[This Transcript is Unedited]

National Committee on Vital and Health Statistics

Subcommittee on Privacy and Confidentiality

September 9, 2005

National Center for Health Statistics/CDC
3311 Toledo Road
Hyattsville, MD 20782

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 180
Fairfax, Virginia 22030
(703) 352-0091


Welcome and Introductions – Mark A. Rothstein, J.D., Chair

P R O C E E D I N G S [8:50 a.m.]

MR. ROTHSTEIN: I would like to call to order this meeting of the subcommittee this morning. We will be meeting until 10:20 and then there will be a ten minute break and then the full committee will resume its two day meeting at 10:30.

Very briefly for the record, I just want to go around the room and have the subcommittee members and other guests and staff introduce themselves and indicate if they have conflicts of interest. I will begin by noting that I do not have any conflicts of interest, other than authorship of the draft that we are going to be discussing today.


MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC and executive secretary for the committee.

MR. HOUSTON: I am John Houston, University of Pittsburgh Medical Center. I am a member of the committee, as well as the subcommittee. I have no conflicts.

MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield of North Carolina, member of the committee, member of the subcommittee and no conflicts.

DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the subcommittee and committee. No conflicts.

MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee. I am not a member of the subcommittee.

MS. SANCHEZ: Linda Sanchez, Office of Civil Rights.

MR. ROHDE: Dan Rohde, American Health Information Management Association.

MS. JACKSON: Debbie Jackson, NCHS, committee staff.

MS. SIGMOND-MUTH: Marilyn Sigmond-Muth(?), America’s Health Insurance Plans.

MR. ROTHSTEIN: So, yesterday, we talked about the process, about our schedules for meetings. Our next meeting is a conference call and then we are scheduled to have a full day meeting on October 21st at the Humphrey Building or here somewhere.

We decided that for the time being we would proceed in the organizational framework in which this document is set out. We may decide we need additional sections, we want to move stuff around, et cetera. But we need to begin somewhere.

It was also decided that we would begin our discussions with Section 2 of the document, which if you have a copy begins on page 3, “Collecting and Compiling Personal Health Information. The thing that I would like to ask the subcommittee members to think about today and in sort of the first round of discussions of the document is I would like us to focus on principles and concepts today and not be concerned about language. There is plenty of time to worry about the language and we can do that perhaps initially more efficiently by e-mail and by submitting marked up copies to me and I will try to send new versions out to everyone, but I think if we stop, you know, and should it be “and” or “or,” we are never going to get through, at least the first cut.

I guarantee you will have ample time for all of the polishing that people want to do. So, the floor is open for discussion of this first stage of what gets into EHRs and then into the NHIN. Let me just by way of background introduce to you what I had in mind. This is really a working draft and I think on rereading it, it may not be clear to everyone what I intended all the way through.

In the first paragraph, talking about was we are going to have a period of time and the designers of the NHIN have not really formulated a policy on this, when we need to decide what we are going to do with existing health records. It is going to be very expensive to put all those in electronic form from the get-go. So, we may have a period of time when there are paper records and electronic records and it is not clear how that is going to work out.

You know, I refer to that sort of obliquely as transitional issues. The key substantive thing that we need to consider is whether people have a right to continue having their health records in paper form or to prevent their paper records from being changed over into electronic form. You will recall we heard a great deal of testimony on that and, in fact, the testimony was fairly unanimous. It was one of the few things that everybody seemed to agree on. But I think it was important to get that testimony on the record so we have some basis for that. Yes, from privacy folks as well.

MR. BLAIR: They said that they wanted to right

to —

MR. ROTHSTEIN: No, they said the opposite. They said that individuals should not have a right to maintain their records in the form that they wanted and that, in fact, is our recommendation here, that they do not have that right in terms of electronic health records.

So, then we went to the issue of the NHIN and the position on the table was whether individuals should have a right to opt out or fail to opt in to the NHIN and can we make this system mandatory? You will recall we heard testimony from lots of people on this issue, including the foreign testimony, where they did have all sorts of in and out provisions that people never exercised. That was their experience, but I think it is important to have that option.

If you adopt the principle that it is a bad idea to make participation in NHIN mandatory, then you have to decide whether it should be an opt in or opt out process, which is then discussed there. I am just going to go through this very briefly.

Then the question is, okay, for people who are in the system, what rights, if any, should they have to limit the type of information that is accessible both to health care providers and beyond that and so there is a recommendation from that, dealing with that. There is a discussion of the concerns of the providers in doing that and the two main arguments that I think we heard were concern for quality and concern for liability and those are addressed. Then there is a recommendation on what sort of system is possible to limit access, but also not destroy the decision support that would be valuable to patient care and patient safety. So, that is a very quick overview.

Does anyone have any kind of overview comments that we can entertain before we go to the specific issues?


MR. ROHDE: Mark, just one comment. I think you need to address both health information networks, as well as a national health information network, so that your advice is available to groups that are already beginning this process in various regions.

MR. ROTHSTEIN: So, you think that in the document we ought to explicitly add that the recommendations apply to RHIOs, irrespective of whether we ever get an NHIN?

MR. ROHDE: I think the advice applies to both and you ought to really let people know it is both.

MR. BLAIR: I thought his choice of words was proper. He said health information network. Some people are calling them health information exchanges, some are calling them RHIOs. Some are calling it LHIIs, health information — and some, it is tele-health.

So, his word was right to refer to them as health information networks.

MR. ROTHSTEIN: Well, I thank you for that comment and we will work that into the next version of the draft.

MR. BLAIR: May I ask a question?


MR. BLAIR: As a non-subcommittee member?

MS. GREENBERG: You are a committee member.

MR. BLAIR: Does the scope of the letter include discussion of the issue of what type of legislative regulatory or federal policy we will have when there is a tradeoff between privacy and patient safety, ala with clinical decision support?


John, background stuff, are you ready to —


MR. ROTHSTEIN: If there are no other background comments, we are ready to start. Is it your preference to just sort of open up the whole section or should we try to go paragraph by paragraph.

MR. HOUSTON: I think the issue of the paper records is one I think we all agree with. I mean, it doesn’t — I think that it is not an option — I think really the issue on the table is really there are sort of the twofold issue of participation and opt in versus opt out. I guess I may be at odds with the rest of the subcommittee but I am not sure I personally agree with the concept that it should be something patients can have some type of control over. I think there is an argument to be made that it should be mandatory and that we have heard some testimony against it.

You know, as you indicated in your opening comments that, you know, the other examples throughout the world seemed to indicate that while there is this desire to have that functionality, it is rarely exercised and I do believe that —

MR. ROTHSTEIN: But greatly valued, I would add.

MR. HOUSTON: But there are serious implications. I believe and later in this section you talk about the fact that you don’t believe there is significant risk and liability of risks and things of that sort. I am not sure I agree with that, nor do I think that there is going to be standard of care issues that are going to — expectations are going to increase as we develop a much more comprehensive electronic record environment with things like clinical decision support that might be dependent upon having to have a lot of information about the patient to really function completely.

So, I think that if we are going to put a recommendation like this in this section, my preference would be that we think that this should be explored and opt for some type of non-mandatory record system should be considered or explored, but I am not convinced personally.

MR. ROTHSTEIN: Well, I think that is a very good starting point for us to talk about and I would like to see if we can flesh out the issue of whether participation not in EHRs because — unless anyone wants to address that, I think we are all on board on that. But whether there can be mandatory participation in the NHIN. I suppose we could talk about the issue of whether information networks as well as a national system.

So, let me recognize Simon, then Harry and then Paul.

DR. COHN: It is actually fun being over here for a change.

I think I wanted to comment that as I was looking at this one, I am intrigued by a lot of the pieces and I haven’t quite, I mean, said exactly where I sit on all of these things, but I am actually not sure that opt in or opt out is the right way to frame even what we are talking about here. Let me describe it. I guess I am thinking that there are two different frameworks we are talking about here, sort of almost simultaneously. One is one that we have talked about in the 2001 NHII report and was shown yesterday in that personal health record piece, where it is data flowing between dimensions. I think what we are seeing is is that, at least as I am reading this set of recommendations, we are saying that, gee, even if you are not hard — even if you decided to opt out, you would still be having data flowing, at least in that way, because you would be using decision support. You might block information. But what we are proposing is, gee, we want to have that information available for decision support to prevent drug errors and all of that. At least that is what I was reading here. Maybe I am misunderstanding.

So, that is not clearly — even if you are opting out, you are not opting out from that. But then there is the piece that goes from within an organization, outside of an organization or whatever. So, I mean, once again, I am framing this — it is a little more complicated than just opt in, opt out. This is sort of a multidimensional view, which is I think something we probably need to articulate here. Am I off on this, Mark?

MR. ROTHSTEIN: No. I think that we definitely need to address the issue that Dan raised at the beginning and sort of the intermediate level of health information networks. To the extent — I will tell you what my thinking was. When I drafted this, I didn’t want to be sort of committed to the RHIO model, not knowing what the planners were going to come up with. So, I addressed issues at sort of an abstraction of our national level. But as long as we are making recommendations, I think we would be remiss — I am convinced of the argument that we need to discuss the network issue, even not knowing what shape the national network is going to be. It is not necessarily that valuable to talk about these things in such a degree of abstraction.

I also agree, Simon, I think your point is a good one, that we need to perhaps be clear what it means when we say you are opting in or opting out because if we are saying that electronic health record participation is not optional, in other words, your provider can say I store your information in an electronic form, that already suggests that they will have access to decision support and all sorts of other things, even if we agree and it becomes a part of the agreement that personal health information doesn’t get aggregated and used for other purposes as well.

So, I think that needs to be spelled out. I think that is part of what your point was.

DR. COHN: Yes, I think what I was describing was I think what we are really talking about is a blended opt piece here. Obviously, we would have to decide if we agree with it, but on one extreme there clearly is an opt out that — there is opt out called paper. There is also an opt out that your record is not only not shared for whatever outside of your organizational unit that probably isn’t available for decision support and then there is this other level, which is the sort of where it is in the background potentially for decision support.

I am just sort of commenting that these are maybe even more subtle but I think important differentiations.

MR. ROTHSTEIN: And I hope that in the next draft, it will reflect that.

So, we are going as indicated, Harry, Paul and then we will get Jeff’s comments.

MR. REYNOLDS: I wouldn’t normally say this but I actually agree with John. This is a big enough issue to do it. This whole idea of a person being able to adjust their record once it becomes electronic, the whole idea of whether — it concerns me.

MS. GREENBERG: What was your verb there?

MR. REYNOLDS: Adjust their record because that is — I mean, we heard Paul yesterday say in significant terms how difficult that is going to be to actually administer. We are struggling enough with opt in, opt out. You know, to me, if we don’t keep this simple, almost that you are in or out and once you are in, you are in and you are in all the way because trying to administer this, I mean, privacy notices now are unacceptable in most places.

Trying to explain things — and if you take — if you go to the doctor or you go to the hospital, that hospital has got doctors that work in other things. You are going to be moved around. You are in an EHR. You don’t know it. As you all know, I was just in the hospital. Nobody came up to me and said we are going to put your stuff in EHR. I went into the emergency room. I was in EHR. They were passing it around everywhere. I don’t know if that is good or bad, but it what was the treatment. I got a copy of it.

The other thing is is as we get into a situation where if we are going to continue as a country to require the liability of physicians to treat people based on the information that is available and we let people take a lot of stuff out, I don’t know why the physicians would not start all over again because if I don’t know what is not there and if I don’t know what I am not dealing with, then I start over I would think if I am a physician.

So, I think that this whole issue, we have to be real careful because we may talk about doing something and one of the things I am — I am kind of an implementer and this whole idea of letting people go in and parse their records and pull this piece out, pull that piece, where there is no indication that something got pulled out, really to me dramatically changes the idea that you have somebody’s record electronically. You have whatever they may have put in there. You may have put in there or some doctor did or didn’t put in there, that somebody took out. Somebody said they could or couldn’t have. Then the doctor says I will or won’t treat you if you don’t do electronic. I mean, when you go to the real world of the real people and, again, I deal with a couple of elderly people right now, trying to explain this whole process and trying to figure out it really does or doesn’t work is one thing I hope we keep in mind as we go through this. On this particular one, this whole idea of opting in or opting out, I am really more for the idea of opting all the way out, which means I don’t want to be in anything electronically.

But once I am in, I am in. So, if I have decided with Paul as a doctor that I am in, then I am going to decide with Simon as a doctor that I am in. I am going to decide with everybody because otherwise I don’t have an electronic record. I have what we have now.

MR. ROTHSTEIN: So, Harry, are you — on the first issue of whether people should have a choice as to be in the entire network, are you saying that it should be optional or — I understand what you are —

MR. REYNOLDS: The whole thing about trying to delineate between — we got into it yesterday — PHRs, EHRs, NHIN, people aren’t going to understand what NHIN — they are going to say I went to this hospital and they got my records. Now what does it mean? I am going to be in the NHIN. I don’t go to other states. I want to be if you are in, you are in. That is not very —

MR. ROTHSTEIN: Anyone who has an electronic health record is automatically — so, our patients have no choices at all? Can I say I don’t want something else?

MR. REYNOLDS: At the most basic level, that if you decide as a patient, that you are in —

MR. ROTHSTEIN: What does “in” mean?


MS. GREENBERG: You are saying you should have the option —

MR. REYNOLDS: I am going to the base level. Once you decide you are in or not, then you are in all the way.

MR. ROTHSTEIN: But isn’t it likely to be the case that within a few years, people really won’t have that choice. All the providers are going to be electronic and so your choice is you get health care or not, right?

MR. REYNOLDS: Well, yes, because — let me finish — I have one other comment. We put in here in a statement that the doctor can decide to treat them or not treat them, based on whether they would go into the EHR. Okay. So, let me take your statement. So, if we are truly driving to a functionality where most of the doctors would be electronic, then I would reverse your question and make it a little different. Then how will anybody get care if they aren’t in? Because that doctor then has just gone completely electronic, says I am not going two ways. I am not having a persistence, everything else for you.

So, I want to make sure whichever way we decide, we balance all the pieces. That is the hardest part of this thing and I think you did a masterful job of putting it down. Once we pick one answer, then it is like a domino game. Everything starts falling in a certain way. So, that is what I want to make sure —

MR. ROTHSTEIN: Okay. Paul is next, but Marjorie wanted to comment on Harry’s point.

MS. GREENBERG: Well, I think Paul wants to comment on this, too.

MR. ROTHSTEIN: Okay. So, it is Paul, then Jeff, then Marjorie — oh, then Maya, then —

DR. TANG: I think the approach that Harry is proposing, that is simplicity, so you could explain to everyone and understand it, is the supreme principle, I think. I can’t think of it stated more eloquently than what Harry just did. I thought it was absolutely compelling the way he told it and I totally believe it.

MR. ROTHSTEIN: Let me just interrupt you by saying that on page 2 at the last sentence of the first paragraph, I think, recognizes that, but my solution is, obviously, not necessarily the one that will come through.

DR. TANG: I am going to pick on, you know, three phrases in your document that have words that actually have — represent concepts that I think are important to discuss in the context of what Harry and John just said. One was towards the bottom of page 4, you talked about, and this is what John commented on, and the statement you made was, “We believe that such a risk is not significant.” That is, the liability of having what you called incomplete medical records. I think that is actually much more accurately stated as hidden information, as hidden information.

Incomplete is what we normally deal with and I refer to it as a scrapbook, which we don’t know. There are pieces there, but I don’t know whether it is complete or not. So, I delve down. Hidden is a different concept and an important one and I think it is one that Harry referred to. If there is information that presumably somebody needed to know but you have elected not to share with me, it creates a real uncertainty and tension.

MR. ROTHSTEIN: You don’t think that happens everyday of the week?

DR. TANG: But we are trying to avoid — we are trying to make that problem less so. We are certainly not trying to create a record system that now makes it possible to choose which pieces are hidden or not. That is not the

— he went to someone to get care and to the extent now we will get into later pieces of your recommendation that says and that information should be treated equally everywhere by everyone and that is sort of the comprehensive legislation piece, will get there.

I think that is necessary for him to have trust in the whole system so that I can share it with Simon if Simon has a need to know, but there shouldn’t be a concept of hidden, either from a medical point of view or from a legal liability point of view.

In that same paragraph, you made the statement, “Physicians learn to maintain a level of skepticism about what patients say.” The word is not one I would choose. It is not a skepticism. The provider is responsible for maintaining accurate contemporary records. Accuracy is a judgment call, but the physician tries to validate the accuracy of information told by the patient, no matter whether it is something verbally or let’s say they bring a diary of, let’s say, glucose readings from home.

I will give you one case example. We are trying to improve the ability to understand and interpret the glucose readings from home monitoring for a diabetic. So, we give explicit instructions and we are graphing it to see if graphs help the patient even understand it. It so happens that the patient didn’t get the point about it should be fasting so there were non-fasting sugars on the graph that could be misinterpreted, in fact, were initially until later on, they asked the patient why does it go up and down so much and they explained it.

So, that is an example where it is not skepticism. It is trying to make sure accurate information gets into the record because you are going to make decisions based on it. It is very common to make —

MR. ROTHSTEIN: I think we agree in concept. Maybe it is just the word.

DR. TANG: Okay. Well, I just wanted to make

sure —

MR. ROTHSTEIN: The need for independent verification, I think, is the point.

DR. TANG: Because it affects the process and procedure of validating something the patient hands to you verbally or on paper or electronically before it is accepted into the medical record. Once it is, it is distributed with some amount of endorsement or approval by the provider.

So, I guess the final point has to do with how we started this, which is your concluding paragraph is of endorsing the ability of patients to block their information. I don’t think that is a pattern that should go down for the reasons that Harry eloquently stated.

MR. ROTHSTEIN: Okay. Jeff was next.

MR. BLAIR: Thank you.

Mark, I like the idea that you are directing us to talk about the basic concepts at this point. I just want to make sure as a preface to my suggestion that I understand what you say the privacy advocates told us and I think I heard you say that they said that patients should not be given a choice of the media upon which their medical record is put, whether it is an EHR or paper. Is that correct?


MR. BLAIR: That is wonderful and that, I think, provides us an outstanding foundation upon which to build because if we take that issue, that directive, that guidance, then I think that it would mean that we don’t give the patient a choice of whether or not that electronic health record is connected to a network within a hospital or a network within a RHIO or the National Health Information Network. If we start opening that Pandora’s Box, who knows where that will go.

So, I think that the basic principle that is there is that the rights of the patient are to indicate to whom the information would be disclosed, which is in the HIPAA privacy reg and when consent or whether disclosure information is required, which I think is pretty much in the privacy reg, although there may be some clarifications on that. If we stick to the issue, which the surveys tell us is the main concern of our population, which might be an impediment to using electronic health records, their concern is that an employer could get that information or some other government agency would get that information that would impair their freedoms or their employment or their mobility or other aspects of their privacy. That is where their concern is.

That is the issue that for the most part the privacy regs address and if there are some gaps or loopholes in that, I think if we focus in on those gaps or loopholes, then we are addressing the primary concern of our population. I think we should not open the door to letting them choose the media or the network.

Now, my observation is really quite consistent with from what I could tell what John has said and Harry has said and Paul and Simon has said, only I have tried —

MS. GREENBERG: Simon is looking —

DR. COHN: I am not sure I said quite that, but go ahead.

MR. BLAIR: No, but you got into the opting and I kind of extended it to where the boundaries are. Okay? To what do they opt on? Okay? I am saying that the thing we don’t give them a choice on opting on is the media on which it is stored or what that network is connected to, other than what the privacy regs have already decreed, which is indicating who will have access to their information and that that should be accountable. They should have access to that and that they could provide either consent or be fully informed and have full disclosure.

MR. ROTHSTEIN: Okay. The list was Marjorie, then Maya and then I want to say something.

MS. GREENBERG: I really feel there are two steps here. One is the media and we don’t seem to have any disagreement on that. I am just sitting here thinking like, you know, can I go into — I realize it is different, but can I go into a grocery store and say, no, I don’t want you to ring up my order on electronic machines. I want you to, you know, do this by hand. I am sorry. We don’t have that capacity. Really, I mean, to some degree we are talking about a business here and the consumer, whatever, can’t really tell the business owner how they want to keep their records.

I mean, there may be a small number of people who will just keep paper records and then they will track the people who only want paper records. But I just don’t think this is a practical thing in a real world. But I do think that is a separate issue. I mean, that is a separate step then — and it sounds like it is one in which we can all reach agreement and we really didn’t even hear any disagreement from people who made what I thought were, you know, very strong privacy arguments from whether it goes into a network.

I am persuaded by my colleagues here to the right that we should keep it simple and that at least for starters, I mean, if people are very confused even by what is out there now and the sort of boutique approach is probably — it is not workable, but — so, that would — I was persuaded, frankly, by Harry’s argument. It is either opt in or opt out. But of the network, I do not agree with it is either opt in or opt out of the electronic record. I mean, I think that is just, you know, doing business and it is not, you know, again, as I said, there may be a small subset of providers, who just want to keep health records. They have opted out and you could opt for them, but beyond that, I think, no. You would say this is what I have, an electronic record. If you don’t want it, then I am sorry. That is the only way I keep my — that is the way I run my office because I feel that I can do a better job that way and I don’t have the capacity. I got rid of all those file cabinets. I don’t have the capacity for paper records.

But I do think then there is a second decision about allowing your information into a network. I think that probably a simple opt in or opt out is the most practical. I was persuaded at the same time by some testimony that I think Paul provided when we were in San Francisco that, you know, everyday or maybe every week a patient will say to a physician I would really rather you didn’t put this in the record. Then the physician — and that wouldn’t change. I think then the physician has two choices. He or she can say, okay, you know, I think that is okay. You are seeing me for this condition and, you know, you had better remind me when you — you know, whatever, but I understand or it could say, well, if I don’t put this in the record, it has these consequences and you need to understand that and I am uncomfortable with it.

That is where I get back to the educational function and I mean I think it is — it may be fantasy to think that clinicians can really spend the kind of time with people that they need to to explain this, but it is the only hope from my point of view. I was very impressed when Minnesota passed this law that all the sudden, you know, every — for the people who are treated at Mayo, they had to positively opt in to their database and people had so much trust in Mayo that they — you know, that should be our goal, obviously, that I think almost nobody opted out. They almost all opted in.

I mean, they thought it would be a disaster for their research base when that legislation passed, but it turned out it wasn’t. So, I think there is a tremendous educational function and you make that educational function so much more difficult if there are all these little, you know, variants. So, I would argue for two steps, the first step being you can’t see me — you know, if I keep electronic records, this is what I keep. You can’t opt out of it, but the network is a separate decision but I think Harry makes a persuasive case that it is opt in or opt out of the network. It is not some, you know, form of it.

Then I do think, as Paul suggested, that you always have that option of asking your clinician not to record something in the record and you take it from there.

MR. BLAIR: Can we ask a question or clarification?


MR. BLAIR: Marjorie, if over time electronic health record systems become indistinguishable from networks, is it practical?

MS. GREENBERG: You mean the clinician accesses his record from a network —

MR. BLAIR: More and more you wind up seeing that networks and electronic health record systems are so interdependent and integrated that the ability to separate the electronic health record system over time from a local, regional or national network may become impossible.

MS. GREENBERG: Well, I mean, that is a point. When I am saying “network,” I don’t mean that you would be a Kaiser patient and you could opt out of the Kaiser network. I mean, that is a closed network. I am talking about open networks.

Let me just say one other thing, too. One of our presenters — we had some really good presenters, I thought, out in San Francisco and one of them was talking about the cult of privacy and I don’t think he meant it in a negative way, but we can’t encourage that totally but I don’t think we should minimize what Mark pointed out about how much subset of the population, it might be a small subset, but they are very vocal and they are very influential, values this ability to opt out of the network.

Not giving that option, I think, or not — I mean, it is not our decision, but not recommending that that be an option for people could really undermine the whole effort because there is a — I mean, it is not — yes, it is true that most of us would say we don’t want our health information going to non-health people. We don’t want it going to our employers. We don’t want our neighbor to know about it, et cetera, but there is a smaller subset that have a very strong sense of personal privacy and really don’t want it — don’t want to play in this world.

I mean, some of them feel so strongly that they don’t even want the electronic records and that is what I said, they are going to have to find somebody who keeps the paper record or they will be out of luck.

But I think it is a larger number who just don’t want to be in this type of a network as is described and I think they have to have that option, but they have got to understand what the consequences are. I just think that is reality in a country like this.

MR. ROTHSTEIN: Thank you.


MS. BERNSTEIN: I am very sympathetic with what Harry is saying, with what Paul is saying about simplicity with the idea that we should be able to stay out of the network, but I also think that, you know, sort of — that it may be unrealistic. We are saying that it is okay for us to not allow patients to tell their doctor they don’t want to be recorded electronically. If that is the way the doctor does business then you don’t really have a choice about that. But I can fairly easily imagine a point at which the way the doctor does business is to be connected to a network that provides services to that physician and that that is going to be their way of doing business most efficiently and relying — I think it will become increasingly difficult to draw a line about how far, you know, your record as an electronic health record can go with — before it is in the network, that that line will be fluid, that there will be a variety of different networks interconnected and that —

MS. GREENBERG: That is what Jeff is saying.

MS. BERNSTEIN: Right. That is what Jeff is saying.

I do think, though, that if we focused on getting the rules right in that environment, we might be less concerned about where the information went. If we were more concerned about sort of the antidiscrimination kinds of things, if we focused on having people not have legal, technical, managerial and other ways of ensuring that people are not going to be harmed in their employment or their financial condition or their personal reputation, then we might be less concerned about where actually the information went because even if you got hold of it, which is very likely anyway, you couldn’t do anything with it legally.

I think that where the information — you know, the information is going leak even if we have rules that I think realistically, the information will leak, even if we have rules that say that it shouldn’t. We have to recognize there will always be bad actors in the environment, but, you know, I think the best we can do is to create legal, social sort of managerial, technical control with what actually happens with that information and what the consequences are.

There is one other — when we first opened the conversation, I had one other comment that maybe or question that I don’t know is apt right now, but really for Mark on the bottom of page 3, what I wanted to know was what you imagined it would look like to be able to opt out or opt in, that at the bottom it sort of says we don’t want to have somebody just provide another piece of paper —

MR. ROTHSTEIN: Where are you?

MS. BERNSTEIN: At the bottom of page 3, the last paragraph is sort of two-thirds of the way down. It is placing a burden on the individual to opt out of the NHIN nor merely providing another piece of paper for the individual to sign, to opt in, basically it is not appropriate, but that yet individuals should have to be — should have to make an affirmative informed decision. So, I am wondering what is an affirmative informed decision look like if not I have read this, I understand it, I agree, I sign my name?

MR. ROTHSTEIN: Well, there are two questions. One is the last sentence that says,”We do not address…,” that is meant to deal with the issue of — witnesses in San Francisco that said that there are some specialized health care providers, such as the Betty Ford Clinic, that will not share their records with anybody and will not be part of any system, et cetera. So, the “We do not address…” sentence goes to that. Whether a health care provider, such as an inpatient substance abuse treatment or whatever could say we are not — we are off the grid and so on and so forth.

I left that issue aside. We could take it up. So, that is one. The other issue that you raise is a very good one and it is a practical one and I did sort of finesse this issue. We are all very unhappy and, in fact, we are planning to have hearings after we finish this on the issue of notices and acknowledgements because it is frankly a joke. I would be very unhappy if we came up with a system that was a similar joke. Okay? I mean, I am sorry. Everybody knows that. It just hasn’t worked out.

I don’t know what would be better, but it hasn’t worked out. And I kind of left that open and maybe if we get that far, we can put our heads together and come up with something better. So, that answers Maya’s questions.

But I want to take a minute and just talk to you very frankly about this. The issue of mandatory participation, if we don’t get this right, we don’t need to go any further on this document, as far as I am concerned. I think that ethically, to require people to have their health information part of an interoperable longitudinal comprehensive, et cetera, system is ethically extremely problematic. I think from a legal standpoint, it may well be unconstitutional.

Other countries have uniformly not adopted this model. No country that we have studied that has an information network system has gone to a mandatory system and the ones that have tried have regretted it and have backed off and gone to some system where they are found. Let me just say that I truly believe that from a U.S. political standpoint and if you want to kill the NHIN, this is the way to do it. Just think about national identifier. If we came up with a recommendation that you have no choice, everybody is in, everybody gets everything, the system would not go forward. I don’t think it ought to go forward under those circumstances, but as a practical matter, I think it is not going to fly.

The final thing that I want to say is — and I don’t want this to appear to be a criticism of my colleagues, all of whom I like immensely and respect. We do not represent our employers here. We represent the people of the United States. This is a public advisory committee. We need to think about the health care system that we would want if we were patients and not what might be inconvenient or more expensive for organizations that we are very close to.

I also want to comment on both Maya’s and Jeff’s earlier comment that what we need to do is to fix the downstream bad uses of the information and then everybody will be happy. The fact of the matter is sadly I wish that were possible, but I have been working on that issue for the last 30 years and you have no idea how complicated it would be to do that. We would have to revise all of our life insurance laws, which are all different in the 50 states. We would have to sort of federalize life insurance law. We would have to federalize disability insurance, auto insurance, employment. The number of laws and the fundamental nature of what we would have to do to prevent these unpleasant uses of health information are astounding.

From my research somewhere — and this is a very soft figure — between 30 and 50 million times every year people are compelled to sign authorizations of their medical records. They are usually comprehensive and even when they are more limited, practically it can’t be done. They just send everything because it is much too expensive to do that.

So, I wish we could fix that. I have got some recommendations on how we might begin to address the problem of, quote, secondary uses of the information, but giving everybody everything and trying to move in at the end and make sure that bad things don’t happen, I think is not the right strategy and it would take so long, that we would have to get the information system up and running before we could get the legislation through to do all these other things so we would start it on a kind of trust me, we will fix it later basis, which I think also politically is a non-starter.

So, you may have detected, but I feel strongly about this issue because if we do this, I mean, I think it is curtains.

All right. Who is next on the list? Okay. John and then Harry.

MR. HOUSTON: I have had my hand raised for about a half hour.

MR. ROTHSTEIN: Then we have Paul and then Harry and Simon.

MR. HOUSTON: I have some fundamental disagreements. My concerns are I guess in no particular order is is that — and I agree that we don’t represent our employers, but we all have a great deal of practical experience with people in the health care setting. I deal with people all the time, who call me, a privacy officer, for my health system to discuss these matters. My fear is that people do not necessarily know what they want. Now, I will give you the example. I have been using this example for a number of years because I think it is great.

The example is that a gentleman calls me up on the phone and says I read the article about your new electronic health records environment and I want nothing to do with it. I don’t want to be part of it. I want my records back. I don’t want to be part of it. When I expressed to him the fact of what happens if he was driving down the Pennsylvania Turnpike, was in an accident in Bedford and got taken to UPMC Bedford Hospital and he was comatose and he had some type of chronic illness and that we were going to give him the wrong medication, he says, well, I want you to have my information then.

I said but you just told me you want to have nothing to do with this environment, that you are concerned about the privacy of your information and —

MR. ROTHSTEIN: John, what that anecdote proves is the value of a knowledgeable, informed, opt in because that is what he did, but —

MR. HOUSTON: He, I think, like a lot of people don’t necessarily understand the implications of the issue. Now let me just say this because — I think that individuals also, I think that the issue here is — I believe very strongly in personal privacy as people wanting to deal with their medical records are private. I expect the same from my records, as well as my family’s, but that has to do with putting, I believe, the structures in place that allow us to have the capability to control access to only those providers, who have — or payers or organizations that have an established relationship with the patient that necessitates their access to the record, as well as the capability for the patient to be able to understand who has access to the record.

So, if they believe they have been — their privacy rights have been violated, that they can go and find out who — if that has, in fact, occurred and then take action. I think that is a reasonable way to look at it. If you look at HIPAA, what the privacy rule says is HIPAA says that you don’t need patient authorization for the purposes of treatment.

Now, I think there was a lot of discussion about why that was — as it was in the privacy rule, but, obviously, somebody has already decided that the value of information is great and having information, complete information is great. I think there are very serious cost and quality implications that we are trying to address on having a comprehensive electronic health record.

I think that the cost implications clearly, if we want to be that capitalist is is that, you know, insurance companies are going to have to deal, you know, with sort of two different populations here, those who aren’t going to cost potentially more money in the aggregate because of the fact that they don’t — there isn’t good information available to treat them and then there is going to be this other group that is going to have — you know, who we hopefully will have good information for ultimately, that maybe we will have more efficient treatment.

I think the quality implications there are also very clear. I think that this is why everybody is doing this is because you know, we hear about all of these, the deaths that are attributed to medical errors and I think the implication here is that we are trying to reverse that.

I just think overall, you know, I think that the issue — I think we are looking at the effect rather than the cause here and, again, I am going to go back to this and then I am going to shut up. But I think that, you know, it is — I don’t think that patients don’t want their providers to have the information that is necessary to care for them. They are concerned about the inappropriate use of their information, inappropriate access to their information by whomever. I think that is the nut that we have to address.

If you can say if people were told that we are developing an environment that is extremely secure, that has the controls, as well as the ability for you to look at the people who have access to your record and you will have the ability in the event that you don’t believe some of the appropriate access to your record to be able to go and have an investigation done and there will be some type of reliability for that individual, I think that goes to putting in place the appropriate privacy, as well as allowing for information to be readily available providers as necessary in order to provide efficient quality health care. I think that otherwise, as Harry said, you know, it is what the scrapbook of information, that scares the hell out of me. It really really scares the hell out of me and I just think that we are going in the wrong direction here.


MR. REYNOLDS: Since this is a public hearing, I would like to have it on the record that I am personally affronted by the comments of the chair.

MR. ROTHSTEIN: Well, I apologize —

MR. REYNOLDS: I don’t need an apology.

Each of us have heard a lot of information. Each of us come from diverse environments. Some of us speak more eloquently than others. I probably would be the least eloquent of all of you. If I use a word wrong, two people on the committee reacted when I used that word. That is unacceptable to me. We are all in this to look at the entire extent of what this issue is. This is the only probably honorable debate that is going on right now in this country about this, where the people respect each other around the table, people don’t have that big of an interest in actually making it happen. We do our day jobs before we get here. So, you are right. But everything that we are talking about here and everything that we are dealing with, each of us is facing it as a patient.

I had major surgery this year. I had major surgery this year. I am dealing with two elderly adults, looking at it from every way you can, probably closer than most of you around here, even though you may treat patients and other things. I just think it is important that we keep it at a level — I don’t know the answers. I made a statement this morning. Would I vote entirely for everything I said? Maybe not because the point is if we don’t have the honorable discussion and we don’t twist it and spin it and make sure we understand what the issues are — and I have got a list of five things I think are exactly have to have them and they didn’t even mention anything I mentioned earlier.

So, my point is I hope we can remain at that level because this is ugly. You heard all of our testifiers say that is the toughest problem you can have because it is not going to be pretty. So, I hope we can maintain a level of decorum and maintain a level of discussion that in the end none of us may know the answers. But as long as we collectively figure out what we think or don’t think, I am good for that. Otherwise, I have really got a problem.

DR. TANG: Like John and Harry, I also believe that probably the patient advocacies — my biggest point is to be a patient advocate and where you see the passion around the issues that I have been talking about, either yesterday or at the past hearings, has to do with experience with patients and on behalf of patients.

And secondary uses — and I will come to that in just a minute — is all about patients. So, it has nothing to do with my employment. It is with my experience and everything that I have heard.

I want to go back actually to Harry’s earlier point. When we deal with complex situations and this is about as complex as it gets, but there are other complex situations. Simplicity actually is one of the most elegant ways to solve the problem because it solves it for so many people.

Let me give you an example. CPR. When I first learned about ABCs, airway, breathing and circulations, I thought this is sort of a — you know, it is just one of those — then, you know, the proof is in Seattle, where they had a massive program, their survival rates from cardiac arrests were better than the rest of the country. So, ABCs, when applied and it applies to public policies, does a lot of good at this population level.

So, the simplicity, I think, that Harry — again, I liked the way he said it — makes so much sense and probably can reach and help and protect so many more people than a slew of if this, then that. So, as an example, your organization of your document, where you talk about importance of confidentiality, Section 1 — let me just rearrange that just a little bit. First about trust, you talked about this, too. We do not want to nail this coffin when it is the saving grace of not only American health care, but American society, as Katrina has just proved to us really.

We need to be able to get the people’s health information and to take care of the health of the individuals in the population. An electronic way of keeping and using that information is the salvation for that. Let’s not nail that coffin.

So, let’s talk about trust and how confidentiality and privacy are the linchpin of maintaining that trust and then get into a simple method of opt in, opt out. Just like we trust the plumber to fix the plumbing in our house with whatever tools he or she needs, just like we trust people who designed and built the bridges not to collapse or a home, essentially all our infrastructure is built on experts and the tools that those experts bring to bear.

When you go to a doctor, sick, a little bit sick or urgently ill, you do have to trust this person and the team that she has put around her to take care of you. So, health care is delivered by using information — I know there are surgeons also that are doctors, but — I didn’t mean it that way — but that is part of our armamentarium and we have got to use it right.

So then what do you do next? I think there is this opt in, opt out because it is so simple that can be opt in local and opt in national, but then we have got to — we as an advisory body and represented public have to go protect — do the best we can to protect that information once it is out. That is the confidentiality piece. The way to do that, just like anything else in life is to prioritize. Where is the low-hanging fruit? Where is the biggest risk?

One of the low hanging fruits or biggest risks in my mind is this whole secondary use because there is such a financial incentive to misuse that information. So, that is where I have been, as you can tell, passionately going after to try to close that loophole and practically try to close the loophole. I understand it is hard. I think legislation is probably the only way to be cross cutting, but maybe we have to be smart about how we do it. We have to be politically smart about what do we pick on, but that is where it is. It is the misuse of information once it legitimately gets out to certain individuals. There are tons of ways that it is legal to get information that can cause secondary harm. That is, I think, what we need to pick on.

So, in short I think we need to — what can we do to put this enabling technology in front of health care professionals to take care of individuals in society and then how do we protect that information — the decision, an individual like a patient needs to make has to be simple, just like the CPR provider, it has got to be ABC. Then by policy, we have to find ways to protect it from the highest risk.

MR. ROTHSTEIN: Next, Simon.

DR. COHN: Well, Mark, thank you. I think I am going to start off by apologizing for Dr. Tang to the American College of Surgeons for his previous remark. Mark, I do understand your passion and I think we all realize and take this responsibility of being on the committee very seriously and, obviously, come here — I think we bring a lot of expertise and a lot of perspective.

I think the good news is is that as well as deliverers of health care and people may in some cases understand some of the architectural issues are also patients. So, certainly whenever I talk about privacy and confidentiality, I always tend to think of, well, myself as a patient, how is this going to affect me. I think that probably stands us all in good stead considering that.

I had a couple of comments and I mean one of them is like others, I think that somehow simplicity I think needs to be a guiding principle or a system property. Now, as I say that, really what I mean is simplicity as far as the patient is concerned because I don’t necessarily believe that the technical solutions that enable things need — I am a little more agnostic about whether that needs to be simple or not.

So, yes, patients need to understand. They need to be able to make decisions about all this in a way that they aren’t confused about. On the other hand, Harry or Paul or I or Jeff or whatever, we may have to go through some technical complexity. So, I am not necessarily as I talk about simplicity, I don’t necessarily say, well, gee, simplicity means that it either has to be a straight opt in or opt out and there can’t be some gray areas where people, you know, might be able, for example, to have sort of disguised information that in use for decision support throughout the architecture.

This is sort of where the architecture and privacy and security begin to all sort of come together. You may be able to do all of this in a way that maybe is more technically complex, but still is simplistic from the patient view. So, I think simplicity doesn’t — I mean it is an important principle, but doesn’t necessarily, you know, answer all of our questions.

Now, one would also observe that in this world of simplicity, now, you know, this out world of complete opt in, opt out, black and white, we already have psychiatry and psychiatric records as a visible exception to opt in or opt out. So, by definition, there is a complexity there that I doubt is going to go away and there are probably other issues. So, we already have to engineer, architect and think about the fact that there is not a black and white even to begin with and, clearly, from a patient safety point of view, you know, if you are prescribing a medication, you want to know if they are on a psychiatric medication or you want to be able to be alerted even if you don’t have complete access to their records to make sure you don’t inappropriately — you know, you don’t do harm.

So, we need to somehow — you know, in our world of simplicity, we need to recognize that there is some inherent complexity. Now, the final point I would make about all of this and as I just sort of think about it, we have all talked about sort of privacy — I didn’t think of this as trust and I keep going back to, well, gee, exactly how do we trust all of this and I would suggest to you that there may be another dimension to all of this.

I mean, we may in one hand be talking about sort of target architectures or target whatevers, but I personally believe that trust is earned. I trust my own environment. I trust my physicians that I work with. I trust my — you know, as a patient, I trust my environment. We need to realize that, you know, we don’t necessarily go out of the box with a completely developed trust environment.

I mean, I am willing to believe that some things may change over the next 10 or 15 years, after we have the trust. Now, Paul is, obviously, concerned about secondary uses. I am concerned about security. I mean, to me, you know, if somebody walks away with a tape that has my records and everyone else, you know, that may be a security lapse, but that is an invasion of my privacy, yes, the results. So, you know, I want to say that, you know, all of this stuff is earned. I would want to see evidence and proof as we develop all of this stuff that it is going to have all of those properties that we articulate about and we need to somehow reflect that in our view.

My final comment and then I will stop is given the wealth of our conversation, I am trying to think of how we are getting from here to November with a consensus report that represents all of our views. We may have to talk about that at the end.

MR. ROTHSTEIN: Yes, that did occur to me as well.


MR. BLAIR: The first thought I had was I wanted to acknowledge the point that you made, Mark. You were very concerned that if we didn’t give individuals a choice, that we may face something that if legally challenged might be unconstitutional. I completely respect your judgment on that and accept that without question. Okay? I hadn’t heard it before but your observation on that is something that I take to heart.

So then what is the alternatives? So we have to give individuals choice of how they participate in terms of having their information in place. We have gotten guidance from some folks and it sound to me like it could be very simplistic of, yes, you can capture my information, Mr. and Mrs., you know, male or female provider, or you don’t. But the other piece, we don’t want to challenge the point that you made, is that we have got to give them a choice.

On the other hand, if we start to give them a choice, my feeling is that we give them a choice in terms of in or out of the system, per se. If you wind up thinking that the alternative might be to limit it in terms of technology or media, which is a form of technology, we could cripple the evolution of the information infrastructure going forward and lead the country into some very uneconomic, some impairments in the evolution of medical informatics in terms of protecting patient safety and reducing costs and improving quality.

So, I don’t think we want to go in the direction of giving a patient a choice as to what media or what network or any other thing because we may wind up 10 or 15 years from now deciding that flash drives are an option or we may decide that information over wireless is an option or we may decide — you know, you could — even technologies that we don’t even know about right now.

So, that is kind of my — I think that as cumbersome as the privacy regs might be and that started with some simple ideas that it provides a pretty good construct. I think that I wouldn’t add complexity to that. I might try to fill some gaps as Paul Tang has mentioned and I very much agree with him and I agree with Simon on security as well, you know, plugging some of those gaps, but I don’t want to add complexity and I don’t want to get into the idea that we could use media or technology to provide our constraints or barriers.


MS. BERNSTEIN: I will just let the committee — I mean, I have lots of thoughts, but it is more important for the committee to —


MR. REYNOLDS: Mark, if I look at Section 2, if it started off — I guess the one thing that I continue to plan off to comment on the privacy regs, if we had something in place that said PHI, PHI, PHI. If you touch it, you have got to protect it. The only way you can use it now is treatment, payment, health care operations that is defined. With that as a basis, which adds to this ability of if you touch it, you have it because secondary uses keeps coming up and one of the reasons is it is kind of out there. That is business associates and that is other things. So, that is very troubling and it is very troubling sitting here anytime we deal with this, we keep kind of tripping over it because it is not clearly defined.

But back to the reality of what is going on now, Simon just made a point about psychiatry information, if you look at a PBM, those records are available. I can download from the prescribing. You download from PBM and you know that that person is on a drug for some of these things. We talked about networks earlier. I just saw a demonstration from a large university health system on their electronic medical records. You may be seeing one doctor, but all the doctors in that whole facility and everything that they deal with has access to that data. I didn’t know that until I sat through the demo.

So, I think back to some of the earlier points, defining what we are getting into or not getting into, one, it is not clearly understood even what has happened to us as individuals and I will just go as a patient right now, as to what is happening to us, let alone what is going to happen to us on this. So, that is why this opt in, opt out is so important because — Simon made a very factual statement is his mind, but the fact that those drugs through normal process, that drug information would be available to another doctor or to somebody else as we are looking at it, kind of negates some of these things.

So, I think if we can stay — you know, I like to build it off a PHI and I thought I heard great discriminations out, strong Internet security, patient quality of care, I agree with Paul. I think the patient and the doctor may agree on things that get withheld. At least there is a doctor involved and they never put it in in the first place. I think those are some good practices.

MR. ROTHSTEIN: Okay. Thank you.

John is next.

MR. HOUSTON: A couple of points. First of all, to echo I think what Simon said is that — and I proposed this yesterday and I offer it again is I think that we do need to at least make mention of security. I know this is a privacy letter, but I don’t think we can avoid the conversation and I will be happy to put my thoughts together in terms of a section on security. Maybe what we need to do is separately construct a letter if, in fact, it appears that it is too long for this letter, maybe we can separately construct a security letter as a companion letter. I will open that up to you guys.

Simon is nodding “no.”

MS. GREENBERG: I think it should be in here. Given that David Brailer is really looking at this as being together, I think having some — I don’t know whether you need additional hearings or what —

MR. HOUSTON: I don’t think we do to get across the points I think are necessary, based upon our privacy discussions. I think that —

MR. ROTHSTEIN: We could make some principles without going into the technical stuff.

MR. REYNOLDS: We also have a quorum of the Standards and Security Committee in this meeting.

MR. HOUSTON: So, I will put my thoughts together and try to make them consistent, you know, make them something we can sort into the letter. I think that is very important and so go with that.

I did want to go back to one point you made a little bit earlier about the compelled authorization issue, which I still have — I personally, again, I guess I have a lot of strong feelings here — and I think that — whether you call them compelled authorizations, I think there is a bona fide right or organizations that are going to provide a service or something to you that is based upon your health or upon your health status. I think it is fair for them to have complete information in order to provide that service.

Now, the best example is —

MR. ROTHSTEIN: You mean complete relevant information or complete —

MR. HOUSTON: Yes, complete relevant information and I guess —

MR. ROTHSTEIN: I agree with that statement, with that qualifier.

MR. HOUSTON: I will go back to the example of the insurance company. You know, when you are dealing with health insurance, people that are healthy are less likely to get insurance than people that have chronic illnesses and the like and if you — so, you have to have some mechanism for these companies to do for what they have, I think, a reasonable right to do.

So, again, I wanted to make — the whole concept to me — compelled authorization scares me when I hear that phrase. It is a guttural reaction —

MR. ROTHSTEIN: What I am referring to is if you apply for a job in anywhere but Minnesota or California, as a condition of employment, you can be required to sign an authorization, authorizing the disclosure of your entire medical records regardless of the job for which you are applying or your medical history. So, you could be applying for a job as — and working in an office, you know, where there are no hazards. It is not strenuous or anything and they get everything in your medical file and even if we enacted laws like California or Minnesota has, we currently have no practical way of sort of filtering and only giving them the stuff.

So, that is the point I was trying to make.

MR. HOUSTON: I think that can be mentioned in that context. You know, I don’t disagree with that. I do believe though that there are probably — well, I don’t know what an employer needs to see and doesn’t need to see in each case. That, obviously, is going to be very difficult to try to police because what is relevant for one job may not be relevant for another, even in the same company in what seemingly seem like very similar jobs.

So, I just think we need to be very careful in the way we couch our recommendation in this regard because I think it is problematic and I do believe that there are some bona fide reasons why they should be able to get at certain data.

MR. ROTHSTEIN: I would like to — we are running out of time and I would like to see if we can sort of step back and see where we are on this as a committee. I don’t know whether it was a good idea or a bad idea to start with Section 2 because, in fact, there are many areas in this document, I think — I don’t know for sure, but I think — that we would all agree on. They might need to be tweaked a little bit but there are many things in here that I think are of the kind — of the first paragraph, where we all agree that electronic health records can be a required use.

So, one possible strategy is to — I don’t know whether this would work or not, but kind of skip over the things that we have the most disagreements on and try to start on the stuff where we actually do agree and then maybe the shape of the document from the stuff that we do agree on will sort of lead us in a direction so that we can solve these other things.

I suppose the other way is — I mean, there is no other way because —


I mean, the other alternative is —

MS. BERNSTEIN: We can do the hard stuff now or we can do the hard stuff later, but we are going to have to get to it.

MR. ROTHSTEIN: The hard stuff might be easier if we got some other things under our belt and I mean sort of

— maybe all of us to an extent and I put myself at the top of the list are thinking of sort of the worst case scenario, not only some of the stuff that we talked about today doesn’t work, but they don’t go for the rest of the stuff either, I mean, which is sort of a really bad situation, but our comfort level as a subcommittee might rise if we were happier with the rest of the stuff, the things that we could agree on and then maybe over time we can figure out a way to solve what seems now to be a very kind of stark series of options that are sort of mutually incompatible, maybe we would be able to figure out something over time.

So, that is my suggestion at least. Paul, do you want to —

DR. TANG: I am just trying to deal with — I think actually if we either stumble upon or deliberately arrive at an organizing approach, I think that could help us through the rest of it. Harry’s approach was one of those potential, you know, gateways.

There is probably three or four major issues and maybe with the remaining ten minutes, we —

MS. GREENBERG: I don’t think we have ten minutes.

MR. ROTHSTEIN: We have got five minutes. The next meeting starts at 10:30.

DR. TANG: With the remaining minute, enumerate those three or four topics for us even to deal with and then we can figure out how to deal with them on what schedule. I thought we did some vetting of an approach to the rest of the document. If we were to agree on that, I think actually it would very much influence the rest of the major —

MR. ROTHSTEIN: Can I ask you before we go to the next person, who I think is John, if you were to sort of want to pull out kind of an idea or principle to take up next, to try to build some momentum, what would that be? All right. Well, you don’t have to give an answer. Maybe somebody else —

MR. BLAIR: Well, Mark, he was saying there are five, I think —

DR. TANG: Well, I mean, I would be happy personally to take up Harry’s sort of you touch it, you own it principle, which is currently in 4(a) on page 6.

MR. ROTHSTEIN: So, in terms of owning it and being responsible for it, that requires in my mind a national legislation.

DR. TANG: Exactly, more comprehensive —

MR. ROTHSTEIN: That is one of the major things in there —

DR. TANG: We sort of promised yesterday that we would take that up, didn’t we?

MR. HOUSTON: Isn’t the one RFP that is out there intended to really assess the 50 state issues related to —

DR. TANG: I don’t think it reaches this specific point.

MR. HOUSTON: But there is going to be feedback and information that comes from that. Is there going to be this — should we put a place holder in place because of the fact that that work isn’t even done yet, at least —

MR. ROTHSTEIN: That is going to take, oh, a long time before — I mean, they are not going to even start until after the first of the year. The contract is going to be let sometime in the next week or so, but then they are going to do the research — I mean, we would have to put this on hold for awhile.

MS. BERNSTEIN: But more, too, as we — your feelings about this may have — it may be an opportunity for this group to influence that process. You may want to be in beforehand —

MR. HOUSTON: I have one other substantive comment that I think is important and being a techie, I guess, at the core, one of the things that I think we do need to be mindful of in all of this and know this is again a privacy-focused letter, is that pathologies are going to change dramatically and we have to assume that whatever we propose, though, may not be practical today. I think if we couch things the right way about focusing on where we, I think, technology will take us over the next 10 or 15, 20 years to try to set an architecture, I think we just need to take in consideration the fact that we have to be sort of technology agnostic, recognizing that there will be substantial advancements overall and trying to make recommendations that have a timeless quality with that regard.

I think there are going to be some recommendations that we can make that will not be practical today, that might be practical in five years. I think, again, as we are going through this, I just — hopefully, we can try to couch recommendations in terms of that direction.

MR. ROTHSTEIN: Marjorie.

MS. GREENBERG: I am persuaded by what everybody said and this is why I am going to actually say what I am going to say and that is that I think this has been a very rich conversation. It has been a little stressful, but I think, you know, we are — I have tremendous respect for everyone around the table and I think it is shared by those around the table and it has always been a privilege for me to work with the National Committee and continues to be.

I, again, felt that there was some really rich testimony in the hearings I have been able to participate in. The most recent one is the most salient to me but — and I know I missed a few or a few days at least. But because of that, I think there is really value to Mark’s approach of looking where there is agreement and where you can actually put out — put together what you have heard and how you interpret it and what you would recommend.

There are areas I am sure where there are. Then on the other issues, potentially just laying out the richness and the complexity of the issues and saying that you will either continue to address these — I mean, at the end of the day these are kind of — some of these really, really contentious issues are political ones and this is — and you need to be sensitive to that, but those decisions are going to be made in the political environment,whether it be in the Executive Branch or the Legislative.

But having the benefit of the AHIC and the Department and the Congress of the benefit of your — you know, your combined thinking and best thoughts on this, even if you can’t reach a conclusion, I think is a service to those who have to make the decision at the end of the day. So, although I — you know, whether November is — we are ready for prime time in November, I mean, it all depends on how much you all can work and time spent in the next few months, but I don’t think because — I don’t think necessarily you should withhold any kind of comments or letter or reports because you can’t agree on everything because I do think — somebody on this side of the table, I can’t remember whether it was Harry or Paul said this may be one of the most important in a sense venues in which people really are here not being paid to be here to represent their employers, but to represent their expertise and to advise the Department and to really think thoughtfully about these issues.

I think, you know, we are not going to agree on everything, but I am convinced everyone is thinking very thoughtfully about them. So, that is just sort of what I was thinking about as a way forward. As I said, I am not so sure November, but I wouldn’t want to wait until, you know, another year to at least get something down where you agree and where you see the issues and what the richness of the conversation is.

MR. ROTHSTEIN: Thank you.


DR. COHN: I think I basically agree with Marjorie. I was just — we need to stop. We need to finish here momentarily. Can you go through what the planned conference calls and meeting schedules —

MR. ROTHSTEIN: That is what I was going to do. Our conference call is scheduled for October 3rd from 12:00 to 2:00 Eastern Time. Then we have a meeting October 21st from 9:00 to 5:00 at some place to be determined.

Here is a suggestion that I would like to float and see what happens. I will work with Maya and put out — and distribute by e-mail a list of topics to the subcommittee members that we think — and your input would be very helpful in this even beforehand — that we think we might be able to get through and reach some agreement on, sort of the least controversial, but nevertheless important elements to that and we will sort of poll the subcommittee members and from that come up with an agenda for the October 3rd conference call. Maybe we can get through a few of these issues.

Does that sound acceptable, John?

MR. HOUSTON: I remember the reason for the conference call on the 3rd and I am questioning whether we shouldn’t look at our calendars again and see if we can get something earlier. I think we are going to need the conference call on the 3rd. I suspect we are going to need some other ones.

MR. ROTHSTEIN: So, you want to see if we can have an additional conference call.

MR. REYNOLDS: When we were doing e-prescribing, we came up with some foundation things. That is what you are talking about, things we believe in from a foundation standpoint and then there were other things that we either couldn’t close or we couldn’t come to consensus on necessarily.

MR. ROTHSTEIN: And your input would be helpful in coming up with that agenda.


DR. TANG: And I also support what John says, which is to add additional time because I would like to support Marjorie in what she said. I think it is important for us to put in public — and I am timing it with AHIC actually — what our thoughts are and where we agree, but also the issues, even if we have yet to conclude on those issues and may need more hearings because some secondary uses was not a topic of a hearing. It came up. So, we may need to explore that more, but I do think we need to —

MR. ROTHSTEIN: Well, actually we did have a full day hearing in January on employment.

DR. TANG: But I think it is important to get on the record earlier rather than later.

MR. ROTHSTEIN: We had a half day on life insurance and a half day on employment.

We are going to do that and I think we will also circulate a calendar between now and October 3rd to see if there are any dates that people can also make a conference call.

MS. BERNSTEIN: I was just going to expand on your suggestion and include Marjorie’s. We make a list of not just topics we think we can agree on, but topics that we think need to be addressed in this and then we can pick off an agenda, but on those things where we think might be particularly contentious, I wonder if it might be useful to try to draft the best arguments for each of the, you know, positions we can think of on a particular topic. This is what Marjorie was saying that we could — you know, this is coming from your career staff kind of way of thinking, but, you know, Option A, here are your advantages and disadvantages, Option B —

DR. COHN: John Paul, we need to stop. Right after the introductions at our meeting, we are going to have — Mark is going to give an update and you are free to continue that conversation during that time with the full committee.

MR. HOUSTON: I just want to make one real brief comment. I think this is one of the most important letters that we are writing and have written in a long time. We need to take the time we need to take. We also need to be diligent that we have to get this done quickly.

DR. COHN: Let’s give everybody about a five minute break.


[Whereupon at 10:26 a.m., the meeting of the subcommittee was concluded.]