mayo Clinic, but I would not cite anything else. And, frankly, the reason for that is I think it could red flag using foreign examples.

MR. ROTHSTEIN: I’m not entirely clear what you’re — you said if we want to drop the footnote. Would it be your recommendation to keep the footnote, but shorten it, or —

DR. TANG: The meat of our letter is yet to come. We have 35 minutes, and to achieve your goal we have zero probability if we don’t get to the meat.

DR. FRANCIS: I would take out most of that. However you want to do it, figure it out.

DR. COHN: We support your idea of taking out the footnote.

MR. ROTHSTEIN: Wonderful. That’s out.

DR. HORLICK: Then you could just somehow in the letter just reference the website with the testimony for people that want to in general read more on that.


MR. ROTHSTEIN: So that takes care of page 3. In page 4, there are no changes in the first paragraph. A slight change in the second paragraph, but does anybody have any problems with it? Okay.

So now we’re into the category. And as an introduction to our considering this version, this may well be a paragraph, the one that begins “The NCVHS recognizes,” we’re going to need to do some work. Keeping that in mind, because there are a lot of concerns raised and we may have to play around with that language. Okay. Now, let’s just take a look at the — well, there are two areas of concern. Under mental health, you have comment, but not a change, so do you want to explain that.

DR. TANG: Yes. The comment, it goes back to how can you, one, expect physicians to do a good job. And in California, as an example, you are permitted to have mental health diagnosis on your problem list and include all medications in the active medication list. And the reason is that’s the balance between obscuring information that could potentially cause harm by its masking, and yet respecting the need for privacy in mental health areas. That’s a balance. It’s not a perfection, but it’s a balance. And it seems like it would be a good idea, from a physician’s perspective, to keep that provision.

DR. COHN: I think that I’ve mentioned this before, but given that we have a recommendation that says we don’t know what the categories should be, I can’t imagine why we’re spending time getting into a discussion of these categories. I think we sort of need a sentence or two that says, you know, that NCHVS believes that here are sets or subsets of information potentially related to mental health, reproductive history, domestic violence, social and family history, that may be appropriate for sequestering, but recognizes that further work needs to be done to determine what they are.

I just think that all of these things, to my view, are just hot buttons and we’re going to spend weeks talking about them as samples. I think they’re all wrong, personally. I’m sure there’s something in there that needs to be sequestered.

DR. TANG: That was the second part of my suggestion, and this is sustentative difference from the current draft, is that we enumerate concrete sections. And the reason is because it’s to address the concerns that were raised yesterday. In other words, people understand that when treated in a designated substance abuse institution, that information is sequestered by law. People know how to deal with that and know what that means. Similarly, you could imagine being able to describe genetic information and a physician would probably understand what that is.

Looking for things that would be easy to define. It would be nice if they were already used to it like the substance abuse treatment, so that it doesn’t interfere with practice. So that was the thought I had, at least, and I think that would be a way of addressing the concerns that were raised.

MR. ROTHSTEIN: Well, I want to comment on Simon’s point, and sort of phrase it as something we can respond to and consider. As I understand it, Simon is suggesting all these little paragraphs and add just a list where we say some of the categories that might be included would include genetic information, mental health, et cetera, and not explaining them. And my sort of initial reason is that does have the advantage of maybe diffusing a lot of controversy. On the other hand, without giving indication of what sort of things we’re talking about, it weakens our case that certain kinds of things need to be sequestered, like sexually transmitted diseases and domestic violence reports and so on. So I think there’s a trade off there, and I would be interested in how the members feel.

John and then Leslie.

MR. HOUSTON: I think the other way to try to approach this is to state that it’s not just the broad categories that we might decide to sequester information by, but even the examples underneath each broad category could individually be sequestered. And what I mean by that —


MR. HOUSTON: Hear me out. You made the example specifically that under California law that a diagnosis of mental health, including medications, is permitted in the general record. Correct? Is that what you just said?

My point to all of this is, is rather than saying on a broad brush level that mental health information should be sequestered, what we say is that within mental health, there is an opportunity to say that recommendations regarding about what specific types of mental health information should be sequestered. And so each one of these broad categories contains these types of things, which you may decide on a much more granular basis, should be or should not be sequestered. That’s my only point.

So Simon’s reacting, I think, or what I thought heard was, is reacting to these broad categories. I don’t know if I agree with him. And what I’m saying is, is that we’ve made some examples within those broad categories and we might say there might be things within the broad categories that should not be sequestered, but there are other things within those broad categories that should be, so leave it with a fair amount of granularity up to somebody to decide what should and shouldn’t be in there. And I would say at the end of the day, you may find that there are 50 to 100 elements that you might say are separately seqesterable.

DR. BERNSTEIN: Can I just ask? Is that kind of responding to Paul’s comment that you should try to be concrete and easy to understand? Is that the point?

MR. HOUSTON: My point, I guess more so, is that it’s not that we want to be more concrete, but we should make the recommendation that the categories of sequestration would not necessarily be at as high of level of simply five or six categories. Literally, you could come up at the end of the day with 30 or 40 or 50 categories of things that could separately be sequestered, or we might decide that there’s things within these categories that should be and things that should not be.

DR. BERNSTEIN: So on that particular part, are you also asking that the subcommittee would make recommendations about things that should not be sequestered in those categories?

MR. HOUSTON: No. Any recommendations which should or shouldn’t be. All I’m trying to do is react to the fact that these — I think it’s reasonable to say that we should be making recommendations that seems to have the tone of there’s some broad categories and we should sequester them, but rather, we should give the opportunity to allow people to decide with however much granularity is appropriate, what should be sequestered.

MR. ROTHSTEIN: So your suggestion actually would reflect a considerable change from the recommendations. That’s not to say that we shouldn’t consider it, but what you’re saying, as I understand it, is as it currently reads now, if a patient wanted to sequester any element of let’s say a woman’s reproductive health history, that whole category would be sequestered. And you’re saying that maybe they could elect to sequester a history of an abortion, but keep the rest of the reproductive health history there.

MR. HOUSTON: That’s correct. It’s more basic, though, because what we’re trying to do is make a recommendation that says that somebody needs to decide what the categories should be, right?


MR. HOUSTON: All I’m saying is that the tone of this letter should simply be — let’s not make the tone such that it should be these broad brush categories, but rather simply allow somebody to make the decision that it might be in the case of reproductive health, that there might be five or six separate categories.

MR. ROTHSTEIN: My sense of this, John, is that —

MR. HOUSTON: It’s not a big change.

MR. ROTHSTEIN: Well, I think it is a big change. And can we satisfy your concern by putting in some language? I mean, we’re not even saying that these are the categories. These are examples of categories, and that in deciding what categories there should be a consideration of inclusion and exclusion criteria, and granularity.

DR. COHN: Let me just jump in here, because I’m just looking at recommendation, or I guess the new one, 1C, isn’t that what we’re recommending? I mean, it seems like we’re having a conversation about something else. I mean, isn’t that the recommendation on page 6 that we’re supporting?

So I think that’s sort of what John’s trying to say, the fact is, we don’t know what level. I mean, we’re talking about initiating a public process to figure this one out.

MR. HOUSTON: And I’m just reacting to Simon’s claim, which is I’m concerned that these six broad categories aren’t appropriate. I’m saying, wait, they can —


DR. FRANCIS: I think we need to say two things here. The first is, I think it’s very important to give a list of the categories that we have thought of. And I agree with Mark, that saying something about how these could be fleshed out makes sense, so people understand what they are. So I would keep what we have here about the categories. What I would do is go up to the sentence that starts, “However, NCVHS recognizes that the categories may need to change over time.” That’s not our only point about these categories, and it’s the sentence that gave Jeff heartburn.

I think we need a sentence after we say, so there’s considerable experience with at least some types of information. I think we need a sentence after that however, which says some thing like, we recognize —

MR. HOUSTON: Excuse me. The “however” is the last sentence in second full paragraph.

DR. FRANCIS: What we recognize is that these categories require definition and discussion of — they require definition. They require study about how including them might effect physician/patient relationships. They require discussion of technical problems. They require all kinds of issues. The reason way even including them might change is that there all of these difficulties out here and we recognize that, but what we don’t want to do here is take them off the table. I mean, we ant to say these are the important categories to work on, and here are the issues involved in working on them. They’re definitional issues and they’re technical issues and there are all kinds of issues about it. And so what I think we ought to do is say, however, NCVHS recognizes that these categories will require further study along a number of fronts, including, and then we can just list what some of the study issues are. And then say, below is a sample of the categories and types of information that it’s critical to study, or that it’s critical to be thinking about or considering. Does that work?

DR. COHN: I like your introductory language, however I guess I still have questions about — I think we all agree that the end game is that there needs to be a process set up to get to great specificity about all of this stuff. And I agree with John and Paul and everybody, that you just can’t say mental health or whatever. We need to get down to very specific items. I think the real question I had was whether the examples that were given — and I actually agree that genetic information, I mean some aspects of genetic information and mental health, I mean we heard that these were categories that were important, so I think that we need to say that we heard that these categories are reasonable star sets for further investigation.

I think the one question that I have is whether or not the additional language that we’re sort of throwing in here about we might include this, it might include that, I mean, to me, there’s neither the expertise around the table to identify whether signs and symptoms for mental health are appropriate. I would just sort of throw out that insomnia is a symptom of depression. Are we going to knock out insomnia from — I mean, it just raises all of these issues. I just don’t know that we gain anything by waxing and waning around the examples of the subsets and things that might be included or not.

MR. ROTHSTEIN: The reason that we put it in there is to indicate the kinds of very sensitive things that people testified they would be very concerned about. And so I think to no include some examples, doesn’t really make our case. You’ve got to — if you list, you know, HIV status, history of substance abuse, these are things that people are very concerned about and these are the kinds of things that need to be worked through. We’re not saying this is the list or anything else.

DR. BERNSTEIN: I just don’t think we can make the case at all if we don’t give some people some indication of what we’re talking about, and we can’t do that without some help.

MR. ROTHSTEIN: I mean, if we took that out, as a reader, the first thing I would say was, well, why do you need this? What do you want to sequester and why is that important? But if you say, well, we’re talking about, you know, HIV status, history of an abortion, drug abuse treatment, mental health, that’s the kind of stuff. And we’re not saying that these are necessarily the categories. We’re not saying we know what’s in those categories. We’re saying that this is what HHS needs to get going in researching.

DR. COHN: Well, I think we’re talking about maybe then a very sparse list of e.g.’s for each of them, aren’t we?

DR. TANG: How is the list that you just enumerated different from Simon’s suggestion?

MR. ROTHSTEIN: In interpreted what Simon was saying as to not include specifics, just — for example, it wouldn’t include anything other than mental health, reproductive health, et cetera. And I’m going sort of one level lower than that and giving examples of the kind of reproductive health. Well, what’s reproductive health? Well, what we mean is sexually transmitted diseases, pregnancies, et cetera.

DR. BERNSTEIN: And I think the reason we did that is because we were uncomfortable with the broadness of the categories before, and we tried to get more specific to satisfy that concern.

DR. TANG: So would Simon accept your e.g. list?

DR. COHN: Well, I guess the question is that there’s some I would and some I wouldn’t, I guess. And I think that you had the same issue, Paul. I was actually trying to short circuit the long conversation of what actually is in these lists by sort of saying I’m not sure that we have the expertise to worry.

DR. TANG: Can we say genetic information, substance abuse, sexually transmitted diseases, as the e.g.?

MR. ROTHSTEIN: The problem is when we had this sort of thing earlier, Marjorie wrote a note that said, genetic information, that’s everything. And you better specify what you mean by genetic information. So then I went back and put in this includes test results, counseling report results, certain specified genetic disorders, so that it wouldn’t include familial hypercholesterolemia, as opposed to Huntington disease.

DR. TANG: So for the purposes of today, could we defer that particular, what goes in the e.g. to offline, but are we okay with the direction you’re going, which we’re still suggesting that having some kind of specific categories, a patient be permitted to sequester?

MR. ROTHSTEIN: I would be more than happy to flag this or note this as something that the subcommittee needs to revisit, but I would like to get through the whole document. And then we’re going to come back and look at this.

DR. TANG: Now, there’s another comment and I don’t know whether you want to postpone that regarding this, do you think that — well, I would suggest that these lists have to be enumerated, a full list have to enumerated ahead of time and a patient does not get to create lists at their option.

(Many affirmative answers)

DR. TANG: Okay. That’s not said in here. I think we could.

MR. HOUSTON: To identify possible categories of sensitive information. If you look at the recommendation, transparent public process to identify possible categories of sensitive information.

DR. BERNSTEIN: I think we’re all agreed with that. Does anybody disagree with that?

(Many negative answers)

DR. BERNSTEIN: I think we can come up with that list that will satisfy the subcommittee.

MS. MCANDREWS: Just a note. If you are going with this absolute category even as a suggestion, other than in the parenthetical on reproductive health, what would you do with HIV status? Did you decide not to include that as a sensitive category?

MR. ROTHSTEIN: No, we included it under reproductive health.

MS. MCANDREWS: But only as reproductive health? I understand this is examples, but how would you —

MR. ROTHSTEIN: It would be covered somewhere. Under sexually transmitted diseases, under infectious diseases, under something, that you and your colleagues would get the opportunity to figure out.

DR. BERNSTEIN: What I was actually going to suggest is, skip the categories and go directly into subcategories and pick six examples. HIV status, abortion, you know, schizophrenia, whatever, just pick six very, very concrete things as examples. You don’t have to have the categories. You don’t have to know that they’re too broad or whatever, since they’re just examples.

MR. ROTHSTEIN: Well, the problem with that is that might suggest to people more granular control.

DR. BERNSTEIN: Right. So this is something we need to continue to talk about, but I think we need to move on.

MR. ROTHSTEIN: Let’s get through this. We are now ready to move page 5, notations of missing data for health care providers. And, Paul, you highlighted the second sentence.

DR. TANG: I highlighted it to show what change I was making, but I forgot to make the change. The change that I was suggesting was that it would suggest which category was sequestered. And although I know the objection would be, well, gosh, you’re revealing something, it seems like you would have less change of causing the need to break that glass if you know what area it was so that you — I don’t need to do that for my broken bone. If you just say there’s missing information, then I think whoever was sitting here — it isn’t incumbent on the physician to go explore the missing information almost every time. That’s the liability piece. So in somewhat of a paradox, it seems like if I knew there was something in genetic, well, I don’t need to know that for my broken bone. I’m not even going to bother exploring further. And that was the rationale behind suggesting that we just basically say, well, there’s some — and we’ll start getting used to it over time. Even the sexually transmitted disease, I don’t need to know for the —

MR. ROTHSTEIN: I know, but if you’re the patient and your notation to the provider has, in essence, sexually transmitted disease history with health.

MR. TANG: Yes. And it could be positive or negative. So if I had a genetic test performed, whether it indicated anything, quote, positive or not, it would be sequestered.

MR. ROTHSTEIN: Well, one of the things that I would ask you to consider is that if our health records for range of providers, beyond physicians, and so that, I mean, the physical therapist who’s going to rehab my knee, that gets my health records, I might be unhappy that there was a notation, sexually transmitted disease sequestered.

MR. TANG: History about —

MR. ROTHSTEIN: Well, I don’t care.

DR. FRANCIS: Mark, may I make a suggestion? We heard three different positions yesterday on this point. One position that we heard was that there shouldn’t be any indication about sequestering. That was Carol’s position. Because once there’s any indication. Then we’ve heard that there should be indication about which category. That’s Paul’s suggestion. And then, of course, we could go and not —

SPEAKER: And the third one would be general sequestering.

DR. FRANCIS: Right. And I think what we should do with that right now, I can’t solve it right now, but this is an area that would need to be nailed down one way or the other. And this is an area where I think we should note what the issues are and say that we don’t have an answer on this one yet, but it’s a critical one. And I don’t think that takes away. See, my strategy for saying that where we’ve identified serious open issues, the way we should handle is we shouldn’t say this is a reason to pull back. What we should say is that we’re really contributing to how this can be implemented in the US, because if you try to take what’s going on in Britain, say, liability concerns look different in Britain. And so, you know, I would just point out this problem and say this is an urgent are where we’ve got to figure it out, and we’re ready to take the next step in figuring it out for you. This is part of what are committee needs to be continuing to do.

DR. COHN: I’m not sure what the next step is to figure it out. I guess I would be — I mean, I actually agree with everything that you’ve commented, Leslie, but it seems to me that this is an area we would want to recommend additional R and D and pilots, demonstrations. And so it really isn’t we’re ready to take the next step for you. It’s more like we’re recommending that HHS does do some things to help figure this one out.

DR. BERNSTEIN: Well, in some cases, it could that we take testimony, have hearings or whatever, and explore it directly ourselves, and in some cases recommend that somebody else do it.

DR. COHN: Well, I just think we could hold testimonies probably up the whazoo on this one, and I think that at the end of the day there probably needs to be some quantitation around privacy.

MR. ROTHSTEIN: From that side of the table I hear the support for just not making a specific recommendation about this, just identifying the options. What about from this side of the table? Are you okay with that?

MR. HOUSTON: My preference is always to make a recommendation and work through it at least at some level, rather than just throwing out options. Anybody can do that.

MR. ROTHSTEIN: Of course, if we can’t get it through, it’s not a recommendation. Jeff?

MR. BLAIR: I’d like to support your thinking on this. Leslie articulated the three options, and our recommendation is the one that’s a compromise. So it’s the middle one. If we articulated the three different options and indicated that the NCVHS considers that a compromise position would be the middle one, I think maybe we’ve accommodated that. And we don’t have to have a complete consensus. If a majority does support just a flag indicating that there is some sequestration, and not specifying what category it’s in, if that could be a compromise position, then we can say that.

MR. ROTHSTEIN: Well, the question is, would that satisfy Simon and Paul’s concern?

MR. BLAIR: Well, I’m suggesting that if the majority would agree with a compromise, then we could state that it’s a compromise.

MR. ROTHSTEIN: Well, if we’re going to recommend something, I don’t want to say that it’s a compromise. Either we recommend it or we don’t recommend it. If we have to be so vague as to say, you know, by a five to four vote, I would rather just put the options out there and let the Department to decide ultimately.

Simon and Paul.

DR. TANG: I think there needs to be a flag so that the physician or clinician who is using this information is not caught unaware. I would be willing to go with the majority as far as whether it’s flagged just as an overall flag or flagged on a section. And the comment I’m thinking about is Bill Scanlon’s, and that has to do with the liability. And what I’d play through your mind is which will cause more breaking of glass, more unnecessary, unneeded breaking of the glass.

MR. ROTHSTEIN: So maybe if we reworked the language and recognize the other option, and then gave a better rationale for why we are recommending the one that we did, it might be a better —

MR. REYNOLDS: I think if fits into the same thing as we talked about with categories and everything else. In other words, we’re putting what the options might be, just like we were talking about on our categories what the options might be. I mean, we either know this subject far enough to be absolutely correct, or we just continue to educate and say what we want tested and what we want to be evaluated. We do want a flag of some kind, but it’s just like we want categories of some kind.

DR. COHN: So is the recommendation really that we want a flag, but we think that further evaluation and demonstrations need to occur about whether it’s specific or all?

MR. ROTHSTEIN: I think the consensus is that we are going to recommend a non-specific flag, but note that there are other options and the pros and cons of those other options.

DR. COHN: I guess the question I have is that why — I guess I’m thinking about the testimony as well as our internal level of expertise, and is this something that we’re absolutely certain about, that this is the right answer, or does it just seem like a good idea of the moment? I mean, I thought Paul brought up a very interesting idea and I think it probably deserves greater discussion.

DR. FRANCIS: I think we could out line the reasons and say that while we think this one is more protective of patient privacy, we think there needs to pilots and so on. Why not do something like that?

MR. HOUSTON: To react to Simon’s point, I think it’s past thinking it’s a good idea at the time. I know from, again, my own experience at my facility that this discussion has gone on a good about how you protect and how you make sure people know that there’s something out there. I think the only variance in discussion I’ve ever heard, though, is at what level do you provide the flagging. Some people would argue that you do it in the broad category sense, which I think that some people might find doesn’t really provide much protection, or do you just put a general flag out there and when we break that glass and then you get to the next level, okay, you get to a different level of flags. But I think it goes beyond.

MR. ROTHSTEIN: Okay. We’ve got five minutes left and I have two quick points on this point, and then we need to talk about strategy.

MR. REYNOLDS: I’m struggling a little bit with the break the glass, because we had previously defined break the glass as the medical emergency. The other reason we had talked about the flag was to say that there is information and then whoever is treating the patient can discuss it with them, but I’m really struggling with break the glass all of the sudden jumping in.

Paul, your comment was, that’s going to require more break the glass, well if there’s aren’t more medical emergencies, that’s another thing we have in there, then there may be more discussion with the patient, but I’m not sure that it’s more break the glass. So you kind of confused me when you spun that one in there.

DR. TANG: Actually, the break the glass is a method, and there are two general ways to apply it. One, is only in the case of an emergency, the other is to do it for anything protected with special protection. In fact, the HR we use uses that method. So that was what I was going to suggest, is because if I do it at the individual level, then I’ve broken the glass and the notice to the patient can go that I’ve that piece of information. And I would have to justify in my own mind, and later to the patient or whoever, that I needed to know genetic information for this particular encounter. Whereas, if it were a general flag, it seems to me that I would almost have to figure out what’s going on or one would argue that way. And that would be an additional way of, one, protecting it, and two, making an individual who, quote, opens that section, that protective section, accountable for that.

MR. HOUSTON: Harry’s point is a very important one, though. I agree with Harry, which is that I thought the break the glass was always in the case of an emergency. Where the patient has the ability to be asked, I always thought that the standard would be that the physician and clinician would need to ask the patient, because there’s the opportunity.

DR. TANG: That’s correct, but the technical mechanism would be that I press the button and I go in.

DR. FRANCIS: There are two separate problems here. One is the emergency problem, and the other is that — and Paul is point out that with a general flag, it’s going to be more likely that physicians will push patients to reveal.

DR. TANG: And having justification.

MR. ROTHSTEIN: Okay. I’m going to have to call a stop to this, even though it’s fascinating. We have not gotten to the recommendations, but from what I have seen, there are just minor changes made in reordering and so forth. So now we’re at the point of, okay, we’ve got a lot of work to do yet on this letter. I don’t know what it exactly looks like yet, because we’ve marked some places where we need to add language to various things. We have not considered the substance of some specific recommendations that were presented by subcommittee members this morning, to be additional or amplifying existing recommendation. And we have not actually had the opportunity to go through the list of things that were generated at the full committee discussion yesterday.

So, I personally don’t think that the types of things that we are still having to deal with can be done electronically. In other words, I don’t think that the changes that have to do be done can be done by e-mail. And I would be willing to consider other —

DR. FRANCIS: I think we could do a lot electronically, Mark. I think we could generate a draft that starts with where we are, puts in some of the suggestions that have been this morning. Then we all look at it and we send comments to Mia or to you, who puts them all in, and then we have a conference call.

MR. HOUSTON: I actually think that even though we haven’t gone specifically into the recommendations, we’ve done a lot of talking that would allow Mia and you and whomever to focus and refine these recommendations.

MR. ROTHSTEIN: I didn’t want to be seen as sort of abrogating to the lead staff and chair this responsibility.

MR. HOUSTON: The other point I think that is important here is if we’re going to get this out in February, then I think we are at the point where we need to consider sending it out to full committee for review, as we’re going to review it as a draft, because I think we need to solicit their input earlier —

DR. BERNSTEIN: You mean simultaneous review with the subcommittee?

DR. TANG: I think we made a lot of progress, to tell you the truth. I agree with you that I don’t think we can do it electronically, because we had some back and forth, and actually some introduction of new ideas that actually opened up ways to reconcile. So I think the good news, I think we’re making progress and, in fact, I think we’ve generated a little bit of momentum, so I think we almost need to have the conference call fairly soon, but that it does have to be talking to each other in order to resolve this.

MR. ROTHSTEIN: We will have schedules circulated today.

DR. BERNSTEIN: Today. And if you don’t have your calendar, call your office and find out what it is. I mean, I don’t want to schedule it while we’re sitting here, but Janine can circulate a calendar before this afternoon, before people leave, because the sooner we get on people’s schedules the easier it is.

DR. TANG: I would do it now, because otherwise you’re going to have schedules get out of sync.

MR. ROTHSTEIN: I think before we leave we should try to set up a time. And Mia and I are going to have to get together to figure out how much time it’s going to take to put the draft together to respond to this.

DR. BERNSTEIN: If we set a date for a conference call, it will be ready. Before we get off to administrative stuff, I just want to ask one other question about the draft, which is Paul made a suggestion that we reorder and group together the recommendations. And he renumbered them so that they’re grouped together like that. Is that sort of thing okay with people? Do we want to hear objections to that?


DR. BERNSTEIN: Okay. I assumed that was okay, but I just want to know if it’s okay or everybody has a problem with that.

Who is leaving earliest? That’s what we need to know, basically.

MR. ROTHSTEIN: Well, we will have an opportunity to chat informally and make sure that we have a time selected.

DR. BERNSTEIN: If people could have their schedules available from now until the February meeting, essentially.

MR. ROTHSTEIN: Right. And with that, thank you all very much. And I have a tinge of optimism.

DR. COHN: And the full committee starts at 10:15, so get your coffee.

MR. ROTHSTEIN: So we do have some time. And thank you all, and the subcommittee meeting is adjourned.

(Meeting adjourned at 10:05 a.m.)