[This Transcript is Unedited]



Subcommittee on Privacy and Confidentiality

November 15, 2005

Room 705A
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201

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


  • Welcome and Overview – MARK ROTHSTEIN, Chair
  • Discussion of Letter/Report to the Secretary on Privacy and the NHIN


  • Mark A. Rothstein, Chair
  • Dr. Simon P. Cohn
  • John P. Houston
  • Harry Reynolds
  • Dr. Paul C. Tang
  • Maya Bernstein
  • Amy Chapper
  • Beverly Dozier-Peeples
  • Kathleen Fyffe
  • Gail Horlick
  • Evelyn Kappeler
  • Lora Kutkat
  • Catherine Lorraine
  • Susan McAndrew
  • Dr. Helga Rippen
  • Bill Tibbits
  • Sarah Wattenberg

P R O C E E D I N G S [11:05 a.m.]

AGENDA ITEM: Welcome & Introduction —


MR. ROTHSTEIN: Okay, let me tell you what I hope to accomplish today.

As you know, we left off with Section B; we have not done that at all. We’ve done some work on the other stuff to varying degrees, all the other sections.

And my goal for today would be to get some agreement in principle — I don’t care about the language — on Section B, which is Pages 4 through 6 in the draft.

The other things we need to do are to plan our presentation to the full Committee tomorrow. We are scheduled to have an hour and 15-minute slot, from 1 to 2:15, and we talked a little about this, assigned people different sections, and we should spend a few minutes talking about what we’re going to say and what our goals are for that presentation.

I think my view is that we should try to have sort of two-way benefit from the presentation — one, to give them some idea of where we’re going with this to kind of bring them up to speed on our process of the letter, and also get some input from them which will be valuable on some of the various sections, but we need to talk about that.

If we have extra time today, we need to work on — we can work on cleaning up some of the language in the other sections that we’ve already agreed on sort of in theory or in general terms —

MR. HOUSTON: Principle.

MR. ROTHSTEIN: — and then — principle, and then, finally, we need to talk about our Thursday morning working session that is scheduled from 8 to 9:50 and what we want to do then and how many more meetings we need, conference calls, et cetera. So if that’s agreeable, I’d like to do that.

Okay, I have an idea on how to start Section B, and that is not to look at the draft. [Laughs.]

MR. HOUSTON: Hold on — how can you not look at the draft?

MR. ROTHSTEIN: Because, I’ll tell you — I’m glad you asked.

We agreed, I think, exclusively on the first paragraph of the section, which is that patients should not have a right to demand that their records be kept in paper form in the future. That is so if the provider says “I’ve gone to electronic,” well, that’s the way it is.

There may be providers who want to say, you know, “cash only, paper only,” whatever; that’s their business. But I don’t think —

The thing that we need to work out is what level of patient control there can be in the system. And so what I’d like to talk about are the two main issues that I see relative to patient control, and then — we can write it up later. What I wrote up is how you would write up if you adopted some sort of theory.

The first is whether patients should have any right to be outside the NHIN for some or part of their health records. In other words — and we need to talk about what that means to be outside the NHIN, outside the health care network, outside the institution, you know, and so forth.

And if we agreed that they should have some right in that area, then how do you do it? Is it opt in/opt out?

Okay, so that’s the first broad issue we need to talk about.

And the second broad issue we need to talk about is sort of at a level of more detail, and that is: Should the patients have a right to block or delete certain health information from their records or from disclosure of their records, et cetera, and then, of course, if so, when/how/what limit’s place on it, et cetera?

So in my view, I think there are only two things that we need to work out, right? The sort of the system participation and then the control over specifics of their records.

And if you buy that, then we really don’t need to look at the draft language yet.

MR. HOUSTON: We can use pieces of the draft language —

MR. ROTHSTEIN: Yes, certainly.

MR. HOUSTON: — which is the basis for —

MR. ROTHSTEIN: But what I would like to do is to try to figure out if we can get some sort of agreement in principle on where we want to go on these issues, keeping in mind that they’re, we’re, you know, three/eighteenths of the NCVHS and that we may need to —

PARTICIPANT: Sixteenths.

MR. ROTHSTEIN: Oh, we’re down to sixteenths?


MR. ROTHSTEIN: Well, if Paul showed up, we’d be a quarter, but we’re less than a quarter. And that it could change. So I don’t know whether we want to leave, you know, escape hatches or whatever.

MR. HOUSTON: I think that’s why it’s important, twofold, that, A, we do choreograph, plan, this presentation tomorrow so that people understand the thought process, that a lot of work has gone into this, so that they don’t — you know, that they recognize that this wasn’t just sort of a — what we’re proposing hasn’t just simply been ad hoc put together without a lot of forethought and hard decisions made.


MR. HOUSTON: So I think that will help, maybe allow some individuals to be more comfortable with the work product without, you know, consisting of a lot of dialogue about — see, in theory, this Committee, the whole Committee, could get into the rumble of dialogue we’ve gotten into in these meetings, which is “this isn’t going to work.”

MR. ROTHSTEIN: Unfortunately, I expect it. It would be a pleasant surprise if it were not the case. Gail?

MS. HORLICK: Now I have question, because I read this really for the first time on the plane — I had read an earlier draft — and I think it really is excellent. I mean, it really — you know, for me, just pulling things together, but you can’t really look at the draft now, but the one part that was really not clear to me was Section B.

MR. ROTHSTEIN: Well — [laughs] — there’s a reason for that.

MS. HORLICK: And my question is, in reading this, I thought that there was a resolution. I mean, I thought when I read this, just once, but I thought that it was sort of saying that an individual should have the opportunity to opt out or —

MR. HOUSTON: Well, no, no, no. Mark’s point is that Section 2 — most of the other sections already have been discussed in this Subcommittee. Section 2 has not been discussed yet.

MS. HORLICK: Okay, now I understand.

MR. HOUSTON: No, no, no — these are Mark’s philosophical ramblings.

MS. HORLICK: Oh, okay, because I was saying —

MR. ROTHSTEIN: Everything but B has gone through the Subcommittee process.

MS. HORLICK: Okay, and you can tell, because it reads differently.



MS. BERNSTEIN: My writing, basically — it’s my writing that pulling — trying to pull together what the Subcommittee’s discussion was, rather than Mark’s original, you know, thought.

MS. HORLICK: Okay. I’m with you.

MS. BERNSTEIN: So partly it’s different authors and partly it’s because it’s been discussed and vetted and, you know, compromised to the needs of the —

MR. ROTHSTEIN: Right. That’s why the —

MS. HORLICK: Well — and a little bit it read like, it says, “So our conclusion –” I was like, what? You know, because I didn’t know that was a conclusion. I didn’t — so that’s what I mean — whereas the rest of it did not read like that at all.

MR. ROTHSTEIN: We need to get Stephanie in here. We could have a staff reunion.

MS. HORLICK: That’s right.

MR. HOUSTON: Well, Susan McAndrew said she was going to attend here today.

MS. BERNSTEIN: She’s been attending regularly.

PARTICIPANT: She’s coming this afternoon. She’s coming at 1. Oh, Marjorie is coming.

MR. ROTHSTEIN: Harry, can I ask you — at our last meeting, you described a system that you like.


MR. ROTHSTEIN: So could you go over that again, and maybe we can talk about that?

MR. REYNOLDS: Yes. I had the opportunity to — we’re doing a lot of this in North Carolina, so I had an opportunity to meet with a physician that’s got 115 doctors in their practice, and I was fascinated as a systems person as much as a member of the Committee or anything else with

the capability of what they’ve put together.

Everybody’s record is electronic, but the patient has the right to go into each section of the record and block it. When they block it, or when they change it — it’s their own personal stuff — and email those to their primary doctor.

Also, if it is displayed by anyone, that section shows blank, that it has been blocked by the patient. Okay?

So one of the things that I have had the most consternation about as I have listened to this entire, you know, debate was the fact that if somebody takes it out — so if you’ve got liability of a doctor, you got — we’re all trying to do good medicine and good treatment and all the other things that we’re all trying to get to, but if something is omitted and there is no alert to anyone that’s omitted, then we basically could be putting the physician back in a situation where they’re not going to count on anything.

But what was so fascinating about this was every time they touched the record, if they blocked something, then it in fact has — that’s the message. So they can set up a public record and a private record, okay, just by setting it up.

So whatever is blocked in the private record or

in the record with their physician — a physician could see everything —

MR. HOUSTON: Well, wait — regardless —

MR. REYNOLDS: No — and again, I’m not all the way down the — I’m giving you a primer.

I spent a lunch with this guy and I’m going to spend more time with him, but I’m just kind of giving you a framework.

But the point is, anything that’s blocked on the public record, if that section is blocked, it comes up and says “there is information here that is blocked.”

MR. HOUSTON: But give me a difference. What’s the difference between a public and private record, though? I mean, just —

MR. REYNOLDS: The private record is everything about that patient.

MR. HOUSTON: But who can —

MR. REYNOLDS: The patient controls it.

MR. HOUSTON: Just the patient.

MR. REYNOLDS: Well, no, the doctor could put stuff in there, and the doctor can — but any time the patient touches it, the doctor sent an email, if they want to block something or they want to do something with it.

MS. BERNSTEIN: I just have a question. Who is it blocked from? Can the physician, the patient’s own

physician, see everything or can the patient block things from the physician him or herself?

MR. REYNOLDS: I think they can block it from everyone. And again, remember, I’m giving you a framework.

The reason I’m giving the framework is not to start the debate up again. I was amazed. My number one issue has been that we can’t have people parsing systems out there and some of these other things to where every time something happens, you know, things disappear or they explain what they were, and I thought they have done an elegant solution of just saying that that information is blocked.

So if I am another physician that’s seeing that person and I look at the public record and they have blocked information in that category, I then have the capability as a doctor to ask before I treat. That’s different than receiving a record and assuming that I have everything, okay, and that’s what’s been one of my big stumbling blocks personally as I’ve gone through this, is that somebody could pull it out, block it, or do something and the doctor would or wouldn’t know that it was gone.

Now, that doesn’t say what information was pulled out; it’s by category.

MS. WATTENBERG: Do you know what the categories are?

MS. HORLICK: So, I mean, when you say “have the capability to ask,” are you saying ask the patient or — I see a section here is blocked —

MR. REYNOLDS: That is correct. Here’s your record, and —

MR. HOUSTON: And how granular is that I guess is Sarah’s point. By category, big difference.

MR. REYNOLDS: Well, it — again, because I’m giving an update.

MR. HOUSTON: Let me give you an example why it’s important, is that our inpatient clinical system, there’s this lock box; you can lock all sorts of sensitive information. But you could say the lock box contains information but you wouldn’t necessarily know whether it’s, you know, HIV or psych or cosmetic surgery-related information.

But if you were to say that there’s a psych bucket, that you know there’s psych data in there but it’s sort of psych meds or current psych meds, so you can break it down in different levels of granularity.

And then the next question that I would have, too, is that: Are things like current medications — can they block things like current medications or other information that actually may have a very direct impact on care especially from a good —

MR. REYNOLDS: Again, I haven’t gone that far. I was using it as an example to where I had not seen the delivery of what appeared to be a reasonable framework, honorable system, where it kind of let everybody — the patient was deciding it, but it also still gave the doctor a chance that if they’re looking at an electronic record, they’re not hanging themselves out there when somebody blocked information.

MS. WATTENBERG: Okay. I mean, based on some of the testimony that we heard earlier in the year, my understanding is that there are systems that can process medication interactions in a background without revealing.


MS. WATTENBERG: So you could block something and have that capability.

And my understanding, because we’ve been working at this from an addiction point of view, is that, you know, you can literally — any system can get to the point of granularity that you can block almost anything. So, you know, whether or not that’s done in an invisible way or in a way that reveals.

For instance, with addictions, you know, you can’t reveal that somebody even has the addiction, so you couldn’t have a category that sort of reveals that. But I think a lot of these systems are structured that way and I think doctors, you know, have felt like that does minimize their liability to a certain extent.

But I will refresh everybody’s memory that last time when I said that, I was almost laughed out of the room, and you all said that, no, there’s nothing that would limit liability from a doctor, that if they don’t have all the information that’s there to be had, that they would all continue to be liable. And I said, that can’t be possible if they’re providing treatment.

MR. HOUSTON: And I didn’t say that to you, did I?

MS. WATTENBERG: You did. You all laughed at me.

MR. HOUSTON: No, we were laughing with you.

MS. WATTENBERG: I’m sure it’s in the transcript somewhere.

MR. ROTHSTEIN: “Laughter.”


MR. ROTHSTEIN: Harry, can I ask you what the reaction or the experience has been for both the doc and the patient standpoints, this?

MR. REYNOLDS: The doctors love it. The patients, they’ve got — and again, this is — they’ve got 200 test patients going through there right now. So, I mean, this is not something that’s been out there forever.

They’ve got 200 test patients going through this thing right now as they plan to roll it out, and they’re working with some big technology companies and everything.

I guess what I’d maybe make another comment on, on what Sarah said a minute ago: Systems can do anything; there’s no question.

However, if we’re talking about the reality of establishing something that is a reasonable electronic health record, a reasonable electronic medical record, whatever, you know, all these different terms that are out there, then the more you get into parsing, the less chance you’re going to have of standard, the less chance you’re going to have of something that makes any sense, and the less standards you’re going to have of the patient being able to actually manage it.

And that’s what I found fascinating about this. And this may be a gentleman that would be great to come talk because, you know, he’s very, very straightforward, very professional, has a vision, has this thing set up. But the point is, it allowed me a different framework than I had been able to listen to.

And again, I can’t answer all your detailed questions.

MR. ROTHSTEIN: Well, you remember, we heard from

the guy in Denmark, and also from Australia, describing their systems. Paul, welcome. We were talking — Harry was describing a system in North Carolina that he heard about where a patient had an opportunity to block certain information, and to summarize, he said he thought it worked well.

PARTICIPANT: The doctor could see that there was a block.

MR. ROTHSTEIN: Yes, and it would indicate a patient had blocked certain information, but it wouldn’t say what.

MR. REYNOLDS: And any time the doctor touched it — so let’s say, for example, the doctor was putting notes out there or there was a new lab result or anything, it would send an email to the patient.

So what’s interesting is any time that record gets touched, including the public sector, if somebody pulls it up, sends an email to the patient saying “these people are looking at your records.”

So, again, what it did, and remember, this was an hour and a half lunch; this was not a sit-down designed deal. But the point is, it’s just the idea that now you’ve got people out there on the street.

The other difference I guess I would draw between this and Denmark, Denmark kind of set it up as a national environment and they had really — we talk about CCHIP and those other things — they really — they had government set up. It was one way. When you look at free enterprise —

So I’m trying to relate between you get the government decides it all and then you’ve got a free for all which is out there right now where there are 250 clearly present EHR vendors. So between those two, there’s 249 opportunities to be different — if not more, you know, multiplied by every time you get into a segment of it.

So that’s why I just tried to listen to him and tried to understand from a standpoint of his philosophy and how he allowed the patient to stay totally involved.

MR. HOUSTON: Let me ask you — how did they make the decision as to how to design it?

MR. REYNOLDS: How did they? I don’t know. But I had one hour and a half and got flooded with all this, so, I mean, I’ve got 10,000 questions. Matter of fact, he’s coming to speak to us because we’re doing a whole session on EHRs and we’re coming to say “Why would a doctor use it?/Why wouldn’t a doctor use it?” In fact, this whole idea of adoption and everything else.

And so I’m going to find out a whole lot more, but I have not had follow-up discussion so I don’t want to make myself appear to be an expert. But he sure put a different framework on it for me than I thought was possible, so I may be more interested now in having a different opinion here than I may have had in a very strict sense before because I couldn’t see it, I couldn’t visualize how it could happen, and I couldn’t visualize how you could really communicate back and forth.

And we could have 10,000 debates on good, bad or indifferent, but I just felt that he framed it in a way that took a lot of our discussion where we were, you know, very — we have very diverse feelings coming from lots of different ways, personal, professional, what we’ve done in our careers and what we see and what we don’t see. And that was just kind of chaos when we went through that.

But he just kind of at least gave me a framework to think about it differently, not whether I like it, don’t like because I haven’t seen it enough. And actually he gave me the ability to actually create one of my own if I want to, but I haven’t had time to sit down and do that.

DR. TANG: Is this a vendor or single person?

MR. REYNOLDS: It’s a doctor, but he’s starting to build a system and he’s working with SISCO and some other people.

But the point is he’s going to put this thing out and he’s rolling it out for his own practice of 115 doctors, and they fill a whole facility that’s got kiosks in the place. It’s kind of the next step, in my opinion, of what you would expect, kind of the primary environment.

So that’s about the extent of what I have to say.

MR. ROTHSTEIN: Well, here’s — as a strategy matter where I think we need to focus, and that is on the concept. I think if we got bogged down in the details about what you can block and who gets emails, that’s going to be the end of life as we know it. [Laughs.]

MR. HOUSTON: Let me say this. I think it is fair game to say — to weigh in on things like patient auditing because an email is just a way that the patient would have the right to do auditing.


MR. HOUSTON: I could think of other schemes that frankly are just as viable that would work, but I think we should talk about patient auditing of records and who accessed the record because I think we said in the last meeting — I know I’m a strong proponent. That’s by far in my mind the best way, the easiest way, of insuring that access is appropriate because if employees know that the patient is going to be able to look at the record, they’re not going to take the chances if they’re the neighbor or the friend because there’s much more higher likelihood of being caught.

And I think at the same time, too, I think we can speak generally about blocking and granularity and get into that general discussion about some of the issues associated with blocking of information in a record. I think it is fair game.

MR. ROTHSTEIN: Well, I think —

MS. BERNSTEIN: We’re going to get questions about it with the Committee. You have to have some —

MR. ROTHSTEIN: Yes. I think — I don’t want to be at, you know, 10,000 feet, but what we would recommend is — just to make something up — is that suppose we said that we think that patient control over the contents of the electronic health record needs to be enabled in the system and such as through blocking technology that would allow you to do X, Y and Z.

But not go, you know, into it because, first of all, even if the Secretary bought the idea, then there would be these task forces and — you know, to implement it. We’re not solving the problem. We’re just sort of suggesting an approach.

MS. BERNSTEIN: It’d be full employment for us! [Laughs.]


MR. HOUSTON: I mean, I agree with your point, but I think we can go into some level of discussion about it, recognizing that either somebody’s going to recommend, you know, approaches or granularity or at least make it into some type of framework. But —

MS. WATTENBERG: So you’re recommending that we don’t sort of get specifics around real time auditing or —

MR. ROTHSTEIN: Well, not too many specifics. But, I mean, yes, we can add principles that there should be some sort of audit trail for — you know, that alerts patients when there is access to their records, or whatever.

And I think one of the things that is important if we adopted this, you know, a recommendation along the lines that Harry discussed, that there is notice that information has been blocked. I mean, that’s an important decision point, whether physicians get notice or not. Some would argue that they can’t even get notice.

I mean, at that level — I mean, that’s just a proposal.

MR. REYNOLDS: Yes. The other issue, I think, is going to be hard. This whole idea of the — under the current HIPAA privacy law with treatment, payment and health care operations, that whole situation of where data resides and what do people use it for because everything gets — it’s still another issue I’m going to struggle with here because we use EHR like it’s sometimes magical data, but it’s created in your institution and it’s created in there when you’re in there as a patient or you’re being seen as a patient.

So it’s used in that institution under all these umbrellas of what they can or can’t do. Now, whether or not a patient should be able to block information that was gathered basically when they were a patient here from — in John’s institution is another step that I still personally struggle with.

MR. HOUSTON: Well, let me say this. You’re distinguishing — there’s a couple of levels to your point, which I think is important, that we have to flesh out separately.

There is this concept in my mind of the record that is managed by a single covered entity, or single entity, and is used for the purposes of your care at that entity as well as their management of that entity, and then you’re talking about another separate matter of data that would be shared as part of the National Health Information Network.

And there really are in my mind, at least the way I feel about level of access and control, those are two different animals. And I would be more willing to accept the thought that a patient could agree to participate in a National Health Information Network or exclude certain data from the network.

I feel strongly to the opposite way that I think that if an institution — if a patient comes in an institution, the institution needs to have all the data available to it for which it is already the custodian of, because there’s a lot of reasons for that, and I think often — and I’m going to sound very insensitive, but I think it’s important — often, patients are not the best, in certain states especially, are not necessarily in the best position to know what they should and shouldn’t be excluding the provider when the provider has got to deliver a care.

And in the best interest of care, I think there are some real tricky issues associated with the thing —

MR. ROTHSTEIN: But how would you distinguish, then, between UPMC and Kaiser, where they’ve got places all over the country?

MR. ROTHSTEIN: Well, I think that’s an interesting question, and I’m not sure I have an answer for it other than, you know, my organization has 19 hospitals spread across a region, but we deal with some of those same types of issues. I guess maybe part of comes down to what the patient buys into when they decide they’ll avail themselves of your services.

And I know we already — and case in point is we do, as part of our consent process, makes sure the patient understands that we have this global environment for which — that we are going to use data throughout the environment through our different facilities for the purposes of delivering care to that patient.

So the patient does understand. Now, it’s not an on-and-off, in or opt-out; it’s a statement of what we are going to do with that data. But the patient does understand if they read the consent form very clearly that we are going to use that data for the purposes of treating them.

MS. BERNSTEIN: Can I just ask sort of — it’s like a more microcosm really of what you’re saying. If the patient is treated at one office in one hospital of your 19, can the patient decide “I only want my information to go that one office in that one hospital?” —

MR. HOUSTON: In our case —

MS. BERNSTEIN: — and not to your whole network of 19? It’s the same as saying —

MR. HOUSTON: — no. In our case, we have an Enterprise electronic medical records environment where we — and again, this was a value judgment from the physician community; we have a physician advisory committee, and there’s very strong feelings as to the access to data.

MS. BERNSTEIN: And I think Kaiser said the same thing, except that its network has to be national. But you can get — if you’re Kaiser here, you can get information from Kaiser in California.

MR. HOUSTON: And by the way, Kaiser is much more of a tricky issue because of the fact that Kaiser is this going across state bounds. We are —

MR. ROTHSTEIN: Okay, appreciate that. I just want to follow up on this.

MR. HOUSTON: Excuse me.

MR. ROTHSTEIN: Suppose my employer has a single provider arrangement and everybody who works for my company has to — if you’re going to get benefits, it’s through Kaiser. So now I’m sort of like in a take-it-or-leave-it-situation, right?

MR. HOUSTON: You’re captive.

MR. ROTHSTEIN: Okay. I just wanted to follow up.

MR. REYNOLDS: I like the direction John — you’re not captive, but it sure benefits you to be captive.

Some things are out of network; I mean, there’s different ways of —

MR. HOUSTON: Oh, by the way. Let me — to apply what you described hypothetically to like my environment, I am captive. We have a health plan which has hundreds of thousands of members, three-quarters of a million members. And if we were employed by my employer, I have one option, unless my spouse has a different insurance or I’m willing to pay privately. My option is to go to my health plan and select one of the packages they offer.

MR. ROTHSTEIN: So that would be a drawback to the system where the network can say “if you sign with us, it goes everywhere,” and we would have to think about.

DR. TANG: What I’d like to suggest is something in the middle. And I like what John was initially telling in the sense of there is less of abilities to opt out of granular data within the treating environment.

Now, what I’m going to make a distinction with this — unlike UPMC, but the way we do it is the treating environment process — you sign up with a medical group. Almost every plan has a medical group, including Kaiser. Then your information is contained in that medical treating group unless you decide to have, let’s say, a referral or go for services in another treating group within the health system.

At that point, the floodgates are open and for your benefit you could just see everything, and nothing would be excluded.

MS. BERNSTEIN: Who do you get to see everything?

DR. TANG: The other treating facility, let’s see it a referring — a specialist, or a PT, whatever the provider is, would get to see everything, but still, only the authorized professional use.

But you do have this blockade — we call it a service area, and that makes sort of sense — that I can’t just can’t — oh, you’re a Kaiser patient; I’ll just drift over there to Atlanta and go look. I don’t even have that temptation because — not that I’m entitled — but let’s say another facility, I cannot see you unless there is some reason you are in either (?) except in referral, accepting treatment from my service area.

MR. ROTHSTEIN: Are you saying that you can’t do it, or there’s no legitimate reason for you —


MR. ROTHSTEIN: — to do it?

DR. TANG: There is a lot —

MR. ROTHSTEIN: But you could do it if you wanted?

DR. TANG: No. There’s a logical barrier. We’re in one physical database but we’re divided into service areas, and that’s throughout the treating facility. If you have a treatment relationship with me —


DR. TANG: — then I am allowed to see within my service area. You being in another hospital, even within

Kaiser, even within Sutter, would not have access even if you wanted to until the patient walks over and signs a release saying “I’m now engaging in services.”

MR. HOUSTON: So basically once you establish the patient/physician relationship —

DR. TANG: Correct.

MR. HOUSTON: — and the physician has broad access to the record.

DR. TANG: In a local treating agency. We call it the service area.

MS. WATTENBERG: So it’s not just that physician but it could be people that you —

DR. TANG: That is correct.

MS. WATTENBERG: — have provided relationships with or —

My only problem with that is that, you know, in this day and age, these referral relationship service areas are so huge. I mean, Blue Cross Blue Shield in this area — I mean almost everybody.

DR. TANG: No, no — so my definition of “treating entity” is a medical group. So, yes, you could have the Cardiologists Inc. over there and the pulmonologists — but until they request the service of the Cardiologists Inc., that group cannot see.

MS. WATTENBERG: The service area —

DR. TANG: No, it’s based on the providing entity.

Now, another advantage of that is we do have the power over our physicians in this, but not over in Cardiology Inc., so we can enforce our policy.

It goes back to their record locator service idea with Markle in the sense of what you’re doing is instead one thing that controls all, then you have this magic entity that has to be able to enforce everything, but you can’t. So you bring the decision point, which is the allow access, and the enforcement to the local level.

I think that achieves a balance sort of that you —

MR. ROTHSTEIN: Suppose your group is the internal medicine group and I’m your patient, okay? Now, that means if my records cannot go to the neurology group or the oncology group unless you do something?

DR. TANG: No. Let me try —

I’m trying to get the operational definition so we can all figure out the answers to every question we ask.

So look at the governing board level. So the service area will extend at the level that you have a governing board that controls the physician behavior.

In our case, we are multi-specialty, so any of those places, it’s controlled by a single governing board, which means we can terminate any one of those folks, okay?

But if I’m in a small practice and I just have internal medicine and you need to see a cardiologist, then I will — you will walk over there and you’ll sign one of their notices and when you sign that, then the doors open.

But until — and what you’re doing is when you sign that, you’ve engaged in essentially a contract with that group saying “I’m going to let you see my data; you’re now obligated to be accountable for that data and do you have such policies that say that you’ll do that and with enforcement?”

MR. ROTHSTEIN: No, but actually, at the point where you wrote the signatures, that goes beyond, right? Because now, if I go to you as my internist and you think that I need to be referred to somebody outside of your group. I need to go to MD Anderson in Houston, under HIPAA, because it’s treatment —

DR. TANG: It will allow you — it’ll permit this. But will I do that? No, I’m going to say “I’d like to refer you to MD Anderson; would you like to go?” I’m not going to go — I have this relationship and responsibility to you.

MR. ROTHSTEIN: No, I understand that. I mean, that’s what medical ethics pre-HIPAA would have demanded.

But the fact of the matter is now many physicians

are getting comfortable sort of lowering their standard to, “Well, I’m allowed to do this and I want to send this to my friend in California to get a second opinion.”

DR. TANG: You still can’t professionally do that without consulting the patient. And the other piece, you wouldn’t be able to be reimbursed.

But basically I can’t do that. Just because I’m allowed to share data, I still have the other requirements which — minimum necessary, a professional need to know. There’s lots of reasons why I can’t just willy-nilly share.

MR. ROTHSTEIN: No, there’s lots of reasons why you ought not do it, but —

MS. WATTENBERG: It would be advantageous to just send information — now that we’re here about the context; how would that be advantageous for a physician to just send information?

MR. ROTHSTEIN: I’ve got a difficult case. I’m not sure whether this guy — he’s got this lesion here and I think it’s benign but I’ve never seen anything like this; would you take a look at it?

MR. HOUSTON: That could be done on an anonymous —

MR. ROTHSTEIN: It can be done. I’m saying that — and I’m not saying it ought to be done.

Here’s the point I’m trying to make. I mean, I like what Paul’s describing, but this is another area where — remember, there’s a point in the letter where we say “if we do X, Y, and Z, that will necessitate that the privacy rule be amended” and if we put something in place like Paul’s suggesting, that seems to me it would require —

DR. TANG: We’d be creating a principle which would exist and be consistent with HIPAA and not extend HIPAA. We’re dealing with transfer of information outside of the treating entity, which HIPAA did not describe per se but —

MR. HOUSTON: That’s permitted without authorization.

DR. TANG: That’s correct.


DR. TANG: So we’re establishing a principle for treatment.

MR. HOUSTON: But let me say this. I would think there’s still yet another option. It’s Paul’s option but in a more lightweight fashion and something that we were working on internally in our organization, which is this concept of simply establishing a patient/physician relationship, not one that has to be documented and signed on, but the physician — you have to have a certain amount of trust in your physician community and the other questions.

It’s simply to say that the physician can decide to declare a relationship with a patient, and as soon as the physician declares that relationship, all of those rights that Paul described sort of inured to that physician and that group.

But it doesn’t have to be this ultra-formal relationship. It’s you trust the physician. The physician doesn’t declare the relationship until the relationship actually exists, and the relationship could be everything from, you know, they’re consulted by another physician, you know, at three in the morning.

It could also be that the patient comes to the physician practice. It could be that they show up with an E.D. where the physician is an E.D. physician. It could be, you know, that they’re the anesthesiologist for the patient when a procedure is performed.

But there’s a lot of ways to establish the relationship. And the fact that the relationship is established based upon the physician — realize, physicians are credentialed. I mean, they can do all sorts of things. And there’s a lot of ways to compel them to do the right thing. Physicians want to do the right thing.

So, the point being is I think really the key criteria here is this concept of the patient/physician relationship and what rights that inure to the physician and the physician’s extenders, if you want to call them that, as soon as that relationship’s established.

I think that really — I think is what we really what to provide.

DR. TANG: Well, I think all that’s consistent with what I said.

MR. HOUSTON: Absolutely.

DR. TANG: An extension, as an example, the signing. You need to sign to get paid, anyway. There’s always a registration, you know.

MR. ROTHSTEIN: It’s authorized.

DR. TANG: Yes, you have to authorize the thing anyway. So it’s already being done. That’s just a nice, written —

MS. BERNSTEIN: It’s customary. That’s right. You don’t have to sign.

DR. TANG: To get paid.

MS. BERNSTEIN: You have to sign what to get paid?

DR. TANG: Basically, first, you’re registering.

MS. BERNSTEIN: A physician has to sign?

MS. HORLICK: No, the patient has to sign to authorize them.

DR. TANG: No, no. The patient.

MR. HOUSTON: Actually, it depends on state law.

MS. BERNSTEIN: You have to have authorization. You don’t have to have written authorization to prevent that or you just have to have my permission.

MR. HOUSTON: But let me say this. But in a hospital setting, okay, let’s just say I’m an inpatient and I’m on a unit, and you’re asked to consult or determine that I have a certain condition, E.D. aside, I might have Condition X, and Paul Tang happens to be a specialist on Condition X. You could come in under the consent that the patient’s already signed in almost all cases and perform services.

So there would be a physician —

DR. TANG: That’s because I’m on the medical staff.

MR. HOUSTON: But to my point, though, is it’s the establishment of that patient/physician relationship. It may or may not be necessary to have a signature. And I deal on the inpatient side more than anything, but the point being is that the important event in my mind is when there’s a meeting of the minds at some level that there is a patient/physician relationship. Not even a meeting of the minds; I shouldn’t even say it that way, because the patient may be incapacitated at the time that you’re doing the consult.

But the point is where there is a good faith, bona fide physician/patient relationship established for the purpose of treating that patient I think is the point where —

DR. TANG: Okay. Our principle is that — to go back to the EHR versus NHIN, is there’s a boundary, and it’s the principle that determines how far that boundary should be, not, let’s say, Kaiser nationwide should be the governing board over the treating entity, the treating facility. And that does a couple things. It gives —

MR. ROTHSTEIN: Okay. Let’s — Harry and Gail have questions.

MR. HOUSTON: We’re just lining for comments.

MS. HORLICK: I was just going to say, as I was listening to you, I think I know now we’re not talking about just NHIN but a lot was the public’s perception and understanding.

And I think that concept fits with what the public thinks because I really do expect that if my doc needs to call in a specialist that I don’t need a separate consent because he’s treating me. But I don’t expect that anyone in the hospital — so it’s very consistent with something that you would, you know —

DR. TANG: And that’s a good principle.


DR. TANG: What’s the public perception? And we want to live up to that. And that gets into other secondary uses. But I think that’s another test.

MR. ROTHSTEIN: Harry? You’re Number 4.

MR. REYNOLDS: I’ve got a comment and how to structure it maybe later, but using Paul’s premise a little bit, as you think of payment, though, and I’ll just paint a picture for you now, good or bad or indifferent, just a picture.

If I get hurt here, or if I get sick here in Washington and I go to the hospital, the local Blue Cross would get the claim. So the treatment would be done a local facility; the claim would go to Care First.

Care First would go back and forth just like they would paying any claim. And they may have to trade records back and forth as part of the treatment and payment, okay? Part of the whole HIPAA deal.

Now, since I am actually covered by North Carolina, there could be a transfer of records from Care First to North Carolina if there is dispute, because the benefits are based on what I have as benefits based in North Carolina, because there’s an agreement amongst all the players whether it could be a Kaiser, it’s a Blue Cross in this case, or whatever, that says that the local Blue Cross is paid, using Care First as the agent because Care First has, you know, contracts and everything else which means that they’re going to get probably paid — the provider will get paid better and more appropriately based on what the agreement.

So you take — that’s one example where, you know, we underestimate what’s already going on in the world and what’s already agreed to because as a patient, although I have maybe not signed up, I know I have coverage all over the country and I know that that coverage is going to be dealt with and so I kind of buy into that, and I don’t know the details. The details is where this issue always falls apart.

The next issue that we have is this whole idea as we look at e-prescribing, because right now you go to a pharmacy, you didn’t sign anything with the pharmacy. But when that pharmacy puts a drug in, it’s a PBM, and a patient didn’t block anything. The only way the patient could block it then is if they didn’t go get it from — paid out of pocket — and in some cases —

PARTICIPANT: No, no, no!

MR. REYNOLDS: Let me finish. Let me finish, then. In some cases, that doesn’t work. That doesn’t work sometimes because if you go into your regular pharmacy, your regular pharmacy already has who you’re covered by, and it goes in as a “no pay.”

So all I’m saying is I’m trying to make sure we don’t lose track of it.

There’s this whole thing called treatment, payment and health care operations that goes on now and will continue. So as we parse this thing apart, we’ve got to really be careful on treatment and I’ll play off something I read in the letter — “treatment and role-based access.”

So if you’re doing treatment, then there’s some role-based access within that institution — that’s one idea. I’m not voting for or against it; that’s a premise.

The second is payment, and what is the whole process of payment? Because everybody that signs up — if you’ve got insurance, you want them to pay it. So that’s a second thing.

And then you’ve got this whole employer life insurance thing which we all worry about because that’s kind of the dark side; you don’t want people to know certain things.

And then you’ve got these non-covered entities which we’re all very worried about in this whole new world of “let’s spread the data around,” you know, because HIPAA is weak there.

And then you’ve got this whole thing of “now that I’ve got all this” — and an EHR, we talk about EHRs like they’re a single thing. Taking care of two elderly family members, the EHR is my wife and she now has a notebook, okay? And so there is no EHR; there’s an EHR here, an EHR here, and her EHR and all the others.

But when that becomes electronically now available, the issue becomes, other than the things I’ve already talked about — how I want it sent around, how I want it dealt with — and that’s kind of where I’m putting it together in my mind, because each of those has pluses and minuses and each of those has kind of normal processes that are already in place which most people don’t understand.

So that’s how this thing gets real goofy to me. It’s just as an idea of how at least I’m thinking about it. And if we can all come up with some way to think about in pieces, and then in the end try to put it back together — because generally you can take any one of these subjects, say something and you immediately have three of these go — ain’t going to work; it doesn’t happen; can’t be that way. Or it can be that way, but then it doesn’t work for everything else because we’ve already signed up for certain things.

We’ve already, under HIPAA, signed up for treatment, payment and health care operations; we signed up for it. Everybody that’s involved has signed up for it. Now, what does that mean and where does that diverge, and now we’ve got this magical electronic record: Where does that come in?

That’s where I struggle, just trying — you know, how do you really help somebody get that deal and know that we’re recommending something reasonable to the Secretary that doesn’t just blow everything that’s already been agreed to, you know, versus just strengthening it or making sure that the patient has — you know, we all know consent things.

So, end of my comments.

MR. ROTHSTEIN: Thank you. John, and Sarah, and then I’m next unless somebody else wants to —

MR. HOUSTON: A couple points here. First of all, specifically to Harry’s one point. You know, even though we’re discussing the needs and the bounds of providing access to information through NHIN, the reality is on the other side of the fence, on the payer side, it’s amazing how much information is already available to the payer in a consolidated fashion, that, you know, there is already an enormous amount of consolidated data that could probably be used to describe a patient’s overall condition in health and the like that sits over there that nobody’s even thinking about.

It’s just sort of sitting in repositories already, you know, to the extent that an insurer already has a big piece of the market. They’ve already probably got — no, they don’t have all the detailed information. You could probably look at the insurer’s records and look at the records in an NHIN in a particular community and find out a patient’s overall health probably pretty closely.

You may not get all the allergies but you get a lot of good information about the patient’s condition and chronic illnesses, and, you know, things like that.

That’s one point. So, recognizing that there already is an enormous amount of data consolidated about a patient today and from a lot of disparate sources, you know, whether it be the physician, whether it be the pharmacy, whether it be from inpatient encounters, things like that.

So we have to recognize that a lot of this data is already sitting there in some fashion already. So it’s not like by a patient opting out of NHIN they’re going to be able to keep themselves immune from being under — you know, information about them being known.

MR. REYNOLDS: With the patient’s consent, and sent to the patient as information, that it is in the payer’s —

MR. HOUSTON: But if the patient enrolls in an insurance program, that consent is given, just like if they come into our facility for treatment, they’re going to come consent given, and how much does the patient have the ability to challenge that consent? It’s already — so that’s one point I wanted to make.

But the other point is that, you know, one of the overarching philosophical constructs of the NHIN was the desire to improve care, reduce error rates of the population.

Now we’re talking about limiting information that would be made available to clinicians, and I’m concerned that what we’re doing, it does in one sense improve patient confidence in the environment. We have to be very careful about not frustrating the role of the NHIN.

And I’m also concerned about liability implications.

Now, obviously there’s a lot of old historic data in the patient record that has nothing to with the patient’s current condition or care, and, you know, something that happened — a pregnancy was aborted by somebody 20 years ago — it’s probably not going to have a huge impact on their care today.

But I think there is probably other types of data that the patient very well may want to exclude that is extremely relevant to the care that might be provided to a patient. You know, if the patient has certain psychiatric

illnesses and they present in an E.D. in an incoherent state, it could be because they were hit on the head, it could be because they weren’t taking their medications, or it could be, you know, maybe not even psychiatric; it could be because of drug abuse and the fact that this person’s gone through treatment.

There’s just a lot of information that I think we have to trust the clinician who wants to see me in order to provide care, and it really does scare me a little bit to think that we’re going to set up an environment where the patient is going to be able to block the information that very well might be relevant and still expect then the clinicians to deliver high quality care.

MR. ROTHSTEIN: Which is the way it is today.

MR. HOUSTON: But, Mark, what we’re trying to do here —

MR. ROTHSTEIN: No, I understand.

MR. HOUSTON: Why is the NHIN so important? Why was it on Bush’s agenda? Why was it, you know, on Thompson’s agenda? Why is it on Leavitt’s agenda now?

It’s because of the fact we have an enormous increase in costs. We have medical error rates that are unacceptable by any measure. We have a lot of problem in our health care environment that an NHIN, having good data about patients holistically is going to solve.

And I’m just voicing the fact that I understand a patient’s desire to block and, I mean — but I’m just trying to look at the other side, which is why are we doing this? And you shared the horror stories about not having certain data available and what ended up happening.

We’ve got to have a lot better data, and I think there should be certain types of data that absolutely have to be provided — current medications, allergies, you know. A lot of these types of data almost at a minimum have to be there because you feel this is compelling information for the physician.

But I think there’s a lot more other information that’s qualitative that I think physicians will also say “I really want to have it; I need to have it in order to deliver quality care.”

And I’m just afraid that what we’re doing is setting up an environment where the people that probably have the greatest need and are at the greatest risk are the ones that very well could be the ones that are opting to block information.

We can only hope that, you know, like accounting and disclosure and things like that, it really hasn’t become an issue. We can only hope that — but it could be.

MR. ROTHSTEIN: When we talked to the people (?), one of the questions that we asked, and I know I ask all the time: How often do patients do this?

And the answer was, “Very rarely.” But they like having the opportunity to do that. So it’s my guess that’s more likely to —

MR. HOUSTON: And I’m hoping that’s the case. I really am hoping that’s the case. And if you give them the right — you know, just sort of like opting into research. You know, people will almost always agree to allow the records to be used for research; they just want to be asked. And that’s what one study out of Canada showed.

And I’m hoping that’s the case here, too, but I just want to make sure we don’t lose sight in all of this as to what the goals of an NHIN are and we try to make sure the letter reflects those needs.


MS. WATTENBERG: I forgot what I was going to say. I would like to reserve a spot next time I’m allowed to speak.

MR. ROTHSTEIN: You’ve got a wild card spot.


DR. TANG: Harry, I’ve got one question on the North Carolina EMR. When they block, do they block individual elements or an entire encounter?

MR. REYNOLDS: It’s a category of information.

DR. TANG: A category?

MR. REYNOLDS: Right. And again, remember, I — when he said it, it sounded good. But it was a very — we were talking about lots of things.

MS. HORLICK: I just have a question.


MS. HORLICK: If tomorrow there was this NHIN, and I opted in if that was an option, or I didn’t opt out, so would that mean that every doctor I go to would send that information to that — I mean, is that operationally what we’re talking about?

I mean, I’m trying to understand this.

MS. WATTENBERG: Are electronic health records different than the NHIN or is it in —

MS. HORLICK: Well, I mean, I’m just trying to — like everything we talked about would be different within the system, you know. If I went from you and I went to the cardiologist, I understand that.

But if I went to you as my internist and I went right now and I went to a different orthopedist outside of your thing, I could say, “Get my records from my internist?” or they might just look at my broken leg and not need it.

But I’m trying to understand the whole — if we have it, you know, the NHIN, it seems like —

DR. TANG: So let me give a scenario that might work.

So you know the Markle thing about the record locator. Basically, if you sign up and you want me to take care of you, I would be presented a list of all places that have registered information on you.

Now, let’s say you went to a psychiatrist and you said, “Lock that from the NHIN.” Now we’re just asking whether that’s — but let’s say that we do.


DR. TANG: It would not show up on my list because you and your psychiatrist decided not to opt in for that piece.

Okay, that’s point one.

Then point two is I can imagine a scenario where I say, okay, when you’re signing up and you’re presented with this on a computer and it says “check which records you would like to include.” And we might even say, “and I’d encourage you to check all available information so that we have the best available information to make good decisions.

And that’s a way we could do it. But it’s not as if — I think what you’re asking is all of a sudden we can send up — all of sudden they’re just going to flood this new physician is —

MS. HORLICK: Well, I’m just trying to understand

what exactly would you be consenting to or not opting out of.

DR. TANG: Right.

MS. WATTENBERG: But aren’t we also talking about two things? One is —

MR. ROTHSTEIN: Is this your wild card?

MS. WATTENBERG: Yes, this my wild card!


MS. WATTENBERG: One is whether or not a doctor’s EHR gets put on to the NHIN sort of record locator system and what a client, or a patient, may want to block from an individual electronic health record.

So there are two —

DR. TANG: So far — and I don’t know that we’ve had that discussion yet, but we’ve sort of been leaning on you can shield records from this entity to be enrolled or subscribe to the NHIN. So it would be at the big level.

So if you are encountered with my group, my governing body group would be blocked.

MS. WATTENBERG: So it’s not — so when you were talking before — Harry, were you talking that you could block something from a patient record, from an EHR, or just the patient could block it from being available in the NHIN?

MR. REYNOLDS: You could block it from an EHR.

DR. TANG: He’s talking about real examples.

MR. REYNOLDS: No, I was talking about two things. The private record is that person’s, all the different data from the doctors they’re seeing in their practice, plus their own personal stuff.

MS. WATTENBERG: What’s their own personal stuff?

MR. REYNOLDS: They could put in their own allergy —

MS. WATTENBERG: You can add something. A personal health record is part of it.

MR. REYNOLDS: Yes, it’s part of it.

But then the issue becomes there is a public view of that.


MR. ROTHSTEIN: And in that public view, they go in and start saying yes or no.

DR. TANG: Very different.

MS. WATTENBERG: You guys, one at a time; the guy cannot get this on the transcript if we’re talking at once.


MR. ROTHSTEIN: In the transcript it reads —

MS. WATTENBERG: I can’t listen to you all at the same time.

MR. ROTHSTEIN: Well, I’m next on the list, and I want to raise the issue of lunch. It’s almost 12:30. If everyone agrees, 12:30? Then we’re at 12:30.

But it’s, you know, subject to change.

MR. HOUSTON: Well, if that’s your comment, we’re down to the next one.

MR. ROTHSTEIN: Okay. Now, on the second, the substantive thing, I think we’re talking about two different things, at least.

One is carving out information and the other is carving out people who can get access to it.

And on the carving out of the information, we may want to distinguish in some way the (?) information about people versus historical information. Now, I have no idea what the NHIN is going to do in terms of putting old paper records in electronic form.

MS. WATTENBERG: That’s what I was wondering, yes.

MR. ROTHSTEIN: There are lots of transitional issues.

But it seems to me that many of the privacy concerns involve things that happened 20 years ago that people think have no relevance that they don’t want following them around.

DR. TANG: I disagree with that. I mean, I know that’s in the paragraph in here, but —

MR. HOUSTON: I think there’s psych information, other bits of information that people —

MR. ROTHSTEIN: No, you’re disagreeing on your opinion of whether that information is relevant.

My statement is people are concerned about old information and I think there are lots of studies that show that in terms of what people don’t want.

DR. TANG: Let’s call it “old” rather than “sensitive.”

MR. ROTHSTEIN: Because it’s different. If I’m in a current group now and I have ongoing treatment for A, B or C, that in my view, in someone’s view, might be different than what I was treated for 20 years ago because people, I think, would have less of a realization or an acceptance of the relevance of what happened to me 20 years ago than what’s happening now.

I mean, it’s much more important to my treatment now, what meds I’m on, regardless of the diagnosis, than what happened to me 20 years ago for certain kinds of conditions like, you know, a cut leg or whatever.

MR. HOUSTON: What’s in bounds and what’s out of bounds.

Let’s say you had a bypass 20 years ago versus an abortion —

MR. ROTHSTEIN: I’m not trying to draw — all I’m saying is we’ve got, in one category, the information carve-out, what information, and the other is what providers get access to it, and that was, I think, Paul’s discussion.

And I think that’s very important.

I don’t know how technically we handle this situation of Paul’s my internist and I see him and he wants to refer me to the Mayo Clinic for cardiology follow-up versus there’s somebody at the Mayo Clinic, my ex-wife — I have no ex-wife — who — she or some snooper in her office knows all my information because I’m known to them and how do we keep people out of the system who have no business in the system and still allowing people in the system?

I mean, if you want to refer me with my permission for a cardiology consult at the Mayo Clinic whether I actually go there or not, I mean, do you have to flip some sort of switch to allow that to happen legitimately and how do we account for that?

And also, the blocking even within institutions. We had people — I remember I asked this question somewhere: Can I say that I’m treated at Georgetown Hospital; can I say I want these two providers, you know, my ex-mother-in-law and father-in-law who are on staff there, I want them blocked? Can I do that somehow?

DR. TANG: If you get treatment. And you’re treated at Georgetown for other reasons?



MR. ROTHSTEIN: Well, some places said they could do that.

DR. TANG: Well, of course you could do that, but is it —

MR. ROTHSTEIN: So the question is whether we ought to be able to do that.

So I don’t want to get into detail. I want to present to you the two different ways that I see it — blocking information, blocking people.

MR. HOUSTON: There’s a problem here. And the problem is that we’re — you know, if you look and sort of do the root cause analysis, look at the root issue here, is the issue that you’re raising — it’s just sort of twofold.

One is, I mean, there’s a public trust/confidence issue. But I think, you know, if the father-in-law, mother-in-law, whomever, is at the facility and they need to access that information for the purposes of delivering care, then they need to access that information.

MR. ROTHSTEIN: They don’t. They’re obstetricians, but they’re on staff.

MR. HOUSTON: But if they don’t, then I think the piece of this that we’re missing, losing sight of, is this whole concept of role-based access, and that should the

environment systemically be able to recognize the fact that there is no relationship between the physician or whomever and the patient sufficient to allow access to that information or should we put the controls in the system to allow — to cause the patient to have to block that information?

There is a key difference from a design perspective, and I think we need to be mindful of the scenario where you have people within the facility who inappropriately look at information is one of enforcement and putting the controls in place on the systems side to prevent that from occurring versus giving the patient the ability to do something that they may misapply and cause an unintended consequence of that, which is my point.

MR. ROTHSTEIN: Well, let me just respond to that.

I would disagree with that approach.

First of all, what you’re suggesting — I think what you said initially I like, and that is extending our concept of role-based access beyond the context in which we use it. In the paragraph, wherever it is, we said, okay, physicians need a certain level, but dieticians and billing clerks need a different level —


MR. ROTHSTEIN: — but role-based access —

MR. HOUSTON: But role-based access is more than that.

MR. ROTHSTEIN: Well, we can make it more than that. I think if you use it, we can, you know, divide within those categories.

I would not like to see us take the position that we’re not going to do anything structurally to prevent these people from getting access to it. We’re going to do it on the back end. In other words, we’re saying you shouldn’t do this; we’ll find out who you are and we’ll deal with you after the fact.

MR. HOUSTON: No, I’m not really saying that, because I’m not getting to that level. But let me just respond, and Paul’s chomping at the bit here.

It all comes back to —

MR. ROTHSTEIN: But Maya’s next on the list.

MR. HOUSTON: But I have to respond.

I think that — again, going back to the concept which I think is valid, is this issue of having an established physician/ or clinician/patient relationship is such that can be used to enforce not allowing the individual to get at the record absent the relationship being established. That’s the first piece of this.

But then you also have the ability in the event of an emergency — you know, this other concept of break the glass —


MR. HOUSTON: — that says, you know something? Paul does not have an established physician/patient relationship with me, but you know something? It’s now three in the morning and he’s now consulting and he’s now breaking the glass, at which time he’s able to add why he’s broken the glass.

And it can always go back and be audited to that point.

But if these controls — and I do believe this part of role-based access criteria is having the concept of, you know, if you’re a nurse, if the patient’s in the facility for whom you’re a nurse, you might say maybe it is appropriate for that nurse to get access, or if that patient’s on the nurse’s unit as part of my larger health system and they’re in another health system and the patient is in yet another hospital, is there any justification for saying that nurse needs to have access to that record?

I can’t imagine it, absent maybe still break the glass and say that person has to try to document why they’re in the record.

The point being is those types of controls, I think — and by the way, there are systems today that do just these types of things. They do provide structurally the types of protections I think that you’re talking about without the patient needing to be involved in making what potentially could be inappropriate decisions about access.

That’s my only point.

MS. BERNSTEIN: This discussion makes me — I mean, I’m not sure why — figure out how do I want to say. The technology can do a lot of things for us, and, you know, the concept of role-based access is in place in systems, for example, at the IRS; I may have talked to you about this before.

At the IRS, if you’re auditing tax records, when you come on board as an employee, there are — after an interview with you and your boss decides, there are certain records in the IRS system that are completely blocked from you personally. Your parents, your children, I don’t think they can get to your siblings — they might have different names. But you could identify “these are people whose records I shouldn’t get.”

They look at, you know, anyone on your block, basically, in your neighborhood, because they can do that by address; any of your co-workers; and they also keep, you know, separately a list of celebrities, however you get on the celebrity, you know, records that cannot be accessed by someone unless you are the person who is responsible for examining or auditing that tax record and your boss has given you the authority to go into that record.

And if you mistype a Social Security number or transpose the digits or if you look at something inappropriately, you have to document every time you call up one by mistake because there’s an audit trail that showed and there’s — you know, looked at by the IG on a regular basis for anomalies. If you access one of those records you weren’t supposed to look at — your child, your parents, your neighbor — you know, you get called on the carpet.

So, the same type of thing, it seems to me, could happen in a hospital setting. If you say, you know — I mean, it seems to me that if my cardiologist wants me to go to the Mayo Clinic and I say, “You know what? I don’t want to go to the Mayo Clinic because my ex-spouse works there and I’m afraid to get treated there because we have a bad relationship” that, you know, you’re prevented from, you know, a medical resource with top experts, that is unfortunate, right?

So there should be a way for you to say, “I want to block my ex-spouse’s record but I still want to be treated at the Mayo Clinic and know that I don’t have to worry about my ex-spouse looking at my record.”

And that should be able to be done on the patient’s request.

And I agree that if some reason you’re in an isolated place in an emergency and your ex-spouse is the only one there to treat you, your ex-spouse can do whatever it takes to break the glass and that is likely to cause an audit and it’s likely to have that — you know, but if you were treated properly and that ex-spouse, you know, treated you appropriately and acted professionally in that circumstance, no problem, right?

But there should be a way for the patient to have comfort that they shouldn’t have to give up the opportunity to get treatment at a particular place where there’s a particular resource, whether it’s locally or it’s in Minnesota, because they’re afraid that somebody would access that record.

And so there should be a way. Basically, your role changes.

MR. HOUSTON: I agree with you, that’s right.

MS. BERNSTEIN: If you’re in an emergency, your role changes to an emergency, you know, role rather than your regular, everyday, you know, internist role. And that would be an appropriate —

MR. HOUSTON: I don’t disagree with your description.

MR. ROTHSTEIN: Paul, and then Harry.

DR. TANG: I think we want to make sure that as we build down in these details, we don’t violate the principle of we want to do good and do no harm, because do good is to deliver safer care, and do no harm is provide reasonable assurance that privacy won’t be breached and your confidentiality won’t be violated.

Unlike the IRS — the IRS doesn’t have the concept of coverage for night calls. So —

MS. BERNSTEIN: Everybody pays taxes! [Laughs.]

DR. TANG: You are in the health care situation when you refer someone. You don’t refer him to Dr. Jones and Dr. Jones (?) but to do neurology.

So, writing the rules that say “I can predict who has a relationship or who is being brought into my care,” we don’t have those rules reliably — the nurse, the float nurse who comes from North to work on East today because they’re short-staffed, you’re going to transfer. So who are you going to go to? And that nurse needs to know.

It’s really — it’s hard to predict that.

Then you end of the break the glass and everybody’s breaking the glass and you basically destroy the inhibitor effect, you know.

When you do things, when you make inhibitions of — it’s just like our decision support. There’s an alert factor and you can drive the effectiveness down to zero and then if you scale back, you actually — and there’s actually a study that was just like that.

So in answer to your question, I like the way you broke it up into access to data and prevention. I don’t know how to prevent the Mayo situation with your ex-wife. If you want to Mayo, I think what you’re saying is “I trust you, but you do have policies that do such-and-such? Do you have enforcement and do you terminate people for this behavior?”

If they answer “yes,” you can additionally say — and this is my concern — I think that’s sort of as far as we can go with policy because we don’t design cars not to go past 55, but we make it illegal and we have escalating now, there’s a lot of (?). We make it escalating enforcement policy. It’s like John’s audit that make it — that are inhibitors, you know, to violating those policies.

And I don’t know that we want to go really deep into prediction because the first part, we can’t predict who has the need, and then we’ll throw out the baby with the bath water by making break the glass nonsensical.

MR. ROTHSTEIN: We’ve got Gail.

DR. TANG: Who’s the nurse taking care of you?

MS. HORLICK: But if she’s an OB/GYN and he’s going there for something —

MS. WATTENBERG: But that’s an exception. Can’t you predict for 90 percent of the patients coming in, they wouldn’t have to —

DR. TANG: Who did I see?

MS. WATTENBERG: What unit that would be on.

DR. TANG: No, but they get transferred.

MS. WATTENBERG: Okay, so when they get transferred —

MS. HORLICK: But the point is not just to predict in advance what person they’re going to see —


MS. HORLICK: — but is to assign access based on the role that the professional has in that hospital. The nurses have access to all records. Billing agents have access —

DR. TANG: Zero problem, zero problem. This problem of “I want to go to the Mayo Clinic but I don’t want specific people at the Mayo Clinic to see my record.”

MS. HORLICK: And is this an essential aspect, that’s what I’m understanding — then if his ex-wife is a nurse in whatever department, she has no treatment reason to be accessing. So none of the security — and even if you could do it physically, there would be that audit and be accountable.

MS. WATTENBERG: Security between the audit trail and the system not even allowing her to look at the record.

MS. HORLICK: But, I mean, if the patient requests it.

MS. WATTENBERG: This is what I don’t get. If I’m in my office and we have a new employee or somebody just — we can call IT and we can say “this person can no longer have access to any of the records in the system.”

So why can’t, in this case, why can’t you handle, why can’t you create a system that does role-based based on units or departments for 90 percent of the people and you carry the other anomalies by calling (?) and saying —

MR. HOUSTON: There are systems that can do those types of things. The question is always going to be to Paul’s point, is the false hits. If you make security too granular, you have too many people falling outside of the rules, that’s where it gets really, really tricky.

You know, and sometimes you might say, you know something? If a patient’s in the facility, then any nurse, any physician can look at the entire record. The phlebotomist can look at this part of the record. The anesthesiologist — or the dietician can see this.

There is definitely a balance between —

MS. WATTENBERG: But that’s not role-based. That’s degree-based.

MR. HOUSTON: No, no, no, but there’s still role. There’s role- and degree-based.

MS. WATTENBERG: All right.

MR. ROTHSTEIN: Well, Harry’s been very patient.

MR. REYNOLDS: One thing we haven’t touched base at all on is the public health aspect to this because at some point — back to John’s point — there’s this big picture of what the NHIN is going to be and how it’s going to feed information twice as — and information will be available. So public health, I don’t think we’ve spent enough time on it.

The other thing, as I go back to what we were sent today, and it says what this Subcommittee wants to say is —

MS. BERNSTEIN: This is a covering letter, yes, okay.

MR. REYNOLDS: But I’m not sure it is a covering letter.

Where I’m going with this is, we heard an incredible amount of testimony. We’ve had good, honorable debate, you know, and the more granular it gets, the more separated we become, just because it’s individual.

I mean, privacy and your health information and how people react, it’s real individual, the closer you get down to the situations. And the last 15 minutes or so, we’re talking about somebody, somebody, somebody.

And so maybe in this particular section, especially B, we try to focus on maybe not as much major recommendations as considerations as key issues that are going to have to be vetted in lots of other arenas, because I think you put it perfectly the other day — we’re four of 16, dealing with a subject that affects hundreds of millions of people who each are going to have their own opinions.

So as we have our discussions, we’re getting down to what we’re going to recommend, and I think maybe what should be considered at the next step. So as we’re writing to the Secretary, you know, what should be considered in pilots, what should be considered in this, what should be considered in that. Where is really going to blow up?

I mean, we’ve heard a lot of testimony and we know kind of where it’s going to blow up.

So that’s just a thought, because recommendations are going to be extremely, extremely hard to come up with on some of this.

DR. TANG: But if not we — who? I mean, we heard the testimony. We have to somehow render some advice and suggestion.

MR. REYNOLDS: There’s a difference between advice and suggestions and recommendations, how it should happen. And we’re spending a lot of time getting into how it actually is going to work.

MS. WATTENBERG: Trying to define what it needs to work on.

MR. REYNOLDS: I understand. No, I understand. But at some point — we have a meeting tomorrow, and we’re talking about making presentations, and all I’m saying is at some point we’re either going to let this go on forever, and that’s fine. I mean, I’ll debate as long as we want to. But as we’re trying to get to something that’s going to be —

MR. ROTHSTEIN: Here’s what I’d like to suggest, after lunch that we ask everyone to come up with general principles that we think that the Subcommittee and the whole Committee can agree on.

For example, just to make one up: The patient should have some control of his or her records. Some control, you wouldn’t say that? [Laughs.]

Well, wait a minute.

Okay, then we would go beyond that to sort of a second-level principle to how to do that. And at the point that we lose consensus, then we sort of branch into considerations.

MR. REYNOLDS: Okay, so that’s — yes.

MR. ROTHSTEIN: So, in other words —

MR. REYNOLDS: Principles and considerations.

MR. ROTHSTEIN: And so once we say, well, we want to make sure that patient care is not jeopardized, that we not open physicians to liability. On the other hand, trust in the system is absolutely essential and patients need to blah-blah-blah.

And we’ll see how far down from the general principles we can get.

MR. REYNOLDS: Yes. We’ve been tending to work upward. I like — I guess my point. We start working down, when we hit where we all separate, then maybe that’s as far as we go. That’s where I’ll stop.


DR. TANG: As a suggestion for the afternoon, since we’re reporting out tomorrow, could each of us —

MR. ROTHSTEIN: We’re not reporting necessarily this. We’re going to discuss what we’re reporting tomorrow.

DR. TANG: When are we going to discuss —

MR. ROTHSTEIN: We’re not necessarily going to be reporting B. We’re going to be reporting maybe A —

DR. TANG: Somehow I got assigned Section E and I got very nervous with what’s still in here.


DR. TANG: So —

MR. ROTHSTEIN: Yes, we’re going to talk about that at some point.

DR. TANG: — either talk about that or stick with your plan and say what I’d like each of us who’s reporting on sections give our take away principle that we report out on and not deal with the text at tomorrow’s meeting.

MR. ROTHSTEIN: I think that’s fine.

DR. TANG: And that may make more sense. And then we can vet out, deal with these —

MR. ROTHSTEIN: And we want to get input from the folks.

MR. REYNOLDS: And can you remind us what sections we’re having?

MR. ROTHSTEIN: Yes, I’d be happy to.



MR. REYNOLDS: I’ve got no problem with that!

MR. ROTHSTEIN: This is subject to change. I said that I would give an overview of the various hearings that we had and what we’re trying to do. Harry was going to do F, on maintaining trust. Paul, you were going to do E, on secondary uses. And John was going to do D, on regulatory.

We don’t have to cover everything. I mean, we can —

MR. ROTHSTEIN: Well, let’s see where we are.

DR. TANG: We might be able to come up with principles.

MR. HOUSTON: I agree with the concept of establishing principles and I do believe we may find out that there are two countervailing positions in that we need to present both of those.

MS. BERNSTEIN: I actually thought that we weren’t going to present B at all, that we were going to present pieces of the report that we could get agreement on.

MR. REYNOLDS: No, he was talking about the principles.

MS. BERNSTEIN: I’m saying, I thought we were not going to discuss —

MR. REYNOLDS: He wasn’t talking about tomorrow’s meeting. He’s talking about this afternoon.

MR. HOUSTON: I think we would be remiss if B is really the weighty issue. If we don’t put it on the table, we’re delaying discussion on it and just delaying the letter. I think —

MR. ROTHSTEIN: Whether we have something that is in presentable form —

DR. TANG: Agreed. And what we need to do right after lunch then is get to the meat of it. You started laying out before what’s — we sort of talked around the philosophy here. Let’s get to — let’s flush this out a little bit to see where we can get to.

DR. TANG: The alternative, though, is to make sure we can get something that we can approve. So if we thought we had D, E and F done — unfortunately, I don’t think we have F done, I mean, E, done — I don’t think we have anything we can stick with principles. If we want to get something approved, then we ought just make sure we get —

MS. BERNSTEIN: Well, we’re not trying to get it approved. What we’re trying to get is input from the rest of the Committee members about whether the directions are all — we’re not near approval.

MR. ROTHSTEIN: Because of the language in every section.

MS. BERNSTEIN: And they don’t have a copy of it. They don’t know that yet.

DR. TANG: Maybe we should approve the principles we think, each of us reporters think, we have on —


DR. TANG: — D, E and F and then into B.

MR. ROTHSTEIN: How about if our plan is for the afternoon we work on B up until no later than 4 o’clock, saving an hour to work on our presentations for tomorrow?

DR. TANG: Agreed.


DR. TANG: That’s fine. I think that’s great.

MR. REYNOLDS: Good discussion.

DR. TANG: Harry, excellent discussion. I’ll throw out my excuse. I was behind a train and then a demonstration.


[Whereupon, a luncheon recess was taken at 12:23 p.m.)


MR. ROTHSTEIN: We’re going to resume and take up the issue of what principles can we agree to and then we’ll try to sort of paint in as many details as we think appropriate.

MS. BERNSTEIN: So when you get to something you want me to call a principle, you tell me and I’ll record it: “This is a principle,” right?

MR. ROTHSTEIN: The first words out of whoever asks to be recognized will be a principle. Who would like to put the first principle on the floor?

MR. HOUSTON: If I could think of something witty to say, I would say it right now.


MR. HOUSTON: I think, based upon our morning discussion, I think the first principle generally — or globally — should be that patient information should be — how do we say this? — only accessed based upon — wait, I don’t even know how to say this; I’m not even sure I’m saying it the right say — based upon a bona fide, good faith need to know and that systems to support this need to be established.

And why I say it this way is that it might be —

MS. BERNSTEIN: It’s a good principle.

MR. ROTHSTEIN: Yes, but I can I hear the first part of that?

MS. BERNSTEIN: Patient information should only be accessed based upon a bona fide, good faith need to know.

DR. TANG: If it’s totally HIPAA, we really need to set another — restate that principle?

MR. HOUSTON: Well, because the reason why I say it this way is it sort of — if you think about what we talked about this morning with regards to the patients that are blocking information because they have concern that they don’t want their relative to see it, or you think about having rule and contextual-based access criteria — I’m just trying to think of a way without —

MR. ROTHSTEIN: Okay. So is your principle an attempt to sort of encompass both of those concepts?

MR. HOUSTON: Yes, without having to say one or the other. I’m just trying to think of a way to say we have to put something in place that’ll allow the patient to be comfortable that somebody is not going to be inappropriately accessing their data.

MR. ROTHSTEIN: Okay, now, keeping in mind that we already have — maybe this will make things easier — in Part C, we’ve already — I mean, we could revisit it if you want, but we’ve already embraced the principle of role-based access criteria and contextual acts of criteria, so that if you wanted to sort of leave that aside and focus on the other aspect —


MR. ROTHSTEIN: — that we haven’t addressed, maybe it would be easier for you.

MR. HOUSTON: That’s fine. I just — I guess I’m trying to think of these. You know, but you’re asking us to put the core principles in place.


MR. HOUSTON: I don’t disagree with you. I agree with you that it’s in there in that context.


MR. HOUSTON: I just want to — I’m afraid that if we — when we start talking about blocking versus other things that what we’re really trying achieve here is give the patient confidence that his or her data will only be accessed by appropriate individuals for bona fide reasons and that, you know, the whole purpose of why patients want their information blocked is not that they want their information blocked. They’re afraid that people are — whether it be a relative or a neighbor or somebody else is going to inappropriately look at that data.

That’s why I sort of tried to say it the way that I did, and I know it doesn’t come across as —

MR. ROTHSTEIN: Okay. But we can use that as a starting point. So, Maya, do you have that?

MS. BERNSTEIN: Patient information should only be accessed based upon a bona fide, good faith need to know. And I wrote we’ll note that the purpose is to allow the patient to be comfortable and confident that someone is not accessing your data inappropriately.


MR. HOUSTON: You might even say that this could involve schemes involving patients’ rights to put information blocks on their record or other types of protections.

MS. BERNSTEIN: Now you’re getting to details, right?

MR. HOUSTON: Well, I’m just saying if you’re putting notes in there, you might want to say this could involve both —

MS. HORLICK: That might be consideration. I mean — and we all agree with that principle.


MS. BERNSTEIN: We were going to see how far with that —

MR. HOUSTON: I’m sorry, then.

MR. ROTHSTEIN: Okay. Harry, do you have a principle for us?

MR. REYNOLDS: Yes. Protected health information should be equally protected whether it resides with a covered entity, a business associate or any other business entity.

DR. TANG: Why do you mean anybody — just say protected uniformly?

MR. REYNOLDS: Well, the reason I want to make the distinction, I think that HIPAA — I think, you know, everybody thinks, everybody would say HIPAA. I want to make sure that’s clear.

In other words, we’ve already got the first two covered, and I just — back to the trust thing, back to this whole idea of who touches it or doesn’t touch it.

MR. ROTHSTEIN: And of course we also have that principle later.

MR. REYNOLDS: No, I understand. But I think back to John’s point. I think we’re trying to build some core principles and they show up in multiple sections of this, but if we have those to use as our basis, then whatever words we use on a particular subject should tie back to this and then we can all — as we’re explaining it to everybody else, we can all use it as —


MR. REYNOLDS: — like even tomorrow.

I mean, philosophically tomorrow, your start-off, maybe, we came up with five or six basic principles, and as we go through sections of the letter, you may hear them said differently or play off of them, but this is really what — that’s what I’m thinking of.

MS. HORLICK: We might even incorporate this on the letter, like everything that follows is going to flow from this.

MR. REYNOLDS: So again, back to like our one discussion, I’m not saying that we need new legislation, I’m saying it. I’m putting it as a premise so we’re not saying exactly how to do it.

MR. HOUSTON: Can I add to what you said?

MS. BERNSTEIN: Can I just sort of respond to Paul’s comment before about HIPAA? Imagine that, you know, you can recommend to the Secretary anything, including things that would require change in the law. You don’t have to —

DR. TANG: But he’s restating HIPAA.

MS. BERNSTEIN: Right. But I’m saying that when you’re saying that, you know, we already have that at HIPAA or that goes beyond HIPAA, whatever, I mean, it’s a wish list, right?

MR. REYNOLDS: No, I’m restating HIPAA.

DR. TANG: He was wrong; you were right, okay?


MR. REYNOLDS: Could we have it again on the record? Harry was right!

MR. HOUSTON: All right. Can I just make a comment about it?


MR. HOUSTON: I think the only nuance I would say to that is that should not preclude a patient by private agreement with an entity which holds his or her data, the patient’s data, by private agreement, allowing that covered entity or private entity to do something other than what HIPAA currently provides.

MR. ROTHSTEIN: What are you — I mean, I don’t understand what you’re —

MR. HOUSTON: What Harry said basically was is that the privacy law should apply to everybody. It should sort of follow the record.

My point is that — maybe what I’m saying it putting at the beginning of that, absent an informed, knowing agreement on behalf of the patient permitting his or her data to be used for other purposes, that privacy — that there should be uniformity across entity regardless whether they’re a covered entity or not a covered entity.

MR. REYNOLDS: I don’t think my principle restricts what you said.

MR. HOUSTON: I’m just trying to clarify it. I think clarification then is simply that we need to have the capability of entities to be able to enter into private agreements with —

MR. ROTHSTEIN: You mean like authorization?

MR. HOUSTON: Yes, well, like an authorization.

MS. BERNSTEIN: With patients.

MR. HOUSTON: With the patient. Like if I decide to subscribe to a website to manage my health information and part of it — you could opt into allow your data to be used for other purposes.


MR. HOUSTON: I just want to make sure it’s clear that this doesn’t preclude other types of activities going on but it needs to be done with the patient’s, you know, informed consent, to use that phrase.

MS. BERNSTEIN: That concept reminds me of like the protection follows the information.


MS. BERNSTEIN: Which is what we wanted originally, you know. Paul, number three?

DR. TANG: Confidential health information should remain under the control of the treating entity unless the patient specifically permits its disclosure.

MS. BERNSTEIN: Unless the patient —

DR. TANG: Specifically permits its disclosure. The concepts there are it basically is —

MR. HOUSTON: Opt in.

DR. TANG: Pardon me?

MR. HOUSTON: It’s basically opt in.

DR. TANG: No, it’s an opt out —

MR. HOUSTON: It’s opt in to NHIN.

DR. TANG: It could — you need to opt in, correct. So it also addresses your point about this, so — and we might define treating entity, so, again, the confidential health information remains under the control of the treating entity and only the treating entity unless the patient consents to its disclosure.

And then other one either that’s encompassed with this or you may state it explicitly: The patient should have the option to opt out of sharing data on the NHIN.

MR. ROTHSTEIN: Okay, so this —

DR. TANG: That should be included with it, in the first one. It is, but it —

MR. HOUSTON: Can we word the concept of opt in versus opt out? Why don’t we say that there has to be some consumer control.

DR. TANG: That’s what my first statement said, I think.

MR. HOUSTON: No, you basically said opt in, but my point is consumers should have some level of control over whether his or her data is included, whether they participate in the NHIN.

DR. TANG: It actually has that, but let’s see if you need it explicit.

So in some sense, one of the principles is this is what I think the patient expects. So I got to a treating entity; my confidential health information should remain under the control of that treating entity unless I specifically permit its disclosure.

MR. HOUSTON: That’s opt out.

DR. TANG: That’s correct.

MR. HOUSTON: But what I’m saying is I think we should be silent as to whether it’s opt in or opt out.

What we should say is that the consumer should have some measure of control over whether his or her information is included in the NHIN.

DR. TANG: Why do you say it that way?

MR. HOUSTON: Why I say it that it way is it could be an opt out.

MS. BERNSTEIN: It could be an opt out, some measure of control.

MR. HOUSTON: It could ultimately be decided that opting in will be too complex, that opt out would be a better way.

DR. TANG: So my concern about the control word is then we’d have this granularity stuff.

MR. HOUSTON: I’m just trying to think of a way to avoid saying opt in versus opt out.

MS. BERNSTEIN: What he just said is the consumer should have some measure of control over whether their health information of patient information gets to the NHIN.


MS. HORLICK: And then your consideration is opt in/opt out.

MR. HOUSTON: That’s my point. That’s the decision that needs to be made, which is the right scheme.

DR. TANG: Maybe the second section, we edit the second sentence. My second sentence was originally opt out, so the patient should have control over the sharing of data — sharing of his or her data on the NHIN.

MR. REYNOLDS: That was my — because I think when you get into treating, you get into treatment, that’s our whole idea of the whole flow of — I’ll just use health insurance as an example. I mean, patients come to health plans; you send medical records. So now it’s — what it says, it’s under the control and whether or not it goes out.

There are other processes that are standard in health care.


MR. REYNOLDS: There was something that’s moving around, so I like — so you focus that on NHIN, I’ll go with you.

MR. ROTHSTEIN: Okay, can I hear the rest of the —

DR. TANG: Well, I made two statements. He may still disagree with my first one because I used the term —

MR. ROTHSTEIN: Well, I’m not sure what —

MS. BERNSTEIN: They aren’t disagreeing with your first one.

The first one says, confidential health — your original statement says confidential health information should remain under the control of a treating entity and only the treating entity unless the patient specifically permits its disclosure.

DR. TANG: And only the treatment is parenthetical, but — so —

MS. BERNSTEIN: Okay, fine, whether it’s parenthetical or not, that was your intention, right?

MR. REYNOLDS: Which is directly against the entire reimbursement logic.

MS. BERNSTEIN: Treatment and payment, the whole — yes.

MR. REYNOLDS: CMS, I mean, it’s against CMS.

MS. BERNSTEIN: All the things that are exceptions to HIPAA would not be allowed without patient signature.

DR. TANG: No, I —

MS. BERNSTEIN: That’s what that would mean, is the point.

DR. TANG: It’s actually an interesting point. A patient walks up and expects to — they are disclosing private information in return for treatment, okay? That is what a patient thinks about.


DR. TANG: Now, we might add another qualifier to that concept — treating entity — and saying “and to conduct the health care and whatever.” But I’m trying to say, how I can explain this to a patient and it meet — this is what I’m expecting?

So, one, I’m expecting that you hold my information confidential, and I’m also understanding that you have to deal with other parties in order to transact this business. But I want to bring it to the patient. Is that concept —

MR. REYNOLDS: Yes, I agree with the concept.

MS. HORLICK: So maybe part of it is knowledge, not just permission. I mean, if, you know — maybe they need some knowledge of — I mean, if you’re going to report child abuse, you’re going to do it, you’re going to tell them, you’re going to notify them, but they don’t really have to give permission.

MR. ROTHSTEIN: Well, let me tell you the problem that I had when I wrote this part of the section.

It seemed to me that there were three ways we could go. You could have an opt in and opt out or a — just provide notice, like HIPAA. And under any of those models, I was concerned that people would have a piece of paper shoved in their face and they would be asked to sign, you know, an opt in, for example, or an acknowledgment that my information is now part of the NHIN or whatever.

And so the patient choice was really not going to be a patient choice.

I don’t know how to get around that. So it almost doesn’t matter what we say, whether it’s — I mean, the difference between the entity and an acknowledgment being signed and a consent being signed, as I know we’ve gone through for years, is really a meaningless distinction if people aren’t going to be evaluating. If they have a piece of paper shoved in front of them and they’ve got a pain in their gut and I don’t want to read five more pages, you’re going to sign.

MS. BERNSTEIN: You know what? Maybe that’s the principle. Maybe that is the thing, that there is no difference in real — in practice between giving a patient notice of what’s going to happen and asking them to sign essentially under duress. But in practice, patients are going to sign because they need treatment or they’re going to read or not read because they need treatment.

And it’s a difficult, intractable — you know, there should be some — basically, that’s not the mechanism or the time to tell the patients. Maybe the mechanism and the time is education on a national scale about how the system works and not at the point of treatment.

MR. ROTHSTEIN: Okay, we get Gail and then John.

MS. HORLICK: I was just going to say I think that the time issue is for treatment and for payment, you are in that situation. But maybe the NHIN is different. I mean, maybe you don’t have to make that decision under pressure. Maybe you get literature like you do on Medicare Part B and it’s in your doctor’s office and you get the opportunity to ask questions. I mean, you could decide next month whether or not. Or you could come back and ask questions. Or whatever. Either opt out or in. Because if it’s opt out —


MR. HOUSTON: This is not a monolithic opt in and opt out. Let’s just say the scenario that Maya brought up, which is the patient presents it to the E.D. and they have a pain in their stomach and they’re not in the right —

DR. TANG: No, it doesn’t have to be the E.D.

MR. HOUSTON: Let’s just say the best example, and the patient really is not thinking about what they want to opt in or opt out and they just want treated their severe pain. So they sign everything, and there’s an opt out provision in there, rather than opt in.

So the facility goes out and uses — avails themselves of the NHIN and gets information about this patient, treats the patient. The patient says, you know something? I don’t know if I really want to have this covered entity have my data. I wish I didn’t signed it.

They can always go and opt out later. Thereafter, they will never have the right to go back and request (?). So I think the possibility of a long-term harm can be managed appropriately. I think that if we’re going in core principles, can I just bring one up because I think it does flow very nicely with this one —


MR. HOUSTON: — issue, and we haven’t talked about it yet? There needs to be some level of right for the patient to expect who will get their record, whether that be they’ll be emailed some things or —

MS. BERNSTEIN: Who will get it or who has gotten it?

MR. HOUSTON: Who has gotten access to the record.

DR. TANG: Audit.

MR. HOUSTON: By the way, you could say that both of them — accounting, or who you’ve opted in to permit to see a record, as well as who’s actually —


MS. BERNSTEIN: The accounting.

MR. ROTHSTEIN: — accounting, because —

MR. HOUSTON: It could be just something as simple as having a website and as soon as a request is made to the NHIN, it generates a record that the patient, when they log into the website, they can see who’s looked at the record.

And the reason why I think it’s important in the context of our last discussion — even if the patient decides — let’s assume it’s an opt out, and the patient doesn’t exercise the right to opt out. That patient can still go back and look to see who actually had access to the information in his or her record. And so there is — this does provide a balance. It prevents this black hole from occurring: Oh, my God! Who looked at my record?

MS. BERNSTEIN: You said two things that are very different.

One is that the patient has — at the beginning of your last segment, you said the patient has to have the opportunity to request that their data should be removed from the NHIN.

MR. HOUSTON: And I didn’t say that. No, no, no. What I said was is the patient —

MS. BERNSTEIN: Basically, you said the patient can opt out later.

MR. HOUSTON: Well, maybe I’m thinking architecturally the NHIN is not going to hold data; it’s going to bring providers — great. So that’s to my point, is it doesn’t hold data, so therefore what you’re opting out of later is that you participate —


MR. HOUSTON: — through the NHIN.

MS. BERNSTEIN: Right, but that was exactly my point, is that once it’s gone, once you have — you go to a

doctor and you got treated in your scenario —


MS. BERNSTEIN: — and they used — you know, they stuck your data up there, or whatever — I mean, look, if that data was transferred for a consult and you got treated, you got help; 30 days later you decide, you know, I didn’t really want that to happen. I don’t want my data going out there.

MR. ROTHSTEIN: It may have already gone somewhere.

MS. BERNSTEIN: It’s already gone. And what you’re saying — your second part is addressing that part which is, okay, where did it go to?

But my point is, I don’t think we can be under the illusion that you can get it back.

MR. HOUSTON: No, no, no. The way that the NHIN is architecturally being structured would be that —

MS. BERNSTEIN: We have five different people who are on contract to tell us how it should be structured.

MR. HOUSTON: But none of them talk about developing massive repositories.

MS. BERNSTEIN: No, but —

MR. HOUSTON: But the point is that if I go to Paul Chang and he goes —


MR. HOUSTON: I work with a Paul Chang — sorry. You know Paul Chang. Actually, he’s a Stanford type, too, I think. He’s a radiologist from the University of Pittsburgh Medical Center.

So Paul Tang. If I go to Paul Tang, and mistakenly don’t opt out; I decide to allow — he pulls down my record — he grabs information through the NHIN related to me. The information is still with the original entity that held my data, but it’s also residing potentially in Paul’s record. It doesn’t sit out in a NHIN — you know, a data repository. It’s now in Paul’s possession.


MR. HOUSTON: It’s in the original provider’s possession. And what I can do is through the NHIN, I can say, “NHIN, I don’t want any of my records released through your network in the future.”

But it doesn’t — the reality is still that you saw it go to Paul, there was an accounting that it went to Paul; Paul, you know, hopefully, through these other mechanisms, has the obligation to keep this information confidential.

All I’m trying to do is —

MS. BERNSTEIN: Well, once he’s got it, it’s not coming back.

MR. HOUSTON: Oh, it can’t come back and it shouldn’t come back. And he may have also made medical decisions based upon the data —

MS. BERNSTEIN: That’s my point.

MR. HOUSTON: — and he has every right to say that this is what he relied upon.


MR. HOUSTON: My point, though, is rather than having an opt in, if you have an opt out, by providing an accounting capability, you sort of balance out the fact that you lose a little control with an opt out. You get some of it back by being able to see who actually looked at the data. So you’re balancing these controls.

So the other principle I have is simply that there should be some mechanism for a patient in some fashion to get an accounting of who has access to their data or who’ve they permitted to access their data through the NHIN.

MS. BERNSTEIN: Nobody talk till I get this — [laughs] —

MR. ROTHSTEIN: I will give you a minute.

MS. BERNSTEIN: So you have both retrospective — that is, who has seen my data in the past, where has it been sent to —


MS. BERNSTEIN: — and also prospective — to whom have I allowed my data to be sent in the future —


MS. BERNSTEIN: — or what are my accesses look like.

MR. HOUSTON: Who you’re permitting to look at your NHIN.

MR. ROTHSTEIN: Okay — I — I’m sorry —

MS. BERNSTEIN: I was going to say, that, I think, is harder because some of them are defaults, right, so —

MR. HOUSTON: Depends upon the architect of NHIN, but you could argue there could be an individual, an entity, everybody, but you could look at what your permissions you can provide.

MS. BERNSTEIN: But what I’m saying is, say for the sake of these — we don’t change anything that has to do with HIPAA. We have HIPAA, plus we have NHIN. The list of to whom in the future could possibly get my data is everybody in the law that’s permitted in the future — is permitted under the rule — sorry.

PARTICIPANT: Public health, research —

MS. BERNSTEIN: All those things. Also, treatment, payment, health care operations and coroners and whatever, plus anyone who is specifically added to that list.

MR. HOUSTON: But I want to throw another principle in front of that, which is that there should be some granularity as to who can access NHIN data, authorization for people to access an NHIN —

MS. BERNSTEIN: What do you mean by that? Can you talk more about that?

MR. HOUSTON: Meaning that the opt in can’t be a global opt in for everybody. Or opt out. That —

PARTICIPANT: We were talking about that.

MR. HOUSTON: Yes, I guess related.

MS. BERNSTEIN: Can we just go back to the high level things.

MR. ROTHSTEIN: I want go back to Paul’s point which I think has been lost, and that is, simplifying your first principle is: There should be some degree of patient choice for certain stuff.

DR. TANG: Right.

MR. ROTHSTEIN: And my concern is — I mean, I support that principle, but the question is: How do we make the patient choice really meaningful and not pro forma?

And I don’t know what the answer — I don’t know that there is an answer, but if we could come up with something, that would make me feel a lot better and it may make others feel a lot better, too.

I’m not sure I would be happy with coming up with any system that just gives the patient another piece of paper to sign.

MS. WATTENBERG: The new health privacy survey that came out that was talking about how many people won’t share data and then how that changes once they’re told how the data could be of benefit to them — so I’d sort of be curious what is that process that they described, what was described to them.

Is it your cardiologist telling you, you know, here are the five people I may share it with, or these are the kinds of things I may be able to diagnose if I get the data? Is it something written? Is it something — you know, did we get any testimony from people on sort of what is meaningful or not?

MS. BERNSTEIN: From the patient point of view?

MS. WATTENBERG: Mmh-hmm. Yes, like what shifts them from that position of, no, I’m not going to share the data to, you know, doubling it and saying, oh, well, in that case, sure, I’ll share the data?

MS. BERNSTEIN: Well, I keep coming back to sort of Bernie Lowe’s — I always think of him when we have this part of the discussion, sort of you’re talking about his, you know, personal relationship with his patients and how

he has worked with his patients who don’t want information to go in the record, for example. They ask him to keep out certain meds or certain diagnoses.

But after talking with them and saying, you know, we’ve been working on this mental health problem for quite a while and that kept it out, but, you know, now you’re on a medication, but he has a personal interaction with an individual patient with whom he already has a relationship which is, you know, very intense. I mean, that’s not the way it’s going to work for every single person, right, and that’s hard to regulate.

It’s going to continue to happen.

MS. WATTENBERG: I think what we have found, to your point about how do we make this meaningful, is that in order to process the volume and depending on, you know, the range of providers that we have in mental health to a pharmacy, all supposedly operating under the rules, I mean you’re going to have varying levels of patient interest in having choice. It’s one of the things that you see pushed back even on the Part D, is that too much choice —


MS. BERNSTEIN: — I can’t deal with the choice. It’s too complicated, the choice. I don’t have time for this. I just want to get my drugs paid for.

And, you know, the pros and cons in terms of how meaningful the notice is, it is in good part, I think, a reflection of people’s, you know, interest or tolerance to put the time into that dialogue.

And I think when we were trying to struggle through this on the privacy side, you know, the best we could come up with was to do the good faith acknowledgment, you know, but that they could go all sorts of ways about that.


MS. WATTENBERG: But it was an attempt to preserve, you know, a formalized opportunity to have this discussion if you wanted to have the discussion, without imposing if you put that discussion on everybody. And so it’s a way of —

MR. ROTHSTEIN: Well, would it be possible, trying to reach some closure on this point, to have a system where there were — where we had a universal sort of opt/opt where if the patient at their primary care docs or their first doctors, they elect to be in the system?

That takes — they don’t have to do anything more with their pharmacist, with their PT, with any other service provider, because now it’s automatically linked to their desire to be a part of the system or whatever?

So in that sense it might be simpler than the, you know, notice acknowledgment, where you have to do it many times.

Paul, you want to —

DR. TANG: To your comment about how do we avoid it from becoming just this perfunctory paper you sign, I think basically the piece of paper that you sign basically advises them that we are going to have uniform access within this entity in a role-based way.

I would imagine the sharing within an NHIN would be this check-off box that says, “Do you also permit us to make available to authorized users on the NHIN to access your records?” and give examples, which is probably what the survey did, such as a specialist or whatever. “And you may revoke this agreement in the future.”

Something like that. And so in that way I think that would make it more visible and distinguish it from all the nuances about sharing within. I mean, let’s just make it simple. When you come here, we store your information, we protect it, but it’s available besides, and then make a separate check-off that says “Do you give us permission to share it when you have –“

MR. ROTHSTEIN: Okay, but from an IT perspective, would it be possible to have me sign something at my primary care doc’s office —

DR. TANG: Right.

MR. ROTHSTEIN: — and now I don’t have to do that anymore?

DR. TANG: Correct.

MS. BERNSTEIN: But, Mark, I think that has implications for other policies that you’re interested in.

So, for example, if I go to my — say, it’s my PCP, the first time, I’ve checked the box; I never have to ask again. When I go to my mental health provider —


MS. BERNSTEIN: — and say, “I don’t want the records in there,” you’re on opt out now —


MS. BERNSTEIN: — because you don’t have an opportunity for opt in anymore because you’ve already taken that away the first time you had the encounter, right?


MS. BERNSTEIN: And so every time I go to another health care professional, I have to — I’m not going to be asked, you know, whether it’s okay. I mean, it has those implications if you do that. It’s certainly possible, I would think.

MS. WATTENBERG: It would happen for all your treatment, I mean, for each —

MS. BERNSTEIN: That’s what he’s saying. Mark is saying —

MR. ROTHSTEIN: Also what I would add, but I don’t know how you do it, is to make this as simple as possible for consumers and as —

MS. BERNSTEIN: Formalize that because that’s a new concept.

MR. ROTHSTEIN: I think the process needs — the NHIN process of either getting in, getting out, whatever the consumer’s role is, needs to be as simple as possible.

You’ll love the second part. And as minimally burdensome on the providers as possible.

MR. HOUSTON: I’m hearing this Utopian state that I think that — you know, listening to Susan about what they had to wrestle with with HIPAA in trying to make things practical.

I think my biggest concern, you know, went back to whoever talked about, you know, the doctor that would talk about why it was beneficial to have your information included.

The concern that I have over all of this is, depending upon who’s going to work with the patient to describe the benefits of an NHIN, and some of them may spend a lot of time, others may do nothing. If you put the wrong scheme in place, you could have substantial numbers of individuals who simply out of not being given the right information have chosen to opt out to the detriment of this entire enterprise.

I mean, it really — I’m just concerned. We have to be — I think we have to be concerned not just the practicality of you making it easy but the likelihood that we get individuals who reasonably would want to be included in an NHIN actually including themselves in an NHIN and we don’t want to find ourselves conversely in a situation where we have a very low participation simply because the scheme we put in place for them to opt in causes simply people to opt out simply because they just didn’t know any better.

MS. HORLICK: I think that many people outside of our professional colleagues — I mean, I can’t imagine that one of my friends that doesn’t work in this area would have a clue what the NHIN is.

And so how could you possibly know whether or not you want to opt in? It’s not like saying “if I don’t sign this, they won’t pay for my care.”

DR. TANG: Right.

MS. HORLICK: I mean, why would you want to do that? I mean, I can imagine if I said I went to this meeting, we talked about this, they’d say, “Well, what’s going to keep my insurance from getting that? What about my employer?”

MR. HOUSTON: I mean, we just simply perfunctorily opt out.

MS. HORLICK: You know, why would you want to do that? I mean — well, look at Katrina, so they would have your records. They’d say, “Well, my doctor has my records.”

I mean, I think we need a whole lot of education.

MR. HOUSTON: The whole issue about education about the drug benefit —

MS. HORLICK: But that’s a different part, it’s a different population.

MR. HOUSTON: But is it because the people that probably have the most encounters with providers are the older people?

I think that they’re the ones that are the biggest consumers of health care, and we need to be concerned about them as a population. And I think this does become — this is a thorny issue that I think that we all in good faith sort of understand we want to try to get good participation, we want to do the right thing.

But there’s a lot of practical considerations here.

MS. BERNSTEIN: What Sue was saying before about the Medicaid prescription — you know, it’s all over the papers, about people are finding how complicated it is; there’s like 45 different possible choices, whatever there are.

I’m just thinking about how much more — I mean, there’s been a huge education campaign on the part of various private entities like AARP and, you know, other organizations that have constituencies are going — CMS has also been doing it.

So it’s not just at the time that you sign up. You’re getting information. There’s been lots of information out there, a huge education campaign, and it still hasn’t been very successful, apparently.

But, you know, just imagine if we hadn’t had all that, how much worse it would be. The people might not even know that they could do it.

So, I mean, I just keep coming back to that. Maybe it’s not at the point of care where we’re signing a notice or figuring out about a consent or, you know, whatever that is. Maybe it’s some other mechanism completely, an education campaign.

MR. HOUSTON: But that’s really the only point where — certainly that would be the really the point where you’d have the ability to sign and —

MS. BERNSTEIN: Right. But I’m saying there’s got to be something more than what happens at that point. There’s not just — you know, right now, with HIPAA what we get is the notice that we get when we go to our doctor’s office, and you may have heard something about it in the

newspaper. But mostly people know about it because when they showed up to their doctor’s office, they got some piece of paper for the first time a year ago April, two years ago now April.


MR. REYNOLDS: I want to separate into two distinct differences.

You know, we already have stuff in place for treatment, payment, health care operations. I’m just using those because it’s HIPAA —


MR. REYNOLDS: — not for any other reasons.

And then we get into this magic thing called the NHIN. One of the reasons that we all struggle is that we don’t have that in front of us to decide how it works, what it means. I’ve heard the word “Google” a number of times, I’ve heard “record locator,” I’ve heard all these things.

So one of the other things that we had talked at length, that I talked during that lunch to that doctor about — once somebody else wants my records, if you think of the idea of the public key philosophy of access to where if you have a record locator or if you have a Google, whatever you’ve — it’s probably Google right now if you’re on the Internet, there’s no restriction; it just goes out and finds everywhere that you are.

Well, I don’t think anybody’s into that for NHIN where you can just stick somebody’s name in and, oh, happy day, you got it.

On the other hand, whatever this turns out to be, if I had a key that’s in the record locator or it’s in the Google or whatever, that without that key, you’re not going to get my records. And if I know you are treating me — and this is part of what you were talking about — but I know you’re treating me or I know you want to give them to somebody else, then if I give them that key, then they can go get it.

Now, at any time I can change that key. If I’m not happy with who might be out there or who’s not out there — the fact that John’s point of an audit trail — because NHIN is a nebulous — it’s still a philosophy.

And so, you know, we’re trying to practically make private a philosophy. So I’m trying to take it down just one level lower to say: I am going to my individual doctors, and remember, I just had that big surgery this year, so I go to the hospital; I was in pain and I signed whatever they gave me. I didn’t care what they did.

But the point is, after that, after time you see a doctor, you sign a notice that they can have what they have.

At the same time, if they were to say, “Well, you

know, I’d like your other records,” then the patient can do something right then because again, back to this idea of the patient having some control, signing something and then hoping — then they’re going to start shooting it around, I don’t know if I can get into that.

But we’re going to make NHIN magical, so let’s go ahead and make it practical. And the practical says if it’s magical, I should be able to have a key that’s out there in that record locator somewhere, that when you put my name in, if you can’t put that key in, whether you’re a doctor — I can give it to Paul just because I say, Paul, I don’t feel good, and I know — you know, I appreciate what you do. I believe you being a doctor, but I worry about you on the Committee but —


MR. REYNOLDS: I could give Paul that key and he can look at them.

But the point is I know that I gave it to Paul and I know Paul has the key.

So I’m not trying to design it, but the whole issue is we take a philosophy of an NHIN, which can mean anything, and I’m still struggling. We’re setting rules and regulations on something that we don’t even know how it would work.


MR. REYNOLDS: And we can’t even get down to where it — because as soon as you tell me how it works, I’ll tell you how I think it might not work, or vice versa. So it’s what I’m struggling with.

MR. ROTHSTEIN: Well, I think it’s a point. I mean, it’s hard to have concrete applications to something that’s not at a concrete level yet.

MS. HORLICK: That’s why we’re trying to keep it at a level —

MR. ROTHSTEIN: Exactly, exactly. Maya?

MS. BERNSTEIN: Are you suggesting a public/private fee thing would — is there a way that you would want (?) to run? Because that sounds a lot like opt in and it sounds like, you know — insurance would not like that.

MR. REYNOLDS: I separated them. Remember, I separated it. Treatment, payment, health care operations have already been taken care of under HIPAA.


MR. REYNOLDS: You’re allowed to treat them. When I signed into the hospital, they said, “You got a health card?” I said, “Yes.” Then when I signed the thing, it said they could send my record so that I could pay. So I opted in. I opted in right there. If I didn’t give my Blue Cross card, I was out. In other words, they were going to do that.

So that’s already in place. This — what we’re talking about here is now we go into never-never land, and so I’m a patient and you want to shoot my stuff around to never-never land, I want in, I want some say.

MS. BERNSTEIN: But NHIN is not about never land. It’s about treatment and insurers and — it might be about other folks.

MR. REYNOLDS: Is it? Well, but —

MR. ROTHSTEIN: It’s a principle.

MS. HORLICK: I think another principle that goes along with this patient having some control or choice is that sort of revocation or changing mind. I think when I read this, this is sort of missing in here.

When we talked about opt in or opt out, but if you do opt in or if you don’t opt out, I think we need to actually come out and state that it’s not irrevocable.

MR. HOUSTON: The other component of this, too, is it’s not to say that we don’t opt into certain things and opt out for others —

MS. BERNSTEIN: Right, sure.

MR. HOUSTON: — by default. Treatment may be an automatic opt which should be by default be an opt out. But any uses for third party purposes, unrelated treatment or payment, you have to opt into them.

MS. WATTENBERG: The other thing is, I mean, if we’re really — it would seem to me, getting to your initial question about what’s meaningful, you know what Sue was saying I think was really important, is what’s meaningful is very different for different people.

And so some people want nothing to do with the whole process but just want to let their physicians decide. And what’s meaningful for somebody else is being able to go to the Medicare website and looking at the 40 plans and spending, you know, the next six weekends comparing things because that’s what they get into.

And for other people, what’s meaningful is having the conversation with the physician when the test is done to say, “Well, what do you mean when you say you’re going to share it? Like who would you share it with?” You know?

So if there’s a way to craft this so that it is flexible and can adapt to sort of changing technology that makes some things easier and less easier over time, that is responsive to generations so that old people may want nothing to do with the Internet but the new generation coming up will want nothing to do with the old way of doing things.

I mean, that it has to be done in a way that is both broad enough so that it’s flexible but broad enough to allow different levels, because if you try and craft something that just seems to me to be one and the same, you’re going to miss the boat on all different levels.

MR. ROTHSTEIN: Well, this is not a principle; it’s just an observation. I don’t know where that falls in the —


MR. ROTHSTEIN: I appreciate what you’re saying, but maybe we need to say somewhere that we are trying to strike the appropriate balance between these two different sets of considerations.

On the one hand, we want to promote choice, we want to promote patient control, we want to promote flexibility, we want to promote autonomy. On the other hand, the more that we do that, the more complicated it gets, difficult for individuals, difficult for entities, the more expensive it gets, and this goes to John’s point, I think, the more we risk losing the health benefits both at the individual level and at the societal level.

MR. REYNOLDS: Wonderful. Wonderfully said.

MR. ROTHSTEIN: But, I mean, that’s not any guidance.

MR. REYNOLDS: No, but then you could take that and take two divergent paths. So if you want to really focus just on good health, here are some of the things you consider guidance. If you want to really make choices, that’s what I hear.

So you’re still putting them both up there. You don’t have to walk away from the whole subject. Then you can at least put two different multiple views in there.

MS. WATTENBERG: I mean, why can’t you say, “I choose to let my physician decide. I choose to decide every time I see a treatment provider. I want every treatment provider to — you know.”

I mean, would that be unworkable?

MR. HOUSTON: But that’s a detail.

MS. WATTENBERG: No, but it’s a detail that informs the question about whether or not flexibility gets to a level of granularity what Mark was talking about.

MR. HOUSTON: The argument is that in emergency care treatments that by default in all NHIN data that’s available that when you go to a physician office visit that you have to explicitly opt the physician into looking at your record.

I mean, there’s a lot of ways that we could — I think there’s a lot of rules you could put in place to make this really attractive. I just think we should try to stay away from discussing those rules right now because it gets into a lot of detail which —

MS. BERNSTEIN: No, I agree. I don’t want to specify the rules. I want to see if there’s a way for

people to be comfortable with the principle of allowing for flexibility and different levels of participation is doable. Do you want to reflect on some of those? Okay, so two thoughts — well, let me just get the first because it’s easy.

You said something I think as a side comment which may be another principle for us.

You were talking about generational differences, and that reminded me to think about being responsive to cultural diversity, you know, generational stuff, all those different kinds of diversity interests and allowing for different communities who have different values about health to have their choices to be valid. And we haven’t had a principle that says something like that.

MS. WATTENBERG: It speaks to the Medicare Part D thing which is 75 percent of people of that population don’t have access to the Internet. So they have these amazing comparative tools. But almost 75 percent of the people can’t use them. So, I mean, that —

MS. BERNSTEIN: I mean, they could get to a public library. There are —

MS. WATTENBERG: Ways for people to do that, right. But if they’ve never done it before they’re older. They’re of a different generation.

So, yes, I think cultural competencies is —

MS. BERNSTEIN: I don’t want to just think it’s generational.

MS. WATTENBERG: Yes, no, no, no, but you’re right, you’re right.

MS. BERNSTEIN: You know, cultural, religious, whatever differences that people have that affect their health care and they should be — whatever the right language is.

MR. ROTHSTEIN: There are lots of reasons and people — mobility —

MS. BERNSTEIN: Right. Abilities if they’re not — well, cognitive ability may have legal implications about making choices about their health care, right? I’m not talking about people who are not competent —


MS. BERNSTEIN: — to make choices about their health care. I’m talking about people who are competent but are, you know, Christian Scientists, or people who are competent but are, you know, Native peoples who have certain — whatever their religious, you know — Orthodox Jews who don’t want, you know, transplants, whatever, various kinds, whatever it is.

I want it to be able to take into account those kind of —

I think we’ve got a principle that says we should take into account that. That’s not just an easy idea; I don’t think anyone disagrees so much about it.

The hardest thing is getting to what Sarah was saying about both having it be easy if you want it to be easy and complex if you are able to take advantage of all the possible complexities.

I think the problem is making it easy — we can make the whole system complex. The way to make a complex system easy is to have defaults, usually, and our problem has been deciding what those defaults should be.

You know, it’s easy for me to walk into my doctor’s office and say, “Just give me the default thing; I don’t want to read it, I don’t want to know about it. I’m just going to sign the piece of paper. Do whatever the rules say to do.” Right? Or, “I don’t want to know about it.”

And usually that means that there’s some default group of rules. And our problem is: What is the proper set of default rules? Right? The problem is deciding what those default rules are. I mean, saying that everybody should have lots of choices and there should be complexity, we don’t have to decide what the rules are. We just have to say the system is complex and expensive. Okay, we can do that, too. I mean —

MS. WATTENBERG: Is that (?) is the default rules? I mean, I guess the assumption for the default is, you know, physicians decide, and everybody gets put on whatever’s administratively more expedient.

MS. BERNSTEIN: Well, but physicians don’t want to have to decide on a case-by-case basis, either.

MS. BERNSTEIN: Right, right.

MS. WATTENBERG: They also want to have — they’re going to have default, too.

And the thing is, in order to make something easy and simple, I think the way to do that is to have a default set of rules, and the problem is deciding what those rules should be, because I don’t think anybody would argue with, you know, some people want to have it easy and some people want to have more complexity. The system with enough money and time can certainly make that happen.

The problem is: What’s the easy choice?

MR. ROTHSTEIN: Well, let me just backtrack a little bit to my personal dilemma in this section as I was going through opt in/opt out notice, whatever.

After thinking it through, my thinking was, okay, look, we’ve got to do something sort of structurally to get away from this pro forma piece of paper thing. I don’t know what that is other than education and so on and so forth.

But, if we’re going to have a piece of paper that someone’s going to have to sign, I’d like to make it a consent form that they’re affirmatively doing something rather than we’re doing it to you and you’re just saying you know we’re doing it to you.

So just, if for no other reason than it gives some degree of control, maybe only in a theoretical way to patients and some level of empowerment, the practical effect may be nil. And I recognize that.

MR. HOUSTON: We’re getting away from, I think, what we’re talking about.

MR. ROTHSTEIN: No, no, I’m at a much lower level, but all I’m saying is —

MR. HOUSTON: As a fellow Committee member, I have a disagreement with you regarding that approach.


MR. HOUSTON: And so, you know, I’m very concerned that —

MR. ROTHSTEIN: This is not going to be in the document. I’m just —

MR. HOUSTON: I know. But I — I hope — well, I don’t know if it is or not; I mean, we’re having an open dialogue regarding our comfort in the different systems here and I think we absolutely have to balance, you know, the principles you talked about with the concern that if we make it too complex and we base it upon, in this case, maybe an opt out — an opt in versus an opt out environment, we could have such a high rate of people not deciding to participate that the entire — all the benefit of trying to do this simply melts away.

And I think we have to be very careful with that. And I think that the — again, I think the core principle is that — and again, I’m very core principle that there has to be some vehicle, some fashion, something in place that’ll allow the patient to have control over his or her inclusion in this environment.

MR. ROTHSTEIN: I agree with that and that I think I try to capture in my earlier statement about the tradeoffs.

MR. HOUSTON: But we’re getting back into the detail. Do we want to look at more principles, though, I guess?

MR. ROTHSTEIN: Yes, yes.

MS. BERNSTEIN: Let me pop up on that a little. Maybe it’s a little bit higher thought, which is if we think that it’s possible that many, many people will not opt in or will opt out and therefore the benefits of NHIN will be lost, if we really believe in the benefits, to me says the message isn’t getting out there that there are really benefits.

And I personally believe right now that the case has not been made for why this is a great thing to do.

I understand that it’s the Administration policy and I understand that, you know, so I’m not talking for the Administration for the moment and so forth, since we’re on the record, but I think that in terms of from the consumer’s point of view, the case has not been made about why this is going to help my personal health care.

I understand the public health, the research advantages and so forth, but for individual patients, I don’t think that case has been made, and this may lead us to some principle about how the case should be made, if we really believe the case.

MR. HOUSTON: But I don’t think that — well, my concern is this, that you can do all the outreach you want to do, but if it comes down to busy physicians and busy staff and busy offices trying to convince somebody to participate in an NHIN, I don’t care how much — and if it is a complex environment in which to enroll the patient into it where there’s a lot of choices and a lot of this and a lot of that, what you end up with is I think a lot of people simply saying “no.” Some people will say yes.

MS. WATTENBERG: You would make the case at a higher level.

MS. BERNSTEIN: Yes, I’m saying the case is not going to be made in the physician’s office at the moment of care. In Denmark, nobody opts out, pretty much, is what we heard. Everybody’s, you know — you have the opportunity to do so, but people don’t. Somehow, they understand that there’s a benefit to them, their treatment, their physicians or something by this.

And I just think that that case —

DR. TANG: Or they sign the same piece of paper.


DR. TANG: They sign a piece of paper.

MS. BERNSTEIN: I don’t remember exactly what the mechanism is is what you’re commenting on. But all I’m saying is that we may want to have something about — maybe I keep coming back to this, you know; it’s sort of motherhood and apple pie, about public education, but the case has not been made —

MR. ROTHSTEIN: But basically we want to that with our letter.

MS. BERNSTEIN: Right. But if the case has not be made, people are going to opt out.

So somewhere we have to make the case, and I agree, the case cannot be made by individual physicians on a one-by-one basis or individual nurses in a particular practice when their patient walks in and hears about for the first time. There’s got to be something else.

MR. HOUSTON: But to the scheme, I mean, I think what we’re talking about here, and I think a lot of good dialogue about, you know, all the nuances to opt in and opt out. And let’s just say we do an opt in, and all the different use cases and scenarios as to what you would opt in to and what should be excluded.

This all becomes a very complex cell even if you try to do a really good public education campaign. And I guess I’m a little concerned that we do end up with a system that we opt out of.

And I think maybe what we need to do as part of our recommendation is make the general recommendation about the consumer control and say that there needs to be maybe some type of study or some type of pilot whereby we can evaluate the different mechanisms and their relative success in enrolling individuals.

MS. BERNSTEIN: The different mechanisms for —

MR. HOUSTON: Enrolling individuals, opt in versus opt out, and how, and to what degree, so —

MR. ROTHSTEIN: But you are on board with the idea that one or the other should be available, right, some control?

MR. HOUSTON: Absolutely. Absolutely.

MR. ROTHSTEIN: I think Paul is next.

DR. TANG: I’m going to try to take it another level.


DR. TANG: Higher and higher levels. Simple is always better, too.

I think we have been assembled around the table and Leavitt and Thompson and Bush have said something because there’s a fundamental belief that there is good to come out of responsible sharing of information.

MS. BERNSTEIN: Come out of what?

DR. TANG: The responsible sharing of health information —


DR. TANG: — on behalf of individual patients and public health.

So why don’t we go ahead with that assumption and say — and that’s one of the reasons I would actually abdicate for an opt out because, as you heard, opt in — the way you put an opt in is to have them sign the pieces of paper and they’ll opt in. But why even go through that?

When Minnesota passed the law and had everybody opt in, Mayo, at great expense, got 95 or 97 percent go and return their envelopes. Why do that? Why waste that money? Educate them on the benefits of doing this, but then make it an opt out, because we believe this is the principle that it is good when people responsibly share their health education.

Then our job then is to recommend policies that would try to deter or prevent abuses and to punish them when they occur and that goes to — pardon me?

MS. BERNSTEIN: Now we’re up to enforcement. We haven’t talked about enforcement.

DR. TANG: Right, but I’m trying to simplify what it takes to get this to work.

It’s a little bit like what John said, you know. If we have the audits and they have the opportunity to examine those things, that is our back-up strategy.

But, one, assuming that these credentialed health care professionals are held accountable to do the right thing, we believe that sharing data appropriately is in everybody’s good, let’s just design the policies that make it simple — that’s the other principle we had — for both the provider and the receiver of care and then go deter, prevent and punish violations. That’s a — sort of a —

MS. BERNSTEIN: I don’t have a problem with the part that providers should be held accountable —

DR. TANG: Right.

MS. BERNSTEIN: — somehow. There should be enforcement mechanism, and actually I stuck them in here from our discussion last time on enforcement stuff.

But I’m stuck on the part about we have to assume that sharing is to everyone’s good. I mean, as sort of the devil’s advocate — if I’m a patient and I don’t anything about NHIN, can you make the case to me about why I should participate? What case would you make?

DR. TANG: So the stepping-back point is if we really have to make a case to every single person, we wouldn’t have enough time in the day to give flu shots.


DR. TANG: So that’s why I’m saying —

MS. BERNSTEIN: If you are going to make in a speech to the nation, what case would you make?

DR. TANG: I think we can do that in speeches to the nation. I cannot guarantee that I can give everybody informed consent on making a specific, deliberate opt in.

Yet, I believe that it is in their best interest.

MS. BERNSTEIN: Right. My concern is, so far, is that I’ve heard the case on public and I have heard the case on research and I think those cases are easy to make.

And I think the case on individual care improvement is much harder to make and that that case has not been made and that the policy decision is — I mean, I don’t hear that case being made. I hear the case for public health, I heard the case for research. The only case I normally hear for NHIN on individual care is if I’m on vacation in some other place and I’m, you know, in an emergency situation —

DR. TANG: Every day, when you walk over to the lab to get your blood drawn, you get assigned a new number. When you go get an X-ray, you get assigned a new number. And guess what? At least John Halamka quotes the ten percent, I can’t match them correctly.

So every day we make this kind of mistake.

MR. ROTHSTEIN: But you don’t think NHIN can fix that, right?

DR. TANG: Well, right now that’s because the lab mails me a little piece of paper that I try to match with the record. If I had an NHIN, there wouldn’t be any of this.

MR. HOUSTON: I don’t agree that it’s only the cases on vacation somewhere. In the whole marketplace, you’ve got four or five large providers vying for, you know, the market, and there’s — I think the root of NHIN and what it’s strongest is relating to treatment care. I think the research and the public health arguments are much more for public purposes. I think the public is much more speculative.

MS. HORLICK: But how do you direct that concern like to the individual, just to give you that power with immunization registries? Well, we tell people, well, they have your shot history and I’ve worked in this field for years, you know. Then your kids won’t get over-immunized, under-immunized. All that makes sense.

Really, to me, I know where my children’s records are. I don’t need that. I understand it for the population that doesn’t know where in changes and all that.

So what I’m saying is you have to make the case to the population that’s going to ask the questions.

MR. HOUSTON: There’s a lot of different cases, a lot of different scenarios.

MR. ROTHSTEIN: But, John, I appreciate your concern, but if you require an opt in that many people won’t do it and destroy the system.

MR. HOUSTON: It’s a fear.

MR. ROTHSTEIN: Okay, it’s a fear.


MR. ROTHSTEIN: I share that fear. But you have to recognize if you give people a choice and even the right to opt out, hypothetically AARP could decide that this system is awful and they send the notice to all of their zillions of members saying “this stinks,” like they did with the earlier prescription drug plan and we urge you to opt out of the NHIN.

Okay, so the fact of the matter is that as long as you give people some choice under either arrangement, you’re going to have to convince them of the merits of the system, right?

MR. HOUSTON: I agree, but going back to Paul’s very articulate comments about you might as well opt out because when you tell them to opt in, hopefully the people do it; they’re going to opt in anyways.

I think, you know, there’s — I’m just trying to be practical and I wish I could articulate it differently or better. I just — and I understand everybody’s perspective. I just keep coming back to the fact that if you give good education to people as to the benefits of an NHIN and then opt them and they automatically — they can only opt out.

The education’s good and the message is still the message and they will still know enough to decide to opt out.

DR. TANG: The opt out is a choice.

MR. HOUSTON: Why is that not a choice?

MR. ROTHSTEIN: No, no, no, I didn’t say it wasn’t a choice.

DR. TANG: It’s much more practical when you know what — I’m going to be a little declarative categorically — when you know what the right answer is, let’s try to make that easy and then try to protect, prevent, deter the abuse, because it really is a public safety.

It’s just like — okay, I’m going to say something else — gun control. I mean, if the evidence says that guns kill people, then you figure out how to make it less easy for the guns in the community and punishment deterrents to make it — violating that principle.

Okay, I’m not trying to make a philosophical statement. I’m just giving an example. When you know speeding is bad, whatever it is.

MS. BERNSTEIN: But you’re convinced, you’re convinced, that NHIN is a good thing —


MS. BERNSTEIN: — and you’re convinced —

DR. TANG: No, I’m convinced that the appropriate sharing of health information and maintaining its confidentiality is a good thing for individuals and public health. I’m convinced.

And I believe with enough time, I could convince most of the population, including you, but I don’t have that amount of time.

MR. ROTHSTEIN: Let’s assume you’re right. Okay, let’s assume you’re right that the NHIN is a good thing.

We still, in my view, and this is language we approved at one time on page 14 said: “The NHIN cannot be imposed on the public. The public must be informed about its weaknesses and strengths, risks and benefits, and become convinced of its merits.”

And, I mean, even if — what I’m saying is we don’t want everyone opting out, right?

MR. HOUSTON: They won’t.

MR. ROTHSTEIN: We want people to be confident that the system works for them, and I think people will react very unfavorably if it’s just crammed down their throats.

MS. BERNSTEIN: I think, getting back to what Sarah was saying, if people are presented with choice after choice after choice, at some point it gets to be a burden. Even if the choice is just to opt out, you have to check, you know — even if you don’t opt out, you’re presented with the piece of paper that asks you whether you want to opt out. And every time you’re presented with that piece of paper —

DR. TANG: A registration.


DR. TANG: A registration —

MS. BERNSTEIN: But, you know, depending on how much choice you want to preserve, if you do it once the first time you see your primary care person and you are not presented with that choice again, that —

MR. ROTHSTEIN: Let me help clarify this discussion. I don’t know what we’re opting in or out of, first. And if I go to your institution or I go to your institution, I don’t think, based on even the way Part B was written as a draft, I don’t think that I’ve got an option of opting out of the sharing of the information throughout the institution.

DR. TANG: Correct.

MR. ROTHSTEIN: Okay? I think what the opting in and opting out of, whatever that means, has to do with beyond —

DR. TANG: Right.

MR. ROTHSTEIN: — the institution.

MR. HOUSTON: Well, I agree with that.


DR. TANG: Let me define that.


DR. TANG: Providing electronic access to authorized users of that information.

MS. WATTENBERG: Outside of the treating facility or whatever.

DR. TANG: Yes. So that’s what I would ask you to —

MS. BERNSTEIN: Wait, wait — providing access and authorized users —

MR. HOUSTON: To authorized users.

DR. TANG: Providing access to —

MS. BERNSTEIN: You mean, deciding who is authorized?

DR. TANG: No. So you have already agreed and HIPAA allows the sharing within my organization. And you have a perception. You walked in the store; I know what this facility is.


DR. TANG: And then I’m going to ask you, and I’m going to advise you, that we, with your consent, we will make available, make — we will provide electronic access to your health information to authorized users for payment, treatment, blah-blah-blah, unless you tell us, unless you check this box and —

MR. ROTHSTEIN: Okay, but when I agree to have both of your institutions, whatever, have my stuff passed around your institution —

DR. TANG: We will not exchange.

MR. ROTHSTEIN: No, no, no. Do you have a right to — you can’t grab stuff from his institution —


MR. ROTHSTEIN: — unless — that’s the NHIN element.

DR. TANG: Correct.

MR. HOUSTON: By the way, it all goes back to — to clarify what Paul was saying a little bit — it would go back to, again, this concept of a relationship, the provider/physician/patient relationship, having that established. It gives you the right to access that data by the NHIN for the purposes of treatment.

And you’d still have the hurdle. You’d still have to deal with the fact that that anyone that received the data would still have to have the processes in place to insure that only those individuals who needed access of that data for a bona fide purpose were looking at the data, because once that organization gets that data — it’s like under HIPAA today.

If my organization received data today for the purposes of treatment, I still have the obligation, or HIPAA, to be a steward of that data and to use it only for appropriate purposes.

It isn’t a free-for-all once that data comes in related to Mark Rothstein. I still have to make sure that my organization appropriately manages that data of yours and only uses it for the purposes it was intended.

MS. BERNSTEIN: May I ask a few questions about that?

DR. TANG: One additional thing. You may go to him for him for care, you may go to us for care. If you check opt out or you do not refer — he does not refer, you know, he doesn’t refer it to me, we are not permitted to share.

MR. ROTHSTEIN: All right, let me add sort of a comment that shows the interrelation between the opt in/opt out stuff and the blocking element, okay?


MR. ROTHSTEIN: Because if I can’t block my substance abuse or my mental health care that I got from him, I’m opting out of the entire system.

DR. TANG: So the proposal that I have made was at the Departmental level. So you could visit his mental health provider and say, “I don’t want mental records on –“

MS. WATTENBERG: I would just say, which is why it really — the decision point has to be at the provider, provider, provider level.

DR. TANG: Right.

MR. HOUSTON: Okay, and to support all that, recognize under HIPAA today, what HIPAA says is that providers can exchange data.

I as a sending provider can rely upon the receiving providers’ ascertation that the information I’m asking for is information that I need. And I think part of this, too, is there’s a trust issue here that we may or may not want to accept, but HIPAA trusts that the providers are going to ask for the information that’s necessary for the treatment or for the —

MR. ROTHSTEIN: What I’m suggesting is that if you want to avoid people opting out, we have to make sure that we’ve got the limitation, the blocking, in effect —


MR. ROTHSTEIN: — for, you know, certain kinds of information or people, as a matter of defense, defensive practices or whatever, are going to just say, “Get me out of this.” So they can’t get a hold of my stuff.

MR. HOUSTON: Today, though — I mean, well, first of all, I guess there’s state laws that typically preclude the provision of certain sensitive information, but today HIPAA doesn’t distinguish the provision of data between covered entities, what type of data it is.


MR. HOUSTON: So you’re really relying on state law that may or may not exist.

But I wanted to just very quickly focus on one point that Maya brought up that concerns me. If a patient has the right to opt out every time they show up at a provider, wouldn’t the corollary be true, too, which is the patient has to opt in every time they go to a provider? And how would you know whether they have opted in in each case?

My concern is that if they’re presented with an opt in each time, well, I’ll tell you right now they could opt in today and —

MR. ROTHSTEIN: No, it would be sort of a change of position.

MR. HOUSTON: But they could do it. But then you need to do the same thing for opt out.

MR. ROTHSTEIN: If you’re opting out, you’re out unless you opt in.

MR. HOUSTON: Well, no, no, no, I’m responding to one point that she made, which was every time you present, you’d have the ability to opt out each time.

MS. BERNSTEIN: I was only saying that if you do that, it would make the system very complex. I’m not saying that that’s the right thing to do.


MS. BERNSTEIN: In fact, in response to what Mark said earlier — we were talking about the policy disagreement — I actually have, after lots of thinking about it over time and arguing with other folks in the process of getting to where HIPAA was, decided that that theoretical difference you’re talking about, the difference between consent and reading a notice, that for the patient there is no practical difference.


MS. BERNSTEIN: And the patient is going to sign or they’re going to get acknowledgment — they’re going to, either one way or the other, know where their data’s going.

But the practical difference on the other side administratively is huge, that it requires a huge amount of record-keeping and a huge amount of administrative support and that for the slight good feeling basically that a patient gets that they’ve consented when it’s really like one of those cores of consent that you don’t like — I’ve come to the policy that it’s not worth that administrative burden, because one way or the other, the data’s got to move, in general.

MR. ROTHSTEIN: I agree. That’s why I surprised people when I was not upset when the rule was amended before it went out to go from consent to acknowledgment.

MS. HORLICK: It was back to the original proposal.

MR. ROTHSTEIN: Yes, and people, you know, were giving these speeches. It violates the right to privacy and all this other stuff. (?) difference. I don’t know whether the scale of the NHIN changes.

MS. HORLICK: Can’t make it better, but I think that gets back to the public perception. I think everything you were talking about, you know — can you get it from his? Well, if you’re a patient walking in there thinking treatment, you’re thinking yes; well, maybe not my mental health stuff.

But I don’t think people know what the NHIN —

MS. WATTENBERG: I just wanted to take exception because I think it really depends on what patients you’re talking about. You know, we’ve sort of gotten to this place where consent is sort of this very diluted concept, but —

MS. BERNSTEIN: I mean consent for treatment.


MS. BERNSTEIN: Okay. I mean consent for basic treatment and payment, not for other stuff, but for treatment and payment and things that are within that. Consent for other things — I agree that you can’t just tell people what you’re going to do and that’s okay.

But consent for treatment and payment and the basic stuff, I mean, there is absolutely no practical difference between getting a notice and signing a consent because it’s going to happen. You want it to get paid for and you want the treatment.

And I just don’t think there’s a practical difference there that’s big enough to justify the administrative problems.

MR. HOUSTON: I’m going to ask a question. Three ladies have been sitting back there the whole day listening to us very attentively. I want to hear what their opinion — they’ve heard all the arguments. Does anybody have an opinion?

MS. BERNSTEIN: Who are they and where are they from?

MR. HOUSTON: Well, obviously one —

MS. BERNSTEIN: They don’t have to be on the record.

MR. HOUSTON: That doesn’t matter. I would be interested. I mean, it looks like you’re all very attentively listening. Anybody have an opinion?

MR. ROTHSTEIN: Your statements may influence —

MR. HOUSTON: That’s right.

MS. BERNSTEIN: Whether you’re invited?

MR. HOUSTON: That’s right.

MS. BERNSTEIN: Mark, if you’d like them to respond on the record but they should come and get on the record then. If they have something to say, I’m glad to hear it, but into the microphone.

MR. HOUSTON: And if they don’t, that’s fine, too.

MS. BERNSTEIN: Well, there’ll be a transcript of the meeting, but it’s not being broadcast or whatever. Come on!

Could you please introduce yourself and where you’re from and so forth.

MS. COMMON(?): I’m Patty Common from CDC, National Center for Health Statistics. I’m a health

informatics specialist and I’m a registered nurse.

MR. HOUSTON: And what’s your opinion? All this dialogue of all of us waxing philosophically about this.

MS. COMMON: I’ve listened to a lot of the dialogue and I think a lot of the basic information that I’m hearing is correct because we don’t really have a National Health Information Network that we can see, that we know exactly what it entails and what it’s like.

So we’re actually pretty much trying to envision and trying to foresee what our consumers, what are our patients, are going to desire from this network.

And I feel very confident that Susan and Sarah had brought up the point the consumers need to know what it is that a health information network is and where their records are going to go. And I think education, it’s what I’m hearing, is a big — really big — aspect of that and it’s better being done sooner than later.

MR. HOUSTON: Well, what about opt in versus opt out?

MS. BERNSTEIN: You know what? We’re not going to get to the bottom of that today.

MR. ROTHSTEIN: Even if we agreed, it would be a subject that’s going to be fought again in the entire full Committee and even if the entire full Committee agreed, you know, by a 10-6 vote or whatever, it’ll be fought again at some Secretarial level.

So I think the best we can do is recognize the principle that patients should have some choice, there are two main options, and —

MS. BERNSTEIN: If you’re going to summarize, I’m going to write it down.

MR. ROTHSTEIN: — here are the advantages of one and here are the advantages of the other.

MR. HOUSTON: Actually, there are two options. I guess arguably there could be a combination of both, based upon the intended use of the data.

So you could say you have to opt out of treatment-related disclosures where you’d have to opt in to research and opt in to public health or opt in to — that’s a third.

MS. BERNSTEIN: Right. You know, a default version of just that —


MS. BERNSTEIN: — is in the HIPAA rule. You know, the whole thing talks about in which case you have to have consent, in which case you can do it by, you know, opt out, in which case you have to have — you know, that’s what the rule is.

MR. HOUSTON: That’s true.

MS. BERNSTEIN: A default version of that that has been argued and thought about by a bunch of professionals. And maybe those people who sat around the table got it right the first time, and maybe not. But, you know, the rule now has two and half years of — a little more — of experience, and, you know, obviously the public, the Department, whatever, is evaluating whether those choices were the right choices.

I think that certainly this group and others will — this group will have the formal authority to advise the Secretary about, among other things, whether they got that right, but —

MR. ROTHSTEIN: Going to back to our pre-lunch vision, we agree on the principle, the big principle, of choice. And now we’ll set out the different —

DR. TANG: So are we going to render an opinion on let’s assume it’s a good thing and make it easy to do?

That is a principle you could decide upon and that would make —

MS. BERNSTEIN: I think it’s okay to say that the Committee, the Department, the whatever, assumes that it’s a good thing. But all I was saying was the public isn’t there yet, and that that may inform one of our principles is that —

MR. ROTHSTEIN: The public doesn’t — isn’t opposed to NHIN.

MS. WATTENBERG: How about if we introduce this principle of choice but we describe it as an informed choice, or an educated choice?

DR. TANG: That’s the same thing as requiring it to be informed choice, because I think that that’s where all of the overhead comes in.

MS. WATTENBERG: I don’t think you can have choice with something like this without it being informed. And how would you —

MS. BERNSTEIN: No, no, no. You can say, just like you said before, I don’t want to deal with it; whatever my physician says is okay is okay. I just don’t want to know. I just want to get treated and go away healthy. I don’t care how my records are stored, I don’t care where my information goes.

MS. HORLICK: Somehow, people have to at least understand how this would be different from the current system that we have now.

MS. BERNSTEIN: I don’t know how the system today is different than it was 20 years ago.

MS. HORLICK: I’m just saying — I mean, you know, yes, there’s people who could say I don’t care; I’m in, I’m out, without reading it. But, I mean, somehow I think if what we’re talking about in the education — I mean —

MS. BERNSTEIN: It would have to be available.

MS. WATTENBERG: I think it has to be more than that. I mean, I think part of the problem —

MS. HORLICK: I would say it would be a lot more than that, but —

MS. WATTENBERG: The education piece of it was not funded or executed in a way that really could have made it far more successful in its implementation than it was.

MR. HOUSTON: And by the way, was there any public outcry about the provision of information for treatment purposes between covered entities?


MR. HOUSTON: Yes. Did anybody come back and say “I cannot believe that you’re going to allow my data to be sent to another provider for treatment purposes, and HIPAA permits that.”

MS. McANDREW: Well, there was a huge outcry in the rule-making process.

MS. BERNSTEIN: It was tough.

MS. McANDREW: Particularly in terms of those who, I think as you may have heard in these hearings, were interested in getting a from scratch, no history, second opinion.


MS. McANDREW: And so we heard from that constituency in terms of the HIPAA rules essentially allowing that sharing for treatment purposes as a decision between the covered entities.

And the consumer, of course, — in today’s world it’s very difficult for the second opinion doctor to know whether or from whom the original opinion came as long as the patient doesn’t tell.

DR. TANG: Can I react to something that Sarah mentioned, which is we didn’t do a good job of educating people on HIPAA, and that is true, but it’s almost impossible because HIPAA’s so complex.

So, to me, that’s part of — and I actually think the people who wrote did a really excellent job in trying to count all the responses that came in and tried all these contingencies.

But I think the fatal flaw there was actually the covered entity thing. In other words, if we had uniform protection, much of that complexity would go away and the teachability would be much simpler.

MR. ROTHSTEIN: Universal coverage.

DR. TANG: This is the loophole. So the lesson learned for this exercise then is I think we want to make sure we keep it simple, because making it complex, no matter how much you invest in the education, you won’t get there.

MS. WATTENBERG: I sort of disagree. I think the regulations are complex, but I think that, you know, the principles are fairly basic. The treatment provider should be able to share information and, you know, for certain public health purposes that make the society go.

DR. TANG: You know people are falling down? The providers are saying, “I’m not telling you a thing whether you’re –“

MS. BERNSTEIN: That’s the problem.

DR. TANG: That’s the fundamental thing that’s cutting off the very things we wanted to share. And it’s because of all these nuances. But if everybody had equal responsibility, I think —

MS. WATTENBERG: Also because there is nobody there to interpret it and explain it to them.


MR. HOUSTON: We’re going to fight this battle all day long.

MS. BERNSTEIN: We’ve got an hour left.

MR. ROTHSTEIN: We’ve got 25 minutes left.

Let me go over the schedule. The schedule is we’re supposed to take a break from 3:30 to 4, and at 4 o’clock — that’s what the schedule is; we can take a shorter break — but at 4 o’clock, from 4 to 5, we’re discussing tomorrow’s testimony at the full hearing.

So we’ve got, at tops, 55 minutes.

MR. HOUSTON: I would then propose we take a break —


MR. HOUSTON: — now, that we go over, read the core principles one more time over so that we all — because we’ve been doing a lot of talking around and around, and we really haven’t talked — restate the principles, make sure we’re all on board.

MR. ROTHSTEIN: I’m actually — I’m comfortable at some level with the choice issue, that we’ve got some agreement that would support explaining it.

What I’m not comfortable that we’ve got decent agreement on is the limitations of certain subject matter, blocking sort of strategies or other things, and I think we need to come to some kind of agreement where we could —


MR. ROTHSTEIN: — address that.

MR. HOUSTON: All I’m saying is could we take a break now —


MR. HOUSTON: — read the principles when we come back, decide whether they are reasonably complete, and we can delve into specific issues with regards to things like that, because that really is part of the core principles for us.

MS. BERNSTEIN: That issue — whether they’re reasonable and complete. I mean, I think I’ll over the break, you know, pluck ’em out. But I want you guys to think about: Are there other topics that we haven’t yet discussed?

MR. ROTHSTEIN: The whole essence of this is to support Section B. We’ve got lots of principles already embedded in C, D and F that we don’t necessarily have to revisit. This is to support B.

MS. BERNSTEIN: Which is about —

MR. ROTHSTEIN: This is disclosures, collecting —

MS. BERNSTEIN: — collecting and compiling.

MR. ROTHSTEIN: And so how about if we break till 3:20, and then we’ll go from 3:20 to 4, and then move into tomorrow’s testimony?


MR. ROTHSTEIN: Okay, Maya.

MS. BERNSTEIN: Not in perfect order, but what I guess what we should do is, thumbs up or thumbs out, if this is (?) at this point. I just put down everything that I thought might be a principle.

MR. ROTHSTEIN: How many principles do we have?


MR. HOUSTON: Oh, I didn’t think it was that high.

MS. BERNSTEIN: I didn’t think so, either, but some of them might be just slight variations or whatever.


MS. BERNSTEIN: Patient information should only be accessed based on a bona fide, good faith need to know.

MS. GREENBERG: Would you repeat that?

MS. BERNSTEIN: Patient information, individually identifiable, should only be accessed based upon bona fide, good faith need to know.

And systems to support that need to know should be established. That’s the second one.

Protected health information should be equally protected whether it resides with a covered entity, a business associate, or any other party. Which is already in D.


MS. BERNSTEIN: In Section D.

Okay. Entities can enter into private agreements with patients.

Consumers should have some measure of control or meaningful — this is the one we’ve been talking about — consumers should have some measure of control or meaningful choice over whether their patient information is in the National Health Information Network.


MS. BERNSTEIN: Or, over how information is used and shared — you could say more generally, if you don’t want to specifically say NHIN.

And we have the two considerations about opt in versus opt out and how — what does meaningful choice mean.

The NHIN process from the consumer’s point of view has to be as simple as possible.


MS. BERNSTEIN: NHIN should be —

MR. HOUSTON: Isn’t that specifically related to opt in versus opt out?

MR. ROTHSTEIN: No, it’s overall.

MR. HOUSTON: Okay, I got it, okay.

MS. BERNSTEIN: NHIN should be minimally burdensome on providers or as many as — how did I want to say this? — on providers or others as possible. Should be minimally maybe isn’t the right word, but —

DR. TANG: That’s under simple to —

MR. ROTHSTEIN: Simple for everybody.

DR. TANG: For everybody.

MR. ROTHSTEIN: Simple and minimum cost, too —


MR. ROTHSTEIN: — because you could have simple and very expensive.

DR. TANG: Right.

MR. ROTHSTEIN: Just say the last two, whatever.

MS. BERNSTEIN: Okay. Burdensome meaning cost, administrative details.

Let’s see. A patient should have the right to information about who has gotten access to their records in the past. I’m going to clean up the actual language, but that’s it.

DR. TANG: To their records?

MS. BERNSTEIN: To who has gotten access to their information.

DR. TANG: Through NHIN.


DR. TANG: So what you’re trying to say is —

MS. BERNSTEIN: Mark is leaning back in his chair thoughtfully, which is why I’m paused. [Laughs.]

MR. HOUSTON: These recommendations are related to NHIN, so I think —

MS. HORLICK: Do we want to say “in the past?” I mean —


MS. BERNSTEIN: I haven’t gotten to the next one, which is —

MS. HORLICK: I mean, it’s just generally —

MS. BERNSTEIN: Prospectively.

MR. ROTHSTEIN: Justify saying that with regard to NHIN when they don’t have that right now which regard under HIPAA.

MS. HORLICK: I’m thinking the same thing.

MR. ROTHSTEIN: They don’t have that right under HIPAA —

MS. BERNSTEIN: They do have that right under HIPAA.

MR. ROTHSTEIN: — for treatment disclosures.

MS. BERNSTEIN: Well, not for treatment, but the assumption is anywhere you got treated, they got your record.

MR. HOUSTON: This is the enhancement for NHIN. I mean —

MR. ROTHSTEIN: I don’t want to be in the position of taking, you know, patient rights away, but if you want to give them —


MR. HOUSTON: By the way, if we’re not consistent, I mean, we might as well do any of this if it’s consistent with HIPAA.


MR. HOUSTON: The point being is I think this is an additional enhancement we thought was necessary to improve patient confidence in the NHIN, was to say there needed to be some type of accounting capability —

MR. ROTHSTEIN: How about if you say, instead of saying through the NHIN, saying beyond the network or beyond the entity or treating entity, something like that? Then I think that would be —

MR. HOUSTON: Right. Because that’s the implication, yes. That’s the intent.

MS. BERNSTEIN: Beyond — but then we have the question of —

MR. HOUSTON: What is it?

MS. BERNSTEIN: — what is the thing? You always have that problem. Is it the provider, your treatment — what did you call it?

DR. TANG: Treatment entity.

MR. HOUSTON: You could argue at least as a way we define covered entities under HIPAA. It would be sort of the covered entity though we’re talking about wanting to extend past.

MS. BERNSTEIN: You know, you could say that you want people to be able to get access to who has the record for treatment. Just because it isn’t allowed by HIPAA now, you could decide to recommend it.

Maybe patients should see. Because it’s a way of auditing whether the right people got it for the treatment

that I know I got. If somebody else said they got it for treatment because they’re a nurse on the staff but in fact that’s not somebody I know should have gotten it.

MR. ROTHSTEIN: I don’t know what that would do in terms of a burden to —

MS. BERNSTEIN: It would be more burdensome.


MS. BERNSTEIN: That’s all.


MS. BERNSTEIN: You recommend the —

MR. ROTHSTEIN: It would solve the ex-wife problem, the next door neighbor, the whatever. Okay.

MS. BERNSTEIN: Okay, what?

MR. ROTHSTEIN: What’s next?

MS. BERNSTEIN: Okay, you want me to say this? Now it says patients should have the right to see who has gotten access to their records — who has gotten access through the NHIN, yes? — to their record. Is that what you wanted to say?

DR. TANG: To the record through the NHIN.

MS. WATTENBERG: Access to their record through the NHIN.

DR. TANG: It is a point that you’ve increased the burden tremendously.

MR. ROTHSTEIN: Okay, next?

MS. WATTENBERG: But you increased the burden.

MS. BERNSTEIN: The patient should have the right to see and inspect to whom they have given permission for future disclosures. The patient should have the right to see the list of persons to whom they have given permission for future disclosures.

MR. ROTHSTEIN: Does this mean by becoming a part of the NHIN, you need to know who you’re authorized to —

MS. BERNSTEIN: I want to be able to say —

DR. TANG: But how could you enumerate all those people?

MR. HOUSTON: No, no — it could be in classes. You could say, all providers, all this. If it’s an opt out, by default, if you don’t opt out, then you might say for treatment purposes, any provider — somehow you’ve got to know who you —

DR. TANG: Just the HIPAA list, the TPO, plus all the other characters.

MR. HOUSTON: But the point is you could opt out with certain things about others. You could be able to go back and query that to see what you actually permitted, who you permitted access to.

MR. ROTHSTEIN: So you’re allowing people to do a check list? Is that —

MS. BERNSTEIN: If I say I don’t want, you know,

the Mayo Clinic to have my record, I should be able to —


MS. BERNSTEIN: — in the future see that I said that. That’s all he’s saying.

DR. TANG: No, you can’t get everybody in the country. You can only say that I’m going to be on that record locator service or not. So that principle has a high cost.

MS. BERNSTEIN: You’re making an assumption about this principle that I don’t think is there. All we’re saying is whatever permissions I have —


MS. BERNSTEIN: — given, I can see that list. How else do I change it? The next one is I get to change my list.

DR. TANG: Okay. Well, I’m just saying that the principle that I would say, it’s sort of an all or nothing deal. It’s almost like the —

MS. BERNSTEIN: Everybody gets to see it or nobody gets to see it?

DR. TANG: Everybody who has a legitimate need to know can see it, or it is blocked.

MS. BERNSTEIN: Wait — in your example before from your practice, if I go to your practice, my record goes anywhere within your practice there, whatever you called it, your governing board.

DR. TANG: Well, we have policies and we’re responsible for enforcing them.

MS. BERNSTEIN: Right. That’s not on my list, okay? But when I go to specialists in Governing Board 2, I have to sign something that says you can share my information with Governing Board 2, right? Some other governing board, okay?

Next week, I want to come and see that I have permission for Governing Board 2 where my allergy specialist is. I get to see the list that I —

DR. TANG: Oh, I see.

MS. BERNSTEIN: That’s all I’m saying, is that I can see to whom I’ve given permission.

DR. TANG: Okay, so —

MS. BERNSTEIN: If I’ve opted out, if we have opt outs, to whom I have said no.

MS. GREENBERG: I didn’t think you ever had to give permission for treatment.

MR. ROTHSTEIN: This is the system of the future.

MS. BERNSTEIN: We’re not talking about HIPAA. We’re talking about —

MS. GREENBERG: No, I know.

DR. TANG: We’re taking all the efficiencies that HIPAA tried to look out for and trashing them.

MS. BERNSTEIN: Well, not necessarily, but —


MS. BERNSTEIN: It’s not saying anything about — as I understand this principle, it’s not saying anything about whether or not we should have opt out or how; we’re just saying that if there is a list of opt ins and opt outs that I personally made, I can see my list. I change my list, that’s the next one.

MR. HOUSTON: I thought the whole concept here was that we didn’t feel compelled with regards to HIPAA. I mean, we shouldn’t feel compelled just to strictly abide by HIPAA, that we’re going to make what we thought were reasonable recommendations in support of an NHIN that we thought to be reasonably adopted.

And I think some of them have to relate to the concept of more granularity and opt in and opt out.

At least if we decide to do that, then there needs to also needs to be the mechanism to track the opt ins and opt outs so that somebody can make a decision of informed change and what they’re opting in and out of. And that’s what this supports.

MR. ROTHSTEIN: Harry was waiting.

MR. REYNOLDS: Have you got to mending the patient option as to Google theory, where if you’re in NHIN and everybody can get it?

DR. TANG: No. If you opt in, then you’re in the white page directory. And someone who — this record locator service, for someone who has a need to know that information, then you have to solicit this service from someone; that person can look at the white pages directory and go get your information.

MR. HOUSTON: Now, that sort of runs contrary the first recommendation. I know Marjorie found it sort of strange, that first recommendation, who the white paper was.

And there was a big debate at the time over do we allow patients to decide to block information from being accessible? You know, so the patient would decide versus the covered entity, putting appropriate protections in place to insure that only individuals who had a need to know could actually see it, because there was some disagreement as to, you know, whose role that was, and we decided overall that there needed to be appropriate access.

But I think, you know, this is — what you were just saying, Paul — my fear is that it does sort of run contrary to, I think, the Subcommittee’s thoughts that there needed to be some level of proscription or protection here.

And what you were sort of saying is that you subscribe, you’re sort of in. And that would go contrary to blocking.

DR. TANG: The white page analogy is you can un-list yourself. You can de-list yourself.

MR. HOUSTON: Yes, but from everything.

DR. TANG: From people knowing that you even had transaction with this treating agency.

MR. HOUSTON: But I think the thought was that there either needed to the ability — again, the two sort of camps were that the patient has the right to specifically block types of information from specific individuals or entities or, in the alternative, what I had proposed at one point was that no, you make sure that the entities recognize that they need to provide role-based access and contextual access to insure that only appropriate individuals have the right to see the information associated with the patient so that the patient confidence is higher.

But there’s one or two. It means we’ve either got to come down on one side or the other.

MR. REYNOLDS: So is the hierarchy you’re either in or out —

DR. TANG: Right.

MR. REYNOLDS: If you’re in, you can block, and if you block, it’s obvious that you blocked.

DR. TANG: No, you’re either listed — your record locator system says service or not.

MR. REYNOLDS: You’re in or out.

DR. TANG: You’re in or out.

MR. REYNOLDS: Yes, right.

DR. TANG: But then you have the block thing.

MR. REYNOLDS: Well, I’m going to the hierarchy. So once I’m in —

MR. HOUSTON: No, the point being is you’re either in or out. But the two methods that we discussed for insuring that provision of data was appropriate was the patient can decide who to block. Or the other alternative was that we heavily rely upon a role and contextual access scheme which provides appropriate protections to insure that only appropriate individuals ever get data.

MS. BERNSTEIN: Wait — I didn’t understand that those were two separate things. I thought the two things could be in the same system.

MR. HOUSTON: They could be in a mix, but I was arguing heavily for the latter, which I think blocking is a flawed scheme.

But I think blocking specific data elements — I could see — well, I don’t know; I guess we’re —

MR. ROTHSTEIN: Okay, can we hear the rest of the list?

MR. HOUSTON: I’m closer to Paul’s philosophy.

MR. ROTHSTEIN: Oh, no. Think it over again.

MS. BERNSTEIN: Okay, so we were on eight, which was a patient should have the right to see who has gotten to their records through the NHIN.

And nine, patients should have the right to see to what parties they have given permission for access or to whom they have forbidden access through the NHIN.

Should we adopt those kinds of policies, right? I mean, the presumption is not that such policies would exist, but to the extent they do that you can see the lists.

MR. ROTHSTEIN: Yes, but that makes an assumption that we’re agreeing that you should be allowed to do that and some people may not have agreed to that, so —

MS. BERNSTEIN: Okay, so —

DR. TANG: You’re right that you have to enumerate those people that you’ve granted access to. It’s like you have an NHIN function that says, you know, here’s the (?) I have, so, yes, you couldn’t know who you signed over otherwise.

MS. BERNSTEIN: If you’ve given affirmative permission —

DR. TANG: Correct.

MS. BERNSTEIN: — you should be able to see the list of affirmative permission.

DR. TANG: Right.

MS. BERNSTEIN: And we haven’t decided yet —

MR. ROTHSTEIN: See, we can finesse this without going into detail. You know, we can just say individuals should have the right of access to review all the terms and conditions of their entry into the system, record locator system, whatever we want to call it, and that doesn’t pass any judgment on whatever —

MR. REYNOLDS: I can support that.

MS. BERNSTEIN: So, individuals should be able to review and access the terms and conditions of their entry —

MR. ROTHSTEIN: Of their — yes.

MS. BERNSTEIN: — participation —

MR. ROTHSTEIN: Participation in the system.

MR. REYNOLDS: So they can get in when they want and out when they want.

MR. ROTHSTEIN: And that way, we won’t have to say what they can do.



MS. BERNSTEIN: Well, I was sort of making myself a side note here which is: Should other people have access to see what permissions you have given?


MS. BERNSTEIN: Well, some people need to see that list to carry out their — right?


MS. BERNSTEIN: So until they try to access — I mean, your doctor might need to know I never want my information going to my ex-wife —


MS. BERNSTEIN: — so they have to see that list, or the custodian of the record. But other people, until they try to access the record, might not need to see that list, right? I mean —

MR. ROTHSTEIN: Well, you know, just put that down as kind of a —

MS. BERNSTEIN: Consideration, right?

MR. ROTHSTEIN: I really want to get to the blocking.

MS. BERNSTEIN: The blocking — we haven’t reached agreement. It’s the last —

MS. BERNSTEIN: We have 15 minutes.

A patient must have the right to change permissions given — that is, revoke choices earlier made.


MS. BERNSTEIN: Different generational population, cultural, religious, whatever, differences should be accommodated.


MS. BERNSTEIN: I’ll work out the language.

The provider should be held accountable for mis — you know —

MR. ROTHSTEIN: Well, we’ve got a section on enforcement.


MR. REYNOLDS: It’s not just the provider.

MR. ROTHSTEIN: It’s anybody else who violates the — should be made to sit through these meetings.


MS. BERNSTEIN: The NHIN cannot be imposed on the public. There must be education about the risks and the merits and — we put this in there somewhere. People must be convinced of its merits.

MR. ROTHSTEIN: Yes, that’s on page —

MS. WATTENBERG: What does that mean, it should be imposed, though?

MR. ROTHSTEIN: Well, it should be mandatory, you can’t get out, you’ve got no choice, you’ve got — you know, that sort of.

MS. WATTENBERG: That’s what I thought. The main part of that sentence makes it sound like you’re talking about the term mandatory/voluntary.

MS. BERNSTEIN: Well, what it’s saying is instead of imposing it on the public as a mandatory condition of your care, there should be public education about the risks and merits and the public must be convinced of the merits of the system.


MS. BERNSTEIN: Right? Some sort of study or pilot should be undertaken to evaluate the different mechanisms for enrolling individuals and how and to what degree those mechanisms work.

MR. ROTHSTEIN: That would be — could be part of the statement of — sort of the non-statement of in or out, right? We’re finessing the opt in/opt out and that could go — that it needs more study.


MS. HORLICK: Let me just ask you a question. When you say “education” — I’m backing up one — about the benefits and the risks, are we really saying that we actually want to educate people about the risks? I mean, think about it.

I mean, really what you’re trying to do, I think, is educate them about the benefits because you believe it’s a good thing. I’m not saying that — I mean, how do you educate people about the risks? I mean —

MR. ROTHSTEIN: Well, actually it’s not the risks so much as the way the system operates. It’s not the risks; it’s the nature —

MS. HORLICK: Well, that’s different, okay.

MR. ROTHSTEIN: — of the disclosure. And if you’re uncomfortable —

MS. HORLICK: No, I think that’s different.

MR. ROTHSTEIN: — with the disclosures.

MS. HORLICK: Okay. Totally that’s different, okay.

MR. ROTHSTEIN: It’s the nature of the system.

MS. HORLICK: Right. And then they can ask questions and make choices.

MR. ROTHSTEIN: And they’ll draw their own conclusion —


MR. ROTHSTEIN: — about whether it’s a risk or a benefit.

MS. BERNSTEIN: I’ve sort of made something about our working assumption is, you know, providers will ask for information that is necessary to treatment and senders of information will send what is reasonable in response to those requests, right? So that’s — our going assumption is that people are going to behave properly, right? It’s not a huge —


MS. BERNSTEIN: I mean, I don’t know what that means, exactly. We still enforcement.

MR. HOUSTON: We had talked in the context of what HIPAA says today. And I know HIPAA is not necessarily the benchmark, but HIPAA says today that providers should ask for what they need and that the provider who’s being asked for the information can rely upon the information request as being what is necessary for treatment.

So there’s some reliance by the —

MS. BERNSTEIN: Custodian of the record?

MR. HOUSTON: Yes, the custodian, thank you. I was trying to think of how to phrase that.

MR. REYNOLDS: Isn’t the real term “minimum necessary?”

MR. HOUSTON: Yes, but I mean if I ask —

MR. ROTHSTEIN: But if Provider A —

MS. BERNSTEIN: Has to rely on what you tell me — that’s what he said.

MR. HOUSTON: If Provider A asked Provider B for a record about a patient, Provider B can rely what A is asking for is what A needs. That’s what HIPAA says. So that doesn’t have to by any analysis: Well, do they really need this information? No, it’s assumed to be what’s necessary.

MS. BERNSTEIN: Something obvious about it that you should have it.

MS. WATTENBERG: It does have to be reasonable.

MS. BERNSTEIN: Right, it’s reasonable. So it has to exercise some judgment about the kinds of requests. That’s excellent.

MR. HOUSTON: If it seems unreasonable —

MR. ROTHSTEIN: That’s for this one. Okay —

MS. BERNSTEIN: That’s 14.

MR. ROTHSTEIN: — so we need to phrase some sort of blocking principle and this is not ready for transcription language. I mean, we need to get across the idea that a patient should have some control, some choice, to exclude certain sensitive matters from their records and —

MS. BERNSTEIN: You mean records that are transmitted over the NHIN.


MR. REYNOLDS: Can I ask you a question? If the NHIN — Paul’s institution will keep their records, John’s will keep theirs, and then the person will make the records available.

So they’re not going to modify their records. Those are their records. It’s the patient’s information but it’s their record, okay? Because that’s what they did, okay?

Okay, so now there’s a difference when the record is a PHR, something owned by the member. So now we’ve got a situation where is the patient going to be able to go in and block what is already part of his record when he sends it to Paul? Because then that changes his record which he is the custodian of.

MR. HOUSTON: You don’t have PHRs —

MR. REYNOLDS: The NHIN, through the NHIN, in other words — once I’m out there in magic cyberspace, whether I’m a PHR, EHR or what I am, I’m going to have a record locator philosophically —


MR. REYNOLDS: — a record locator service. And it’s going to say Paul saw me, John saw me, you saw me, and Gail saw me. So then I want to pull it in.

Well, it’s in part of John’s if I was in there for something and then I have some psychiatric occurrences while I was in there, so I had this and then I had this. How can I go into John’s record? I mean, there’s no mechanism. How can I go into John’s record?

MS. BERNSTEIN: Well, John’s going to transmit you his record, but he’s not going to transmit you the psychiatric part.

MR. REYNOLDS: But how do I — I mean, back to —

MR. ROTHSTEIN: Let me make a suggestion as to the contour of this discussion.

I think this is another area like opt in/opt out where it’s a snake pit for us to get into too many details.

DR. TANG: Right. I agree.

MR. ROTHSTEIN: So how about if we try to reach agreement on sort of the high level principle that patients should have some ability to block certain kinds of information from disclosure through the NHIN and then discuss the consequences of doing that, the pluses and minuses that, in devising any system to promote patient care, providers should — a possibility would be that providers be notified that there is information that has been blocked, that decision support should run the need to block information, that information should perhaps be blocked in only certain designated classes like substance abuse, reproductive health and so forth?

MS. BERNSTEIN: Say that again —

MR. ROTHSTEIN: Well, I’m just —

MS. BERNSTEIN: No, but I want to capture these considerations.

MR. ROTHSTEIN: What was the last thing I said?

MR. HOUSTON: Substance abuse.

MR. ROTHSTEIN: Substance abuse, reproductive health.

MS. BERNSTEIN: But the question I have is: Are you saying that only designated classes should even be eligible for blocking?

MR. ROTHSTEIN: But that’s a consideration.

MS. BERNSTEIN: Right, okay.

MR. ROTHSTEIN: I’m not saying that. That’s a consideration.

MS. BERNSTEIN: Right. Is there some information that should never be blocked?

MR. ROTHSTEIN: And also something that is a consideration is the effect on — we said on adequate patient care.

We also need to mention the liability issues, need to be addressed, but you can’t have people liable for not doing stuff that they couldn’t find, that wasn’t in the record, and stuff like that.

MR. HOUSTON: Well, there’s a couple pitfalls with this.

I mean, first of all, I think that if you’re going to block information is counter-intuitive than to say that you’re going to do clinical decision support on data that’s being blocked and never sent. That’s a real problem.

MR. ROTHSTEIN: They did that. That’s what they did in Denmark.

MR. HOUSTON: No, no, no. You’re assuming there’s a repository-based solution for which you can —

DR. TANG: Which they do have in Denmark.

MR. HOUSTON: Right. And what I think we’re talking about here is a different — all the models I’ve heard is a different —

MS. BERNSTEIN: Well, you can do drug interaction stuff even if you can’t see what the drugs are.

DR. TANG: But what do you say — there’s something wrong here? How can you —

MS. BERNSTEIN: This drug shouldn’t be prescribed.

MR. HOUSTON: What happens here is this is all predicated upon the receiving system getting the data to be able to perform the interaction to perform the clinical decision support.

MR. ROTHSTEIN: I’m the doc and I want to prescribe X and X pops up: “Don’t do this; there’s a drug interaction.” Now I call the patient in and say, “Listen, I wanted to give you X; this is the best thing for you, normally. But I have a drug interaction thing and I need to know what drugs are on or I can’t” —

You know what I think people are going to say? Well, all right, I’ll tell you?

MR. HOUSTON: I am disputing the need for clinical decision support. All I’m saying is that if the system is going to do things, for example, with clinical — I mean, if they’re going to do drug-to-drug interaction, the only way that can occur is if the data about what drugs the patient is on is actually transmitted to the system that’s going to be doing the clinical decision support.

My concern is based upon your scenario of blocking information. That data would never make it to the receiving system in order for the receiving system to do the clinical decision support.

MS. BERNSTEIN: Right, okay.

MR. HOUSTON: It’s an issue with the model that we’re talking about. It’s my only concern.

MR. ROTHSTEIN: I mean, let’s suppose — I mean, I’m not an IT person, but you would send encrypt — part of it would be encrypted, and you just couldn’t read it. It’s there, and the decision support could read the encryption but you couldn’t.

You would transmit the blocked information but you couldn’t see the blocked information.

MS. BERNSTEIN: Well, another choice is that you could transmit the fact that there is blocked information in a certain category and when you prescribe a drug, even if it can’t do the decision support that says for sure that there’s a drug interaction, it could say — it could give you a warning saying “there is blocked drug information; there might be a drug interaction here.”

MR. HOUSTON: The irony of this is going to be the patient is going to get to the pharmacy and the pharmacist is going to say, “You’ve got a drug-to-drug interaction because you prescribed these two medications.” And it’s going to be like — then it’s going to look pretty stupid that we this in NHIN and we can’t even figure out until we get to the pharmacy that there’s a drug interaction problem.

MR. REYNOLDS: Yes, I feel there are two premises. One, I’ll go back to something Paul said earlier.

One, if you’re in, you’re in. If you’re able to say, here’s what I’m willing to disclose it to, here I can see who I say I disclose it to, then if you’re in the NHIN, your base is in the NHIN. Okay, that’s one train of thought.


MR. REYNOLDS: Not voting for or against it, but that’s one school of thought.

The second school of thought gets into this blocking and all this special system work that goes in the background and for certain things does this and does that.

So, I mean, those are the two premises we’re talking about, I mean, and I can — so I guess if you go let somebody decide here’s who I’m willing — I’m in or out, and if I’m in, I get to say who gets it and I get to see who gets it, then if we truly believe in good medicine and good health, then I think going any further creates a situation that the end game complication means unless you get very prescriptive on the areas that you can block and how they’re communicated —

MR. ROTHSTEIN: But didn’t you say — I mean, at the very first —

MR. REYNOLDS: Yes, how he did it.


MR. REYNOLDS: But I’m saying — but that would have to be a standard that’s set.


MR. REYNOLDS: And remember, they’ve got one system, one process. They’ve got one thing and they clearly state it.

So I’m just saying — and when we get down to the premise, you’ve got really two basic things. You’re in all the way or if there is some blocking, it has to be a structured blocking so that it is consistent throughout the NHIN — remember, we’re talking about the NHIN; we’re not talking about Paul’s system and John’s system.


MR. REYNOLDS: So those are the two things, that I’d be willing to talk at those levels.

But if we just leave it so wide open and you can block and pull and tug and —

MR. ROTHSTEIN: Well, that’s why said —

MR. REYNOLDS: But I think both of those premises ought to be on the table —


MR. REYNOLDS: — because I just think that’s two distinctly different approaches, neither right nor neither wrong, in my opinion.

MR. ROTHSTEIN: That falls into the sort of the choice area that we have. I mean, if you’re flexible and have control, autonomy, that makes it more expensive, more complicated, and it’s a risk to health care.

MR. REYNOLDS: Right. So all I’m saying is if we’re going to have a premise, I would like both of those noted in the premise.

MS. BERNSTEIN: So Mark’s — did we skip somebody?

MR. ROTHSTEIN: It’s past 4 o’clock.

MS. BERNSTEIN: I’ll be quick. Mark’s statement was that the patient should have the ability to exclude certain types of information or categories of information.

There’s another way you could exclude, which is just to have control over who gets your information. If you decided to trust a particular health care provider, they get everything.

Otherwise, you don’t trust them and you shouldn’t be going to them if you’re not willing to give them everything, so that the control over how the information moves could be by person or provider but not by category of information.

You know, in my view, if I’m going to go to a doctor for treatment, they can see everything. If I’m not willing to show them everything, I probably don’t want to go to them for treatment, you know? I have other choices, right?

MR. HOUSTON: But the other option is, again what we went back to, you have role-based, contextual — the systems, the recipient systems, are designed so that there is both role- and contextual-based controls to insure that only people that really need to see that information —

MS. BERNSTEIN: But that’s different than what we’re talking about.

MR. HOUSTON: — get it. No, it isn’t, because at the end of the day, it’s getting the appropriate information in the hands of the individuals who need it in order to provide quality care.

And the problem is when you have a patient block or you try to put some other type of restriction in place to prevent data from flowing, what you end up having is you have an environment which is what you have today — you have incomplete information which leads to bad clinical decisions.

MR. ROTHSTEIN: Okay, I know what Paul thinks about this. I know what Harry thinks about this. I’m not sure what you’re saying. Are you categorically opposed to patient control in this way in terms of blocking stuff?

MR. HOUSTON: Yes. I believe that the mitigating control that you put in place is that you permit the patient to see who’s accessed his or her record.

DR. TANG: Don’t you think that would cause people to drop out?

MR. HOUSTON: No. What that would do is cause — if a person found that they had a concern over a specific individual looking at their information, what it would do is it would provide — it would have a deterrent effect because, you know, I’m your neighbor and I know you can see who looked at your record. I’m less likely to want to go into your record and look at it because I might be found out.

MS. BERNSTEIN: I think that’s true.

MR. HOUSTON: If I’m found out, then you’re going to go to my employer and say, “You know something? Why was my next door neighbor looking at my record?”

And then my employer is going to come back to me and say, “Why were you looking at that record?” You say, “Wellllll –“

And he’s going to say, “You’re fired.”

MR. ROTHSTEIN: Okay. And, Paul, your view is that you’re in or you’re out, right?

DR. TANG: I think Harry stated it very well in one of the alternatives and I support that view. Sorry, Harry.

And the other thing —

MS. BERNSTEIN: Wait — he gave two.

DR. TANG: The obvious one, which is basically you’re in or out and you say who can get it; those people can get it and get it all, and it’s used for your care.

MR. ROTHSTEIN: So you agree with John?

DR. TANG: That’s exactly right.

MR. REYNOLDS: And half of mine.

MR. ROTHSTEIN: One of your options.

MR. REYNOLDS: I put two on the table.

MR. HOUSTON: But my point is also coupled with the fact that there need to be — the entity that gets the data still needs to put in place role- and contextual-based systems to insure that they’re only providing appropriate information.

DR. TANG: One other point I was going to make was, interestingly, we have never raised it, I don’t think.

The way this happens on paper is you go say “I would like to transfer these encounters or dealing with this operation to that entity.”

That’s not a blocking strategy. That’s a permissive strategy. That’s a requesting, permissive. And we actually haven’t — that’s another option we haven’t discussed and it’s more positive in promoting and caretaking than it is blocking things.

MS. BERNSTEIN: But it seems that the default is that you don’t share unless you give that permission, and that’s an opt in. We have talked about that.

In that scenario, it would be if the model is positive/permissive, I give permission for you to see something, it implies that unless I give you permission, you don’t have the option.

DR. TANG: Opt in in the sense of I’m going to let myself be exposed on the NHIN for appropriate use.


DR. TANG: This ROI, release of information, says take this specific information, which could include the whole chart, and transfer it to that entity. And that’s different from saying block-block-block.

MS. BERNSTEIN: What if it’s managing by a RHIO?

DR. TANG: Well, I just wanted to —

MR. ROTHSTEIN: All right, here’s — I think I know where everybody is on this, and I’m trying to figure out what to say that will accurately capture our various viewpoints.

There is an issue of whether the patient should be able to limit the disclosure of some kinds of information through the NHIN.

Some of us feel that patients who are part of the system are in for the whole, everything, and some of us feel that people ought to be able to exclude certain kinds of information.

MS. BERNSTEIN: Well, I don’t know if there’s anybody who thinks we should be able to exclude your ex-wife.

MR. ROTHSTEIN: Well, that’s a separate issue, I think.

MS. BERNSTEIN: It’s a different way of exclusion.


MR. HOUSTON: But that’s covered.

MR. ROTHSTEIN: And everybody’s with me so far.

And then what I’d like to be able to say is the advantages of having people in for the whole everything are simplicity, a better health outcome, et cetera, et cetera, et cetera, and the advantages of giving people more choices is a greater public support, promotes autonomy, encourages people to go to doctors when they’ve got sensitive information they might disclose.

Is that acceptable to everybody?


MR. ROTHSTEIN: Because I don’t know what more we can say.

MR. REYNOLDS: And we have one byline.


MR. REYNOLDS: If the second one is selected, what I’m hoping, the second one is selected, there are already processes in place in the health environment that would be outside of that (?).

A good example is if you go to a pharmacy right now, you may have said on the NHIN, I’m holding stuff back. You go to a pharmacy, they go to the PBM, you authorized all that stuff going to a PBM and when it comes back down to the pharmacy, there it all is. So I’m running around at the NHIN — so I blocked it on the NHIN but —

MR. ROTHSTEIN: Now I’ve got Prozac as a —

MR. REYNOLDS: It’s showing up to the pharmacy.

So all I’m saying is we’ve got to be careful that we also take into consideration already existing processes that people, whether they know it or not, have bought into and actually say do it.

So on all of these, whatever we decide on any of this stuff, and I think going forward is going to be hard because there’s a whole lot of stuff whether it’s HIPAA, HIPAA privacy, HIPAA transactions, code sets, e-prescribing, everything. And we’ve all been involved in e-prescribing.

In e-prescribing, one of the main pluses of e-prescribing is the doctor gets to see downloaded to their PDA all of your drugs so they don’t hurt you, okay?

So those are the things that I’m not — so I’m not throwing water on either one of them, but we are also putting things in place. So how we mesh these I think is at least worth a comment, that once we decide whatever we decide, it needs to be laid over top of the other things that have already been agreed to, whether it be e-prescribing and some of this other stuff so that we make sure that there is a synergy because I’d hate to tell a patient —

MR. ROTHSTEIN: We’re letting you block it over here but —

MR. HOUSTON: I said it this morning — I agree.

MR. ROTHSTEIN: Maya, do you have anything approaching that?

MS. BERNSTEIN: Not even close. [Laughs.] Wait, wait, wait.


MS. BERNSTEIN: Harry’s point is that — you were saying you need to take into account already existing processes like the sharing of information among PBMs, electronic prescribing, whatever, because —

MR. ROTHSTEIN: And you might want to give an example, that you could block your mental health records but if you had a prescription filled for an SSRI, then the PBM would know, the payer would know —

DR. TANG: And the doctor may know.

MS. HORLICK: Do you think most people are worried about their doctor knowing their other medical history or other people?

MR. REYNOLDS: It doesn’t matter. But if we accept the premise, we’ve got to make sure that we’re consistent —


MR. REYNOLDS: — that they understand what they got into.

MR. ROTHSTEIN: Or even not necessarily that we’re consistent, but we recognize that there are sort of loopholes even if we —


MR. ROTHSTEIN: — try to protect it.

MR. REYNOLDS: That’s what I think we’re saying.

DR. TANG: Which is sort of why I wasn’t being facetious when I talked about let’s assume we believe such-and-such is good and let’s figure out how to make good easy to do, not burdensome, and to try to prevent, deter and punish the bad parts of harm.

I really think, again, if we somehow embrace that, we might actually come to a different set of rules that are easier to explain and easier to implement. So that’s just sort of a parting shot.

MR. ROTHSTEIN: Well, Marjorie?

MS. GREENBERG: I tend to think you’re right, but I guess this is going back now to the last time I was with this group, which was a few times ago because I wasn’t around the last — I was out of town I think the last time you met.

I think there also has to be a recognition that there is a probably a minority of people, maybe a small number of people, but nonetheless they are there, who put a very high value on their personal autonomy and privacy and who do not share this view that you articulated and that some procedures or methods — I don’t know what the word is — approaches, some approaches need to be seriously considered to address their concerns.

DR. TANG: Well, the point of it was try to make what we think is a good thing easy and unburdensome to do. But we can’t address those corner cases because there are so few people who want to exercise that right.

MS. GREENBERG: There probably are relatively few, yes.

MR. ROTHSTEIN: But I think there would be more who would exercise that right if we don’t give them enough escape hatches.

MS. GREENBERG: And there are more — and there are those who’d want to exercise the right and then there’s a larger number who would want people to be able to exercise that right even though they might not exercise it.

MR. ROTHSTEIN: Exactly, exactly.

MS. HORLICK: Even if they don’t use it? Is that what you’re saying?

MS. GREENBERG: Yes, right.

DR. TANG: And for the special cases where they want —

MS. GREENBERG: And that others have the choice.

DR. TANG: — the autonomy, they could just turn on the brakes and every provider who touches them will do that. And that actually — the percent that’ll do it, just like in Denmark, will be vanishingly small, once we have done an adequate job of educating the general public, not individuals which opt in would require, about the benefits of that, just like the benefits of not beating —


MS. BERNSTEIN: If you accommodate those people, if your goal is to accommodate those people, that’s different than saying we think that the system is good and benevolent and we’re going to try to make it as — you know, reduce the harm as much as possible and to increase the simplicity as much as possible.

DR. TANG: Right.

MS. GREENBERG: You owe that to everyone.

MS. BERNSTEIN: Right. But the assumption of those people is that the system is not benevolent and good and I want out, but there is a complexity for that small group. The complexity comes from making choices for the small part of the population that doesn’t like what we’re doing.

DR. TANG: It depends on how you make that choice, right? So the opt out — so that’s — how did you say that? I really liked what you said, doing good for everybody.

MS. GREENBERG: Well, I said what she said you need to do is really you have to do that for everybody.

DR. TANG: Yes, have to do the good for every —

MS. GREENBERG: It’s not that — because I don’t think the majority of people just think this is wonderful.

DR. TANG: Right.

MS. GREENBERG: But I think with appropriate information and with concern about their health care and that of their family, they’d probably go for it.

DR. TANG: So the way we would do that, Maya, is not that expensive. It would be costly to — individually costly for people to handle that particular patient, to break the glass, switch on for that patient.

So everybody would have to break the glass to touch that patient. So that patient gets special consideration. But fortunately, there are very, very few of those, based on history.

MS. BERNSTEIN: Yes, I understand that.

DR. TANG: And that isn’t too costly to do that kind of a thing.

MS. BERNSTEIN: Well, it’s costly to create those possibilities. If we didn’t have any of those people —

DR. TANG: Right.

MS. BERNSTEIN: — you wouldn’t have to create —

DR. TANG: No, we always have to have a break-the-glass. So that’s just part of the system.

MS. BERNSTEIN: Your break-the-glass is something missing that we’re talking about.

MR. ROTHSTEIN: You’re making an assumption that you always have to have the break-the-glass.

MR. HOUSTON: I think you do.

MR. ROTHSTEIN: I don’t want you to break my glass.

MS. GREENBERG: I thought that Paul said there always will be some people who will want you to want their information kept private.

DR. TANG: Exactly, yes.

MR. ROTHSTEIN: But he’s saying there has to be a rule in place that even as to these people, there is always a break-the-glass option that they can get information that people want —

MS. BERNSTEIN: No, you don’t. That person has the right to take a risk and say, in an emergency situation when I’m unconscious and unable to sign, I take the risk that I’m going to die in that situation.

MR. ROTHSTEIN: And I wear a bracelet that says —

MS. BERNSTEIN: Do not resuscitate.

MR. ROTHSTEIN: — any treatment, leave me alone.

MS. BERNSTEIN: You know? It’s a —

MS. GREENBERG: Like in the hospital, where the hospitals have to at least stabilize somebody or something, I don’t know.

MS. BERNSTEIN: They’d be doing it without information. That’s what we have today.

MR. HOUSTON: Let me ask another philosophical question here, because where we’re going is twofold.

One is you’re dealing with a standard of care issue and you’re also dealing with increased liability. You’re also dealing with an increased cost, potentially. And, you know, other similar types of things.

If people decide to opt out of this environment — maybe this is out of the scope of what we’re talking about — is there also going to be some burden upon these individuals maybe that they have a higher insurance rate or they have —

MS. BERNSTEIN: It could be. I mean, they certainly take higher risks in other things.

MR. HOUSTON: Because, you know, there’s some liability, limitation of liability because — you know. There’s all sorts of inherent risks now.

MS. BERNSTEIN: I don’t understand why people are so focused on the liability thing. I mean, if you didn’t know it and you had no way of knowing it, how could you be liable for it?

You should treat them according to the standard of care.

MR. REYNOLDS: I don’t think it’s important to push it on people who are serious about it. We’re all trying to keep it above —

MR. ROTHSTEIN: Okay, now —

MS. BERNSTEIN: No, no, no. But I’m saying — okay. We don’t have to get to that point.

MR. ROTHSTEIN: — I think that I’ve got enough information from Maya’s notes that the two that I think — the two principles that we struggled with that I think we can get forward — actually, it’s sort of one and a half — we agree on the initial choice that people should have an opportunity to decide whether they want to be in the system somehow, and the second is we’ve talked about, but have not reached any sort of consensus, on the issue of whether people should be able to withhold certain kinds of information from inclusion in the records and the reasons in favor of not allowing them to do it are X, Y and Z and in favor of allowing them to do it are A, B and C.

PARTICIPANT: Not just in your office, but in the whole NHIN.

MR. ROTHSTEIN: So I think we can —

MS. BERNSTEIN: You have that choice now. You tell your doctor not to put it in the record, it’s not on the record.

MR. ROTHSTEIN: It has to do with transmission through the NHIN.

So I think we’re okay. I mean, you’ll get ten

chances to see anything we come up with. But personally I feel that I’ve got enough to set out those arguments, use the others to sort of fill in the gaps. Some of them we’ve already set out in other sections.

Is there something else that we need to do before getting to tomorrow?

MR. REYNOLDS: To the second one, if you would just add that harmonization I mentioned —


MR. REYNOLDS: — between what we would tell them in NHIN versus what’s going to happen to them in other environments. That’s that harmonization.

MR. ROTHSTEIN: Right. So we could put even if we went for the block —

MR. REYNOLDS: There you go.

MR. ROTHSTEIN: — people should realize —

MR. REYNOLDS: I’m good with that, because that’s full disclosure.

MR. ROTHSTEIN: Okay, let’s think about tomorrow and then we’ll have a few words to say about what we’re going to do Thursday morning at our meeting. John?

MR. HOUSTON: Are you the only person on the Security Subcommittee out of this group?

MR. REYNOLDS: Yes, Standards and Security, yes.

MR. HOUSTON: The reason why I asked that question, and I know it’s excluding you, but I noticed when we looked at —

DR. TANG: Secondary uses.

MR. HOUSTON: No, no — when we look at the schedule for these meetings, there is a hole in the schedule for some of us between 3:30 and 5. At least I’m on an NHII. I know, Mark, you’re probably done.

MS. GREENBERG: We’ve had this discussion, I think.

MR. HOUSTON: There’s a hole there. Is there any practical value in us trying to meet as an at least — and I understand, Harry, you won’t be there, but is there any value for some of us to meet for a couple of hours?

MR. ROTHSTEIN: Tomorrow afternoon, in addition to Thursday morning, is that what you’re saying, John?

MS. GREENBERG: The three of you I guess is what he’s saying.

MR. ROTHSTEIN: Are you saying in lieu of or in addition to Thursday morning?

MR. HOUSTON: In addition to Thursday. I’m just thinking whether there’s anything practical for us to do. There is an hour and a half which we can do things in if need be. Well, I can just go to Standards and Security.

DR. TANG: Is there a reason why we can’t hold the NHII?

MS. GREENBERG: Why you can’t what?

DR. TANG: Hold the NHII from 3:45 to 5.

MS. GREENBERG: Oh, yeah. There’s a lot of overlap.

MR. HOUSTON: Okay, yes, that’s reasonable.

MS. GREENBERG: I don’t even have to look, I mean — you’ve got several people from Standards on the NHII.

MS. BERNSTEIN: Your presentation on this is tomorrow afternoon, is that right?

MR. ROTHSTEIN: 1 to 2:15.

MS. BERNSTEIN: Tomorrow, and not Thursday?

MR. ROTHSTEIN: Tomorrow.

DR. TANG: Correct.

MR. ROTHSTEIN: But we’ve also got our Subcommittee meeting between 8 and 9:50 on Thursday morning.

So we need to figure out — how about if we talk about what we’re going to do tomorrow from 1 to 2:15 and then the last thing will be future meetings?

MR. HOUSTON: Okay, because if it makes sense to meet tomorrow, I’m going to —

MR. ROTHSTEIN: Okay. Well, we’d have to decide what we would talk about and so on.

MS. GREENBERG: This would be completely kind of informal, okay?

MR. ROTHSTEIN: No, but because we didn’t publish it?

MS. GREENBERG: Well, we haven’t published it.

MS. BERNSTEIN: We’re not required to —

MS. GREENBERG: We don’t have the facilities to transcribe it. We — you know.

MR. HOUSTON: Someone does a bad thing, we don’t know!

MS. GREENBERG: We don’t have a room for it.

MS. BERNSTEIN: We’re not required to publicize it or transcribe it. We’re a Subcommittee and not the Committee.

MS. GREENBERG: That’s true, although it is our habit to do so. But I would see it —

MR. ROTHSTEIN: As an important discussion.

MR. HOUSTON: So, Marjorie, what you’re telling me is I’m doing a bad thing by proposing it?

MR. ROTHSTEIN: Well, we’re going to meet two hours —

MS. BERNSTEIN: Meet in a half an hour!

MS. GREENBERG: If it’s the three of you want to go up to the cafeteria and discuss these things with Maya, I mean, you’re — if Maya has a room that you can meet in, fine, but I wouldn’t consider it even — any — an official meeting.

MR. ROTHSTEIN: We might actually have a drafting session to try to put this in —

MR. HOUSTON: That’s what I meant to say.

MS. BERNSTEIN: Did we actually give up that conference room, or no?


MS. BERNSTEIN: If we didn’t, hah, we have a room!

MR. ROTHSTEIN: — how about if we move to tomorrow?

You’ll see that we’re on the schedule between 1 and 2:15 and —

MS. GREENBERG: Actually, the fact that it wasn’t publicized is not important because the whole Committee meeting was announced. It’s just that I’m saying that it can’t — certainly can’t be transcribed because we don’t have the facilities to do that.

MR. ROTHSTEIN: Before we talk about what we are going to say, I want to spend a couple of minutes talking about what we’re not going to say, not going to talk about tomorrow, and I don’t think the stuff that we worked on all day today is ready for prime time, for sharing with the rest of the Committee.

I mean, we’ve talked about it for months, but I don’t feel that we have a document or even a position that everybody can buy into, and I don’t want four of saying, “Well, that’s not exactly what we agreed to.”

And so with your consent, I would just like to keep B, today’s topic, off the table.

In my opening remarks, I will discuss the six parts of the report and mention what’s in each one. You know, the title, the topic, that’s in each one. But in terms of reporting out, only D, E and F are in decent enough shape where we’re all in agreement that we can give them an update. Maya?

MS. BERNSTEIN: I thought that the two principles that we just finished discussing were what was going to be the presentation —


MS. BERNSTEIN: — these the two issues that are at the moment intractable and here’s some considerations that go with them. Period.

MR. ROTHSTEIN: To present on B?

MS. BERNSTEIN: Yes. I thought that was going to be the presentation on B, that these are the two things that are difficult. Here’s where some people say this, some people say that; here’s a couple considerations. And that’s the presentation on B.

MR. HOUSTON: We could easily just sort of prime —

MS. BERNSTEIN: Just to get them thinking, that these are things they should be thinking about.

MR. HOUSTON: Say that there were discussions about it. I agree with Maya that it might be good to throw it on the table just in — I won’t say in passing, but in passing to get it on the table so that it’s not a new — it’s brought up anew at the next meeting.

MR. ROTHSTEIN: What about C? C is where we introduce role-based access and contextual access criteria. Shall we mention C?

MR. REYNOLDS: My feeling in general is this will be one of the more controversial letters and subjects —


MR. REYNOLDS: — that we deal with as an entire Committee. I don’t think it’s going to hurt at all — we structured — to let them see the amount of work, the amount of discussion we’ve heard, the amount of discussion we’ve had, the amount of consternation that this creates, the positive consternation, and that we are willing to throw out at least the subjects and the issues on each of these things because if we don’t let them — I’m interested in letting them see the process.


MR. REYNOLDS: I’d do the same thing if I was doing Standards.

I’m interested in letting them see the process and letting them see — you know, us wringing our hands at times, because when it finally comes in for review by the Committee, it’s not going to be a drill. It’s going to be — I mean, this is going to take some oomph. But don’t underestimate that we’re together.

I mean, that’s one thing we agreed to do is clasp hands around this table when we go in there. Don’t think we’re not together and don’t think that we’re not going to be adamant about why we’re recommending what we’re recommending.


MR. REYNOLDS: We’ll discuss it, but it’s not necessarily going to be another 120 hours worth of testimony or anything else.

MS. BERNSTEIN: It may get them thinking about things outside the meeting and talking to people who they work with and so forth. I think the hard thing —

MR. ROTHSTEIN: All right, I’m persuaded. I’m just disposed a little bit —

MS. BERNSTEIN: But I think the hard thing,

Mark —

DR. TANG: It’s shell shock.


MS. BERNSTEIN: During the meeting tomorrow —

DR. TANG: Could we do this in 15 minutes to provide the input?

MS. BERNSTEIN: Right. That’s the thing I was —

MR. ROTHSTEIN: Oh, we’re ready to give them —

DR. TANG: No, I mean on this topic. I think you may go topic by topic.

MS. BERNSTEIN: I agree, and that is the part I think, Mark, if you’re going to preside over the discussion of that, the hard thing will be not to dig into the discussion that we’ve been having because that’ll be a lot longer than 15 minutes but to respond by saying, well, on the one hand, A, on the one hand, B, over and over and over. That’s what that’s going to like, right, if you don’t want to —

MR. ROTHSTEIN: How about if we do this? I will give an overview. The overview will be tell them who we heard from and so on. And we’ve been working in six different sections so we’ll skip the first one because it’s just definitions and background stuff and I will read a brief discussion on B, but we’ll set a time limit because it could take up the rest of the day.

And then Paul —

MR. HOUSTON: I can do C.

MR. ROTHSTEIN: — Paul — do you want to do C? Okay, we’ll —

MR. HOUSTON: I can do C and D; I’m not worried.

MR. ROTHSTEIN: All right. I’ll have John do C and D, and then Paul’s going to do E and Harry, F.


MR. ROTHSTEIN: All right, now let’s think about how we want to do this.

I would think that our presentation of the issues should be five minutes.


MR. HOUSTON: Based upon the recommendations.

MR. ROTHSTEIN: Yes. And then give them a chance to ask questions and to weigh in. And then we’ll keep — we’ve got —

MS. HORLICK: Are you talking about having them weigh in on each issue as you do it?

MR. ROTHSTEIN: Yes. But I will — I think that we’ve got five sections, and if we give like 15 minutes to each section —

MS. GREENBERG: Total, with the weighing in?

MR. ROTHSTEIN: Do you have a — Maya?

MS. BERNSTEIN: Yes. My suggestion is just about process, is that perhaps we present it in the same way that we did it here in the Subcommittee, which is, you know, do

the low-hanging fruit first and leave the discussion for B last because it’s very likely to be the most contentious, but if we have to move on the schedule, it will limit the time for discussion.

That means, you know, you don’t want to go off too far on the other ones, but I think they’re going to be less controversial.

MR. HOUSTON: And if we can expedite those conversations.

MS. BERNSTEIN: We could get them through the —

MR. ROTHSTEIN: That’s a good suggestion. I’ll give the overview. Then we’ll go to John to do C and D.

MS. BERNSTEIN: They don’t know what order the paper’s in; they haven’t seen it.


MS. BERNSTEIN: They don’t know what order we’re taking this in, right?


MS. BERNSTEIN: You can take up whatever order you want to do the presentation. We don’t have to do it in the order it’s in the document.

MR. ROTHSTEIN: Okay. So John will go first and then Paul and then Harry and then I’ll go last on B. And maybe we can save a half an hour for B because that’s going to be the most contentious.

MR. REYNOLDS: The only other possibility is they’re going to hear all this new. And is it more having them ask questions of understanding rather than debating the issues? Because we have no chance — I mean, we open any of these for serious discussion, I mean, it’s going — well, I mean, I would expect them to.

MS. BERNSTEIN: Right. And I expect them to.

MR. HOUSTON: If they start debating these points, we’ve just simply got to say questions about what this means.

MS. HORLICK: I was actually thinking that Mark would give an overview of the principles and kind of run down the whole thing.

Then, I know you’ll have questions on each of these and we’re going to go back to them, but let me just put the whole thing in context — because otherwise you’re talking about, you know, control over this before you’ve said they’ll even get education about them. I mean, they don’t even have the whole picture.

MS. BERNSTEIN: We could do education —

MS. HORLICK: This is sort of interesting — I mean, we all know B is the hot issue, but, you know, let them — go back and see what issues they have.

MR. ROTHSTEIN: Oh, see if they can figure that out for themselves.


MR. HOUSTON: Let me say this. I think that — I mean, yes, you provide the overview so they get the basic context. And I absolutely agree with Harry.

But then we start going through, sort of using the recommendations as the framework for discussion, but simply describe what the recommendations are and a little back of a background behind it and just focus on whether people understand what the recommendation is so that they can try to go back before the next meeting and internalize what the recommendations are so when they see the letter, they see the recommendations, they can understand the context, and then we can have some debate.

Now, I will say this. In the next meeting, we’re going to need a couple hours to get this — minimally.

MS. GREENBERG: There is something I wanted to ask you. Is it your goal to actually bring a document to the February meeting?


MS. GREENBERG: That’s another reason for putting it all out there at this one because if you want to bring up article — I don’t mean everything out there, but, I mean, not leaving any — holding anything back, because if

you’re going to bring this letter then —

MR. ROTHSTEIN: How about if we separate the full Committee discussion in the following ways? After each of us gives our five minutes about what’s in our section, say, okay, the floor is open for questions that you need to ask us to understand this for clarification, or information questions, and only if those are addressed and there’s time left, then we’ll say, okay, the floor’s open for discussion to add your views or whatever.

MR. HOUSTON: I’ve only got one thing and I think it’s important. We need to find a moderator, like Marjorie, or somebody, who can sit on the — disinterested, not even listening to the conversation for substantive purposes but be willing to sit there and say, “Stay away from the details” because we’re going to get involved, I think, and start getting defensive or start to describe and talk about nuances.

We need somebody who’s willing to stand on the side and say “we’re not here to go into this; let’s go back for more questions about –“

MR. ROTHSTEIN: Well, I think that’s Simon’s role, really.

MS. GREENBERG: It is Simon’s role.

MR. HOUSTON: But Simon’s part of it — well —

MS. BERNSTEIN: The problem is, well, Simon

hasn’t been here, which has advantages and disadvantages, actually, because he hasn’t heard this part of the discussion. But he also hasn’t heard all the previous debate basically for the last couple of meetings, really.

MR. REYNOLDS: Or another way to do it is have somebody else on the Committee and you be the moderator.

MR. ROTHSTEIN: Well, I think we’ll just the ground rules here. Everybody knows that this is very complicated stuff. We’re not going to be able to get into all the details. And if you start going onto too many sort of small issues, I’m sorry I’m just going to have to just cut you off.

MS. BERNSTEIN: We have to cut you off, Mark. [Laughs.]

MS. GREENBERG: I hope you’re going to have some more either meetings or conference calls or whatever between now and February.


MS. GREENBERG: So I think also if you can lay that out and say if there are any members who, you know — and you know what you’re going to be discussing at each one —

MR. HOUSTON: We could do that. We could set up —

MS. GREENBERG: We could say, you know, if any of you — if anyone really has some strong feelings about these or feel they have something to contribute, et cetera, then I would welcome them to come to the meeting.

MR. HOUSTON: Marjorie, take it one step further. You know, CMS has these open forums. We could say we’re going to hold an hour conference call available to Committee members on each one of these sections to specifically discuss it so that we can get around some of those issues, to get at the issues.

MS. GREENBERG: I think that might be a bit much.


MS. BERNSTEIN: The scheduling will be —

MR. HOUSTON: But if you say the meetings will be then a half-hour — a half-hour for this section, half-hour for this section —

MS. GREENBERG: If you start doing that, I think we probably should probably make them open to the public and that gets really complicated.

I mean, I don’t mind doing one, but not five.

MR. HOUSTON: But somehow we need — I agree with you. Before we get back together in — was it February, you said?


MR. ROTHSTEIN: I don’t think a conference call is the appropriate vehicle for this because you can’t see people jumping in —

MR. HOUSTON: But, Mark, the problem is if we’re going to get it back in February with hopefully the final work product that we’re going to want to have members sign off on, to try to do a two-hour — it’s going to be a free-for-all to try to get some of these issues vetted.

I think we have to be practical. We’ve got to say, okay, we’ve got to try to flush out the major issues before we get into final drafting in preparation for that meeting so that when we get to the final meeting, hopefully the members will have had an opportunity to say their piece if they have major concerns, we’ve had a chance to try to address it so that we’re not redrafting and trying to get it passed all in one two-day session.

I think we’ve got to get — we’ve got to set ourselves up so that we’re trying to get the final product through in that February Committee hearing.


MR. REYNOLDS: We had part of this discussion on the Executive Committee. The whole Committee structure is set up so that people spend the time and the effort to look at these things.


MR. REYNOLDS: To look — to deal with these things.


MR. REYNOLDS: I mean deal — many, many hours. I mean, we did e-prescribing forever last year.

And when the letter came — I mean, the point is, yes, this is an emotional subject, but everything we bring in from now on is going to be big. And I think if we turn it into a dramatic open discussion, we’re going to blow it up again.

I mean, I’ll tell you what: It’s going to blow sky high because privacy is real personal, privacy is real structured, and people haven’t heard the 120 hours of testimony plus all of our sessions and everything else.

So we’re taking a recommendation forward. I don’t think we’re reopening it for a whole let’s take it apart and —

MR. HOUSTON: But in advance of that, we need to have —

MR. REYNOLDS: What are you trying to answer for?

MR. ROTHSTEIN: That’s the way it ought to be in theory, but there’s no stopping —

MR. HOUSTON: February is not going to cut it then. If we bring a final work product in February, it’s going to be the next meeting before it goes through. I just know it, because we’re —

MS. GREENBERG: It may be.


MR. HOUSTON: But my point is I think what we talked about a while ago was that if we don’t have the — remember, the original deadline was if we don’t have this done by the end of the year, this might be a stale issue.

Now, I’m going to say we’re not going to get it done by the end of the year, obviously, but if we don’t get it done in February and it lingers off to March/April, this all could become very, very stale and we’ve done a lot of work and we —

MR. ROTHSTEIN: Can we go off the record for a second?


(Brief discussion off the record)

MS. GREENBERG: Are we still off the record?


MS. GREENBERG: Oh, well. But anyway —

MR. ROTHSTEIN: We can be, if you want to be.

MS. GREENBERG: Well, to some degree, the Subcommittee just was ambivalent and couldn’t kind of fully bring their recommendations together.

MR. HOUSTON: They should never have brought it forward then.

MS. GREENBERG: Maybe they shouldn’t have. But, I mean, you thought you had agreement and then you didn’t have agreement. You had — you know, you brought it forward and then somebody is coming from who knows where saying, you know — who you thought was part of the process — who is not.

So this can happen. But I would say — I would put it a different way. I really think this is the role of the Chair, the Chair of the Committee.

And so I do think it’s a discussion for the Executive Subcommittee because I actually don’t agree with a statement that the full Committee should be showing more deference to the Subcommittees. I think it’s the role of the Subcommittee to really make their case. And if they haven’t really made it or they’ve missed something or they’ve assumed a certain level of acceptance or understanding that wasn’t there, then they’ve got to go back to the drawing boards.

If, on the other hand, the Chair lets people who’ve heard this before just keep, you know, riding the same horse or — and doesn’t set limits for a certain — you know, almost like harassment, which we’ve had that. We haven’t had that recently, but we’ve had a form of almost harassment. Then I think that’s the Chair’s responsibility.

And I have seen the Chairs sort of make it clear sometime “we’re going to approve something at this meeting on this subject,” and — you know. And then generally you get past it.

So I don’t really think that they need to be

showing deference. But I think that, you know, there’s a point at which you just have to move on.

So I observed, for the most part, when something really runs into trouble with the full Committee, it wasn’t sufficiently thought out or explained by the Subcommittee. But also, there are times, I assure you, when I want to jump in if the Chair isn’t by saying, you know, “let’s move on here,” .

So, I think, you know, everyone serves on something, on some Subcommittee. So I think people are aware of the amount of effort and time it takes to sit through the hearings and to sit through all this.

But even the new FACA arrangements make it even clearer that really it’s the Committee that is making recommendations and it is the full Committee that must be listened to, not the individual Subcommittee.

So I think that’s just reality.

MS. BERNSTEIN: My sense — you know, maybe I haven’t been so much privy to what the other Subcommittees are doing, but it’s my sense that the problem that this Subcommittee will have in particular is that the nature of the topic is something that everybody knows about because everybody’s a patient.

Some of them are also providers or have other, you know, access in their professional role to patient information, unlike Standards or Populations or other parts where there’s a particular subject matter expertise, you know —

And I consider myself and Mark, whatever others, subject matter experts on privacy concepts and policy and whatever, but everybody — it’s easy to explain to people about their own data, it’s easy for everybody to have an opinion, and I think that’s why I was sort of throwing up my hands at what Harry was saying because it’s going to bubble up. I mean, people are going to want to talk about this. It’s going to generate a lot of discussion.

We’re going to have to go over a lot of this stuff again.


MS. BERNSTEIN: And I — you know, two hours — it’s not going to happen in two hours.

MS. GREENBERG: Well, Harry can kick me if he wants to but — you’re close and you’ve got long legs there, but I sometimes think the Committee shows too much deference to the Subcommittee on Standards and Security because they just don’t understand these issues.

MR. REYNOLDS: Or, we might be good.


MS. GREENBERG: But I also think you are very careful about — you know, by the time you get everything out there. But also —

MR. ROTHSTEIN: No, and I don’t know Standards and Security, and if they tell me that’s the way it is —

MR. HOUSTON: That’s just Standards and Security. Populations — if you’re one of those that really enjoys populations, that’s great stuff, but it’s — I think it may be lost on a bunch of us.

MS. WATTENBERG: Committee members may be affected by privacy issues. It doesn’t mean they have a level of expertise that the Subcommittee does because they haven’t heard the issues, they don’t — you know.

MS. BERNSTEIN: I totally agree with that.


MS. BERNSTEIN: But I also think that’s — but that’s also part of what I think —

MS. WATTENBERG: To fill the full Committee on is to say you may have opinions about it, but we’re the people who’ve heard the testimony, we’re the people who’ve made it our business to be the experts. And that may be part of the group dynamic management that Marjorie is talking about.

MR. ROTHSTEIN: Okay, I’ll take the prerogative of the Chair to move to another topic before we run out of time, and that is: What should we do in our meeting Thursday morning from 8 to 9:50.

DR. TANG: I still wanted to vet my thoughts on E to make sure that they’re on tune because I’m not sure, because I don’t recognize some of the changes that were not made —

MS. GREENBERG: The changes that were not made?

DR. TANG: I thought we discussed some of the things but they’re not —

MR. ROTHSTEIN: On secondary uses?

DR. TANG: Yes.


DR. TANG: I just want to make sure I’m in tune with these so I can sing your song.


DR. TANG: So without going into detail, which I can go into with someone, there’s a lot of stuff — well, here’s my distillation; see if this floats your boat:

The point of this section is that we believe that the uses of data should be used — okay; here’s the way I say it: Use of data for purposes other than direct patient care, i.e., secondary uses, can be valuable but poses privacy risks. That’s a principle, or a statement.

Second, the HIPAA privacy regulation has loopholes, namely, it does not cover those. It does not apply to non-covered entities.

MS. BERNSTEIN: You might want to pick another word than loopholes.

MR. ROTHSTEIN: It’s at the very bottom of page 11.


DR. TANG: Yes. And then so the recommendation then — that’s not consistent with what we have here, was just as the reason that we would need uniform and comprehensive privacy and confidentiality laws.

Now, I realize that concept is also stated in another section. So the way it differs from here — or among the ways it differs from here is I don’t know where we got this marketing stuff, or why we’ve picked on this marketing thing to be the recommendation.

MS. BERNSTEIN: There were a list of recommendations that were separate from the whole document. Originally, there was a long list at the end of all the recommendations, and I just tried to match them up with the section that they went into.

DR. TANG: So I —

MS. BERNSTEIN: We haven’t actually talked about whether we’re missing recommendations or whether there are — these are the right recommendations that match the thing and so forth.

MR. ROTHSTEIN: (?) 17, good.

DR. TANG: That was one of my hang-ups. I mean, I had no idea where that came from and —

MR. ROTHSTEIN: The recommendations are just —

DR. TANG: Okay. So, well, I mean, when you said we’re going to —

MS. GREENBERG: So you’re not going to have any recommendations in this area?



MR. HOUSTON: We’re going to talk about the body of the letter tomorrow, right?

MR. ROTHSTEIN: So how do the principles —

MS. BERNSTEIN: Marketing is a secondary use. That’s the only —

DR. TANG: So how did the principles that I — the summary that I laid out, those three points, sound to you?

MR. ROTHSTEIN: Well, we’re going to talk about — you might want to —

DR. TANG: What else is in there that I missed that —

MR. REYNOLDS: I have a question on your — you mentioned a comprehensive — tell me what you said about the law again.

DR. TANG: Okay, that I thought we need uniform and comprehensive privacy and confidentiality law, okay? Comprehensive means it covers everybody, not just three stand alone groups.

MR. REYNOLDS: Okay, but I — yes, but I think we had zeroed that in a little more about people that dealt with PHR. I guess when comprehensive comes up, when we were talking about things that somebody could get done, when we talk about a comprehensive privacy law, it starts sounding a whole lot more than we were really focused, that anybody —

MS. GREENBERG: Basically, you want coverage of anybody —

MR. REYNOLDS: Anybody that touches PH —


MR. REYNOLDS: So I thought we were a little more prescriptive rather than saying we need this huge, comprehensive —

MR. ROTHSTEIN: Well, the other thing — we think that it should be a more comprehensive or integrated or unitary system or something like that. But that’s covered elsewhere.

MR. REYNOLDS: I understand.

MR. ROTHSTEIN: What E says is we’re talking about secondary uses — that is, uses of PHI by employers, insurers and so forth.

MR. REYNOLDS: Correct.

MR. ROTHSTEIN: So in the second paragraph of 12, we talk about the ability of holders of PHI to limit disclosure and we have to draw on the other essential element is insuring that if information not relevant to a third party is nevertheless obtained by a third party in a context outside of the health care system, it is not used unfairly to adversely affect an individual’s financial, personal or professional opportunities.

Now, this was the soft way of saying we need legislation protecting against unfair health-based discrimination.

MR. HOUSTON: Right. And I think, again, whether it be contextual criteria to try to limit, that was one of the components of it. But the other component was — this all sort of stemmed from the — what was it? — the compelled disclosure.


MR. HOUSTON: We’ve sort of backed off of that, but the concept is still there.

MS. BERNSTEIN: It’s still in there.

MR. ROTHSTEIN: No, no, we didn’t back off.

MR. HOUSTON: But we put that below.

MS. BERNSTEIN: It’s a different section.

DR. TANG: In the sentence that you just read, first of all, I had some —

MR. ROTHSTEIN: That’s in C.

DR. TANG: The sentence that you read, I have much difficulty in understanding and parsing it and —

MR. ROTHSTEIN: Well, it’s because it was so obfuscated.

DR. TANG: So I just want to make sure I get your point.

But the other piece that’s missing — because you talked about information not relevant to a third party — we are also concerned about information that it is relevant but is re-purposed, and JCAHO is an example of that.


DR. TANG: So my take away message from this was the sense that the HIPAA privacy has whatever the replacement for a loophole is in —

MR. ROTHSTEIN: Has limited applicability.

DR. TANG: Limited applicability.

Okay, that’s what I took. That’s the sentence I have for summarizing that concept.


DR. TANG: So my three concepts were —

MR. ROTHSTEIN: So we’re concerned about the methods or the process or the procedures by which third parties get access to PHI, but that’s what we talk about in C. In D, we’re talking — or E, sorry — in E, we’re talking about the actual use of that information for ways that we think might not be such a hot idea.

MS. BERNSTEIN: I don’t know, but I still don’t get the difference between those two things, I have to say. Secondary users who are not — I mean, the difference between —

MR. ROTHSTEIN: How the secondary users get information, right?

MS. BERNSTEIN: The mechanism by which they get it?


MS. BERNSTEIN: Whether it’s authorization —

MR. ROTHSTEIN: They might get it lawfully by virtue of an authorization, okay?


MR. ROTHSTEIN: And we’re trying to attack that problem by having contextual access criteria so they only get relevant stuff and not all the other junk.

And then what they do with it is in E, sort of you can’t use information to discriminate.

MS. BERNSTEIN: But the contextual part of the

access in the first part is what they’re going to do with it. I mean, the context — those two are inextricably linked, to me. You only know — whose context do you understand by what it is they’re going to do with your information or what kind of decisions they’re going to make.

So I’m still confused about what the difference is between those disclosures.

DR. TANG: Paul isn’t. He’s got it.


DR. TANG: Well, I just wanted — as I say, what I had taken away from it is a bit different than the words on these pages, and I just want to check my presentation.

MR. ROTHSTEIN: Okay. Anything else you want to —

DR. TANG: No, no.

MR. ROTHSTEIN: Nobody’s going to be, you know, tied into or locked into anything that anybody says.

DR. TANG: Under our code! [Laughs.]

MR. ROTHSTEIN: Well, I appreciate that, and I will honor our code by not jumping up and down when you say something that I think is wrong. I’ll just quietly correct it.

Okay, Thursday morning’s meeting, what do you want to — what do you think is the most efficient use of

our time? I can — I don’t have a computer, but Wednesday night I could take a crack at writing a draft of Section B, of a new Section B in accordance with the principles of B spelled out today, or I could —

MS. BERNSTEIN: On Wednesday night?

MR. ROTHSTEIN: Either Wednesday night or maybe there’s some time Wednesday afternoon I could do it.

MS. BERNSTEIN: We’re not going to have time to review it between Wednesday night and 8 A.M. on Thursday morning.

MR. ROTHSTEIN: No, that’s what we’re going to do Thursday morning. We’re going to talk about it.

MS. BERNSTEIN: Right. But, I mean, you draft a new section. We will not have read it before 8 A.M.



MS. HORLICK: So then we’ll read it together.



MR. ROTHSTEIN: Okay, I’m open to other suggestions about what you all —

MR. HOUSTON: One thought that you might want to consider. I had a chance to sit down with Susan today and Linda Sanchez and talk about some of the data that they compiled with regards to complaints.

And I think it might be worthwhile to sit down and discuss through the data that they have available to us and whether we would like for them to maybe run some reports to help us identify whether there are specific provisions of privacy that we should focus on because of the type of complaints that OCR is receiving.

I don’t know how long of a conversation that would be, whether that’s only 15 or 20 minutes or whether it’s longer, but it might be helpful to get a request in.

MR. ROTHSTEIN: I’m happy to add that to the agenda. We could do that first or whatever.

But I think we need to spend the bulk of our time Thursday morning on some aspect of this —

MS. BERNSTEIN: But I’m not suggesting that we don’t —

MR. HOUSTON: But the reason why I want to put it on the table now is because Susan said it might take some time on their behalf to get the request actually addressed, so if we asked them if they’ve got something now, it might take until the next meeting or after to get it done, so —

MR. ROTHSTEIN: 8:05, after we have the introductions? You’re on.

MR. HOUSTON: That would be great.

MR. ROTHSTEIN: Okay. Harry?

MR. REYNOLDS: The other thing — back to our

earlier discussion about the full Committee. After tomorrow, you could offer that any full Committee member that has any questions that they would like us to address when we get together in the next day and make sure they got with one of us, gotten at least back to the idea of starting to — if somebody gets fired up on something, let’s hear it, let’s see it, and let’s go ahead and start the discussion.

MS. GREENBERG: If you’re not on quality and —

MR. REYNOLDS: Right. So I just think because, you know, most of us are going to dinner tomorrow night so they can catch any member of the Committee and then we can make sure that at least we would get a sense of where people are falling out.

MR. HOUSTON: You know, we also have another advantage here, too. If we start at 8 o’clock before the other Committee, we see Work Group in Quality comes in, so — I’m sorry; Populations and Quality are at 8:30.

In theory, we could leave a half-hour at the beginning of Friday morning if people wanted to come in and talk to me directly, for those people that are on those two Subcommittees. For individuals who are on Security, they could come in just before the meeting and if they had some issue that they wanted to discuss, and then we could sort of fit this discussion in doing the reports.

MS. BERNSTEIN: So if everybody wants to show up at 8 to come and —

MR. HOUSTON: They could either show up at 8 if they’re on the Populations or the Quality Subcommittee, and they’d have a half-hour.

MS. BERNSTEIN: That’s not a bad idea.

DR. TANG: So you’re suggesting that the Thursday meeting is an open forum meeting?

MR. HOUSTON: 8:30. The only reason why I said 8:30 is because Quality and Populations start at 8:30. We start at 8.

DR. TANG: Right.

MR. HOUSTON: So that gives them a half-hour if they really wanted to say something.


MR. HOUSTON: Now, if someone was on Standards and said, hey, listen, I’m not coming till before 10 because we don’t have anything before 10, they could come at 9:30.

But nonetheless we would have the opportunity during some period during this meeting to hear and discuss issues that maybe people had from the day before. We could still fit in the discussion that we wanted to have about Section B, and I think we just spend a few minutes talking about the —

MS. BERNSTEIN: That doesn’t cause us any problem.

MS. CHRISTIANI(?): We could schedule the meeting at 4433. If everyone shows up, it could possibly be a thing —

MS. BERNSTEIN: No, that’s not going to happen. It’s a very big room and it’ll fit — we were in the room last time. There’s plenty of chairs in that room.

MR. HOUSTON: I mean, I don’t think everybody’s going to show up, but I would —

MS. BERNSTEIN: No, that’s a good idea. We don’t have any problem with that.

MS. GREENBERG: We already are here to be meeting at 8 o’clock.

MS. BERNSTEIN: Yes, okay.

MR. ROTHSTEIN: Okay, everybody know what we’re supposed to do? Maya?

MS. BERNSTEIN: What was I going to say?

MR. HOUSTON: Simon’s presenting tomorrow?

MS. BERNSTEIN: Oh — about whether you should, you know, spend your evening on Wednesday drafting a new draft, whether — all I was saying is not whether we should —

You should go to dinner, because we’re not going to have an opportunity to read it, and the wording itself,

I still don’t think by Thursday morning, I think we’re going to be in the same boat that we’re now —

MR. HOUSTON: Well, what we could do is —

MS. BERNSTEIN: I don’t think it’s worth it to give up your night doing that.

MR. ROTHSTEIN: We’ll move to different sections. We’ve got plenty of work to do on C, D and F and to just go over the language.

MR. REYNOLDS: And if we don’t have anybody coming and asking questions.

MR. ROTHSTEIN: We’ll work on C, D.

MR. HOUSTON: That’s great.

MR. REYNOLDS: Okay, let’s move on.

MS. BERNSTEIN: You could be here Wednesday night, frankly, and we’re going to need time to really fix a lot —

MR. ROTHSTEIN: Yes, I know.

MS. BERNSTEIN: — as fast as you are.

MR. ROTHSTEIN: That’s fine.

MS. BERNSTEIN: I’m recommending that there are better ways to spend your evening.

MR. REYNOLDS: Hey, Mark?


MR. REYNOLDS: Yes, and when they say stuff at dinner —

MS. HORLICK: I don’t know if there’ll be time to discuss any future meetings or conference calls during the breakout or did you want to hold off on that?

MS. BERNSTEIN: Yes, actually, can you — given the trouble we had last time just scheduling conference calls and whatever, would you circulate one calendar that we can pass around?

MR. ROTHSTEIN: For December, January —

MS. BERNSTEIN: December, January and February to, you know, March, if we have to. But, I mean, the longer we have in advance —

MR. HOUSTON: Yes, I think we should shoot for a meeting in December and January.

MS. BERNSTEIN: And January, at least one. Or two in January.

MR. HOUSTON: Or at least a conference call.

DR. TANG: Should we do it interactively or it seems to me your meeting request probably is actually harder than trying to interactively —

MS. BERNSTEIN: Well, last time we just had everybody fill in.

DR. TANG: I know. But you had that little problem. You can’t show any flexibility when you do it that way.

MR. HOUSTON: Another question I have, too, is

about meetings. I mean, if we have a conference call versus a meeting, you know, Mark, and I and what’s this guy’s name?


MR. HOUSTON: Harry. We sit here in person and, you know, Simon and Paul were out.

MS. BERNSTEIN: It’s a burden on —

MR. HOUSTON: The question is you guys want to have a common meeting place out there and we be here or —

DR. TANG: (?) time.

MR. HOUSTON: Well, Paul, I like you, but — we could pass something later, but —

MS. BERNSTEIN: We can meet in Kansas City then.

MR. HOUSTON: — Paul was driving and you were doing something and —

MS. GREENBERG: We budgeted the Committee to meet on a monthly basis.

MR. ROTHSTEIN: Right. We can do a December conference call at which time there should be a draft Section B to discuss, and then we’ll see whether we maybe have a — maybe we could meet a day before the February meeting, have a conference call in January, work out something like that so that we don’t have to make special trips.

MR. HOUSTON: I’m just thinking we talked about I think we lost some of the quality. We sort of lost some of the interaction there the last — when you and I and Harry met because, you know, Paul and Simon were out.


MR. HOUSTON: And that was something that, you know — I think it’s important that we all have as much face time as we can, or at least have as much quality time as we can.


MS. BERNSTEIN: Do we have the next coming year’s meeting schedule? This looks like the last year’s meeting schedule.

MS. GREENBERG: On the back.

MS. BERNSTEIN: This is the coming year. And so we have no Subcommittee meetings scheduled at all?

MR. ROTHSTEIN: That’s right.

MS. BERNSTEIN: So the other thing is whether we could — if NHII or Standards or whatever is meeting at some point, whether we could — we have overlap on those Committees — whether we would save time, money, whatever, by meeting at the same time as those meetings. One and a half days, one and a half days, or something.

MR. ROTHSTEIN: Maybe we can indicate that on the master schedule that we’re passing around.

MS. BERNSTEIN: We’re looking for a time when

both groups can meet so that people don’t have to travel twice.

DR. TANG: Harry, does the Standards and Security Subcommittee have 2006 meeting dates?

MR. REYNOLDS: Yes, we’re polling them right now.

MS. BERNSTEIN: Right. So —

MR. ROTHSTEIN: Let me just check February. The February meeting is the 22nd and 23rd.

MS. BERNSTEIN: That’s right.

MR. ROTHSTEIN: So we could meet on the 21st.

MS. BERNSTEIN: Which is what day of the week?


MS. GREENBERG: Yes, you could meet on Tuesday.

MS. BERNSTEIN: Is that the short week?

MS. GREENBERG: The Monday is the holiday.


MR. ROTHSTEIN: Does that make it — is that bad or —

MS. GREENBERG: It’s not the kind of holiday that people probably mind traveling on that much.

MS. BERNSTEIN: Unless you ski. A good holiday to ski.

DR. TANG: It’s February 21st.

MS. BERNSTEIN: Okay. That’s a bad week for you anyway, then.

DR. TANG: It is a bad week.

MS. BERNSTEIN: So you don’t want to come in and get out of here as soon as you can, then.

MR. HOUSTON: What’s that week?

MS. BERNSTEIN: It’s spring break.

MR. HOUSTON: Maybe you want to be away. Bring ’em to DC.

MS. BERNSTEIN: Yeah, bring ’em to DC.

MR. HOUSTON: Yeah, what a great experience.

MR. ROTHSTEIN: All right, we’re going to meet then.

MS. GREENBERG: You’re going to meet on the 21st?


There’s a motion on the table to adjourn.

DR. TANG: There’s nobody left to second it.

MS. BERNSTEIN: Is there anything that you need from me for tomorrow or Thursday’s meeting that I can do between now and then?

MR. ROTHSTEIN: No. I’m going to work tonight on what we’re going to do tomorrow.

Okay, thank you all.

MS. BERNSTEIN: Thank you very much.

[Whereupon, the meeting was adjourned at 5:10 P.M.]